Fully degradable sacral nerve stimulator and preparation method thereof

Abstract

The invention provides a fully degradable sacral nerve stimulator and a preparation method thereof, and the fully degradable sacral nerve stimulator comprises an air battery and a terminal device. The air battery is made of degradable materials and used for being implanted under the hip skin, the air battery comprises a base body, a strain gauge, a wireless communication module, a compound positive electrode and a metal negative electrode, pins are further formed at the tail ends of the compound positive electrode and the metal negative electrode respectively, and the pins are used for being arranged at the positions, close to sacral nerves, under the hip skin. The strain gauge is connected to the compound positive electrode or the metal negative electrode close to the pin; the wireless communication module is used for wireless communication between the terminal device and the air battery, and the terminal device is used for receiving information detected by the strain gauge and controlling the pin of the air battery to be powered on. According to the fully-degradable sacral nerve stimulator, the nerve repairing capacity of electrical stimulation can be achieved, the situation that neurogenic bladder contraction power is insufficient after stroke can be effectively treated, and urination can be better facilitated.

Description

Technical Field

[0001] The present application relates to the field of medical machinery, and in particular to a fully degradable sacral nerve stimulator and a preparation method thereof. Background Art

[0002] Neurogenic bladder after stroke is a condition in which ischemic stroke causes damage to the brain and spinal nerves, affecting the neural signals of the bladder to store and urinate urine, leading to difficulty urinating. Summary of the invention

[0003] In view of this, the present application provides a fully degradable sacral nerve stimulator and a preparation method thereof, which can realize the repair ability of nerves by electrical stimulation, can effectively treat the neurogenic bladder contraction deficiency caused by stroke, and facilitate better urination.

[0004] To solve at least one of the above technical problems, the present application adopts the following technical solutions:

[0005] According to the first aspect of the present application, a fully degradable sacral nerve stimulator is provided, comprising: an air battery and a terminal device; wherein the air battery is made of a degradable material and is used to be implanted subcutaneously in the buttocks, the air battery comprises a substrate, a strain gauge, a wireless communication module, a composite positive electrode and a metal negative electrode, the wireless communication module, the composite positive electrode and the metal negative electrode are correspondingly arranged on the substrate, and pins are respectively formed on the ends of the composite positive electrode and the metal negative electrode, the pins are used to be arranged at a position close to the sacral nerve under the buttocks, and the strain gauge is connected to the composite positive electrode or the metal negative electrode close to the pins; the wireless communication module is used for wireless communication between the terminal device and the air battery, and the terminal device is used to receive information detected by the strain gauge and control the power supply of the pins of the air battery.

[0006] In a possible implementation of the first aspect above, the air battery further includes: a control switch, the control switch is connected to the composite positive electrode or the metal negative electrode near the pin, and the control switch is used to control the on and off of the end of the composite positive electrode or the metal negative electrode; wherein the pin is powered on by controlling the control switch.

[0007] In a possible implementation of the first aspect, the substrate includes a first substrate and a second substrate, the first substrate and the second substrate are bonded to each other, and the composite positive electrode and the metal negative electrode are correspondingly disposed between the first substrate and the second substrate.

[0008] In a possible implementation of the first aspect above, the thickness of the first substrate and the second substrate is 0.1-0.2 cm.

[0009] In a possible implementation of the first aspect, the material of the matrix includes one of polylactic acid-glycolic acid copolymer, polylactic acid, polyglycolic acid, polycaprolactone or polyglycolic acid.

[0010] In a possible implementation of the first aspect, the composite positive electrode and the metal negative electrode are both formed as coils, and pins are formed at the ends of the coils.

[0011] In a possible implementation of the first aspect above, the number of turns of the coil is 15-25 turns, and the wire diameter of the coil is 0.1-0.2 cm.

[0012] In a possible implementation of the first aspect above, the material of the composite positive electrode includes one or more of metal carbides, metal nitrides, metal carbonitrides, sodium ferrocyanide, or potassium ferrocyanide.

[0013] In a possible implementation of the first aspect above, the material of the metal negative electrode and the pin includes one of magnesium, magnesium-copper alloy, magnesium-iron alloy, magnesium-lithium alloy or magnesium-cobalt alloy.

[0014] In a possible implementation of the first aspect above, the pin includes a substrate and punctures formed on the substrate.

