Electrode preparation method for implantable neurostimulator and neurostimulator system

Abstract

The application provides a method for preparing an electrode of an implantable nerve stimulator and a nerve stimulator system, and the method comprises the following steps: sleeving an insulating tube on a first fixing device with wire slots, passing all wires extended from a pulse stimulator through the insulating tube through different wire slots, fixing the insulating tube with the pulse generator, and fixing the first fixing device and the insulating tube; passing all the wires through an electrode ring, making the electrode ring contact with the insulating tube, and making one of the wires electrically connected with the electrode ring; inserting a second fixing device with wire slots into the electrode ring and making all the wires located in different wire slots; sleeving an insulating spacer ring on the second fixing device and fixing and connecting the insulating spacer ring with the electrode ring to form an electrode ring segment; and sequentially connecting a plurality of electrode ring segments in series, the nerve stimulator prepared by the method can reduce the risk of electrode end fracture, has a small volume, does not need to replace a battery, can be closer to the skin during implantation, reduces surgical complications, and has a smaller influence on the human body.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a method for preparing electrodes for an implantable neurostimulator and a neurostimulator system. Background Technology

[0002] Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by urinary frequency and nocturia, with or without urge incontinence. It significantly impacts patients' daily lives and social activities, becoming a major health concern. In recent years, with my country's aging population and the increase in diabetes and neurological disorders, the incidence of related conditions—overactive bladder—has also been rising annually.

[0003] The main treatments for overactive bladder (OAB) on the market include sacral nerve modulation techniques and tibial nerve modulation.

[0004] Sacral neuromodulation (SNM) is an effective treatment for various lower urinary tract dysfunctions and is becoming increasingly popular in China. This therapy uses an implantable neurostimulator and electrodes. The electrodes are placed near the sacral nerve, and the neurostimulator is placed in a subcutaneous pouch in the lower back. By stimulating the sacral nerve, it modulates the nerve reflexes related to urination and defecation in the bladder, colon, sphincter, and pelvic floor, restoring balance to abnormal nerve reflexes and thus safely and effectively controlling the symptoms of urinary and defecation dysfunction. However, this product has many drawbacks, such as: electrodes are prone to displacement or breakage, the implanted device is large, batteries need to be replaced, and the incidence of device-related side effects and the proportion of repeat surgical interventions are high.

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

[0006] Tibial nerve modulation includes two methods: percutaneous tibial nerve modulation and implantable tibial nerve modulation. A tibial nerve stimulator called eCoin has been developed. Although it has a wirelessly rechargeable battery and a small overall size, its electrode stimulation ends are relatively short. If implanted deeper into the skin, it requires greater power during charging, which can have some impact on the ankle. Conversely, if implanted superficially, the electrode stimulation ends are farther from the tibial nerve, resulting in greater energy attenuation during transmission. This requires the pulse generator to use higher power and greater current to achieve the desired stimulation effect, which may have unknown effects on the human body. Summary of the Invention

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

[0008] This invention provides a method for preparing electrodes for an implantable neurostimulator, comprising: Fabrication of the main body segment: The insulating tube is fitted onto the first fixing device with wire grooves, and all the wires extending from the pulse stimulator are passed 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, all the wires have at least one positive wire and at least one negative wire; Fabricating the electrode segment: Pass 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. Insert the second fixing device with wire grooves into the electrode ring and place all the wires in different wire grooves. Fit the insulating spacer ring onto the second fixing device and fix it to the electrode ring to form the electrode ring segment. Multiple electrode ring segments are sequentially connected in series, and each electrode ring segment is provided with the second fixing device, the insulating spacer ring and the electrode ring; Secure all the second conductor fixing devices, all the insulating spacer rings, and all the electrode rings.

[0009] Furthermore, the first fixing device is located inside 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, within the insulating tube and the insulating spacer ring, the included angle between adjacent conductors in all conductors is greater than or equal to 90°.

