Implantable pulse generator, stimulator and stimulation system

Abstract

The invention provides an implantable pulse generator, which belongs to the technical field of medical instruments and comprises a main body part, a top cover part and a top cover connecting flange, wherein the main body part comprises a shell and a circuit board, and the circuit board is arranged in the shell; the top cover part comprises an electrode connector, the electrode connector comprises a first connecting ring and a second connecting ring, and the axial directions of the first connecting ring and the second connecting ring are arranged in the length direction of the shell; the top cover connecting flange is connected between the main body part and the top cover part and is provided with a mounting sleeve, and the mounting sleeve is used for accommodating the first connecting ring; the top cover connecting flange is provided with a feed-through connector, the axial direction of the feed-through connector and the axial direction of the mounting sleeve are arranged in parallel, and the feed-through connector is used for connecting the electrode connector and the circuit board. The pulse generator has the effect of reducing the size of the pulse generator.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an implantable pulse generator and a stimulator and a stimulation system having the pulse generator. Background Art

[0002] Implantable neurostimulators are implanted in different locations in the human body to send stimulation pulses to specific tissues in the body, thereby treating or improving the symptoms of related diseases. It is a reversible neuroregulation method.

[0003] At present, the applications of neuromodulation using implantable neurostimulators mainly include deep brain stimulation (DBS), vagus nerve stimulation (VNS), spinal nerve stimulation (SCS), sacral nerve stimulation (SNM) and tibial nerve stimulation (TNS), etc., and the diseases treated include: Parkinson's disease, epilepsy, pain, urinary retention, etc. However, the implantation of neurostimulators will inevitably cause harm to patients.

[0004] Therefore, miniaturizing the neurostimulator according to the location in the human body where it is implanted can reduce the harm of the implantation surgery to the patient and also reduce the difficulty of the surgery. Summary of the invention

[0005] The purpose of the present application is to provide an implantable pulse generator and a stimulator and a stimulation system having the pulse generator, aiming to miniaturize the pulse generator in the prior art.

[0006] Additional aspects and advantages of the present application will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the present application.

[0007] According to the first aspect of the present application, there is provided an implantable pulse generator, comprising: a main body component, a top cover component and a top cover connecting flange which are sequentially connected to form a column; wherein the main body component comprises a shell and a circuit board, the circuit board is arranged in the shell for generating stimulation pulses; the top cover component is located at one end of the main body component, the top cover component comprises an electrode connector, the electrode connector comprises a first connecting ring and a second connecting ring, at least one second connecting ring is provided, and the axial directions of the first connecting ring and the second connecting ring are arranged along the length direction of the shell; the top cover connecting flange is connected between the main body component and the top cover component, the top cover connecting flange is provided with a mounting sleeve, the mounting sleeve is provided with a groove, the groove is used to accommodate a part of the first connecting ring or the electrode end; the top cover connecting flange is provided with a feed-through connector, the axial direction of the feed-through connector is arranged parallel to the axial direction of the mounting sleeve, and the feed-through connector is used to connect the electrode connector and the circuit board.

[0008] In an exemplary embodiment of the present application, the mounting sleeve is made of a conductive material, a connecting conductor is connected between the circuit board and the mounting sleeve, the mounting sleeve electrically connects the first connecting ring and the circuit board, and the feed-through connector electrically connects the second connecting ring and the circuit board.

[0009] In an exemplary embodiment of the present application, an insulating pad is arranged between the mounting sleeve and the first connecting ring for blocking the circuit conduction between the two, a connecting conductor is connected between the circuit board and the mounting sleeve, and the mounting sleeve, the top cover connecting flange and the shell are all made of conductive materials; the feed-through connector electrically connects the first connecting ring and the second connecting ring to the circuit board respectively.

[0010] In an exemplary embodiment of the present application, an intermediate seal is provided between the first connecting ring and the second connecting ring, and an intermediate seal is also provided between the plurality of second connecting rings; the intermediate seal is used to block the circuit conduction between the respective connecting rings.

