WO2024036325A1 - Dispositifs, systèmes et méthodes de désintégration et/ou d'élimination de matières fécales - Google Patents

Dispositifs, systèmes et méthodes de désintégration et/ou d'élimination de matières fécales Download PDF

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Publication number
WO2024036325A1
WO2024036325A1 PCT/US2023/072114 US2023072114W WO2024036325A1 WO 2024036325 A1 WO2024036325 A1 WO 2024036325A1 US 2023072114 W US2023072114 W US 2023072114W WO 2024036325 A1 WO2024036325 A1 WO 2024036325A1
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WIPO (PCT)
Prior art keywords
hub
distal
proximal
channel
anus
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PCT/US2023/072114
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English (en)
Inventor
George TRIADAFILOPOULOS
Peter Garcia-Meza
Patrick Wu
Daniel Chan
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Shockevac Medical, Inc.
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Application filed by Shockevac Medical, Inc. filed Critical Shockevac Medical, Inc.
Publication of WO2024036325A1 publication Critical patent/WO2024036325A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
    • A61B2017/00123—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation and automatic shutdown
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22037—Fecal impaction removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop

Definitions

  • the present technology relates to devices, systems, and methods for the disruption and/or removal of fecal matter.
  • OC and FI Obstructive constipation and fecal impaction (FI) occur because hardened fecal matter is retained in the distal large bowel and cannot be evacuated by regular peristaltic colonic activity and coordinated pelvic floor muscle contractility. If OC and FI are not recognized and treated early, they can give rise to the formation of large fecahths or stone-like feces OC and FI cause increased morbidity and a significant decrease in the patient’s quality of life. OC and FI commonly occur among the elderly who are hospitalized, bedridden or under institutional, long-term care. Among hospitalized patients, administration of opioids can result in OC and FI, especially in those with a prior history of chronic constipation and are bedridden. OC and FI also account for frequent and repetitive visits to the emergency departments (ED), increasing health care costs because of acute medical visits, medical and nursing personnel engagement, ED overcrowding and ambulance transportation.
  • ED emergency departments
  • FI Severe constipation, the leading predisposing condition to FI, is a significant problem that affects almost 70% of elderly residing in nursing homes. Among those affected by FI, only 7% are detected by a digital rectal examination and further imaging studies are frequently needed. FI is more common among older women with pelvic floor descent from previous multiparity or pelvic surgery' who may be institutionalized or have associated neuropsychiatric disorders and it can lead to complications, such as vaginal and urinary prolapse, recurrent urinary tract infections, morbidity, and mortality. [0005
  • FI may also cause an increase in intraluminal pressure in the colon which causes a decrease in perfusion of the colonic wall.
  • the resulting inflammation can give rise to stercoral ulcers, recurrent rectal bleeding and sometimes rectosigmoid perforation attributed to feces being hardest in the rectosigmoid colon.
  • a digital rectal examination is mandatory to confirm the diagnosis of OC and FI, but this is frequently uncomfortable to the patient and omitted or avoided by clinicians and nursing personnel.
  • a rectal examination does not reveal fecal impaction or a hard fecal mass in the rectum, the possibility of fecal impaction more proximally (typically in the sigmoid colon) or other causes of obstipation, such as strictures, colonic malignancy, or colonic volvulus, should be considered.
  • the most useful and commonly used radiological imaging for evaluation is a CT abdomen, preferably with oral or rectal contrast.
  • a plain x-ray of the abdomen can, at times, reveal fecal overloading of the colon, with colonic distention of the segment proximal to the region of fecal impaction. Rarely, a contrast enema or sigmoidoscopy are used.
  • Treatment options include a digital evacuation of the impacted fecal mass or the rectal administration of stool softening agents, usually enemas or suppositories, but often manual disimpaction is required. This is an essential therapeutic procedure if one can palpate hard stool in the rectal area. The procedure is best done using ample lubrication and by gentle removal of the impacted stool using the index and middle fingers. Most patients find immediate relief once fecal disimpaction is effectively performed. Unfortunately, this is painful to the patient and time consuming to the operator, sometimes requiring general anesthesia.
  • the abdominal x-ray reveals that the fecal impaction is located distally, then the use of enemas and suppositories can be helpful.
  • the enema is best delivered with a catheter past the hardened stool, but this is challenging to accomplish given the soft nature of the catheter that may coil.
  • the best method is to use ample water and combine it with laxatives, such as docusate or sorbitol. It is important to administer small amounts (60-120ml) of enema so as not to create discomfort in the patient.
  • Once the enema is administered one can help the process of evacuation by gently massaging the lower abdomen. This process may have to be repeated several times until only clear liquid passes and the rectal vault is checked empty upon repeat digital examination.
  • the ideal laxative is orally administered polyethylene glycol.
  • Another laxative that can help with proximal impaction is magnesium citrate.
  • Polyethylene glycol can be given orally only if conditions, like volvulus or structural bowel obstruction due to any cause, are ruled out.
  • Administration of an appropriate laxative or fiber supplement with increased intake of water after the evacuation of the impacted fecal mass is administered to prevent recurrence. Early surgical evaluation and intervention are necessary if there are associated signs of peritonitis.
  • Stercoral perforation is associated with a high mortality in the elderly if not recognized and treated early. Sometimes impaction occurs after a barium study; to mitigate this risk, all patients should be encouraged to consume extra fluids after the procedure. In some cases, preventive use of an osmotic laxative, like sorbitol or milk of magnesia, may be helpful.
  • OC and FI are very common. These are related to use of opiates, sphincter spasm, edema around the anal tissues, and a fear of going to the bathroom due to pain. In most mild cases, administration of an enema is sufficient; but in severe cases, one may need to perform manual disimpaction in the operating room. The patient will usually need some type of anesthesia to relax the anal sphincter complex before FI can be removed.
  • OC and FI are significant but preventable problems in the elderly population residing in hospitals and other long-term facilities. The best treatment for OC and FI is prevention. Often these patients present to the ED because of symptoms that mimic other sinister intestinal pathology, such as colorectal cancer.
  • OC and particularly FI are serious disorders that affect many older adults.
  • the disorders are best managed by an interprofessional team that includes a physician, nurse, pharmacist, neurologist, social worker, and physical therapist.
  • the pharmacist should ensure that the patient is not on any medications that slow down bowel movements and avoid polypharmacy.
  • the dietitian should encourage an increase in fluid intake and high-fiber diet, as needed. Both exercise and ambulation are vital. But it is usually the nurse or medical assistant who must manage the patient with FI diagnosed by the physician.
  • Education of the family and the patient about dietary habits and lifestyle are essential to preventing recurrences. If chronic constipation cannot be cured, then attempts at improving the quality of life using various laxative regimens must be made.
  • the present technology relates to devices, systems, and methods for the efficient disruption and/or removal of fecal matter.
  • the present technology includes, for example, a hand-held device configured for insertion through the anus into the rectum to engage impacted fecal matter.
  • the device can include a disruption element that, when activated, translates, rotates, and/or vibrates at the treatment site to dislodge or otherwise disrupt impacted fecal matter.
  • the disruption element can be coupled to a hub that is configured to be positioned within the anal canal to help support and anchor the disruption element during use, and to prevent intestinal fluids and/or fecal matter from leaking out of the rectum through the anus.
