CN102500057B - Multifunctional implanted gastrointestinal electrical stimulation system - Google Patents
Multifunctional implanted gastrointestinal electrical stimulation system Download PDFInfo
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- CN102500057B CN102500057B CN201110298613.4A CN201110298613A CN102500057B CN 102500057 B CN102500057 B CN 102500057B CN 201110298613 A CN201110298613 A CN 201110298613A CN 102500057 B CN102500057 B CN 102500057B
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Abstract
The invention provides a multifunctional implanted gastrointestinal electrical stimulation system in the technical field of medical apparatus and instruments. The system comprises an in-vivo implantation device and an in-vitro control device and has the functions of multichannel gastrointestinal electrical stimulation signal generation, in-vivo gastrointestinal track pressure detection, in-vivo gastrointestinal electrical detection and in-vitro wireless charging, wherein the in-vivo implantation device comprises an energy receiving coil, an implanted electrical stimulator, a stimulating electrode, a detection electrode and a minitype pressure sensor. According to the invention, the setting and regulation of electrical stimulation parameters and transmission of various control commands can be flexibly achieved through the wireless communication between the in-vitro control device and the in-vivo implantation device, and the in-vivo implantation device can transmit the in-vivo gastrointestinal track pressure and the gastrointestinal electrical detection result to the in-vitro control device in real time for receiving and storage. By using the system, the working life of a device can be greatly prolonged without frequently changing a battery when operation is carried out; and the limitation of the millisecond-stage impulse in the existing gastrointestinal stimulator is broken through, the intestinal pressure and intestinal electrical measurement accuracy can be improved, and convenience is provided for detecting or researching the effect of the gastrointestinal electric stimulation.
Description
Technical field
The present invention relates to a kind of implanted gastrointestinal electrical stimulation system, relate in particular to a kind of can wireless charging, the implanted gastrointestinal electrical stimulation system simultaneously with Gastroenteric Electrical stimulation, Gastroenteric Electrical signal detection and gastrointestinal cavity internal pressure signal testing function, belongs to technical field of medical instruments.
Background technology
Functional gastrointestinal disease is common clinical, has data to show, functional gastrointestinal disorder Zhan Liao Gastroenterology dept. outpatient service over half.Due to pathogenic factor and pathogeny indefinite, still lack at present desirable Therapeutic Method.In recent years, Gastroenteric Electrical stimulating method has been subject to extensive concern, lot of research and clinical trial have confirmed its therapeutical effect to diseases such as gastroparesis, short intestinal disease, intestinal pseudo obstruction, fecal incontinence, constipation, obesity, especially in gastroparesis field, be regarded as treating the safe and effective means of obstinate type gastroparesis, had a good application prospect.
It is slow wave generation theory that the treatment principle that Gastroenteric Electrical stimulates derives from gastrointestinal pacemaker point current potential.The same with heart, in gastrointestinal tract, also exist natural electric pacemaker, different parts respectively has its intrinsic slow wave frequency, and the contraction movement of gastrointestinal is controlled by slow wave just.Therefore in theory, control slow wave and can reach the abnormal Gastroenteric Electrical of correction, the object of regulation and control digestive tract power.It is exactly to utilize impressed current directly or indirectly to act on pacemaker and effector thereof---the smooth muscle cell of each portion of gastrointestinal tract that Gastroenteric Electrical stimulates, thereby makes intestinal recover the normal electric rhythm and pace of moving things and relax contracting motion.Current in this field, during short term therapy, stimulating electrode is generally by being connected with stimulated in vitro device through subcutaneous electrode cable, stimulated in vitro device uses mostly is universal pulse signal generator, in long-term treatment, adopt implantable neural electrical stimulation devices more, its structure and profile are all similar with cardiac pacemaker, and Core Feature is to realize electric pulse stimulation and remote control, as by the Enterra@Gastroenteric Electrical stimulator of numerous gastroparesiss and U.S. Medtronic Inc. that bariatrician adopted.Owing to generally adopting lithium battery power supply, the working life of implanted electric stimulator is determined by enforcement time, enforcement frequency and the relevant parameter of electricity irritation, if be 5～10 years the life expectancy of Enterra@device.Once running down of battery, must again perform the operation and change.This energy-provision way also makes existing implanted electric stimulator be difficult to provide low-frequency high-amplitude long pulse and multi-lead stimulus signal, even there is no to produce at present the implantation type electric stimulation device of the above pulse width of 2ms.And have scholar to think, and digestive organs mainly consist of smooth muscle, and it is much slow that the responsive time constant of smooth muscle is about 100-300ms ， compare nervous tissue, so the long pulse of ms level stimulates changing the function of these organs more effective.Typically, if pulse pace-making, pulse width should be greater than 50ms.In the electric pace-making of small intestinal, pulse width should be at least 50-150ms.If signal is comprised of train of pulse,, for the frequency of 40Hz, the pulse width needing should be greater than 2ms, in the treatment of obesity, higher to the requirement of broad pulse output.
