Electrode preparation method of implantable nerve stimulator and nerve stimulator system

Abstract

The invention provides an electrode preparation method of an implantable nerve stimulator and a nerve stimulator system.The method comprises the steps that an insulating tube is arranged on a first fixing device with wire grooves in a sleeving mode, all wires extending out of a pulse stimulator penetrate through the insulating tube through the different wire grooves, the insulating tube is fixed to a pulse generator, and the first fixing device is fixed to the pulse generator; the first fixing device and the insulating tube are fixed; all the wires penetrate through the electrode ring, the electrode ring makes contact with the insulating tube, one wire is electrically connected with the electrode ring, a second fixing device with wire grooves is inserted into the electrode ring, all the wires are located in the different wire grooves, and an insulating spacer ring is arranged on the second fixing device in a sleeving mode and fixedly connected with the electrode ring to form an electrode ring section; according to the nerve stimulator prepared by the method, the risk of electrode end breakage can be reduced, the size is small, a battery does not need to be replaced, the nerve stimulator can be closer to the skin during implantation, operative complications are reduced, and the influence on the human body is small.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an electrode preparation method for an implantable neural stimulator and a neural stimulator system. Background Art

[0002] Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequent urination and nocturia, with or without urge urinary incontinence. It significantly affects patients' daily life and social activities and has become a major disease that troubles people. In recent years, as my country has entered an aging society and as diabetes and neurological diseases have increased, the incidence of secondary related diseases - overactive bladder - has also increased year by year.

[0003] The methods for treating overactive bladder (OAB) on the market mainly include sacral nerve regulation technology and tibial nerve regulation.

[0004] Sacral neuromodulation (SNM) is an effective method for treating a variety of lower urinary tract dysfunctions and is becoming increasingly popular in China. The therapy uses an implantable neurostimulator and electrodes. The electrodes are placed close to the sacral nerves, and the neurostimulator is placed in a subcutaneous pouch on the lower back. By stimulating the sacral nerves, the nerve reflexes of the bladder, colorectum, sphincter, and pelvic floor related to urination and defecation are regulated, so that abnormal nerve reflexes can be restored to balance, thereby safely and effectively controlling the symptoms of urination and defecation dysfunction. However, this product has many disadvantages, such as: the electrodes are easily displaced or broken, the implanted device is large in size, the battery needs to be replaced, etc., and the incidence of device-related side effects and the proportion of re-surgical intervention are high.

[0005] Tibial nerve stimulation has several advantages over sacral nerve stimulation for the treatment of overactive bladder, and the procedure for tibial nerve stimulation is less invasive than sacral nerve stimulation, the current standard of care.

[0006] There are two methods of tibial nerve regulation: one is percutaneous tibial nerve regulation, and the other is implantable tibial nerve regulation. At present, a tibial nerve stimulator named eCoin has been developed. Although this tibial nerve stimulator has a battery that is charged wirelessly and its overall size is small, the electrode stimulation end of this tibial nerve stimulator is short. If it is implanted deeper in the skin, it will require a larger power when charging, which will have a certain impact on the ankle; if it is implanted shallowly in the skin, the electrode stimulation end is far away from the tibial nerve, and the energy attenuation during the transmission process is large. Then the pulse generator needs to use a higher power and a larger current to achieve the desired stimulation effect. A higher power and a larger current will have unknown effects on the human body. Summary of the invention

[0007] The purpose of the present invention is to provide an electrode preparation method for an implantable neurostimulator and a neurostimulator system. The neurostimulator prepared by the method of the present invention can reduce the risk of electrode end breakage, has a small size, does not require battery replacement, can be closer to the skin when implanted, can simplify operation, reduce surgical complications, and has less impact on the human body.

[0008] The present invention provides a method for preparing electrodes of an implantable neural stimulator, comprising: Making the body section: putting an insulating tube on a first fixing device with a wire groove, passing all the wires extending from the pulse stimulator through the insulating tube through different wire grooves, so that the insulating tube is fixedly connected to the pulse generator, and the first fixing device and the insulating tube are fixed; wherein, among all the wires, there is at least one positive wire and at least one negative wire; Making an electrode segment: passing all the wires through an electrode ring so that the electrode ring contacts the insulating tube and one of the wires is electrically connected to the electrode ring, inserting a second fixture with a wire groove into the electrode ring so that all the wires are located in different wire grooves, and sleeve an insulating spacer ring on the second fixture and fixedly connected to the electrode ring to form an electrode ring segment; A plurality of the electrode ring segments are sequentially connected in series, each of which is provided with the second fixing device, the insulating spacer ring and the electrode ring; Fix all the second wire fixing devices, all the insulating spacer rings, and all the electrode rings.