  • the device includes an infusion channel for the delivery of saline, laxatives, and/or other fluids into the rectum to soften the impacted stool.
  • the device can include an aspiration channel that evacuates the dislodged and/or softened fecal matter and other fluids into a vacuum canister.
  • a device for removing fecal matter from an intestine of a patient comprising: a proximal portion configured to be engaged by a user, and a distal portion, configured to be positioned at a treatment site within a lumen of the intestine proximate to impacted fecal matter; a disruptor comprising a proximal region configured to be handled by a user, a distal region, and an elongated member extending therebetween, wherein the disruptor further comprises: a distal element carried by a distal portion of the elongate member and configured for insertion into the intestinal lumen through an anus of the patient, an energy source operably coupled to the distal element, and wherein activation of the energy source energizes the distal element, thereby causing the distal element to deliver energy to the impacted fecal matter and dislodge a portion of the impacted fecal matter; an expandable member configured to be positioned in the intestinal lumen, the expandable member having
  • the channel is a first channel
  • the port is a first port
  • the opening is a first opening
  • the device further comprises a second channel extending distally from a second port at the proximal portion of the device to a second opening at the distal portion of the device, wherein the second port is configured to be fluidly coupled to a fluid source to deliver a fluid through the second channel to the treatment site.
  • the channel is a first channel
  • the port is a first port
  • the opening is a first opening
  • the device further comprises a third channel extending distally from a third port at the proximal portion of the device to a third opening at the expandable member, wherein the third port is configured to be fluidly coupled to a positive pressure source to transform the expandable member from a collapsed state to an expanded state.
  • a proximal element configured to be positioned proximal of the anus at an extracorporeal location, wherein the proximal element has a diameter that is greater than a diameter of the anus such that the expandable member and the proximal element together secure the device at the anus.
  • the energy source is a motor, and wherein activation of the motor causes the distal element to move, thereby dislodging a portion of the fecal matter.
  • a device for removing fecal matter from an intestine of a patient comprising: a proximal portion configured to be engaged by a user and a distal portion configured to be positioned at a treatment site within a lumen of the intestine proximate to impacted fecal matter; a disruptor comprising a proximal region configured to be handled by a user, a distal region, and an elongate member extending therebetween, wherein the disruptor further comprises a distal element carried by a distal portion of the elongate member and configured for insertion into the intestinal lumen through an anus of the patient, wherein the distal element is actuatable to dislodge a portion of the impacted fecal matter; and a hub having a distal portion configured to be positioned in the intestinal lumen, a proximal portion configured to be positioned proximal of the anus at an extracorporeal location, and an intermediate portion extending between the distal and
  • distal portion of the hub comprises an expandable member having a collapsed state for introduction into the intestinal lumen and an expanded state in which the expandable member is configured to conform to the inner wall of the intestinal lumen to prevent or reduce leakage of intestinal fluids and/or fecal matter through the anus to an extracorporeal location.
  • the channel is a first channel and the hub further comprises a second channel extending distally from a proximal opening at the proximal portion of the hub to a distal opening at the distal portion of the hub, wherein the second channel is configured to be fluidly coupled to a negative pressure source to apply a negative pressure at the treatment site to remove the portion of the fecal matter and/or other matter present in the intestinal lumen.
  • the second channel is configured to be fluidly coupled to a fluid source and deliver a fluid to the treatment site.
  • the hub further comprises a third channel extending distally from a proximal opening at the proximal portion of the hub to a distal opening at the distal portion of the hub, wherein the third channel is configured to be fluidly coupled to a fluid source and deliver a fluid to the treatment site.
  • the hub comprises a sidewall defining an interior region of the hub that is configured to receive all or a portion of the distal element therein.
  • a method for removing fecal matter from an intestine of a patient comprising: positioning a treatment device through the anus to a treatment site within an intestine of a patient proximate to impacted fecal matter, wherein the treatment device comprises (a) a hub and (b) a disruptor including an elongated member and a distal element carried by a distal portion of the elongated member, the disruptor configured to be operably coupled to an energy source, and wherein the treatment device is positioned such that the hub is positioned on either side of the anus; expanding a portion of the hub that is positioned within the rectum such that the portion conforms to an inner surface of the rectal lumen; engaging the impacted fecal matter with the distal element of the disruptor and activating an energy source of the disruptor to deliver energy to the treatment site via the distal element, thereby dislodging a portion of the impacted fecal matter; and aspirating the dislodged portion of the
  • the channel is a first channel and the hub comprises a second channel configured to receive the elongated member of the disruptor therethrough, and wherein the method further comprises translating the elongated member within the second channel to advance and retract the distal element of the disruptor.
  • positioning the treatment device includes inserting the hub through the anus with a distal region of the distal element extending distally from a distal end of the hub.
  • a method of removing fecal matter from the intestine of a patient comprising: introducing into the rectum a device configured to aid insertion of a mechanical energy source; securing the device to abut and seal itself against the inner surface of the anal canal and stabilize itself in the anus; introducing liquids through the device to soften fecal matter; and activating said device mechanically rotates a brush to break down fecal matter into small pieces to allow passive and/or active evacuation of liquified fecal matter.
  • the mechanical energy source comprises a brush and a drive module, and wherein the brush is attached to the distal end of the drive module, and wherein the drive module is configured to oscillate, rotate, or advance the brush.
  • a device for removing fecal matter from an intestine of a patient comprising: a proximal portion configured to be engaged by a user, and a distal portion, configured to be positioned at a treatment site within a lumen of the intestine proximate to impacted fecal mater; a disruptor comprising a proximal region configured to be handled by a user, a distal region, and an elongated member extending therebetween, wherein the disruptor further comprises: a distal element carried by a distal portion of the elongate member and configured for insertion into the intestinal lumen through an anus of the patient, an energy delivery element operably coupled to the distal element, and wherein activation of an energy source causes energy delivery element to direct energy towards the impacted fecal matter and dislodge a portion of the impacted fecal mater; an expandable member configured to be positioned in the intestinal lumen, the expandable member having a collapsed state for introduction into
  • the energy' delivery element is a reflector configured to reflect ultrasonic energy at the treatment site, and wherein the ultrasonic energy is generated by the energy source that is positioned at an extracorporeal location.
  • a device for removing fecal matter from an intestine of a patient comprising: a proximal portion comprising a handle configured to be engaged by a user and a distal portion configured to be positioned at a treatment site within a lumen of the intestine proximate to impacted fecal matter, the device having a longitudinal axis extending between the proximal and distal portions; an elongate member extending between a proximal region at the handle and a distal region; an elongate distal element at the distal portion of the device, wherein the distal element is configured for insertion into the intestinal lumen through an anus of the patient; and a hub positioned between the distal region of the elongate member and the distal element along the longitudinal axis of the device, the hub having a distal portion configured to be positioned in the intestinal lumen, a proximal portion configured to be positioned proximal of the anus at an extracorporeal location,
  • the elongate member comprises a bend along its length, wherein the bend positions a longitudinal axis of the hub at an angle relative to the longitudinal axis of the handle.
  • an outer surface of the distal element comprises one or more openings configured to deliver a fluid from an extracorporeal fluid source to the treatment site.
  • the energy source is a motor
  • activation of the motor causes the distal element to move, thereby dislodging a portion of the fecal matter and/or stimulate muscles adjacent the rectum.