In addition, for understanding the curative effect of electrical stimulation method, during enforcement electronic stimulation, change situation that also must monitoring test object digestive tract power, at present mainly by means of gastrointestinal cavity internal pressure detecting apparatus, Electrogastrograph meter or gastrointestinal emptying inspection method monitoring gastrointestinal shrink wriggles, the parameters such as the gastrointestinal slow wave rhythm and pace of moving things or intestinal transmission time, exist pilot system complexity, with high costs, the problems such as operation inconvenience, the summary of electrical stimulation method curative effect and the discussion of mechanism of action have greatly been affected, as Gastroenteric Electrical stimulates the effect to gastrointestinal contraction movement, to small intestinal, the problems such as control of colon slow wave rhythm disturbance still do not have clear and definite conclusion so far, long-term human clinical's experiment is more difficult to carry out.
In sum, existing implanted electric stimulator function singleness, pulse parameter range of accommodation is limited, limited energy, far can not meet the needs of clinical treatment and research, becomes one of major obstacle hindering the development of Gastroenteric Electrical stimulating technology.
Summary of the invention
The object of the invention is to for the deficiencies in the prior art, a kind of Multifunctional implanted gastrointestinal electrical stimulation system simultaneously with the generation of multichannel Gastroenteric Electrical stimulus signal, gastrointestinal cavity internal pressure signal detection, Gastroenteric Electrical signal testing function is provided, by outer control device and body, be implanted into the radio communication between device, can realize flexibly the transmission of setting, adjustment and the operational order of electrical stimulation parameters, and gastrointestinal internal pressure, Gastroenteric Electrical testing result can be sent in real time to outer control device reception preservation, with the action effect of checking Gastroenteric Electrical to stimulate.Body is implanted into device and adopts chargeable battery power supply, when battery capacity is during lower than setting threshold, can be its wireless charging by percutaneous energy transmission system.
According to an aspect of the present invention, a kind of Multifunctional implanted gastrointestinal electrical stimulation system is provided, comprise that body is implanted into device and outer control device, wherein, body is implanted into device and all implants, and under the control for control device in vitro, implementing Gastroenteric Electrical stimulates and detect gastrointestinal internal pressure and electromyographic signal; Outer control device is preserved for body being implanted into the remote control of device and receiving the wireless receiving that detects data in the body of its transmitting.
Particularly, for realizing such object, Multifunctional implanted gastrointestinal electrical stimulation system of the present invention comprises that body is implanted into device and outer control device, during use, body is implanted into device and implants completely, has the function of output multi-channel stimulus signal, detection gastrointestinal stress signal and Gastroenteric Electrical signal; Outer control device works in external, is responsible for realizing the interior wireless receiving that detects data of wireless transmission, body of setting, stimulus parameter and the control command of stimulus parameter and preserves and external wireless energy emission function.
Described body is implanted into device and comprises energy receiving coil, implanted electric stimulator, stimulating electrode, detecting electrode and micro pressure sensor, wherein implanted electric stimulator be one with the small-sized sealing device of interface, during use, implant subcutaneously completely, energy receiving coil, stimulating electrode, detecting electrode and micro pressure sensor are connected via wires to respectively on the interface of implanted electric stimulator.Implanted electric stimulator specifically comprises again control module in stimulator shell, external interface, chargeable battery, charge management module, wireless energy receiver module, body, the interior radio receiving transmitting module of body, stimulus signal generation module, pressure signal processing module, Gastroenteric Electrical signal processing module, in-body power source administration module, normally closed dry reed pipe and permanent magnet.
Described energy receiving coil is flat, and during use, coil head is implanted subcutaneous abdomen, and the other end is connected via wires to the external interface of implanted electric stimulator.
Described stimulating electrode comprises multi-electrode wire, one end of every electrode cable is connected in implanted electric stimulator, and the other end inserts gastrointestinal wall, sews up fixing with surgical thread, the electric impulse signal that is used for transmitting implanted electric stimulator output is in gastrointestinal pacemaker point, to promote gastrointestinal to shrink.