[0009] Further, the first fixing device is located in the insulating tube, and / or, The second fixing device is inserted into the electrode ring and the length of the second fixing device is greater than the length of the electrode ring.

[0010] Furthermore, in the insulating tube and the insulating spacer ring, the angle between adjacent wires in all the wires is greater than or equal to 90°.

[0011] Furthermore, the first fixing device and the adjacent second fixing device, and the adjacent two second fixing devices are in end-face contact, The first electrode ring and the insulating tube, as well as the adjacent insulating spacer ring and the electrode ring are in end-face contact.

[0012] Furthermore, the first fixing device and the second fixing device are both provided with a central hole along the length direction. Before the wire passes through the first fixture or the second fixture, a removable mandrel is first installed in the central hole.

[0013] Furthermore, the electrode preparation method of the implantable neural stimulator also includes: forming a tip of the insulating spacer ring located at the end of the electrode segment, and processing a fixing hole at the end of the insulating spacer ring.

[0014] Furthermore, the wire and the electrode ring are fixed together by laser welding.

[0015] Furthermore, the process of fixing the first fixing device and the insulating tube is: inserting a heat shrink tube into the insulating tube and fixing it by heat shrinking; The process for fixing all the second wire fixing devices, all the insulating spacer rings, and all the electrode rings is as follows: inserting a heat shrink tube between the end of the insulating tube and the end of the last insulating spacer ring, and fixing them by heat shrinking.

[0016] The present invention also provides a method for preparing an implantable neural stimulator, comprising: A pulse generator is manufactured and encapsulated with epoxy resin, wherein the pulse generator has a plurality of extended wires and a power receiving module is disposed on a circuit board in the pulse generator; Making stimulation electrodes on the plurality of wires, wherein the stimulation electrodes are made by the electrode making method for an implantable neural stimulator according to any one of claims 1 to 8; The symmetry center line of the pulse generator is collinear with the stimulation electrode.

[0017] Furthermore, between the manufacturing body segment and the manufacturing electrode segment, the pulse generator with the epoxy resin is encapsulated with silicone, and during the silicone encapsulation, part of the insulating tube is encapsulated in the silicone.

[0018] Furthermore, the pulse generator includes a shell and the circuit board encapsulated in the shell, and the shell has a mounting hole for fixing.

[0019] The present invention also provides an implantable neural stimulation system, comprising: an external power supply device, an external controller and an implantable neural stimulator, wherein the implantable neural stimulator is prepared by the method for preparing the implantable neural stimulator according to any one of claims 9 to 11.

[0020] Beneficial effects of the present invention: The electrode preparation method of the implantable neurostimulator of the present invention adopts segmented and modular preparation of the electrode terminal, which not only facilitates the welding of the electrode and the wire, but also makes the first fixing device and the plurality of second fixing devices inside the prepared electrode terminal a straight structure similar to a joint, that is, the first fixing device and the plurality of second fixing devices are connected in sequence, and the connection of this embodiment can be surface contact. Compared with the linear fixing device formed in one piece, the straight structure similar to the joint can withstand greater bending deformation at the connection, so that the electrode terminal has better connection strength and flexibility, and reduces the risk of electrode terminal breakage. Since no battery is installed in the implantable neurostimulator, the volume of the implant is significantly reduced. Since the symmetrical center line of the pulse generator and the stimulation electrode are collinear and shaped like a "lollipop", the electrode terminal can be minimally invasively implanted into the human body through a sheath delivery with a wound size of 1cm-2cm. The surgical operation is simple and can reduce surgical complications. The stimulation electrode can be set to a certain length as needed. Therefore, when the implantable neurostimulator is implanted in the human body, the pulse generator of the implantable neurostimulator (i.e., the power receiving module of the pulse generator) can be closer to the skin, and the stimulation electrode at the electrode terminal can be closer to the nerve, which can not only reduce the communication distance with the external power supply equipment to obtain more stable communication and power supply, and ensure the effectiveness of the treatment, but also ensure the effectiveness of current transmission under the same stimulation intensity, with little impact on the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present disclosure, but are not intended to limit the present disclosure.