[0011] In an exemplary embodiment of the present application, the top cover component further includes a coil body, and the axial direction of the coil body is perpendicular to the length direction and the width direction of the shell.

[0012] In an exemplary embodiment of the present application, the top cover component also includes a top cover body, and the top cover body is used to accommodate other components of the top cover component. The interior of the coil body is a hollow structure, and the top cover body also has a through hole extending through the hollow part of the coil body.

[0013] In an exemplary embodiment of the present application, the coil body is a combined coil for charging and communication.

[0014] In an exemplary embodiment of the present application, the shell includes a middle part and a tail cover part, the circuit board is located in the middle part, the battery body is located in the tail cover part, and the battery body and the circuit board are arranged along the length direction of the shell.

[0015] According to a second aspect of the present application, a stimulator is provided, comprising the above-mentioned implantable pulse generator and electrodes.

[0016] According to a third aspect of the present application, a stimulation system is provided, comprising: the above-mentioned stimulator; and an external control device for communicating with the stimulator so as to be able to program and / or charge the stimulator.

[0017] The exemplary embodiments of the present application may have some or all of the following beneficial effects:

[0018] 1. In an exemplary implementation of the present application, an implantable pulse generator is provided, in which the volume of the pulse generator is reduced by rationally arranging the internal components of the pulse generator to facilitate implantation of the pulse generator; specifically, a mounting sleeve is added to the top cover connecting flange so that the first connecting ring can be installed in the mounting sleeve, thereby reducing the internal space occupied by the top cover body and reducing the volume of the top cover body, thereby achieving the purpose of miniaturizing the pulse generator.

[0019] 2. The through hole of the top cover body used for suturing and fixing the medical device is designed at the corresponding position of the hollow structure of the coil, realizing a rational layout without wasting the remaining space inside the top cover component, thereby achieving the purpose of miniaturizing the pulse generator.

[0020] 3. The circuit board is connected to the mounting sleeve through a connecting conductor, and the current is transferred to the first connecting ring through the mounting sleeve. The mounting sleeve is used as a part of the circuit connection, thereby saving the feed-through conductor between the circuit board and the first connecting ring, so as to achieve the purpose of miniaturizing the pulse generator.

[0021] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings herein are incorporated into the specification and constitute a part of the specification, illustrate embodiments consistent with the present application, and together with the specification are used to explain the principles of the present application. Obviously, the drawings described below are only some embodiments of the present application, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0023] Figure 1 A schematic diagram showing the overall structure of an implantable pulse generator in Example 1 of the present application is shown;

[0024] Figure 2 An exploded view of the internal structure of the housing in Example 1 of the present application is shown;

[0025] Figure 3 A schematic diagram of the structure of the top cover connecting flange in Example 1 of the present application is shown;

[0026] Figure 4 A cross-sectional view of the top cover component structure in Example 1 of the present application is shown;

[0027] Figure 5 A schematic diagram of the structure of the circuit board in Embodiment 1 of the present application is shown;

[0028] Figure 6 A schematic diagram showing the connection between the circuit board and the feed-through connector in Embodiment 1 of the present application is shown;

[0029] Figure 7 A cross-sectional view showing the connection between the feed-through connector and the electrode connector in Embodiment 1 of the present application is shown;

[0030] Figure 8 A cross-sectional view showing the internal structure of the feed-through connector in Embodiment 1 of the present application is shown;

[0031] Fig. 9 A cross-sectional view of the entire pulse generator in Example 1 of the present application is shown;

[0032] Fig.10 A schematic diagram showing the structure of the tail cover part in Example 1 of the present application is shown;

[0033] Fig.11 The schematic diagram of the structure of the whole bracket in the embodiment 1 of the present application is shown;

[0034] Fig.12 A schematic diagram of the structure of the top cover component in Example 2 of the present application is shown;

[0035] Fig.13 A cross-sectional view of the top cover component structure in Example 2 of the present application is shown;

[0036] Fig.14 A schematic diagram of a stimulator in Example 3 of the present application is shown;

[0037] Fig.15 A schematic diagram of a stimulation system in Example 4 of the present application is shown. DETAILED DESCRIPTION

[0038] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in a variety of forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present application will be comprehensive and complete and fully convey the concepts of the example embodiments to those skilled in the art. The same reference numerals in the figures represent the same or similar structures, and thus their detailed descriptions will be omitted. In addition, the drawings are only schematic illustrations of the present application and are not necessarily drawn to scale.

