CN106621042A - Implanted device tissue rupture detection system - Google Patents
Implanted device tissue rupture detection system Download PDFInfo
- Publication number
- CN106621042A CN106621042A CN201611194500.9A CN201611194500A CN106621042A CN 106621042 A CN106621042 A CN 106621042A CN 201611194500 A CN201611194500 A CN 201611194500A CN 106621042 A CN106621042 A CN 106621042A
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- China
- Prior art keywords
- module
- implantable medical
- medical device
- short
- sensor
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
Abstract
The invention discloses a tissue rupture detection system comprising an implantable medical device and an external module, the implantable medical device includes a sensing module, a drug elution module, a processor, a first short-range communication module; the external module comprises a second short-range communication module and an early warning module; the drug elution module is located in an implantable medical device housing, exposes a preset area, and carries an anti-infective agent; and the sensing module is distributed outside the implantable medical device and includes a bacterial sensor, an amylase sensor, and an antibody detection sensor. The system is effective in preventing tissue rupture complication caused by implantable medical devices.
Description
Technical field
The present invention relates to a kind of implantable medical equipment, in particular to a kind of implanted device ulceration detecting system is organized.
Background technology
Implantable medical device(IMDS)Be for clinical implanted device, it is postoperative because friction or rejection cause group around
Knit the risk of ulceration infection.
U.S. Patent application US20150110849A1 discloses a kind of increase on the shell of implantable medical device and configures
There is the annex of anti-microbial agents, can effectively reduce or substantially eliminate the risk of implantation postoperative infection, but due to antimicrobial
Preparation is big in implantable medical device shell area, dosage is also big, and time length microorganism is it is possible that the resistance to the action of a drug, it is also possible to
Cause allergy.
U.S. Patent application US20100098744A1 discloses one kind anti-infectious preparation in implantable medical device,
But there was only a small amount of anti-infectious preparation outside implantable device, internal anti-infectious preparation can Fast Stripping when needed, prevent anti-sense
There is the resistance to the action of a drug or causes the allergy of patient dye formulation dosage in big microorganism, but cannot learn once there is infection, this feelings
Condition initial stage patient is also without sense of discomfort, but interior tissue ulceration, need to process in time, it is to avoid cause serious concurrent
Disease.
It can be seen that, how effectively to prevent the tissue ulceration complication that implantable medical device causes from being that the technology for facing at present is difficult
Point.
The content of the invention
It is an object of the invention to overcome the shortcomings of in above-mentioned technology, there is provided one kind tissue ulceration monitoring system, including can
Implantable medical equipment and external module;Implantable medical device include sensing module, medicament elution module, processor, first is near
Journey communication module;External module includes the second short-range communications module, and warning module;Medicament elution module is located at implantable medical
Device housings, expose preset area, carry anti-infective medicament such as antimicrobial, can be with the certain content of Fast Stripping, for resisting
Infection;Sensor assembly is distributed in outside implantable medical device, including bacterium sensor, starch enzyme sensor and antibody test
Sensor, surrounding tissue occur ulceration infection it is possible that bacterial number increase, amylase secretion become it is many, there is rejection
It is possible that antibody-secreting increases;Processor detects that the parameter value of each sensor judges whether to reach preset alarm threshold value, if
Reach and then communicated with the second short-range communications module by the first short-range communications module, notify early warning;External module receives notice
Signal carries out early warning.
Further, also including remote server and doctor terminal, external module increases remote communication module;External module
Early warning uploads infection information to remote server by remote communication module simultaneously, notifies doctor terminal.
Further, also including wake module, with the wake-up mould of implantable medical device when external charger charges every time
Block communicates, and wake module wakes up sensor assembly and measures, and processor detects that the parameter value of each sensor judges whether to reach
Preset alarm threshold value, is communicated by the first short-range communications module if reaching with the second short-range communications module, notifies early warning.
Further, also including drug efflux pump, early warning is simultaneously in vivo to the medicine for the treatment of inflammation.
It can be seen that, the tissue ulceration that above-mentioned tissue ulceration monitoring system can effectively prevent implantable medical device from causing
Complication.
Description of the drawings
Fig. 1 is the implanted device tissue ulceration detecting system figure of the present invention;
The external module of 101. implantable medical device 102.(External charger)The doctor terminal of 103. remote server 104.
201. sensing module, 202. medicament elution module, 203. 204. first short-range communications module of processor 205. wakes up mould
Block
The warning module of 301. second short-range communications module 302..