[0015] In a possible implementation of the first aspect above, the substrate has a length of 0.5-1 cm, a width of 0.5-1 cm, and a thickness of 0.1-0.2 cm.

[0016] In a possible implementation of the first aspect above, the needle is a cone with a bottom diameter of 0.05-0.1 cm and a height of 0.2-0.3 cm.

[0017] In a possible implementation of the first aspect above, the air battery also includes: a pressure sensor, the pressure sensor is made of a degradable material, the pressure sensor is electrically connected to the air battery, the pressure sensor is used to detect the pressure exerted on the air battery, the terminal device is also electrically connected to the pressure sensor, and the terminal device is also used to receive information detected by the pressure sensor.

[0018] According to a second aspect of the present application, a method for preparing a fully degradable sacral nerve stimulator is provided. The fully degradable sacral nerve stimulator includes an air battery and a terminal device. The preparation of the air battery includes at least the following steps:

[0019] The matrix, strain gauge, wireless communication module, composite positive electrode and metal negative electrode of the air battery are prepared by using degradable materials, and pins are formed on the ends of the composite positive electrode and the metal negative electrode respectively;

[0020] The prepared wireless communication module, composite positive electrode and metal negative electrode are arranged on the substrate respectively, and the prepared strain gauge is connected to the composite positive electrode or the metal negative electrode close to the pin to assemble into an air battery;

[0021] The assembled air battery can communicate wirelessly with the terminal device so as to send the information detected by the strain gauge to the terminal device, so that the terminal device controls the pins of the air battery to be energized.

[0022] In a possible implementation of the second aspect, the material of the substrate includes one of polylactic acid-co-glycolic acid, polylactic acid, polyglycolic acid, polycaprolactone or polyglycolic acid;

[0023] The preparation of the lactic acid-glycolic acid copolymer comprises:

[0024] preparing lactic acid and glycolic acid, mixing the lactic acid and glycolic acid in proportion and adding them into a reactor, then adding a catalyst, and then heating the reactor to perform a polymerization reaction to obtain a reaction product;

[0025] The obtained reaction product is cooled, and impurities therein are removed by a solvent precipitation method to obtain a lactic acid-glycolic acid copolymer.

[0026] In a possible implementation of the second aspect, the material of the composite positive electrode includes one or more of metal carbides, metal nitrides, metal carbonitrides, sodium ferrocyanide, or potassium ferrocyanide;

[0027] The preparation of the composite positive electrode includes:

[0028] Prepare stock solution;

[0029] Under stirring conditions, gradually adding an appropriate amount of a regulator to the raw material solution to produce a precipitate with a Prussian blue structure;

[0030] Collect the precipitate and remove the impurities therein;

[0031] Then the precipitate is dried to obtain a positive electrode material with a Prussian blue layered structure.

[0032] Then the positive electrode material is used to prepare the composite positive electrode.

[0033] In a possible implementation of the second aspect, the material of the metal negative electrode includes one of magnesium, magnesium-copper alloy, magnesium-iron alloy, magnesium-lithium alloy or magnesium-cobalt alloy;

[0034] Preparation of metal negative electrode includes:

[0035] Preparing a raw material substrate, and cleaning and drying the raw material substrate;

[0036] Then, the photosensitive material is evenly coated on the surface of the raw material substrate, and the photosensitive material is cured;

[0037] Then the raw material substrate is placed in a photolithography machine for photolithography, a designated area of ​​the photosensitive material on the raw material substrate is exposed to form a desired pattern, and then the unexposed portion of the photosensitive material is removed;

[0038] Then the raw material substrate is etched to remove excess material of the raw material substrate to form a negative electrode material consistent with the pattern shape;

[0039] Then, impurities on the negative electrode material are removed to obtain a metal negative electrode.

[0040] The above technical solution of the present application has at least one of the following beneficial effects:

[0041] According to the fully degradable sacral nerve stimulator of the present application, the terminal device controls the pins of the air battery to be energized, and the sacral nerves are electrically stimulated by the pins, which can realize the repair ability of the nerves by electrical stimulation, and can effectively treat the neurogenic bladder contraction power deficiency caused by stroke, facilitate better urination, be convenient and reliable, have a long service life, and cause very little damage to the patient's organ tissues, be non-toxic and friendly, and the strain gauge can also detect the degree of deformation of the terminal part of the composite positive electrode or metal negative electrode near the pin after being implanted under the buttocks, thereby improving safety and reliability. In addition, the part of the fully degradable sacral nerve stimulator of the present application implanted under the buttocks can be completely degraded, reducing the cost and risk of secondary surgery for removal.

