Implantable nerve stimulator, lead, nerve stimulator system and method for assembling nerve stimulator system

Abstract

The invention relates to the technical field of medical products, and discloses an implantable nerve stimulator, a wire, a nerve stimulator system and an assembling method of the nerve stimulator system. The implantable nerve stimulator comprises a channel module and a main body, the channel module comprises at least one connecting assembly, the connecting assembly forms a connecting channel for insertion of a wire, the connecting assembly comprises a plurality of first conductive sheets and a plurality of first conductors, the plurality of first conductors are in one-to-one correspondence with the plurality of first conductive sheets, and the plurality of first conductors are in one-to-one correspondence with the plurality of first conductive sheets. The first conductors are electrically connected to the first conducting strips, the multiple first conducting strips are arranged at intervals in the circumferential direction of the connecting channel, and the first conducting strips are used for being electrically connected to wires; the main body is provided with a circuit board electrically connected with the first conductor. According to the implantable nerve stimulator, the size of the implantable nerve stimulator is reduced, more contacts can be provided, and the product structure requirement is met.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical products, in particular to an implantable neurostimulator, a lead, a neurostimulator system and an assembly method of the neurostimulator system. BACKGROUND

[0002] At present, for Parkinson's disease, epilepsy, dystonia, spinal cord pain and other motor diseases or depression, alcoholism, obsessive-compulsive disorder and other mental diseases, when the drug treatment effect decreases, the treatment effect can be improved by deep brain stimulation or spinal cord stimulation. Taking deep brain stimulation as an example, the main implanted components are IPG, extension lead and electrode lead. The main components for realizing electrical connection between IPG and extension lead, extension lead and electrode lead are channel modules. The main implementation mode of the channel modules on the market is to assemble through a metal connecting block and a spring ring. The spring rings are arranged at intervals along the length direction of the channel, and each spring ring can only correspond to one connecting contact.

[0003] With the development of technology and the expansion of indications, the demand for matching deep brain electrical stimulation and monitoring is increasing, and more and more touch points of deep brain stimulators are needed. When the number of touch points increases, the number of spring rings also increases, thereby increasing the length of the channel. If the conventional technology of single spring ring corresponding to single touch point is still used, the shape of the implanted instruments such as IPG or extension lead will become larger and larger, which reduces the comfort of patients. SUMMARY

[0004] Based on the above, the purpose of the present application is to provide an implantable neurostimulator, a lead, a neurostimulator system and an assembly method of the neurostimulator system. The present application reduces the size of the implantable neurostimulator and can provide more touch points to meet the product structure requirements.

[0005] To achieve the above purpose, the following technical solutions are adopted:

[0006] In a first aspect, an implantable neurostimulator is provided, which comprises:

[0007] A channel module comprises at least one connecting component, at least one connecting component forms a connecting channel for lead insertion, the connecting component comprises a plurality of first conductive sheets and a plurality of first conductors, the plurality of first conductors correspond to the plurality of first conductive sheets one by one, the first conductors are electrically connected to the first conductive sheets, the plurality of first conductive sheets are arranged at intervals in the circumferential direction of the connecting channel, and the first conductive sheets are used for electrical connection with the lead;

[0008] A main body is provided with a circuit board electrically connected to the first conductors.

[0009] As a preferred technical scheme of the implantable nerve stimulator, the channel module further comprises a plurality of annular insulation bases, the connecting assembly is installed on the annular insulation bases and corresponds one by one, and the annular insulation bases are sequentially spliced along the axial direction of the connecting channel.

[0010] As a preferred technical scheme of the implantable nerve stimulator, the channel module further comprises an annular insulation base, the connecting channel penetrates through the annular insulation base, and a plurality of the first conductive sheets are arranged on the inner wall of the annular insulation base.

[0011] As a preferred technical scheme of the implantable nerve stimulator, one of the opposite side walls of adjacent annular insulation bases is provided with a positioning column, and the other is provided with a positioning hole, and the positioning column can be inserted into the positioning hole.

[0012] As a preferred technical scheme of the implantable nerve stimulator, the implantable nerve stimulator further comprises a feedthrough assembly, the feedthrough assembly is installed on the main body, one side of the feedthrough assembly is electrically connected with the first conductor, and the other side of the feedthrough assembly is electrically connected with the circuit board.

