CN109862937A - System and method for electro photoluminescence anal orifice and rectal intestine structure to treat urinary dysfunction - Google Patents

Abstract

A kind of system and method for treating anal orifice and rectal intestine and/or Genitourinary dysfunction include being implanted into electric medical device in a minimally invasive manner, for stimulating two or more dissections or institutional framework in anorectal areas and/or genitourinary area.The electrode for being operatively coupled to device is positioned close to targeted anatomic or institutional framework.Device provides identical or different stimulation algorithm for each dissection that can be identical or different or institutional framework.Limit the stimulation parameter (such as pulse width, impulse amplitude and pulse frequency) of variation, so that abdominal pressure reveals pressure, abdominal pressure amount of leakage or urine volume increase or incontinence number or the average incontinence amount of each incontinence reduces relative to the parameter before electric pulse application after electric pulse application.

Description

System and method for electro photoluminescence anal orifice and rectal intestine structure to treat urinary dysfunction

Cross reference

The application is entitled " the System and Method For Electrical submitted on March 20th, 2016 The United States Patent (USP) Shen of Stimulation of Anorectal Structures To Treat Urinary Dysfunction " Please No.15/075,164 part continuation application, the part continuation application dependent on March 20th, 2015 submit it is entitled “System and Method For Electrical Stimulation of Anorectal Structures To The U.S. Provisional Patent Application No.62/136,389 of Treat Anal and Urinary Dysfunction " and require its excellent First weigh.Entitled " the System and Method that U.S. Patent application No.15/075,164 or on March 7th, 2014 submit for Electrical Stimulation of Anorectal Structures to Treat Anal Dysfunction” U.S. Patent application No.14/201,659 part continuation application, the part continuation application be on 2 21st, 2012 submit and The U.S. Patent application No.13/400 of the same title of United States Patent (USP) No.8,706,234 bulletin is pressed on April 22nd, 2014, 868 continuation application.

The application further relies on entitled " the System and Method For submitted on August 25th, 2016 Electrical Stimulation of Anorectal Structures To Treat Urinary Dysfunction” U.S. Provisional Patent Application No.62/379,612 and require its priority.

All above-mentioned patent applications are all incorporated in herein by quoting.

Technical field

The method and apparatus that this specification generally relates to gastrointestinal tract electro photoluminescence.More specifically, this specification is related to using Anus function is treated in by submucosa or muscular layer of mucosa to rectum or anal sphincter or muscularis propria carrying out electro photoluminescence The method and apparatus of energy obstacle.This specification is further related to for by gluing to rectum, anal sphincter or other anal intestine structures The method and apparatus that film lower layer or muscular layer of mucosa or muscularis propria carry out electro photoluminescence to treat urinary dysfunction.

Background technique

Incontinence of faces refers to unconscious release gas or liquid manure (mild incontinence) or unconscious release solid excrement Just (heavy incontinence).Investigation shows 2 to 7 percent influence by incontinence of faces of total population, but because many people are ashamed of The problem is discussed with medical supplier, practical disease incidence may be much higher.

Slight incontinence of faces similarly influences men and women, but woman is several in terms of a possibility that reporting heavy incontinence It is two times of man.Incontinence of faces is also more common in the elderly.It is common especially in home for destitute, research shows that almost one There are gatism in half home for destitute.Incontinence of faces can destroy self-confident, formation anxiety and lead to society isolation；However, stool Incontinence is a kind of medicable illness.Treatment can in most cases mitigate symptom and can usually cure incontinence completely.

The self-control of stool and urine needs the normal function of both lower digestive tract and nervous system.Around alimentary canal end Anal sphincter and bone Pelvic floor ensure the controlled motion of alimentary canal content.There are many possible incontinence of faces reasons. In most cases, caused by incontinence is some combinations of these reasons.

The treatment of usual three types can be used for incontinence of faces: drug therapy, biofeedback therapy and surgical operation.Medicine Object treatment includes medication and certain measures, can reduce the frequency of incontinence and stablize excrement, this can reduce or eliminate excrement leakage Generation.In general, basic measures can improve mild incontinence, but it may require that more radical measure to control frequent or serious attack Leakage.Facilitating the dilatant (bulking substance) of more bulk excrement can contribute to by making excrement thicken To control diarrhea.Methylcellulose (a form of fiber) is a kind of common dilatant.Increasing dietary fiber can also be with Help to make excrement blocking.Such as antidiarrheal agent as LOPERAMIDE HCL and Diphenoxylate can reduce stool frequency and be beneficial to control Treat incontinence of faces.LOPERAMIDE HCL can also increase the robustness (degree of packing) of anal sphincter.At some, taken between meal When, cholinolytic object (such as prescription medicine hyoscyamine) can reduce the incontinence occurred between meal by reducing the contraction in colon.

Biofeedback therapy is a kind of safe and noninvasive mode of re -training muscle.During biofeedback training, Sensor is used to help patient and identifies and shrink the anal sphincter for helping to maintain automatic control.This is usually medical supplier or reason It is completed in the office for the treatment of teacher.Although result may be different, biofeedback therapy is successful.Most probable has benefited from this The people of class therapy is the people that can be shunk anal sphincter and have some feelings when they need to carry out defecation.Biofeedback therapy Effect can fall into a decline within six months after initial training and re -training can be beneficial.

For 40 to 75 percent people complete for anal sphincter, recommending nerve electric stimulation can stop a leak.Electrode The nerve in rumpbone is inserted into nearby (lower rear portion) by modus operandi.Imperfectly understand how rumpbone nerve stimulation works. Treatment be it is invasive, need surgical operation to be implanted into.Some patients form complication, including the event of pain, device because of surgical operation Barrier or infection, this may require that removal or more changing device.Currently, this therapy is generally used for complete or repaired anus Sphincter but fail the people to make moderate progress by other treatment.

The electro photoluminescence of anal sphincter is related to stimulating anal sphincter using weak current, so that it shrinks, this can be at any time Between tone up the muscles.Apply electric current using the small probe being inserted into rectum by patient, is carried out several minutes daily within 8 to 12 weeks.It is right According to experiments have shown that unique some advantages of electro photoluminescence are can to can increase the feeling of anal regions；But this therapy is not held high It is expensive, it is noninvasive, and few side effects.But it is very uncomfortable for the undesirable patient for being frequently inserted stimulating apparatus.

Some different surgical procedures can help to alleviate incontinence of faces.Surgical revision can reduce or solve to lose Prohibit, especially during childbirth the woman of external sphincter muscle of anus tearing and due to surgical operation or other reasons make sphincter by The people of wound.Surgical operation can allow the incontinence of faces of percent 80 woman with related sphincter tearing of giving a birth to be cured.

There is the people of irrecoverable damage for sphincter, it can be from other regions (usually leg or buttocks) of body Muscle is transplanted, and is placed in around anal canal by operation.These muscle imitate the movement of damage sphincter.Muscle transplantation operation can allow Percent 73 people with irrecoverable damage restores automatic control.The alternative for transplanting muscle is artificial anus hoop (anal Cuff it) may expand to bottle up excrement and collapsible to allow defecation.However, this class process is only capable of executing in specific department centers.Logical Cross when expert executes these operations or even can occur complication.

Colostomy is a kind of surgical procedure, and wherein colon is attached to stomach wall by operation.Excrement is collected in the skin that reclines In the sack of skin assembly.This eliminates excrement and leaks from rectum.The variant of process can permit people and control intestines emptying.Colostomy is logical It is often the last resort after other treatment fails.It can also be to being not desired to attempt any other therapy and symptom can not be endured People consider use the art.

Onuf core (Onuf's nucleus) is one group of uniqueness neuron in the abdomen of the anterior angle in people's vertebra sacrum area. Onuf core be related to maintain urination and defecation automatic control and climax during contraction of muscle.The core contains motor neuron and private parts mind From source.The sacrum area of vertebra includes Section of four vertebra in vertebra.Group's nerve cell is between S1 and S2 or S2 Between S3 and it may extend into the tail end of first segment rumpbone or extend to the middle part of third section rumpbone.Onuf core is in ventral horn two sides It is almost symmetrical.In animal, core is located in neuropilem and averagely there is 300-500 in left ventral horn and right ventral horn the two A neuron.There are average 625 neurons in backbone two sides in people, this is measured in the range of every side about 4-6mm in total 's.Onuf core includes motor neuron, its main feature is that multipolarity and big tigroid body.Onuf core is for rectum and sphincter urethrae Striated muscle innervation origin.The neuron of Onuf core is responsible for controlling the external sphincter of anus and urethra in human body. Onuf core also can control the ischiocavernosus and bulbocavernosus for playing male's yin channel erection and ejaculation function.Back inside is sub- It checks rectum striated anal sphincter and carries out innervation, and groupuscule is connected to striated urethral sphincter on the outside of abdomen.The movement of Onuf core Neuron carries out innervation to the striated muscle system (striated anal sphincter) of the spontaneous control of energy.Neuron in Onuf core lacks autonomous Large dense-cored vesicle (even if they receive identical joint conference's nerve endings as A-MN).In motor neuron disease In disease/amyotrophic lateral sclerosis, Onuf nucleus has cytoskeleton identical with A-MN abnormal.With urination and Disease with the characteristics of defecation imbalance similarly influences vegetal cell and Onuf nucleus.Both cell types are not by amyotrophia Lateral schlerosis influences.Onuf nucleus anatomically connect with sacral parasympathetic nervimotion neuron and has many peptides Nerve tip.Cell similar plants in Onuf core are neural and not incoming from neighbouring neuron reception.

Motor neuron in Onuf core includes thrombocytin (5-HT)) and norepinephrine (NE) receptor and mediator is close Collect array and is activated by glutamate.When 5-HT and NE receptor is stimulated, defence sexual reflex occurs, to prevent because unexpected Abdominal pressure causes bladder drainage.

There are three layers of muscle, are used to control the urine flow by urethra: the internal layer of longitudinal smooth muscle；In annular smooth muscle Layer；The referred to as striated muscle outer layer of striated urethral sphincter.By the sympathetic nerve of peripheral nervous system, parasympathetic nerve, Urethra is controlled with body cell part.From stomodaeal nervous system preganglionic neuron, (it is located at along hypogastric nerve for sympathetic nerve domination In upper spinal column marrow) and terminate at the longitudinal direction in urethra and annular smooth muscle layer.Secondary friendship of the parasympathetic nerve distribution in sacrum marrow Feel preganglionic neuron and also terminates in longitudinal and annular smooth muscle layer.Finally, urethra of the somatic nerves distribution in Onuf core Sphincter muscle neuron.The nervus pudendus extended from Onuf core is directly connected to striated urethral sphincter, to control urination.

Cause the reflection of sympathetic nerve urine storage or pelvis-hypogastric reflex in distended bladder.It upholds receptor and makes neuromere Neuron release norepinephrine (NE) afterwards.NE loosens bladder and makes urethral contraction, thus prevents urine from losing.In people Cause the reflection of body urine storage or pelvis-private parts or defence sexual reflex when laughing, sneeze, coughing, this increases bladder pressure. Glutamate is the major excitatory mediator for reflection.Glutamate makes asparatate (N-methyl-D- ) and AminomethylphosphoniAcid Acid (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic aspartame:NMDA Acid:AMPA) receptor activation generates action potential.These action potentials start the release of acetylcholine, so that urethra band Sphincter filament contraction.When defending sexual reflex that cannot correctly function, stress incontinence occurs.

Parasympathetic nerve and stomodaeal nervous system form pelvis in the cross side of rectum before reaching bladder and sphincter Neuropile.Sympathetic nerve path is originated from T11-L2 (sympathetic nerve core；Lateral column among the spinal cord of grey matter), inhibit body of urinary bladder and makes Bladder base portion and proximal urethra sphincter are excited.Parasympathetic nerve is originated from S2-4 (parasympathetic nerve core；The spinal cord medial side of grey matter Column) so that Bladder Irritation and urethra is allowed to loosen.Body of sacrum path is derived from S2-4 (Onuf core；Ventral horn), it forms nervus pudendus and is Band sphincter urethrae provides innervation.Nervus pudendus from S2-4 makes distal end band sphincter urethrae excited.Outflow Effect (efferent action) includes nerve after the parasympathetic ganglion being located in detrusor parietal layer and pelvic plexus Member discharges excitatory transmitter acetylcholine.The activation of pelvic nerve causes body of urinary bladder to shrink, and contributes to bladder emptying. Sympathetic nerve inputs to bladder and urethra and provides the excitability and inhibition input of norepinephrine energy.The activation of hypogastric nerve Cause the relaxation of body of urinary bladder and the contraction of bladder outlet and urethra, in bladder urine storage contribute.The activation of nervus pudendus So that band sphincter urethrae is shunk.Incoming aixs cylinder (afferent in pelvic nerve, hypogastric nerve and nervus pudendus Axons) also from lower urinary tract to spinal transmission sensory information.Incoming pelvic nerve includes myelin A δ fiber and unmyelinated C fine Dimension, the A δ fiber alleviate the sensitive normal voiding that gradually expands to bladder, which does not expand bladder under normal circumstances It opens and makes a response.It is quick including spinal cord injury, chemocepter and power from bladder and urethra under the conditions of various pathological Perceptual nociceptor becomes hyperactive, and will cause exagger bladder and the urinary incontinence.

Outflow parasympathetic nerve aixs cylinder in the neural preganglionic neuron in sacrum marrow is across pelvic nerve and in pelvis Cynapse is formed in neuropile.When postganglionic neuron is main cholinomimetic but they also may include purine, peptide and nitrogen Serotonergic neuron.Postganglionic neuron to force urine smooth muscle carry out innervation.From the incoming sensory nerve for forcing urine smooth muscle Mediator includes glutamate, neuropeptide and nitrogen oxides.Hypogastric nerve includes sympathetic nerve postganglionic fibers, mainly removes first kidney Upper parathyrine, but it is also possible to purine and peptide, and mainly smooth to longitudinal direction and annular in neck of urinary bladder and proximal urethra Muscle layer carries out innervation, has sub-fraction to carry out innervation to detrusor.Nervus pudendus provide striated urethral sphincter with And the efferent nerve domination of external sphincter muscle of anus and some perineum muscle.Women levator ani is not dominated by nervus pudendus, but by To the domination for being originated from sacral nerve roots (S3-S5), and at the distribution of the upper surface of pelvis bottom (levator ani nerve).

Being normally defined and being unable to control the urinary incontinence that urine passes through is relatively common obstacle, especially in women.It is right It is the unfortunate problem that a kind of pair of quality of life has profound influence for many people.The urinary incontinence is nearly all that gene basis can be controlled Caused by treating medical condition, but seldom practitioner is reported.It is generally known that the urinary incontinence illness rate in the U.S. is 3% to 14%, the elderly is up to 40%.

Bladder control problem is considered related with the high rate of many other health problems, such as fat and diabetes. The difficulty of bladder control aspect leads to the oppressive and limitation of activity of more height ratio.Incontinence is to personal (with the shape of bladder control product Formula) and medical system and residential care industry for cost it is high.Injury related with incontinence is to introduce auxiliary life and shield Manage the main cause of facility.Introducing greater than 50% nursing facility is related with incontinence.

Man more often tends to undergo the urinary incontinence than woman.Although the urinary incontinence more often influences old male compared with young men Property, but the generation of incontinence can occur at any age.During urination, contraction of muscle in the bladder wall forces urine flow to go out wing Guang simultaneously enters urethra.Meanwhile loosening around the sphincter of urethra, urine is allowed to pass through urethra from bladder and body is discharged.If wing The sudden contraction of Guang muscle is loosened suddenly around the muscle of urethra, then incontinence will occur.

The urinary incontinence is complicated obstacle and is classified as many hypotypes.These hypotypes include stress incontinence, urgency The urinary incontinence, FUNCTIONAL INCONTINENCE, overflow incontinence, the structural urinary incontinence, mixed urinary incontinence and the temporary urinary incontinence.

Stress incontinence (SUI) is also referred to as stress incontinence, mainly since the intensity deficiency of bone Pelvic floor causes 's.SUI is related to and coughs, size, sneezing, exercise or other increase intraabdominal pressures and thus increase the movement of pressure on bladder Related a small amount of urine are lost.Urethra is by pelvis bottom fascial support.If this underbraced, urethra can increase in abdominal pressure When move downward, allow urine flow mistake.

Stress incontinence is that the most common urinary incontinence form and usually occur after prostatectomy in male.? In women, because of pregnancy, childbirth and body variation caused by climacteric is usually the origin cause of formation of stress incontinence.Stress incontinence Deteriorate in one week before menstruation.At this point, lower estrogen level will lead to the lower muscle pressure of Periurethral, increase Leakage of urine possibility.The incidence of stress incontinence increases after climacteric, is similarly because of lower estrogen level Caused by.In women high performance athlete, stress incontinence is being related to being more than perineum bottom resistance (perineal floor Resistance) can all occur in unexpected repeatedly increased all movements of intraabdominal pressure.Most of laboratory results (such as urinate Remaining urine volume after liquid analysis, intravesical pressure measurement and discharge) it is normal.

Unconscious urine caused by abnormal bladder contraction caused by urge incontinence is defined as because of urgent concomitant sensation Pass through.Research shows that urge incontinence may be because of neurotrosis or caused by the psychosomatic factor because leading to unconscious bladder contraction 's.The most common reason of urge incontinence is unconscious and unsuitable detrusor contractions.Overactive detrusor is subdivided For idiopathic overactive detrusor (IDO), due to part or surrounding infection, bladder inflammation or stimulation and nerve detrusor Over-activity (NDO), since defective central nervous system (CNS) inhibits caused by reaction.Medical Technologist will have urgently The bladder of the patient of the property urinary incontinence is described as " unstable ", " spasm " or " excessively active ".If it is because controlling wing Caused by the neural overacfivity of Guang, then urge incontinence is referred to as " REFLEX INCOMTINENCE ".

Patient with urge incontinence can during sleep, drink after a small amount of water or contact water at it or hear water flow By the urinary incontinence when dynamic (such as washing the dishes or hearing that someone has a bath).The unconscious movement of bladder muscle may be because nervi vesicales inferiores, The damage of nervous system (spinal cord and brain) or muscle itself and occur.Multiple sclerosis, Parkinson's disease, Alzheimer's disease, in Wind, congenital spinal dysraphism and wound (including the wound occurred during operation) be likely to injury nervi vesicales inferiores or Muscle.

Have recognized the need to urine in people but when since on action edge limited physical lavatory can not be reached in time, it may occur that function It can the property urinary incontinence.Urine loss may be very big.The reason of FUNCTIONAL INCONTINENCE includes clouding of consciousness, dull-witted, weak-eyed, action edge Difference, flexibility ratio be poor, because of depression and anxiety or indignation, it is drunk or in the case where can not reaching lavatory lavatory of being unwilling.

Overflow incontinence is that patient can not stop the continuous floor drain of its bladder whithin a period of time after it has been urinated Let out or persistently drip urine.Overflow incontinence occurs when making its frequent leakage of urine in the always slow of bladder of patient.Bladder muscle is weak Bladder will be caused not exclusively to empty, or the urethra being obstructed will cause this kind of incontinence.Because diabetes or other diseases are (such as multiple Hardening) caused by autonomic neuropathy can reduce the nerve signal (causing excessive spill-over) from bladder, it may also reduce by force urine Flesh is discharged to urine and (causes urinary retention).In addition, tumour and kidney stone also can urethral obstructions.Spinal cord injury or nervous system disease Disease is the additional reason of overflow incontinence.In male, benign prostatic hyperplasis (BPH) also will limit the flowing of urine.Spill-over Property urinary incontinence case in women, but can also cause sometimes because of fibroid or ovarian neoplasm.In addition, overflow incontinence may Resistance to flow output is increased due to advanced stage kysthoptosis or is caused after the anti-urinary incontinence process of the exaggerated correction problem, it is this Kysthoptosis causes " to twist together " in urethra.

The structural urinary incontinence can be usually being diagnosed during one's childhood, such as may include different as caused by structure problem Because of gynemetrics's wound or caused by damaging, fistula also results in the structural urinary incontinence to position ureter.This kind of fistula most commonly may include bladder Vaginal fistula and seldom include uretero vaginal fistula.These are difficult to, but can by vaginogram using standard technique or Fornix vaginae is observed to be diagnosed by injection contrast agent with radial pattern.

Mixed urinary incontinence illness is not common in old women, and sometimes with urinary retention complication, so that illness Need the such difficult therapy of multi-mode treatment stage by stage.

The temporary urinary incontinence is the temporary form of the urinary incontinence.It is because of drug, urinary tract infections, hurt in spirits, action edge are limited, Urinary tract may be pressed against and prevent fecal impaction (serious constipation) triggering of outflow.

Therapeutic scheme can range selection from conservative therapy to operation, including behavior management and medication.For the urinary incontinence Behavior management technology includes re -training bladder to keep more urinating.Target is to extend the interval between micturition time.This includes relaxation Training technique, how study copes with urination impulsion, alcohol, caffeine or acidic food are managed and avoided to liquid.It is most common to control Treating one of suggestion includes training pelvic muscles.For reinforcing or the Kegel of re -training bone Pelvic floor and sphincter exercise can Reduce repressive leakage of urine.More and more evidences show that pelvic floor muscles temper (PFME) and can effectively improve bladder control.Pass through Execution PFME can improve the urinary incontinence after childbirth.

Biofeedback helps patient to learn his or her physical function using measuring device.By in bladder and urethra It is tracked when contraction of muscle using electronic equipment or log, patient can enhance the control to these muscle.Biofeedback can It is used together with pelvic muscle exercises with electro photoluminescence, to alleviate repressive and urge incontinence.Timing urination (urine) and wing Guang training is the technology using biofeedback.In timing urination, patient fills in tracking number of micturitions and the table of leakage of urine occurs. The mode occurred from table, patient can may empty his or her bladder before leakage of urine at him or she.Biofeedback and flesh Meat adjusts (referred to as bladder training) and can be changed for storing and the bladder period planning of drained of urine.These technologies can be used for urgency Compel the property urinary incontinence and overflow incontinence.

Increase some form of urinary incontinence of urethra volume (bulk) (resistance of thus increasing export) available treatment.This ground has It is most effective for the patient of relatively fixed urethra.There are a variety of materials for increasing volume, including blood in history And fat, but limited success.(collagen (GAX collagen) of glutaraldehyde cross-linking has been proved to perhaps the substance being most widely used More patients are valuable.The main problem for increasing urethra volume using GAX collagen is that the volume of urethra needs to repeat this at any time Process.

Drug can reduce the leakage of many types.The excessively active bladder of some Drug inhibitions, other relax one's muscles, cause to arrange More complete bladder emptying during urine, and other tightening muscle at neck of urinary bladder and urethra, prevent from leaking.Some hormones (such as it is female Hormone) it is considered to so that muscle involved in urinating works orderly.The drug therapy of the urinary incontinence includes: that part or vagina are female Hormone, be used in vaginal atrophy the case where；TolterodineOxybutynin Pro-banthine；DarifenacinSolifenacinTrospium chlorideWith In urge incontinence；ImipramineFor mixed urinary incontinence and stress incontinence；Pseudoephedrine；With DuloxetineFor stress incontinence.If used for a long time, some in these drugs can be generated Harmful side effect.Specifically, the estrin treatment cancer wind with increased breast and endometrium (inner membrance in uterus) Danger is related.

In history, with various actions treatment, drug and operative treatment urge incontinence.Urge incontinence (UUI) it is caused frequently by the bladder of overacfivity (OAB), and the most effective drug therapy currently used for OAB includes anti-gallbladder Alkali drug.However, many patients do not have reaction to these drugs, or there is significant side effect, cause to be discontinued, so that these are suffered from The UUI of person's experience persistent symptoms.The influence of botulin toxin (BTX-A) on striated muscle is outside neurology and shaping Science is documented.Some researchs (including Randomised placebo-controlled trial in recent years) it has been shown that BTX-A to detrusor Over-activity (NDO) is effective.In terms of non-control case series has shown that the significant urinary incontinence reduces and improves idiopathic OAB Urodynamic parameters.Botulin toxin can significantly reduce the urine of the urgency as caused by the bladder of overacfivity in six weeks Incontinence.However, there is the urinary retention risk for needing voluntarily urethral catheterization.