[0039] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of the diagram to another component, these terms are used in this specification only for convenience, such as according to the direction of the examples in the drawings. It is understood that if the device of the diagram is turned upside down, the component described as "upper" will become the component "lower". When a structure is "on" other structures, it may mean that the structure is formed integrally on the other structure, or that the structure is "directly" disposed on the other structure, or that the structure is "indirectly" disposed on the other structure through another structure.

[0040] The terms "a", "an", "the" and "at least one" are used to indicate the presence of one or more elements / components / etc.; the terms "including" and "having" are used to express an open-ended inclusive meaning and mean that additional elements / components / etc. may exist in addition to the listed elements / components / etc.; the terms "first" and "second" are used merely as labels and are not intended to limit the quantity of their objects.

[0041] Example 1

[0042] To solve relevant technical problems, such as Figure 1-3 As shown, an embodiment of the present invention provides an implantable pulse generator, including: a main body component 1, a top cover component 2 and a top cover connecting flange 3.

[0043] The main body 1 includes a housing 11 and a circuit board 12. The circuit board 12 is arranged in the housing 11 and is used to generate stimulation pulses. The top cover part 2 is located at one end of the main body 1, and the top cover part 2 includes an electrode connector; wherein the electrode connector includes a first connecting ring 21 and a second connecting ring. At least one second connecting ring is provided, and different numbers of second connecting rings can be set according to actual needs. The first connecting ring 21 and the second connecting ring are coaxially arranged and arranged along the length direction of the housing 11. The top cover connecting flange 3 is connected between the main body 1 and the top cover part 2, and the top cover connecting flange 3 is provided with a mounting sleeve 31, and the mounting sleeve 31 is used to accommodate the first connecting ring 21 or a part of the electrode end when the electrode is inserted. The top cover connecting flange 3 is also provided with a feed-through connector 30, and the axial direction of the feed-through connector 30 is arranged in parallel with the axial direction of the mounting sleeve 31. The feed-through connector 30 is used to electrically connect the electrode connector and the circuit board 12. The top cover connecting flange 3 and the electrode connector are both made of metal materials. The top cover part 2 also includes a top cover body 20, which is used to accommodate various components of the top cover part 2.

[0044] The implantable pulse generator needs to be implanted in the human body and used in conjunction with electrodes. When in use, the proximal end of the electrode is inserted into the top cover component 2, and the various connection contacts of the electrode are electrically connected one by one with the connection ring of the electrode connector; the circuit board 12 generates a stimulation pulse and transmits the stimulation pulse to the electrode through the electrode connector; the distal end of the electrode contains a plurality of stimulation contacts that are electrically connected one by one with the connection contacts, and the stimulation contacts stimulate the nerves of the human body. In order for the electrical stimulation of the pulse generator acting on the nerves to form a complete closed loop at the target point, at least two stimulation contacts are provided, and the polarity in the stimulation contacts can be set to positive and negative, respectively. Optionally, the stimulation contacts can also be used as collection contacts, configured to collect nerve signals at the target position.

[0045] In the embodiment of the present application, the pulse generator can be arranged outside the fascia close to the limb nerve (such as the tibial nerve), the length direction of the device is consistent with the direction of the nerve, the stimulation contact of the electrode is in contact with the nerve, and the pulse generator generates a stimulation pulse to stimulate the nerve through the electrode. Since the electrode connector of the pulse generator is arranged along the length direction of the shell 11, the shape of the pulse generator is more slender, so as to facilitate implantation in the limb; on this basis, the top cover connecting flange 3 is provided with a mounting sleeve 31, and the first connecting ring 21 and / or a part of the electrode insertion end can be placed in the mounting sleeve 31, thereby reducing the length of the top cover component 2, that is, reducing the overall length and volume of the pulse generator.