[0022] Figure 1 A flow chart of a method for preparing electrodes of an implantable neural stimulator according to an embodiment of the present invention is shown; Figure 2 A flow chart of a method for preparing an implantable neural stimulator according to an embodiment of the present invention is shown; Figure 3 A flow chart of preparing an implantable tibial nerve stimulator in one embodiment of the present invention is shown; Figure 4 It shows a structural diagram of the insulating tube and the first fixing device during installation in one embodiment of the present invention; Figure 5 for Figure 4 Right view of; Figure 6 It shows a structural diagram of an insulating sleeve installed on a pulse stimulator in one embodiment of the present invention; Figure 7 It shows a structural diagram after the preparation of the main body section is completed in one embodiment of the present invention; Figure 8 A structural diagram showing the electrical connection between the electrode ring and the wire in the first electrode ring segment in one embodiment of the present invention is shown; Figure 9 It shows a structural diagram of a second fixing device in a first electrode ring segment inserted into an electrode ring in one embodiment of the present invention; Figure 10 It shows a structural diagram of an insulating spacer ring in a first electrode ring segment in an embodiment of the present invention being sleeved on a second fixing device; Figure 11 It shows a structural diagram of the second fixing device in the fourth electrode ring segment inserted into the electrode ring in one embodiment of the present invention; Figure 12 It shows a structural diagram of an insulating spacer ring in a fourth electrode ring segment in an embodiment of the present invention being sleeved on a second fixing device; Figure 13 A structural diagram of an implantable tibial nerve stimulator according to an embodiment of the present invention is shown; Figure 14 A simplified structural diagram of an implantable neural stimulation system in one embodiment of the present invention is shown. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical solution and advantages of the embodiments of the present disclosure clearer, the technical solution of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings of the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0024] Unless otherwise defined, the technical or scientific terms used herein shall have the usual meanings understood by persons of ordinary skill in the field to which the present disclosure belongs. The words "first", "second" and similar terms used in the patent application specification and claims of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "connected" or "connected" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0025] This embodiment provides a method for preparing electrodes of an implantable neural stimulator. The method for preparing electrodes of an implantable neural stimulator includes: Making the main body section: putting an insulating tube on a first fixing device with a wire groove, passing all the wires extending from the pulse stimulator through the insulating tube through different wire grooves, so that the insulating tube is fixedly connected to the pulse generator, and the first fixing device and the insulating tube are fixed; wherein, among all the wires, there is at least one positive wire and at least one negative wire.

[0026] Making electrode segments: passing all the wires through the electrode ring so that the electrode ring contacts the insulating tube and one of the wires is electrically connected to the electrode ring; inserting a second fixture with wire grooves into the electrode ring so that all the wires are located in different wire grooves; sleeve an insulating spacer ring on the second fixture and fixedly connected to the electrode ring to form an electrode ring segment.

[0027] A plurality of the electrode ring segments are arranged in series in sequence, and each electrode ring segment is provided with the second fixing device, the insulating spacer ring and the electrode ring.

[0028] Fix all the second wire fixing devices, all the insulating spacer rings, and all the electrode rings.

[0029] The present invention adopts a segmented and modular preparation of the electrode end, and divides the electrode end into a main body section and an electrode section, and the electrode section is divided into a plurality of electrode ring sections. The plurality of electrode ring sections are prepared in a modular manner, which not only facilitates the welding of the electrode and the wire, but also makes the first fixing device and the plurality of second fixing devices inside the prepared electrode end a straight line structure similar to a bone joint, that is, the first fixing device and the plurality of second fixing devices are connected in sequence, and the connection in this embodiment can be surface contact. Compared with an integrally formed straight line fixing device, the straight line structure similar to a bone joint can withstand greater bending deformation at the connection, so that the electrode end has better connection strength and flexibility, and reduces the risk of fracture of the electrode end; the main body section is directly formed on the wire extending from the pulse generator, so that the present invention can be convenient for welding the electrode and the wire, and the first fixing device and the plurality of second fixing devices inside the prepared electrode end are straight line structures similar to bone joints, that is, the first fixing device and the plurality of second fixing devices are connected in sequence, and the connection in this embodiment can be surface contact. Compared with an integrally formed straight line fixing device, the straight line structure similar to bone joints can withstand greater bending deformation at the connection, so that the electrode end has better connection strength and flexibility, and reduces the risk of fracture of the electrode end; the main body section is directly formed on the wire extending from the pulse generator, so that the present invention can be convenient for welding the electrode and the wire, and can be convenient for welding The colinearity of the body segment and the pulse generator is better, so that the prepared implantable neurostimulator has a "lollipop" structure. When the implantable neurostimulator is implanted in the human body, the electrode terminal can be minimally invasively implanted into the human body with a wound size of 1cm-2cm by means of a sheath delivery. The surgical operation is simple and can reduce surgical complications. The stimulation electrode can be set to a certain length as needed. Therefore, when the implantable neurostimulator is implanted in the human body, the implantable neurostimulator can be closer to the skin, and the stimulation electrode at the electrode terminal can be closer to the nerve, which can not only reduce the communication distance with the external power supply equipment to obtain more stable communication and power supply, and ensure the effectiveness of the treatment, but also ensure the effectiveness of current transmission under the same stimulation intensity, with little impact on the human body.