[0042] In addition, in the technical solution of the present application, unless otherwise specified, the technical solution can be implemented by adopting conventional means in the art. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 This is a schematic diagram of the structure of a fully degradable sacral nerve stimulator implanted subcutaneously in the buttocks according to one embodiment of the present application;

[0044] Figure 2 A schematic diagram of the structure of an air battery in a fully degradable sacral nerve stimulator according to an embodiment of the present application;

[0045] Figure 3 A flow chart of the preparation of an air battery for a fully degradable sacral nerve stimulator according to an embodiment of the present application;

[0046] Figure 4 This is a flow chart of a method for preparing a lactic acid-glycolic acid copolymer according to an embodiment of the present application;

[0047] Figure 5 A flow chart of a method for preparing a composite positive electrode of an air battery according to an embodiment of the present application;

[0048] Figure 6The present invention is a flow chart of a method for preparing a metal negative electrode of an air battery according to an embodiment of the present application.

[0049] Reference numerals:

[0050] 10. Pressure sensor;

[0051] 20. Air battery; 21. Matrix; 22. Composite positive electrode; 23. Metal negative electrode; 24. Pin; 25. Strain gauge; 26. Control switch;

[0052] 30. Subcutaneous buttocks;

[0053] 40. Sacral nerves. DETAILED DESCRIPTION

[0054] In order to make the purpose, technical solutions and advantages of the present application clearer, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are part of the embodiments of the present application, rather than all of the embodiments, and are only used to explain the present application, and are not used to limit the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of the present application.

[0055] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "front", "back", "vertical", "horizontal", "inside", "outside", "two ends", "both sides", "bottom", "top" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the referred elements must have a specific orientation or be constructed and operated in a specific orientation, and therefore cannot be understood as limitations on the present application. In addition, the terms "first", "second", "superior", "inferior", "primary", "secondary" and the like are only used for descriptive purposes and can be simply used to more clearly distinguish different components, but cannot be understood as indicating or implying relative importance.

[0056] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0057] The fully degradable sacral nerve stimulator according to the embodiment of the present application is first described in detail below with reference to the accompanying drawings.

[0058] According to a fully degradable sacral nerve stimulator provided in an embodiment of the present application, Figures 1-2 As shown, it may include: an air battery 20 and a terminal device (not shown in the drawings).

[0059] Among them, the air battery 20 is made of degradable material and is used to be implanted under the buttocks 30. The air battery 20 includes a substrate 21, a strain gauge 25, a wireless communication module (not shown), a composite positive electrode 22 and a metal negative electrode 23. The wireless communication module, the composite positive electrode 22 and the metal negative electrode 23 are correspondingly arranged on the substrate 21. Pins 24 are also formed on the ends of the composite positive electrode 22 and the metal negative electrode 23, respectively. The pins 24 are used to be set at a position under the buttocks near the sacral nerve 40.

[0060] The strain gauge 25 is connected to the composite positive electrode 22 or the metal negative electrode 23 near the pin 24. The strain gauge 25 is used to detect the deformation degree of the end portion of the composite positive electrode 22 or the metal negative electrode 23 near the pin 24 after being implanted under the buttocks 42, and send the detected information to the terminal device, thereby protecting the composite positive electrode 22, the metal negative electrode 23 and the corresponding pin 24 from damage during implantation.

[0061] The wireless communication module is used for wireless communication between the terminal device and the air battery 20. The terminal device is used to receive information detected by the strain gauge 25 and control the power supply of the pin 24 of the air battery 20. The terminal device can be a remote control, a mobile phone, a computer, etc. The wireless communication module can use WIFI (Wireless Fidelity), Bluetooth or Zigbee (i.e. Zigbee protocol) to achieve wireless communication, which will not be described in detail here.