Although doctor suggests operation to mitigate incontinence, many surgery hands usually after having had attempted to other treatment Art scheme has high success rate.Urodynamics test almost confirms that the surgical operation recovery of Vault prolapse can treat movement Urge incontinence.A kind of surgical operation scheme is related to implantable stimulation device, generates electric pulse, which makes pelvis And/or the contraction of muscle of urethra.This stimulation can strengthen these muscle, to help to reduce the generation of urge incontinence Rate.For example, the device for being referred to as InterStim of Medtronic Inc.'s production, is generated by the pulse that surgical operation is implanted into Device has the conducting wire for being connected to one or more rumpbone nerves.Device is implanted to back and the conducting wire from device is connected to Rumpbone nerve is with to neurotransmission electric signal.The stimulation of rumpbone nerve can with activation or inhibition to urine control contributive muscle and Organ, including bladder, sphincter and bone Pelvic floor.In general, this stimulator is implanted into using invasive surgical procedures, It is related to the abdomen in patient, body side or buttocks stimulator for implantation.But there is the stimulation of report surface rumpbone nerve to about 30- 40% women that treated has good reaction.

The stimulation of nervus pudendus also has been used to treatment urge incontinence.For example, Medtronic is transferred, Inc.'s U.S. Patent Publication No. 2008-0183236 describe " a method of treat at least one pelvic floor abnormality, at least one Exception is from urinary dysfunction, dysfunction, constipation, stress incontinence, urge incontinence, urinary retention exception, property function It can be selected in obstacle, orgasm dysfunction, erectile dysfunction pelvic pain, prostatitis, prostatodynia and prostatodynia , method includes: from the medical device of the patient body for being diagnosed pelvic floor abnormality is implanted to the first of the first side of patient At least one first electro photoluminescence of electrodes transfer of nervus pudendus or its branch or some parts via first lead, the first lead It is implanted to patient's body and close to nervus pudendus or its branch or some parts；From medical device patient second side via At least one electrode of second lead transmits the second electro photoluminescence to the second nervus pudendus or its branch or some parts, this second draws Line is implanted to patient's body and close to the second nervus pudendus or its branch or some parts；It is configured with by the first and second electro photoluminescence To provide at least partly alleviation to pelvic floor abnormality." stimulating apparatus of nervus pudendus is connected in addition to being implanted into, it is a kind of common Method is related to transmitting electro photoluminescence by intravaginal or perineum surface electrode.Although using implantable stimulator to urge incontinence Being treated is successful in many cases, but can have some defects using conventional implanted device and method.

Erectile dysfunction (ED) or erection incapability are sex dysfunctions, its main feature is that can not be formed during sexual behaviour or Keep telotism.Erectile dysfunction has an impact to the male over 40 years old, has a significant impact to quality of life.This is common to ask It inscribes very complicated and is related to many aspects.Telotism is by being related to nervous centralis, peripheral nerve, hormone and the life of vascular system Caused by the synthesis of reason process.Any exception of these systems, either because of drug therapy or disease, to erection, ejaculation Formation and continuous capability with climax experience all have a significant impact.Telotism is in the Sponge for entering and being maintained in penis Blood hydraulic effect caused by.The process is usually when signal is transmitted to the nerve in penis from brain due to sexual stimulus Caused.The most important Organic reason of erectile dysfunction includes that cardiovascular disease and diabetes (cause neuropathy Become), neurologic problems (for example, because of prostatectomy caused by wound), hormone insufficient (hypogonadism) and drug pair work With.

Common arteria penis (it is derived from arteria pudenda interna) is branched off into back, urethra bulb, cavernous artery.Carry on the back artery The hyperemia of glans penis is used for during erection, and urethra bulb artery is caulome and cavernous body of urethra blood supply.Cavernous artery influences The expansion of the cavernous body of urethra and thus it is mainly responsible for erection.Cavernous artery separates many helicine arteries, girder erectile tissue With sinusoid blood supply.These helicine arteries reduce in a relaxed state and are bent and broaden and straighten during erection.Cavernous body Venous return is derived from tiny veins, which draws below tunica albuginea from sinusoid around.These veinlets in film and It advances in bone trabecula between surrounding sinusoid, to form veniplex under film before leaving as vena emissaria.

Due to thought and feel (psychological causes) rather than on body cannot and psychology occurs when can not erect or be inserted into Property impotence.Mental impoetence less often occurs, and is commonly available help.It should be noted that for mental impoetence, to peace Consoling agent treatment has Qiang Fanying.Erectile dysfunction have it is serious psychological as a result, because its usually with relationship difficulties and male Self-image is related.

The first-line treatment of erectile dysfunction includes that 5th type phosphate diester enzyme (PDE5) inhibitor on probation (its first is Silaenafil or vigour).In some cases, treatment can be related to put prostate plain piece in urethra, inject to penis, penis Prosthese, penile pump or vessel reconstruction art.

Erectile dysfunction is analyzed in many ways.Sometimes complete erection can be obtained, such as the night yin in sleep Stem expansion (in thought and unobvious psychological problems, if there is) tend to indicate that body mechanism functionally plays a role.

Telotism pass through two kinds of mechanism controls: reflectivity erect, by with phallosome portion two sides (penile Shaft) directly contact is realized；With psychological erection, realized by erotic stimulus or emotional distress.The former uses the week of spinal cord Nerve and low portion are enclosed, and the latter uses the limbic system of brain.In both cases, need complete nervous system at Function and complete erection.Cause nitrogen monoxide (NO) to secrete the stimulation of phallosome portion two sides by nervous system, causes Corpora cavernosa penis (the main erectile tissue of penis), and then realize telotism.In addition, it is necessary to cortisol horizontal enough (being generated by testis) and complete pituitary come formed health erection mechanism.Such as from normal erection mechanism it is understood that impotence It is as caused by answering anhormonia, nervous system abnormality, the enough penis blood supplies of shortage or psychological problems.The limitation of blood flow Because of caused by Endothelial dysfunction caused by common cause related with coronary artery disease, but can also be because of long-time exposure Cause under to strong light.

Sexual behaviour is related to many spinal cords and ridge in the participation and central nervous system (CNS) of autonomic nerve and somatic nerves The synthesis of position on marrow.The effect of the penis part for the process erected is caused only to represent one component part.It has been described Some paths explain how information from hypothalamus advances to the autonomous center of sacrum.Pass through when one path from dorsomedial nucleus of hypothalamus Back and central gray matter drop to locus coeruleus and with the stretching of formatio reticularis mesencephali hemad.Input from brain is by back backbone It is transported to Thoracolumbar disk and rumpbone autonomic nucleus.

Main nerve fibre to penis be from the back side of penis nerve, nervus pudendus branch and come.Cavernosal nerve It is a part of autonomic nerves system and merges sympathetic nerve and parasympathetic fibers.Along prostate, outside is advanced backward for they And enter corpora cavernosa penis and the cavernous body of urethra, to adjust the blood flow erected with during atrophy.Back somatic nerves is also The branch of nervus pudendus.They are mainly responsible for penile sense.

Erection occurs in response to tactile, smell and visual stimulus.It realizes and the ability erected completely is kept not only to depend on The bioid thing of perineural state, the integrality of vascularity and cavernous body is depended in the penis part second phase of the process Part.Autonomic nerves system is related to erection, climax and expansion.Parasympathetic relates generally to support and keep to erect, this is It is realized from S2-S4 nerve root.

Sexual stimulus causes neurotransmitter from the release of cavernosal nerve tip and relaxation factor out of as sinusoid liner Chrotoplast release.NOS generates NO from L arginine, and it generates other again makes the chemical substance of loosening all muscles, such as cGMP and ring Adenylate (cAMP), works via calcium channel and protein kinase mechanism.This is realized to the artery of erectile tissue blood supply and small Smooth muscle loosens in artery, generates dramatically increasing for penile blood flow.Loosening for sinusoid smooth muscle increases its biddability, This facilitates quickly congested and expansion.Veinlet below hard tunica albuginea is extruded, and realizes the vein outflow of intervention occlusion.These things Part generates erection, the intracavernosal pressure with 100mmHg.

Additional sexual stimulus causes bulbocavernous reflex.Ischiocavernosus forcefully compresses the base of congested cavernous body Portion, and penis realizes complete erection and hardness when intracavernosal pressure reaches 200mmHg or higher.At this pressure, blood Flowing in and out for liquid temporarily ceases.Because of the stopping of neurotransmitter regulator, by phosphodiesterase caused by second messenger watt Sympathetic nervous during solution and ejaculation is excited and realizes atrophy.The contraction of trabecular smooth muscles reopens venous access, Blood is allowed to be discharged and thereby result in softening.

Cyclic Nucleotide Phosphodiesterases constitutes one group of enzyme, destroys cyclic nucleotide cyclic adenosine monophosphate (cAMP) and cycli phosphate bird Glycosides (cGMP).Phosphodiesterase exists with different molecular forms and is non-uniformly distributed in the body.Phosphodiesterase its A kind of middle form is referred to as PDE5, and PDE5 is inhibited to can increase the available cGMP amount into the blood supply of penis, thus increases Blood flow.PDE5 inhibitor silaenafil (vigour), Vardenafil (Ai Lida) and Tadalafei (sharp scholar) are orally available Prescription medicine.

Topical cream that Alprostadil is combined with penetration enhancer DDAIP has been taken by trade (brand) name Vitaros adding Big approval is as the first-line treatment for being used for erectile dysfunction.Another therapeutic scheme is injection treatment, the wherein appropriate drawing of papaverine, phenol Bright and prostaglandin E1 is injected into penis.Vacuum erectile device (vacuum erection device) facilitates by applying Add negative pressure that blood is drawn in penis.This kind of device is sometimes referred to as penile pump and can use before sexual intercourse.It can root The vacuum-therapy device ratified according to the kitchen of doctor using several FDA.In pharmacological methods failure, the outside purposefully designed Vacuum pump can be used for realizing erection, and individual extrusion ring is assembled to penis to keep to it.These pumps should be different from it (it does not have extrusion ring to his penile pump, is not intended to the temporary treatment of impotence, but it is long to increase penis when being commonly used Degree, or can vibrate as the auxiliary consoled oneself.More strongly, can by perform the operation assembly can fill or rigidity penile implant. In general, if other treatment all fails as a last resort, the most common process is prothesis implant body, it is related to inserting to penis Enter artificial bar.

Perineal body (or central tendon of perineum) is being urinated at the fluidic junction grown between trigonometric sum anus triangle in perineum middle line On tapered fibre flesh object.It is found in male and female.In male, sent out between bulb of penis and anus It is existing.It in women, is found between vagina and anus, and in front of the latter at about 1.25cm.Perineal body is complete to pelvis bottom Whole property be it is vital, especially to women.It is ruptured during vaginal delivery, can widen the preceding freedom of two sides levator ani Thus gap between edge becomes the factor that women suffers from uterus, rectum or even prolapse of bladder.Perineum cavernous body is tissue With the foam-rubber cushion of blood vessel, it is present in the lower genital region of women.It is between introitus and rectum and in perineum and perineum Within body.Perineum cavernous body includes erectile tissue.During excitation, because blood becomes enlargement, the outer one third of vagina is squeezed, And bulbus vestibuli and urethra Sponge, be consequently formed to penis tightlier squeeze and extra stimulation.Perineum cavernous body is to cause The tissue of sexual desire, it includes a large amount of nerve endings, and can therefore be stimulated by posterior vaginal wall or rectum top wall.

Female sexual arousal disorder (FSAD) is a kind of exception, commonly referred to as Candace syndrome, its main feature is that a kind of lasting Or the recurrent disabling conditions that cannot achieve sexual arousal or sexual arousal is kept to complete until sexual behaviour.Can refer to sexual arousal and Usually existing insufficient lubrication-expansion reaction diagnoses during sexual behaviour to make.Symptom should in sexual behaviour common interest Lack and other sex dysfunctions differentiate, such as Orgasmic Disorder (ahedonia) and Female Sexual Desire Disorder, it is specific be Lack in a period of time or without sex fantasy and to the desire of sexual behaviour.

Medical conditions are the not good enough common causes of direct or indirect sexual life.Vascular diseases related with diabetes may hamper Hinder enough sexual arousals.Cardiovascular disease can inhibit sexual intercourse, be only second to have difficulty in breathing.Arthritis or the urinary incontinence or incontinence of faces Uncomfortable or embarrassment can be made, dysfunction is caused or reduces sexual behaviour.With women's reproduction age (such as puberty, pregnancy, post-partum period and Climacteric) variation of related gynaecology bring some uniquenesses problem and gender-related potential obstacle.Puberty will lead to The problem of related sex identification.Pregnancy and post-partum period are usually related with sexual behaviour, desire and satisfaction reduction, this can be due to lactation Extend.Involutional low estrogen activated state can make significant body variation, such as vagina elasticity becomes smaller and loses, and reduces Physiological secretions, vaginal pH risen to from 3.5 to 4.5 5 or more and epithelial layer it is thinning.

In a physiologically, medial preoptic nucleus, Anterior hypothalamus and edge hippocampal formation of the sexual arousal in central nervous system Start.Electric signal then passes through parasympathetic nerve and stomodaeal nervous system transmitting.Currently research adjustment vagina and clitoris are flat The medium of sliding Muscle tensility and the physiology and biochemistry of relaxation.Had found in vagina tissue nerve fibre neuropeptide tyrosine, Vasoactive intestinal peptide, nitric oxide synthetase, cyclic guanylic acid and Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-NH2.Nitric oxide is considered to adjust clitoris and lip is congested, However vagina blood flow, lubrication and secretion can be enhanced in vasoactive intestinal polypeptide, non-adrenaline/non-cholinergic neuronal mediator Object.Many variations occur being vexed in genitals during sexual arousal.Increased blood flow promotes the phallic congestion of blood vessel. Secretion from uterus and greater vestibular gland can lubricate vaginal canal.Vagina smooth muscle relaxation allows the extension and expansion of vagina.? When clitoris is stimulated, length and diameter increases and occurs congested.In addition, nymphae promotes to fill because of increased blood flow Blood.

The exact position of autonomic nerve related with uterus, cervix and vagina and blood vessel structure is understood limited.Uterus Nerve is derived from and is formed by by the combination of hypogastric nerve (sympathetic nerve T10-L1) and visceral nerve fiber (parasympathetic nerve S2-S4) Inferior hypogastric plexus.There are three parts for clump tool: plexus vesicalis；Plexus rectalis；With uterovaginal plexus (frankenhauser's ganglion), it is located at The base portion of broad ligament, the back side of vessels of the uterus and in utero-sacral ligament and cardinal ligament side.The clump is via cardinal ligament and utero-sacral ligament Innervation is provided to cervix, upper vagina, urethra, bulbus vestibuli and clitoris.At cervix, sympathetic nerve and parasympathetic mind Through forming paracervical ganglion.Larger one is referred to as cervicouterine ganglion.It is in this level, to vagina, labia, son Uterine neck can occur from the damage of principal fiber during uterectomy.Nervus pudendus (S2-S4) by the road Alcock reach perineum and Perception is provided for external genital organs and kinesitherapy nerve dominates.

The reaction of the sexual arousal of a variety of reproductions and non-reproduction surrounding anatomical structures is mainly the product of spinal reflex mechanism.Spinal cord Segment is in the downlink stimulation from multiple vertebra positions and inhibits under control.Incoming reflex arc is mainly via private parts mind Through.Spreading out of reflex arc includes the body and autonomic activities mutually coordinated.A kind of spinal cord sexual reflex is bulbospongiosus muscular reflex, is related to Sacrum myelomere section S2,3 and 4, wherein nervus pudendus stimulation cause pelvic floor muscles to shrink.Another spinal cord sexual reflex is related to the sum of vagina Corpora cavernosa clitoridis autonomic nerve stimulation realizes the hyperemia of clitoris, labia and vagina.

Under base state, clitoris and vagina smooth muscle are under shrinkage tension.After sexual stimulus, nitric oxide (NO) weight is played in nerve release and endothelium release in terms of corpora cavernosa clitoridis artery and corkscrew arteries smooth muscle relaxation It acts on.This cause corpora cavernosa clitoridis arterial blood flow into increase, pressure increase and clitoral engorgement in corpora cavernosa clitoridis.The result is that negative Base of a fruit head process goes out and sensibility enhances.

Under base state, vagina epithelium is from reuptaking sodium in capillary Plasma transudates under mucous membrane.After sexual stimulus, Various neurotransmitters including NO and vasoactive intestinal peptide (VIP) are released, and adjust blood vessels of vagina and without vessel smooth muscle Relaxation.Dramatically increasing for capillary blood flow looked into reuptaking for Na in submucosa, led to the vagina diffusate of 3-5ml, Increase the lubrication very crucial for pleasant sexual intercourse.The relaxation of vagina smooth muscle meat causes vagina length and blood vessel diameter to increase, especially It is in 2/3rds part of the distal end of vagina.Vasoactive intestinal polypeptide is nonadrenergic noncholinergic never mediator, is being increased It plays an important role in terms of strong vagina blood flow, lubrication and secretion.Research shows that reproduction sexual arousal is nerve and blood vessel thing Part, its main feature is that reproductive organs blood flow increases and smooth muscle relaxation.Electrical field stimulation causes non-in the corpora cavernosa clitoridis of rabbit Adrenaline non-cholinergic relaxation response.

The patient of the about one third of sacral nerve stimulation is undergone to report the improvement of its overall sexual experience, but it improves machine It makes still unclear.About 20% patient reports that its sexual experience deteriorates.Improvement of sexual function improves independently of urinary function.

During sexual arousal, the blood flow to vagina, labia and clitoris increases.This expands organ, vagina loosens, Increase vaginal lubrication and genital sensitivity.It is reported that spontaneous orgasm can be caused for the stimulation of women stiffness of waist in children film.

Prior art systems and method for electro photoluminescence solve anal sphincter, on the whole, and in internal and anus It cannot be distinguished between sphincter stimulation outdoors, can produce very different physiologic result.Musculus sphincter ani internus is smooth muscle, It is shunk because spirit is excited, rather than through autonomous control, and the innervation by meissnar's plexus.Musculus sphincter ani internus is protected Hold sphincter tensioning and resisting fatigue.On the other hand, external sphincter muscle of anus is skeletal muscle, is not shunk because nerve is excited, and It is to be provided autonomous control by autonomous control, and the innervation of receipts ground sacral nerve and nervus pudendus for sphincter, it is very easy By fatigue.Resting Pressure is mainly provided by musculus sphincter ani internus, and squeeze pressure is provided by external sphincter.

It is therefore advantageous that according to its different physilogical characteristics and function, by different stimulation algorithms or different leads Construct (lead configuration) stimulates two kinds of sphincters in different ways.Because sphincter control depends on a variety of machines System, is especially for energy efficiency, tolerance, fatigue problem, it is advantageous that stimulates various structures with different stimulated algorithm.In order to Electro photoluminescence is carried out to two kinds of anatomical structures, the system and method for the prior art require at least two pairs of stimulating electrodes (that is, at least two Micro device or at least four leads).Due to anatomical structure limitation, it may be difficult to accommodate or accurately by multiple lead placements Into anal sphincter.But it is advantageous an electrode is put into each structure, thus using less lead and/or Micro device realizes desired stimulus modality.

It is then desired to safely effectively treatment method, can help to mitigate long-term fecal incontinence symptom, without There are invasive procedures.In addition, not only needing to improve electrical stimulation device based on the therapy for fecal incontinence, but also need safety With minimally invasive method and system, in fact the device deployment easily and quickly at existing any desired position in the body.It is most of It is currently available that device can be used for surgical operation or laparoscope implantation, and faces common pouch infection, lead movement or fracture Problem.In turn, it is also necessary to the device and method for the implantable miniature device in rectum or anal canal.

Accordingly, there exist the needs of the improvement treatment to urge incontinence, should be more more effective than conventional method.Institute as above State, in recent years, the treatment method for urge incontinence concentrate on to specific muscle carry out innervation it is certain nerve into Row electro photoluminescence.It remains desirable, however, that improved method realizes effective treatment of various forms incontinence, as described herein.

The urinary incontinence and incontinence of faces can cause extremely because of around sphincter neuromuscular, and be common in many patients.Two kinds Abnormal pathogenic factor can be similar and can make a response to similar therapy intervention.In addition, sphincter urethrae is difficult to intervene, Especially for male, and it is therefore desirable for be can by stimulation anal sphincter treat sphincter urethrae dysfunction, this is more It is easy to accomplish.It is also contemplated that the anal sphincter of stimulation people, to improve the patient of abnormal, abnormal defecation or both by uropoiesis Anal sphincter and sphincter urethrae function.

Prior art systems and method for electro photoluminescence solve anal sphincter and urinary system according to different bases. The prior art do not instruct by anal sphincter or sphincter urethrae implant electrode it is abnormal come overall therapeutic sphincter urethrae With the method for anal sphincter exception.Opposite multiple sphincters are reduced when the treatment advantage that this method has is implanted into multiple electrodes Needs, therefore reduce operation wound.In addition, this method reduces and is difficult to intervene the related intrusion of sphincter urethrae, especially To male.

It would thus be advantageous to single device Co stituation sphincter urethrae and anal sphincter.Two sphincters can be directed to Its different anatomic position and function different stimulated algorithm or different wiring configuration stimulations, to treat one or two sphincter Dysfunction.It is especially for energy efficiency, tolerance, fatigue problem, favorably because sphincter control depends on number of mechanisms Be with different stimulated algorithm stimulate various structures.In order to carry out electro photoluminescence to two kinds of anatomical structures, the system of the prior art and Method requires at least two pairs of stimulating electrodes, including at least two micro devices or at least four leads.Due between destination organization Anatomical structure separation, device implantation require larger range of cutting, multiple leads are put into anal sphincter and urethra includes About flesh.It would thus be advantageous to an electrode is placed on any in each structure, less lead and/or miniature is thus used Device simultaneously needs less cutting

Alternatively, electrode can plant sphincter urethrae, and apply electro photoluminescence to adjust sphincter urethrae and anal sphincter The function of the two, this is the desired method for women, wherein can be with wound to the intervention of the Via vagina of sphincter urethrae It is smaller.

Optionally, electrode is implanted into anal sphincter, and is applied electro photoluminescence and included with adjusting sphincter urethrae and anus The about function of both flesh, this is the desired method for male, wherein the intervention to sphincter urethrae is more difficult.

This method is to the patient with both sphincter urethrae and anal sphincter exception or to abnormal with sphincter And in future, there are be desired for the patient of other sphincter abnormal risks.

Accordingly, there exist the needs to improvement treatment of urinary incontinence, should be more more effective than conventional method.As described above, in recent years, Treatment method for the urinary incontinence concentrates on the certain nerves for carrying out innervation to specific muscle and carries out electro photoluminescence.However, still The method so needed to be improved realizes effective treatment of the various forms urinary incontinence, as described herein.

Summary of the invention

This disclosure is a kind of for using stimulating apparatus to improve the method for patient's urethra sphincter function, moderate stimulation Device includes being operatively coupled at least one electrode of stimulation generator and being configured at least one stimulus signal being transmitted to The controller for stimulating generator, this method comprises: electrode to be positioned as to the target group in the anorectal areas with patient Knit electric connection；Stimulus signal is generated based on the multiple program instructions of storage in the controller using the controller；And sound Stimulus signal described in Ying Yu generates electric stimulation pulse using stimulation generator, wherein the electric stimulation pulse is via described at least one The destination organization of a electrodes transfer into the anorectal areas.

Optionally, destination organization includes rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, yin It is included about in portion's nerve or nervus pudendus branch, joint longitudinal muscle, the superficial part of external sphincter muscle of anus or deep part, anus Flesh, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), rectum anus At least one of (corpusculum tactus) clump and perineum tissue under the mucous membrane of door.

Optionally, electric stimulation pulse includes having the 10 μ seconds pulse width for arriving 500ms range, 1 microampere to 100 milliamperes The pulse frequency of impulse amplitude and 0.02Hz to 100Hz.

Optionally, device further comprises at least one sensor for being configured to obtain data, and the method is further Including based on from least one sensor and come data change the electric stimulation pulse.At least one sensor may include pressure Force snesor electrical activity sensors, impedance transducer, accelerometer or inclinometer.