[0030] The ablation device and ablation system of some embodiments of the present disclosure are exemplarily described below with reference to the accompanying drawings.

[0031] In the disclosed embodiment, the term "head end" refers to the end close to the pulse generator, and the term "end end" refers to the end away from the pulse generator. "Multiple" refers to two or more. The term "tube" includes but is not limited to a hollow tube with a circular cross-sectional shape, and may also include a hollow tube with other cross-sectional shapes.

[0032] like Figure 1 As shown, this embodiment provides a method for preparing electrodes of an implantable neural stimulator, comprising: Step S1-1, making the main body section: putting an insulating tube on a first fixing device with a wire groove, passing all wires extending from the pulse stimulator through different wire grooves through the insulating tube, so that the insulating tube is fixedly connected to the pulse generator, and the first fixing device and the insulating tube are fixed. Among all the wires, there is at least one positive wire and at least one negative wire.

[0033] Specifically, Figure 6 As shown, after the main body segment is manufactured, the left end of the first fixing device is in close contact with the extending end of the wire of the pulse stimulator.

[0034] In some examples, the first fixing device 35 is located inside the insulating tube 34. Figure 6 As shown, the insulating tube 34 covers the first fixing device 35 , and the length of the insulating tube 34 is greater than the length of the first fixing device 35 , and both ends of the first fixing device 35 are at a predetermined distance from both end surfaces of the insulating tube 36 .

[0035] Specifically, at least two grooves extending in the length direction are arranged on the periphery of the first fixture, for example, 8 grooves are arranged at equal angles on the periphery of the first fixture. In some examples, the angle between adjacent wires in all wires is greater than or equal to 90°, which facilitates the fixation of the wires to the electrode ring. Specifically, the angle between adjacent wires is 90°, for example, the pulse stimulator extends two wires, one is a positive wire connected to the positive pole of the pulse stimulator, and the other is a negative wire connected to the negative pole of the pulse stimulator, and the two wires are arranged with a groove spaced apart.

[0036] Specifically, the wire is a DFT wire (Drawn Filled Tube).

[0037] In some examples, the process of fixing the first fixing device and the insulating tube is: inserting a heat shrink tube on the insulating tube, heat shrinking and fixing it, and finally removing the heat shrink tube. Specifically, the length of the heat shrink tube is the same as the length of the insulating tube, so that the heat shrink tube completely covers the insulating tube. Specifically, during heat shrinkage, the temperature of the heat machine is set to 420°F, the automatic moving platform is set to move at a speed of 0.5 mm / sec, and the delay time is 10 seconds. When the temperature of the hot air blower reaches 420°F, the automatic moving platform drives the hot air blower to move from one end of the heat shrink tube to the other end at a set speed, so that the heat shrink tube shrinks, and then, after cooling with cold air for 5 seconds, it is removed from the automatic moving platform and the external heat shrink tube is removed.

[0038] In some examples, the first fixture is provided with a central hole along the length direction, and before the wire passes through the first fixture, a removable mandrel is first installed in the central hole, and the installation of the mandrel facilitates the wire to pass through the first fixture. After the wire passes through the first fixture, the mandrel is removed.

[0039] Specifically, the steps of making the body segment include: Figure 4 As shown, the insulating tube 34 is sleeved on the first fixture 35, and the left ends of the insulating tube 34 and the first fixture 35 are aligned. Then, the mandrel 40 is installed in the center hole of the first fixture 35, as shown in FIG. Figure 5 As shown, one of the wires 36 is passed through any groove of the first fixture 35, and the other wire 36 is passed through the groove of the first fixture with a gap of one groove. The angle between the two wires is equal to 90°. The insulating tube 34 is inserted into the wire extension end of the pulse stimulator 33. At this time, the pulse stimulator is not encapsulated with silicone but encapsulated with epoxy resin. Figure 6 As shown, the left end of the first fixing device 35 is in close contact with the protruding end of the wire of the pulse stimulator 33. Then place the pulse stimulator 33 in the jig, and then push the insulating tube 34 in the direction of the pulse stimulator 33 to prevent the position of the insulating tube from moving during the process of placing the pulse stimulator 33 into the jig. Put the heat shrink tube on the insulating tube so that the heat shrink tube completely covers the insulating tube, and then heat the insulating tube with a hot air blower. The hot air blower moves from one end of the heat shrink tube to the other end. The heating temperature of the hot air blower is 420°F, the moving speed of the hot air blower is 0.5 mm / sec, and the delay time is 10 seconds. After the heat shrinkage is completed, cool it. Finally, remove the heat shrink tube to obtain the following Figure 7 The pulse stimulator of the body segment is shown installed.