[0062] Specifically, according to the fully degradable sacral nerve stimulator of the embodiment of the present application, the air battery 20 is implanted at the corresponding position of the buttocks subcutaneous 30, the pins 24 on the composite positive electrode 22 and the metal negative electrode 23 are close to the sacral nerve 40, and the terminal device communicates wirelessly with the air battery 20, and determines whether the composite positive electrode 22 or the metal negative electrode 23 at the pin 24 is greatly deformed or damaged according to the information detected by the strain gauge 25 received by the terminal device. When the composite positive electrode 22 or the metal negative electrode 23 at the pin 24 is not deformed or deformed very little and can work normally, the terminal device controls the pins 24 on the composite positive electrode 22 and the metal negative electrode 23 to be energized, and the pins 24 on the composite positive electrode 22 and the metal negative electrode 23 are electrically stimulated to the sacral nerve 40, so as to realize the repair ability of the nerve by electrical stimulation, and can effectively treat the situation of insufficient neurogenic bladder contraction power caused by stroke, so as to facilitate better urination. It should be noted that in the fully degradable sacral nerve stimulator of the present application, "fully degradable" means that the part implanted in the human body can be fully degraded and does not need to be removed by secondary surgery.

[0063] Therefore, the fully degradable sacral nerve stimulator of the present application can achieve the repairing ability of the nerve by electrical stimulation of the sacral nerve 40, and can effectively treat the neurogenic bladder contraction power deficiency caused by stroke, facilitate better urination, be convenient and reliable, have a long service life, and cause very little damage to the patient's organ tissues, be non-toxic and friendly, and the strain gauge 25 can also detect the degree of deformation of the end part of the composite positive electrode 22 or the metal negative electrode 23 near the pin 24 after being implanted under the buttocks 42, thereby improving safety and reliability. In addition, the part of the fully degradable sacral nerve stimulator of the present application implanted under the buttocks 30 can be completely degraded, reducing the cost and risk of secondary surgery for removal. In addition, the corresponding drug can also be placed on the pin 24, and the release of the drug can be achieved by electrolysis or degradation of the pin 24, further improving the therapeutic recovery effect.

[0064] In some embodiments, Figure 2 As shown, the air battery 20 may further include a control switch 26 .

[0065] The control switch 26 is connected to the composite positive electrode 22 or the metal negative electrode 23 near the pin 24 , and the control switch 26 is used to control the on and off of the end of the composite positive electrode 22 or the metal negative electrode 23 .

[0066] The pin 24 is energized by the control switch 26 to stimulate the sacral nerve 40 .

[0067] That is to say, the control switch 26 is in an open state under normal conditions. When electrical stimulation of the sacral nerve 40 is required, a signal is sent to the control switch 26 through the terminal device to close it. As a result, the composite positive electrode 22 and the metal negative electrode 23 of the air battery 20 are in an energized state, and then discharge is performed through the pin 24 to stimulate the sacral nerve 40, thereby realizing the repairing ability of electrical stimulation on the nerves, which can effectively treat the neurogenic bladder contraction deficiency caused by stroke and facilitate better urination.

[0068] In some embodiments, Figure 2 As shown, the substrate 21 may include a first substrate and a second substrate, the first substrate and the second substrate are laminated up and down, and the composite positive electrode 22 and the metal negative electrode 23 are correspondingly arranged between the first substrate and the second substrate.

[0069] That is, the substrate 21 includes a first substrate and a second substrate which are attached to each other from top to bottom, and corresponding components of the air battery 20 are clamped and carried between the first substrate and the second substrate, thereby achieving maximum protection.

[0070] Further, the material of the substrate 21 may include one of polylactic acid-co-glycolic acid, polylactic acid, polyglycolic acid, polycaprolactone or polyglycolic acid.

[0071] Specifically, when using polylactic acid-glycolic acid copolymer materials, since polylactic acid (PLA) and glycolic acid (PGA) are both biocompatible materials, they can be used in vivo, reducing the body's rejection reaction; the copolymer can gradually degrade in the biological environment, does not require secondary surgery to remove, reduces environmental pollution, and is not prone to adhesion problems caused by long implantation time, etc.; and by adjusting the ratio of polylactic acid and glycolic acid, the degradation rate can also be controlled. In addition, polylactic acid-glycolic acid copolymer has good mechanical strength and toughness, and can be processed by thermoplasticity, suitable for a variety of molding.

[0072] The selected polylactic acid material has the advantages of good thermal stability, biodegradability, good mechanical and physical properties and is conducive to processing and molding.

[0073] The selected polyglycolic acid and polycaprolactone materials have good biodegradability and biocompatibility. After a certain use cycle, they will automatically decompose into carbon dioxide and water that are harmless to the human body.

[0074] Furthermore, the thickness of the first substrate and the second substrate is 0.1-0.2 cm.

[0075] Therefore, the material consumption of the base body 21 is small, which reduces the material cost, and at the same time has good mechanical properties.

