CN111714133A

CN111714133A - Implantable medical device with glucose biofuel cell

Info

Publication number: CN111714133A
Application number: CN202010366504.0A
Authority: CN
Inventors: 李娜
Original assignee: Suzhou Wushuang Medical Equipment Co ltd
Current assignee: Suzhou Wushuang Medical Equipment Co ltd
Priority date: 2020-04-30
Filing date: 2020-04-30
Publication date: 2020-09-29

Abstract

The invention relates to an implantable medical device with a glucose biofuel cell, comprising an implantable medical device housing for housing the glucose biofuel cell; a glucose biofuel cell comprising: a negative electrode carrying a glucose oxidation reaction catalyst; a positive electrode for a reduction reaction to occur; the anode and the cathode are isolated by an ion semi-permeable die; exchanging redox products of the biological raw material battery and a dialysis membrane of glucose with a biological tissue environment at the outer layer of the biological fuel battery; the fuel cell can prolong the service life of the implanted medical equipment.

Description

Implantable medical device with glucose biofuel cell

Technical Field

The invention belongs to the field of implantable medical equipment, and particularly relates to an improvement on the technology of a battery of implantable medical equipment.

Background

Most commercially available ICMs are powered by lithium batteries, with ICMs having a service life of 2-4 years. Because the ICM is only used for monitoring tachycardia, bradycardia, asystole and atrial fibrillation at present, the service life of 2-4 years can basically meet the functional requirements. The development direction of the ICM in the future is used for chronic disease monitoring, integration platforms of various health information of a body and the like, the service life of 2-4 years cannot meet the functional requirements, the service life of a battery can be prolonged by increasing the battery capacity or replacing the battery type, the lifetime use cannot be guaranteed, and after the battery is exhausted, the operation is needed when equipment is implanted, and the cost is high.

Similarly, ICDs have a lifetime of 3-6 years, and ICDs operate in a low power mode for the majority of the non-treatment period, which can be extended if a stable power source can be additionally provided in the low power mode.

Disclosure of Invention

The present invention aims to provide a technology for prolonging the service life of a battery of an implantable medical device such as an ICM or ICD by using a battery using glucose in a human body as biofuel, wherein the battery life is prolonged by reasonably managing the power supply sequence and the charge and discharge logic of the biofuel battery and a storage battery.

The implantable medical device has an implantable medical device with a glucose biofuel cell, comprising,

a glucose biofuel cell and battery for providing electrical energy for the operation of the medical device;

a power management module for electrically connecting the glucose biofuel cell and a battery;

the control module is used for controlling the power management module;

the control module and power management module are configured to:

the operation electric energy of the implanted medical equipment is provided by a glucose biofuel cell;

monitoring the life of the biofuel cell;

and when the service life of the biofuel cell reaches a life threshold, switching the power supply of the implantable medical device to the storage battery.

In a preferred aspect, the implantable medical device includes a high power mode of operation and a low power mode of operation; the control module and power management module are configured to:

detecting an operational mode of the implantable medical device;

the operation electric energy of the implanted medical equipment in the low power consumption mode is provided by the biofuel cell;

in the high power consumption mode, the operation electric energy of the implanted medical device is provided by the storage battery.

In a preferred aspect, the control module and power supply are configured to: and in the low power consumption mode, the biofuel cell provides electric energy and charges the storage battery through the power management module.

In a preferred embodiment, the implantable medical device is an ICD, the ICD switches to supply power to the storage battery when performing therapy charging, and the ICD is in a low power consumption mode when performing heart rate detection.

Through the scheme, the glucose biofuel cell in the implantable medical device can provide electric energy for the implantable medical device and is switched into the storage battery when the service life of the implantable medical device is about to end. The storage battery is in a dormant state all the time during the period of supplying power to the biofuel battery, and the original factory electricity quantity can be basically kept due to the extremely low self-discharge rate of the storage battery, so that the implantable medical device can still continue to be used for the designed time when being switched to the storage battery mode.

Furthermore, surplus power of the glucose biofuel cell can be used for charging the storage battery, and electric quantity consumed in the processes of high power consumption detection, treatment and the like of the equipment can be supplemented when the electric quantity is considered, so that a higher energy level can be maintained, and the service life of the whole implantable medical equipment is prolonged.