[0013] As a preferred technical scheme of the implantable nerve stimulator, the connecting assembly further comprises an annular compression sheet, the annular compression sheet is installed on the annular insulation base, the annular compression sheet is annularly provided with a plurality of compression portions, the plurality of compression portions correspond to the plurality of first conductive sheets one by one, and the compression portions can compress the first conductive sheets on the inner wall of the annular insulation base.

[0014] As a preferred technical scheme of the implantable nerve stimulator, the inner wall of the annular insulation base is provided with a first mounting groove, and the first conductive sheet can be embedded in the first mounting groove.

[0015] As a preferred technical scheme of the implantable nerve stimulator, both ends of the first conductive sheet are provided with stepped portions, the stepped portion of one end of the first conductive sheet is clamped on the inner wall of the first mounting groove, and the compression portion is compressed on the stepped portion of the other end of the first conductive sheet.

[0016] As a preferred technical scheme of the implantable nerve stimulator, the inner wall of the annular insulation base is provided with a second mounting groove, and the annular compression sheet can be embedded in the second mounting groove.

[0017] As a preferred technical scheme of the implantable nerve stimulator, the annular insulation base is provided with a first avoiding portion, the first conductor can pass through the first avoiding portion and be electrically connected with the first conductive sheet.

[0018] As a preferred technical scheme of the implantable nerve stimulator, the first avoiding part is an avoiding hole, and the avoiding hole is arranged on the side wall of the annular insulating base.

[0019] The first avoiding part is an avoiding groove, and the avoiding groove is arranged on the end face of the annular insulating base.

[0020] As a preferred technical scheme of the implantable nerve stimulator, the first conductive sheet is elastic, and the middle part of the first conductive sheet is bent towards the direction close to the axis of the connecting channel.

[0021] In a second aspect, a wire is provided, which comprises a connecting end for being connected to an implantable nerve stimulator, and the connecting end comprises at least one connecting component, the connecting component comprises a plurality of second conductive sheets and a plurality of guide wires, the plurality of second conductive sheets are arranged in a ring in a circumferential direction of the wire, and the plurality of guide wires correspond to the plurality of second conductive sheets one by one, and the guide wires electrically connect the second conductive sheets and the other end of the wire.

[0022] As a preferred technical scheme of the wire, the connecting component further comprises an insulating ring, the plurality of second conductive sheets are arranged in a ring on the outer wall of the insulating ring, and the guide wires are arranged in the insulating ring.

[0023] As a preferred technical scheme of the wire, the insulating ring is a plurality of insulating rings, and the plurality of insulating rings are connected in sequence in the axial direction of the insulating ring.

[0024] As a preferred technical scheme of the wire, the outer wall of the insulating ring is provided with a third mounting groove, and the two ends of the second conductive sheet are clamped in the third mounting groove.

[0025] As a preferred technical scheme of the wire, the second conductive sheet is elastic, the middle part of the second conductive sheet is bent away from the axial direction of the insulating ring, and the second conductive sheet is elastically protruded from the outer wall of the insulating ring.

[0026] In a third aspect, a nerve stimulator system is provided, which comprises an implantable nerve stimulator and a wire, the implantable nerve stimulator comprises a channel module and a main body, the channel module comprises at least one connecting component, at least one connecting component forms a connecting channel, the connecting component comprises a plurality of first conductive sheets and a plurality of first conductors, the plurality of first conductors correspond to the plurality of first conductive sheets one by one, the first conductors are electrically connected to the first conductive sheets, and the plurality of first conductive sheets are arranged in a ring in a circumferential direction of the connecting channel and arranged in the connecting channel; the main body is provided with a circuit board electrically connected to the first conductors;

[0027] The lead includes a connecting end that is connected to the implantable neurostimulator, the connecting end includes at least one connecting assembly, the connecting assembly includes a plurality of second conductive sheets and a plurality of wires, the second conductive sheets and the first conductive sheets are one-to-one corresponding, a plurality of the second conductive sheets are arranged in a ring along the circumference of the lead, a plurality of the wires are one-to-one corresponding to a plurality of the second conductive sheets, and the wires electrically connect the second conductive sheets and the other end of the lead.

[0028] The lead can be inserted into the connecting channel to electrically connect the first conductive sheet to the second conductive sheet.