[0076] In some embodiments, Figure 2 As shown, the composite positive electrode 22 and the metal negative electrode 23 are both formed into coils, and a pin 24 is formed at the end of the coil.

[0077] Therefore, the composite positive electrode 22 and the metal negative electrode 23 as a whole have a large specific surface area, which helps to improve the energy storage performance of the material, as well as the rate and efficiency of the electrochemical reaction, and have good mechanical properties when supported inside the matrix 21.

[0078] Furthermore, the number of turns of the coil is 15-25 turns, and the wire diameter of the coil is 0.1-0.2 cm.

[0079] As a result, the discharge efficiency of the air battery 20 can be greatly ensured, and the battery performance can be improved.

[0080] Furthermore, the material of the composite positive electrode 22 may include one or more of metal carbides, metal nitrides, metal carbonitrides, sodium ferrocyanide, or potassium ferrocyanide.

[0081] The metal carbide, metal nitride or metal carbonitride material used as the composite positive electrode 22 has high electrical conductivity, good strength and toughness. In particular, the chemical composition and surface chemical properties of these materials can be adjusted through chemical doping and surface modification to give the materials different functions, which can greatly improve the applicability of the composite positive electrode 22.

[0082] Sodium ferrocyanide or potassium ferrocyanide material is selected as the composite positive electrode 22. Sodium ferrocyanide or potassium ferrocyanide material can form a Prussian blue layered structure, which has a high electrical conductivity, so that it can effectively conduct current when used as a cathode material in batteries and supercapacitors. The raw materials of sodium ferrocyanide or potassium ferrocyanide are relatively non-toxic and have good energy storage capacity, and have good chemical stability, and can maintain performance in multiple charge and discharge cycles.

[0083] Furthermore, the material of the metal negative electrode 23 and the pin 24 may include one of magnesium, magnesium-copper alloy, magnesium-iron alloy, magnesium-lithium alloy or magnesium-cobalt alloy.

[0084] Specifically, a magnesium-containing alloy is selected as the material of the metal negative electrode 23 and the pin 24, and its chemical properties are stable, so that it is not easy to have thermal runaway when overcharged or short-circuited. The cost of magnesium element is relatively low, and it is more sustainable, has less impact on the environment, and is relatively simple to recycle and handle. Magnesium-containing alloys theoretically have a higher energy density and can store more energy, and the migration rate of magnesium ions in the battery is faster, which helps to improve the charge and discharge efficiency of the battery. In addition, magnesium-containing alloys can degrade by themselves after a certain period of time, and the degradation products are harmless to the human body.

[0085] In some embodiments, Figure 2 As shown, the pin 24 includes a base and needle punctures formed on the base, so that when the pin 24 is implanted under the skin 42 of the buttocks, the connection is stable and reliable, and it is not easy to cause pain or damage to the human body.

[0086] Furthermore, the substrate has a length of 0.5-1 cm, a width of 0.5-1 cm, and a thickness of 0.1-0.2 cm.

[0087] Furthermore, the needle punch is a cone with a bottom diameter of 0.05-0.1 cm and a height of 0.2-0.3 cm.

[0088] It should be noted here that in the fully degradable sacral nerve stimulator according to the embodiment of the present application, the specifications of the air battery 20 can be 2cm×3cm×0.6cm, the electrical stimulation intensity of the released current can be 6-20mA, and the degradation cycle of each material in the air battery 20 can be 3-6 months, and the service life is relatively long.

[0089] In some embodiments, the air battery 20 further includes: a pressure sensor 10. The pressure sensor 10 is made of a degradable material, and is electrically connected to the air battery 20. For example, the pressure sensor 10 can be disposed on a substrate 21 of the air battery 20. The pressure sensor 10 is used to detect the pressure on the air battery 20, and the terminal device is also electrically connected to the pressure sensor 10, and the terminal device is also used to receive information detected by the pressure sensor 10.

[0090] Specifically, the terminal device may include a controller and a display, etc. The controller communicates wirelessly with the air battery 20, the controller can control the power on and off of the air battery 20, and the display can display the information detected by the pressure sensor 10, the information detected by the strain gauge 25, and the power-on state, current size and power-on duration of the air battery 20. The pressure sensor 10 detects the pressure on the air battery 20, so as to determine whether the air battery 20 is deformed or damaged due to excessive force. Thus, on the one hand, the safety and reliability are improved, and on the other hand, the pressure sensor 10 can also be degraded, and does not need to be removed by a secondary operation, thereby reducing the cost and risk of secondary operation removal.