The implantable medical device biofuel cell comprises:

an implantable medical device housing for housing the glucose biofuel cell;

the glucose biofuel cell comprising:

a negative electrode carrying a glucose oxidation reaction catalyst;

a positive electrode for a reduction reaction to occur;

the anode and the cathode are isolated by an ion semi-permeable die;

and exchanging the redox product of the biological raw material battery and the dialysis membrane of the glucose with the biological tissue environment at the outer layer of the biological fuel battery.

The biofuel cell can continuously supply energy by using glucose contained in human body environments such as blood, interstitial fluid and the like in a human body, theoretically, the continuous energy supply time is not limited, the service time of implantable medical equipment can be prolonged, and an energy basis is provided for chronic disease monitoring in the future. And the electrical energy generated by the glucose fuel cell can be used to charge a battery in the implantable medical device.

In a preferred embodiment, the housing forms a cavity for accommodating the biofuel cell therein, and the surface of the housing covers a protective part of the dialysis membrane, the protective part having a porous surface for allowing flat glucose in a biological tissue environment to enter the glucose biofuel cell.

In a preferred embodiment, the surface housing of the implantable medical device is subjected to a drug elution process, and the drugs for the drug elution process include: an anti-inflammatory agent; an antiproliferative agent; anti-arrhythmic agents; an anti-migration agent; an anti-neoplastic agent; (ii) an antibiotic; an anti-restenosis agent; an anti-coagulating agent; an anti-infective agent; an antioxidant; an anti-macrophage agent; an anti-agglomerating agent; an antithrombotic agent; an immunosuppressant; agents that promote healing; and combinations thereof.

In a preferred embodiment, the glucose oxidation reaction catalyst is attached to the surface of the negative electrode.

In a preferred embodiment, the negative electrode is a porous material,

in a preferred solution, a structural reinforcement element for the structural strength of the dialysis membrane is included, said structural reinforcement element being arranged above, below, within or on top of the dialysis membrane.

In a preferred scheme, the ion semipermeable membrane comprises a structure and a reinforcing part for reinforcing the structural strength of the ion semipermeable membrane, and the structure reinforcing part is arranged inside and outside the ion semipermeable membrane.

In a preferred embodiment, the structural reinforcement comprises a surface for passage of the redox product and glucose pores.

In a preferred scheme, the casing comprises a hybrid circuit, and the glucose fuel cell is connected with the hybrid circuit to supply power to the hybrid circuit.

In a preferred scheme, the hybrid circuit comprises a power management module, and the power management module is electrically connected with the glucose biofuel cell.

In a preferred scheme, the shell comprises a battery module, and the battery module is connected with the power management module.

Drawings

Fig. 1 is a schematic diagram of an implantable medical device.

Fig. 2 is a schematic diagram of an implantable medical device glucose fuel cell structure.

Fig. 3 is a schematic diagram of another embodiment of an ion exchange membrane fixing mode of an implantable medical device.

Fig. 4 is a schematic diagram of another embodiment of an ion exchange membrane fixing mode of the implantable medical device.

Fig. 5 is a schematic diagram of another embodiment of an ion exchange membrane fixing mode of the implantable medical device.

FIG. 6 is a schematic diagram of yet another glucose fuel cell configuration of an implantable medical device

Fig. 7 is a top view of the mechanical reinforcing plate.

Fig. 8 is a modular schematic diagram of an implantable medical device circuit configuration.

Fig. 9 is a schematic view of a biofuel cell management process.

Fig. 10 is a schematic flow chart of another embodiment of a biofuel cell management process.

Fig. 11 is a schematic flow chart of another embodiment of a biofuel cell management process.

Detailed Description

The implantable medical device shown with reference to fig. 1 is an implantable cardiac monitor. Fig. 1 is a dashed box schematically representing an environment 10 within a human body, wherein physiological structures of the human body not relevant to the present invention are omitted for simplicity, wherein an ICM is implanted subcutaneously in the chest of the human body. The size, configuration and proportions of the various implantable medical devices in the figures are adjusted for ease of viewing and do not represent actual configurations.