[0011] Furthermore, the first fixing device and the adjacent second fixing device, as well as two adjacent 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, both the first fixing device and the second fixing device have a central hole along their length. Before the wire passes through the first fixing device or the second fixing device, a removable mandrel is first installed in the center hole.

[0013] Furthermore, the electrode fabrication method for the implantable neurostimulator also includes: forming the tip of the insulating spacer ring located at the end of the electrode segment, and machining 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 as follows: heat shrink tubing is inserted onto the insulating tube and fixed by heat shrinking; The process of fixing all the second conductor fixing devices, all the insulating spacer rings, and all the electrode rings is as follows: heat shrink tubing is inserted between the end of the insulating tube and the end of the last insulating spacer ring, and then heat-shrinked for fixing.

[0016] The present invention also provides a method for preparing an implantable neurostimulator, comprising: A pulse generator is fabricated and encapsulated in epoxy resin. The pulse generator has multiple extending wires, and a power receiving module is provided on the circuit board inside the pulse generator. Stimulating electrodes are fabricated on the plurality of wires, and the stimulating electrodes are fabricated using the electrode fabrication method of the implantable neurostimulator according to any one of claims 1-8; The center line of symmetry of the pulse generator and the stimulation electrode are collinear.

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

[0018] Furthermore, the pulse generator includes a housing and a circuit board encapsulated within the housing, the housing having mounting holes for fixing.

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

[0020] The beneficial effects of this invention are: The electrode fabrication method for the implantable neurostimulator of the present invention employs a segmented and modular fabrication method for the electrode ends. This not only facilitates the welding of the electrodes and wires but also allows the first fixation device and multiple second fixation devices inside the fabricated electrode ends to form a skeletal, linear structure. That is, the first fixation device and multiple second fixation devices are sequentially connected. In this embodiment, the connection can be a surface contact. Compared to a one-piece molded linear fixation device, the skeletal, linear structure can withstand greater bending deformation at the connection point, thereby giving the electrode ends better connection strength and flexibility, and reducing the risk of electrode breakage. Since no battery is installed in the implantable neurostimulator, the implant volume is significantly reduced. Because the symmetrical center line of the pulse generator and the stimulation electrode are collinear, and the shape is similar to a "lollipop," the electrode can be implanted into the human body through a sheath via a minimally invasive procedure with an incision size of 1cm-2cm. This simplifies the surgical operation and reduces surgical complications. The stimulation electrode can be set to a certain length as needed. Therefore, when the implantable neurostimulator is implanted into the human body, the pulse generator (i.e., the power receiving module of the pulse generator) can be closer to the skin, and the stimulation electrode can be closer to the nerve. This not only reduces the communication distance with the external power supply device, resulting in more stable communication and power supply and ensuring the effectiveness of treatment, but also ensures the effectiveness of current transmission under the same stimulation intensity, with minimal impact on the human body. Attached Figure Description

[0021] To more clearly illustrate the technical solutions of the embodiments of this disclosure, the accompanying drawings of the embodiments will be briefly described below. Obviously, the drawings described below only relate to some embodiments of this disclosure and are not intended to limit this disclosure.