[0091] In some embodiments, the materials of the strain gauge 25, the control switch 26 and the pressure sensor 10 may be the materials of the above-mentioned substrate 21, the composite positive electrode 22 or the metal negative electrode 23, such as magnesium, which will not be described in detail here.

[0092] The following is a detailed description of the preparation method of the fully degradable sacral nerve stimulator according to the embodiment of the present application in conjunction with the accompanying drawings.

[0093] According to a method for preparing a fully degradable sacral nerve stimulator provided in an embodiment of the present application, for preparing the above-mentioned fully degradable sacral nerve stimulator, refer to Figure 3 As shown, the preparation of the air battery of the fully degradable sacral nerve stimulator includes at least the following steps:

[0094] Step S1, using degradable materials to prepare a matrix, a strain gauge, a wireless communication module, a composite positive electrode and a metal negative electrode of the air battery, respectively, and pins are formed on the ends of the composite positive electrode and the metal negative electrode respectively;

[0095] Step S2, the prepared wireless communication module, composite positive electrode and metal negative electrode are arranged on the substrate respectively, and the prepared strain gauge is connected to the composite positive electrode or the metal negative electrode close to the pin to assemble into an air battery;

[0096] Step S3: The assembled air battery can communicate wirelessly with the terminal device so as to send the information detected by the strain gauge to the terminal device, so that the terminal device controls the pins of the air battery to be energized.

[0097] Therefore, the preparation method of the air battery of the fully degradable sacral nerve stimulator of the present application has a simple process, convenient and fast operation, high efficiency, and reduces production costs.

[0098] In some embodiments, the material of the matrix includes one of poly(lactic-co-glycolic acid), polylactic acid, polyglycolic acid, polycaprolactone or polyglycolic acid.

[0099] Exemplarily, the material of the matrix is ​​lactic acid-glycolic acid copolymer, referring to Figure 4 As shown, preparing the lactic acid-glycolic acid copolymer may include:

[0100] Prepare lactic acid and glycolic acid, mix the lactic acid and glycolic acid in proportion and add them to a corresponding reactor, the monomer ratio of lactic acid to glycolic acid may be 1:1, then add a catalyst, for example, the catalyst may be stannous octoate (Sn(Oct)2), then heat the reactor, the heating temperature may be 150-200° C., remove water therein, perform a polymerization reaction, and obtain a reaction product;

[0101] The obtained reaction product is cooled, and impurities therein are removed by a solvent precipitation method to obtain a lactic acid-glycolic acid copolymer. For example, unreacted monomers and by-products can be removed by a solvent precipitation method, and then the concoction is dissolved using a suitable solvent (such as chloroform or ethyl acetate), the precipitate is filtered out or the polymer is precipitated, and then the solvent is removed by rotary evaporation to obtain a high-purity lactic acid-glycolic acid copolymer.

[0102] Thus, a high-purity polylactic acid-co-glycolic acid copolymer can be obtained, and then a high-quality matrix can be obtained through corresponding equipment such as a mold. In addition, the obtained polylactic acid-co-glycolic acid copolymer can be characterized by means such as nuclear magnetic resonance (NMR), Fourier transform infrared spectrometer (FTIR Spectrometer, FTIR), differential scanning calorimetry (DSC) and thermal gravimetric analyzer (TGA) to confirm its chemical structure and thermal properties.

[0103] In some embodiments, the material of the composite positive electrode includes one or more of metal carbides, metal nitrides, metal carbonitrides, sodium ferrocyanide, or potassium ferrocyanide.

[0104] For example, the material of the composite positive electrode is sodium ferrocyanide, Figure 5 As shown, preparing the composite positive electrode may include:

[0105] Prepare a raw material solution, which is a mixed solution of sodium cyanide and ferric chloride, and the molar ratio of iron ion (Fe3+) to cyanide ion (CN-) is 1:6;

[0106] Under stirring conditions, gradually adding an appropriate amount of a regulator, such as ammonia water or sodium hydroxide, to the raw material solution to adjust the hydrogen ion concentration index (pH) of the raw material solution to 6-7, so as to produce a precipitate of a Prussian blue structure;

[0107] collecting the precipitate and removing impurities therein, for example, by filtering it through a filter and washing it with deionized water to remove excess salts and unreacted substances;

[0108] Then the precipitate is dried at a temperature of 60-80° C. to obtain a positive electrode material with a Prussian blue layered structure;

[0109] Then the positive electrode material is used to prepare the composite positive electrode.