[0046] In the embodiment of the present application, the outer surface of the first connecting ring 21 may be stepped, with the small diameter end extending into the mounting sleeve 31 and the large diameter end abutting against the end of the mounting sleeve 31. A connecting spring 211 is embedded in the first connecting ring 21, and is used for elastically abutting the connecting spring 211 against the electrode connection contact when the electrode is inserted. The mounting sleeve 31 includes a side wall 311 extending toward the main body part 1, and the extended end is sealed by the bottom 312 to form a groove opening toward the top cover part 2. Figure 4 As shown, the first connecting ring 21 is partially embedded in the mounting sleeve 31 , and a gap may be provided between the first connecting ring 21 and the bottom 311 to accommodate the non-conductive end of the inserted electrode.

[0047] As a preferred embodiment of the present application, Figure 4 As shown, the second connecting ring is provided as one, and the second connecting ring is provided as a locking member 22 for fixing the electrode. The locking member 22 is located on the side of the first connecting ring 21 away from the mounting sleeve 31. Figure 4 As shown, the locking member 22 includes a locking ring 221 and a locking screw 222. The locking ring 221 is provided with a through hole along the length direction of the shell 11 for the electrode to pass through the through hole; the side wall of the locking ring 221 is provided with a threaded hole 2221, and the locking screw 222 is threadedly connected at the threaded hole 2221. When in use, the electrode is installed into the electrode connector, and after the connecting contact is aligned with the corresponding connecting ring, the locking screw 222 is screwed so that the locking screw 222 is firmly against the connecting contact of the electrode, thereby forming a stable mechanical connection and electrical connection between the connecting contact and the locking member 22. Therefore, the present application does not need to design a structure with only a locking function, thereby reducing the number of components of the top cover component 2.

[0048] In order to form a seal for the locking member, the corresponding sealing structure is introduced below. Figure 4As shown, the threaded hole 2221 extends from the side wall of the locking ring 221 to form a protrusion, and the end of the locking screw 222 away from the locking ring 221 extends out of the threaded hole 2221; and a screw sealing plug 23 is also provided, and the screw sealing plug 23 wraps the protrusion of the threaded hole 2221 extending relative to the side wall of the locking ring 221, and the part of the locking screw 222 extending out of the threaded hole 2221. The locking screw 222 can be made of an insulating material; or, the locking screw 222 is not made of an insulating material, but the screw sealing plug 23 needs to completely wrap the exposed part of the locking screw 222. A plurality of annular protrusions are formed inside the screw sealing plug 23 to improve the sealing effect of the device; the screw sealing plug 23 is made of an insulating material, such as rubber, silicone, but not limited thereto. The screw sealing plug 23 plays a role in sealing and insulating the locking member 22.

[0049] In the embodiment of the present application, the top cover component 2 also includes an intermediate seal 24 arranged between the connecting rings of the electrode connector, which is made of an insulating material, such as rubber, silicone, but not limited thereto. In the present embodiment, only one intermediate seal 24 is provided and is located between the first connecting ring 21 and the locking member 22. The inner hole of the first connecting ring 21 is stepped, and the outer surface of the intermediate seal 24 is also stepped. The small diameter end of the intermediate seal 24 abuts against the large diameter end of the inner hole of the first connecting ring 21; the large diameter end of the intermediate seal 24 wraps around the locking member 22 toward one end of the first connecting ring 21 to play a sealing and insulating role. In addition, a plurality of annular protrusions are formed inside the intermediate seal 24 to wrap the electrode when the electrode is inserted, thereby improving the sealing effect.