[0022] Figure 1 A flowchart of an electrode fabrication method for an implantable neurostimulator according to an embodiment of the present invention is shown; Figure 2 A flowchart illustrating a method for preparing an implantable neurostimulator according to an embodiment of the present invention is shown; Figure 3 A flowchart illustrating the fabrication of an implantable tibial nerve stimulator according to an embodiment of the present invention is shown; Figure 4 A structural diagram showing the installation process of the insulating tube and the first fixing device in one embodiment of the present invention is shown; Figure 5 for Figure 4 The right view; Figure 6 A structural diagram showing an embodiment of the present invention, in which an insulating sleeve is mounted on a pulse stimulator, is illustrated. Figure 7 This diagram shows the structure of the body segment after preparation in one embodiment of the present invention; Figure 8 This diagram illustrates the structure of the first electrode ring segment after it is electrically connected to the wire in one embodiment of the present invention. Figure 9 This diagram illustrates the structure of a second fixing device inserted into the electrode ring in a first electrode ring segment according to an embodiment of the present invention. Figure 10 This diagram shows a structure in which an insulating spacer ring in the first electrode ring segment is sleeved on a second fixing device according to an embodiment of the present invention. Figure 11 This diagram illustrates the structure of the second fixing device inserted into the electrode ring in the fourth electrode ring segment according to an embodiment of the present invention. Figure 12 This diagram shows a structure in which the insulating spacer ring in the fourth electrode ring segment is sleeved on the second fixing device in one embodiment of the present invention; 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 nerve stimulation system according to an embodiment of the present invention is shown. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of the embodiments of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the described embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0024] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure pertains. The terms “first,” “second,” and similar terms used in this patent application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as “connected” or “linked” are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Terms such as “upper,” “lower,” “left,” and “right” are used only to indicate relative positional relationships, which may change accordingly when the absolute position of the described object changes.

[0025] This embodiment provides a method for fabricating electrodes for an implantable neurostimulator. The method for fabricating electrodes for an implantable neurostimulator includes: Fabrication of the main body section: The insulating tube is fitted onto the first fixing device with the wire groove, and all the wires extending from the pulse stimulator are passed 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, all the wires have at least one positive wire and at least one negative wire.

[0026] Fabricating the electrode segment: Pass all the wires through the electrode ring, so that the electrode ring is in contact with the insulating tube, and one of the wires is electrically connected to the electrode ring. Insert the second fixing device with wire grooves into the electrode ring and place all the wires in different wire grooves. Fit the insulating spacer ring onto the second fixing device and fix it to the electrode ring to form the electrode ring segment.

[0027] Multiple electrode ring segments are connected in series, and each electrode ring segment is provided with the second fixing device, the insulating spacer ring and the electrode ring.

[0028] Secure all the second conductor fixing devices, all the insulating spacer rings, and all the electrode rings.

[0029] This invention employs a segmented, modular fabrication method for electrode terminals. The electrode terminal is divided into a body segment and an electrode segment. The electrode segment is further divided into multiple electrode ring segments, which are fabricated modularly. This not only facilitates the welding of the electrodes and wires but also allows the first fixing device and multiple second fixing devices inside the fabricated electrode terminal to form a skeletal, linear structure. That is, the first fixing device and multiple second fixing devices are sequentially connected. In this embodiment, the connection can be a surface contact. Compared to a one-piece molded linear fixing device, the skeletal, linear structure can withstand greater bending deformation at the connection point, thus giving the electrode terminal better connection strength and flexibility, reducing the risk of electrode terminal breakage. The body segment is directly formed on the wires extending from the pulse generator, making this... The improved collinearity between the body segment and the pulse generator allows the resulting implantable neurostimulator to have a "lollipop"-like structure. When implanted, the electrode can be delivered via a sheath, allowing for minimally invasive implantation with a 1-2 cm incision. This simplifies the procedure and reduces surgical complications. The stimulation electrode can be set to a specific length as needed, allowing the implantable neurostimulator to be placed closer to the skin and the stimulation electrode closer to the nerve. This not only reduces the communication distance with the external power supply, resulting in more stable communication and power supply to ensure treatment effectiveness, but also ensures effective current transmission at the same stimulation intensity with minimal impact on the human body.

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

[0031] In this embodiment of the disclosure, the term "head end" refers to the end closest to the pulse generator, and the term "end end" refers to the end furthest from the pulse generator. "A plurality of" 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 hollow tubes with other cross-sectional shapes.

[0032] like Figure 1 As shown, this embodiment provides a method for preparing electrodes for an implantable neurostimulator, including: Step S1-1, Fabrication of the main body segment: The insulating tube is fitted onto the first fixing device with wire grooves. All wires extending from the pulse stimulator are passed through the insulating tube via different wire grooves, fixing the insulating tube to the pulse generator. The first fixing device and the insulating tube are then secured. Each wire has at least one positive wire and at least one negative wire.