[0029] In a fourth aspect, a method for assembling a neurostimulator system is provided, comprising the following steps:

[0030] S1, assembling an implantable neurostimulator;

[0031] S2, assembling a lead;

[0032] S3, inserting the lead into the implantable neurostimulator;

[0033] The S1 step includes a channel module assembly method, the channel module assembly method comprising the following steps:

[0034] S11, electrically connecting the first conductive sheet to the first conductor;

[0035] S12, installing the first conductive sheet in a plurality of first installation slots of a ring-shaped insulating seat;

[0036] S13, embedding a ring-shaped pressing sheet through one end of the ring-shaped insulating seat into a second installation slot of the ring-shaped insulating seat until a pressing portion of the ring-shaped pressing sheet is pressed into a plurality of the first conductive sheets, and the ring-shaped pressing sheet is connected to the ring-shaped insulating seat;

[0037] S14, sequentially connecting a plurality of ring-shaped insulating seats assembled with connecting assemblies.

[0038] As a preferred technical solution of the method for assembling a neurostimulator system, the S2 step includes a lead assembly method, the lead assembly method comprising the following steps:

[0039] S21, installing a plurality of second conductive sheets in a plurality of third installation slots in an insulating ring;

[0040] S22, electrically connecting the second conductive sheets and the wires, and the insulating ring assembled with the second conductive sheets and the wires forms a connecting assembly;

[0041] S23, sequentially connecting an outer sleeve and a plurality of the connecting assemblies, and then filling and pouring glue into the inside of the outer sleeve and a plurality of the connecting assemblies;

[0042] S24, install the guide head.

[0043] The beneficial effects of the present application are:

[0044] The present application provides an implantable neurostimulator, in the present application, each first conductive sheet corresponds to a contact, when the number of contacts increases, only the number of first conductive sheets along the circumference of the connecting channel needs to be increased, without increasing the length of the connecting channel, under the condition that the length of the connecting channel is constant, the number of contacts is increased, the present application reduces the size of the implantable neurostimulator, and can provide more contacts to meet the product structure requirements.

[0045] The present application provides a lead, each second conductive sheet corresponds to a contact, when the number of contacts increases, only the number of second conductive sheets along the circumference of the lead needs to be increased, without increasing the length of the lead, the present application reduces the size of the lead, and can provide more contacts to meet the product structure requirements.

[0046] The present application provides a neurostimulator system, including an implantable neurostimulator and a lead, which can reduce the overall size of the neurostimulator system.

[0047] The present application provides an assembly method of a neurostimulator system, which realizes the electrical connection of the implantable neurostimulator and the lead, and reduces the overall size of the neurostimulator system. BRIEF DESCRIPTION OF DRAWINGS

[0048] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the description of the embodiments of the present application will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained according to the contents of the embodiments of the present application and these drawings without creative labor.

[0049] Figure 1 is a structural schematic diagram of an implantable neurostimulator provided by the specific embodiment of the present application;

[0050] Figure 2 is an exploded view of the structure of the implantable neurostimulator provided by the specific embodiment of the present application;

[0051] Figure 3 is a structural schematic diagram of the lead inserted into the channel module provided by the specific embodiment of the present application;

[0052] Figure 4 is a structural schematic diagram of the channel module including two annular insulating seats provided by the specific embodiment of the present application;

[0053] Figure 5is a structural schematic diagram of the channel module provided by the embodiment of the present application;

[0054] Figure 6 is an exploded view of the channel module provided by the embodiment of the present application;

[0055] Figure 7 is a sectional view of the channel module provided by the embodiment of the present application;

[0056] Figure 8 is a structural schematic diagram of the wire provided by the embodiment of the present application;

[0057] Figure 9 is a sectional view of the wire provided by the embodiment of the present application.

[0058] The figures are marked as follows:

[0059] 1. Channel module; 11. Connecting channel; 12. Connecting assembly; 121. First conductive sheet; 1211. Step portion; 122. Annular pressing sheet; 1221. Pressing portion; 123. First conductor; 13. Annular insulating seat; 131. Positioning column; 132. Positioning hole; 133. First mounting groove; 134. Second mounting groove; 135. First avoiding portion;

[0060] 2. Main body;

[0061] 3. Wire; 31. Insulating ring; 311. Third mounting groove; 32. Guide wire; 33. Second conductive sheet; 34. Guide head; 35. Outer sleeve tube;

[0062] 4. Feedthrough assembly; 5. Silicone cover. DETAILED DESCRIPTION

[0063] The present application will be further described below in conjunction with the drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application. In addition, it should be noted that, for the convenience of description, only the parts related to the present application are shown in the drawings, but not all the structures.