[0050] In the embodiment of the present application, the top cover component 2 further includes an end seal 25 disposed at the end of the electrode connector. Figure 4 As shown, an end seal 25 is provided at one end of the locking member 22 away from the first connecting ring 21. The end seal 25 is made of an insulating material, such as rubber, silicone, but not limited thereto. A through hole is provided in the end seal 25 along the length direction of the housing 11 for the electrode to pass through the through hole. In order to play a sealing and insulating role, the end seal 25 wraps the end of the locking member 22 at the connection between the end seal 25 and the locking member 22; and a plurality of annular protrusions are formed inside the end seal 25 to wrap the electrode when the electrode is inserted, thereby improving the sealing effect. When the electrode is inserted, the electrode extends from the central through hole of the end seal 25 into the locking member 22 and the first connecting ring 21. On the one hand, the end seal 25 can improve the stability of the electrode; on the other hand, the end seal 25 can also play a sealing role on the inside of the housing 11, so that impurities are not easy to enter the electrode connector; on the other hand, the end seal 25 also plays a role in insulating the locking member 22, thereby preventing the locking member 22 from directly conducting a circuit with the adjacent tissue.

[0051] like Figure 4As shown, in an embodiment of the present application, in order to realize charging of the pulse generator, or to adjust the parameters of the stimulation pulse signal generated by the pulse generator, the top cover component 2 also includes a coil body 26, and the interior of the coil body 26 is a hollow structure. The coil body 26 is located on one side of the electrode connector, and the axial direction of the coil body 26 is perpendicular to the length direction and width direction of the shell 11. The coil body 26 can be a charging coil or a communication coil, or a composite coil for charging and communication, and the material can be selected from gold, platinum, and copper, but not limited to this. By rationally arranging the position of the coil body 26 and the electrode connector, the space of the top cover component 2 can be more fully utilized, and the shape of the pulse generator can be arranged into a flat, slender column, so that it can fit inside the limb, and it is also convenient for charging and communication. In addition, the coil body 26 is located outside the metal shell, which can improve the charging efficiency and reduce the charging temperature rise.

[0052] As a preferred embodiment of the present application, the top cover connecting flange 3 is made of a biocompatible metal material, which may be titanium or titanium alloy, but is not limited thereto. Figure 5-6 As shown, there is a connecting conductor 33 between the mounting sleeve 31 and the circuit board 12, so that the mounting sleeve 31 can be used as a part of the circuit conduction between the circuit board 12 and the first connecting ring 21. It should be pointed out that in one implementation of the embodiment of the present application, the mounting sleeve 31 and the top cover connecting flange 3 are an integrated structure. At this time, in order to avoid the circuit conduction between the pulse generator and the adjacent tissue, so that the current only flows out from the electrode connector, it is necessary to insulate the outer exposed parts of the housing 11 and the top cover connecting flange 3, such as adding an insulating layer.

[0053] like Figure 7-8 As shown, a feed-through connection hole 32 is provided on the top cover connection flange 3 at an axially parallel position with the mounting sleeve 31, and a side wall 321 of the feed-through connection hole 32 extends from the main body surface of the top cover connection flange 3 toward the housing 11. The feed-through connector 30 includes a feed-through insulator 340 and a plurality of feed-through conductors passing through the feed-through insulator 340. The feed-through insulator 340 is made of materials such as ceramics and glass; the feed-through conductor is made of materials such as platinum, platinum-iridium alloy or Kovar alloy, and is welded to the feed-through insulator 340 by solder 3401. The feed-through conductor includes a first feed-through conductor 341 and a second feed-through conductor 342. One end of the first feed-through conductor 341 is connected to the second connection ring, and the number of the first feed-through conductors 341 is the same as the number of the second connection rings, and they correspond one to one; two second feed-through conductors 342 are provided, and one end of the second feed-through conductor 342 is respectively connected to the two leads of the coil body 26. The other ends of the first feed-through conductor 341 and the second feed-through conductor 342 extend into the feed-through insulator 340 and pass through the connection between the feed-through insulator 340 and the circuit board 12 .

[0054] As a preferred embodiment of the present application, since the second connecting ring is provided as one, namely, the locking member 22 , the first feed-through conductor 341 is provided as one.