[0040] Step S1-2, making an electrode segment: passing all the wires through the electrode ring so that the electrode ring contacts the insulating tube, and one of the wires is electrically connected to the electrode ring, inserting a second fixing device with a wire groove into the electrode ring and placing all the wires in different wire grooves, sleeve an insulating spacer ring on the second fixing device and contact the electrode ring to form an electrode ring segment; sequentially connecting a plurality of electrode ring segments in series, each electrode ring segment being provided with a second fixing device, an insulating spacer ring and an electrode ring; fixing all second wire fixing devices, all insulating spacer rings and all electrode rings.

[0041] In some examples, the wire and the electrode ring are fixed together by laser welding.

[0042] Specifically, the specific process of laser welding the wire and the electrode ring is: After passing an electrode ring through all the wires, peel off the outer insulation of the wire inside the electrode ring to expose the inner metal wire, and make the wire to be welded directly above (relative to the operating platform, the wire to be welded is located at the end away from the operating platform and at the top), and then use the special-shaped wire for welding to pass under the wire to be welded, and let the remaining wires be under the special-shaped wire. (Check whether the welding point of the electrode ring is directly above the special-shaped wire, specifically: turn the electrode ring and the special-shaped wire to the back at the same time, confirm that the welding point of the electrode ring is directly below the special-shaped wire, and turn it back to the front after confirmation.) Then, place the electrode ring on the welding fixture and clamp it to prevent the electrode ring from sliding or rotating, and then perform laser welding to weld the exposed metal wire of the wire to be welded with the electrode ring. The welding parameters are: laser working voltage is 245V, pulse width is 4.0ms, and spot diameter is 0.5mm. After welding is completed, remove the excess special-shaped wire.

[0043] In some examples, the second fixture is inserted into the electrode ring and the length of the second fixture is greater than the length of the electrode ring. That is, the second fixture is inserted into the electrode ring and both ends of the second fixture extend into two insulating spacer rings adjacent to the inserted electrode ring, that is, the ends of the second fixture overlap with the insulating spacer rings. In this way, after the second wire fixture and all insulating spacer rings and all electrode rings are fixed, the connection strength of the electrode end is stronger and less likely to break.

[0044] In some examples, the first fixture and the adjacent second fixture are in end-face contact, as well as between two adjacent second fixtures, and the first electrode ring and the insulating tube, as well as between adjacent insulating spacer rings and the electrode ring, are in end-face contact.

[0045] In some examples, the second fixture is provided with a central hole along the length direction, and before the wire passes through the second fixture, a removable mandrel is first installed in the central hole to facilitate the wire to pass through the second fixture. After the wire passes through the second fixture, the mandrel is removed.

[0046] In some examples, the process of fixing all the second wire fixtures and all the insulating spacer rings and all the electrode rings is as follows: insert a heat shrink tube between the end of the insulating tube and the end of the last insulating spacer ring, so that the heat shrink tube completely covers all the insulating spacer rings and all the electrode rings, and covers a certain distance from the end of the insulating tube, heat shrinks and fixes, and finally removes the heat shrink tube. Specifically, the distance that the heat shrink tube is sleeved on the end of the insulating tube is at least greater than the depth of the second wire fixture inserted into the insulating tube in the first electrode ring segment. The heat shrink process is the same as the heat shrink process when making the main tube, which is omitted here and will not be repeated. After heat shrinking, the second wire fixture and all the insulating spacer rings are heat-fused together, so that the electrode rings are tightly embedded between adjacent insulating spacer rings, and at the same time, the ends of adjacent second wire fixtures are melted together to form a complete core rod.

[0047] Specifically, the outer diameters and inner diameters of the insulating tube, the first wire fixture, the second wire fixture, the insulating spacer ring, and the electrode ring are selected to ensure that the insulating tube, the insulating spacer ring, and the electrode ring are flat after heat shrinkage.

[0048] In some examples, the method for preparing an electrode for an implantable neurostimulator further includes: forming a tip of an insulating spacer ring located at the end of the electrode segment, and processing a fixing hole at the end of the insulating spacer ring.

[0049] Specifically, except for the second fixing device and the insulating spacer ring in the last electrode ring segment, the length of the second fixing device and the length of the insulating spacer ring used in each of the remaining electrode ring segments are the same. Of course, the length of the second fixing device and the length of the insulating spacer ring in each electrode ring segment can also be set to different lengths as needed.