[0064] In the description of the present application, unless otherwise explicitly specified and limited, the terms "connected", "connected", "fixed" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0065] In the present application, unless specifically defined and limited otherwise, the first feature "on" or "under" the second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, the first feature "on", "above" and "over" the second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is higher than the second feature in horizontal height. The first feature "under", "below" and "under" the second feature includes that the first feature is directly below and obliquely below the second feature, or only indicates that the first feature is lower than the second feature in horizontal height.

[0066] In the description of the present embodiment, the terms "upper", "lower", "left", "right", and the like, orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of description and simplification of operation, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second" are only used to distinguish in description, and have no special meaning.

[0067] The technical field and related terms of the present application are briefly described below.

[0068] Implantable medical systems include implantable neuro-electric stimulation systems, implantable cardiac electric stimulation systems (also known as cardiac pacemakers), implantable drug delivery systems (IDDS) and lead switching systems, etc. Implantable neuro-electric stimulation systems are, for example, deep brain stimulation systems (DBS), implantable cortical nerve stimulation systems (CNS), implantable spinal cord stimulation systems (SCS), implantable sacral nerve stimulation systems (SNS), implantable vagus nerve stimulation systems (VNS), etc.

[0069] An implantable neurostimulation system includes an implantable neurostimulator (i.e., an implantable neurostimulation device) implanted in a patient and a programming device disposed outside the patient. That is, the implantable neurostimulator is a medical device, or, stated differently, the medical device includes the implantable neurostimulator. The related neuromodulation technology is mainly through stereotactic surgery to implant electrodes (electrodes are, for example, in the form of electrode leads) at a specific site (i.e., a target site) of the patient's tissue, and deliver electrical pulses to the target site through the electrodes to modulate the electrical activity of the corresponding neural structures and networks and their functions, thereby improving symptoms and relieving pain.

[0070] As one example, DBS includes an IPG (Implantable Pulse Generator), an extension lead, and an electrode lead, with the IPG connected to the extension lead and the electrode lead. The IPG is implanted in the patient, for example, in the front of the patient's chest or other body part.

[0071] As another example, DBS includes an IPG and an electrode lead, with the IPG directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, by slotting the patient's skull and then installing the IPG in the slot of the skull, in which case the IPG can not protrude out of the outer surface of the skull or can partially protrude out of the outer surface of the skull.

[0072] The IPG provides controllable electrical stimulation therapy (or, stated differently, electrical stimulation energy) to the tissue in the body in response to programming instructions sent by the programming device, relying on a sealed battery and circuitry. The IPG delivers one or more controllable specific electrical stimulations to a specific area of the tissue in the body through the electrode lead.

[0073] In some embodiments, the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation, delivering electrical stimulation generated by the IPG to the electrode lead.

[0074] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or in the form of a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Thus, electrical stimulation in the form of a non-pulsed signal can be a continuous signal, which can have a sinusoidal waveform or other continuous waveform.

[0075] The electrode lead delivers electrical stimulation to a specific region of the body tissue through a plurality of electrode contacts after receiving the electrical stimulation transmitted by the IPG or the extension lead. The stimulator is provided with one or more electrode leads, for example, on one side or on both sides, and the electrode leads are provided with a plurality of electrode contacts which can be arranged uniformly or non-uniformly in the circumferential direction of the electrode lead. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode lead. The electrode contacts can include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts can have a shape such as a sheet, a ring, a dot, etc.

[0076] In some embodiments, the body tissue to be stimulated can be brain tissue of the patient, and the site to be stimulated can be a specific site of the brain tissue. The site to be stimulated is generally different when the type of disease of the patient is different, and the number of stimulation contacts (single source or multiple sources) used, the use of one or more specific electrical stimulations (single channel or multiple channels), and the stimulation parameters (values) are also different.

[0077] The embodiments of the present application are not limited to the type of disease to be treated, and can be used for deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, functional electrical stimulation, etc. The types of diseases that can be treated or managed by DBS include, but are not limited to, convulsive diseases (e.g., epilepsy), pain, migraine, mental diseases (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorder, post-traumatic stress disorder, dysthymia, obsessive-compulsive disorder (OCD), behavioral disorders, emotional disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and injuries.