Described detecting electrode comprises Single lead wire, and the needle-like head of electrode cable inserts gastrointestinal wall, and one end is connected to implanted electric stimulator, for detection of gastrointestinal electromyographic signal, and is sent to the signal processing module in implanted electric stimulator.
Described micro pressure sensor changes for detection of the pressure in gastrointestinal cavity, during use, its responsive head is sutured on gastrointestinal wall, and the power line being connected with sensing unit and holding wire are connected to the external interface of implanted electric stimulator.
Wireless energy receiver module in described implanted electric stimulator is connected with energy receiving coil, comprise rectification, filtering and mu balanced circuit, during wireless charging, the alternating voltage that the induction of energy receiving coil is produced is converted to DC voltage-stabilizing output, under non-charged state, Non voltage output.
Described charge management module comprises battery charging management chip and peripheral circuit.Under charged state, the induction electromotive force that energy receiving coil produces after wireless energy receiver module rectifying and wave-filtering for charge management module provides direct current input, for chargeable battery charges, the exportable signal of charged state prompting pin of battery charging management chip is to control module in body, for the judgement of charged state;
Described chargeable battery is connected with in-body power source administration module, can adopt various types of rechargeable batteries, should there is less volume and higher capacity, when implanted electric stimulator is under non-charged state, by chargeable battery, provide power supply input for in-body power source administration module; In-body power source administration module comprises a plurality of direct current regulation circuits, converts the output of chargeable battery in the implanted electric stimulator required direct-current working volts of other modules;
Described stimulus signal generation module is in vivo under the effect of control module, can produce the adjustable electric impulse signal output of the parameters such as multichannel amplitude, frequency, pulsewidth, persistent period, the stimulus waveform ，Mei road signal that can produce pulse and two kinds of patterns of train of pulse is separate.Stimulus signal generation module has multiple implementation, as adopt the method for programmable power supply and power amplification circuit, using the output of programmable power supply as the power supply of power amplification circuit, in body, the original burst signal of control module output, after power amplification circuit amplifies, becomes the stimulus signal of required amplitude, frequency and pulsewidth.Another kind method is the combination that adopts D/A converter and operational amplification circuit, and D/A converter is the adjustable pulse signal of output amplitude under the control of control module in vivo, then after operational amplification circuit amplifies, produces the output of pulse signal of final required amplitude;
Described pressure signal processing module comprises signal amplification circuit and A/D change-over circuit, wherein signal amplification circuit is for amplifying the faint primary signal of micro pressure sensor output, A/D change-over circuit is realized the analog digital conversion of amplified signal, so that control module gathers in body;
Described Gastroenteric Electrical signal processing module comprises signal amplification circuit, filter circuit and A/D change-over circuit, for realizing amplification, filtering and the analog digital conversion of the Gastroenteric Electrical signal that detecting electrode is obtained;
In described body, control module comprises microprocessor chip and peripheral circuit, is responsible for controlling realization and the conversion of implanted electric stimulator various functions.In control volume, radio receiving transmitting module receives after the stimulus parameter and command information of outer control device transmission, control stimulus signal generation module and produce the electric impulse signal output of regulation parameter or read pressure signal processing module and the testing result of Gastroenteric Electrical signal processing module output, in control volume, radio receiving transmitting module outwards sends body internal pressure and checking with EMG method data; Regularly detect the battery capacity (being embodied by cell voltage) of chargeable battery, when lower than certain threshold value, in control volume, radio receiving transmitting module outwards sends charge prompting signal.In battery charging process, the level that detects the charged state indication pin of charge management module changes, so that timely complete charge prevents from overcharging.
Described normally closed dry reed pipe and permanent magnet form the magnet controlled switch of implanted electric stimulator, normally closed dry reed pipe is serially connected between chargeable battery and in-body power source administration module, permanent magnet is positioned over stimulator shell near normally closed dry reed pipe place, make tongue tube under permanent magnet effect, in normally open, in implanted electric stimulator, do not form power circuit, when permanent magnet is after shell takes away, normally closed dry reed pipe recovers closure state, and implanted electric stimulator starts to work on power.
Described outer control device comprises external controller and energy transmitting coil, and energy transmitting coil is connected via wires to external controller.External controller specifically comprises coil interface, human-machine interface module, LCD MODULE, real-time clock module, external control unit, external wireless communication module, data memory module, wireless energy transmitter module, external power management module and battery.
Described wireless energy transmitter module comprises DC-AC translation circuit and LC resonance circuit, its outfan coils interface is connected with energy transmitting coil, when charging in body, the sinusoidal signal output that can produce the certain amplitude of certain frequency, excitation energy transmitting coil produces the alternating magnetic field of corresponding frequencies.