[0110] Thus, a high-quality composite positive electrode can be produced.

[0111] In some embodiments, the material of the metal negative electrode includes one of magnesium, magnesium-copper alloy, magnesium-iron alloy, magnesium-lithium alloy or magnesium-cobalt alloy.

[0112] For example, the material of the metal negative electrode is magnesium, Figure 6 As shown, preparing a metal negative electrode may include:

[0113] Preparing a raw material substrate, such as magnesium foil, and cleaning and drying the raw material substrate, such as first removing pollutants and oxides on the surface of the raw material substrate by cleaning, and then drying the raw material substrate by blowing with nitrogen or using an oven;

[0114] Then, a photosensitive material is evenly coated on the surface of the raw material substrate. The photosensitive material can be a photoresist. The photoresist can be coated by spin coating, and then the photoresist is cured by heating or the like to improve its adhesion.

[0115] Then the raw material substrate is placed in a photolithography machine for photolithography, and a designated area of ​​the photosensitive material on the raw material substrate is exposed by ultraviolet irradiation or the like to form a desired pattern, the shape of the pattern being substantially consistent with the shape of the metal negative electrode when viewed from above, and then treated with a specific developer to remove the unexposed portion of the photosensitive material, leaving the desired pattern;

[0116] Then the raw material substrate is etched, for example, by reactive ion etching (RIE), using plasma to remove excess material from the raw material substrate to form a negative electrode material consistent with the pattern shape, so that the negative electrode material has higher selectivity and precision;

[0117] Then, impurities on the negative electrode material are removed to obtain a metal negative electrode. For example, the residual photoresist can be removed by chemical solvents or heat treatment to expose the etched pattern, and then the negative electrode material is finally cleaned to remove any residual chemicals. In addition, the pattern can be checked using tools such as microscopes to ensure the quality and accuracy of the pattern.

[0118] In some embodiments, the materials of the strain gauge, control switch and pressure sensor can be the materials of the above-mentioned matrix, composite positive electrode or metal negative electrode, and the preparation methods of the strain gauge, control switch and pressure sensor can be the corresponding preparation methods in the prior art, which will not be repeated here.

[0119] Based on the above-mentioned embodiments of the present application, in the absence of explicit negation or conflict, the technical features of one embodiment may be beneficially combined with one or more other embodiments.

[0120] The above are only some embodiments of the present application, which are only used to illustrate the technical solution of the present application, rather than to limit it. It should be understood that, for those skilled in the art, without departing from the creative concept of the present application, it is possible to improve or replace it according to the above description, and all these improvements and replacements should belong to the protection scope of the claims attached to the present application. In this case, all details can be replaced by equivalent elements, and the materials, shapes and sizes can also be arbitrary.

Claims

1. A fully degradable sacral nerve stimulator, characterized in that: include: Air batteries and terminal equipment; The air battery is made of a degradable material and is implanted under the buttocks. The air battery includes a substrate, a strain gauge, a wireless communication module, a composite positive electrode, and a metal negative electrode. The wireless communication module, the composite positive electrode, and the metal negative electrode are correspondingly arranged on the substrate. Pins are formed at the ends of the composite positive electrode and the metal negative electrode, respectively. The pins are used to be arranged under the buttocks near the sacral nerve. The strain gauge is connected to the composite positive electrode or the metal negative electrode near the pins. The wireless communication module is used for wireless communication between the terminal device and the air battery, and the terminal device is used to receive information detected by the strain gauge and control the pins of the air battery to be powered on.

2. The fully degradable sacral nerve stimulator according to claim 1, characterized in that: The air battery further comprises: A control switch, the control switch is connected to the composite positive electrode or the metal negative electrode near the pin, and the control switch is used to control the on and off of the end of the composite positive electrode or the metal negative electrode; The pin is powered on by controlling the control switch.

3. The fully degradable sacral nerve stimulator according to claim 1, characterized in that: The substrate comprises a first substrate and a second substrate, the first substrate and the second substrate are bonded to each other, and the composite positive electrode and the metal negative electrode are correspondingly arranged between the first substrate and the second substrate; The thickness of the first substrate and the second substrate is 0.1-0.2 cm; The material of the matrix includes one of polylactic acid-glycolic acid copolymer, polylactic acid, polyglycolic acid, polycaprolactone or polyglycolic acid.