  • FIGS. 1A and IB depict a treatment device in accordance with the present technology, shown in different configurations.
  • FIG. 2 is a side cross-sectional view of the hub of the treatment device of FIGS. 1 A and IB in accordance with several embodiments of the present technology.
  • the hub is in an expanded configuration.
  • FIGS. 3A-3D depict a method of using the treatment device of FIGS. 1A and IB to treat fecal impaction in accordance with several embodiments of the present technology.
  • FIGS. 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 show various distal elements configured for use with the disruptors of the treatment devices of the present technology.
  • FIGS. 17, 18 and 19 show various hubs configured for use with the treatment devices of the present technology.
  • FIG. 20 is an example control diagram for the treatment devices of the present technology.
  • FIG. 21 depicts a treatment device configured in accordance with the present technology, shown with a distal portion positioned in the rectum.
  • FIGS. 1A and IB depict a treatment device 100 (also referred to herein as “device 100”) configured in accordance with several embodiments of the present technology.
  • the device 100 can be configured for insertion through the anus into a lumen of an intestine (such as the colon) and disrupt, capture, and/or remove obstructive material, such as impacted fecal matter, from the intestinal lumen.
  • the act of “disrupting” fecal matter includes breaking the material into smaller pieces, modifying the shape of the material, stretching and/or elongating the material, compressing the material, permanently or temporarily repositioning all or a portion of the material, extracting all or a portion of the material, macerating the matenal, morcellating the material, softening the material, shaving the material, shearing the material, and/or any other action that modifies the shape, size, and/or position of the fecal matter.
  • the device 100 comprises a proximal region 100a configured to be positioned outside of the patient’s body and manipulated by a user, and a distal region 100b configured to be positioned at a treatment site within a lumen of the intestine (e.g., the colon, the rectum, the anal canal, etc.) proximate fecal matter, such as impacted fecal matter.
  • proximal refers to a position that is closer to the clinician along a longitudinal axis of the device 100
  • distal refers to a position that is farther from the clinician along the longitudinal axis of the device 100. As best shown in FIGS.
  • the device 100 can comprise a hub 300 configured to be positioned across the patient’s anus to help anchor and seal the device 100, and a disruptor 400 slidably received through the hub 300 and configured to engage fecal matter at the treatment site.
  • the disruptor 400 comprises a proximal region including a handle 406, a distal region including a distal element 402 (only partially shown in FIG. 1 A), and an elongate member 404 extending therebetween.
  • the elongate member 404 can have a proximal portion 404a coupled to the handle 406 and a distal portion 404b (only visible in FIG. IB) coupled to the distal element 402.
  • the elongate member 404 can comprise a solid rod or may be a hollow shaft having a lumen extending therethrough.
  • the device 100 and/or disruptor 400 includes an energy source 407 (shown schematically) operably coupled to the distal element 402 (e.g., via the elongate member 404). Activation of the energy source energizes the distal element 402, thereby causing the distal element 402 to deliver energy to the fecal matter and dislodge a portion of the fecal matter.
  • the energy source 407 is a motor, and activation of the motor causes the distal element 402 to move (e.g., vibrate, translate, and/or rotate), thereby agitating the fecal matter.
  • the motor can be housed within the handle 406 and activated by an actuator 408 on the handle 406, such as a button, switch, knob, etc.
  • the motor is powered by a batteiy. which may be contained in the handle 406. Additionally, or alternatively, the motor may be configured to be electrically coupled to an external power source, such as a wall outlet.
  • the distal element 402 can comprise one or more ultrasound transducers and the energy source 407 comprises a pulse generator.
  • the ultrasound transducer can convert the electrical signals created by the pulse generator into ultrasound signals that are configured to disrupt fecal matter at the treatment site.
  • the ultrasound signals can vary in shape, duration, and length.
  • electrical signals from the pulse generator, and the corresponding ultrasound signals may be a train of pulses of a fixed or variable frequency, duty-cycle, and duration.
  • the pulse generator and ultrasound transducer are configured to deliver acoustical waves having a frequency of about 10 kHz to 100 kHz, 10 kHz to 50 kHz, 10 kHz to 1000 kHz, at least 10 kHz, at least 20 kHz, at least 30 kHz, at least 40 kHz, or more than 1000 kHz.
  • the distal element 402 comprises one or more reflectors, and the system includes one or more transducers configured to be positioned outside the body and not in direct contact with the distal element 402.
  • the intensity of the disruptive energy may be adjustable, for example via one or more actuators on the handle 406.
  • the device 100 does not include an energy source and the user moves the distal element 402 to dislodge the fecal matter manually .
  • the device 100 can include one or more fluid channels extending between the proximal and distal regions 100a, 100b of the device 100 for infusing fluids to and/ or removing fluids and fecal matter from the treatment site.
  • the device 100 can comprise a first channel 110 extending distally from a port at the proximal region 100a to an opening at the distal region of the device 100 (e.g., at or distal of the hub 300).
  • the first channel 110 can be fluidly coupled to a negative pressure source 112 (e.g., a vacuum pump, a syringe, etc.) to apply a negative pressure at the treatment site to remove disrupted fecal matter present in the intestinal lumen (e.g., 0 to 800 mm Hg).
  • a negative pressure source 112 e.g., a vacuum pump, a syringe, etc.
  • at least a portion of the first channel 110 extends through the body of the hub 300 (as shown in FIG. 2), and at least another portion of the first channel 110 extends through a tube coupled to and extending proximally away from a proximal portion of the hub 300.
  • the tube can optionally include a flush port, such as a T-port 114.
  • the first channel 110 can be used both for aspiration and infusion of fluids.
  • the first channel 110 can be configured to be operably coupled to a fluid source.
  • the device 100 comprises a second channel 120 extending distally from a port at the proximal region 100a of the device 100 to an opening at the distal region 100b of the device 100 (e.g., at or along the hub 300, at or along the elongate member 404, at or along the distal element 402, etc.).
  • the second channel 120 can be configured to be fluidly coupled to a fluid source 122 to deliver a fluid through the second channel 120 to the treatment site.
  • the fluid can be, for example, water, saline, mineral oil, water mixed with soap suds, a water-based solution with stool softener, and/or other non-toxic fluids.
  • the second channel 120 extends through the body of the hub 300 (as shown in FIG. 2), and at least another portion of the second channel 120 extends through a tube coupled to and extending proximally away from a proximal portion of the hub 300.
  • the second channel 120 extends through the elongate member 404 and terminates at one or more openings at the distal portion 404b of the elongate member 404 and/or along the distal element 402.
  • the device 100 does not include a second channel 120.
  • the device 100 can further comprise a third channel 130 extending distally from a port at the proximal region 100a of the device 100 to an opening within an expandable portion of the hub 300.
  • the third channel 130 can be configured to be fluidly coupled to a fluid source and/or a pressure source 132 to transform the expandable portion of the hub 300 from a collapsed state (shown in FIG. 1A) to an expanded state (shown in FIG. IB).
  • at least a portion of the third channel 130 extends through the body of the hub 300 (as shown in FIG. 2), and at least another portion of the third channel 130 extends through a tube coupled to and extending proximally away from a proximal portion of the hub 300.
  • the device 100 does not include a third channel 130. It will be appreciated that the device 100 can include a single channel (which may be any one of the first, second, or third channels), two channels (which may be any two of the first, second, or third channels), three channels, or more than three channels.