[0050] Specifically, at least one of the multiple electrode rings is connected to the positive wire, and at least one is connected to the negative wire. For example, multiple electrode rings are alternately connected to the positive wire and the negative wire, that is, the polarity of the multiple electrode rings is positive→negative→positive→negative..., or, one electrode ring is connected to the positive wire, and the other electrode rings are connected to the negative wire, etc. The multiple electrode rings can be controlled as a whole, that is, only one positive wire and one negative wire are set, and according to the polarity of the set electrode rings, the positive electrode rings are all connected to the positive wire, and the negative electrode rings are all connected to the negative wire. Of course, the multiple electrode rings can also be individually controlled, that is, multiple wires are set, and each wire is connected to an electrode, that is, if two positive electrodes and two negative electrodes are set, two positive wires and two negative wires are required.

[0051] Specifically, the steps of making the electrode ring segment include: Preparation of electrode ring segments: After passing an electrode ring 37 through all the wires 36, the head end of the electrode ring 37 is in contact with the end surface of the insulating tube 34, and one of the wires 36 is connected to the electrode ring 37 by laser welding. After the welding is completed, the structure is as follows Figure 8 As shown. Then, insert the mandrel 40 into the center hole of the second fixture 38, and then insert all the wires 36 into the grooves of the second fixture according to the positions inserted into the first fixture, so that when the first fixture and the second fixture are in a straight line, all the wires are in a straight line. During the process of inserting the second fixture 38 into the electrode ring 37 and the insulating tube 34, if the second fixture feels stuck, you can confirm that all the wires are in a straight line, then pull it out a little and then reinsert it, so that the end faces of the first fixture and the second fixture are in contact. When the end faces of the first fixture and the second fixture are in contact, the head end of the second fixture 38 is located in the end of the insulating tube 34. After the second fixture 38 is installed, as shown Figure 9 Finally, the insulating spacer ring 39 is sleeved on the second fixing device 38, so that the head end of the insulating spacer ring 39 contacts the end surface of the electrode ring 37, and the end of the second fixing device 38 is located in the insulating spacer ring 39. The structure after the insulating spacer ring 39 is installed is as shown in FIG. Figure 10 As shown. This forms a modular structure.

[0052] According to the modular structure, multiple electrode ring segments are formed, and multiple electrode ring segments are connected in series in sequence: the above steps are repeated according to the number of electrode rings, and a section of electrode ring, a section of insulating spacer ring and a section of second fixing device are added to each electrode ring segment, and the head end of the electrode ring is in contact with the end face of the insulating spacer ring in the previous cycle. After the last section of the insulating spacer ring is installed, the excess part of the insulating spacer ring or the second fixing device is removed so that the end of the last section of the insulating spacer ring is aligned with the end of the last section of the second fixing device. Finally, a tip is formed at the end of the last section of the insulating spacer ring, and a fixing hole 32 is processed at the end of the insulating spacer ring, such as Figure 13 shown.

[0053] like Figure 2 As shown, the present invention also provides a method for preparing an implantable neural stimulator, comprising: Step S2-1, manufacturing a pulse generator and encapsulating the pulse generator with epoxy resin, wherein the pulse generator has a plurality of extending wires, and a power receiving module is provided on a circuit board inside the pulse generator.

[0054] Step S2-2, making stimulation electrodes on multiple wires, and the stimulation electrodes are made using the above-mentioned electrode preparation method of the implantable neural stimulator.

[0055] The symmetry center line of the pulse generator and the stimulation electrode are collinear.

[0056] In some examples, the pulse generator with epoxy resin is encapsulated with silicone between the manufacturing of the body segment and the manufacturing of the electrode segment, and during the silicone encapsulation, part of the insulating tube is encapsulated in the silicone, so as to enhance the connection stability and smoothness of the insulating tube and the pulse generator.

[0057] In some examples, the pulse generator includes a housing and a circuit board encapsulated in the housing, such as Figure 13 As shown, the housing has a mounting hole 31 for fixing. When the implantable neurostimulator is implanted in a human body, the mounting hole and the fixing hole of the electrode terminal are used to fix it on certain tissues of the human body (for example, fascia) to reduce the risk of displacement.

[0058] Specifically, taking the preparation of an implantable tibial nerve stimulator as an example, there are four stimulating electrodes in the implantable tibial nerve stimulator, such as Figure 3 As shown, the specific process of implanting the tibial nerve stimulator is as follows: Step 1: Make a pulse generator and encapsulate the pulse generator with epoxy resin.