Optionally, institute of the abdominal pressure leakage point pressure relative to the electric stimulation pulse after the application electric stimulation pulse State the abdominal pressure leakage point pressure increase at least 5 percent or at least 60cmH before applying₂O。

Optionally, after the application electric stimulation pulse, the institute relative to the electric stimulation pulse is measured in abdominal pressure leak point State the abdominal pressure leakage point amount increase at least 5 percent before applying or at least 50cc.

Optionally, after the application electric stimulation pulse, residual urine volume is determined relative to the electro photoluminescence arteries and veins after urination Residual urine volume, which determines, after urinating before the application of punching increases at least 5 percent.

Optionally, after the application electric stimulation pulse, the application of the urine flow rate relative to the electric stimulation pulse Urine flow rate increase at least 5 percent before.

Optionally, after the application electric stimulation pulse, bladder compliance monitoring is relative to described in the electric stimulation pulse Using before bladder compliance monitoring increase at least 5 percent or at least 20ml/cm H₂O。

Optionally, after the application electric stimulation pulse, detrusor leaks point pressure relative to the electric stimulation pulse The application before detrusor leakage point pressure increase at least 5 percent or at least 40cmH₂O。

Optionally, after the application electric stimulation pulse, there is sensibility reciprocal relative to described in the electric stimulation pulse for the first time Using before there is sensibility reciprocal to increase to few 5% or at least 50ml for the first time.

Optionally, after the application electric stimulation pulse, secondary (full) amount of thoughts is relative to the electric stimulation pulse The application before (full) amount of secondary thoughts increase by least 5% or at least 200ml.

Optionally, after the application electric stimulation pulse, institute of the maximum bladder capacity relative to the electric stimulation pulse State the maximum bladder capacity increase at least 5% before applying or at least 400ml.

Optionally, after the application electric stimulation pulse, maximum detrusor pressure power is relative to the electric stimulation pulse Maximum detrusor pressure power increase at least 5% or at least 20cmH before the application₂O。

Optionally, after the application electric stimulation pulse, institute of the detrusor contractions relative to the electric stimulation pulse It states the detrusor contractions increase at least 5% before applying but is no more than 25%.

Optionally, after the application electric stimulation pulse, the average incontinence of incontinence attack times or each incontinence breaking-out Measure relative to the electric stimulation pulse it is described before incontinence attack times or each incontinence break out average incontinence amount It is reduced at least 5%.

Optionally, after the application electric stimulation pulse, tatol emiction quantity is answered relative to described in the electric stimulation pulse With tatol emiction quantity increase at least 5% before.

Optionally, after the application electric stimulation pulse, isuria amount is relative to described in the electric stimulation pulse Using isuria amount increase at least 5% before.

Optionally, maximum single urine volume is urinated relative to the maximum single before the application of the electric stimulation pulse Amount increases at least 5%.

Optionally, after the application electric stimulation pulse, the patient incontinences of visual analogue scales feel scoring relative to The patient incontinence of visual analogue scales before the application of the electric stimulation pulse feels that scoring improves at least 5%.

Optionally, after the application electric stimulation pulse, Stamey incontinence is scored relative to the electric stimulation pulse Stamey incontinence scoring before the application improves at least one grade.

Optionally, after the application electric stimulation pulse, female urogenital perplexs scale relative to the electro photoluminescence Female urogenital before the application of pulse perplexs scale increase at least 5%.

Optionally, after the application electric stimulation pulse, female incontinence severity index is relative to the electricity thorn Female incontinence severity index increase at least 5% or improvement at least one point before the application of sharp pulse.

Optionally, application the electric stimulation pulse after, with stress incontinence women leakage of urine index relative to The women leakage of urine index increase at least 5% with stress incontinence before the application of the electric stimulation pulse.

Optionally, after the application electric stimulation pulse, ((1 hour and 24 hours) test result is opposite for diaper test Diaper before the application of the electric stimulation pulse, which tests test in (1 hour and 24 hours), improves at least 5%.

Optionally, after the application electric stimulation pulse, the life matter of SF6, SF12 and Roger Goldberg scale Life of the amount scoring relative to SF6, SF12 and Roger Goldberg scale before the application of the electric stimulation pulse Quality score increase at least 5%.

This specification is also disclosed a kind of for treating the bowel movement function barrier device of patient, comprising: first electrode is configured to Contact the first tissue region；Second electrode is configured to contact minor microstructure region；Waveform generator, be connected to first electrode and Second electrode, wherein waveform generator is configured to generate electric pulse, and the wherein electric pulse to first electrode and second electrode Including the pulse width with 10 μ s to 500ms；1 microampere to 100 milliamperes of impulse amplitude；With the pulse of 0.02Hz to 100Hz Frequency；The wherein pulse width, impulse amplitude, the pulse frequency of the pulse for being transmitted to first electrode and second electrode Rate and duty cycle be defined so that, after the application electric pulse, the bowel movement function that is measured by technique of anorectal manometry art Barrier parameter improves at least 5% relative to value before treatment.

Optionally, the bowel movement function barrier parameter includes musculus sphincter ani internus, Resting Pressure, external sphincter muscle of anus tranquillization Pressure, anal sphincter extruding force, pressure test (abdominal pressure leakage point pressure), pressure test (abdominal pressure leak point amount), anus are high When intermediate pressure section, anus squeeze the duration, have sensibility reciprocal for the first time, want amount when defecation, is urgent during amount, capsule efflux time, discharge Rectal pressure and discharge during anal pressure.

Optionally, the first tissue region includes under rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, mucous membrane of rectum In layer, nervus pudendus or nervus pudendus branch, joint longitudinal muscle, the superficial part of external sphincter muscle of anus or deep part, anus It is sphincter, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), straight At least one of (corpusculum tactus) clump and perineum tissue under the mucous membrane of intestines anus.

Minor microstructure region includes rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, private parts Nerve or nervus pudendus branch, joint longitudinal muscle, external sphincter muscle of anus superficial part or deep part, musculus sphincter ani internus, Lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), anorectum Mucous membrane under at least one of (corpusculum tactus) clump and perineum tissue.

Minor microstructure region can separate and different from the first tissue region.

The electric pulse for being transmitted to first electrode can have the pulse identical or different with the electric pulse of transmitting second electrode Width, impulse amplitude or pulse frequency.

Optionally, device further comprises at least one sensor for being configured to obtain data, wherein the waveform occurs Device is configured so that the data modification is transmitted to the electric pulse of first electrode and is transmitted in the electric pulse of second electrode extremely It is one few.At least one sensor may include pressure sensor electrical activity sensors, impedance transducer, accelerometer or incline Tiltedly meter.

Optionally, the device further comprise based on from the patient and come input modification be transmitted to the electricity of first electrode At least one of pulse and the electric pulse for being transmitted to second electrode.

Optionally, device further comprises transceiver, for passing through induction, radio frequency (RF), electricity, magnetic, light or other electromagnetism Coupling other than the body of patient to send and receive data and/or power.

Optionally, device further comprises for multiple stimulation parameters to be decoded and stored and generate the electric pulse Integrated circuit (IC) chip and for storing data with the programmable storage of stimulation parameter.

This specification also discloses the device for improving patient's bowel movement function obstacle, comprising: first electrode is configured to connect Touch the first tissue region；Second electrode is configured to contact minor microstructure region；Waveform generator is connected to first electrode and Two electrodes, wherein waveform generator is configured to generate electric pulse, and the wherein electric pulse packet to first electrode and second electrode Include the pulse width with 10 μ s to 500ms；1 microampere to 100 milliamperes of impulse amplitude；With the pulse frequency of 0.02Hz to 100Hz Rate；Wherein the pulse width, impulse amplitude, pulse frequency of the pulse for being transmitted to first electrode and second electrode, Be defined so that with duty cycle, application the electric pulse after by Rothenberger scale, Wexner scale, The Variables Score that Vaizey scale or incontinence of faces severity index (FISI) scale obtain improves relative to scoring before treatment At least 5%.

Optionally, the first tissue region includes under rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, mucous membrane of rectum In layer, nervus pudendus or nervus pudendus branch, joint longitudinal muscle, the superficial part of external sphincter muscle of anus or deep part, anus It is sphincter, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), straight At least one of (corpusculum tactus) clump and perineum tissue under the mucous membrane of intestines anus.

Minor microstructure region includes rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, private parts Nerve or nervus pudendus branch, joint longitudinal muscle, external sphincter muscle of anus superficial part or deep part, musculus sphincter ani internus, Lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), anorectum Mucous membrane under at least one of (corpusculum tactus) clump and perineum tissue.

Minor microstructure region can separate and different from the first tissue region.

The electric pulse for being transmitted to first electrode can have the pulse identical or different with the electric pulse of transmitting second electrode Width, impulse amplitude or pulse frequency.

Optionally, device further comprises at least one sensor for being configured to obtain data, wherein the waveform occurs Device is configured so that the data modification is transmitted to the electric pulse of first electrode and is transmitted in the electric pulse of second electrode extremely It is one few.At least one sensor may include pressure sensor electrical activity sensors, impedance transducer, accelerometer or incline Tiltedly meter.

This specification also discloses the device for improving patient's bowel movement function obstacle, comprising: first electrode is configured to connect Touch the first tissue region；Second electrode is configured to contact minor microstructure region；Waveform generator is connected to first electrode and Two electrodes, wherein waveform generator is configured to generate electric pulse, and the wherein electric pulse packet to first electrode and second electrode Include the pulse width with 10 μ s to 500ms；1 microampere to 100 milliamperes of impulse amplitude；With the pulse frequency of 0.02Hz to 100Hz Rate；Wherein the pulse width, impulse amplitude, pulse frequency of the pulse for being transmitted to first electrode and second electrode, It is defined so that with duty cycle, it is any in visual analogue scale and life quality scores after the application electric pulse One or combination relative to treatment before scoring improve at least 5%.

This specification also discloses a kind of for improving the device of patient's urethra sphincter function, comprising: first electrode is matched Be set to contact the first tissue region, wherein the first tissue region not with the urethra internal sphincter material contact of patient；Second Electrode is configured to contact minor microstructure region, wherein the minor microstructure region is not real with the urethra internal sphincter of patient Body contact；Waveform generator is connected to first electrode and second electrode, and wherein waveform generator is configured to first electrode and Two electrodes generate electric pulse, and wherein the electric pulse includes the pulse width with 10 μ s to 500ms；1 microampere to 100 milliamperes Impulse amplitude；With the pulse frequency of 0.02Hz to 100Hz；Wherein for being transmitted to the electric arteries and veins of first electrode and second electrode Punching the pulse width, impulse amplitude, pulse frequency and duty cycle be defined so that, application the electric pulse it Afterwards, abdominal pressure leakage pressure reveals pressure increase at least 5 percent relative to the abdominal pressure before the application of the electric pulse, Or make after the electric pulse is applied, abdominal pressure amount of leakage is revealed relative to the abdominal pressure before the application of the electric pulse Amount increases at least 5 percent.

The first tissue region may include rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, It is included about in nervus pudendus or nervus pudendus branch, joint longitudinal muscle, the superficial part of external sphincter muscle of anus or deep part, anus Flesh, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), rectum anus At least one of (corpusculum tactus) clump and perineum tissue under the mucous membrane of door.

Minor microstructure region may include rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, It is included about in nervus pudendus or nervus pudendus branch, joint longitudinal muscle, the superficial part of external sphincter muscle of anus or deep part, anus Flesh, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), rectum anus At least one of (corpusculum tactus) clump and perineum tissue under the mucous membrane of door.

Optionally, minor microstructure region separates and different from the first tissue region.

Optionally, the electric pulse for being transmitted to first electrode has the pulse different from the transmitting electric pulse of second electrode wide Degree, impulse amplitude or pulse frequency.

Optionally, be transmitted to first electrode electric pulse have with the pulse width of the electric pulse for being transmitted to second electrode, Impulse amplitude and pulse frequency

Equal pulse width, impulse amplitude and pulse frequency.

Optionally, device further comprises at least one sensor for being configured to obtain data, wherein the waveform occurs Device is configured so that the data modification is transmitted to the electric pulse of first electrode and is transmitted in the electric pulse of second electrode extremely It is one few.Sensor may include pressure sensor electrical activity sensors, impedance transducer, accelerometer or inclinometer.

Optionally, the device further comprise based on from the patient and come input modification be transmitted to the electricity of first electrode At least one of pulse and the electric pulse for being transmitted to second electrode.

Optionally, device further comprises transceiver, for passing through induction, radio frequency (RF), electricity, magnetic, light or other electromagnetism Coupling other than the body of patient to send and receive data and/or power.

Optionally, device further comprises for multiple stimulation parameters to be decoded and stored and generate the electric pulse Integrated circuit (IC) chip and for storing data with the programmable storage of stimulation parameter.

First electrode can be at least distally from the urethra internal sphincter at least 1cm of patient.

Second electrode can be at least distally from the urethra internal sphincter at least 1cm of patient.

This specification also discloses a kind of for improving the device of patient's urethra sphincter function, comprising: first electrode is matched It is set to contact the first tissue region, wherein the first tissue region is far from urethra internal sphincter at least 1cm；Second electrode is matched It is set to contact minor microstructure region, wherein the minor microstructure region is far from urethra internal sphincter at least 1cm；Waveform generator, It is connected to first electrode and second electrode, wherein waveform generator is configured to generate electric pulse to first electrode and second electrode, And wherein the electric pulse includes the pulse width with 10 μ s to 500ms；1 microampere to 100 milliamperes of impulse amplitude；With The pulse frequency of 0.02Hz to 100Hz；The pulse width for the pulse for being wherein used to transmit to first electrode and second electrode, Impulse amplitude, pulse frequency and duty cycle are defined so that, after the application electric pulse, are become by weight in absorption pad Change measurement urine volume than no electric pulse the application when urine volume be reduced at least 5 percent.

The first tissue region may include rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, It is included about in nervus pudendus or nervus pudendus branch, joint longitudinal muscle, the superficial part of external sphincter muscle of anus or deep part, anus Flesh, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), rectum anus At least one of (corpusculum tactus) clump and perineum tissue under the mucous membrane of door.

Minor microstructure region may include rectum longitudinal muscle, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, It is included about in nervus pudendus or nervus pudendus branch, joint longitudinal muscle, the superficial part of external sphincter muscle of anus or deep part, anus Flesh, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, circular muscle clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), rectum anus At least one of (corpusculum tactus) clump and perineum tissue under the mucous membrane of door.

Optionally, minor microstructure region separates and different from the first tissue region.

Optionally, the electric pulse for being transmitted to first electrode has the pulse different from the transmitting electric pulse of second electrode wide Degree, impulse amplitude or pulse frequency.

Optionally, be transmitted to first electrode electric pulse have with the pulse width of the electric pulse for being transmitted to second electrode, Impulse amplitude and equal pulse width, impulse amplitude and the pulse frequency of pulse frequency.

Optionally, device further comprises at least one sensor for being configured to obtain data, wherein the waveform occurs Device is configured so that the data modification is transmitted to the electric pulse of first electrode and is transmitted in the electric pulse of second electrode extremely It is one few.Sensor may include pressure sensor electrical activity sensors, impedance transducer, accelerometer or inclinometer.

This specification also discloses a kind of for improving the device of patient's urethra sphincter function, comprising: first electrode is matched It is set to contact the first tissue region, wherein the not same urethra internal sphincter material contact in the first tissue region；Second electrode, Be configured to contact minor microstructure region, wherein the minor microstructure region not with urethra internal sphincter material contact；Waveform occurs Device is connected to first electrode and second electrode, and wherein waveform generator is configured to generate electric arteries and veins to first electrode and second electrode Punching, and wherein the electric pulse includes the pulse width with 10 μ s to 500ms；1 microampere to 100 milliamperes of impulse amplitude；With The pulse frequency of 0.02Hz to 100Hz；The pulse width for the pulse for being wherein used to transmit to first electrode and second electrode, Impulse amplitude, pulse frequency and duty cycle are defined so that incontinence attack times or average incontinence amount of breaking out every time are decreased to Few 5 percent.

In one embodiment, present specification describes a kind of methods for treating patient anus rectal dysfunction, including Following steps: providing a device, includes at least the first electrode and second electrode for being operatively coupled to stimulation generator, the thorn Sharp generator is configured to receive at least one stimulus signal from controller；Described device is implanted to the anal orifice and rectal intestine tissue of patient In；The first object tissue first electrode being positioned as in the anorectal areas with patient is electrically connected；By described second Electrode is positioned as the second destination organization in the anorectal areas with patient and is electrically connected, wherein second destination organization and institute First object tissue is stated to distinguish and different；So that the controller is based on the first programmed algorithm and generates the first stimulus signal, and The second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator；With stimulation generator in response to the One stimulus signal, which is generated, is transmitted to the first electric stimulation pulse of the first object tissue via the first electrode, and in response to Second stimulus signal generates the second boost pulse that second destination organization is transmitted to via the second electrode.

In one embodiment, the first object tissue and second destination organization are from chosen below: rectum it is vertical It walks flesh, the circular muscle of rectum, the muscular layer of mucosa of rectum, the submucosa nervus pudendus of rectum or nervus pudendus branch and combines to indulge away Flesh, the part of external sphincter muscle of anus superficial or deep part, musculus sphincter ani internus, the muscular layer of mucosa of anal canal, subserous plexus (subserosal plexus), longitudinal muscle clump, circular muscle clump, gland Zhou Cong (periglandular plexus), myenteric plexus (corpusculum tactus) clump under (myenteric nerve plexus) or the mucous membrane of anorectum.

In one embodiment, the first stimulation algorithm and second algorithm are programmable and generate pulse sequence Column, wherein the pulse train can be changed in the following areas: the number of pulses of each pulse train, the pulse form in pulse train Shape, the interval between the repetition of pulse train, the duration of each pulse, the timing and width of pulse in each sequence Degree, the desired amount of the magnitude of current or potential to be offered and the shape of each sequence, wherein shape be from square, rectangle, sine Any one selected in shape or zigzag.

In one embodiment, the first stimulation algorithm is identical as the second stimulation algorithm.In another embodiment, The first stimulation algorithm is different from the second stimulation algorithm.

In one embodiment, the first stimulation arithmetic programming is into device, and to be automatically passed to patient, and the second stimulation is calculated Method is transmitted using external input by patient.The first stimulation of transmitting mainly to adjust the function of musculus sphincter ani internus, and transmits the Two stimulation algorithms, mainly to adjust the function of external sphincter muscle of anus.First stimulation algorithm is continuous or is transmitted with aturegularaintervals, and the Two stimulation algorithms intermittently transmit as needed.

In one embodiment, wherein the first and second stimulation algorithms are identical, identical stimulation algorithm passes through each electricity Pole transmitting, and an electrode is used as impolarizable electrode and another electrode is used as super polarizing electrode.In one embodiment, it is expected When stimulating musculus sphincter ani internus, the electrode near musculus sphincter ani internus will be impolarizable electrode.In one embodiment, it is expected When stimulating external sphincter muscle of anus, the electrode near external sphincter muscle of anus will be impolarizable electrode and another electrode will be hyperpolarization electricity Pole.

In one embodiment, described device further comprises at least one sensor, wherein the sensor detect to A few parameter, further wherein, the data obtained by the sensor are for modifying the first stimulation algorithm and/or institute State the second stimulation algorithm.In one embodiment, the sensor includes pressure sensor, electrical activity sensors, impedance sensing Device, accelerometer or inclinometer.

In one embodiment, described device further comprises controller, which is to be grasped by the patient Make, wherein patient can modify and activate the first stimulation algorithm and/or second algorithm.

In one embodiment, patient is provided with hand-held device, to start to stimulate, and in another embodiment, Huan Zheke Operation is executed, is sensed by internal sensor, to trigger the transmitting specifically stimulated.For example, patient can start to squeeze, lead to Internal pressure sensor sensing is crossed, to transmit the stimulation for being exclusively used in external sphincter muscle of anus, to promote external sphincter muscle of anus tension.

In another embodiment, device can clinical symptoms, manometry in rectum data or other clinical or researchs based on patient Data programming, to compile the dedicated stimulation algorithm of patient.

In one embodiment, two or more stimulation algorithms can be used for different function.For example, being configured to promote muscle The stimulation algorithm of power can with prevent pulse, to prevent the feeling come by the rectum of patient or anal canal, to prevent patient's excretion Impulsion.

In one embodiment, present specification describes a kind of devices, for treating the Anorectal and sphincter dysfunction of patient, It include: microcontroller, including being used for by way of induction, radio frequency (RF), electricity, magnetic, optics or other electromagnetic couplings from patient The transceiver of data and/or power is received and transmitted other than body；Integrated circuit (IC) chip, for multiple stimulation parameters into Row decodes and stores and generate multiple boost pulses；And programmable storage, for storing data, stimulation and control parameter group； Stimulate generator；Power supply；With at least two electrodes, for implantation into anal orifice and rectal intestine tissue and anal orifice and rectal intestine tissue is stimulated.

In one embodiment, the device for treating patient anus rectal dysfunction further comprises as described above At least one sensor.In one embodiment, device further comprises for device to be anchored in rectum or anal canal extremely A few anchoring piece.In one embodiment, device further comprises controller, is designed as operating by the patient, such as It is upper described.

In one embodiment, present specification describes for by micro device be implanted into anorectum in conduit device, It include: long narrow sheath, with proximal open end and distal open end；Long narrow pusher slidably moves in the sheath, packet It includes: proximal end and distal end；Sharp turning head, close to the distal end；With at its distal end and far from described sharp The attachment point of turning head, for being attached the micro device.

In one embodiment, present specification describes for the device in subsidiary minute device implantation anorectum, packet It includes: conical distal part, comprising: distal end and proximal end, wherein the distal end has than the proximal end Smaller diameter；Rectangular duct, for capturing a part of anal orifice and rectal intestine tissue；Opening, in the distal end；With it is movable Valve covers the opening at the distal end；Cylindrical proximal end part, comprising: distal end and proximal end, wherein institute It states distal end and is attached to the proximal end of the distal portions and in communication；And handle；One mechanism is used to form pumping It inhales, to extract a part of anal orifice and rectal intestine tissue by conduit and distal end portion；And channel, extend through the proximal part And enter the distal portions, for allowing conduit or needle to pass through.Optionally, and applying suction to described device from external source Vacuum is provided.Optionally, instrument is used to measure and standardize to being formed by vacuum capacity.

In one embodiment, this specification describes a kind of for micro device to be implanted into the anorectal areas of patient Method, comprising the following steps: provide an insertion apparatus, the insertion apparatus includes: conical distal part comprising: it is remote End and proximal end are held, wherein the distal end has than the proximal end smaller diameter；Rectangular duct, for catching Catch a part of anal orifice and rectal intestine tissue；Opening, in the distal end；And movable valve, it covers described at the distal end Opening；Cylindrical proximal end part, comprising: distal end and proximal end, wherein the distal end is attached to the distal portion Point the proximal end and in communication；And handle；One mechanism is used to form suction, to pass through conduit and distal end portion Extract a part of anal orifice and rectal intestine tissue；And channel, it extends through the proximal part and enters the distal portions, for allowing Conduit or needle pass through；A conduit is provided, the conduit includes: long narrow sheath, has proximal open end and distal open end；It is long narrow to push away Dynamic device, slidably moves in the sheath, comprising: proximal end and distal end；Sharp turning head, close to the distal end； With at its distal end and far from it is described it is sharp turning head attachment point, for being attached the micro device；Insertion apparatus is inserted Enter the rectum of patient；Suction is formed, a part of anal orifice and rectal intestine tissue is extracted into the insertion apparatus；The conduit is inserted Enter in the channel of the insertion apparatus；The pusher with the micro device being attached is allowed to extend past the sheath Distal open end, so that the sharp elbow part that turns is expanded；The pusher is withdrawn into the sheath, so that described miniature It sets to become to engage with anal orifice and rectal intestine tissue；The pusher is completely retracted into the sheath so that the micro device with The pusher is separated and is retained in the anal orifice and rectal intestine tissue；It is shifted onto described in the insertion apparatus, to discharge anus The part of rectal tissue；It is removed with by the insertion apparatus from the rectum of patient.