Those skilled in the art will appreciate that the implantable medical device 100 in the body may also be an implantable cardiac pacemaker (pacemaker), Implantable Cardiac Defibrillator (ICD), implantable sacral neurostimulator, implantable glucometer, etc., which may be combined with the glucose biofuel cell of the present invention to extend the useful life of the implantable medical device.

In fig. 1 the ICM100 includes a housing 102 for housing internal components, the surface of the housing 102 is treated by drug elution, and after the ICM is implanted in a human body, the human body's environmental tissues form a protein film on the surface, which can block or reduce the flow of tissue fluid inside and outside the film, so that the ICM surface is treated by drug elution to prevent or delay the formation of the protein film. These include, but are not limited to: an anti-inflammatory agent; an antiproliferative agent; anti-arrhythmic agents; an anti-migration agent; an anti-neoplastic agent; (ii) an antibiotic; an anti-restenosis agent; an anti-coagulating agent; an anti-infective agent; an antioxidant; an anti-macrophage agent; an anti-agglomerating agent; an antithrombotic agent; an immunosuppressant; agents that promote healing; and combinations thereof.

The ICM100 is a long strip structure, the two side ends of the ICM are provided with electrodes 104 and 104', the electrodes 104 are used for sensing the subcutaneous electrocardiosignals of a patient, the electrodes are connected with a mixed circuit in the ICM shell, and the mixed circuit is used for analyzing the electrocardiosignals to execute the diagnosis function.

A glucose biofuel cell 106 is disposed on the ICM, with the biofuel cell 106 serving as one of the ICM power supplies.

The ICM shell described with reference to fig. 2 is provided with a storage chamber 200 for storing glucose biofuel cells, the storage chamber 200 can be completely sealed inside the ICM shell 102, the ICM can be provided with a protective plate 202 at the position of the storage chamber 200, the surface of the protective plate 202 is provided with a through hole 206 for allowing tissue fluid to pass through, oxidation products generated by the glucose fuel cells 106 can be exchanged into the tissue fluid of the human body through the through hole 206, and the reactant of the biofuel cells can be maintained at a reasonable concentration by means of the self-purification function of the tissue fluid of the human body. While glucose in interstitial fluid can be exchanged to glucose biofuel cell 106 through the via 206.

The fuel cell 106 in fig. 1 is a circular structure in a top view, and obviously, the shape of the fuel cell can be varied, for example, those skilled in the art can use a rectangular shape, a triangular shape, an oval shape, a polygonal shape, etc. instead of the circular shape, and form a battery compartment with a three-dimensional space structure corresponding to the above section.

Fig. 2 is a sectional structure taken along a-a in fig. 1, in which the internal structure of the biofuel cell 106 is shown.

Referring to fig. 2 in a preferred embodiment the vias 206 are a plurality of holes 206 disposed on the surface of the guard plate, the diameter dimension of the plurality of holes 206 being much smaller than the cross-sectional width of the portion of the glucose biofuel cell 106. The protective plate prevents the internal structure of the glucose biofuel cell 106 from being mechanically stressed and rubbed by human tissue during or after implantation, resulting in structural damage.

A dialysis membrane 214 is disposed below the through hole, the dialysis membrane 214 is used for exchanging substances inside the biofuel cell with substances outside the biofuel cell, and is mainly used for exchanging reaction products inside the fuel cell into human tissue fluid through the dialysis membrane, and exchanging glucose in the tissue fluid into the biofuel cell through the dialysis membrane, and the dialysis membrane is made of a material through which glucose, glucose metabolites, sodium ions, potassium ions, water and the like can pass.

In a preferred embodiment, with continued reference to fig. 2, a spacer 204 is disposed within the fuel cell cartridge, the upper end of the spacer 204 is connected to the protective plate 202, and the lower end of the spacer 204 is connected to a wall 212 at the bottom of the fuel cell cartridge. The separator 204 is preferably made of a porous material comprising polyurethane, polyethylene, polypropylene, nylon, sintered titanium, deep reactive ion etched silicon, sintered stainless steel, sintered silica, liquid crystal, glass, borosilicate glass, or mixtures or derivatives thereof. The separator may be provided with a plurality of openings which reduce the difficulty of ion exchange between the positive and negative electrode chambers. The two sides of the separator are ion exchange membranes 210, that is, the separator 204 is disposed in the ion exchange membranes, and the ion exchange membranes are used for enabling hydroxide ions to be transferred from the negative electrode to the positive electrode when the biofuel cell is normally discharged, so as to maintain the normal fuel cell discharge.