[0033] Specifically, such as 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 protruding end of the pulse stimulator's wire.

[0034] In some examples, the first fixing device 35 is located inside the insulating tube 34. That is, as follows... 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. Both ends of the first fixing device 35 are at a predetermined distance from the two end faces of the insulating tube 36.

[0035] Specifically, at least two grooves extending along the length direction are provided on the outer periphery of the first fixing device. For example, eight grooves are provided at equal angles on the outer periphery of the first fixing device. In some examples, the included angle between adjacent wires in all wires is greater than or equal to 90°, which facilitates the fixing of the wires to the electrode ring. Specifically, the included angle between adjacent wires is 90°. For example, the pulse stimulator extends two wires, one is a positive wire connected to the positive electrode of the pulse stimulator, and the other is a negative wire connected to the negative electrode of the pulse stimulator. The two wires are arranged with a groove between them.

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

[0037] In some examples, the process of securing the first fixing device and the insulating tube is as follows: heat shrink tubing is fitted onto the insulating tube, heat-shrinked and secured, and finally the heat shrink tubing is removed. Specifically, the length of the heat shrink tubing is the same as the length of the insulating tube, ensuring that the heat shrink tubing completely covers the insulating tube. Specifically, during heat shrinking, the temperature of the heat exchanger is set to 420°F, the automatic moving platform is set to a moving speed of 0.5 mm / sec, and the delay time is 10 seconds. When the temperature of the heat exchanger reaches 420°F, the automatic moving platform drives the heat exchanger to move from one end of the heat shrink tubing to the other at the set speed, causing the heat shrink tubing to shrink. Then, after cooling with cold air for 5 seconds, it is removed from the automatic moving platform, and the outer heat shrink tubing is removed.

[0038] In some examples, the first fixing device has a central hole along its length. Before the wire passes through the first fixing device, a removable mandrel is installed in the central hole to facilitate the wire's passage through the first fixing device. After the wire passes through the first fixing device, the mandrel is removed.

[0039] Specifically, the steps for creating the body segment include: Figure 4 As shown, the insulating tube 34 is fitted onto the first fixing device 35, and the left ends of the insulating tube 34 and the first fixing device 35 are aligned. Then, the mandrel 40 is installed in the center hole of the first fixing device 35, as shown. Figure 5 As shown, one of the wires 36 is passed through any groove of the first fixing device 35, skipping one groove, and then the other wire 36 is passed through a groove of the first fixing device, with the included angle between the two wires equal to 90°. The insulating tube 34 is then inserted into the protruding end of the wire of the pulse stimulator 33. At this point, the pulse stimulator is an epoxy resin-encapsulated pulse stimulator without silicone encapsulation. Figure 6 As shown, the left end of the first fixing device 35 is in close contact with the protruding end of the lead wire of the pulse stimulator 33. Then, the pulse stimulator 33 is placed in the fixture, and the insulating tube 34 is pushed towards the pulse stimulator 33 to prevent the insulating tube from shifting during the placement of the pulse stimulator 33 into the fixture. Heat shrink tubing is then placed over the insulating tube, ensuring complete coverage. The insulating tube is then heated with a hot air blower, moving from one end to the other. The heating temperature is 420°F, the blower speed is 0.5 mm / sec, and the delay time is 10 seconds. After heat shrinking, the tube is cooled. Finally, the heat shrink tubing is removed, resulting in the desired product. Figure 7 The pulse stimulator shown is equipped with the main body segment.

[0040] Step S1-2, fabricating electrode segments: Pass all wires through the electrode ring, making the electrode ring contact the insulating tube, and electrically connect one of the wires to the electrode ring. Insert the second fixing device with wire grooves into the electrode ring, ensuring all wires are located in different wire grooves. Place the insulating spacer ring on the second fixing device and make it contact the electrode ring to form an electrode ring segment. Sequentially connect multiple electrode ring segments, each electrode ring segment having a second fixing device, an insulating spacer ring, and an electrode ring. Fix all the second wire fixing devices, all the insulating spacer rings, and all the electrode rings.