In one embodiment, present specification describes the systems for treating patient anus rectal dysfunction, comprising: At least one electric medical device, the electricity medical device includes microcontroller, and the microcontroller includes for passing through induction, penetrating Frequently the mode of (RF), electricity, magnetic, ultrasound, optics or other electromagnetic couplings receives other than patient body and transmits data and/or function The transceiver of rate；Integrated circuit (IC) chip, for multiple stimulation parameters to be decoded and stored and generate multiple stimulation arteries and veins Punching；And programmable storage, for storing data, stimulation and control parameter group；Stimulate generator；Power supply；With at least two electricity Pole for implantation into anal orifice and rectal intestine tissue and stimulates anal orifice and rectal intestine tissue；Conduit, it is described for being implanted into the electric medical device Conduit includes: long narrow sheath, with proximal open end and distal open end；Long narrow pusher slidably moves in the sheath, It include: proximal end and distal end；Sharp turning head, close to the distal end；With at its distal end and far from described The attachment point of sharp turning head, for being attached the micro device；And insertion apparatus, for assisting the implantation, the insertion dress Setting includes: conical distal part, comprising: distal end and proximal end, wherein the distal end has than the proximal end The smaller diameter of end；Rectangular duct, for capturing a part of anal orifice and rectal intestine tissue；Opening, in the distal end；With can Dynamic valve, covers the opening at the distal end；Cylindrical proximal end part, comprising: distal end and proximal end, wherein The distal end is attached to the proximal end of the distal portions and in communication；And handle；One mechanism, is used to form Suction, to extract a part of anal orifice and rectal intestine tissue by conduit and distal end portion；And channel, extend through the close end Divide and enter the distal portions, for allowing conduit or needle to pass through.

A kind of method for treating patient's urinary dysfunction is also disclosed in this specification, comprising the following steps: a device is provided, It includes at least the first electrode and second electrode for being operatively coupled to stimulation generator, which is configured to from control Device receives at least one stimulus signal；Described device is implanted into patient body；The first electrode is positioned as the institute with patient The first object tissue stated in anal orifice and rectal intestine tissue or genitourinary tissue is electrically connected；The second electrode is positioned as and is suffered from The second destination organization in the anal orifice and rectal intestine tissue or genitourinary tissue of person is electrically connected, wherein second destination organization with The first object tissue distinguishes and difference；So that the controller is based on the first programmed algorithm and generates the first stimulus signal, And the second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator；With stimulation generator in response to First stimulus signal generates the first electric stimulation pulse that the first object tissue is transmitted to via the first electrode, and responds The second boost pulse that second destination organization is transmitted to via the second electrode is generated in the second stimulus signal.

First object tissue and the second destination organization can be from chosen below: the circular muscle, straight of the longitudinal muscle of rectum, rectum The muscular layer of mucosa of intestines, the submucosa nervus pudendus of rectum or nervus pudendus branch combine longitudinal muscle, external sphincter muscle of anus superficial Part or deep part, musculus sphincter ani internus, the muscular layer of mucosa of anal canal, subserous plexus (subserosal plexus), indulge away Flesh clump, circular muscle clump, gland Zhou Cong (periglandular plexus), myenteric plexus (myenteric nerve plexus) or anorectum The genitourinary tissue of (corpusculum tactus) clump or patient under mucous membrane.

First stimulation algorithm and the second algorithm can program and generate pulse train, wherein the pulse train is with lower section Face is variable: the number of pulses of each pulse train, the pulse shape in pulse train, the interval between the repetition of pulse train, The duration of each pulse, the timing and amplitude of pulse, the expectation of the magnitude of current or potential to be offered in each sequence The shape of amount and each sequence, wherein shape be from square, select in rectangle, sinusoidal or zigzag any one.

First stimulation algorithm can be identical or different with the second stimulation algorithm.

Optionally, device further comprises at least one sensor, wherein the sensor detects at least one parameter, into The data that one step is wherein obtained by the sensor are calculated for modifying the first stimulation algorithm and/or second stimulation Method.Sensor may include pressure sensor electrical activity sensors, impedance transducer, accelerometer or inclinometer.

Optionally, device further comprises controller, which is to be operated by the patient, wherein patient's energy Modify and activate the first stimulation algorithm and/or second algorithm.

A kind of device is also disclosed in this specification, for treating the urinary dysfunction of patient, comprising: microcontroller, including For receiving and transmitting other than patient body by way of induction, radio frequency (RF), electricity, magnetic, optics or other electromagnetic couplings The transceiver of data and/or power；Integrated circuit (IC) chip, for multiple stimulation parameters to be decoded and stored and are generated Multiple boost pulses；And programmable storage, for storing data, stimulation and control parameter group；Stimulate generator；Power supply；With At least two electrodes, for implantation into patient anal orifice and rectal intestine tissue or genitourinary tissue and it is stimulated.

Optionally, device further comprises at least one sensor, wherein the sensor includes pressure sensor, electricity work Dynamic sensor, impedance transducer, accelerometer or inclinometer.

Optionally, device further comprises at least one anchoring piece for being anchored at device in rectum or anal canal.

Optionally, device further comprises controller, which is to be operated by the patient, wherein patient's energy Modify and activate the first stimulation algorithm and/or second algorithm.

A kind of method for adjusting patient anus internal sphincter function is also disclosed in this specification, comprising the following steps: provides one Device, includes at least the first electrode and second electrode for being operatively coupled to stimulation generator, which is configured to from control Device processed receives electric signal；Described device is implanted in the anal orifice and rectal intestine tissue of patient；The first electrode is positioned as and is suffered from First object tissue in the anorectal areas of person is electrically connected；The second electrode is positioned as the anal orifice and rectal intestine area with patient The second destination organization in domain is electrically connected, wherein second destination organization it is identical as the first object tissue or distinguish and It is different.So that the controller is based on stimulation algorithm by programming and generates electro photoluminescence, which is passed to stimulation generator, The stimulation generator generates electric stimulation pulse in response to electric signal, wherein the electric stimulation pulse is suitable for adjusting musculus sphincter ani internus Function can remain to continue after this stimulation stopping.

The adjusting of musculus sphincter ani internus function can stop continuing at least 5 minutes in stimulation.

A kind of method for adjusting patient anus internal sphincter function is also disclosed in this specification, comprising the following steps: provides one Device, includes at least the first electrode and second electrode for being operatively coupled to stimulation generator, which is configured to from control Device processed receives electric signal；Described device is implanted in the anal orifice and rectal intestine tissue of patient；The first electrode is positioned as and is suffered from First object tissue in the anorectal areas of person is electrically connected；The second electrode is positioned as the anal orifice and rectal intestine area with patient The second destination organization in domain is electrically connected, wherein second destination organization it is identical as the first object tissue or distinguish and It is different.So that the controller is based on stimulation algorithm by programming and generates electro photoluminescence, which is passed to stimulation generator, The stimulation generator generates electric stimulation pulse in response to electric signal, wherein the electric stimulation pulse is suitable for adjusting musculus sphincter ani internus Function, wherein this adjusting of musculus sphincter ani internus function is further adjusted by proctectasia.

The additional adjusting of musculus sphincter ani internus function can be realized due to stimulation by expansion, Elementary Function is adjusted Increased or decrease at least 10%.

A kind of method for treating patient's urinary dysfunction is also disclosed in this specification, comprising the following steps: one device of implantation, It includes the multiple electrodes for being operatively coupled to electro photoluminescence generator and being placed near patient anus rectal tissue；Described in making Stimulate generator via the anal orifice and rectal intestine tissue of the electrodes transfer electric pulse to patient, to cause the anus to patient straight The stimulation of intestinal tissue；Wherein the delivering of the electric pulse significantly adjusts urinary function.

Stimulate generator that can transmit electric pulse by second electrode, significantly to adjust sphincter urethrae pressure.

A kind of method for adjusting patient's urethra sphincter function is also disclosed in this specification, comprising the following steps: implantable stimulation Generator, wherein the stimulation generators operative be connected to first electrode and second electrode and be configured to receive from controller Electric signal；The first electrode is implanted near the anorectal areas of patient；It is another in patient anus rectal area Areas adjacent is implanted into the second electrode.So that the controller, stimulates algorithm based on the first programming, generation is transmitted to stimulation and produces First electro photoluminescence of raw device, which generates the first electric stimulation pulse in response to the first electric signal, wherein described first Electric stimulation pulse is suitable for adjusting anorectal function；With make the controller, based on second programming stimulate algorithm, generate transmitting To the second electro photoluminescence of stimulation generator, which generates the second electric stimulation pulse in response to the second electric signal, wherein Second electric stimulation pulse is suitable for adjusting urinary function；Wherein transmit first electric stimulation pulse and second electro photoluminescence Pulse significantly adjusts compound anal orifice and rectal intestine and urinary function.

A kind of method for needing to adjust its anal orifice and rectal intestine impairment property by main body is also disclosed in this specification, comprising: provides electricity Signal；It is transmitted to a part of region comprising the anorectum and process certain duration with by electric signal, wherein described Region includes anal sphincter and above the anal sphincter at 5cm, to stimulate anal sphincter and improve anorectal anomaly Symptom, wherein the electric signal is adapted so that the symptom reduces, with maintained after stimulation stops at least 24 hours when Between.

Duration can be greater than 24 hours.

Electric signal can be accomplished continuously or intermittently.

A kind of method for needing to adjust its anal sphincter function by main body is also disclosed in this specification, comprising: provides telecommunications Number；It is transmitted to a part of region comprising the anorectum and process certain duration with by electric signal, wherein the area Domain includes anal sphincter and above anal sphincter or at radially around anal sphincter 5cm, to stimulate anal sphincter And improve sphincter function, wherein the electric signal is adapted so that the sphincter function improves, to tie up after stimulation stops Hold at least 24 hours time.

Duration can be greater than 24 hours.

Electric signal can be accomplished continuously or intermittently.

A kind of method for needing to adjust its anal sphincter function by main body is also disclosed in this specification, comprising: provides telecommunications Number；It is transmitted to a part of region comprising anorectum and process certain duration with by electric signal, wherein the region is wrapped Anal sphincter is included and around radial 5cm, or close to anal sphincter, to stimulate anal sphincter and improve sphincter function Can, wherein the electric signal is suitable for that the sphincter function is caused to improve, to be kept after stimulation stops at least one hour Time.

Duration can be greater than one hour.

Electric signal can be accomplished continuously or intermittently.

A kind of method for treating patient's urinary dysfunction is also disclosed in this specification, comprising the following steps: a device is provided, It includes at least at least one electrode for being operatively coupled to stimulation generator；Described device is implanted in patient anus rectal area Domain nearby and by the electrode is positioned as being electrically connected with the destination organization in patient anus rectal area；With the stimulation is produced Raw device is to generate electro photoluminescence, wherein the electro photoluminescence is via the electrodes transfer to the destination organization；The wherein electro photoluminescence Improve urinary function.

A kind of method for needing to adjust its sphincter urethrae function by main body is also disclosed in this specification, comprising: provides telecommunications Number；It is transmitted to a part of region comprising anorectum and process certain duration with by electric signal, wherein the region is wrapped Anal sphincter is included and around radial 5cm, to stimulate anal sphincter and improve the sphincter function of urine, wherein the telecommunications Number it is suitable for that the sphincter function of the urine is caused to improve, to be kept at least one 24 hours time after stimulation stopping.

Duration can be greater than 24 hours.

Electric signal can be accomplished continuously or intermittently.

A kind of method for needing to adjust its sphincter urethrae function by main body is also disclosed in this specification, comprising: provides telecommunications Number；It is transmitted to a part of region comprising anorectum and process certain duration with by electric signal, wherein the region is wrapped Anal sphincter is included and around radial 5cm, to stimulate anal sphincter and improve the sphincter function of urine, wherein the telecommunications Number it is suitable for that the sphincter function of the urine is caused to improve, to be kept at least one hour time after stimulation stopping.

Duration can be greater than one hour.

Electric signal can be accomplished continuously or intermittently.

A kind of method for treating patient's sex dysfunction is also disclosed in this specification, comprising the following steps: one device of implantation, Including the multiple electrodes for being operatively coupled to electro photoluminescence generator and being placed near patient anus rectal tissue；With make the thorn Generator is swashed via the anal orifice and rectal intestine tissue of the electrodes transfer electric pulse to patient, causes the anal orifice and rectal intestine group to patient The stimulation knitted, wherein transmitting the significant the treatment of sexual dysfunction of the electric pulse.

A kind of method for treating patient's sex dysfunction is also disclosed in this specification, comprising the following steps: one device of implantation, Including the multiple electrodes for being operatively coupled to electro photoluminescence generator and being placed near patient's genitourinary tissue；Described in making Generator is stimulated via the genitourinary tissue of the electrodes transfer electric pulse to patient, causes the uropoiesis to patient raw The stimulation of device tissue is grown, wherein transmitting the significant the treatment of sexual dysfunction of the electric pulse.

Optionally, stimulation is generated for urinary function gut function or sexual function timing.Optionally, stimulation is independently of secreting Function, gut function or sexual function transmitting are urinated, and at least realizes changing at least one of above-mentioned function after single stimulation It is kind, it can also continue other than stimulus duration.

Optionally, transmitting stimulation to improve urinary function, gut function or sexual function at once.Optionally, transmitting stimulation with Time improves urinary function, gut function or sexual function at leisure.Optionally, the improvement of one of above-mentioned function is in stimulation beginning Occur at least 5 minutes afterwards.

This specification also discloses the device for improving patient's sexual function, comprising: first electrode is configured to contact first Tissue regions；Second electrode is configured to contact minor microstructure region；Waveform generator is connected to first electrode and second electrode, Wherein waveform generator is configured to generate electric pulse to first electrode and second electrode, and wherein the electric pulse includes having 10 The pulse width of μ s to 500ms；1 microampere to 100 milliamperes of impulse amplitude；With the pulse frequency of 0.02Hz to 100Hz；Wherein use In the pulse width for the pulse transmitted to first electrode and second electrode, impulse amplitude, pulse frequency and duty cycle limit Be set to so that, after electric pulse application: living by patient's daily log measurement success at any time or satisfactory property Dynamic number is relative to by patient daily log measurement success at any time or making us full before the application of the electric pulse The sexuality number increase at least 5 percent of meaning；Sex dysfunction questionnaire (SDQ) scores relative to the sexual function before stimulation Obstacle questionnaire (SDQ) scoring improves at least 5 percent；By the sexual desire of the daily log measurement of patient than increasing at least before stimulation 5 percent；Or Golombok Rust sexual satisfaction questionnaire (GRISS) scoring is relative to the Golombok before stimulation Rust sexual satisfaction questionnaire (GRISS) scoring improves at least 5 percent.

The above and other embodiment of this specification is described in more detail referring to attached drawing and is described in detail as follows.

Detailed description of the invention

When being associated with appended drawings reading, these and other objects and advantage of this specification become from described in detail below It becomes apparent from, attached drawing has the same reference numerals for showing corresponding portion in attached drawing, in which:

Fig. 1 is the sectional view of rectum and anal canal；

Fig. 2 is the sectional view of the muscle systems of the side of lower part rectum and anal canal；

Fig. 3 A is the cross-sectional view of lower part colon, it is shown that the neuropile in rectum and anal canal wall；

Fig. 3 B is the internal organ of women underbelly and pelvis and the sectional view of innervation；

Fig. 3 C is the figure of female perineum body；

Fig. 3 D is the figure of male perineum body；

Fig. 3 E is showing first figure in the motion control path of genitourinary tract, it is shown that the Onuf in backbone Core；

Fig. 3 F is showing second figure in the motion control path of genitourinary tract, it is shown that the Onuf in backbone Core；

Fig. 3 G is showing the third figure in the motion control path of genitourinary tract, it is shown that the Onuf in backbone Core；

Fig. 3 H is showing the 4th figure in the motion control path of genitourinary tract, it is shown that the Onuf in backbone Core；

What the parasympathetic nerve and sympathetic nerve that Fig. 3 I is showing colon, rectum, bladder and urethra internal sphincter dominated Figure；

Fig. 4 is the signal according to the medical micro device of the implantable electricity of the illustrative programmable of this specification one embodiment Figure；

Fig. 5 is the one of the exemplary electrode group for the micro device being implanted in the musculus sphincter ani internus and muscular layer of mucosa of anal canal The figure of a embodiment；

Fig. 6 is the micro device being implanted in the superficial part and deep part and musculus sphincter ani internus of external sphincter muscle of anus Exemplary electrode group one embodiment figure；

Fig. 7 is implantation and the micro device close to nervus pudendus branch in the circular muscle, musculus sphincter ani internus of rectum The figure of one embodiment of exemplary electrode；

Fig. 8 is the one of the exemplary electrode group of the submucosa of implantation rectum and the micro device in the branch of nervus pudendus The figure of a embodiment；

Fig. 9 is one of the exemplary electrode group of the circular muscle of implantation rectum and the micro device in the branch of nervus pudendus The figure of embodiment；

Figure 10 is the micro device being implanted into the circular muscle of rectum and the superficial part and deep part of external sphincter muscle of anus Exemplary electrode group one embodiment figure；

Figure 11 A is one of the exemplary electrode group for the micro device being implanted into the circular muscle and musculus sphincter ani internus of rectum The figure of embodiment；

Figure 11 B is the one of the exemplary electrode group for the micro device being implanted into female patient back (back side of patient spine) The figure of a embodiment；

Figure 11 C is lower abdominal region and the pelvis area of the patient according to some embodiments of this specification, and which show be used for The target area of electro photoluminescence and the figure in purpose effect region；

Figure 11 D be showing to anal orifice and rectal intestine and/or apparatus urogenitalis structure provide stimulation in be stimulated same or The flow chart of some embodiment steps involved of effect is formed in different structure；

Figure 12 A is the figure of one embodiment of exemplary insertion apparatus, it is shown that pull downward on the plunger of insertion apparatus with The step of forming vacuum and being consequently inhaled a part of anal orifice and rectal intestine tissue；

Figure 12 B is the top view of the same embodiment of the exemplary insertion apparatus of Figure 12 A, it is shown that is drawn into device A part of anal orifice and rectal intestine tissue；

Figure 12 C is the figure of the same embodiment of the exemplary insertion apparatus of Figure 12 A, it is shown that by the plunger of insertion apparatus to The step of above pushing away to discharge anal orifice and rectal intestine tissue；

Figure 13 A is the figure of one embodiment of implantation catheter representative configuration, have in the conduit it is main each other The pusher of parallel arrangement and attached micro device；

Figure 13 B is the figure of the same embodiment of the representative configuration of Figure 13 A implantation catheter, it is shown that is pushed away using pusher The micro device of the conduit out；

Figure 13 C is the figure of the same embodiment of the representative configuration of the implantation catheter of Figure 13 A, it is shown that is completely pushed out of institute State the micro device of conduit；

Figure 13 D is the figure of the same embodiment of the representative configuration of the implantation catheter of Figure 13 A, it is shown that is pulled back to described Pusher in conduit；

Figure 13 E is the figure of the same embodiment of the representative configuration of the implantation catheter of Figure 13 A, it is shown that is withdrawn into completely Thus pusher in the conduit is disconnected from the micro device in implanting tissue position；

Figure 14 A is the figure of one embodiment of the representative configuration of implantation catheter, it is shown that is located in the intestinal mucosa of patient The neighbouring conduit；

Figure 14 B is the figure of the same embodiment of the representative configuration of the implantation catheter of Figure 14 A, it is shown that micro device is pushed away Conduit is for the step of implantation out；

Figure 14 C is the figure of the same embodiment of the representative configuration of the implantation catheter of Figure 14 A, it is shown that due to bending part The step of straightening and micro device be deployed in tissue location deeper inside；

Figure 14 D is the figure of the same embodiment of the representative configuration of the implantation catheter of Figure 14 A, it is shown that by micro device Discharge the step of rear tube at tissue location is pulled away from；

Figure 15 is placed in the anorectal areas of patient with the one of the exemplary insertion apparatus delivered for micro device The figure of a embodiment；

Figure 16 is the one embodiment for the micro device that electrode group has been attached being implanted in ano-rectal mucosae lower layer Figure；

Figure 17 is the figure of this specification one embodiment, it is shown that using hypodermic needle, implantable miniature is filled in female patient The method set；

Figure 18 A is showing according to this specification one embodiment by outside to musculus sphincter ani internus (IAS) and anus Sphincter (EAS) carries out exemplary selection stimulation and the figure of the exemplary force curve of acquisition；

Figure 18 B, which is showing, to be started during stimulation according to this specification one embodiment and has stopped it in stimulation The figure that still lasting musculus sphincter ani internus pressure rises afterwards；

Figure 19 A is with one embodiment including anode end portions electrode and the micro device of the central electrode including cathode Figure；

Figure 19 B is with one embodiment including cathode end electrode and the micro device of the central electrode including anode Figure；

Figure 19 C is with the tip electrodes including anode and cathode and the micro device without polar central electrode The figure of one embodiment；

Figure 20 is showing according to this specification one embodiment by including outside to urethra internal sphincter (IUS) and urethra About flesh (EUS) carries out exemplary selection stimulation and the figure of the exemplary force curve of acquisition；

Figure 21 is the table for sex dysfunction questionnaire (SDQ), list with scoring about patient's sexual behaviour A series of statements；

Figure 22, which is showing when using the system and method for this specification, to be measured to determine that incontinence of faces improves each The table of kind parameter；

Figure 23 A is showing the table of the method for the various points-scoring systems of measurement incontinence of faces；

Figure 23 B is showing another table of the method for the various points-scoring systems of measurement incontinence of faces；

Figure 24 is the representative figure for measuring the high-resolution technique of anorectal manometry art of incontinence of faces parameter；

Figure 25 is showing the flow chart that the method for patient's urinary dysfunction is treated according to the embodiment of this specification；

Figure 26 is showing the flow chart of the method for the treatment of patient's bowel movement function obstacle according to the embodiment；

Figure 27 is showing the flow chart for the treatment of patient's bowel movement function obstacle according to another embodiment of this specification；

Figure 28 is showing the method flow diagram for adjusting patient anus sphincter function；

Figure 29 is showing the method flow diagram for the treatment of patient's urinary dysfunction according to another embodiment of this specification；

Figure 30 is showing the method flow diagram for the treatment of patient's urinary dysfunction according to another embodiment of this specification；

Figure 31 is showing the stream that the method for patient's defecation and urinary dysfunction is treated according to the embodiment of this specification Cheng Tu；

Figure 32 is showing to be hindered according to the treatment patient's bowel movement function obstacle and urinary function of another embodiment of this specification The method flow diagram hindered；

Figure 33 is showing the method flow diagram for the treatment of patient's urinary dysfunction according to another embodiment of this specification；

Figure 34 is showing the method flow diagram of the treatment female patient urinary dysfunction according to this specification embodiment；

Figure 35 is showing the method stream of the treatment female patient urinary dysfunction according to another embodiment of this specification Cheng Tu；

Figure 36 is showing the method flow diagram of the treatment female patient vagina dysfunction according to this specification embodiment；

Figure 37 is showing the method stream of the treatment female patient vagina dysfunction according to another embodiment of this specification Cheng Tu；

Figure 38 is showing the method flow diagram for the treatment of subjects reproductive's dysfunction according to this specification embodiment；

Figure 39 is showing the method flow for the treatment of patient's Genitourinary dysfunction according to this specification embodiment Figure；

Figure 40 is showing the side for needing to adjust main body sphincter urethrae function by main body according to this specification embodiment Method flow chart；

Figure 41, which is showing, needs to adjust main body sphincter urethrae function by main body according to another embodiment of this specification Method flow diagram；

Figure 42 is showing the method flow diagram for the treatment of patient's sex dysfunction according to this specification embodiment；

Figure 43 is showing the method flow diagram for the treatment of patient's sex dysfunction according to another embodiment of this specification；With

Figure 44 is showing the treatment female patient Genitourinary dysfunction according to this specification one embodiment Method flow diagram.