Fig. 3 to 5 are partial structural schematic diagrams of the ion exchange membrane 210 of the biofuel cell.

The ion exchange membrane 210 may also be disposed between the protective plate and the bottom wall 212 of the biofuel cell in various forms. For example, in fig. 3, a larger through-hole is provided in the intermediate partition, and an ion exchange membrane 210 is provided in the middle of the through-hole. As shown in fig. 4, the ion exchange membrane 210 is directly fixed between the protection plate 206 and the bottom wall. As another example, as shown in fig. 5, the separator 204 includes two layers, an ion exchange membrane 210 is disposed between the two layers, the separator is made of a porous material, and similarly, the two layers of the separator are optionally provided with a plurality of openings for facilitating the passage of ions.

The openings can reduce the difficulty of ion exchange between the chamber in which the anode of the biofuel cell is positioned and the chamber in which the cathode of the biofuel cell is positioned. And the two sides of the reinforcing plate are provided with ion exchange membranes which allow hydroxide ions generated by the anode of the biofuel cell to enter the electrode bin where the cathode is positioned through the ion exchange membranes.

In the preferred embodiment, with reference to fig. 6, at the location of the biofuel cell 106, the housing is provided with a through hole 306 having a cross-sectional size substantially equal to the cross-sectional size of the fuel cell compartment, the cross-sectional size being slightly smaller than the cross-sectional size of the compartment, and a biofuel cell dialysis membrane 308 is provided in the through hole 306, the dialysis membrane 308 being adapted to exchange glucose and reaction products with the human environmental tissue. A mechanical structure reinforcing plate 310 is arranged in the dialysis membrane 308 of the biofuel cell. In addition to the position shown in fig. 7, the mechanical structure reinforcing plate 310 may be disposed above, below, etc. the fuel cell dialysis membrane.

The mechanical structure reinforcing plate 310 is made of a surface porous material with reference to fig. 7, and the structure reinforcing plate 310 is made of polyurethane, polyethylene, polypropylene, nylon, sintered titanium, deep reactive ion etched silicon, sintered stainless steel, sintered silica, liquid crystal, glass, borosilicate glass, or a mixture or derivative thereof. The surface of the structural reinforcing plate is provided with a plurality of openings 312, and the openings 312 can reduce the material exchange resistance between the inside of the biofuel cell and human tissue fluid.

In a preferred embodiment, the structural reinforcing plate 310 is integrally formed with the battery compartment and the walls of both sides of the battery compartment. In the preferred embodiment, a protective film 314 is placed over the protective plate, and the protective film 314 is removed prior to the implantation procedure.

In fig. 2 or fig. 6, the battery chamber of the glucose biofuel cell is divided into a positive electrode chamber and a negative electrode chamber, and the positive electrode chamber 322 and the negative electrode chamber 324 are separated by an ion exchange membrane. During the manufacturing process of the implantable medical device, the negative electrode chamber and the positive electrode chamber are filled with a biofuel cell matrix liquid, the composition of the matrix liquid is changed along with the change after the implantable medical device is implanted into a human body, and the matrix does not contain glucose before the implantable medical device is implanted into the human body, for example, physiological saline is used as the matrix liquid. After being implanted, the tissue fluid is exchanged with the inner solution of the tissue fluid, glucose in the tissue fluid enters the battery compartment to react to generate electric power in the exchange process, and a reaction product generated by the fuel cell enters the tissue fluid through the dialysis membrane.

Referring to fig. 8, the anode 318 and the cathode 320 of the glucose biofuel cell are connected to an ICM hybrid circuit 900, the cathode 320 serves as a ground reference point, and a glucose oxidation catalyst is supported on the cathode 320 of the glucose biofuel cell, which is preferably a porous material to maximally support the oxidation catalyst.