Described energy transmitting coil is flat, when charging, coil head fits to energy i (in vivo) receiving coil on the skin surface of position with binding agent, and the other end is connected to coil interface, under non-charged state, can take off from coil interface and skin.
Described human-machine interface module comprises keyboard input or touch screen input module or the various communication interface being connected with computer, for setting, revise parameters and the input of control commands of stimulus signal, wherein the parameter of adjustable stimulus waveform comprises amplitude, pulsewidth, frequency, persistent period, intermittent time, channel number etc., the type of control command comprises transmission parameter, starting stimulates, finishing stimulates, start to detect, detection of end, the orders such as system hibernates, external control unit is by reading corresponding input command and stimulus parameter with the communication of human-machine interface module.
Described data memory module can adopt various types of data storage cards to form, and as mmc card, SD card etc., its input is connected to external control unit, and the pressure that external control unit is transmitted, Gastroenteric Electrical detect data and be saved in storage card.
Described external control unit is connected with human-machine interface module, external wireless communication module, data memory module, LCD MODULE, wireless energy transmitter module, real-time clock module, after the various stimulus parameters and control command that arrange the personnel that receive by human-machine interface module, through external wireless communication module, stimulus parameter or control command are wirelessly transmitted to vivo implantation type electrostimulator.External wireless communication module sends external control unit to after receiving the answer signal of device in body or gastrointestinal pressure, checking with EMG method result, by external control unit by data data writing memory module.In charging process, control wireless energy transmitter module and produce pumping signal output, after receiving charging end information, control wireless energy transmitter module and quit work.In system work process, system status information, temporal information or testing result can be shown to LCD MODULE in real time.
Compared with prior art, tool of the present invention has the following advantages: (1) adopts chargeable battery and wireless charging system as the energy resource supply mode of implanted electric stimulator, has greatly extended the working life of installing, and without often performing the operation, changes battery; (2) in the situation that of energy abundance, the boost pulse of the various waveforms of the exportable multichannel of implanted electric stimulator, has broken through the restriction of existing gastrointestinal irritation device Millisecond pulse, and stimulus modelity and stimulus parameter can be revised at any time flexibly simultaneously; (3) existing Gastroenteric Electrical stimulates product only to have the function of output stimulus signal, clinical staff is assessment, research therapeutic effect, also must be in addition by intracavity pressure tester or Electrogastrograph meter etc., and native system integrated above-mentioned functions, when implementing Gastroenteric Electrical and stimulating, can synchronous recording gastrointestinal cavity internal pressure and body in Gastroenteric Electrical signal, greatly simplified system formation, reduced treatment cost, improved measurement accuracy, for the effect of checking or research Gastroenteric Electrical stimulates provides very big convenience.
The present invention has gastrointestinal pressure detection in the generation of multichannel Gastroenteric Electrical stimulus signal, body, the interior Gastroenteric Electrical measuring ability of body simultaneously.During system works, by outer control device and body, be implanted into the radio communication between device, can realize flexibly the transmission of setting, adjustment and the various control commands of electrical stimulation parameters, body is implanted into device also can send to outer control device reception preservation in real time by gastrointestinal pressure in body and Gastroenteric Electrical testing result, with the action effect of checking Gastroenteric Electrical to stimulate.Body is implanted into device and adopts chargeable battery power supply, and regularly detect the capacity of chargeable battery, when chargeable battery capacity is during lower than setting threshold, body is implanted into device and sends charge prompting information, by the wireless energy transfer module in outer control device, is its wireless charging.
Accompanying drawing explanation
Fig. 1 is operation principle schematic diagram of the present invention;
Fig. 2 is the structural representation of vivo implantation type device;
Fig. 3 is the structural representation of outer control device;
Fig. 4 is the principle schematic of wireless charging system.
In figure, body is implanted into device 1, outer control device 2, implanted electric stimulator 3, energy receiving coil 4, stimulating electrode 5, detecting electrode 6, micro pressure sensor 7, wireless energy receiver module 8, charge management module 9, chargeable battery 10, normally closed dry reed pipe 11, permanent magnet 12, in-body power source administration module 13, control module 14 in body, radio receiving transmitting module 15 in body, stimulus signal generation module 16, pressure signal processing module 17, Gastroenteric Electrical signal processing module 18, external interface 19, stimulator shell 20, external controller shell 21, external control unit 22, real-time clock module 23, human-machine interface module 24, LCD MODULE 25, data memory module 26, external wireless communication module 27, external power management module 28, battery 29, wireless energy transmitter module 30, coil interface 31, energy transmitting coil 32, external controller 33.