[0078] In the embodiments of the present application, when the programming device and the stimulator establish a programming connection, the programming device can adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, different stimulation parameters correspond to different electrical stimulation), or the stimulator can sense the electrical physiological activity of the patient to collect an electrical physiological signal, and the stimulation parameters of the stimulator can be continuously adjusted based on the collected electrical physiological signal to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0079] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (for example, electrode contact #2 and electrode contact #3), frequency (for example, the number of electrical stimulation pulse signals within a unit time of 1s, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, in V), timing (for example, it can be continuous or burst, and burst refers to a discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cyclic stimulation mode), upper and lower limits controlled by the doctor (the range that the doctor can adjust) and upper and lower limits controlled by the patient (the range that the patient can adjust independently).

[0080] In some embodiments, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0081] Programmable devices may include doctor-controlled devices (i.e., programmable devices used by doctors) and / or patient-controlled devices (i.e., programmable devices used by patients). Doctor-controlled devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones, and other smart terminal devices equipped with programmable software. Patient-controlled devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones, and other smart terminal devices equipped with programmable software. Patient-controlled devices may also be other electronic devices with programmable functions (e.g., chargers with programmable functions, electrophysiological data acquisition devices, etc.).

[0082] like Figures 1-4 As shown, this embodiment provides an implantable neurostimulator, comprising a channel module 1 and a main body 2. The channel module 1 includes at least one connecting assembly 12, which forms a connecting channel 11 for inserting a wire 3. The connecting assembly 12 includes a plurality of first conductive plates 121 and a plurality of first conductors 123. The plurality of first conductors 123 correspond one-to-one with the plurality of first conductive plates 121. The first conductors 123 are electrically connected to the first conductive plates 121. The plurality of first conductive plates 121 are spaced apart circumferentially along the connecting channel 11, and the first conductive plates 121 are used to electrically connect to the wire 3. The main body 2 is provided with a circuit board electrically connected to the first conductors 123. In this application, each first conductive plate 121 corresponds to a contact. When the number of contacts increases, it is only necessary to increase the number of first conductive plates 121 along the circumference of the connecting channel 11 without increasing the length of the connecting channel 11. When the length of the connecting channel 11 remains constant, the number of contacts is increased. This application reduces the size of the implantable neurostimulator and can provide more contacts, meeting product structure requirements.

[0083] In the embodiment, the implantable nerve stimulator further comprises a feedthrough assembly 4 mounted on the main body 2, one side of the feedthrough assembly 4 is electrically connected with the first conductor 123, and the other side of the feedthrough assembly 4 is electrically connected with the circuit board, thereby realizing the electrical connection between the channel module 1 and the circuit board of the main body 2, wherein the feedthrough assembly 4 is a prior art. The implantable nerve stimulator further comprises a head portion arranged above the main body 2, and the head portion comprises a silicone cover 5 and the channel module 1, and the silicone cover 5 is wrapped outside the channel module 1 to form a seal.

[0084] The connection structure of the implantable nerve stimulator is simple to manufacture, can provide more connection contacts, and provides a basis for realizing the miniaturization of the IPG or the extension lead 3 and matching the electrical stimulation and monitoring.

[0085] In the embodiment, the channel module 1 further comprises an annular insulating seat 13, the connection channel 11 penetrates through the annular insulating seat 13, and a plurality of first conductive sheets 121 are arranged on the inner wall of the annular insulating seat 13, thereby realizing the fixation of the first conductive sheets 121 and the insulation between the plurality of first conductive sheets 121.

[0086] As shown in Figures 3-6 Preferably, the channel module 1 further comprises a plurality of annular insulating seats 13, the connection assembly 12 is mounted on the annular insulating seat 13 and corresponds one by one, and the plurality of annular insulating seats 13 are sequentially spliced along the axial direction of the connection channel 11. Wherein, the connection channel 11 penetrates through the annular insulating seat 13, and a plurality of first conductive sheets 121 are arranged on the inner wall of the annular insulating seat 13, the annular insulating seat 13 is an insulator, thereby realizing the mutual insulation between the first conductive sheets 121 and the mutual non-interference, the annular insulating seat 13 is made of an insulating material, and the material selection can be ceramic, plastic or other insulating materials.

[0087] In the embodiment, the annular insulating seat 13 is two, the connection assembly 12 is arranged in each of the two annular insulating seats 13, and the connection assemblies 12 between the two annular insulating seats 13 are mutually insulated, thereby further increasing the number of contacts.