Specific embodiment

This specification is related to may be programmed implantable electric medical device, for treating various anal orifice and rectal intestines or apparatus urogenitalis Neuromuscular is abnormal, including incontinence of faces, constipation, the urinary incontinence and sex dysfunction.The electric medical device of this specification uses can The microcosmic stimulator (microstimulator) of implantation or macroscopical stimulator (macrostimulator), can be with the smallest It is invasive to be implanted into anorectal areas and/or genitourinary area.In one embodiment, each micro stimulator includes At least two electrodes, for transmitting electro photoluminescence at least two separated destination organizations.In one embodiment, electric medical device Including the electrode in intermediate common anode or cathode and two separation in each end, each of which has and center The opposite polarity of electrode.In another embodiment, device only has there are two electrode, and wherein stimulating electrode is based on the phase to be stimulated Hope regional choice.In various embodiments, electric medical device is implanted to the viscous of anorectal areas and/or genitourinary area Film, submucosa or muscularis propria.Preferably, electric medical device is implanted to submucous stratum of rectum and/or urogenital mucosa Lower layer.Submucous stratum of rectum and urogenital mucosa lower layer are low impedance layers.Submucous stratum of rectum is easy to intervene, and implantation is related to Minimum risk and wound.After being implanted into electric medical device, electrode is deployed to each specific mesh through endoscope or underwent operative Mark tissue.In various embodiments, using Technology design electrode as such as shape memory, to allow for structure appropriate It makes.Different length, shape or the construction of electrode enable them to better adapt to the positioning near desired target tissue.First Electrode is implanted or close to first object tissue and second electrode is implanted or close to the second destination organization.In one embodiment In, destination organization includes muscle and nerve in anorectal areas.In another embodiment, destination organization includes urogenital Muscle and nerve in device region.In various embodiments, destination organization includes the circular muscle, straight of the longitudinal muscle of rectum, rectum The muscular layer of mucosa of intestines, the submucosa nervus pudendus of rectum or nervus pudendus branch combine longitudinal muscle, external sphincter muscle of anus superficial Part or deep part, musculus sphincter ani internus, the muscular layer of mucosa of anal canal, subserous plexus (subserosal plexus), indulge away Flesh clump, circular muscle clump, gland Zhou Cong (periglandular plexus), myenteric plexus (myenteric nerve plexus) or anorectum (corpusculum tactus) clump under mucous membrane.The subcutaneous part of external sphincter muscle of anus is located at skin nearby and has the mind Chong Die with skin is above covered Through dominating, and therefore, the stimulation of its desirably subcutaneous part of external sphincter muscle of anus is minimized or is avoided by, so that with Related feeling is stimulated to minimize.

This specification further relates to the anal orifice and rectal intestine tissue or genitourinary tissue of two kinds of separation of stimulation, various for treating Anal orifice and rectal intestine or apparatus urogenitalis neuromuscular are abnormal, including incontinence of faces, constipation, the urinary incontinence and sex dysfunction.Various In embodiment, using identical or different stimulation algorithm, two kinds of destination organizations are selectively stimulated simultaneously, or in different moments It is stimulated.

For example, in one embodiment, being included about outside first electrode implantation musculus sphincter ani internus and second electrode implantation anus Flesh.Musculus sphincter ani internus is provided with the stimulation of first level, continuously applies.Meanwhile external sphincter muscle of anus is provided with Two horizontal stimulations, apply as required.Stimulate multiple destination organizations that can improve anus with identical or different stimulation algorithm Door rectum function simultaneously increases energy efficiency, while avoiding possessed fatigue and Commpensation And Adaptation in the prior art.In addition, it is necessary to more Few device and electrode, because separated object construction can be different from Different electrodes and device reception via algorithms of different Stimulation.Such as 200 μ s pulse more may be adapted to stimulate musculus sphincter ani internus, and the pulse of 3ms or 300ms more may be adapted to stimulate anus Sphincter outdoors.Therefore, the homemade expectation of holding can be realized by providing these different pulses with identical electrodes in different moments Clinical effectiveness.

This specification further relates to the conduit for being implanted into electric medical device.In one embodiment, the conduit include sheath and For being attached the pusher of electric medical device.Pusher has the sharp turning head (sharp bend) near its distal end. Pusher extends past the opening of sheath distal end, and the sharp elbow part that turns is allowed to stretch and expose electric medical device.Pusher It then returns in sheath, electric medical device is pushed into anal orifice and rectal intestine tissue.When pusher is withdrawn completely into sheath, electricity medical treatment dress It sets from its distal end and is detached from.

This specification further relates to the insertion apparatus delivered for subsidiary conduit and electric medical device is implanted into.In one embodiment In, insertion apparatus includes conical distal part and cylindrical proximal end part.In one embodiment, movable valve covers distal portion The opening at distal end divided.Distal portions include the conduit for capturing a part of anal orifice and rectal intestine tissue.Mechanism (such as column Plug) can in proximal part sliding motion, and be used to form aspirate and a part of anal orifice and rectal intestine tissue is drawn by conduit In distal portions.Alternatively, it can be used for engaging anal orifice and rectal intestine tissue using the external suction that pump carries out.Conduit as described above with Afterwards for being implanted into electric medical device.

Device also standard endoscope, laparoscope, directional operation or other medical technology known in the art can be used to place.

The present invention relates to multiple embodiments.The following contents is provided so that those skilled in the art can implement the present invention.This Language used in the specification should not be construed as to the general negation of any one specific embodiment or more than making herein Term limits claim.The General Principle limited herein can be applied to other embodiments and application, without departing from The spirit and scope of the present invention.In addition, the term and wording that use are for describing the purpose of exemplary embodiment without should It is considered restrictive.As a result, the present invention should be consistent with the principle and feature with covering many alternatives, modification Example, the widest range of equivalent are consistent.For purposes of clarity, technology material known to technical field related to the present invention The details of material need not be described in detail, so as not to can unnecessarily influence the present invention.

In specification and claims of this application requirements, word "include", "comprise" and " having " each and its it is various Form is not meant to be limited to component in list relevant to the word.It should be noted that description associated with specific embodiment is appointed What feature or component can be used and be implemented by any other embodiments, unless otherwise clearly describing.

It will be understood by those skilled in the art that normal anorectal function (including self-control) is a kind of mechanism of complexity, need The control of unconscious (subconsciousness) and autonomous (conscious) to sphincter ani system.Fig. 1 is rectum 140 and anal canal 145 Sectional view.Fig. 2 is the sectional view of the muscle systems of the side of lower part rectum 240 and anal canal 245.Fig. 3 A is the section view of lower part colon Figure, it is shown that the neuropile 360,370 in rectum and anal canal wall.Present referring also to Fig. 1 to 3, musculus sphincter ani internus 130,230 It is the smooth muscle through unconscious control, by (corpusculum tactus) neuropile 360 and myenteron neuropile under mucous membrane in intestinal wall (between flesh Neuropile) 370 innervation, and to the rest tension of sphincter (resting tone) be responsible for.External sphincter muscle of anus 150, 250 be the skeletal muscle by autonomous control, the innervation of perineal branches and inferior rectal nerves by the 4th sacral nerve, and to including about The extruding force of flesh and autonomous tension are responsible for.External sphincter muscle of anus be further classified as deep part 250a, superficial part 250b and Subcutaneous part 250c.Due to the composition of its smooth muscle, musculus sphincter ani internus 130,230 is less prone to fatigue and can produce for a long time Raw low-level pressure.On the other hand, external sphincter muscle of anus 150,250 is skeletal muscle and therefore can generate in a short time high Primary pressure.However, it is in several minutes of content fatiguabilities and is not able to maintain lasting high-tension.

The electronic stimulation method of this specification it will be appreciated that anus the internal and external sphincters in institutional framework and functionally It is different and requires different stimulations to realize optimal function.Musculus sphincter ani internus needs prolonged stimulation, to keep Basal tension is simultaneously prevented from anal leakage excrement and mucus.Because even there are the stimulation of lasting internal sphincter Normal defecation can also be realized, so sensing to defecation and be unnecessary to the inhibition of musculus sphincter ani internus stimulation.Anus External sphincter needs very brief stimulation, to generate extruding force, to overcome bowel movement urges.This specification is by for each target group It knits and different stimulation algorithms is provided and solves the continuous of external sphincter muscle of anus or stimulates caused fatigue and pain for a long time.

Mucous membrane down space is (corpusculum tactus) neuropile 360 under Low ESR space, including loose connective tissue and mucous membrane.Cause This, according to the one aspect of this specification, mucous membrane down space is considered to be easy to intervene to allow micro device to be implanted into and go back safely For being stimulated with the algorithm of more energy efficient.

Fig. 3 B is the internal organ of male's underbelly and pelvis and the sectional view of innervation, it is shown that sacral nerve 381, colon 382, Uterus 383, bladder 384, rectum 385, vagina 386, urethra 387, anus 388 and nervus pudendus 389.Fig. 3 C and 3D are female respectively The figure of property perineal body 301 and male perineum body 311.Fig. 3 E to 3H is showing the motion control path of genitourinary tract, Show the Onuf core 320 in backbone.

Fig. 3 I shows the parasympathetic nerve of colon 340, rectum 345, bladder 350 and urethra internal sphincter 355 and sympathetic Innervation.Colon 340 and rectum 345 have the parasympathetic innervation from pelvic nerve 342.Postganglionic neuron is The enteric nervous member of myenteric nerve plexus.Smooth muscle acceptor (smooth muscle receptors) is muscarine 3 (M3) and passes through second Activation caused by phatidylcholine increases the motility in these parts.In terms of sympathetic nerve, colon 340 is by mesenterium The innervation of ganglionic neuron and innervation of the rectum 345 by the nerve derived from inferior mesenteric ganglion.Go first Adrenaline is released from in conjunction with β 2 (B2) receptor on smooth muscle layer, to reduce its motility.In addition, coming from mesenterium Under neuron also to musculus sphincter ani internus carry out innervation, and discharge 1 receptor of α on norepinephrine so that tissue Middle tension increases.

The neural preganglionic neuron 343 of pelvic splanchnic nerve carries out innervation to the wall of bladder 350.They are by acetyl gallbladder Alkali is hidden on the cell body of the rear neuron in the intramural ganglion 352 in wall.Aixs cylinder 353 discharges acetyl gallbladder after neuromere Alkali, to activate 3 receptor of muscarine on smooth muscle cell.These cells are made a response by increasing its tension, so that bladder 350 are not amenable to fill.In terms of sympathetic nerve, the wall muscle systems of bladder 350 has beta 3 receptor, by from neural pitch chain And the innervation of the postganglionic neuron of the hypogastric nerve come.The beta 3 receptor of activation can reduce the muscle in bladder 350 Power helps to fill.

The smooth muscle (including urethra internal sphincter 355) of neck of urinary bladder has 1 receptor of α.By neural under mesenterium from being originated from The postganglionic neuron of section and come norepinephrine activated so that tension increase, facilitate the bladder in expansion Urine is kept in 350.

Fig. 4 is the signal of the medical micro device 400 of the implantable electricity of illustrative programmable according to an embodiment of the invention Figure.Micro device 400 includes stimulator or waveform generator 405, microcontroller 410, optional sensor module 415 and power supply 420, it is all these to be integrated into individual unit, for being easy to quickly deployed in the anorectal areas of patient.Stimulation Device 405, microcontroller 410 and sensor module 415 can use wired or wireless communication and communicate with one another.

Referring to fig. 4, the outer housing 402 of micro device 400 including biocompatibility sealing material, for example, it is glass, ceramics, poly- Close object, titanium or any other suitable material well known by persons skilled in the art.In one embodiment, microcontroller 410 includes: Transceiver, for being received other than the body of patient by way of induction, radio frequency (RF), electricity, magnetic, light or other electromagnetic couplings With transmission data and/or power；Integrated circuit (IC) chip, for multiple stimulation parameters to be decoded and stored and are generated more A boost pulse；And programmable storage, for storing data, stimulation and control parameter group.Programmable storage allows to pass through The mode of induction, radio frequency (RF) or other electromagnetic couplings adjusts stimulation and control parameter for each patient, to be pacified Entirely, effectively and make discomfort minimize setting.

Stimulator or waveform generator 405 are electrophysiological stimulation devices, can generate multiple expectation electric pulses, are suffered from for stimulating Appropriate nerve and/or muscle in the anorectal areas of person.Stimulator 405 generates multiple according to the guidance of microcontroller 410 Stimulating pulsatile series.In one embodiment, pulse train is programmable and its characteristic can change in the following manner: pulse sequence Number of pulses in column；Pulse shape in pulse train；Interval between pulse train repetition；Each pulse it is lasting when Between；The timing and amplitude of pulse in sequence；With the desired amount of the magnitude of current to be provided or potential, depending on patient symptom and It needs.Further, electro photoluminescence can have for generate expected result for necessary any shape, including rectangular, rectangle, Sinusoidal or zigzag.In one embodiment, desired boost pulse is transmitted by multiple stimulating electrodes 425.

In one embodiment, being triggered using the transmitter in exterior by patient is stimulated, and ability is similar to The long-range transmission of pacemaker known to field technique personnel.

In one embodiment, power supply includes micro device 400 is connected to via appropriate device (such as RF link) outer Portion's power supply.In another embodiment, power supply includes utilizing generation or any suitable device of storage energy from power supply 420 is accommodated Part, such as main battery, can feed or rechargeable battery, such as lithium ion battery, electrolytic capacitor etc..

In one embodiment, optional sensor module 415 uses multiple sensing electrodes 422, to detect multiple physiology ginsengs Number, such as pressure, electrical activity and impedance.In another embodiment, optional sensor module 415 includes accelerometer, with detection The change of patient position.In one embodiment, optional sensor module 415 includes inclinometer.Pass through optional sensor module 415 information collected are used to trigger the on-off circulation of stimulation and/or modification stimulation.

In one embodiment, micro device 400 further includes anchoring piece 428, and micro device 400 is made to anchor to patient Anorectal areas in appropriate location.Anchoring element 428 is fixed to micro device 400 by attachment 427.Implement at one In example, attachment 427 is shunk after deployment, and micro device 400 is deeper drawn in specific position or is bonded with wall, is thus mentioned For preferably keeping.

In one embodiment, multiple stimulating electrodes 425 and the conductivity ceramics of sensing electrode 422, conducting polymer and/or Noble metal or refractory metal manufacture.It will be understood by those skilled in the art that application, position or desired physiological stimulation are depended on, one Electrode can be used as sensing electrode and stimulating electrode.In various embodiments, sensing electrode 422 and anchoring piece 428 or stimulating electrode 425 and anchoring piece 428 can be identity element.In other embodiments, identity element may be used as stimulating electrode 425, sensing Electrode 422 and anchoring piece 428.

According to one embodiment of the treatment method of this specification, boost pulse is transmitted according to parameter:

Frequency=0.02Hz-100Hz；

- 100 milliamperes of amplitude=1 microampere；

Pulse width=1ms-1s；With,

Duty cycle < 100%

According to one embodiment, therapeutic scheme includes the continuous treatment of disconnection circulation by the connection circulation and stimulation of stimulation. For example, the muscular layer of mucosa and musculus sphincter ani internus of the continuous treatment anal canal of disconnection circulation for being recycled and being stimulated with the connection of stimulation.? In one embodiment, the connection circulation of stimulation is 1ms-23h and the disconnection circulation of stimulation is 1ms-23h.

Fig. 5 is the exemplary of the micro device 500 being implanted in the muscular layer of mucosa 535 and musculus sphincter ani internus 530 of anal canal The figure of one embodiment of electrode group 525,526.Micro device 500 is implanted into, so that first electrode 525 is close to musculus sphincter ani internus 530 and second electrode 526 close to anal canal 545 muscular layer of mucosa 535.

Fig. 6 be implanted into superficial part 650 and deep part 651 in external sphincter muscle of anus and musculus sphincter ani internus it is micro- The figure of one embodiment of the exemplary electrode group 625,626,627 of type device 600.Micro device 600 is implanted into, so that two the One electrode 626,625 is respectively near the superficial part 650 of external sphincter muscle of anus and deep part 651, and third electrode 627 leans on Nearly musculus sphincter ani internus 630.

Fig. 7 is implanted into the circular muscle, musculus sphincter ani internus 730 of rectum 741 and close to the micro- of 747 branch of nervus pudendus The figure of one embodiment of the exemplary electrode 725,726,729 of type device 700.Micro device 700 is implanted into, so that first electrode 725 close to rectum 741 cyclic annular muscle layer and second electrode 726 close to musculus sphincter ani internus 730.Third electrode 729 is placed in private parts Near the branch of nerve 747.

Fig. 8 be implanted into rectum 836 submucosa and nervus pudendus 847 branch in micro device 800 it is exemplary The figure of one embodiment of electrode group 825,826.Micro device 800 is implanted into, so that first electrode 825 is close to the viscous of rectum 836 The branch of film lower layer and second electrode 826 close to nervus pudendus 847.

Fig. 9 is the exemplary electrical for being implanted into the circular muscle of rectum 941 and the micro device 900 in the branch of nervus pudendus 947 The figure of one embodiment of pole group 925,926.Micro device 900 is implanted into, so that ring-type of the first electrode 925 close to rectum 941 The branch of muscle layer and second electrode 926 close to nervus pudendus 947.

Figure 10 is superficial part 1050 and the deep part 1051 for being implanted into the circular muscle and external sphincter muscle of anus of rectum 1041 In micro device 1000 exemplary electrode group 1025,1026,1029 one embodiment figure.Micro device 1000 is planted Enter, so that cyclic annular muscle layer of the first electrode 1025 close to rectum 1041, and second electrode 1026 is close to external sphincter muscle of anus 1050 Superficial part and third electrode 1029 close to external sphincter muscle of anus 1051 deep part.

Figure 11 A is the exemplary of the micro device 1100 being implanted into the circular muscle and musculus sphincter ani internus 1130 of rectum 1141 The figure of one embodiment of electrode group 1125,1126.Micro device 1100 is implanted into, so that first electrode 1125 is close to rectum 1141 Cyclic annular muscle layer and second electrode 1126 close to musculus sphincter ani internus 1130.

Figure 11 B is the exemplary electrode group for the micro device 1110 being implanted into female patient back (back side of patient spine) 1145, the figure of 1146 one embodiment.Micro device 1110 is implanted into, so that first electrode 1145 is close to nervus pudendus 1149 The second part 1149b of first part 1149a and second electrode 1146 close to nervus pudendus 1149.

In various embodiments, subject description discloses by the abdomen of patient, anal orifice and rectal intestine or apparatus urogenitalis area Domain implantable stimulation device and at least one destination organization into any one or more of described anatomic region provide electricity and pierce Swash the method to treat the urinary incontinence and/or incontinence of faces, is such as further described below.In various embodiments, stimulating apparatus Including controller and the stimulation generator communicated with controller.At least one electrode with stimulation generator be electrically connected and be configured to At least one destination organization provides electro photoluminescence.Algorithm generates stimulus signal to controller based on programming, is transmitted to stimulation generator. Generator generates electric stimulation pulse in response to signal, and the electric stimulation pulse is via at least one electrodes transfer to destination organization.

In one embodiment, present specification describes the methods for the treatment of patient's urinary dysfunction.This method such as Figure 25 Shown and the following steps are included: provide a device in step 2501, which includes being operatively coupled to stimulation generator extremely A few electrode, the stimulation generator are configured to receive at least one stimulus signal from controller；In step 2502, in the trouble Described device is implanted into the anorectal areas of person；In step 2503, the electrode is positioned as the anus with the patient Destination organization in door rectal area is electrically connected；With in step 2504, algorithm makes the controller generate stimulation based on programming Signal, the stimulus signal are passed to stimulation generator.In step 2505, generator is stimulated to generate electricity thorn in response to stimulus signal Swash pulse, which is passed to the destination organization in the anorectal areas via the electrode, wherein The electric stimulation pulse improves the function of the sphincter urethrae of the patient.Optionally, in step 2506, it is included in the device On at least one sensor obtain data and based on from least one sensor and come data change electric stimulation pulse.? In various embodiments, at least one described sensor includes pressure sensor, electrical activity sensors, impedance transducer, acceleration Meter or inclinometer.

In various embodiments, any device disclosed in this specification includes at least one sensor, and this specification Disclosed in any method optionally include a step: obtain data simultaneously based on by described using at least one described sensor The data that at least one sensor obtains change electric stimulation pulse.In various embodiments, at least one described sensor includes Pressure sensor, electrical activity sensors, impedance transducer, accelerometer or inclinometer.

In another embodiment, present specification describes the methods of the bowel movement function obstacle for the treatment of patient.This method is as schemed Shown in 26 and the following steps are included: providing a device in step 2601, which includes being operatively coupled to stimulation generator At least one electrode, the stimulation generator are configured to receive at least one stimulus signal from controller；In step 2602, described Described device is implanted into the urogenital region of patient；In step 2603, the electrode is positioned as the uropoiesis with the patient Destination organization in region is electrically connected；With in step 2604, the controller is made to generate stimulus signal based on pre-defined algorithm, it should Stimulus signal is passed to stimulation generator.In step 2605, generator is stimulated to generate electric stimulation pulse in response to stimulus signal, The electric stimulation pulse is passed to the destination organization in the urogenital region via the electrode, wherein the electro photoluminescence arteries and veins Punching improves the function of the anal sphincter of the patient.

In another embodiment, present specification describes the methods of the bowel movement function obstacle for the treatment of patient.This method is as schemed Shown in 27 and the following steps are included: providing a device in step 2701, which, which includes at least, is operatively coupled to stimulation generation The first electrode and second electrode of device, the stimulation generator are configured to receive at least one stimulus signal from controller；In step Rapid 2702, described device is implanted into the anorectal areas of the patient；In step 2703, the first electrode is positioned as It is electrically connected with the first object tissue in the anorectal areas of the patient；In step 2704, by the second electrode The second destination organization being positioned as in the anorectal areas with patient is electrically connected, wherein second destination organization and institute First object tissue is stated to distinguish and different；With in step 2705 so that the controller is based on the first programmed algorithm and generates the One stimulus signal, and the second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator.In step 2706, stimulation generator generates in response to the first stimulus signal and is transmitted to the first object tissue via the first electrode First electric stimulation pulse, and generated in response to the second stimulus signal and be transmitted to second destination organization via the second electrode The second electric stimulation pulse, wherein first electric stimulation pulse is optimised, to stimulate the anal orifice and rectal intestine tissue of the patient, and Second electric stimulation pulse is optimised, to stimulate the sphincter urethrae tissue of the patient.

In another embodiment, present specification describes the methods for the anal sphincter function for adjusting patient.This method is such as It shown in Figure 28 and include: that a device is provided, which includes at least one electrode for being operatively coupled to stimulation generator, the thorn Sharp generator is configured to receive at least one stimulus signal from controller；With in step 2802, algorithm makes described based on programming Controller generates stimulus signal, which is passed to stimulation generator.In step 2803, in response to stimulus signal, thorn Swash generator to generate electric stimulation pulse and be transported to via at least one described electrode comprising patient anus rectal area A part of region is simultaneously after a period of time, wherein the region includes anal sphincter and the radial direction 5cm near anal sphincter Range, to stimulate anal sphincter and improve sphincter function, wherein the electric stimulation pulse is adapted so that the sphincter function The time that at least one hour is still kept after stimulation stops can be improved.

In another embodiment, present specification describes the methods for the treatment of patient's urinary dysfunction.This method such as Figure 29 Shown and the following steps are included: provide a device in step 2901, which includes at least and is operatively coupled to stimulation generator First electrode and second electrode, the stimulation generator is configured to receive at least one stimulus signal from controller；In step 2902, described device is implanted into the anorectal areas of the patient；In step 2903, by the first electrode be positioned as with First object tissue in the anorectal areas of the patient is electrically connected；In step 2904, the second electrode is determined Position to be electrically connected with the second destination organization in the anorectal areas of patient, wherein second destination organization with it is described First object tissue distinguishes and difference；With in step 2905 so that the controller is based on the first programmed algorithm and generates first Stimulus signal, and the second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator.In step 2906, stimulation generator generates in response to the first stimulus signal and is transmitted to the first object tissue via the first electrode First electric stimulation pulse, and generated in response to the second stimulus signal and be transmitted to second destination organization via the second electrode The second electric stimulation pulse, wherein first electric stimulation pulse is optimised, to stimulate the anal orifice and rectal intestine tissue of the patient, and Second electric stimulation pulse is optimised, to stimulate the sphincter urethrae tissue of the patient.