The specific embodiment
Below in conjunction with accompanying drawing, embodiments of the invention are elaborated: the present embodiment is to take technical solution of the present invention to implement under prerequisite, provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
As shown in Figure 1, according to system provided by the invention, comprise that body is implanted into device 1 and outer control device 2, body all implants while being implanted into device 1 work, and for implementing, Gastroenteric Electrical stimulates and detection gastrointestinal internal pressure and electromyographic signal; Outer control device 2 is designed to portable, detects the wireless receiving of data preserve for body is implanted in the remote control of device 1 and body.
As shown in Figure 2, described body is implanted into device 1 and comprises implanted electric stimulator 3, energy receiving coil 4, stimulating electrode 5, detecting electrode 6 and micro pressure sensor 7.After implantation, the energy receiving coil 4 of implanted electric stimulator 3 and flat is all embedded in subcutaneous abdomen, and energy receiving coil 4 is wired to the external interface 19 of implanted electric stimulator 3.When being 10 charging of chargeable battery in implanted electric stimulator 3, energy receiving coil 4 externally produces induced potential output under the effect of alternating magnetic field, through external interface 19, inputs to implanted electric stimulator 3.Stimulating electrode 5 comprises multi-electrode wire, the needle-like head of every path electrode wire is sewn onto the stimulation location (or claiming pace-making position) on intestinal wall by surgical thread, the electrode cable other end is connected to the external interface 19 of implanted electric stimulator 3, for electric stimulation pulse is exported in each pace-making position, the signal of each path electrode is separate, is independent of each other.Detecting electrode 6 is comprised of 1 electrode cable, and the needle-like head of electrode cable is sewn onto the detection position on intestinal wall by surgical thread, and the other end is connected to the external interface 19 of implanted electric stimulator 3, for gathering the bioelectrical signals of intestinal wall; Micro pressure sensor 7 can adopt miniature diffuse si piezoresistive transducer, sensor sensing head is sewn to the detection position on intestinal wall, be wired to the external interface 19 of implanted electric stimulator 3, for detection of the enteric cavity internal pressure causing because of intestinal peristalsis promoting, change.
Described implanted electric stimulator 3 be integrated long-pending small and exquisite, be easy to implant subcutaneous sealing device, specifically comprise in wireless energy receiver module 8, charge management module 9, chargeable battery 10, normally closed dry reed pipe 11, permanent magnet 12, in-body power source administration module 13, body radio receiving transmitting module 15, stimulus signal generation module 16, pressure signal processing module 17, Gastroenteric Electrical signal processing module 18, external interface 19 and stimulator shell 20 in control module 14, body.
Described stimulator shell 20 adopts nontoxic, corrosion-resistant and has the medical material of excellent compatibility to make with tissue, as titanium alloy material, other parts except permanent magnet 12 in implanted electric stimulator 3 is all sealed within it.Permanent magnet 12 is before implanted electric stimulator 3 is implanted, be positioned on stimulator shell 20 near near the position inner normally closed dry reed pipe 11, the reed that makes normally closed dry reed pipe 11 inside under the magneticaction of permanent magnet 12 in off-state, implanted electric stimulator 3 power-off, quit work; After implanting, permanent magnet 12 is taken away from stimulator shell 20, normally closed dry reed pipe 11 closures in implanted electric stimulator 3, implanted electric stimulator 3 starts to work on power.