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

[0042] Specifically, the laser welding process for the wire and electrode ring is as follows: After passing an electrode ring through all the wires, peel off the outer insulation of the wires inside the electrode ring to expose the inner metal wires, ensuring the wire to be welded is directly above (at the top end away from the operating platform). Then, pass a welding profiled wire under the wire to be welded, while keeping the other wires below the profiled wire. (To check if the weld point of the electrode ring is directly above the profiled wire, flip the electrode ring and profiled wire to the back simultaneously, confirming the weld point of the electrode ring is directly below the profiled wire, then flip it back to the front.) Next, place the electrode ring on the welding fixture and clamp it to prevent slippage or rotation. Then, perform laser welding to weld the exposed metal wire of the wire to be welded to the electrode ring. The welding parameters are: laser operating voltage 245V, pulse width 4.0ms, and spot diameter 0.5mm. After welding, remove any excess profiled wire.

[0043] In some examples, the second fixing device passes through the electrode ring, and the length of the second fixing device is greater than the length of the electrode ring. That is, the second fixing device passes through the electrode ring, and both ends of the second fixing device extend into the two insulating spacer rings adjacent to the electrode ring through which it passes, meaning that the ends of the second fixing device overlap with the insulating spacer rings. In this way, after the second wire fixing device and all insulating spacer rings and all electrode rings are fixed, the connection strength of the electrode ends is stronger and less prone to breakage.

[0044] In some examples, the first fixing device and the adjacent second fixing device, as well as the two adjacent 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.

[0045] In some examples, the second fixing device has a central hole along its length. Before the wire passes through the second fixing device, a removable mandrel is installed in the central hole to facilitate the wire's passage. After the wire passes through the second fixing device, the mandrel is removed.

[0046] In some examples, the process of fixing all the second conductor fixing devices, all insulating spacer rings, and all electrode rings is as follows: Heat shrink tubing is inserted between the end of the insulating tube and the end of the last insulating spacer ring, ensuring the heat shrink tubing completely covers all insulating spacer rings and all electrode rings, with a certain distance covering the end of the insulating tube. This is then heat-shrinked and fixed, and finally the heat shrink tubing is removed. Specifically, the distance the heat shrink tubing covers the end of the insulating tube is at least greater than the depth to which the second conductor fixing device in the first electrode ring segment is inserted into the insulating tube. The heat shrinking process is the same as the heat shrinking process used when manufacturing the main tube, and is omitted here. After heat shrinking, the second conductor fixing devices and all insulating spacer rings are heat-fused together, causing the electrode rings to be tightly embedded between adjacent insulating spacer rings, while the ends of adjacent second conductor fixing devices are fused together to form a complete mandrel.

[0047] Specifically, the selection of the outer diameter and inner diameter of the insulating tube, the first wire fixing device, the second wire fixing device, the insulating spacer ring, and the electrode ring ensures that the insulating tube, the insulating spacer ring, and the electrode ring are flat after heat shrinking.

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

[0049] Specifically, except for the second fixing device and insulating spacer ring in the last electrode ring segment, the lengths of the second fixing device and insulating spacer rings used in each of the other electrode ring segments are the same. Of course, the lengths of the second fixing device and insulating spacer rings 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 and negative wires, i.e., 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 all connected to the negative wires, etc. The multiple electrode rings can be controlled as a whole, i.e., only one positive wire and one negative wire are set, and according to the polarity of the 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 controlled individually, i.e., multiple wires are set, each wire connecting to one electrode; that is, if two positive electrodes and two negative electrodes are set, then two positive wires and two negative wires are needed.