Referring to fig. 6, oxidation of glucose across the catalyst at the negative electrode releases electrons that accumulate at the negative electrode 318 to form an electric field, i.e., the voltage required to power the ICM. Electrons enter the positive electrode 318 from the hybrid circuit 900 and participate in the positive electrode reaction, the positive electrode forms hydroxide ions OH & lt- & gt under the joint participation of oxygen and water as well as the electrons, and the hydroxide ions pass through the ion semi-permeable membrane to form water at the positive electrode.

Strictly speaking, the oxidation reaction process of the negative electrode is as follows: c₆H₁₂O₆+24OH^-→6CO₂+18H₂O+24e^-

The oxidation reaction process of the anode is as follows: 6O₂+12H₂O+24e^-→24OH^-

The overall oxidation reaction process of the biofuel cell is as follows: c₆H₁₂O₆+6O₂→6CO₂+6H₂O

Further, if the above reaction is insufficient, the oxidation reaction process of the anode is: c₆H₁₂O₆+2OH^-→C₆H₁₂O₇+H₂O+2e^-

The oxidation reaction process of the anode is as follows:

the overall oxidation reaction process of the biofuel cell is as follows:

referring to fig. 8, the hybrid circuit includes a plurality of functional modules including a sensing module 906, a control module 902, a communication module 910, a power management module 908, and a storage module 904. The sensing module is connected to electrodes at two ends of the ICM, and the sensing module 906 is configured to sense an electrocardiographic signal and convert the electrocardiographic signal into a digital signal that can be processed by the control module 902.

The electrocardiosignal sensing module 906 comprises a signal input channel connected with the electrode 104 or 104', and the electrocardiosignal sensing module 906 further comprises an amplifying module for processing signals, a filtering module and an analog-to-digital conversion module ADC, the electrocardiosignals are finally converted into digital signals which can be processed by the control module 902, and the digital electrocardiosignals are used as the basis for processing electrocardio data by the control module 902.

The communication module 910 is connected to the control module 902, the control module 902 sends or receives data through the communication module, and the communication module establishes a communication link with the program controller in a wireless communication manner, where the communication link is used to transmit initialization parameters of the communication module at an implantation stage, or set parameters during a follow-up visit of a user, or communicate with a handheld device of a patient to issue timely reminders or warnings to the patient. The communication module preferably establishes a communication link through wireless communication modes such as WIFI, Bluetooth, RF and ultrasonic.

The power management module 908 is connected with a glucose biofuel cell 922 and a storage battery 920, and the power management module 908 is used for predicting the service life of the battery and detecting parameters such as the voltage and the current of the battery. The power management module 908 also includes a switching circuit 924 and a switching circuit 926 that can switch and manage the battery power sequence. The power management module 908 may further include power supply common function circuits such as charging, boosting, filtering, and the like. In application form, the power management module 908 may be an integrated circuit, a combination circuit of separate components, or a mixture of an integrated circuit and a separate component, and in any case, a module capable of achieving the same function may be used as a power module.

The control module 114 may be a functional circuit, preferably an MCU, having a data processing control for executing the implantable medical device. The control module 114 may also be an ASIC specific application integrated circuit. The control module is connected with the communication module 910, the electrocardiosignal sensing module 906 and the power module 906 storage module 904, and is used for controlling the modules to work cooperatively to ensure the normal function of the implantable medical device. In the preferred scheme, the MCU through hole system bus is connected with each functional module.

In a preferred embodiment, the memory module 904 stores a control program for controlling an implantable medical device. The control program comprises parameter data (such as patient information, sensing parameters, diagnosis parameters and treatment parameters), and a power supply control program is pre-programmed in the storage module, and the power supply control program is used for executing a specific power supply control function after the control module loads the control program: in a preferred aspect, the power control program includes a biofuel cell life evaluation module that calculates a remaining effective usage time of the biofuel cell using a predetermined algorithm.

Referring to fig. 8, the power module includes a switch circuit, and both the switch 924 and the switch 926 are respectively responsible for connecting the biofuel cell 922 or the battery 920 into the power circuit, and when the switch 924 is closed, the system uses the biofuel cell to supply power, and the current generated by the biofuel cell is supplied to the hybrid circuit using the power management module 908.