The input of described wireless energy receiver module 8 is connected with energy receiving coil 2 by external interface 19, outfan is connected to charge management module 9, its effect is when wireless charging, after the ac voltage rectifier filtering that energy receiving coil 2 is sensed, export DC voltage stably, as the power supply input of charge management module 9.The outfan of charge management module 9 is connected with chargeable battery 10, the DC source that utilization obtains from wireless energy receiver module 8 is chargeable battery 10 chargings by the flow process of setting, the pin of the charged state of charge management module 9 indication is simultaneously connected to control module 14 in body, this pin is exported high level when charging, charging finishes rear output low level, so that charged state is understood in control module 14 monitoring in real time in body.Chargeable battery 10 is connected to the input of in-body power source administration module 13 by normally closed dry reed pipe 11, permanent magnet 12 is after stimulator shell 20 takes away, the closed conducting of normally closed dry reed pipe 11, provides power supply input by chargeable battery 10 for in-body power source administration module 13.The outfan of in-body power source administration module 13 is connected with radio receiving transmitting module 15, stimulus signal generation module 16, pressure signal processing module 17, Gastroenteric Electrical signal processing module 18 and external interface 19 in control module in body 14, body respectively, for each module and micro pressure sensor 7 provide required DC source.The input of stimulus signal generation module 16 is connected with control module 14 in body, outfan is connected to external interface 19, under the control of control module 14, produce the adjustable electric impulse signals of parameter such as frequency, amplitude, dutycycle, persistent period and output to stimulating electrode 5 through external interface 19 in vivo; In body, radio receiving transmitting module 15 is connected with control module 14 in body, there is two-way wireless communication function, the stimulus signal parameter that the outer control device receiving 2 is sent and various control command transmit donor internal control molding piece 14, gastrointestinal pressure, the checking with EMG method data of 14 outputs of control module in body are sent to outer control device 2 simultaneously and receive preservation.The input of pressure signal processing module 17 is connected with micro pressure sensor 7 through external interface 19, outfan is connected with control module 14 in body, after amplifying the primary signal of micro pressure sensor 7 outputs and converting digital signal to, provides donor internal control molding piece 14; The input of Gastroenteric Electrical signal processing module 18 is connected with detecting electrode 6 through external interface 19, outfan is connected with control module 14 in body, for the electromyographic signal of detecting electrode 6 output is amplified, filtering and A/D conversion, and provide donor internal control molding piece 14.
As shown in Figure 3, described outer control device 2 comprises external controller 33 and energy transmitting coil 32.External controller 33 is a handheld apparatus, when needs charge for implanted electric stimulator 3, the coiler part of flat energy transmitting coil 32 is fitted in subcutaneous energy receiving coil 4 on the skin surface of position, and the other end is wired to external controller 33.
Described external controller 33 specifically comprises external controller shell 21, external control unit 22, real-time clock module 23, human-machine interface module 24, LCD MODULE 25, data memory module 26, external wireless communication module 27, external power management module 28, battery 29, wireless energy transmitter module 30, coil interface 31, and external controller shell 21 is all packaged in inside by other parts.The input of external power management module 28 is connected with battery 29, outfan is connected with wireless energy transmitter module 30, real-time clock module 23, human-machine interface module 24, LCD MODULE 25, data memory module 26, external wireless communication module 27 and external control unit 22 respectively, by after the voltage voltage stabilizing of battery 29 outputs, for modules provides DC source.
Described wireless energy transmitter module 30 outfan coils interfaces 31 are connected with energy transmitting coil 32, input is connected to external control unit 22, after carrying out DC-AC conversion and power amplification, full bridge inverter converts the pulse signal of external control unit 22 outputs the AC signal of certain amplitude and frequency to, again through LC resonance circuit, be sent to energy transmitting coil 32, drive it to produce the alternating electromagnetic field of same frequency around, body is implanted into device 1 and carries out wireless charging.
Described external control unit 22 is connected with human-machine interface module 24, the control command sending for receiving operator.Human-machine interface module 24 is designed to matrix keyboard in the present embodiment, comprise numeral keys and command key, numeral keys is used for revising stimulus parameter, and command key is for input operation order, as sent parameter, start to stimulate, finish to stimulate, start in detection, detection of end, body system hibernates etc.External control unit 22 reads the key command of human-machine interface module 24 by the mode of interrupt response.External control unit 22 is connected by data communication interface with external wireless communication module 27, send the personnel's operational order reading from human-machine interface module 24 to external wireless communication module 27, and be wirelessly transmitted to implanted electric stimulator 3 by external wireless communication module 27, to control implanted electric stimulator 3, produce corresponding operation.External wireless communication module 27, after receiving the body internal pressure of implanted electric stimulator 3 transmissions, Gastroenteric Electrical detection data, can send data to external control unit 22 by communication interface simultaneously.External control unit 22 is connected with LCD MODULE 25, for the waveform of display system work state information, temporal information, detection signal; External control unit 22 is connected with real-time clock module 23, at each wireless receiving to reading corresponding temporal information after data or for the display system working time in LCD MODULE 25 etc.External control unit 22 is connected with data memory module 26, and the body internal pressure at every turn receiving, Gastroenteric Electrical are detected to data and be together saved in storage card together with the real-time clock reading from real-time clock module 23.