[0051] Specifically, the steps for fabricating the electrode ring segment include: Preparation of the electrode ring segment: After passing an electrode ring 37 through all the wires 36, the first end of the electrode ring 37 contacts the end face of the insulating tube 34, and one of the wires 36 is connected to the electrode ring 37 by laser welding. The structure after welding is as follows: Figure 8 As shown. Then, insert the mandrel 40 into the center hole of the second fixing device 38, and then insert all the wires 36 into the grooves of the second fixing device according to the positions inserted into the first fixing device, so that when the first fixing device and the second fixing device are straight, all the wires are straight. During the process of inserting the second fixing device 38 into the electrode ring 37 and the insulating tube 34, if the second fixing device feels stuck, it can be pulled out slightly and then reinserted after confirming that all the wires are straight, so that the end faces of the first fixing device and the second fixing device are in contact. When the end faces of the first fixing device and the second fixing device are in contact, the first end of the second fixing device 38 is located inside the end of the insulating tube 34. After the second fixing device 38 is installed, as Figure 9 As shown. Finally, the insulating spacer ring 39 is fitted onto the second fixing device 38, so that the first end of the insulating spacer ring 39 contacts the end face of the electrode ring 37, and the end of the second fixing device 38 is located inside the insulating spacer ring 39. The structure of the insulating spacer ring 39 after installation is as follows. Figure 10 As shown, this forms a modular structure.

[0052] Multiple electrode ring segments are formed according to the above modular structure, and these segments are sequentially connected in series. The above steps are repeated according to the number of electrode rings. In each electrode ring segment, an electrode ring segment, an insulating spacer ring segment, and a second fixing device segment are added. The first end of each electrode ring contacts the end face of the insulating spacer ring from the previous cycle. After installing the last insulating spacer ring segment, any excess portion of the insulating spacer ring or the second fixing device is removed, aligning the end of the last insulating spacer ring segment with the end of the last second fixing device segment. Finally, a tip is formed at the end of the last insulating spacer ring segment, and a fixing hole 32 is machined at the end of the insulating spacer ring segment, such as... Figure 13 As shown.

[0053] like Figure 2 As shown, the present invention also provides a method for preparing an implantable neurostimulator, comprising: Step S2-1: Fabricate a pulse generator and encapsulate it with epoxy resin. The pulse generator has multiple extending wires, and a power receiving module is provided on the circuit board inside the pulse generator.

[0054] Step S2-2: Stimulation electrodes are fabricated on multiple wires using the electrode fabrication method described above for implantable neurostimulators.

[0055] In this design, the center line of symmetry of the pulse generator and the stimulation electrode are collinear.

[0056] In some examples, the pulse generator with epoxy resin is silicone-encapsulated between the fabrication of the body segment and the fabrication of the electrode segment, and during silicone encapsulation, a portion of the insulating tube is encapsulated within the silicone. This enhances the stability and smoothness of the connection between the insulating tube and the pulse generator.

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

[0058] Specifically, taking the fabrication of an implantable tibial nerve stimulator as an example, the implantable tibial nerve stimulator contains four stimulating electrodes, such as... Figure 3 As shown, the specific procedure for implanting a tibial nerve stimulator is as follows: Step 1: Fabricate a pulse generator and encapsulate it with epoxy resin.