Specific embodiment
With reference to the accompanying drawings and examples the present invention is further described, as shown in Figure 1, organizes ulceration monitoring system bag
Including implantation human body is used for the implantable medical device 101 and external module 102 for the treatment of.Implantable medical device 101 is referred to temporarily
Or persistence is introduced in mammal body, for preventing or treating any device of medical condition.This kind of device includes, artitificial ear
Snail, pacemaker, deep brain stimulator, artificial sphincter, peripheral nerve stimulation device, muscle stimulator, cardiac valves, blood vessel
Support and drug infusion system etc..External module 102 is provided in patient in vitro, for being led to implantable medical device
Letter, so as to realizing data acquisition transmission, control and maintaining the functions such as implantable medical device work, external module to be preferably body
Outer charger, personal digital assistant(PDA)Or the form of smart mobile phone.
Implantable medical device 101 includes sensing module 201, and medicament elution module 202, processor 203, the first short range is led to
Letter module 204;External module includes the second short-range communications module 301, and warning module 302.Medicament elution module 202 is typically wrapped
Containing biocompatible, biodegradable, Bio-erodable, nontoxic, biological absorbable polymer substrate, this Type of Collective
Thing material including but not limited to poly- (lactic acid), poly- (glycolic), PLA, poly- (glycolide), poly- (lactide-co- second
Lactide), poly- (oneself in ketone), Merlon, polyamide, condensing model, poly- (amino acid), poly- (ortho esters), poly- acetal, paracyanogen
Base acrylate, poly- (ether-ether), poly- (dioxanone), poly- (alkenylalkyl compound), PEG and poly- (ortho esters)
Copolymer, degradable polyurethane and their copolymer and mixture.
Medicament elution module 202 is located at the shell of implantable medical device 101, exposes preset area, carries anti-infective medicament
Such as antimicrobial, can be with the certain content of Fast Stripping, for anti-infective.Medicament elution module 202 can be by via immersion coating
Put on the shell of implantable medical device 101.The medicament elution module 202 of immersion coating can cover implantable medical device 101
The different piece of shell or the shell of whole implantable medical device 101.In some non-limiting examples, as dipping
The replacement scheme of coating, the medicament elution module 202 can be put on the shell of implantable medical device 101 via spraying.One
In a little non-limiting examples, as the substitute of dipping or the medicament elution module for spraying coating, the medicament elution mould
Block can have preformed shape, such as ring-type or sleeve-shaped.Other preformed shapes are possible, for example and are not intended to limit
In cylindrical shape, annular or rectangle.
The antimicrobial refers to any medicament harmful to forming biomembranous microorganism (especially pathogenic bacteria).Close
Suitable antimicrobial is included but is not limited to:Antiseptic, antibiotic, Antimycobacterial, antimycotic, antiviral etc..Typically
Antiseptic includes but is not limited to biquanides, for example Chlorhexidine, polymyxins, tetracycline, aminoglycoside, rifampin, bacitracin,
Neomycin, chloramphenicol, Miconazole, quinolone, penicillin, nonoxinol 9, Fusidic Acid, cynnematin, mupirocin, drop of going out
Spirit, cecropin, antibacterial peptide, bacteriocin, sozin, nitrofurazone, mafenide, vancomycin, lindamycin, woods can be mould
Element, sulfanilamide (SN), Norfloxacin, Pefloxacin, nalidixic acid, Oxolinic Acid (quinolone), Enoxacin, Ciprofloxacin and Fu Xi
Ground acid and combinations thereof.Being suitable for the typical broad spectrum antimicrobicide of the present invention includes triclosan, Chlorhexidine, sulphadiazine
Silver, silver ion, benzalkonium chloride, ZPT and broad-spectrum antibiotic such as quinolone, fluoquinolone, aminoglycoside and sulfanilamide (SN), and
Preservative such as iodine, hexamethylenetetramine, nitrofurantoin, nalidixic acid and other acidulants include from Cranberry Juice extraction acid with
And combinations thereof.
Antimicrobial can be chemically bound at medicament elution module 202.It is a kind of in some non-limiting examples
Or various antimicrobials can by via Covalent bonding together in medicament elution module.When one or more in covalent bond rupture
When, the medicament elution module can release one or more antimicrobial.For example, in one non-limiting embodiment, should
Covalent bond can (be for example, in presence of water to deposit in the case of water in interstitial fluid, blood or peritoneal fluid) to rupture.So
And, this is not required in that, and in some alternative embodiments, covalent bond may additionally or alternatively be ultraviolet by being exposed to
Line or visible ray and rupture.In some non-limiting examples, the covalent bond can by being exposed to the light sent by light source and
Fracture.