In another embodiment, present specification describes the methods for the treatment of patient's urinary dysfunction.This method such as Figure 30 Shown and the following steps are included: provide a device in step 3001, which includes at least and is operatively coupled to stimulation generator First electrode and second electrode, the stimulation generator is configured to receive at least one stimulus signal from controller；In step 3002, it will be in the anal orifice and rectal intestine tissue of described device implantation patient；In step 3003, the first electrode is positioned as and patient Anorectal areas in first object tissue be electrically connected；In step 3004, the second electrode is positioned as with patient's The second destination organization in anorectal areas is electrically connected, wherein second destination organization and the first object tissue phase region It is not and different；And in step 3005, so that the controller is based on the first programmed algorithm and generates the first stimulus signal, and based on the Two programmed algorithms generate the second stimulus signal, they are passed to stimulation generator.In step 3006, stimulate generator in response to First stimulus signal generates the first electric stimulation pulse that the first object tissue is transmitted to via the first electrode, and responds The second boost pulse that second destination organization is transmitted to via the second electrode is generated in the second stimulus signal, wherein institute Stating the first boost pulse optimally stimulates anal orifice and rectal intestine tissue and second boost pulse optimally stimulates sphincter urethrae group It knits.

In another embodiment, present specification describes the methods for the treatment of patient's defecation and urinary dysfunction.This method As shown in figure 31 and the following steps are included: providing a device in step 3101, which includes at least and is operatively coupled to stimulation The first electrode and second electrode of generator, the stimulation generator are configured to receive at least one stimulus signal from controller； It, will be in the anal orifice and rectal intestine tissue of described device implantation patient in step 3102；In step 3103, the first electrode is positioned as It is electrically connected with the first object tissue in the anorectal areas of patient；In step 3104, by the second electrode be positioned as with The second destination organization in the genitourinary area of patient is electrically connected, wherein second destination organization and the first object Tissue distinguishes and difference；And in step 3105, so that the controller is based on the first programmed algorithm and generates the first stimulus signal, And the second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator.In step 3106, stimulation is generated Device generates the first electro photoluminescence arteries and veins that the first object tissue is transmitted to via the first electrode in response to the first stimulus signal Punching, and the second stimulation arteries and veins that second destination organization is transmitted to via the second electrode is generated in response to the second stimulus signal Punching, wherein first boost pulse optimally stimulates anal orifice and rectal intestine tissue and second boost pulse optimally stimulates urethra Sphincter tissue.

In another embodiment, present specification describes the sides for the treatment of patient's bowel movement function obstacle and urinary dysfunction Method.This method provides a device as shown in figure 32 and the following steps are included: in step 3201, which includes at least operatively It is connected to the first electrode and second electrode of stimulation generator, the stimulation generator is configured to receive at least one from controller Stimulus signal；In step 3202, described device is implanted into the anorectal areas of the patient and genitourinary area；? Step 3203, the first electrode is positioned as being electrically connected with the first object tissue in the anorectal areas；In step 3204, by the second electrode be positioned as with the genitourinary area in the second destination organization be electrically connected, wherein institute The second destination organization is stated to distinguish from the first object tissue and different；With in step 3205 so that the controller is based on First programmed algorithm generates the first stimulus signal, and generates the second stimulus signal based on the second programmed algorithm, they are passed to Stimulate generator.In step 3206, stimulates generator to generate in response to the first stimulus signal and be transmitted to via the first electrode First electric stimulation pulse of the first object tissue, and generate in response to the second stimulus signal and transmitted via the second electrode To the second boost pulse of second destination organization, wherein first boost pulse optimally stimulates the anal orifice and rectal intestine area The first object tissue in domain, and second boost pulse optimally stimulate it is described in the genitourinary area Minor microstructure.

In one embodiment, present specification describes the methods for the treatment of patient's urinary dysfunction.This method such as Figure 33 Shown and the following steps are included: provide a device in step 3301, which includes at least and is operatively coupled to stimulation generator First electrode and second electrode, the stimulation generator is configured to receive at least one stimulus signal from controller；In step 3302, it will be in the anal orifice and rectal intestine tissue of described device implantation patient；In step 3303, the first electrode is positioned as and patient Anorectal areas in first object tissue be electrically connected；In step 3304, the second electrode is positioned as with patient's The second destination organization in genital region is electrically connected, wherein second destination organization and the first object tissue distinguish and It is different；With in step 3305, so that the controller is based on the first programmed algorithm and generates the first stimulus signal, and compiled based on second Journey algorithm generates the second stimulus signal, they are passed to stimulation generator.In step 3306, stimulate generator in response to first Stimulus signal, which is generated, is transmitted to the first electric stimulation pulse of the first object tissue via the first electrode, and in response to the Two stimulus signals, which are generated, is transmitted to the second boost pulse of second destination organization via the second electrode, wherein described the One electric stimulation pulse optimally stimulates anal orifice and rectal intestine tissue and the second electric stimulation pulse optimally stimulates germinal tissue.

In another embodiment, present specification describes the methods for the treatment of female patient urinary dysfunction.This method is such as Shown in Figure 34 and the following steps are included: in step 3401, a device is provided, which, which includes at least, is operatively coupled to stimulation production The first electrode and second electrode of raw device, the stimulation generator are configured to receive at least one stimulus signal from controller；? It step 3402, will be in the anal orifice and rectal intestine tissue of described device implantation female patient；In step 3403, the first electrode is positioned It is electrically connected for the first object tissue in the anorectal areas with patient；In step 3404, the second electrode is positioned as It is electrically connected with the second destination organization in the vaginal area of female patient, wherein second destination organization and the first object Tissue distinguishes and difference；With in step 3405 so that the controller is based on the first programmed algorithm and generates the first stimulus signal, And the second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator.In step 3406, stimulation is generated Device generates the first electro photoluminescence arteries and veins that the first object tissue is transmitted to via the first electrode in response to the first stimulus signal Punching, and the second stimulation arteries and veins that second destination organization is transmitted to via the second electrode is generated in response to the second stimulus signal Punching, wherein first electric stimulation pulse optimally stimulates anal orifice and rectal intestine tissue and the second electric stimulation pulse optimally stimulates vagina Tissue.

In another embodiment, present specification describes the methods for the treatment of female patient urinary dysfunction.This method is such as Shown in Figure 35 and the following steps are included: in step 3501, a device is provided, which, which includes at least, is operatively coupled to stimulation production The first electrode and second electrode of raw device, the stimulation generator are configured to receive at least one stimulus signal from controller；? It step 3502, will be in the vagina tissue of described device implantation female patient；In step 3503, by the first electrode be positioned as with First object tissue in the vaginal area of patient is electrically connected；In step 3504, the second electrode is positioned as suffering from women The second destination organization in the vaginal area of person is electrically connected, wherein second destination organization and the first object tissue phase region It is not and different；With in step 3505 so that the controller is based on the first programmed algorithm and generates the first stimulus signal, and based on the Two programmed algorithms generate the second stimulus signal, they are passed to stimulation generator.In step 3506, stimulate generator in response to First stimulus signal generates the first electric stimulation pulse that the first object tissue is transmitted to via the first electrode, and responds The second boost pulse that second destination organization is transmitted to via the second electrode is generated in the second stimulus signal, wherein the One electric stimulation pulse optimally stimulates the first object tissue of vagina tissue and the second electric stimulation pulse optimally stimulates vagina group The second destination organization knitted.

In another embodiment, present specification describes treatment female patient vagina or the methods of sex dysfunction.The party Method provides a device as shown in figure 36 and the following steps are included: in step 3601, which includes at least and be operatively coupled to thorn Swash the first electrode and second electrode of generator, the stimulation generator is configured to receive at least one stimulation letter from controller Number；It, will be in the vagina tissue of described device implantation female patient in step 3602；In step 3603, the first electrode is determined Position is to be electrically connected with the first object tissue in the vaginal area of patient；In step 3604, by the second electrode be positioned as with The second destination organization in the vaginal area of female patient is electrically connected, wherein second destination organization and the first object group It knits and distinguishes and different；With in step 3605 so that the controller is based on the first programmed algorithm and generates the first stimulus signal, and The second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator.In step 3606, generator is stimulated The first electric stimulation pulse that the first object tissue is transmitted to via the first electrode is generated in response to the first stimulus signal, And the second boost pulse that second destination organization is transmitted to via the second electrode is generated in response to the second stimulus signal, Wherein the first electric stimulation pulse optimally stimulates the first object tissue of vagina tissue and the second electric stimulation pulse optimally stimulates Second destination organization of vagina tissue.

In another embodiment, present specification describes treatment female patient vagina or the methods of sex dysfunction.The party Method provides a device as shown in figure 37 and the following steps are included: in step 3701, which includes at least and be operatively coupled to thorn Swash the first electrode and second electrode of generator, the stimulation generator is configured to receive at least one stimulation letter from controller Number；It, will be in the anal orifice and rectal intestine tissue of described device implantation female patient in step 3702；In step 3703, by first electricity Pole is positioned as the first object tissue in the anorectal areas with patient and is electrically connected；In step 3704, by the second electrode The second destination organization being positioned as in the vaginal area with female patient is electrically connected, wherein second destination organization and described the One destination organization distinguishes and difference；With in step 3705, pierced so that the controller generates first based on the first programmed algorithm Energizing signal, and the second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator.In step 3706, Stimulation generator generates in response to the first stimulus signal and is transmitted to the first of the first object tissue via the first electrode Electric stimulation pulse, and generated in response to the second stimulus signal and be transmitted to the of second destination organization via the second electrode Two boost pulses, wherein first electric stimulation pulse optimally stimulates anal orifice and rectal intestine tissue and the second electric stimulation pulse is optimally Stimulate vagina tissue.

In another embodiment, present specification describes the methods for the treatment of subjects reproductive's dysfunction.This method such as Figure 38 Shown and the following steps are included: provide a device in step 3801, which includes at least and is operatively coupled to stimulation generator First electrode and second electrode, the stimulation generator is configured to receive at least one stimulus signal from controller；In step 3802, it will be in the perineum tissue of described device implantation patient；In step 3803, the first electrode is positioned as the meeting with patient First object tissue in negative region is electrically connected；In step 3804, the second electrode is positioned as the perineal region with patient In the second destination organization be electrically connected, wherein second destination organization distinguishes and different from the first object tissue；With In step 3805, so that the controller is based on the first programmed algorithm and generates the first stimulus signal, and it is based on the second programmed algorithm The second stimulus signal is generated, they are passed to stimulation generator.In step 3806, generator is stimulated to believe in response to the first stimulation It number generates and to be transmitted to the first electric stimulation pulse of the first object tissue via the first electrode, and in response to the second stimulation Signal generates the second boost pulse that second destination organization is transmitted to via the second electrode, wherein the first electro photoluminescence arteries and veins Punching optimally stimulates first object perineum tissue and the second electric stimulation pulse optimally stimulates the second target perineum tissue.

In one embodiment, one of perineum tissue is perineal body.In another embodiment, one of perineum tissue is Perineum cavernous body.

In various embodiments, device is just implanted under the skin and close to anal orifice and rectal intestine structure or urogenital structure.? In various embodiments, electrode is electrically connected with the object construction and energy electro photoluminescence desired structure is without the material contact structure.

In another embodiment, present specification describes the methods for the treatment of patient's Genitourinary dysfunction.This method As shown in figure 39 and the following steps are included: providing a device in step 3901, which includes at least and is operatively coupled to stimulation The first electrode and second electrode of generator, the stimulation generator are configured to receive at least one stimulus signal from controller； It, will be in the anal orifice and rectal intestine tissue of described device implantation patient in step 3902；In step 3903, the first electrode is positioned as It is electrically connected with the first object tissue in the anorectal areas of patient；In step 3904, by the second electrode be positioned as with The second destination organization in the perineal region of patient is electrically connected, wherein second destination organization and the first object tissue phase Difference and difference；With in step 3905, so that the controller is based on the first programmed algorithm and generates the first stimulus signal, and it is based on Second programmed algorithm generates the second stimulus signal, they are passed to stimulation generator.In step 3906, generator is stimulated to respond The first electric stimulation pulse for being transmitted to the first object tissue via the first electrode is generated in the first stimulus signal, and is rung The second boost pulse of second destination organization should be transmitted to via the second electrode in the generation of the second stimulus signal, wherein First electric stimulation pulse optimally stimulates anal orifice and rectal intestine tissue and the second electric stimulation pulse optimally stimulates perineum tissue.

In one embodiment, perineum tissue is pelvic plexus.In another embodiment, perineum tissue is pelvic nerve The nerve of clump.In another embodiment, perineum tissue is perineal nerves.

In another embodiment, present specification describes the methods for the sphincter urethrae function of adjusting main body as needed.It should Method is as shown in figure 40 and includes: to provide a device, which includes at least one electricity for being operatively coupled to stimulation generator Pole, the stimulation generator are configured to receive at least one stimulus signal from controller；With in step 4002, algorithm makes based on programming It obtains the controller and generates stimulus signal, which is passed to stimulation generator.In step 4003, believe in response to stimulation Number, stimulation generator generates electric stimulation pulse and is transported to the anorectum comprising main body via at least one described electrode Region a part and after a period of time, wherein the region includes anal sphincter and radial near anal sphincter 5cm range, to stimulate anal sphincter and improve sphincter urethrae function, wherein the electric stimulation pulse is adapted for carrying out the urine Road sphincter function improves, to be maintained at least 24 hours after stimulation stops.

In another embodiment, present specification describes the methods for the sphincter urethrae function of adjusting main body as needed.It should Method is as shown in figure 41 and includes: to provide a device, which includes at least one electricity for being operatively coupled to stimulation generator Pole, the stimulation generator are configured to receive at least one stimulus signal from controller；With in step 4102, algorithm makes based on programming It obtains the controller and generates stimulus signal, which is passed to stimulation generator.In step 4103, believe in response to stimulation Number, stimulation generator generates electric stimulation pulse and is transported to the anorectum comprising main body via at least one described electrode Region a part and after a period of time, wherein the region includes anal sphincter and the 5cm near anal sphincter Range, to stimulate anal sphincter and improve sphincter urethrae function, wherein the electric stimulation pulse is adapted for carrying out the urethra Sphincter function improves, to be maintained at least one hour after stimulation stops.

In embodiment as described above, improvement can maintain to be greater than a hour or small greater than 24 after stimulation stops When time.In embodiment as described above, stimulation can be lasting or interval.

In another embodiment, present specification describes the methods for the treatment of patient's sex dysfunction.This method such as Figure 42 institute Show and the following steps are included: in step 4201, be implanted into a device, which includes be operatively coupled to electro photoluminescence generator more A electrode, the electro photoluminescence generator be configured to receive from controller at least one stimulus signal and be placed on patient anus it is straight Near intestinal tissue；With in step 4202, algorithm makes the controller generate stimulus signal based on programming, which is passed It is delivered to stimulation generator.In step 4203, in response to stimulus signal, the stimulation generator generates electric stimulation pulse and via institute Electric stimulation pulse described in anal orifice and rectal intestine organized delivery of the electrode to patient is stated, to cause to the anal orifice and rectal intestine tissue of patient Stimulation, wherein the transmitting of the electric stimulation pulse substantially treatability dysfunction.

In another embodiment, present specification describes the methods for the treatment of patient's sex dysfunction.This method such as Figure 43 institute Show and the following steps are included: in step 4301, be implanted into a device, which includes be operatively coupled to electro photoluminescence generator more A electrode, the electro photoluminescence generator are configured to receive at least one stimulus signal from controller and are placed on the uropoiesis life of patient Grow device adjacent tissue；With in step 4302, algorithm makes the controller generate stimulus signal, the stimulus signal quilt based on programming It is transmitted to stimulation generator.In step 4303, in response to stimulus signal, the stimulation generator generate electric stimulation pulse and via The electrode transmits the electric stimulation pulse to the genitourinary tissue of patient to cause the apparatus urogenitalis to patient The stimulation of tissue, wherein the transmitting the treatment of sexual dysfunction of the electric stimulation pulse.

Optionally, stimulation is generated for urinary function gut function or sexual function timing.Optionally, stimulation is independently of secreting Function, gut function or sexual function transmitting are urinated, and at least realizes changing at least one of above-mentioned function after single stimulation It is kind, it can also continue other than stimulus duration.

Optionally, transmitting stimulation to improve urinary function, gut function or sexual function at once.Optionally, transmitting stimulation with Time improves urinary function, gut function or sexual function at leisure.Optionally, the improvement of one of above-mentioned function is in stimulation beginning Occur at least 5 minutes afterwards.

In another embodiment, present specification describes the methods for the treatment of female patient Genitourinary dysfunction.It should Method provides a device as shown in figure 44 and the following steps are included: in step 4401, which includes at least and be operatively coupled to The first electrode and second electrode of generator are stimulated, the stimulation generator is configured to receive at least one stimulation letter from controller Number；It, will be in the anal orifice and rectal intestine tissue of described device implantation female patient in step 4402；In step 4403, by first electricity Pole is positioned as the first object tissue in the anorectal areas with patient and is electrically connected；In step 4404, by the second electrode The second destination organization being positioned as in the vaginal area with female patient is electrically connected, wherein second destination organization and described the One destination organization distinguishes and difference；With in step 4405, pierced so that the controller generates first based on the first programmed algorithm Energizing signal, and the second stimulus signal is generated based on the second programmed algorithm, they are passed to stimulation generator.In step 4406, Stimulation generator generates in response to the first stimulus signal and is transmitted to the first of the first object tissue via the first electrode Electric stimulation pulse, and generated in response to the second stimulus signal and be transmitted to the of second destination organization via the second electrode Two boost pulses, wherein the first electric stimulation pulse optimally stimulates anal orifice and rectal intestine tissue and the second electric stimulation pulse optimally stimulates Vagina tissue.

Figure 11 C is lower abdominal region and the pelvis area of the patient according to some embodiments of this specification, and which show be used for The target area of electro photoluminescence 1173 and the figure in purpose effect region 1175.According to this specification some aspects, Figure 11 C shows anus It the specific region of door rectum and genitourinary area can be by independently or collaboratively electro photoluminescence, in any region or twoth area Domain generates desired therapeutic effect, as described in multiple exemplary embodiments in below table 1:

Table 1For stimulating anal orifice and rectal intestine and/or apparatus urogenitalis structure to adjust the structure and/or another structure function The distribution of electrodes and combination of energy

Example 1	Anal sphincter	Sphincter urethrae
			Electrode 1	+	-
Electrode 2	-	+
			Function	Anal orifice and rectal intestine/apparatus urogenitalis	Anal orifice and rectal intestine/apparatus urogenitalis
Example 2	Anal sphincter	Vagina tissue
			Electrode 1	+	-
Electrode 2	-	+
			Function	Anal orifice and rectal intestine/apparatus urogenitalis	Anal orifice and rectal intestine/apparatus urogenitalis
Example 3	Anal sphincter	Perineum tissue
			Electrode 1	+	-
Electrode 2	-	+
			Function	Anal orifice and rectal intestine/apparatus urogenitalis	Anal orifice and rectal intestine/apparatus urogenitalis
Example 4	Vagina tissue	Vagina tissue
			Electrode 1	+	-
Electrode 2	-	+
			Function	Anal orifice and rectal intestine/apparatus urogenitalis	Anal orifice and rectal intestine/apparatus urogenitalis
Example 5	Vagina tissue	Perineum tissue
			Electrode 1	+	-
Electrode 2	-	+
			Function	Anal orifice and rectal intestine/apparatus urogenitalis	Anal orifice and rectal intestine/apparatus urogenitalis
Example 6	Anal sphincter	Sphincter urethrae
			Electrode 1	+	+
Electrode 2	+	+
			Function	Sphincter urethrae	Anal sphincter

In example 1, first electrode is positioned as stimulating anal sphincter and second electrode is positioned as stimulating sphincter urethrae, Wherein the effect is to adjust the function of any anal orifice and rectal intestine and/or apparatus urogenitalis structure.In example 2, first electrode positioning For stimulation anal sphincter, second electrode is positioned as stimulating vagina tissue, wherein the effect be adjust any anal orifice and rectal intestine and/ Or the function of apparatus urogenitalis structure.In example 3, first electrode is positioned as stimulating anal sphincter and second electrode is positioned as Perineum tissue is stimulated, wherein the effect is to adjust the function of any anal orifice and rectal intestine and/or apparatus urogenitalis structure.Exemplary 4, First electrode is positioned as stimulating the first part of vagina tissue and second electrode is positioned as described the first of stimulation and vagina tissue The second part of the different and separated vagina tissue in part, wherein effect is to adjust any anal orifice and rectal intestine and/or apparatus urogenitalis The function of structure.In example 5, first electrode is positioned as stimulating vagina tissue and second electrode is positioned as stimulating perineum tissue, Wherein the effect is to adjust the function of any anal orifice and rectal intestine and/or apparatus urogenitalis structure.In example 6, first electrode positioning To stimulate anal sphincter and sphincter urethrae, and second electrode is positioned as that the anal sphincter and the urethra is stimulated to include about Flesh, wherein the effect of the stimulation of two electrodes on the anal sphincter be adjust the function of the sphincter urethrae, and The effect of the stimulation of two electrodes on the sphincter urethrae is to adjust the function of the anal sphincter.Although existing Art describes stimulation anal sphincters to adjust anal sphincter function and stimulation sphincter urethrae to adjust urethra Sphincter function, but another function is adjusted present specification describes one of those is stimulated.

Figure 11 D be showing to anal orifice and rectal intestine and/or apparatus urogenitalis structure provide stimulation in be stimulated same or The flow chart of some embodiment steps involved of effect is formed in different structure.In step 1182, electrical stimulation device implantation is suffered from Person's body.Then, in step 1184, the first electrode of described device is positioned close to the of first object tissue and described device Two electrodes are positioned close to the second destination organization, wherein first and second destination organization be it is mutually the same or separate and not With and be any one of anal orifice and rectal intestine tissue or genitourinary tissue.In step 1186, electro photoluminescence is calculated via stimulation Method is provided to first and second destination organization, to form effect in anal orifice and rectal intestine tissue or genitourinary tissue, It is wherein raw in the anal orifice and rectal intestine tissue or uropoiesis identical or different with the anal orifice and rectal intestine tissue or genitourinary tissue that are stimulated It grows and forms the effect in device tissue.In some embodiments, the stimulation algorithm of first electrode is provided and is provided to the second electricity The stimulation algorithm of pole is identical.In other embodiments, stimulation algorithm is different.

In order to facilitate quickly, easily and comfortably implantable miniature device, this specification further provide for insertion apparatus and Conduit.Figure 12 A to 12C describes the various constructions of the embodiment of insertion apparatus 1200.Figure 12 A is exemplary insertion apparatus 1200 One embodiment figure, it is shown that pull downward on the plunger 1204 of insertion apparatus with formed vacuum and sucking anal orifice and rectal intestine tissue A part step.Figure 12 B is the top view of the same embodiment of the exemplary insertion apparatus 1200 of Figure 12 A, it is shown that anus A part of door rectal tissue 1206 is sucked into device.Figure 12 C is the same reality of the exemplary insertion apparatus 1200 of Figure 12 A Apply the figure of example, it is shown that the step of plunger 1204 of insertion apparatus 1200 is pushed upward into release anal orifice and rectal intestine tissue.

In one embodiment, the part 1201 of insertion apparatus 1200 including conical shaped, have at top The conduit 1202 that circular open is separated by a certain distance, the top are covered by optional movable valve 1203 in one embodiment.Column Plug 1204 slides through lower cylindrical part 1210, further includes handle 1205.In one embodiment, substantial cylindrical channel Be pre-formed in insertion apparatus 1200, conduit is delivered by the channel, micro device is implanted to can be passed through into In the mucous membrane of rectum and submucosa that conduit 1202 sucks.Figure 12 A specifically shows plunger 1204 and is pulled down, true to be formed Empty (closing of valve 1203), anal orifice and rectal intestine tissue 1206 (see Figure 12 B) (such as mucous membrane of rectum and submucosa) is drawn into slotting Enter in the conduit 1202 of device 1200.Figure 12 B shows the top view of insertion apparatus 1200, mucous membrane of rectum and submucosa 1206 Necessary part be sucked into conduit 1202.Using the conduit being then described below, micro device then can be inserted into In the tissue 1206 being inhaled into.As indicated in fig. 12 c, also after micro device implantation therein, plunger 1204 is pushed up Optional valve 1203 can be opened, discharges vacuum, and also discharge the tissue 1206 being inhaled into.