[0059] Step 2, create the main body segment: such as Figure 4 As shown, an insulating tube 34 with a length of 20 mm is fitted onto a first fixing device 35 with a length of 17 mm, and the left ends of the insulating tube 34 and the first fixing device 35 are aligned. Then, a mandrel 40 is installed in the center hole of the first fixing device 35, as shown. Figure 5 As shown, one of the wires 36 is passed through any groove of the first fixing device 35, skipping one groove, and then the other wire 36 is passed through the groove of the first fixing device 35, so that the included angle between the two wires 36 is equal to 90°. The insulating tube 34 is then inserted into the wire extension end of the pulse stimulator 33. At this point, the pulse stimulator is an epoxy resin-encapsulated pulse stimulator without silicone encapsulation, as shown. Figure 6 As shown, the left end of the first fixing device 35 is in close contact with the protruding end of the lead wire of the pulse stimulator 33. Then, the pulse stimulator 33 is placed in the fixture, and the insulating tube 34 is pushed towards the pulse stimulator 33 to prevent the insulating tube from shifting during the placement of the pulse stimulator into the fixture. Heat shrink tubing is then placed over the insulating tube, ensuring complete coverage. The insulating tube is then heated with a hot air blower, moving from one end to the other. The heating temperature is 420°F, the blowing speed is 0.5 mm / sec, and the delay time is 10 seconds. After heat shrinking, the tube is cooled. Finally, the heat shrink tubing is removed, resulting in the desired product. Figure 7 The pulse stimulator shown is equipped with the main body segment.

[0060] Step 3: Encapsulate the pulse generator with epoxy resin in silicone, and during silicone encapsulation, encapsulate part of the insulating tube inside the silicone.

[0061] Step 4, fabricating the electrode segment: After passing an electrode ring 37 through all the wires 36, make the first end of the electrode ring 37 contact the end face of the insulating tube 34, and connect the positive electrode wire to the electrode ring 37 by laser welding. The structure after welding is as follows: Figure 8 As shown. Then, insert the mandrel into the center hole of the second fixing device 38, which is 7mm long. Next, insert all the wires into the grooves of the second fixing device according to their positions in the first fixing device, ensuring that all wires are straight when the first and second fixing devices are aligned. If there is any sticking during the insertion of the second fixing device 38 into the electrode ring 37 and insulating tube 34, after confirming that all wires are straight, pull it out slightly and then reinsert it, ensuring that the end faces of the first and second fixing devices contact each other. After the second fixing device 38 is installed, as shown... Figure 9 As shown. Finally, an insulating spacer ring 39 with a length of 4 mm is fitted onto the second fixing device 38, so that the first end of the insulating spacer ring 39 contacts the end face of the electrode ring 37. The structure after the insulating spacer ring 39 is installed is as follows. Figure 10 As shown. After fabricating one electrode ring segment, three electrode ring segments are sequentially connected in series: In the second and third electrode ring segments, an electrode ring, a 4mm long insulating spacer ring, and a 7mm long second fixing device are added. The first end of each electrode ring contacts the end face of the insulating spacer ring from the previous cycle. In the second electrode ring segment, the electrode ring is electrically connected to the negative electrode wire, and in the third electrode ring segment, the electrode ring is electrically connected to the positive electrode wire. In the fourth electrode ring segment, an electrode ring, a 30mm long insulating spacer ring, and a 40mm long second fixing device are added. The electrode ring is electrically connected to the negative electrode wire, and the 40mm long second fixing device is installed as shown. Figure 11 As shown, after the 30mm long insulating spacer ring is fitted onto the second fixing device, it is as follows: Figure 12 As shown. After the fourth electrode ring segment is completed, the excess portion of the second fixation device in the fourth electrode ring segment is removed. Then, heat-shrink tubing is inserted and heat-shrinked until it completely covers the four electrode rings and four insulating spacer rings, and also covers a short distance from the end of the body segment. This distance is the length by which the second fixation device in the first electrode ring segment is inserted into the end of the body segment. Finally, the end of the insulating spacer ring in the fourth electrode ring segment is tip-shaped, and a fixation hole is machined at the end of this insulating spacer ring segment. The completed implantable tibial nerve stimulator is shown below. Figure 13 As shown.

[0062] The present invention also provides an implantable neurostimulation system 100. For example... Figure 14 As shown, the implantable neurostimulation system 100 includes: an external power supply device 10, an external controller 20, and an implantable neurostimulator 30, which is prepared by the above-described method for preparing an implantable neurostimulator.

[0063] It should be noted that the electrode preparation method, the method for preparing the implantable neurostimulator, and the implantable neurostimulation system of the present invention are not limited to preparing electrodes for implantable tibial nerve stimulators and implantable tibial nerve stimulators, but can also prepare electrodes for sacral nerve stimulators, sacral nerve stimulators, and other neurostimulators.