[0055] In order to stimulate the tibial nerve, the circuit board 12 is connected to the connection contact of the electrode through the connection conductor 33, the mounting sleeve 31, and the first connection ring 21, and is further connected to a stimulation contact at the distal end of the electrode; at the other end, the circuit board 12 is connected to the connection contact of the electrode through the first feed-through conductor 341 and the second connection ring, and is further connected to another stimulation contact at the distal end of the electrode. In order to enable the pulse signal to form a complete closed loop, combined with the above conduction relationship, the polarities of the two stimulation contacts can be set to one positive and one negative.

[0056] In the above embodiment, the mounting sleeve 31 is rationally utilized as a conducting medium between the circuit board 12 and the first connecting ring 21, without the need to reconstruct a circuit between the circuit board 12 and the first connecting ring 21. Therefore, the space required for the shell and the space required for the top cover can be further reduced, thereby achieving the effect of further miniaturization of the pulse generator.

[0057] In the embodiment of the present application, the top cover component 2 also includes a top cover body 20, which is made of a biocompatible polymer material and is used to accommodate other components of the top cover component 2, such as an electrode connector, a sealing ring, a coil body, etc. The material of the top cover body 20 can be epoxy resin, silicone, etc., and is prepared together with other components of the top cover component 2 pre-positioned by tooling by casting molding; or, the material of the top cover body 20 can also be polyurethane, polysulfone, etc., and is pre-prepared by an injection molding process, and then the electrode connector, sealing ring, coil body, etc. are assembled to the designed position.

[0058] Further, such as Figure 2 , 4 As shown, the interior of the coil body 26 is a hollow structure, and the top cover body 20 is provided with a through hole 201 in the hollow of the coil body 26, and the through hole 201 is used to suture and fix the medical device. The present application opens the through hole 201 at the corresponding position of the hollow of the coil body 26, and reasonably utilizes the space in the center of the coil body 26 without occupying the remaining space in the top cover body 20, so that the size of the top cover body 20 can be further reduced, and the size of the pulse generator can also be reduced.

[0059] In the embodiment of the present application, the housing 11 is made of a biocompatible metal material, which may be titanium, titanium alloy, or stainless steel, but is not limited thereto. Figure 9-10As shown, further, the components of the pulse generator are rationally arranged, and the shell 11 includes a middle part 111 and a tail cover part 112. Among them, the middle part 111 and the tail cover part 112 can be an integral structure or a split structure. The circuit board 12 is located in the middle part 111 of the shell 11, and the battery body 42 is located in the tail cover part 112 of the shell 11. The tail cover connecting flange 41 is encapsulated in the opening of the tail cover part 112 to form an airtight environment for protecting the battery body 42; the tail cover part 112 is provided with a protrusion 1121 on the side away from the tail cover connecting flange 41, and the protrusion 1121 is in an arc shape, so that there is no sharp corner structure at the end of the outer shell 11, thereby improving the comfort of the outer shell 11 after implantation into the human body.

[0060] like Fig.10 As shown, in the present application document, in order to make the connection between the tail cover part 112 and the middle part 111 of the housing 11 more firmly, a stopper 1122 is provided on one side of the opening of the tail cover part 112. The stopper 1122 and the tail cover part 112 are an integral structure, an end face is formed between the stopper 1122 and the tail cover part 112, and the stopper 1122 is plugged and matched with the port of the middle part 111 of the housing 11. When the tail cover part 112 and the middle part 111 are installed and fixed, the stopper 1122 is inserted into the port of the middle part 111, and the end face of the middle part 111 is abutted against the end face of the tail cover part 112, and then the middle part 111 and the tail cover part 112 are connected and fixed by welding or pasting.

[0061] The middle part 111 and the tail cover part 112 are first installed by plugging, so that the stopper 1122 plays a positioning role, and then during welding or pasting, the middle part 111 and the tail cover part 112 are not easy to move relative to each other, thereby improving the stability of the middle part 111 and the tail cover part 112 of the shell 11 when connected.