The present invention works in the following manner: permanent magnet 12 is taken away from stimulator shell 20, by operation, energy receiving coil 4 and implanted electric stimulator 3 are embedded in subcutaneous, the head of stimulating electrode 5, detecting electrode 6 and micro pressure sensor 7 utilizes surgical thread to be sewn onto on gastrointestinal wall, and the other end is connected through the external interface 19 of wire and implanted electric stimulator 3.After body is implanted into device 1 operation and installs, first the parameter of stimulus signal is set by the human-machine interface module 24 of external controller 33, comprise stimulus modelity (pulse stimulates or train of pulse stimulates), amplitude, frequency, dutycycle, persistent period, stimulating electrode numbering etc., then stimulus parameter and stimulation order are sent in body by external wireless communication module 27, implanted electric stimulator 3, starts by pattern and the parameter output electric pulse signal set at wireless receiving after stimulus parameter and order.Medical personnel understand the situation of change of gastrointestinal pressure in body now or Gastroenteric Electrical signal as need, by external controller 33, to implanted electric stimulator 3, send corresponding data acquisition command, implanted electric stimulator 3 starts detection bodies internal pressure and Gastroenteric Electrical, and by the fixed cycle, data wireless is sent to external controller 33 reception preservations.In device work process, implanted electric stimulator 3 regularly detects the voltage of chargeable battery 10, when cell voltage is low to moderate a certain threshold value, to the low signal of external transmission battery capacity, external controller 33, after receiving prompting signal, is shown in LCD MODULE 25.Now, operator fit to energy transmitting coil 32 on the skin surface of energy receiving coil 4 positions, external controller 33 open wireless energy transmitter modules 30, driving-energy transmitting coil 32 produces alternating electromagnetic field around, subcutaneous energy receiving coil 4 is through electromagnetic coupled output induction electromotive force, output dc voltage after wireless energy receiver module 8 rectifying and wave-filterings in implanted electric stimulator 3, is charged for chargeable battery 10 by charge management module 9 again.After charging, charge management module 10 output charging end signals are to control module 14 in body, in body, control module 14 is that in control volume, radio receiving transmitting module 15 sends complete charge instruction, external controller 33 is after receiving this instruction, close wireless energy transmitter module 30, operator take off energy transmitting coil 32, finish wireless charging process.
Obviously, the above embodiment of the present invention be only used to clearly to illustrate the present invention does for example, but not the restriction of embodiment of the present invention.Here without also giving exhaustive to all implementation methods.And those belong within other embodiments that spirit of the present invention takes are in protection scope of the present invention.
Claims (5)
1. a Multifunctional implanted gastrointestinal electrical stimulation system, it is characterized in that, comprise that body is implanted into device and outer control device, wherein, body is implanted into device for all implanting, and implements in vitro Gastroenteric Electrical stimulation and detect gastrointestinal internal pressure and electromyographic signal under the control of control device; Outer control device carries out remote control and carries out wireless receiving and preserve detecting data in the body of its transmitting for body being implanted into device;
Described body is implanted into device and comprises energy receiving coil, implanted electric stimulator, stimulating electrode, detecting electrode and micro pressure sensor, and wherein, energy receiving coil is connected to implanted electric stimulator; Stimulating electrode comprises multi-electrode wire, and the needle-like head of every path electrode wire is sewn onto the stimulation location on intestinal wall, and the electrode cable other end is connected to implanted electric stimulator, for electric stimulation pulse is exported in each pace-making position; The needle-like head of detecting electrode is sewn onto the detection position on intestinal wall, and the other end is connected to implanted electric stimulator, for gathering the bioelectrical signals of intestinal wall; Micro pressure sensor is connected to implanted electric stimulator, for detection of the enteric cavity internal pressure causing because of intestinal peristalsis promoting, changes;
Described implanted electric stimulator comprises permanent magnet and stimulator shell, also comprise the external interface being sealed in stimulator shell, chargeable battery, charge management module, wireless energy receiver module, control module in body, radio receiving transmitting module in body, stimulus signal generation module, pressure signal processing module, Gastroenteric Electrical signal processing module, in-body power source administration module, and normally closed dry reed pipe, wherein: the input of wireless energy receiver module is connected with energy receiving coil by external interface, outfan is connected to charge management module, to after the ac voltage rectifier filtering of energy receiving coil output, export DC voltage stably, power supply input as charge management module, the outfan of charge management module is connected with chargeable battery, utilizes the DC source that obtains from wireless energy receiver module to charge for chargeable battery by the flow process of setting, and the pin of the charged state of charge management module indication is simultaneously connected to control module in body, chargeable battery is connected to the input of in-body power source administration module by normally closed dry reed pipe, the outfan of in-body power source administration module is connected with radio receiving transmitting module, stimulus signal generation module, pressure signal processing module, Gastroenteric Electrical signal processing module and external interface in control module, body in body respectively, for each module and micro pressure sensor provide required DC source, the input of stimulus signal generation module is connected with control module in body, and outfan is connected with external interface, under the control of control module, produces the adjustable electric impulse signal of parameter and outputs to stimulating electrode through external interface in vivo, in body, radio receiving transmitting module is connected with control module in body, for two-way wireless communication, the stimulus signal parameter that the outer control device receiving is sent and various control command transmit donor internal control molding piece, the cavity pressure of control module output in body, Gastroenteric Electrical detection data are sent to the reception of body external control device and preserve simultaneously, the input of pressure signal processing module is connected with micro pressure sensor through external interface, and outfan is connected with control module in body, for amplifying the primary signal of micro pressure sensor output and being converted to digital signal, provides donor internal control molding piece, the input of Gastroenteric Electrical signal processing module is connected with detecting electrode through external interface, and in outfan and body, control module is connected, for the primary signal that detecting electrode is exported amplify, filtering, A/D conversion process, and provide donor internal control molding piece.