  • FIG. 2 is a side cross-sectional view of the hub 300 with the disruptor 400 removed for ease of viewing the features of the hub 300.
  • the hub 300 can include a hub body 308 having a proximal portion 300a configured to be positioned proximal of the anus at an extracorporeal location, a distal portion 300b configured to be positioned in the intestinal lumen, and an intermediate portion 304 between the proximal and distal portions 300a, 300b.
  • the intermediate portion 304 can be configured to be positioned along the anal canal when the device 100 is in use.
  • the hub 300 can have a length that is longer than the length of the anal canal (e g., at least 4 cm, at least 5 cm, at least 6 cm, at least 7 cm, or at least 8 cm).
  • the hub body 308 can define an inner cavity 310 that is configured to receive all or a portion of the distal element 402 (FIGS. 1A and IB).
  • the inner cavity 310 may terminate distally at a distal opening 312 configured to receive at least a portion of the distal element 402 therethrough.
  • a distal region of the hub body 308 can taper distally to facilitate introduction of the device through the anus.
  • the portion of the hub body 308 configured to be positioned within the patient’s body can have a constant cross-sectional dimension.
  • the distal portion 300b of the hub 300 includes an expandable portion 302 having a collapsed state and an expanded state.
  • the expandable portion 302 can include a membrane positioned around the circumference of the hub body 308 at the distal portion 300b of the hub 300.
  • the hub body 308 can include an inflation lumen 316 configured to be fluidly coupled to a fluid source 132 (see FIGS. 1A and IB) and that terminates distally at an opening 318 aligned with the membrane.
  • a fluid i.e., a gas or a liquid
  • the inflation lumen 316 can be configured to be fluidly coupled with and/or comprise a portion of the third channel 130.
  • the hub 300 In the collapsed state (shown in FIG. 1A), the hub 300 has a smaller cross- sectional dimension and is configured for introduction through the anal canal into the intestinal (rectal) lumen. In the collapsed state, the hub 300 can have a cross-sectional dimension that is sized to allow comfortable insertion into the anus. For example, when the hub 300 is in the collapsed state, the hub 300 can have a cross-sectional dimension of at least 0.5 inches and no more than about 3 cm, or no more than about 5 cm. In the expanded state (shown in FIGS. IB and 2), the expandable portion 302 is configured to conform and seal against the inner wall of the intestinal lumen (for example, as shown and described below with reference to FIGS.
  • the hub 300 is configured to cover the distal element 402 (e.g., by receiving all or a portion of the distal element 402 within the inner cavity 310) during insertion and removal of the device 100, thus acting as a barrier and protecting the mucosa of the gastrointestinal tract.
  • the hub 300 can include a broad proximal element 306 configured to be positioned proximal of the anus at an extracorporeal location while the device 100 is in use.
  • the proximal element 306 can have a cross-sectional dimension that is greater than a diameter of the anus such that the proximal element 306 is prevented from moving distally through the anus. As a result, the proximal element 306 limits a depth at which the hub 300 can be inserted into the rectum.
  • the proximal element 306 has a substantially fixed cross-sectional area. In other embodiments, the proximal element 306 can be expandable and/or inflatable.
  • the hub body 308 can include one or more lumens extending therethrough.
  • the hub 300 can include a disruptor lumen 320 that is configured to slidably receive the elongate member 404 of the disruptor therethrough.
  • the hub body 308 can include an aspiration lumen 322 configured to be fluidly coupled to and/or comprising a portion of the first channel 110.
  • the aspiration lumen 322 terminates distally at the inner cavity 310 of the hub body 308. In other embodiments, the aspiration lumen 322 can terminate at an outer surface of the hub body 308.
  • the hub body 308 can include an infusion lumen 326 configured to be fluidly coupled to and/or comprising a portion of the second channel 120.
  • the infusion lumen 326 terminates distally at the distal face of the hub body 308.
  • fluid delivered through the infusion lumen 326 is ejected into a space distal of the hub 300 and near the distal element 402.
  • the hub 300 may comprise an inflation lumen 316 for delivering a fluid to a space between the membrane and the outer surface of the hub body 308.
  • the hub 300 may include fewer than four lumens (e.g., three lumens, two lumens, one lumen, etc ).
  • the hub 300 may include only a disruptor lumen 320 and a single other lumen.
  • the single other lumen can be used for both aspiration and fluid infusion.
  • FIGS. 3A-3D depict a method of using the device 100 to dislodge and/or remove impacted fecal matter from a patient’s rectum.
  • a patient is positioned on their side as shown in FIG. 3A. This position advantageously enables easy insertion of the device 100.
  • the user first inserts the hub 300 with the expandable portion 302 in the collapsed state through the anus AN into the rectum R until the proximal element 306 is seated against the tissue surrounding an exterior aspect of the anus AN.
  • the distal element 402 of the disruptor 400 can be positioned at least partially within an interior cavity of the hub 300 with a distal portion of the distal element 402 extending distally beyond a distal end of the hub 300.
  • the distal portion of the distal element 402 can be tapered distally, for example, to facilitate insertion through the anus AN and anal canal AC.
  • the distal portion of the hub 300 can be tapered distally, at least when the expandable portion 302 is in a collapsed state.
  • the hub 300 and/or distal element 402 are lubricated prior to insertion.
  • the entire distal element 402 is housed within the hub 300 during insertion.
  • the hub 300 can be configured such that a length of the intermediate portion 304 approximates a length of the anal canal AC, thereby positioning a proximal end of the expandable portion 302 in the rectum R, just distal of the distal end of the anal canal AC (e.g., at the anorectal junction).
  • the hub 300 can have a maximum outer diameter configured to enable comfortable insertion (e.g., up to approximately 3 cm, or up to approximately 4 cm, or up to approximately 5 cm), and the length of the hub 300 can be configured to be longer than the length of the anal canal AC (e.g., greater than approximately 4 cm, great than approximately 5 cm, or greater than approximately 6 cm).
  • the user holds the hub 300 in place against the anus AN while expanding the expandable portion 302 against the portion of the rectum R just distal of the anorectal junction to secure the hub 300 such that the hub 300 remains in position during the remainder of the procedure without the user having to hold it in position.
  • the expandable portion 302 is in an expanded state, the anal canal tissue is positioned between the expandable portion 302 and the proximal element 306.
  • the expandable portion 302 and proximal element 306 work together to secure the hub 300 throughout the procedure, such as during longitudinal and rotational motion of the distal element 402, injection of irrigation fluid, and aspiration of irrigation fluids and fecal matter, etc.
  • the expandable portion 302 further prevents fecal matter FM from leaking out of the rectum R to maintain a clean procedure.
  • the expandable portion 302 can have a diameter such that it is configured to expand into apposition with the inner surface of the rectal wall and substantially seal against the rectal wall to prevent egress of fluids proximally into the anal canal AC.
  • the rectal wall conforms to the shape of the expandable portion 302.
  • the expandable portion 302 can be slightly oversized relative to a diameter of the rectum just distal of the anal canal such that the expandable portion 302 exerts a radially outward force on the rectum during the procedure.
  • the user can inject a fluid through the device 100 into the rectum R.
  • the fluid can be configured to soften the impacted fecal matter FM to facilitate removal of the fecal matter.