[0088] Further preferably, one of the opposite side walls of adjacent annular insulating seats 13 is provided with a positioning column 131, and the other is provided with a positioning hole 132, and the positioning column 131 can extend into the positioning hole 132. During assembly, the positioning column 131 extends into the positioning hole 132, on the one hand, the assembly convenience of the adjacent annular insulating seats 13 is improved; on the other hand, the assembly precision of the adjacent annular insulating seats 13 is improved.

[0089] Further, the connecting assembly 12 further comprises a ring-shaped pressing plate 122, the ring-shaped pressing plate 122 is installed on the ring-shaped insulating seat 13, the ring-shaped pressing plate 122 is annularly provided with a plurality of pressing portions 1221, the plurality of pressing portions 1221 correspond to the plurality of first conductive sheets 121 one by one, the pressing portions 1221 can press the first conductive sheets 121 on the inner wall of the ring-shaped insulating seat 13, so that the first conductive sheets 121 are fixed on the inner wall of the connecting channel 11.

[0090] Preferably, the inner wall of the ring-shaped insulating seat 13 is provided with a first mounting groove 133, the first conductive sheet 121 can be embedded in the first mounting groove 133, which improves the assembly convenience and assembly precision of the first conductive sheet 121, and the first conductive sheet 121 is flush with the inner wall of the ring-shaped insulating seat 13, so that the space in the connecting channel 11 is not occupied, and the wire 3 is conveniently inserted into the connecting channel 11.

[0091] In the embodiment, the two ends of the first conductive sheet 121 are provided with step portions 1211, the step portion 1211 at one end of the first conductive sheet 121 is clamped on the inner wall of the first mounting groove 133, and the step portion 1211 at the other end of the first conductive sheet 121 is pressed by the pressing portion 1221. The side wall of the first mounting groove 133 away from the ring-shaped pressing plate 122 is provided with a first clamping groove, and the step portion 1211 of the first conductive sheet 121 can be embedded in the first clamping groove.

[0092] Further preferably, the inner wall of the ring-shaped insulating seat 13 is provided with a second mounting groove 134, and the ring-shaped pressing plate 122 can be embedded in the second mounting groove 134, which improves the assembly convenience and assembly precision of the ring-shaped pressing plate 122, and the ring-shaped pressing plate 122 is flush with the inner wall of the ring-shaped insulating seat 13, so that the space in the connecting channel 11 is not occupied, and the wire 3 is conveniently inserted into the connecting channel 11. In the embodiment, the second mounting groove 134 is provided at one end of the first mounting groove 133, and the pressing portion 1221 of the ring-shaped pressing plate 122 extends towards the first mounting groove 133.

[0093] In the embodiment, the ring-shaped pressing plate 122 is an insulator, and the ring-shaped pressing plate 122 is made of an insulating material, and the material selection can be ceramic, plastic or other insulating materials.

[0094] Further, the ring-shaped insulating seat 13 is provided with a first avoiding portion 135, and the first conductor 123 can pass through the first avoiding portion 135 and be electrically connected to the first conductive sheet 121. The first avoiding portion 135 is an avoiding hole provided on the side wall of the ring-shaped insulating seat 13; or the first avoiding portion 135 is an avoiding groove provided on the end face of the ring-shaped insulating seat 13. In the embodiment, the first avoiding portion 135 is an avoiding groove, and the avoiding groove and the second mounting groove 134 are both provided at one end of the ring-shaped insulating seat 13.

[0095] Preferably, as Figure 7As shown, the first conductive sheet 121 has elasticity, and the middle part of the first conductive sheet 121 is bent towards the direction close to the axis of the connecting channel 11; the first conductive sheet 121 is a conductive elastic component, has a certain curvature in shape, is installed on the annular insulating seat 13, and can be deformed when pressed.

[0096] As shown in the drawings, Figure 8 and Figure 9 The embodiment provides an implantable lead 3, which comprises a connecting end for docking with an implantable nerve stimulator, the connecting end comprises at least one docking assembly, the docking assembly comprises a plurality of second conductive sheets 33 and a plurality of guide wires 32, the plurality of second conductive sheets 33 are arranged in a ring along the circumferential direction of the lead 3, and the plurality of guide wires 32 correspond to the plurality of second conductive sheets 33 one by one and electrically connect the second conductive sheets 33 and the other end of the lead 3. Each second conductive sheet 33 corresponds to a contact point, when the number of contact points increases, only the number of second conductive sheets 33 needs to be increased along the circumferential direction of the lead 3, without increasing the length of the lead 3, the size of the lead 3 is reduced, and more contact points can be provided to meet the product structure requirements. The implantable lead 3 can be an extension lead or an electrode lead, when the lead 3 is an electrode lead, the other end of the lead 3 is a stimulation end, and the number of stimulation contact points is less than or equal to the number of second conductive sheets 33. Therefore, under the condition that the size of the lead 3 does not change much, the number of second conductive sheets 33 can be increased, so that the number of stimulation contact points is increased.