[0062] like Figure 5 , Fig.10 As shown, further, the positive and negative electrodes of the battery body 42 pass through the tail cover connecting flange 41 through the battery feedthrough 421 and are connected to the corresponding pads on the circuit board 12. Through this structure, the circuit conduction between the battery and the circuit board 12 is achieved, so that the circuit board 12 can be powered by the battery body 42 to generate a pulse signal. More importantly, by separating the battery body 42 from the circuit board 12 and arranging them along the length direction of the shell 11, it is more conducive to the pulse generator to form a slender shape for easy implantation in the limbs. In addition, packaging the battery body 42 separately from the circuit board facilitates the modular manufacturing of the pulse generator and improves the production efficiency of the equipment. In the present application, the battery body 42 may be a non-rechargeable battery or a rechargeable battery.

[0063] like Figure 5 and Fig.11As shown, further, in order to improve the stability of the circuit board 12 in the housing 11, a bracket 6 is also provided in the middle part 111 of the housing 11. The circuit board 12 is assembled on the inner side of the bracket 6, and the bracket 6 is made of a polymer material. A plurality of buckles 61 are provided on the inner side of the bracket 6, and a flange 62 is fixedly provided on the inner wall of the bracket 6 in a surrounding manner, and a protrusion 63 is provided at the inner corner of the bracket 6. The axial movement of the circuit board 12 is limited by the buckle 61 and the flange 62, and the axial rotation of the circuit board 12 is limited by the protrusion 63.

[0064] like Fig.11 As shown, through grooves 64 are provided on both sides of the bracket 6, and the through grooves 64 are used to allow the feedthrough wires of the connecting conductor 33, the coil body 26 and the electrode connector, and the battery feedthrough 421 to pass through. A plurality of ribs 65 are provided at one end of the bracket 6 that is butt-jointed with the tail cover connection flange 41, and a groove structure is formed between the plurality of ribs 65. The grooves can be filled with an adhesive to improve the connection strength between the bracket 6 and the tail cover connection flange 41. The filler can be silicone rubber, epoxy resin, etc. In addition, a groove 66 and an avoidance groove 67 are also provided at one end of the bracket that is butt-jointed with the top cover connection flange 3, which are used to respectively butt-join the mounting sleeve 31 and the side wall 321 of the feedthrough connection hole.

[0065] Example 2

[0066] like Fig.12 and Fig.13 As shown, the difference between the embodiment of the present application and the embodiment 1 is that an insulating pad 7 is provided between the mounting sleeve 31 and the first connecting ring 21, and the insulating pad 7 is made of an insulating material. The feed-through connector 30 also includes a third feed-through conductor 343, one end of which is electrically connected to the first connecting ring 21, and the other end of which extends into the feed-through insulator 340 and penetrates the connection between the feed-through insulator 340 and the circuit board 12. In this embodiment, the outer exposed parts of the housing 11 and the top cover connecting flange 3 are not insulated, and the circuit board 12, the connecting conductor 33, the top cover connecting flange 3, and the housing 11 form a conductive relationship.

[0067] Based on the above connection relationship, the current can be transmitted to the outer exposed part of the housing 11 and the top cover connection flange 3 through the electrical connection between the connecting conductor 33 and the mounting sleeve 31. In Example 1, the stimulation contacts E1 and E2 can only form the effect of a bipolar closed stimulation field near the target point. In Example 2, the stimulation contacts E1 or E2 can also form a closed loop with the housing 11 to form the effect of a monopolar stimulation field at the neural target point.

[0068] Example 3

[0069] like Fig.14 As shown, this embodiment provides a stimulator, which includes: an implantable pulse generator and electrodes provided in any one of Implementation 1 to Implementation 2.

[0070] Fig.14 The application of the implantable medical device provided by the present invention is shown in FIG. Fig.14 As shown, according to the anatomical position of the tibial nerve, the stimulation electrode is implanted near the tibial nerve, and the stimulation contacts E1 and E2 are close to the tibial nerve. A skin incision and a pouch are prepared at a distance from the stimulation position; the connecting end of the electrode is inserted into the electrode connector channel of the pulse generator and locked and fixed by the locking screw 222; then, the pulse generator is placed in the pouch and fixed by sutures passing through the through hole 201; finally, the incision is sutured to complete the entire implantation operation.