2. Multifunctional implanted gastrointestinal electrical stimulation system according to claim 1, it is characterized in that, implanted electric stimulator shell adopts nontoxic, corrosion-resistant and have the medical material of excellent compatibility to make with tissue, whether implanted electric stimulator adopts magnetic switch to control it and works on power, magnetic switch comprises permanent magnet and normally closed dry reed pipe, permanent magnet is before implanted electric stimulator is implanted, be positioned on stimulator shell near near the position inner normally closed dry reed pipe, make normally closed dry reed pipe in off-state, implanted electric stimulator power-off, quit work, after implanting, permanent magnet is taken away from stimulator shell, implanted electric stimulator starts to work on power.
3. Multifunctional implanted gastrointestinal electrical stimulation system according to claim 1, it is characterized in that, outer control device is preserved for the interior gastrointestinal pressure of the transmission that modification, external control command and stimulus parameter are set, body of stimulus parameter, the reception that Gastroenteric Electrical detects data, is also used to vivo implantation type device wireless charging, outer control device comprises energy transmitting coil and external controller, external controller comprises external controller shell, also comprise the external control unit that is packaged in external controller enclosure, real-time clock module, human-machine interface module, LCD MODULE, data memory module, external wireless communication module, external power management module, battery, wireless energy transmitter module, coil interface, and energy transmitting coil, wherein: the input of external power management module is connected with battery, outfan respectively with wireless energy transmitter module, real-time clock module, human-machine interface module, LCD MODULE, data memory module, external wireless communication module, external control unit connects, by after the voltage voltage stabilizing of battery output, for modules provides DC source, wireless energy transmitter module coils interface is connected with energy transmitting coil, the DC voltage of external power management module output is converted to the AC signal of certain amplitude and frequency, driving-energy transmitting coil produces alternating magnetic field, body is implanted into device and carries out wireless charging, external control unit is connected with human-machine interface module, the stimulus parameter and the control command that for read operation personnel, arrange, external control unit is connected by data communication interface with external wireless communication module, and the personnel's operational order and the stimulus parameter that from human-machine interface module, read are wirelessly transmitted to implanted electric stimulator, for controlling implanted electric stimulator, produces corresponding operation, external wireless communication module, after receiving the body internal pressure of implanted electric stimulator transmission, Gastroenteric Electrical detection data, sends data to external control unit simultaneously, external control unit is connected with LCD MODULE, for the waveform of display system work state information, temporal information, detection signal, external control unit is connected with real-time clock module, at each wireless receiving to reading corresponding temporal information after data or for the display system working time in LCD MODULE etc., external control unit is connected with data memory module, and the body internal pressure at every turn receiving, Gastroenteric Electrical are detected to data and be saved in storage card together with the real-time clock reading from real-time clock module.
4. Multifunctional implanted gastrointestinal electrical stimulation system according to claim 1, it is characterized in that, body is implanted into device and adopts chargeable battery work, outer control device is its charging by wireless mode, implanted electric stimulator regularly detects the voltage of chargeable battery, when cell voltage is low to moderate a certain threshold value, to outer control device, sends the low signal of battery capacity, outer control device receives after prompting signal, display reminding information on Liquid Crystal Module.
5. Multifunctional implanted gastrointestinal electrical stimulation system according to claim 1, it is characterized in that, the adjustable electrical stimulation signal of parameter that the exportable multichannel of implanted electric stimulator is separate, after implantation, by external controller, take wireless mode as vivo implantation type electrostimulator arranges different stimulus parameters, comprise stimulus modelity, pulse amplitude, frequency, dutycycle, persistent period, stimulating electrode numbering.
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