Sensor assembly 201 is distributed in outside implantable medical device 101, including bacterium sensor, starch enzyme sensor
With antibody test sensor, once the surrounding tissue of implantable medical device 101 occur ulceration infect it is possible that bacterial number
Increase, amylase secretion becomes many, rejection occurs and increases so as to antibody-secreting occurs, therefore, using bacterium sensor, form sediment
Powder enzyme and antibody test sensor can carry out effective detection, sensor die to bacterial number, amylase and antibody-secreting amount
The measurement signal that each sensor is obtained is sent to processor 203 and carries out data processing by block 201.In order to meet the implantation present invention's
Using needs, pressure sensor must dimensionally very little be so as to easy implantation and minimizes to the group around pressure sensor
Knit the interference of environment, and they must use radio communication from without line, conduit or need percutaneous passage its
Its part.They must be formed by Resisting fractre, nontoxic and permanent biocompatible materials is drawn with minimizing patient to foreign matter
The immune response that enters and prevent the tissue damage caused by corrosion by-products.The pressure sensor of implantation must provide for keeping reliable
Pressure value cause surely make the decision for the treatment of in the useful life of sensor, to avoid for adjustment purposes
Sensor outside implantation.
Processor 203 detects that the parameter value of each sensor judges whether to reach preset alarm threshold value, by the if reaching
One short-range communications module 204 communicates with the module of the second short-haul connections 301 in external module 102, carries out notice early warning;External mould
Block 102 receives notification signal and carries out early warning, and early warning information includes the prompting of alarm lamp, warning dedicated speakers and screen text
Deng.Processor in sacral nerve stimulation subsystem 300, muscular irritation subsystem 400, sensor subsystem 200 is typically using embedding
Enter microsever, from high integration low-power scm, with various energy-saving modes, its be internally integrated memory,
Analog-to-digital conversion ADC and digital-to-analogue conversion DAC, and support that self-programming is operated, short-range communications module includes wireless communication module, communication
Agreement can be according to physical condition using the short distance wireless technical such as Zigbee, bluetooth, infrared.
Remote server 103 and doctor terminal 104, external module 102 are further comprised in embodiments of the present invention
Middle increase remote communication module 303;External module early warning 302 uploads infection information to far by remote communication module 303 simultaneously
Journey server 103, notifies doctor terminal 104.Remote communication module 303 is connected with launches and the built-in day for receiving for signal
Line;Described remote communication module 303 is designed using high performance wireless communication module, and the communication mode for adopting is for GPRS/
Cdma wireless Cellular Networks+Internet wide area networks, embedded TCP/IP communication protocols.Remote server 103 can be cloud service
Device, for the data that receiving body outer mold piece 102 is uploaded, automatically analyzes the current health status of assessment, generates corresponding guidance and builds
View, by result external module is fed back to;For the result of the data of reception and analysis to be sent into doctor terminal, doctor's end is received
The suggestion of end module feedback is simultaneously sent to external module;The doctor terminal, for receiving the data of remote server transmission, and
Clinical recommendation is fed back into remote server.The preferred form of the doctor terminal is mobile phone or panel computer.
Further, the wake module 205 being arranged in implantable medical device 101 is also included in system, is filled in vitro
Electrical equipment 102 communicates when charging every time with the wake module 205 of implantable medical device 101, and wake module 205 is so as to waking up sensing
Device module 201 carries out corresponding parameter measurement, and processor 203 detects that the parameter value of each sensor judges whether to reach preset alarm
Threshold value, is communicated by the first short-range communications module 204 if reaching with the second short-range communications module 301, carries out notice early warning.Call out
Awake function generally comprises the function of operating with high-power mode only during special time, and the special time is for example for specific
The short cycle of purpose (for example, receiving signal etc.).Important consideration with regard to the receiver part of wake module is that it has
Low-power.This feature may be conducive to provide in implanted receiver small size and maintain from battery longtime running
Power supply.In practice, the receiver of wake module periodically " can wake up " and in low energy consumption so as to via for example supervising
Listen circuit to perform " monitor function ".For the application, term " monitor function " generally referred to as is used to determine whether to deposit
In the short low power function of transmitter.If monitor function detects launcher signal, the equipment can be converted to higher
Power communication decoding schema.If there is no launcher signal, then receiver can be returned and for example be immediately returned to park mode.
In this way, energy is saved during the relative long periods that there is no launcher signal, and there is the relatively few of transmission signal
Period during make power capabilities keep can be used for the operation of efficient decoding schema.
In embodiments of the present invention, preferably also include drug efflux pump, supply is controlled in body while external early warning is carried out
Treat the medicine of inflammation.Drug efflux pump generally has the attachment means for being attached to implantable medical device 101, once processor 203 is examined
The parameter value for surveying each sensor reaches preset alarm threshold value drug efflux pump can be driven to start working so that drug efflux pump is to surrounding tissue
The medicine of pumping treatment inflammation.Anti-inflammatory medicaments are preferably Cefoxitin, amphiphilic enzyme element, neomycin, mupirocin or polymyxins
B, or for antifungal (nystatin, such as Norfloxacin or Ciprofloxacin).