[0071] Example 4

[0072] like Fig.15 As shown, this embodiment provides a stimulation system, which includes: a stimulator in Example 3 and an external device 10, the external device 10 is used to connect to the implantable pulse generator through near field communication to be able to program and / or charge the implantable pulse generator.

[0073] Those skilled in the art will easily think of other embodiments of the present application after considering the specification and practicing the embodiments of the present application. The present application is intended to cover any modification, use or adaptation of the present application, which follows the general principles of the present application and includes common knowledge or customary technical means in the art that the present application does not apply for. The specification and embodiments are only regarded as exemplary, and the true scope and spirit of the present application are indicated by the attached claims.

Claims

1. An implantable pulse generator, characterized in that: include: A main body component (1), a top cover component (2) and a top cover connecting flange (3); wherein, The main body component (1) comprises a housing (11) and a circuit board (12), wherein the circuit board (12) is arranged in the housing (11) and is used to generate stimulation pulses; The top cover component (2) is located at one end of the main body component (1), and the top cover component (2) comprises an electrode connector; the electrode connector comprises a first connecting ring (21) and a second connecting ring, and the axial directions of the first connecting ring (21) and the second connecting ring are arranged along the length direction of the shell (11); The top cover connecting flange (3) is connected between the main body component (1) and the top cover component (2), and the top cover connecting flange (3) is provided with a mounting sleeve (31), and the mounting sleeve (31) is used to accommodate the first connecting ring (21) or a part of the end of the electrode when the electrode is inserted; The top cover connecting flange (3) is provided with a feed-through connector (30), the axial direction of the feed-through connector (30) is arranged in parallel with the axial direction of the mounting sleeve (31), and the feed-through connector (30) is used to connect the electrode connector and the circuit board (12).

2. An implantable pulse generator according to claim 1, characterized in that: The mounting sleeve (31) is made of a conductive material, a connecting conductor (33) is connected between the circuit board (12) and the mounting sleeve (31), the mounting sleeve (31) electrically connects the first connecting ring (21) and the circuit board (12), and the feed-through connector (30) electrically connects the second connecting ring and the circuit board (12).

3. The implantable pulse generator according to claim 1, characterized in that: An insulating pad (7) is provided between the mounting sleeve (31) and the first connecting ring (21) for blocking the conduction of the circuits therebetween; a connecting conductor (33) is connected between the circuit board (12) and the mounting sleeve (31); the mounting sleeve (31), the top cover connecting flange (3) and the shell (11) are all made of conductive materials; and the feed-through connector (30) electrically connects the first connecting ring (21) and the second connecting ring to the circuit board (12) respectively.

4. An implantable pulse generator according to any one of claims 2 or 3, characterized in that: An intermediate seal (24) is provided between the first connecting ring (21) and the second connecting ring.

5. The implantable pulse generator according to claim 1, characterized in that: The top cover component (2) also includes a coil body (26), and the axial direction of the coil body (26) is perpendicular to the length direction and the width direction of the housing (11).

6. According to the implantable pulse generator described in claim 5, the top cover component (2) also includes a top cover body (20), and the top cover body (20) is used to accommodate other devices of the top cover component (2), the interior of the coil body (26) is a hollow structure, and the top cover body (5) is also provided with a through hole (201) penetrating the hollow part of the coil body (26).

7. The implantable pulse generator according to claim 5, characterized in that: The coil body (26) is a combined coil for charging and communication.

8. The implantable pulse generator according to claim 1, characterized in that: The housing (11) comprises a middle portion (111) and a tail cover portion (112); the circuit board (12) is located in the middle portion (111); the battery body (42) is located in the tail cover portion (112); and the battery body (42) and the circuit board (12) are arranged in a longitudinal direction of the housing (11).

9. A stimulator, characterized in that: Comprising the implantable pulse generator and electrode described in any one of claims 1-8.

10. A stimulation system, characterized in that: include: A stimulator as claimed in claim 9; The external control device is used to communicate with the stimulator so as to be able to program and / or charge the stimulator.

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