The power control program described with reference to fig. 9 configures the functions of the control module to: s1 evaluates the life of biofuel cell 922. In the process S2, when the life of the biofuel cell 922 reaches the service life threshold value before the end of its life, the battery 920 is switched on to enable the battery to supply power, and the switch is switched off to remove the biofuel cell from the power supply circuit.

In step S1, the control module 902 performs an evaluation function of a battery life evaluation module, for example, determining that the end of life of the biofuel cell 924 cannot be used further if the average discharge power of the biofuel cell 922 does not reach the minimum power requirement of the life evaluation module.

In a preferred version, the power management module 908 includes a power measurement circuit that evaluates the average power of the cell by measuring the voltage and current of the biofuel cell. In a preferred embodiment, the average power is obtained by averaging a plurality of measurements. It is of course also possible to use known existing evaluation methods for evaluating the life of the fuel cell.

In the step S2, through the evaluation in the step S1, if the battery life reaches the life threshold but can be used normally, and the switch 926 is closed so that the battery can be supplied with power normally, the control module controls the switch 924 to open so that the glucose biofuel cell moves out of the power supply circuit.

So far the biofuel cell 922 is no longer involved in powering the implanted medical device to the end of its useful life. By this method, the fuel cell 922 has a better glucose-powered environment for the human body just after the implantable medical device is implanted into the human body, and can use the glucose fuel cell to supply power for a long time. During this period, the battery 920 is in a "sleep" state, and the glucose fuel cell is switched to supply power to the battery 920 after the glucose fuel cell can no longer provide a continuous and stable power supply due to various factors. Since the implanted medical device battery 920 has a very low self-discharge rate, the charge of the battery remains substantially unchanged during the period of time that the glucose fuel cell is being used to supply power. The increase in the biofuel cell as a whole corresponds to an increase in the overall useful life of the implantable medical device.

The addition of steps in fig. 10 enables the control module to switch the battery based on the power consumption mode of the implantable medical device, and the control module determines 702 whether the device is in a high power consumption mode, which may include the implantable medical device finding a suspected cardiac event that requires the high power consumption mode to be turned on for intensive data sampling to confirm the patient's condition. Or the control module judges whether the patient needs electrical stimulation treatment according to a perception algorithm (for example, electrical stimulation is needed in the case of ICD defibrillation, anti-tachycardia pacing and the like).

In step 702, the control module may predict whether the device is going to enter the high power consumption mode through a diagnostic algorithm, for example, a heart rate diagnostic algorithm may determine whether a malignant heart rate event such as ventricular tachycardia or ventricular fibrillation occurs in the heart of the patient, and when the malignant heart rate event is determined, the patient needs to perform an emergency treatment, and a corresponding treatment discharge capacitor needs to be charged, so the control module may predict whether the device is going to enter the high power consumption mode.

In step 704, when it is determined in step 702 that the high power consumption mode needs to be entered, the switch 926 may be closed so that the storage battery is connected to the power supply circuit, and after entering the charging circuit, the control module needs to perform a high power consumption operation, for example, the therapy module is charged by a battery, where the therapy module includes, for example, a transformer, a high voltage capacitor and a corresponding adapter circuit, the battery charges the high voltage capacitor under the control of the control module through the transformer in the high power consumption mode, and when the high voltage capacitor reaches a predetermined value, the control module stops charging the capacitor, and then the control module controls the high voltage capacitor to discharge.

After the high power consumption mode is finished, the control module after the process 706 closes the switch 924 to connect the glucose fuel cell to the power supply loop, and controls to disconnect the battery switch 926, so that the battery moves out of the power supply loop and then continues to enter the low power consumption mode.

In a further aspect, the power management circuit 908 further includes a charging circuit, the charging circuit further includes a wireless charging module, the battery is a rechargeable battery, such as a lithium ion battery, and the control module 902 controls the charging circuit to charge the battery 920 in a low power consumption mode.

In fig. 11, the

flows

802, 806, 808 are the same as the

flows

702, 704, 706 in fig. 10, and the

flows

804 and 810 are added on the basis of the flows.