Figure 13 A to 13E shows the various constructions of the embodiment of implantation catheter 1300.Conduit 1300 is designed to by inserting Enter the pre-formed channel in device.Figure 13 A is the figure of one embodiment of the representative configuration of implantation catheter 1300, is had Main parallel arranged pusher 1312 and attached micro device 1310 in the conduit 1300.Conduit 1300 includes Epitheca 1311 is to limit pusher 1312 and micro device 1310.In the pre-deployment phase of Figure 13 A, pusher 1312 and miniature 1310 are set to be arranged as main parallel to each other and be limited in sheath 1311.In order to facilitate the arragement construction, pusher 1312 The flexible part 1320 of front end forms sharp needle-shaped edge 1315 to back bending song to interior.Micro device 1310, which is maintained at, to be pushed away The end of the part 1320 that curves inwardly of dynamic device 1312.

Figure 13 B is the figure of the same embodiment of the representative configuration of the implantation catheter 1300 in Figure 13 A, it is shown that using pushing away The micro device 1310 that dynamic device 1312 is released from the conduit 1300.During operation, as shown in Figure 13 B, pusher 1312 is opened Begin the opening 1325 that micro device 1310 is forced through to the conduit being deep into tissue.Figure 13 C is the implantation catheter in Figure 13 A The figure of the same embodiment of 1300 representative configuration, it is shown that the micro device 1310 released completely from the conduit 1300. When micro device 1310 is completely pushed out of sheath 1311, bending part 1320 is popped up (due to the flexible curved work that rebounds outward With), smaller acute angle is formed, device 1310 is thus allowed to separate from sheath 1311.Figure 13 D is showing for the implantation catheter 1300 in Figure 13 A The figure of the same embodiment of construction, it is shown that pusher 1312 is pulled back in the conduit 1300.1312 quilt of pusher It is withdrawn into sheath 1311, so that bending part 1320 straightens and is therefore deeper pushed into device 1310 in tissue.Figure 13 E is figure The figure of the same embodiment of the representative configuration of implantation catheter 1300 in 13A, it is shown that pusher 1312 is withdrawn into completely In the conduit 1300.Pusher 1312, which is pulled completely into sheath 1311, disconnects device 1310 from pusher 1312, by This is in tissue location release device 1310.

Figure 14 A to 14D is for micro device 1420 to be implanted to such as mucous membrane 1428, submucosa 1427 and intrinsic The figure of step in the such tissue of muscle layer 1426.Figure 14 A is one embodiment of the representative configuration of implantation catheter 1400 Figure, shows that the conduit 1400 is positioned near the intestinal mucosa 1428 of patient.Catheter sheath 1421 is located in the mucous membrane of patient Near 1428.Pusher 1422 and micro device 1420 are positioned in sheath 1421.Figure 14 B is the implantation catheter in Figure 14 A The figure of the same embodiment of 1400 representative configuration, it is shown that micro device 1420 is pushed out conduit 1400 for implantation Step.Micro device 1420 is released into sheath 1421 using pusher 1422, so that sharp edges are formed at bending part 1425, With puncturing tissue and implantable miniature device 1420.Micro device 1420 is implanted, so that one end of micro device 1420 is close to viscous Film lower layer 1427 and opposite end are close to muscularis propria 1426.Figure 14 C is the representative configuration of the implantation catheter 1400 in Figure 14 A The same embodiment figure, display straightened due to bending part 1425, micro device 1420 deeper disposed in tissue Step.Pusher 1422 be pulled back at leisure it is dynamic so that bending part 1425 straightens and is deeper deployed in device 1420 In tissue.Figure 14 D is the figure of the same embodiment of the representative configuration of the implantation catheter 1400 in Figure 14 A, it is shown that is being organized The step of conduit 1400 is pulled away from by micro device 1420 later is discharged at position.Micro device 1420 is released in tissue position The place of setting and sheath 1421 is pulled away from.In this embodiment, end, which can shape, is or is designed as with cut edge, to facilitate Insertion.In addition, padded coaming physiological saline as injection such as physiological saline is used to form under bigger mucous membrane hole to hold Receive bigger device.

Figure 15 is placed in the anorectal areas 1549 of patient with the exemplary insertion apparatus for delivering micro device The figure of 1500 one embodiment.Insertion apparatus 1500 is placed in the anorectal areas 1549 of patient, for positioning appropriate position It sets (one or more) and sucks tissue (as described in referring to figures 12A through 12C).Figure 16 is an implementation of micro device 1600 The figure of example, is attached the electrode group 1625,1626 being implanted in ano-rectal mucosae lower layer.Micro device 1600 is planted Enter, first electrode 1625 is placed in rectum ring-type muscle layer 1641 (rather than circular muscle) nearby and second electrode 1626 is placed in anus Near internal sphincter 1630.

Figure 17 is the figure of this specification one embodiment, it is shown that using hypodermic needle, implantable miniature is filled in female patient The method set.Ischial tuberosity 1701 is being identified by perivaginal palpation, and is being percutaneously implantable using hypodermic needle 1703 miniature It sets, close to nervus pudendus 1702.Circle 1704 shows the favored area for implantable miniature device according to this embodiment.

In another embodiment, micro device per rectum is implanted into, to allow an electrode of device close to nervus pudendus and the Two electrodes are close to anal orifice and rectal intestine structure.Per rectum or Via vagina implantation can be further auxiliary for example, by imaging technique as ultrasound It helps.

Figure 18 A is showing according to this specification one embodiment by outside to musculus sphincter ani internus (IAS) and anus Sphincter (EAS) carries out exemplary selection stimulation and the figure of the exemplary force curve 1805,1810,1815 of acquisition.Pressure is bent Line 1805 is by only carrying out selective stimulating acquisition to IAS.IAS pressure rise is non-instantaneous and improved IAS pressure It has been more than the electro photoluminescence duration.Pressure curve 1810 is by only carrying out selective stimulating acquisition to EAS.In EAS pressure It is instantaneous for rising, and although electro photoluminescence continues, improved EAS pressure just declines after a few minutes.1815 generation of pressure curve The cumulative stress curve that table passes through while stimulating IAS and EAS to obtain.Compound sphincter pressure rising is instantaneous and main attribution In the contribution made by EAS pressure, and it can be continued above what stimulus duration and being mainly due to was made by IAS pressure Contribution.

Figure 18 B, which is showing, to be started during stimulation according to this specification one embodiment and has stopped it in stimulation The figure that still lasting musculus sphincter ani internus pressure rises afterwards.First stimulation period 1820 continues 30 minutes.In one embodiment, One stimulation period 1820 has pulse frequency, the pulse width of 5 milliamperes of impulse amplitude and 220 μ s of 20Hz.Musculus sphincter ani internus Pressure increase starts to postpone relative to stimulation, so that a period of time after stimulation has begun, pressure is from baseline pressure 1822 increase to treatment pressure 1824.Then, after stimulation is removed, pressure is kept under holding treatment pressure 1826 simultaneously By 90 minutes turn-off time sections 1828.In order to prevent pressure back to treatment pressure level below, second 30 minutes Stimulation period 1830 starts at the end of 90 minute turn-off time section 1828.In one embodiment, the second stimulation period 1820 has There are the pulse frequency of 20Hz, the pulse width of 5 milliamperes of impulse amplitude and 220 μ s.The electricity provided in the second stimulation period 1830 Stimulation keeps the pressure for the treatment of stress level 1834.In some embodiments, the continuous circulation for switching on and off stimulation period is used Musculus sphincter ani internus pressure is treated in holding.

Figure 19 A to 19C shows the further embodiment of micro device.Figure 19 A is with the tip electrodes as anode 1905 and the central electrode 1910 as cathode micro device 1900 one embodiment figure.Figure 19 B is that have as yin The figure of another embodiment of the micro device 1900 of the tip electrodes 1905 of pole and the central electrode 1910 as anode.Figure 19 C It is to have as the tip electrodes 1905 of anode and the another implementation of the micro device 1900 without polar central electrode 1910 The figure of example.Micro device 1900 include three electrodes so that every a pair of electrodes can be independently controlled it is identical or different to use Algorithm is stimulated to stimulate different anatomical structures.

In one embodiment, single micro device is implanted to two neighbouring anatomical structures (such as two close Nerve or two close muscle are implanted to neighbouring nerves and muscles structure), respectively there is an electricity in two proximity structures Pole.Thereafter, by using the dedicated electrode of structure, boost pulse mode, waveform or algorithm, two proximity structures are by selectively It stimulates simultaneously or at the time of separated.For example, micro device is implanted near nerves and muscles, and use long pulse (1ms- It 1s) stimulates myoarchitecture, and carrys out stimulated neural structure using short pulse (10 μ s -999ms), thus planted from a micro device The advantages of entering to obtain nerves and muscles stimulation.In another embodiment, it can be used as impolarizable electrode close to the electrode of desired structure And it is used as super polarizing electrode close to the electrode of other structures, selectively to stimulate first structure.

Micro device in another embodiment, micro device are implanted to including incoming perception nerve and spread out of motorial Near neuromechanism.In different moments, based on patient's input or physiological sensation input, single micro device can be used low frequency (< 100Hz) stimulus movement nerve and using high-frequency (> 100Hz) inhibit sensing nerve, or in turn also can, this depend on expectation Physiologic result.This will realize the increase of sphincter tone while preventing the excretion sense from rectum.

In another embodiment, micro device is implanted, and an electrode is in mucous membrane down space and an electrode is in muscle In structure.Using nerve under short pulse (<1ms) stimulation mucous membrane and use long pulse (>1ms) stimulation muscle.Nerve thorn under mucous membrane Swash and the alternating directly between muscular irritation is eliminated through only continued stimulus nerve or only tolerance caused by continued stimulus muscle Or the problem of fatigue.

In one example, micro device is implanted, and respectively has a tip electrodes in internal and external sphincter muscle of anus, It is middle to stimulate musculus sphincter ani internus using more continuous boost pulse mode or algorithm, to keep continuous basal tension, to prevent Anal leakage, while external sphincter muscle of anus is stimulated more on demand, to prevent out of season defecation.In addition, being stimulated with short pulse Musculus sphincter ani internus stimulates external sphincter muscle of anus to realize to stimulate nerve in musculus sphincter ani internus or neighbouring with long pulse Direct muscular irritation, or in turn can also be with.The frequency of pulse can also change, in different ways stimulation nerve or muscle or prevention Felt by neurotransmission.

In another embodiment of this specification, micro device is implanted into submucous stratum of rectum, and an electrode is under mucous membrane Neuropile and another electrode is close to myenteron neuropile.Myenteron neuropile is stimulated with low frequency pulse patterns or algorithm, with stimulation Myenteron nerve, and with high-frequency impulse mode or algorithm stimulation submucous plexus to prevent submucous plexus, or in turn can also be with.? In another embodiment, two clumps are stimulated with identical pulse mode or algorithm in different moments, to realize desired physiology effect Fruit.

In another embodiment, in micro device implantation anorectal wall, an electrode close to anal orifice and rectal intestine neuropile and Branch of another electrode close to nervus pudendus or sacral nerve.Anal orifice and rectal intestine neuropile is stimulated in a more continuous fashion to keep base Plinth musculus sphincter ani internus tension, and private parts or sacral nerve are stimulated in a manner of more on demand, are squeezed with generating external sphincter muscle of anus Pressure, to terminate or prevent out of season defecation.

In another embodiment, micro device is implanted into along the length of private parts or sacral nerve, and wherein proximal end paired electrode conveys High frequency prevents pulse, and to prevent perception is incoming from feeling up to brain, and distal end paired electrode conveys low frequency stimulating pulse, to stimulate anus Door one of internal sphincter and external sphincter muscle of anus or both, to keep basic rest tension and/or generate extruding force.

In another embodiment, micro device is implanted into along the length of private parts or sacral nerve, and wherein proximal end paired electrode conveys Low frequency stimulating pulse perceives incoming sense with stimulation and reaches brain, and paired electrode conveying high frequency in distal end stops pulse, to prevent One of musculus sphincter ani internus and external sphincter muscle of anus or both, to eliminate basic rest tension and/or eliminate extruding force, thus Start the bowel movement with the patient's body of abnormal defecation (such as constipation).

In another embodiment, micro device is implanted, and is respectively had in the deep part of external sphincter muscle of anus and superficial part One tip electrodes, wherein the two of external sphincter muscle of anus part is alternately stimulated, and allows a part tranquillization and another portion It point is stimulated, therefore increases the duration of extruding force, the problem of without having tolerance or muscular fatigue.In addition, being included outside anus Two parts of about flesh can alternately be stimulated by short pulse and long pulse, short pulse for stimulate in external sphincter muscle of anus or near Nerve, long pulse further increases the duration of extruding force for realizing muscular irritation outside direct anus, without There is the problem of tolerance or muscular fatigue.

In another embodiment, micro device is implanted, in the inner annular muscle layer of musculus sphincter ani internus and distal end rectum Respectively there is an electrode, two of them structure is stimulated simultaneously.The construction allows two physiological structures synchronous and synergistically shrinks, and increases The length of rectum exit high-pressure area effectively increases the function length of anal sphincter.This is even in sphincter pressure model Enclose the increase that sphincter effective capacity is also able to achieve in lower situation.The embodiment allows the feelings even in low-level electro photoluminescence Also allow to keep sphincter ability under condition, and therefore reduces existing tolerance or muscular fatigue usually under higher level electro photoluminescence The problem of.In addition, the circular muscle of rectum can serve as high-pressure area and functional sphincter, the patient of sphincter damage is thus kept Self-control, such as the women with the maternal infuries (traumatic delivery) for causing laceration of perineum and anal sphincter to damage.

In another embodiment, micro device is implanted, in the inner annular muscle layer of musculus sphincter ani internus and distal end rectum Respectively there is an electrode, two of them structure is by successive stimulus.This allows rectum contraction and anal canal to loosen, and realizes defecation.The construction Realize the treatment of the export-oriented constipation as caused by collaboration sphincter dysfunction.

Figure 20 is showing according to this specification one embodiment by including outside to urethra internal sphincter (IUS) and urethra About flesh (EUS) carries out exemplary selection stimulation and the figure of the exemplary force curve 2005,2010,2015 of acquisition.Pressure curve 2005 be by only carrying out selective stimulating acquisition to IUS.IUS pressure rise is that non-instantaneous and improved IUS pressure is super The electro photoluminescence duration is spent.Pressure curve 2010 is by only carrying out selective stimulating acquisition to EUS.EUS pressure rises It is instantaneous, and despite continuous electro photoluminescence, but improved EUS pressure just declines after a few minutes.Pressure curve 2015 Represent the cumulative stress curve for passing through while stimulating IUS and EUS to obtain.The rising of compound sphincter pressure is instantaneous and main returns Cause can be continued above stimulus duration and be mainly due to make by IUS pressure in the contribution made by EUS pressure Contribution.

The treatment terminal of urinary dysfunction(therapeutic endpoint)

In various embodiments, the system and method for this specification are arranged for carrying out treats eventually with following urinary dysfunction Point is consistent as a result, in particular for the urinary incontinence.It should be understood that the construction is joined by adjusting various stimulations for each patient Number is realized, such as pulse frequency, pulse width, pulse shape and impulse amplitude, until realizing therapeutic purpose disclosed herein. In turn, it should be appreciated that amount (usually after stimulation period) and its standing crop by calculating its new measurement (are in stimulation period Difference between before) simultaneously divides that difference by standing crop, to be determined as specific terminal to have increased X% or reduce X%.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that abdominal pressure leakage point increases by least 5% or at least 60cmH than value before treatment in power test₂O。

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that the amount of abdominal pressure leakage point increases by least 5% or at least 50cc than value before treatment in power test.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that cystometry increases at least 5% than value before treatment in power test.Cystometry is the filling phase assessed in bladder function Technology.It can get many information during cystometry, including diagnosis overactive bladder, bladder sensation do sth. in advance disease, sensory nerve Bladder capacity is lost and determined to disease, biddability.

The identified cystometry stage of 4 kinds of bladder function is:

1. initial a small amount of increases of intravesical pressure in full start；

2. including the steady pressure of most of filling phase；

3. final pressure when reaching bladder capacity rises, the limit for representing viscoplasticity expansion (can not usually be arrived due to discomfort Up to)；With

4. inconsistently observing intravesical pressure increased excretion phase in a small amount.

Single channel cystometry includes recording the independent intravesical pressure that full period is carried out with single conduit.It is led with bladder Pipe and the second conduit execute multichannel cystometry, obtain intra-abdominal pressure with approximation.Second conduit is normally placed in rectum, or is had When be placed in vagina.Data output includes vesica pressure channel, abdominal pressure channel and true detrusor pressure channel.Really force Urinating flesh pressure channel (also referred to as being subtracted channel) is that bladder pressure subtracts abdominal pressure.Depending on various settings, additional channel The urethra pressure reading and continuous electromyographic (EMG) reading that can be accommodated while obtain.Liquid medium (usually physiology salt Water) it is preferred.Most of test is executed with solution at room temperature.Full rate can be changed and model usually 10-100ml per minute It encloses.If obtaining false positive results with faster rate, rate slower, closer to physiology may be used.Equally, more rapidly Rate can be used for causing delicate unstability or can be used for the patient with obvious urgent urination disease, and this patient does not allow in slow rate Enough amounts are injected in the case where longer injection length.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Value increases at least 5% before realizing the treatment of abdominal pressure (or Wa Shi (Valsalva)) leakage point pressure ratio in power test.Wa Shi leakage point Pressure or abdominal pressure leakage point pressure (ALPP) are sphincter urethrae resistances to the increased test of intra-abdominal pressure.It is overall to be assumed to be leakage point Pressure is lower, then sphincter urethrae is weaker, and stress incontinence is more serious.For basic abdominal pressure leakage point pressure test, put Intravesical catheter and rectum inner catheter are set, and bladder is filled with the fluid of 150-250ml.In taking a seat or the trouble of standing place Person is required to execute the Wa Shi operation of slow Accumulated intensity.Minimum pressure when observing from urethral orifice leakage of urine indicates that leakage presses Power.If Wa Shi operation cannot correctly be executed by not generating leakage of urine or patient, can attempt to obtain cough leakage point pressure.It is lower than The leakage point pressure of 60cm water column shows intrinsic sphincter dysfunction.Can filling of bladder empty in bladder or with patient arrive 300ml or subjectivity think to execute cough pressure test in the case where full urine, and then upright or cut stone clinostatism (lithotomy When position), patient is allowed to execute a series of cough of strengths.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Residual urine volume is determining than value increase at least 5% before treatment after realizing urination in power test.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize urine flow rate than value at least 5% before treatment in power test.

In various embodiments, it can be surveyed in urine dynamics using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that bladder compliance monitoring than value before treatment increases at least 5% or to as little as 20ml/cmH in examination₂O。

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that detrusor leakage point pressure (DLPP) increases by least 5% or at least 40cmH than value before treatment in power test₂O。

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize in power test has urine sense urine volume to increase by least 5% or at least 50ml than value before treating for the first time.There is urine sense to be described as the first time Patient feels the amount (term of reference 50-200ml) when having fluid in bladder for the first time.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realizing again in power test has urine sensibility reciprocal (full urine) to increase by least 5% or at least 200ml than value before treating.There is urine sense (full again Urine) have described as the personal amount (term of reference 200-400ml) that would generally be considered when urinating due to sense of urgency.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that maximum capacity increases by least 5% or at least 400ml than value before treatment in power test.Maximum capacity is to feel pain in patient And the capacity (term of reference 400-600ml) when not allowing to continue full.Bladder keeps the urine of 400-500ml on average. Any bladder contraction during full be regarded as it is abnormal, in the above 15cmH of baseline₂The minimum of contraction amplitude of O is considered It is significant.

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that maximum detrusor pressure power increases by least 5% or at least 20cmH than value before treatment in power test₂O

It in various embodiments, can be in urine dynamics pressure using the system and method treatment urinary incontinence in patients with incomplete of this specification Realize that detrusor contractions increase at least 5% than value before treating but are no more than 25% in power test.

Relative to based on the obtained said effect of measured value for using urine dynamics pressure test to collect, in order to clear The purpose of the functional status of lower urinary tract, urine dynamics are to assess the means of pressure-flow relationship between bladder and urethra.Urine Dynamics research assesses the full storage period of bladder and drains phase and urethral function.In addition, challenge test can be increased, to attempt Symptom is re-formed, and assesses the correlated characteristic of leakage of urine.

Simple urine kinetic test is related to executing noninvasive urine flow rate research, remaining urine (PVR) measurement after being urinated, And it executes single channel intravesical pressure and traces (CMG).Single channel CMG (i.e. simple CMG), which is used to assess first fill, has urine to feel, completely Urine and urination impulsion.During this full CMG it should be noted that bladder compliance monitoring and unrestricted detrusor contractions (such as phase Dynamic property is shunk) presence.Simple CMG is executed usually using water as fluid media (medium).

Multichannel urine dynamics research is more more complicated than simple urine dynamics research, and can be used for obtaining additional letter Breath, including noninvasive urine flow rate, PVR, full CMG, abdominal pressure leakage point pressure (ALPP), emptying CMG (pressure-flow) and myoelectricity are retouched Remember (EMG).Water is the fluid media (medium) for the research of multichannel Urinary functional test.

Most complicated research is image urine dynamics research, the evaluation criteria of the patient with the urinary incontinence.In the research In, obtain following information: noninvasive urine flow rate, PVR, full CMG, abdominal pressure (or Wa Shi) leakage point pressure, urination CMG (pressure-stream Quantity research), EMG, static cystography information and urination cystourethrography information.For urine dynamics inspection of making video recording The fluid media (medium) for looking into (videourodynamics) is radiographic contrast agent.

In order to test, patient is commanded arrival urine dynamic experiment room in the case where bladder turgor.It executes noninvasive Remaining (PVR) urine test and persistent cough pressure test after urine flow rate, urination.In order to execute urine kinetic test, patient is first It is previously positioned in interrogation position.Start filling of bladder using room temperature water or contrast agent.Cold fluid can cause false positive detrusor to be received It contracts (i.e. phasic contraction).Bladder fills (such as 60ml/min) with medium rate.It records first bladder turgor and has row for the first time Amount when urine impulsion.Amount variation when bladder compliance and each pressure change is monitored, and unrestricted detrusor is marked to receive The presence of contracting.Bladder compliance range is 40ml/cm H₂O to 120ml/cm H₂O, and 10ml/cm H₂O to 20ml/cm H₂O Value be abnormal.When filling of bladder is to 250ml, measurement abdominal pressure leakage point pressure (ALPP), to study stress incontinence. Patient is commanded after cough (i.e. slight, moderate, severe) is coughed by (i.e. slight, moderate, severe) execution watt in various degree Family name tests (Valsalva).Research has shown that in 60cm H₂ALPP under O proves that there are intrinsic sphincter dysfunctions, and Higher than 90cm H₂O then negates the illness, and value therebetween may indicate that one of them.DLPP be in no detrusor contractions or Pressure when leakage of urine occurs in the increased situation of abdominal pressure.It should be usually less than 40cmH₂O, and if its more than the value Height, then kidney is in damage risk (being only second to counter-pressure).

In various embodiments, using the system and method treatment urinary incontinence in patients with incomplete of this specification by urination log (incontinence Breaking-out) at least 5% can be improved than value before treating, wherein described 5% improvement, which is defined as incontinence attack times, reduces 5% or every The average incontinence amount of secondary breaking-out reduces 5%.Urination log is the record for the urination behavior completed by patient.Compared with other, This is the best feasible means for obtaining the objective data of subjective symptoms.There are the various projects for log of urinating, including urination Time or frequency meter, frequency-urine volume table and bladder or urine log.There are many different types of urination logs, including frequency Table is the urination log of most simple types, because patient can be required only to record the breaking-out of urination and incontinence.Frequency-urine volume Table needs patient to record the urine volume urinated every time, the breaking-out of the time and incontinence urinated every time.Other parameters include used Estimating of fluid intake in diaper quantity and urine cup or cup.It is 0 that urgent urination degree, which can recorde ,+, or ++, or on scale from 0-10 makes marks, and depends on used log.Urgent urination degree can also be by requiring patient to estimate that he or she can be before urination It can wait how long and in a few minutes evaluating.

In various embodiments, tatol emiction quantity ratio is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification Value increases at least 5% before treatment.