The description of aforesaid embodiment and preferred embodiment should be regarded as the explanation of the claims in the present invention, rather than
It is defined.It is appreciated that under the premise of without departing substantially from the present invention as claimed in claim, it is possible to use features described above
Many combinations and variant, this kind of variant does not run counter to the spirit and scope of the present invention, and all these variants are intended to be included in following
The scope of claim.
Claims (4)
- It is 1. a kind of to organize ulceration monitoring system, it is characterised in that:The system includes implantable medical device(101)With external module (102);The implantable medical device(101)Including sensing module(201), medicament elution module(202), processor(203), First short-range communications module(204);The external module(102)Including the second short-range communications module(301)And warning module (302);The medicament elution module(202)Positioned at the implantable medical device(101)Shell, exposes preset area, carries Anti-infective medicament;The sensing module(201)It is distributed in the implantable medical device(101)Outside, including bacterium sensor, Starch enzyme sensor and antibody test sensor;The processor(203)Detect each sensor parameter value and judgement be It is no to reach preset alarm threshold value, first short-range communications module is passed through if reaching(204)With the second short-haul connections mould Block(301)Communication, notifies the warning module(302);The external module(102)Receiving notification signal carries out early warning.
- It is 2. according to claim 1 to organize ulceration monitoring system, it is characterised in that:The detecting system also includes remote service Device(103)And doctor terminal(104), the external module(102)Also include remote communication module;The external module(102) Infection information is passed to the remote server by early warning by the remote communication module simultaneously(103), notify doctor's end End(104).
- It is 3. according to claim 1 to organize ulceration monitoring system, it is characterised in that:The implantable medical device(101) Also include wake module(205);The external module(102)For external charger, it is implantable with described when charging every time Medical treatment device(101)The wake module(205)Communication, the wake module(205)Wake up the sensing module(201)Enter Row measurement, the processor(203)Detect the parameter value of each sensor and judge whether to reach preset alarm threshold value, if reaching To then by first short-range communications module(204)With second short-range communications module(301)Communication, notifies early warning.
- It is 4. according to claim 1 to organize ulceration monitoring system, it is characterised in that:The monitoring system also includes drug efflux pump, Early warning is simultaneously in vivo to the medicine for the treatment of inflammation.
Priority Applications (1)
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CN201611194500.9A CN106621042A (en) | 2016-12-21 | 2016-12-21 | Implanted device tissue rupture detection system |
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CN201611194500.9A CN106621042A (en) | 2016-12-21 | 2016-12-21 | Implanted device tissue rupture detection system |
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CN201611194500.9A Withdrawn CN106621042A (en) | 2016-12-21 | 2016-12-21 | Implanted device tissue rupture detection system |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080064980A1 (en) * | 2006-09-08 | 2008-03-13 | Cardiac Pacemakers, Inc. | Implantable Medical Device and Methods for Automated Detection of Infection |
US20080262374A1 (en) * | 2007-04-19 | 2008-10-23 | Medtronic, Inc. | Event triggered infection monitoring |
US20100204551A1 (en) * | 2008-10-22 | 2010-08-12 | Martin William Roche | Detection, Prevention and Treatment of Infections in Implantable Devices |
US20140303455A1 (en) * | 2013-04-03 | 2014-10-09 | Pharmaco-Kinesis Corporation | Multipurpose cerebrospinal fluid sensor assembly and method of operation of the same |
WO2015200704A1 (en) * | 2014-06-25 | 2015-12-30 | Hunter William L | Devices, systems and methods for using and monitoring implants |
-
2016
- 2016-12-21 CN CN201611194500.9A patent/CN106621042A/en not_active Withdrawn
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080064980A1 (en) * | 2006-09-08 | 2008-03-13 | Cardiac Pacemakers, Inc. | Implantable Medical Device and Methods for Automated Detection of Infection |
US20080262374A1 (en) * | 2007-04-19 | 2008-10-23 | Medtronic, Inc. | Event triggered infection monitoring |
US20100204551A1 (en) * | 2008-10-22 | 2010-08-12 | Martin William Roche | Detection, Prevention and Treatment of Infections in Implantable Devices |
US20140303455A1 (en) * | 2013-04-03 | 2014-10-09 | Pharmaco-Kinesis Corporation | Multipurpose cerebrospinal fluid sensor assembly and method of operation of the same |
WO2015200704A1 (en) * | 2014-06-25 | 2015-12-30 | Hunter William L | Devices, systems and methods for using and monitoring implants |
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