  • fecal modifying fluids include water, saline, mineral oil, water mixed with soap, a water-based solution with stool softener, and other fluids.
  • the fluid can be delivered through the second channel and second port. Additionally, or alternatively, the fluid can be delivered through the first channel and opening. Either way, the fluid passes from an extracorporeal location (such as a syringe or other fluid source) through the hub 300 and into the rectum R.
  • Infusion of one or more fluids can occur before, during, and/or after actuation of the distal element 402 (which is be translation, rotation, or vibration), or in some cases not at all.
  • infusion of one or more fluids can occur before, during, and/or after aspiration, and aspiration can occur before, during and/or after actuation of the distal element 402 (which is be translation, rotation, or vibration), or in some cases not at all.
  • the distal element 402 can be advanced distally to engage or further engage the fecal matter FM. As shown, the user can rotate and/or translate (automatically or manually) the distal element 402 to disrupt or otherwise break up the fecal matter into smaller and/or softer pieces. Aspiration A and/or infusion of fluids can occur while the distal element 402 is activated and breaking up fecal matter to remove the treated fecal matter from the treatment site.
  • the mechanical or ultrasonic energy delivered by the distal element, the introduction of irrigation liquids, and the application of vacuum through the vacuum port work in concert to disimpact the impacted stool and/or fecal matter, creating small particles of fecal matter together with a slurry fluid.
  • the elongate member 404 can be slowly advanced distally, in combination with rotation, to continue breaking the impacted stool into small pieces and eventually, slurry.
  • the vacuum port also has a setting where the port can be cleared and flushed in the situation of large pieces of fecal matter are obstructing this connection.
  • the user can pull the elongate member 404 proximally to withdraw the distal element 402 back into the interior cavity of the hub 300.
  • the user can then collapse and/or deflate the expandable portion so that the hub 300 can be pulled proximally through the anus.
  • FIGS. 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 show various distal elements configured for use with the disruptors of the treatment devices of the present technology'.
  • the distal element is configured to penetrate any inspissated fecal matter without causing any trauma to the surrounding tissue of the anus and rectum.
  • the distal element 402 comprises a shaft 452 and a plurality' of projections 450 extending away from the shaft 452.
  • the distal element 402 can include a first zone 454, a second zone 458, and a third zone 460, each comprising a plurality of projections 450.
  • the distal element 402 can comprise a bending zone 456 between the first and second zones 454, 458 and along which a diameter of the shaft 452 is narrowed. It can be advantageous to include such a bending zone as it provides the distal element 402 with a greater flexibility and improves the distal element’s ability to adapt to the curvature of the rectum, colon, or other section of the intestines.
  • the projections 450 and/or the entirety of the distal element 402 can be made of a soft, durable, biocompatible material, such as nylon, polyester, or polyethylene, and/or other polymers.
  • At least a portion of the shaft 452 along the second zone 458 can taper distally until terminating at the third zone 460, along which the projections 450 extend at a non-90-degree angle relative to the longitudinal axis of the distal element 402 (unlike the projections 450 along the first and second zones 454, 458 which extend away from the shaft 452 at substantially 90 degrees relative to the longitudinal axis).
  • the distal element 402 includes a single distal projection 462.
  • the shaft 452 has a lumen extending therethrough, and the lumen is configured to be fluidly coupled to a fluid source and/or negative pressure source.
  • the distal element 402 can include one or more openings 466 on or along one, some, or all of the projections 450. Additionally or alternatively, the distal element 402 can include one or more openings 464 along the shaft 452. Fluid delivered through the lumen of the shaft can be injected at the treatment site through the openings 464, 466, which can be in addition to, or instead of, an infusion channel in the hub 300.
  • the distal element 402 is solid (e.g., not hollow) and/or does not include any openings.
  • FIG. 5 depicts another distal element 402 for use with the devices 100 of the present technology.
  • the distal element 402 can be coupled to the distal end of the elongate member 404 such that movement of the elongate member 404 (e.g., translation, rotation, and/or mechanical or ultrasonic vibration) causes a corresponding movement in the distal element 402.
  • the distal element 402 can be tapered along all or a portion of its length, and can include a plurality of struts 502 separated by a plurality of windows 504.
  • the windows 504 are in fluid communication with the elongate member 404, and the lumen of the elongate member 404 can be configured to be coupled to a fluid source and/or a negative pressure source.
  • fluid can be delivered through the windows 504 of the distal element 402 to the treatment site, and fluids and/or fecal matter at the treatment site can be removed proximally through the distal element 402 and the elongate member 404.
  • the distal element 402 can include a sharpened tip 506. In other embodiments, the tip is curved or otherwise atraumatic (for example, like tip 706 in FIG. 7).
  • One or both edges of the struts 502 can be sharpened, or may be dull. Either way, rotation of the distal element 402/struts 502 at the treatment site can shear the fecal matter to make it easier to remove the fecal matter through the windows 504.
  • the elongate member 404 is a solid rod, and infusion and/or aspiration occurs exclusively through the hub 300.
  • the distal element 402 is again tapered and terminates at a sharpened tip 606.
  • the distal element 402 need not be tapered along its entire length and/or includes a rounded or otherwise atraumatic tip.
  • the distal element 402 can be coupled to the distal end of the elongate member 404, such that movement of the elongate member 404 (e.g., translation, rotation, and/or vibration) causes a corresponding movement in the distal element 402.
  • the distal element 402 also comprises a circumferentially winding groove 604 that creates a plurality of discs 602 that decrease in diameter in a distal direction. The edges of the discs 602 can be sharpened or dull.
  • FIG. 7 depicts another distal element 402 configured in accordance with the present technology .
  • the distal element 402 of FIG. 7 is again tapered and terminates at a rounded tip 706.
  • the distal element 402 need not be tapered along its entire length and/or includes a sharpened tip.
  • the distal element 402 can be coupled to the distal end of the elongate member 404 such that movement of the elongate member 404 (e.g., translation, rotation, and/or vibration) causes a corresponding movement in the distal element 402.
  • the distal element 402 of FIG. 7 can include longitudinal ridges 702 that are separated by recesses 704 about a circumference of the distal element 402.
  • the inner surfaces of the recesses 704 can be substantially flat and/or linear. Unlike the windows 504 of the distal element 402 of FIG. 5, the recesses 704 of the distal element 402 in FIG. 7 do not open into an interior region.
  • FIG. 8 depicts another embodiment of a distal element 402 comprising a rod or tube with a spiral-shaped distal portion 802 configured to penetrate the fecal matter.
  • the distal element may come to a point 806 or it can have tips that comprise the distal elements 402 in FIGS. 5, 6 and 7.
  • the distal element 402 is configured to create a hole in the fecal matter as the distal element 402 rotates.
  • the distal element 402 can have one or more holes along the distal portion 802.
  • FIG. 9 shows another embodiment of a distal element 402 comprising a plurality of projections 902 extending away from a distal portion of the elongate member 404.
  • FIG. 12 is a perspective view of FIG. 9.
  • the individual projections 902 can be arranged spaced apart about a circumference of the elongate member 404, and spaced apart along the longitudinal axis of the elongate member 404.
  • the projections 902 are arranged in groups 903 that are spaced apart along the longitudinal axis of the elongate member 404 (only three of the groups 903 are labeled in FIG. 9 for ease of viewing).