In various embodiments, average value is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification to urinate Amount increases at least 5% than value before treatment.

In various embodiments, maximum single is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification to arrange Urine volume increases at least 5% than value before treatment.

In various embodiments, patient incontinence is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification to feel Know that scoring of the scoring (visual analogue scales scoring 1-100) than not treating when improves at least 5%.Visual analogue scales (VAS) It is problem-targeted evaluation mechanism, wherein vision measurement is associated with each problem and needs of answering a question select in vision measurement Quantifiable position is selected, shows specific horizontal or degree.Scale generally includes to be fixed on the word that has of each end Sentence (length is different), describes extremum (that is, from ' my the absolutely not incontinence ' on the left side to ' my the always incontinence ' on the right).Suffer from Person, which is required to mark, feels corresponding sentence with it.Measurement quantization is completed at a distance from label by measuring left end line.? In some embodiments, VAS can be used for assessing the severity of incontinence of faces, the urinary incontinence or sex dysfunction.

In various embodiments, Stamey incontinence is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification Scoring improves at least one grade than value before treatment.Stamey incontinence points-scoring system includes the grade scoring of following number and definition: Grade 0=does not have incontinence；Grade 1=is because of cough or incontinence due to pressure；Grade 2=incontinence due to position change or walking；With etc. Grade 3=always complete incontinence.

In various embodiments, the uropoiesis of women is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification Reproduction perplexs scale (UDI) and increases at least 5% than value before treatment.

In various embodiments, it is lost using the urine that the system and method treatment urinary incontinence in patients with incomplete of this specification is able to achieve women Prohibit severity index to increase at least 5% than value before treatment or improve at least one point.Female incontinence severity index includes Two parameters related with investigation result, belong to numeric ratings.The scoring of first parametric results then with the second parametric results Scoring be multiplied, to provide severity index, wherein bigger scoring shows more serious incontinence.First parameter inquires patient The frequency for undergoing leakage of urine is result and corresponding scoring below: never=0；Less than monthly=1；Monthly arrive for several times= 2；It arrives once a week for several times=3；Daily and/or every night=4.The inquiry of second parameter every time how much urinate by loss, is result below With corresponding scoring: several to drip=1；Seldom=2；With it is more=3.Final severity index is defined by following scoring: 1-2= Slightly；3-6=is medium；8-9=is serious；It is very serious with 12=.

In various embodiments, it is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification with repressive The women leakage of urine index of the urinary incontinence increases at least 5% than value before treatment.

In various embodiments, diaper test (1 is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification Hour and 24 hours) result than not treating when diaper test improve at least 5%, wherein 5% improvement is defined as by suction It receives diaper weight and increases measured hypourocrinia 5%.Diaper test represents a kind of verification method, by during measurement test The weight increase of absorption pad quantifies to lose to urine.Diaper test can quantify urine loss.Short-term survey is used It tries (< 1,1,2h) and tests (for 24 hours with longer) for a long time.Short-term test is completed in office facility, and longer test passes through Patient completes in her daily living environment.

In various embodiments, quality of life ratio is able to achieve using the system and method treatment urinary incontinence in patients with incomplete of this specification Value increases by least 5% (SF6, SF12, Roger Goldberg scale) before treatment.The relevant quality of life (HRQOL) of health is Composite sanitary care outcomes are generally divided into health, social functions, mental health, social angle it includes some functions are autonomous Color and common health perception.HRQOL tool generally includes many patients and completes the inquiry or project that are arranged by some scopes. SF-36 is the most common conventional H RQOL tool, is a kind of self-management tool, sets eight scales for HRQOL, is solved Body function, social functions, pain, emotional health, vigor, general health are realized and since body and/or emotional problem cause Role limitation.

Treatment of sexual dysfunctions terminal

In various embodiments, the system and method for this specification are configured to generate and following treatment of sexual dysfunctions terminal Consistent result.It should be understood that the construction is realized by adjusting various stimulation parameters for each patient, such as pulse frequency Rate, pulse width, pulse shape and impulse amplitude, until realizing therapeutic purpose disclosed herein.In turn, it should be appreciated that pass through meter It calculates the difference between the amount (usually after stimulation period) of its new measurement and its standing crop (being before stimulation period) and incites somebody to action The difference is divided by standing crop, to be determined as specific terminal to have increased X% or reduce X%.

In various embodiments, it is able to achieve using system and method treatment patient's sex dysfunction of this specification Golombok Rust sexual satisfaction questionnaire (GRISS) scoring improves at least 5% than scoring before treatment.Golombok Rust Sexual satisfaction questionnaire is the measurement to sex dysfunction, can be used for heterosexual Mr. and Mrs or current with heterosexual relationship Individual.Its TOP SCORES that pass relationship neutral function quality is respectively provided with for male and female.In addition, impotence, premature ejaculation, property Sense missing, coleospastia, frequency be low, without link up, male is discontented, women is discontented with, male is without experiencing (nonsensuality), female Property avoid without impression, male and women avoids such son scoring can be obtained and provide as overview.Norm referenced and standard The combination of reference can generate derived scale, can provide the presence of any problem and the good instruction of severity.It is converted To show the pseudo- stanine measurement of 5 or higher scorings of problem (it is region guiding, from 1 to 9).

In various embodiments, it is able to achieve using system and method treatment patient's sex dysfunction of this specification international vigorous Playing function index table (IIEF) scoring improves at least 5% than scoring before treatment.

In various embodiments, life matter is able to achieve using system and method treatment patient's sex dysfunction of this specification Measuring (SF6, SF12) improves at least 5% than value before treatment.Quality of life similarly measure like that by the urinary incontinence as described above.

In various embodiments, patient is able to achieve using system and method treatment patient's sex dysfunction of this specification to feel Know scoring (visual analogue scales scoring 1-100) than scoring improvement at least 5% before treatment.Similarly urine loses VAS as described above Taboo is measured like that.

In various embodiments, patient's sex dysfunction realizability function is treated using the system and method for this specification Questionnaire scoring improves at least 5% than scoring before treatment.

In various embodiments, patient's sex dysfunction realizability function is treated using the system and method for this specification SDQ scoring of obstacle questionnaire (SDQ) scoring than scoring before treating or less than 45 improves at least 5%.Sex dysfunction questionnaire (SDQ) It is 19 questionnaires of the sexual experience based on preceding December.Critical value (boundary) is 45 points of (0.5 possibility corresponding to dysfunction group Property), higher than this point then main body have property problem feature, have feature growing day by day, thus increase scoring.Figure 21 is to be used for property The table of dysfunction questionnaire (SDQ) lists a series of statements in relation to patient's sexual behaviour 2102, and scoring 2104 is 1 to 5, Wherein 1 expression is always and 5 indicate never.

In various embodiments, women is able to achieve using system and method treatment patient's sex dysfunction of this specification Function index improves at least 5% than scoring before treatment.

In various embodiments, it is able to achieve using system and method treatment patient's sex dysfunction of this specification by patient The sexual desire of daily log measurement increases at least 5% than value before treatment.

In various embodiments, it is able to achieve using system and method treatment patient's sex dysfunction of this specification by patient Successful or satisfactory sexuality or experience value more preceding than treatment increase at least 5% in a period of time of daily log measurement.Thing The sensitivity for the effect of can providing male erectile dysfunction or premature ejaculation research and reliable measurement are measured in part log or diary, or The terminal of independence and observable is provided in other treatment field.These terminals are based on success and satisfactory property in a period of time The number of activity or experience.Success and satisfactory definition are provided by the women participated in, rather than her partner. The tool can be used also to study in additional terminal (such as desire, sexual arousal, climax or pain).In turn, these terminals is tight Weight degree and frequency can be recorded.The number of these terminals gives the objective measure of sex dysfunction and because intervening bring The variation of dysfunction.

In various embodiments, patient's sex dysfunction realizability function is treated using the system and method for this specification Summary index increases at least 5% than value before treatment.

PROMIS sexual function and satisfaction measure scale (PSxFBP) and provide commenting for related 6 kinds of different sexual function subcategories Point: interest, the discomfort of vagina (only women), lubrication (only women), erection function (only male), climax and the sexual life of sexual behaviour Total satisfaction.

It (is indicated by 0 point) confirmed that all items of given scope are answered without " not applicable " reaction of approval Afterwards, reaction scoring is summed for all items of the scope, and the original summation with offer for the scope scores.For example, for For sexual life total satisfaction, original summation scoring be can be from 2 (thinking " not " to two) to 10 (to two Think " very " or " special ").For single climax project, summation scoring is not generated.The project using item response theory and It does not score.Alternatively, primitive reaction can be used for analyzing.

Original scoring is readjusted as normalized score by T- scoring, with 50 average value and 10 standard deviation (SD).Therefore, the artificial sub-average SD that the T- with 40 scores.Standardized T- scoring can be used as by report to be used for The final scoring of each participant of each scope.For example, for sexual life total satisfaction scope, 6 original summation scoring It is converted into 48.15 T- scoring, with 3.52 standard error (SE).95% near observed scoring is set as a result, Believe that interval range is 41.25 to 55.04 (T- scoring+(1.96 × SE) or 48.15+ (1.96 × 3.52).

Patient with irritable bowel syndrome is generally subjected to alternate constipation and diarrhea, has defecation urgency symptom.? In one embodiment, the electric medical device of this specification allows patient to control using different electrode combinations and different stimulated algorithm Corresponding symptom, as described above.

Treatment of faecal incontinence terminal

In various embodiments, the system and method for this specification are configured to generate whole with following bowel movement function treating dysfunction Point is consistent as a result, especially in terms of incontinence of faces.It should be understood that the construction is by adjusting various thorns for each patient Swash parameter to realize, such as pulse frequency, pulse width, pulse shape and impulse amplitude, until realizing treatment mesh disclosed herein Mark.In turn, it should be appreciated that amount (usually after stimulation period) and its standing crop by calculating its new measurement (are to stimulate Before stage) between difference and divide that difference by standing crop, so that specific terminal to be determined as having increased X% or reduce X%,.

Figure 22 is to summarize the improved table realized using this specification system and method treatment patient's incontinence of faces. It can be increaseing or decreasing for measured variable it should be noted that improving.Referring to fig. 22, in various embodiments, use this specification System and method treatment patient's incontinence of faces be able to achieve patient incontinence and perceive scoring (visual analogue scales scoring 1-100) ratio and do not have There is scoring when treatment to improve at least 5%, as shown in 2201.It is directed to before as described in urinary dysfunction, visual analogue scales It (VAS) is problem-targeted evaluation mechanism, wherein vision measurement is associated with each problem and needs of answering a question are in visual degree Quantifiable position is selected in amount, shows specific horizontal or degree.Scale generally includes to be fixed on having for each end The sentence (length different) of word, description extremum (that is, from ' my the absolutely not incontinence ' on the left side to the right ' I always loses Prohibit ').Patient, which is required to mark, feels corresponding sentence with it.It completes to measure at a distance from label by measuring left end line Quantization.In some embodiments, VAS can be used for assessing the severity of incontinence of faces, the urinary incontinence or sex dysfunction.

In various embodiments, it is able to achieve using system and method treatment patient's incontinence of faces of this specification Rothenberger incontinence scale improves at least 5% than value before treatment, as shown in 2202.In various embodiments, this theory is used System and method treatment patient's incontinence of faces of bright book, which is able to achieve Wexner incontinence scale, improves at least 5% than value before treating, such as Shown in 2203.In various embodiments, Vaizey is able to achieve using system and method treatment patient's incontinence of faces of this specification Incontinence scale improves at least 5% than value before treatment, as shown in 2204.

In various embodiments, the big of patient is able to achieve using system and method treatment patient's incontinence of faces of this specification Fecal incontinence severity index (FISI=Fecal Incontinence Severity Index) increases at least than value before treatment 5%, as shown in 2205.Patient's incontinence of faces severity index includes several parameters related with investigation result, then quilt It is classified as numerical point scoring.

It should be noted that Rothenberger, Wexner, Vaizey and FISI are various incontinence points-scoring systems, pass through consideration Some factors (such as incontinence of faces frequency, incontinence of faces type and the element for influencing incontinence of faces generation) are big to patient to provide The measurement of fecal incontinence level.Figure 23 A and 23B show the methodology of various points-scoring systems.3A referring to fig. 2, various incontinence of faces Index 2300 considers incontinence frequency 2301, such as can be less than monthly 1 time to the range being greater than 2 times a day.The index Also consider the fecal matter type 2302 for incontinence purpose, such as solid, liquid, gas and mucus.Index also considers other shadows Ring the factor 2303 of incontinence, such as use and the lifestyle change of pad.

Figure 23 B shows the methods of marking of various indexes.3B referring to fig. 2,2310 range pair of scoring for incontinence of faces It is 0-30 for Rothenberger, be 0-20 for Wexner, is 0-24 for Vaizey and is 0- for FISI 61.Further, different points-scoring systems are also by different weights and different types of incontinence (such as solid, liquids and gases incontinence) Mutually coordinate and mutually coordinates with influence factor as such as lifestyle change.

In various embodiments, it is able to achieve using system and method treatment patient's incontinence of faces of this specification and passes through anus The parameter of manometry in rectum art measurement improves at least 5% than value before treatment.Technique of anorectal manometry art is to be related to placing in patient's body The test of rectal sac.In general, rectal sac is filled with the warm water of 50cc, and same in chamber pot in patients' privacy occupying When capsule is discharged, measure various anuses and rectum parameter.Time needed for rectal sac is discharged in main body forms rectal sac discharge test Basis.In various embodiments, capsule is removed if capsule cannot be discharged in 3 minutes in main body.

In order to use technique of anorectal manometry art to measure, after 2 sodium phosphate bowel lavage, estimated by high-resolution pressure catheter Anal pressure, the conduit include 10 circumferential sensors, and 8 sensors are arranged with the interval 6mm along anal canal and set in rectal sac Set 2 sensors.Pressure is detected in the length of 2.5mm in the pressure sensor of each level, 36 circumferential orientations.With The frequency acquisition data of 35Hz.The pressure of 36 parts is subsequently averaged, to obtain average pressure measured value in each level.Often The response characteristic of one sensing element make they it is recordable be more than the pressure transient of 6000mmHg/s and before thermal recalibration extremely The accuracy of measurement within 1mmHg atmospheric pressure is obtained in research in few last 5 minutes.During each research, click Time sequencing assesses parameter: at tranquillization 20 seconds, having three tries and longest in 20 seconds extrusion process and expands rectal sac every time Before and after simulation be discharged (50ml) when anal orifice and rectal intestine pressure.

Thereafter, by gradually allowing rectal sac to be expanded to 200ml from 0 with the increment of 20ml and being expanded with the increment of 40ml thereafter Until reaching the maximum of 400ml, while assessing rectal and anal sphincter reflexes and rectal sensation.Record first thoughts, it is urgent and Maximum uncomfortable critical quantity.These parameters are analyzed using commercially available software.Pass through the sensor measurement rectum pressure in rectal sac Power.Although anal pressure across several (usual 9) sensors on anal canal by recording, other schemes include by data Being reduced to each time point has single value.However, the calculating for obtaining the single value changes because of different operation.In tranquillization When, during extruding and in proctectasia, this sensing is identified by all of anus sensor record at any point in time Peak in pressure.The value is used to calculate in 20 seconds of each tranquillization and the Mean anal tranquillization of all 3 extruding movement And squeeze pressure.High-pressure area (HPZ) length is the mean pressure d istribution in Resting Pressure frame, is defined as: { rectal pressure + ([anus Resting Pressure-rectal pressure] × 0.25) }.

Contrastingly, during simulating discharge, rectum in 20 seconds periods can be identified by measuring single value at every point of time Maximum positive (or minimal negative) between anus (rectum-anus) pressure is poor.During proctectasia, by slack anus percentage (%) is calculated as [(1-remaining anal pressure/anus Resting Pressure) × 100].If slack anus is greater than 25%, consider straight Intestines-anus inhibits reflection.

Figure 24 is the presentation graphics of high-resolution technique of anorectal manometry art.Referring to fig. 24, the process as the result is shown 2401 and of patient anus in 2406 stages is expanded in the tranquillization 2403 of process as described above, extruding 2404, defecation 2405 and capsule The pressure measured in rectum 2402.

Return to Figure 22, it is shown that the various parameters measured by high-resolution technique of anorectal manometry art.In various embodiments In, using this specification system and method treatment patient's incontinence of faces be able to achieve by by technique of anorectal manometry art measure with Lower parameter improves at least 5% than value before treatment:

In various embodiments, which shows to improve than value before treating musculus sphincter ani internus Resting Pressure 2206- At least 5% or be greater than 33mmHg.Musculus sphincter ani internus pressure be defined as the highest musculus sphincter ani internus pressure recorded when tranquillization and Difference in rectum between pressure.

In various embodiments, which shows to improve than value before treating external sphincter muscle of anus Resting Pressure 2207- At least 5%.External sphincter muscle of anus pressure be defined as in the highest external sphincter muscle of anus pressure and rectum recorded when tranquillization pressure it Between difference.

In various embodiments, which shows to improve at least than value before treating anal sphincter extruding force 2208- 5% or be greater than 99mmHg.Anal sphincter extruding force is defined as recording most at any level in anal canal during extruding acts Difference in high pressure and rectum between pressure.

In various embodiments, which shows than before treatment repressive test (abdominal pressure leakage point pressure) 2209- Value improves at least 5% or is greater than 60cmH₂O。

In various embodiments, which shows than value before treating repressive test (abdominal pressure leak point amount) 2210- Improve at least 5% or is greater than 50cc.

Anus high-pressure area 2211-in various embodiments, the parameter show than treat before value improvement at least 5% or Greater than 2.4cm.

Anus squeezes the duration 2212-in various embodiments, shows to improve at least 5% or big than value before treating In 3 seconds.

There is sensibility reciprocal 2213-in various embodiments for the first time, which shows to improve at least 5% or big than value before treating In 20ml.

In various embodiments, which shows to improve at least 5% than value before treating amount 2214-when desired defecation Or it is greater than 40ml.

In various embodiments, which shows to improve at least 5% than value before treating amount 2215-when feeling urgent Or it is greater than 60ml.

In various embodiments, which shows to improve at least 5% or small than value before treating capsule efflux time 2216- In 3 minutes.Capsule discharge test is coordinated for the rectum during assessing defecation-anus.The ability of patient is assessed in the test, with from straight The capsule having been filled with is discharged in intestines.Capsule can be discharged in 1 minute in most of normal main bodys.

In various embodiments, which shows to improve at least than value before treating rectal pressure 2217- when discharge 5% or be greater than 5mmHg.

Anal pressure-when discharge in various embodiments, the parameter show than treat before value improvement at least 5% or Less than 5mmHg.

In various embodiments, quality of life is able to achieve using system and method treatment patient's incontinence of faces of this specification (SF6, SF12, Roger Goldberg scale) increases at least 5% than value before treatment.The relevant quality of life (HRQOL) of health It is composite sanitary care outcomes, it includes some functions are autonomous, is generally divided into health, social functions, mental health, society Role and common health perception.HRQOL tool generally includes many patients and completes the inquiry or project that are arranged by some scopes. SF-36 is the most common conventional H RQOL tool, is a kind of self-management tool, sets eight scales for HRQOL, is solved Body function, social functions, pain, emotional health, vigor, general health are realized and since body and/or emotional problem cause Role limitation.

Example above is only the displaying of many applications of present system.Although only this document describes of the invention seldom Embodiment, it should be understood that the present invention can be implemented with many other concrete forms, without departing from the spirit or scope of the present invention. Specifically, standard can be used to can plant pulse generator (by the body of operation implantation patient) and draw using standard with main room name Line implanted prosthetics is implanted in the electrode near destination organization to implement.Therefore, example of the invention and embodiment are considered as showing Example property rather than it is restrictive, and the present invention can change within the scope of the appended claims.

Claims (20)

1. a kind of for using stimulating apparatus to improve the method for patient's urethra sphincter function, wherein stimulating apparatus includes operatively It is connected at least one electrode of stimulation generator and is configured at least one stimulus signal to be transmitted to the control of stimulation generator Device processed, this method comprises:

It will be in the anorectal areas of device implantation patient；

Destination organization electrode being positioned as in the anorectal areas with patient is electrically connected；

Stimulus signal is generated based on the multiple program instructions of storage in the controller using the controller；With

Electric stimulation pulse is generated using stimulation generator in response to the stimulus signal, wherein the electric stimulation pulse is via described The destination organization of at least one electrodes transfer into the anorectal areas.

2. improving the method for patient's urethra sphincter function as described in claim 1, wherein destination organization includes that rectum is indulged away Flesh, rectum circular muscle, lamina muscularis mucosae intestini recti, submucous stratum of rectum, nervus pudendus or nervus pudendus branch, joint longitudinal muscle, anus The superficial part of sphincter or deep part, musculus sphincter ani internus, lamina muscularis of anal mucous membrane, subserous plexus, longitudinal muscle clump, ring outdoors Shape flesh clump, gland Zhou Cong, myenteric plexus (myenteric nerve plexus), anorectum mucous membrane under in (corpusculum tactus) clump and perineum tissue At least one.

3. improving the method for patient's urethra sphincter function as described in claim 1, wherein the electric stimulation pulse includes tool There is 10 μ seconds pulse width, the pulse frequency of 1 microampere to 100 milliamperes of impulse amplitude and 0.02Hz to 100Hz for arriving 500ms range Rate.

4. improving the method for patient's urethra sphincter function as described in claim 1, wherein described device further comprises matching Be set to obtain data at least one sensor, and the method further includes based on from least one sensor and come number According to the change electric stimulation pulse.

5. improving the method for patient's urethra sphincter function as claimed in claim 4, wherein at least one described sensor packet Include pressure sensor, electrical activity sensors, impedance transducer, accelerometer or inclinometer.

6. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, abdominal pressure leak point pressure relative to the abdominal pressure leakage point pressure increase before the application of the electric stimulation pulse at least 5 percent or at least 60cmH₂O。

7. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, abdominal pressure leak point amount is relative to the abdominal pressure leakage point amount increase at least percentage before the application of the electric stimulation pulse Five or at least 50cc.

8. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, residual urine volume determines that residual urine volume determines increasing after urination before the application relative to the electric stimulation pulse after urination Add to few 5 percent.

9. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, urine flow rate is relative to the urine flow rate increase at least 5 percent before the application of the electric stimulation pulse.

10. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, bladder compliance monitoring is relative to the bladder compliance monitoring increase at least 5 percent before the application of the electric stimulation pulse Or at least 20ml/cm H₂O。

11. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, detrusor leaks point pressure relative to the detrusor leakage point pressure increase before the application of the electric stimulation pulse At least 5 percent or at least 40cmH₂O。

12. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, sensibility reciprocal has sensibility reciprocal to increase to few 5% or extremely for the first time relative to before the application of the electric stimulation pulse for the first time Few 50ml.

13. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, secondary thoughts (full urine) amount increases relative to secondary thoughts (full urine) amount before the application of the electric stimulation pulse At least 5% or at least 200ml.

14. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, maximum bladder capacity is relative to the maximum bladder capacity increase at least 5% before the application of the electric stimulation pulse Or at least 400ml.

15. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, maximum detrusor pressure power relative to the maximum detrusor pressure power increase before the application of the electric stimulation pulse at least 5% or at least 20cmH₂O。

16. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, detrusor contractions are relative to the detrusor contractions increase at least 5% before the application of the electric stimulation pulse But it is no more than 25%.

17. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electro photoluminescence arteries and veins After punching, incontinence attack times or each incontinence breaking-out average incontinence amount relative to the electric stimulation pulse it is described it Preceding incontinence attack times or the average incontinence amount of each incontinence breaking-out are reduced at least 5%.

18. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, tatol emiction quantity is relative to the tatol emiction quantity increase at least 5% before the application of the electric stimulation pulse.

19. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, the patient incontinence in visual analogue scales feels scoring relative to the vision before the application of the electric stimulation pulse Patient incontinence in analog scale feels that scoring improves at least 5%.

20. improving the method for patient's urethra sphincter function as described in claim 1, wherein applying the electric stimulation pulse Later, Stamey incontinence scoring improves at least relative to the Stamey incontinence scoring before the application of the electric stimulation pulse 1 grade.