4. The fully degradable sacral nerve stimulator according to claim 1, characterized in that: The composite positive electrode and the metal negative electrode are both formed into coils, and the ends of the coils are formed with the pins; The number of turns of the coil is 15-25 turns, and the wire diameter of the coil is 0.1-0.2 cm.

5. The fully degradable sacral nerve stimulator according to claim 4, characterized in that: The material of the composite positive electrode includes one or more of metal carbide, metal nitride, metal carbonitride, sodium ferrocyanide or potassium ferrocyanide; The material of the metal negative electrode and the pin includes one of magnesium, magnesium-copper alloy, magnesium-iron alloy, magnesium-lithium alloy or magnesium-cobalt alloy; The pin includes a substrate and needle punctures formed on the substrate; The length of the substrate is 0.5-1 cm, the width is 0.5-1 cm, and the thickness is 0.1-0.2 cm; The needle is a cone with a bottom diameter of 0.05-0.1 cm and a height of 0.2-0.3 cm.

6. The fully degradable sacral nerve stimulator according to claim 1, characterized in that: The air battery further comprises: A pressure sensor, wherein the pressure sensor is made of a degradable material, the pressure sensor is electrically connected to the air battery, and is used to detect the pressure applied to the air battery. The terminal device is also electrically connected to the pressure sensor, and the terminal device is also used to receive information detected by the pressure sensor.

7. A method for preparing a fully degradable sacral nerve stimulator, characterized in that: The fully degradable sacral nerve stimulator comprises an air battery and a terminal device, and the preparation of the air battery comprises at least the following steps: The matrix, strain gauge, wireless communication module, composite positive electrode and metal negative electrode of the air battery are prepared by using degradable materials, and pins are formed on the ends of the composite positive electrode and the metal negative electrode respectively; The wireless communication module, the composite positive electrode and the metal negative electrode are arranged on the substrate respectively, and the strain gauge is connected to the composite positive electrode or the metal negative electrode near the pin to assemble the air battery; The assembled air battery can wirelessly communicate with the terminal device so as to send the information detected by the strain gauge to the terminal device, so that the terminal device controls the pins of the air battery to be energized.

8. The preparation method according to claim 7, characterized in that: The material of the matrix includes one of polylactic acid-glycolic acid copolymer, polylactic acid, polyglycolic acid, polycaprolactone or polyglycolic acid; The preparation of the lactic acid-glycolic acid copolymer comprises: preparing lactic acid and glycolic acid, mixing the lactic acid and glycolic acid in proportion and adding them into a reactor, then adding a catalyst, and then heating the reactor to perform a polymerization reaction to obtain a reaction product; The obtained reaction product is cooled, and impurities therein are removed by a solvent precipitation method to obtain the lactic acid-glycolic acid copolymer.

9. The preparation method according to claim 7, characterized in that: The material of the composite positive electrode includes one or more of metal carbide, metal nitride, metal carbonitride, sodium ferrocyanide or potassium ferrocyanide; The preparation of the composite positive electrode comprises: Prepare stock solution; Under stirring conditions, gradually adding an appropriate amount of a regulator to the raw material solution to produce a precipitate with a Prussian blue structure; collecting the precipitate and removing impurities therein; Then the precipitate is dried to obtain a positive electrode material with a Prussian blue layered structure. Then, the positive electrode material is used to prepare the composite positive electrode.

10. The preparation method according to claim 7, characterized in that: The material of the metal negative electrode includes one of magnesium, magnesium-copper alloy, magnesium-iron alloy, magnesium-lithium alloy or magnesium-cobalt alloy; The preparation of the metal negative electrode comprises: Preparing a raw material substrate, and cleaning and drying the raw material substrate; Then, a photosensitive material is evenly coated on the surface of the raw material substrate, and the photosensitive material is cured; Then, the raw material substrate is placed in a photolithography machine for photolithography, a designated area of ​​the photosensitive material on the raw material substrate is exposed to form a desired pattern, and then the unexposed portion of the photosensitive material is removed; Then the raw material substrate is etched to remove excess material of the raw material substrate to form a negative electrode material having the same shape as the pattern; Then, impurities on the negative electrode material are removed to obtain the metal negative electrode.

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