  • the individual projections 902 within each group 903 are located at substantially the same axial location along the elongate member 404 but extend away from the elongate member 404 at different circumferential positions and at different angles. In some embodiments, the projections 902 are not arranged in longitudinally spaced groups and instead are randomly disposed along the longitudinal axis. [005
  • the distal element 402 further comprises an atraumatic tip 904 that presents a broad, curved, distally facing surface.
  • the projections 902 can be made of soft, durable, biocompatible materials, such as nylon, polyester, or polyethylene, and/or other polymers.
  • the projections 902 can be the same length or may vary in length. For example, as shown in FIG.
  • the lengths of the projections 902 can decrease in a distal direction.
  • the projections 902 have different lengths but do not necessarily increase or decrease in a particular direction.
  • certain portions of the distal element 402 can have a higher density of projections 902.
  • the projections 902 may be denser along a distal portion, a more central portion, or a proximal portion (as shown in FIG. 10).
  • the projections 902 closer to the distal end of the distal element can be shorter and/or stouter and slightly further apart (as compared to the more proximal projections).
  • a stiffness of the individual projections 902 can vary along a length of the distal element 402.
  • the projections 902 can become progressively more flexible in a proximal direction, or may get stiffer in a proximal direction.
  • the groups 903 of projections 902 can get progressively more flexible in a proximal direction, or may get stiffer in a proximal direction.
  • the elongate member 404 has a lumen extending therethrough, and the lumen is configured to be fluidly coupled to a fluid source and/or negative pressure source.
  • the distal element 402 can include one or more openings 908 on or along one, some, or all of the projections 902. Additionally, or alternatively, the distal element 402 can include one or more openings 910 along the portion of the elongate member 404 coincident with the projections 902. Additionally, or alternatively, the distal element 402 can include one or more openings 906 at the tip 904.
  • Fluid delivered through the lumen of the elongate member 404 can be injected at the treatment site through the openings 906, 908, 910, which can be in addition to or instead of an infusion channel in the hub 300.
  • the distal element 402 is solid (e.g., not hollow) and/or does not include any openings.
  • FIG. 11 shows an embodiment of a distal element 402 that is substantially the same as the distal element 402 shown in FIG. 9, except in FIG. 11 the length of the projections 1104 are the same along the length of the distal element 402, and the distal tip 904 has a single opening 1102. In other embodiments, the distal tip 904 can have a plurality of openings.
  • FIG. 13 depicts the distal element 402 of FIG. 12 while infusing fluid F and aspirating obstructive material OM.
  • FIG. 14 shows another variation in which the elongate member 404 has openings 1406 in addition to the openings 906 of the distal tip 904.
  • the distal element 402 can comprise a basket comprising a plurality of struts 1502 configured to penetrate fecal matter.
  • the basket can be made of one or more wires, or may be a laser-cut stent.
  • the struts 1502 are shaped to present smooth and/or curved surfaces to the mucosa of the wall of the rectum.
  • the wires can be configured to penetrate the fecal matter.
  • FIG. 16 shows a different view of the distal element 402 of FIG. 15 after the elongate member has been rotated.
  • All of the distal elements 402 disclosed herein are configured to be received partially or completely within the inner cavity of a hub of the present technology (for example, inner cavity 310 of the hub 300 in FIG. 2).
  • a hub of the present technology for example, inner cavity 310 of the hub 300 in FIG. 2.
  • Various other shapes and configurations may be used to facilitate penetration, dislodgement, or breakup of the fecal matter (e.g., fecal inspissated mass).
  • FIGS. 17, 18 and 19 show various hubs configured for use with the treatment devices of the present technology. These hubs can be extensions of any of the hubs disclosed herein, or separate elongate elements that are introduced through the hubs of the present technology. In any case, the hubs of FIGS. 17, 18 and 19 can be positioned distal of the expandable portion of a respective treatment device to better allow suction of fecal matter into the hub.
  • FIG. 17 shows a tubular hub 1802 where the distal element 402 is introduced through a lumen in the hub. The lumen can be configured to be fluidly coupled to a negative pressure source and/or a fluid source for aspiration and/or infusion of fluids, respectively.
  • FIG. 17 shows a tubular hub 1802 where the distal element 402 is introduced through a lumen in the hub.
  • the lumen can be configured to be fluidly coupled to a negative pressure source and/or a fluid source for aspiration and/or infusion of fluids, respectively.
  • the holes 1804 are an embodiment of the hub with a series of holes 1804 spaced apart along its sidewall.
  • the holes 1804 are generally perpendicular to the axis of the rectum and provide more points of entry of stool slurry into the hub.
  • the holes can be of various dimensions, both small and large.
  • the holes along with the suction from the aspiration channel allows dispersed fecal matter to move through the holes.
  • the holes 1904 in the hub can also be of various shapes or openings, further enhancing the process of suction of the dispersed fecal material into the hub, rotation of the elongate member, and the associated movement of the distal element in breaking up the fecal matter.
  • FIG. 20 is an overview diagram demonstrating the organization of the control system.
  • the control system includes a display or user interface, a microcontroller, a motherboard, irrigation control, aspiration control, motor control, user outputs, system temperature, brush detection, and battery-type power source and various inputs and outputs.
  • the device includes one or more sensors that are operatively coupled to the control system. The sensors can, for example, provide torque feedback to the control system that, in response, may shut down the motor in order to prevent injury'.
  • the device can include one or more sensors configured to detect fluid levels so that, in response, the control system may release additional irrigation liquids into the hub/rectum to maintain an appropriate amount of liquid inside the rectum.
  • the device can include or more sensors configured to detect the level of maceration of the stool and, in response, the control system can turn the motor on/off and/or turn the suction on/off.
  • the control system can turn the motor on/off and/or turn the suction on/off.
  • FIG. 21 depicts a treatment device 100 configured in accordance with several embodiments of the present technology, shown positioned in a patient’s rectum R.
  • the device 100 can be configured for insertion through the anus AN into a lumen of an intestine (such as the colon) and disrupt, capture, and/or remove obstructive material, such as impacted fecal matter FM, from the intestinal lumen.
  • the device 100 comprises a proximal region 100a configured to be positioned outside of the patient’s body and manipulated by a user, and a distal region 100b configured to be positioned at a treatment site within a lumen of the intestine (e.g., the colon, the rectum R, the anal canal AC, etc.) proximate fecal matter FM, such as impacted fecal matter.
  • a lumen of the intestine e.g., the colon, the rectum R, the anal canal AC, etc.
  • the device 100 can further include a handle 406 at the proximal region 100a, an elongate member 404 extending between the proximal and distal regions 100a, 100b of the device 100, a hub 300 at a distal end portion 404b of the elongate member 404, and a distal element 402 extending distally from a distal end portion of the hub 300.
  • the hub 300 can be configured for positioning across the patient’s anus AN to help anchor and seal the device 100.
  • the hub 300 can include a hub body having a proximal portion configured to be positioned proximal of the anus AN at an extracorporeal location, a distal portion configured to be positioned in the intestinal lumen, and an intermediate portion 304 between the proximal and distal portions.
  • the intermediate portion 304 can be configured to be positioned along the anal canal AC when the device 100 is in use.
  • the distal portion of the hub 300 includes an expandable portion 302 having a collapsed state and an expanded state. It will be appreciated that the description of the hub 300 provided above with reference to FIGS. 1-19 similarly applies to the hub 300 of FIG.