In process 810, when the implantable medical device enters a low power mode, the battery can be charged using the grape sleeve biofuel cell, and the charging time is longer for the longer the corresponding low power mode. In the process, the control module controls 902 controls the

switches

924 and 926 to close so that the biofuel cell forms a charging circuit with the charging circuit and the battery.

In flow 804, if the implanted medical device is ready to enter a high power mode, charging the battery is stopped to enter a discharged state.

Some medical devices (e.g., ICDs) are in a low power mode for a long period of time, and the low power mode for a long period of time following a discharge in a high power mode is in a charging process that may last for a long period of time, e.g., days or months, and can be charged to the level of charge before the high power mode over such a long period of time. Therefore, the long battery life of the implanted medical equipment can be maintained, and the physical pain and the economic pressure of a patient caused by equipment replacement are reduced.

Therefore, the storage battery of the device is automatically charged when the device is in the low power consumption mode so as to prolong the service life of the device, and the storage battery is used for discharging when the device is in the high power consumption mode so as to meet the high power use in the high power consumption mode.

Claims

1. An implantable medical device having a glucose biofuel cell, wherein,

the control module is used for controlling the power management module;

the control module and power management module are configured to:

evaluating the life of the biofuel cell;

2. The implantable medical device of claim 1, wherein the implantable medical device comprises a high power consumption mode of operation and a low power consumption mode of operation; the control module and power management module are configured to:

detecting an operational mode of the implantable medical device;

3. The implantable medical device of claim 2, wherein the control module and power supply are configured to: in the low power consumption mode, the medical equipment runs electric energy and is supplied with electric energy by the biofuel cell, and meanwhile, the storage battery is charged through the power management module.

4. The implantable medical device with a glucose biofuel cell of claim 2 or claim 3, wherein the implantable medical device is an ICD that switches to battery power when it is therapeutically charged and a low power consumption mode when it is performing heart rate detection.

5. The implantable medical device of claim 1 having a glucose biofuel cell, wherein the glucose biofuel cell comprises:

a negative electrode carrying a glucose oxidation reaction catalyst;

a positive electrode for a reduction reaction to occur;

the anode and the cathode are isolated by an ion semi-permeable die;

exchanging the biofuel cell redox product and the dialysis membrane of glucose with the biological tissue environment at the outer layer of the biofuel cell.

6. The implantable medical device having a glucose biofuel cell of claim 5, wherein the housing of the implantable medical device forms a cavity inside which the biofuel cell is housed, and wherein the surface of the housing comprises a protective portion covering the dialysis membrane, the protective portion having a porous surface to allow flat glucose in a biological tissue environment to enter the glucose biofuel cell.

7. The implantable medical device of claim 5, wherein the implantable medical device surface housing is subjected to a drug elution process, and wherein the drug for the drug elution process comprises: an anti-inflammatory agent; an antiproliferative agent; anti-arrhythmic agents; an anti-migration agent; an anti-neoplastic agent; (ii) an antibiotic; an anti-restenosis agent; an anti-coagulating agent; an anti-infective agent; an antioxidant; an anti-macrophage agent; an anti-agglomerating agent; an antithrombotic agent; an immunosuppressant; agents that promote healing; and combinations thereof.

8. The implantable medical device of claim 5, wherein the glucose oxidation reaction catalyst is attached to the surface of the negative electrode.

9. The implantable medical device of claim 5, wherein the negative electrode is a porous material.

10. The implantable medical device with a glucose biofuel cell of claim 5, comprising a structural reinforcement element for reinforcing the structural strength of the dialysis membrane, the structural reinforcement element being arranged above, below, within or on top of the dialysis membrane.

11. The implantable medical device having a glucose biofuel cell of claim 10, comprising structural reinforcements for reinforcing the structural strength of the ionic semipermeable membrane, said structural reinforcements being disposed inside and outside the ionic semipermeable membrane.

12. The implantable medical device of claim 11, wherein the structural reinforcement comprises a surface for passage of the redox product and glucose pores.

13. The implantable medical device of claim 5, wherein the housing includes a hybrid circuit therein, the glucose fuel cell being coupled to the hybrid circuit to power the hybrid circuit.

14. The implantable medical device of claim 13, comprising a hybrid circuit comprising a power management module electrically coupled to the glucose biofuel cell.