[0059] Step 2, make the body segment: Figure 4 As shown, an insulating tube 34 with a length of 20 mm is placed on a first fixture 35 with a length of 17 mm, and the left ends of the insulating tube 34 and the first fixture 35 are aligned. Then, a mandrel 40 is installed in the center hole of the first fixture 35, as shown in FIG. Figure 5 As shown, one of the wires 36 is passed through any groove of the first fixture 35, and the other wire 36 is passed through the groove of the first fixture 35 at intervals, so that the angle between the two wires 36 is equal to 90°. The insulating tube 34 is inserted into the wire extension end of the pulse stimulator 33. At this time, the pulse stimulator is not encapsulated with silicone but encapsulated with epoxy resin. Figure 6 As shown, the left end of the first fixing device 35 is in close contact with the protruding end of the wire of the pulse stimulator 33. Then place the pulse stimulator 33 in the jig, and then push the insulating tube 34 in the direction of the pulse stimulator 33 to prevent the position of the insulating tube from moving during the process of placing the pulse stimulator into the jig. Put the heat shrink tube on the insulating tube so that the heat shrink tube completely covers the insulating tube, and then heat the insulating tube with a hot air blower. The hot air blower moves from one end of the heat shrink tube to the other end. The heating temperature of the hot air blower is 420°F, the moving speed of the hot air blower is 0.5 mm / sec, and the delay time is 10 seconds. After the heat shrinkage is completed, cool it. Finally, remove the heat shrink tube to obtain the following Figure 7 The pulse stimulator of the body segment is shown installed.

[0060] Step 3, the pulse generator with epoxy resin is encapsulated with silicone, and when the silicone is encapsulated, part of the insulating tube is encapsulated in the silicone.

[0061] Step 4, making electrode segments: After passing an electrode ring 37 through all the wires 36, the head end of the electrode ring 37 is in contact with the end surface of the end of the insulating tube 34, and the positive wire and the electrode ring 37 are connected by laser welding. The structure after welding is as follows Figure 8 Then, insert the mandrel into the center hole of the second fixture 38 with a length of 7 mm, and then insert all the wires into the grooves of the second fixture according to the positions inserted into the first fixture, so that when the first fixture and the second fixture are in a straight line, all the wires are in a straight line. During the process of inserting the second fixture 38 into the electrode ring 37 and the insulating tube 34, if the second fixture feels stuck, you can pull it out a little and then reinsert it after confirming that all the wires are in a straight line, so that the end faces of the first fixture and the second fixture are in contact. After the second fixture 38 is installed, as shown Figure 9 Finally, an insulating spacer ring 39 with a length of 4 mm is sleeved on the second fixing device 38 so that the head end of the insulating spacer ring 39 contacts the end surface of the electrode ring 37. The structure after the insulating spacer ring 39 is installed is as shown in FIG. Figure 10 As shown. After one electrode ring segment is manufactured, three electrode ring segments are sequentially connected in series: in the second electrode ring segment and the third electrode ring segment, an electrode ring, an insulating spacer ring with a length of 4mm and a second fixing device with a length of 7mm are added, and the head ends of the electrode rings are in contact with the end faces of the insulating spacer rings in the previous cycle, wherein the electrode ring in the second electrode ring segment is electrically connected to the negative electrode wire, and the electrode ring in the third electrode ring segment is electrically connected to the positive electrode wire. In the fourth electrode ring segment, an electrode ring, an insulating spacer ring with a length of 30mm and a second fixing device with a length of 40mm are added, and the electrode ring is electrically connected to the negative electrode wire. After the second fixing device with a length of 40mm is installed, as shown Figure 11 As shown in the figure, the insulating spacer ring with a length of 30 mm is sleeved on the second fixing device. Figure 12 As shown. After the fourth electrode ring segment is completed, the excess part of the second fixing device in the fourth electrode ring segment is removed. Then, a heat shrink tube is inserted for heat shrinkage. The heat shrink tube completely covers the four electrode rings and the four insulating spacer rings, and covers a short distance from the end of the main body segment. This distance is the length of the second fixing device in the first electrode ring segment inserted into the end of the main body segment. Finally, the end of the insulating spacer ring in the fourth electrode ring segment is tip-formed, and a fixing hole is processed at the end of the insulating spacer ring in this segment. The prepared implantable tibial nerve stimulator is shown as follows Figure 13 shown.

[0062] The present invention also provides an implantable neural stimulation system 100.Figure 14 As shown, the implantable nerve stimulation system 100 includes: an external power supply device 10, an external controller 20, and an implantable nerve stimulator 30, and the implantable nerve stimulator 30 is prepared by the preparation method of the implantable nerve stimulator described above.

[0063] It should be noted that the electrode preparation method of the implantable nerve stimulator, the preparation method of the implantable nerve stimulator, and the implantable nerve stimulation system of the present invention are not limited to preparing the electrodes of the implantable tibial nerve stimulator and the implantable tibial nerve stimulator, but can also prepare the electrodes of other nerve stimulators such as the sacral nerve stimulator and the sacral nerve stimulator, etc.