[0064] The text and accompanying drawings in this disclosure are provided by way of example only to aid in understanding this disclosure. They should not be construed as limiting the scope of this 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 changes can be made to the illustrated embodiments and examples without departing from the scope of this disclosure.

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

[0066] Nothing described in this disclosure should 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 neurostimulator, characterized in that, include: Fabrication of the main body segment: The insulating tube is fitted onto the first fixing device with wire grooves, and all the wires extending from the pulse stimulator are passed through the insulating tube via different wire grooves, so that the insulating tube is fixedly connected to the pulse stimulator, and the first fixing device and the insulating tube are fixed; wherein, all the wires have at least one positive wire and at least one negative wire; Fabricating the electrode segment: Pass 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. Insert the second fixing device with wire grooves into the electrode ring and place all the wires in different wire grooves. Fit the insulating spacer ring onto the second fixing device and fix it to the electrode ring to form the electrode ring segment. Multiple electrode ring segments are sequentially connected in series, and each electrode ring segment is provided with the second fixing device, the insulating spacer ring and the electrode ring; Secure all the second fixing devices, all the insulating spacer rings, and all the electrode rings.

2. The electrode fabrication method for the implantable neurostimulator according to claim 1, characterized in that, The first fixing device is located inside 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 electrode fabrication method for the implantable neurostimulator according to claim 1, characterized in that, Within the insulating tube and the insulating spacer ring, the included angle between adjacent conductors in all conductors is greater than or equal to 90°.

4. The electrode fabrication method for the implantable neurostimulator according to claim 1, characterized in that, The first fixing device and the adjacent second fixing device, as well as two adjacent 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 electrode fabrication method for the implantable neurostimulator according to claim 1, characterized in that, Both the first fixing device and the second fixing device have a central hole along their length. Before the wire passes through the first fixing device or the second fixing device, a removable mandrel is first installed in the center hole.

6. The electrode fabrication method for the implantable neurostimulator according to claim 1, characterized in that, Also includes: The insulating spacer ring located at the end of the electrode segment is tip-shaped, and a fixing hole is machined at the end of the insulating spacer ring.

7. The electrode fabrication method for the implantable neurostimulator according to claim 1, characterized in that, The wire and the electrode ring are fixed together by laser welding.

8. The electrode fabrication method for the implantable neurostimulator according to claim 1, characterized in that, The process for fixing the first fixing device and the insulating tube is as follows: heat shrink tubing is inserted onto the insulating tube and then heat-shrinked for fixation; The process of fixing all the second fixing devices, all the insulating spacer rings, and all the electrode rings is as follows: heat shrink tubing is inserted between the end of the insulating tube and the end of the last insulating spacer ring, and then heat-shrinked for fixing.

9. A method for preparing an implantable neurostimulator, characterized in that, include: A pulse generator is fabricated and encapsulated in epoxy resin. The pulse generator has multiple extending wires, and a power receiving module is provided on the circuit board inside the pulse generator. Stimulating electrodes are fabricated on the plurality of wires, and the stimulating electrodes are fabricated using the electrode fabrication method of the implantable neurostimulator according to any one of claims 1-8; The center line of symmetry of the pulse generator and the stimulation electrode are collinear.

10. The electrode fabrication method for the implantable neurostimulator according to claim 9, characterized in that, Between the fabrication body section and the fabrication electrode section, the pulse generator with the epoxy resin is encapsulated in silicone, and during silicone encapsulation, part of the insulating tube is encapsulated inside the silicone.

11. The electrode fabrication method for the implantable neurostimulator according to claim 9, characterized in that, The pulse generator includes a housing and a circuit board encapsulated within the housing, the housing having mounting holes for fixing.

12. An implantable neurostimulation system, characterized in that, include: An external power supply device, an external 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.

Images