[0097] Further, in the embodiment, the docking assembly further comprises an insulating ring 31, the plurality of second conductive sheets 33 are arranged in a ring on the outer wall of the insulating ring 31, and the guide wire 32 is arranged in the insulating ring 31. The guide wire 32 is arranged in the side wall of the insulating ring 31 and is electrically connected to the second conductive sheet 33. The insulating ring 31 is made of insulating material, and the material selection can be ceramic, plastic or other insulating materials. The insulating ring 31 realizes the mutual insulation between the plurality of second conductive sheets 33.

[0098] Preferably, the insulating ring 31 is a plurality of insulating rings 31, and the plurality of insulating rings 31 are connected in sequence along the axial direction of the insulating ring 31. In the embodiment, the insulating ring 31, the plurality of guide wires 32 and the plurality of second conductive sheets 33 can form a conductive module, and the plurality of conductive modules are connected in sequence along the axial direction of the lead 3 to form more contact points.

[0099] Further preferably, the outer wall of the insulating ring 31 is provided with a third mounting groove 311, and the two ends of the second conductive sheet 33 are clamped in the third mounting groove 311. The second conductive sheet 33 is installed in the plurality of third mounting grooves 311 of the insulating ring 31, which improves the assembly convenience and assembly precision of the second conductive sheet 33. In the embodiment, the two ends of the third mounting groove 311 along the length direction of the lead 3 are provided with second clamping grooves, the two ends of the second conductive sheet 33 are clamped in the two second clamping grooves, and the middle part of the second conductive sheet 33 is bent and protrudes outward.

[0100] Preferably, the second conductive sheet 33 is elastic, and a middle portion of the second conductive sheet 33 is bent away from the axis of the connecting channel 11. The second conductive sheet 33 is an electrically-conductive elastic component, and has a certain curvature. When pressed, the second conductive sheet 33 can be deformed.

[0101] In the embodiment, the lead wire 3 further comprises a guide head 34 and an outer sleeve 35. The outer sleeve 35, the plurality of conductive modules, and the guide head 34 are connected in sequence. The guide head 34 is conical, and has a guiding effect when the lead wire 3 is inserted.

[0102] The embodiment further provides a nerve stimulator system, which comprises an implantable nerve stimulator and the lead wire 3. The implantable nerve stimulator comprises the channel module 1 and the main body 2. The channel module 1 comprises at least one connecting assembly 12, and the connecting assembly 12 forms the connecting channel 11. The connecting assembly 12 comprises a plurality of first conductive sheets 121 and a plurality of first conductors 123. The plurality of first conductors 123 correspond to the plurality of first conductive sheets 121 in a one-to-one manner. The first conductors 123 are electrically connected to the first conductive sheets 121. The plurality of first conductive sheets 121 are arranged along the circumference of the connecting channel 11 at intervals. The main body 2 is provided with a circuit board electrically connected to the first conductors 123. The lead wire 3 comprises a connecting end for interfacing with the implantable nerve stimulator. The connecting end comprises at least one interfacing assembly. The interfacing assembly comprises a plurality of second conductive sheets 33 and a plurality of guide wires 32. The second conductive sheets 33 correspond to the first conductive sheets 121 in a one-to-one manner. The plurality of second conductive sheets 33 are arranged along the circumference of the lead wire 3 at intervals. The plurality of guide wires 32 correspond to the plurality of second conductive sheets 33 in a one-to-one manner. The guide wires 32 electrically connect the second conductive sheets 33 to the other end of the lead wire 3. The lead wire 3 can be inserted into the connecting channel 11 of the channel module 1, so that the first conductive sheets 121 are electrically connected to the second conductive sheets 33. In use, the lead wire 3 is inserted into the connecting channel 11 of the channel module 1. At this time, the first conductive sheets 121 of the channel module 1 are electrically connected to the second conductive sheets 33 of the lead wire 3 and the first conductors 123 of the main body 2, thereby realizing the transmission of signals between the lead wire 3 and the main body 2. When the number of contacts increases, the number of first conductive sheets 121 along the circumference of the connecting channel 11 and the number of second conductive sheets 33 along the circumference of the lead wire 3 only need to be increased. The embodiment reduces the overall size of the nerve stimulator system, and can provide more contacts to meet the product structure requirements.