  • the elongate member 404 can have a proximal portion 404a coupled to the handle 406 and a distal portion 404b coupled to the hub 300.
  • the elongate member 404 can comprise a solid rod or may be a hollow shaft having a lumen extending therethrough.
  • the elongate member 404 may include a bend 2102 along its length.
  • the bend 2102 can position a longitudinal axis Ld of the distal element 402 at an angle relative to the longitudinal axis Lh of the handle 406 and/or the longitudinal axis Lb of the hub 300.
  • the angle provided by the bend 2102 can make it easier for the user to contact the rectal wall with sufficient force with the distal element 402 during manual rotation/swirling of the distal element 402 (via rotation of the handle 406 by the user).
  • the device 100 and/or handle 406 optionally includes an energy source 407 (shown schematically) operably coupled to the distal element 402 (e.g., via wires extending through the elongate member 404).
  • Activation of the energy source 407 energizes the distal element 402, thereby causing the distal element 402 to deliver energy to the fecal matter FM and dislodge a portion of the fecal matter FM.
  • the energy source 407 can be coupled to a motor, and activation of the motor causes the distal element 402 to move (e.g., vibrate, translate, rotate, swirl, etc.), thereby agitating the fecal matter FM.
  • the motor can be housed within the handle 406 and activated by an actuator 408 on the handle 406, such as a button, switch, knob, etc.
  • the motor is powered by a battery, which may be contained in the handle 406.
  • the motor may be configured to be electrically coupled to an external power source, such as a wall outlet.
  • the distal element 402 can comprise one or more ultrasound transducers and the energy source 407 comprises a pulse generator.
  • the ultrasound transducer can convert the electrical signals created by the pulse generator into ultrasound signals that are configured to disrupt fecal matter at the treatment site.
  • the ultrasound signals can vary in shape, duration, and length.
  • electrical signals from the pulse generator, and the corresponding ultrasound signals may be a train of pulses of a fixed or variable frequency, duty-cycle, and duration.
  • the pulse generator and ultrasound transducer are configured to deliver acoustical waves having a frequency of about 10 kHz to 100 kHz, 10 kHz to 50 kHz, 10 kHz to 1000 kHz, at least 10 kHz, at least 20 kHz, at least 30 kHz, at least 40 kHz, or more than 1000 kHz.
  • the distal element 402 comprises one or more reflectors, and the system includes one or more transducers configured to be positioned outside the body and not in direct contact with the distal element 402.
  • the intensity of the disruptive energy may be adjustable, for example via one or more actuators on the handle 406
  • the device 100 does not include an energy source and the user moves the distal element 402 (by manipulating the handle 406 and/or elongate member 404) to dislodge the fecal matter manually.
  • the distal element 402 can extend distally from a distal portion of the hub 300 and have an elongated shape with a curved, distally facing surface at its distal end.
  • the distal element 402 can have a cross-sectional dimension that tapers distally, for example to facilitate insertion through the anus AN and anal canal AC.
  • the distal element 402 has a substantially constant diameter along its length.
  • the distal element 402 can be substantially straight (as shown), or may be curved along all or a portion of its length.
  • the distal element 402 has a proximal end portion 402a, a distal end portion 402b, and a longitudinal axis Ld extending therebetween. While FIG. 21 shows a configuration of the distal element 402 in which the longitudinal axis Ld is angled relative to the longitudinal axis Lb of the hub 300 (e.g., statically or during a swirling motion, as described below), at any point during the procedure the longitudinal axis Ld may be aligned with the longitudinal axis Lb of the hub 300 (for example, when the distal element 402 is inserted through the anus AN into the rectum R).
  • the distal element 402 can be configured to move in a circular motion and/or swirl while positioned in the rectum R (see arrows SI and S2 in FIG. 21) to help disrupt the fecal matter FM and/or to induce rectal muscle constriction.
  • activation of the energy source 407 can cause the distal element 402 to swirl.
  • the distal element 402 can be angled relative to the hub 300 during the swirling motion, with the distal end portion 402b of the distal element 402 radially farther from the longitudinal axis Lh of the hub 300 than the proximal end portion 402a.
  • the swirl radius Sr measured as the radial distance between the longitudinal axis Lb of the hub 300 and the distal end portion 402b of the distal element 402, can be varied.
  • the distal element 402 swirls SI at a swirl radius Sr that causes no or minimal forces to be exerted on the rectal wall by the distal end portion 402b.
  • the distal element 402 can swirl S2 at a swirl radius Sr large enough such that the distal element 402 exerts a force on the rectal wall sufficient to induce rectal muscle constriction. As shown in FIG.
  • the rectum can narrow proximally, such that the distance between the proximal end portion 402a of the distal element 402 and the rectal wall is less than the distance between the distal end portion 402b and the rectal wall.
  • swirling of the distal element 402 can cause all or a portion of the distal element 402 to contact the rectal wall.
  • the distal element 402 can be configured to vibrate while swirling (for example, by activation of the energy source 407).
  • the swirling motion can be achieved by moving the handle 406 in a circular motion, which may occur while vibratory and/or a swirling motion is provided by the energy source, or without additional energy inputs.
  • the longitudinal axis Ld of the distal element 402 may be aligned with the longitudinal axis Lb of the hub 300, or may be angled relative to the longitudinal axis Lb of the hub 300.
  • the device 100 can include one or more fluid channels extending between the proximal and distal regions 100a, 100b of the device 100 for infusing fluids to and/or removing fluids and fecal matter from the treatment site.
  • the device 100 can comprise a first channel extending distally from a port at the proximal region 100a to one or more openings at the distal region of the device 100 (e.g., at the hub 300, at the distal tip of the distal element 402 and/or along the sidewalls of the distal element 402, etc.).
  • the first channel can be fluidly coupled to a negative pressure source (e.g., a vacuum pump, a syringe, etc.) to apply a negative pressure at the treatment site to remove disrupted fecal matter present in the intestinal lumen (e.g., O to 800 mmHg).
  • a negative pressure source e.g., a vacuum pump, a syringe, etc.
  • At least a portion of the first channel may extend through the body of the hub 300, and at least another portion of the first channel extends through a tube coupled to and extending proximally away from a proximal portion of the hub 300.
  • the tube can optionally include a flush port, such as a T-port.
  • the first channel can be used both for aspiration and infusion of fluids.
  • the first channel can be configured to be operably coupled to a fluid source.
  • the device 100 comprises a second channel extending distally from a port at the proximal region 100a of the device 100 to an opening at the distal region 100b of the device 100 (e.g., at or along the hub 300, at the distal tip of the distal element 402 and/or along the sidewalls of the distal element 402, etc.).
  • the second channel can be configured to be fluidly coupled to a fluid source to deliver a fluid through the second channel to the treatment site.
  • the fluid can be, for example, water, saline, mineral oil, water mixed with soap suds, a water-based solution with stool softener, and/or other non-toxic fluids.
  • the second channel extends through the body of the hub 300, and at least another portion of the second channel extends through a tube coupled to and extending proximally away from a proximal portion of the hub 300.
  • the second channel extends through the elongate member 404 and terminates at one or more openings along the distal element 402.
  • the device 100 does not include a second channel.