[0064] The text and drawings in this disclosure are provided only as examples to assist in understanding the disclosure. They should not be construed as limiting the scope of the disclosure in any way. Although certain embodiments and examples have been provided, it will be apparent to those skilled in the art based on the content disclosed herein that the illustrated embodiments and examples can be changed without departing from the scope of the disclosure.

[0065] Although the present disclosure has been described with exemplary embodiments, various changes and modifications can be suggested to those skilled in the art. The present disclosure is intended to cover such changes and modifications that fall within the scope of the appended claims.

[0066] Any description in this disclosure should not be construed as implying that any particular element, step, or function is an essential element that must be included within the scope of the claims. The scope of the patent subject matter is defined only by the claims.

Claims

1. A method for preparing electrodes for an implantable neural stimulator, characterized in that: include: Making the body section: putting an insulating tube on a first fixing device with a wire groove, passing all the wires extending from the pulse stimulator through the insulating tube through different wire grooves, so that the insulating tube is fixedly connected to the pulse generator, and the first fixing device and the insulating tube are fixed; wherein, among all the wires, there is at least one positive wire and at least one negative wire; Making an electrode segment: passing all the wires through an electrode ring so that the electrode ring contacts the insulating tube and one of the wires is electrically connected to the electrode ring, inserting a second fixture with a wire groove into the electrode ring so that all the wires are located in different wire grooves, and sleeve an insulating spacer ring on the second fixture and fixedly connected to the electrode ring to form an electrode ring segment; A plurality of the electrode ring segments are sequentially connected in series, each of which is provided with the second fixing device, the insulating spacer ring and the electrode ring; Fix all the second wire fixing devices, all the insulating spacer rings, and all the electrode rings.

2. The method for preparing electrodes for an implantable neural stimulator according to claim 1, characterized in that: The first fixing device is located in the insulating tube, and / or, The second fixing device is inserted into the electrode ring and the length of the second fixing device is greater than the length of the electrode ring.

3. The method for preparing electrodes for an implantable neural stimulator according to claim 1, characterized in that: In the insulating tube and the insulating spacer ring, the angle between adjacent wires in all the wires is greater than or equal to 90°.

4. The method for preparing electrodes for an implantable neural stimulator according to claim 1, characterized in that: The first fixing device and the adjacent second fixing device, as well as the adjacent two second fixing devices, are in end-face contact. The first electrode ring and the insulating tube, as well as the adjacent insulating spacer ring and the electrode ring are in end-face contact.

5. The method for preparing electrodes for an implantable neural stimulator according to claim 1, characterized in that: The first fixing device and the second fixing device are both provided with a central hole along the length direction. Before the wire passes through the first fixture or the second fixture, a removable mandrel is first installed in the central hole.

6. The method for preparing electrodes of an implantable neural stimulator according to claim 1, characterized in that: Also includes: The insulating spacer ring at the end of the electrode segment is tip-formed, and a fixing hole is processed at the end of the insulating spacer ring.

7. The method for preparing electrodes for an implantable neural stimulator according to claim 1, characterized in that: The wire and the electrode ring are fixed together by laser welding.

8. The method for preparing electrodes of an implantable neural stimulator according to claim 1, characterized in that: The process of fixing the first fixing device and the insulating tube is: inserting a heat shrink tube into the insulating tube and fixing it by heat shrinking; The process for fixing all the second wire fixing devices, all the insulating spacer rings, and all the electrode rings is as follows: inserting a heat shrink tube between the end of the insulating tube and the end of the last insulating spacer ring, and fixing them by heat shrinking.

9. A method for preparing an implantable neural stimulator, characterized in that: include: A pulse generator is manufactured and encapsulated with epoxy resin, wherein the pulse generator has a plurality of extended wires and a power receiving module is disposed on a circuit board in the pulse generator; Making stimulation electrodes on the plurality of wires, wherein the stimulation electrodes are made by the electrode making method for an implantable neural stimulator according to any one of claims 1 to 8; The symmetry center line of the pulse generator is collinear with the stimulation electrode.

10. The method for preparing electrodes of an implantable neural stimulator according to claim 9, characterized in that: The pulse generator with the epoxy resin is encapsulated with silicone between the main body segment and the electrode segment, and during the silicone encapsulation, part of the insulating tube is encapsulated in the silicone.

11. The method for preparing electrodes of an implantable neural stimulator according to claim 9, characterized in that: The pulse generator comprises a shell and the circuit board encapsulated in the shell, and the shell is provided with a mounting hole for fixing.

12. An implantable neural stimulation system, characterized in that: include: An extracorporeal power supply device, an extracorporeal controller and an implantable neurostimulator, wherein the implantable neurostimulator is prepared by the method for preparing an implantable neurostimulator according to any one of claims 9 to 11.

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