  • the device 100 can further comprise a third channel extending distally from a port at the proximal region 100a of the device 100 to an opening within an expandable portion of the hub 300.
  • the third channel can be configured to be fluidly coupled to a fluid source and/or a pressure source to transform the expandable portion 302 of the hub 300 from a collapsed state (not shown in FIG. 21) to an expanded state.
  • at least a portion of the third channel extends through the body of the hub 300, and at least another portion of the third channel extends through a tube coupled to and extending proximally away from a proximal portion of the hub 300.
  • the device 100 does not include a third channel. It will be appreciated that the device 100 can include a single channel (which may be any one of the first, second, or third channels), two channels (which may be any two of the first, second, or third channels), three channels, or more than three channels.
  • the patient is positioned on their side (for example, as shown in FIG. 3A). This position enables easy insertion of the device 100.
  • the user then inserts the distal element 402 and hub 300 (with the expandable portion 302 in the collapsed state) through the anus AN into the rectum R until the proximal element 306 is seated against the tissue surrounding an exterior aspect of the anus AN.
  • the hub 300 is inserted with the proximal element 306 abutting the tissue surrounding the anus AN, all or a portion of the intermediate portion 304 of the hub 300 is positioned within the anal canal AC and all or substantially all of the collapsed expandable portion 302 and protruding distal element 402 are positioned within the rectum R.
  • the hub 300 can be configured such that a length of the intermediate portion 304 approximates a length of the anal canal AC, thereby positioning a proximal end of the expandable portion 302 in the rectum R, just distal of the distal end of the anal canal AC (e.g., at the anorectal junction).
  • the hub 300 can have a maximum outer diameter configured to enable comfortable insertion (e.g., up to approximately 3 cm, or up to approximately 4 cm, or up to approximately 5 cm), and the length of the hub 300 can be configured to be longer than the length of the anal canal AC (e.g., greater than approximately 4 cm, great than approximately 5 cm, or greater than approximately 6 cm).
  • the method continues with the user holding the hub 300 in place against the anus AN while expanding the expandable portion 302 against the portion of the rectum R just distal of the anorectal junction to secure the hub 300 such that the hub 300 remains in position during the remainder of the procedure without the user having to hold it in position.
  • the expandable portion 302 when the expandable portion 302 is in an expanded state, the anal canal tissue is positioned between the expandable portion 302 and the proximal element 306.
  • the expandable portion 302 and proximal element 306 work together to secure the hub 300 throughout the procedure, such as during vibrational and/or swirling motion of the distal element 402, injection of irrigation fluid, and aspiration of irrigation fluids and fecal matter, etc.
  • the expandable portion 302 further prevents fecal matter FM from leaking out of the rectum R to maintain a clean procedure.
  • the user can optionally inject a fluid through the device 100 into the rectum R.
  • the fluid can be configured to soften the impacted fecal matter FM to facilitate removal of the fecal matter.
  • fluids include water, saline, mineral oil, water mixed with soap, a water-based solution with stool softener, and other fluids.
  • the fluid can be delivered, for example, through the second channel and second port. Additionally or alternatively, the fluid can be delivered through the first channel and opening. Either way, the fluid passes from an extracorporeal location (such as a syringe or other fluid source) through the hub 300 and into the rectum R.
  • Infusion of one or more fluids can occur before, during, and/or after actuation of the distal element 402, or in some cases not at all. Likewise, infusion of one or more fluids can occur before, during, and/or after aspiration, and aspiration can occur before, during and/or after actuation of the distal element 402, or in some cases not at all.
  • the distal element 402 can be moved in a circular and/or swirling motion (via the energy source, manually, or both) within the rectum R to disrupt or otherwise break up the fecal matter into smaller and/or softer pieces, and/or induce rectal muscle constriction. Vibratory' motion may be applied to the distal element 402 before, during, and/or after the whirling motion.
  • aspiration and/or infusion of fluids can occur while the distal element 402 is activated and breaking up fecal mater to remove the treated fecal mater from the treatment site.
  • the entire device 100 may be disposable, or in some cases only the patientcontacting portions of the device 100 (such as the distal element 402 and hub 300) are disposable while the energy source and motor can be reusable.
  • the distal element 402 and hub 300 can be detachable from the elongate member 404 and handle 406, or the distal element 402, hub 300, and elongate member 404 are detachable from the handle 406.
  • the technology is applicable to other applications and/or other approaches, such as Hirschsprung’s disease, pelvic floor dyssynergia, neurodegenerative conditions (i.e., Parkinson’s disease, multiple sclerosis, spinal cord injury, etc.) associated with chronic recurrent episodes of OC and FI.
  • the devices of the present technology can be used in an at- home or other clinical settings, and may be size-adjusted for use with adult and pediatric patients.
  • other embodiments in addition to those described herein are within the scope of the technology.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne des dispositifs, des systèmes et des méthodes permettant de désintégrer les matières fécales dans les lumières d'un corps. Selon certains modes de réalisation, la présente technologie comprend un désintégrateur comprenant une région proximale configurée pour être manipulée par un utilisateur, une région distale et un élément allongé s'étendant entre les deux, le désintégrateur comprenant en outre un élément distal porté par une partie distale de l'élément allongé et configuré pour être inséré dans la lumière intestinale par l'anus du patient, ainsi qu'une source d'énergie couplée de manière opérationnelle à l'élément distal. Le dispositif peut comprendre un élément extensible configuré pour être positionné dans la lumière intestinale, l'élément extensible présentant un état replié pour l'introduction dans la lumière intestinale et un état déployé dans lequel l'élément extensible est configuré pour se conformer à la paroi interne de la lumière intestinale afin d'empêcher ou de réduire les fuites de fluides intestinaux et/ou de matières fécales par l'anus vers un endroit extracorporel.
PCT/US2023/072114 2022-08-11 2023-08-11 Dispositifs, systèmes et méthodes de désintégration et/ou d'élimination de matières fécales WO2024036325A1 (fr)

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US202263371160P 2022-08-11 2022-08-11
US63/371,160 2022-08-11
US202263387256P 2022-12-13 2022-12-13
US63/387,256 2022-12-13

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03140161A (ja) * 1989-10-27 1991-06-14 Gijutsu Kenkyu Kumiai Iryo Fukushi Kiki Kenkyusho ***処理装置の挿入具
JP2000167041A (ja) * 1998-12-02 2000-06-20 Shigenobu Takane 排便装置
JP2002065845A (ja) * 2000-09-04 2002-03-05 Shigenobu Takane 排便装置
CN109498107A (zh) * 2018-12-10 2019-03-22 郑州大学第五附属医院 肠造瘘稀释通便装置
CN215194878U (zh) * 2021-06-02 2021-12-17 刘连成 ***封闭灌肠导管

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03140161A (ja) * 1989-10-27 1991-06-14 Gijutsu Kenkyu Kumiai Iryo Fukushi Kiki Kenkyusho ***処理装置の挿入具
JP2000167041A (ja) * 1998-12-02 2000-06-20 Shigenobu Takane 排便装置
JP2002065845A (ja) * 2000-09-04 2002-03-05 Shigenobu Takane 排便装置
CN109498107A (zh) * 2018-12-10 2019-03-22 郑州大学第五附属医院 肠造瘘稀释通便装置
CN215194878U (zh) * 2021-06-02 2021-12-17 刘连成 ***封闭灌肠导管

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