[0103] In the embodiment, after the lead wire 3 is inserted into the connecting channel 11, the first conductive sheets 121 or the second conductive sheets 33 are elastically pressed, and the two are in interference fit electrical connection, thereby improving the electrical connection reliability of the first conductive sheets 121 and the second conductive sheets 33. The first conductive sheets 121 and the second conductive sheets 33 are made of elastic conductors. The materials can be stainless steel, pure titanium, nickel-titanium alloy, etc. The main forming methods are laser cutting or stamping, etc.

[0104] The embodiment also provides an assembly method of the neural stimulator system, comprising the following steps:

[0105] S1, assembling the implantable neural stimulator.

[0106] S2, assembling the lead 3.

[0107] S3, the lead 3 is plugged into the implantable neural stimulator, so that the lead 3 is electrically connected to the implantable neural stimulator.

[0108] In the embodiment, the S1 step comprises a channel module assembly method, and the channel module assembly method comprises the following steps:

[0109] S11, electrically connecting the first conductive sheet 121 to the first conductor 123, and the electrical connection can be welding or cold pressing pipe switching.

[0110] S12, installing the first conductive sheet 121 in the plurality of first installation grooves 133 of the annular insulating seat 13, at this time, the first conductor 123 is located in the avoidance groove, and the stepped portion 1211 at one end of the plurality of first conductive sheets 121 extends into the plurality of first clamping grooves.

[0111] S13, embedding the annular pressing sheet 122 through one end of the annular insulating seat 13 into the second installation groove 134 of the annular insulating seat 13, until the pressing portion 1221 of the annular pressing sheet 122 is pressed to the plurality of first conductive sheets 121, the annular pressing sheet 122 is connected to the annular insulating seat 13, and the fixation of the first conductive sheet 121 is realized; wherein the connection mode of the annular pressing sheet 122 and the annular insulating seat 13 can be welding, adhesive bonding or buckle connection.

[0112] S14, sequentially connecting a plurality of annular insulating seats 13 assembled with the connecting assembly 12 to combine a channel module 1 with more contacts, thereby improving the assembly efficiency.

[0113] Preferably, the S2 step comprises a lead assembly method, and the lead assembly method comprises the following steps:

[0114] S21, installing the plurality of second conductive sheets 33 in the plurality of third installation grooves 311 in the insulating ring 31.

[0115] S22, electrically connecting the second conductive sheet 33 and the guide wire 32, and the main mode is welding or conductive adhesive bonding; the insulating ring 31 assembled with the second conductive sheet 33 and the guide wire 32 forms a butt joint assembly.

[0116] S23, sequentially connecting the outer sleeve 35 and the plurality of butt joint assemblies, and then filling and filling glue in the inside of the outer sleeve 35 and the plurality of butt joint assemblies, and the filler can be polyurethane or epoxy resin or other insulating material.

[0117] S24, installing the guide head 34.

[0118] Note that the above merely describes preferred embodiments of the present application and the principles of technology applied. Those skilled in the art will understand that the present application is not limited to the specific embodiments described herein, and that various obvious changes, modifications and substitutions can be made by those skilled in the art without departing from the scope of the present application. Therefore, although the present application has been described in detail through the above embodiments, the present application is not limited to the above embodiments, and can include more other equivalent embodiments without departing from the concept of the present application, and the scope of the present application is determined by the scope of the claims.

Claims

1. An implantable neurostimulator, characterized in that: The implantable neurostimulator comprises: A channel module (1), the channel module (1) comprising at least one connecting component (12), the connecting component (12) forming a connecting channel (11) for connecting a wire, the connecting component (12) comprising a plurality of first conductive sheets (121) and a plurality of first conductors (123), the plurality of first conductors (123) corresponding one-to-one to the plurality of first conductive sheets (121), the first conductors (123) being electrically connected to the first conductive sheets (121), the plurality of first conductive sheets (121) being circumferentially spaced apart along the connecting channel (11), and the first conductive sheets (121) being used to be electrically connected to the wires; The main body (2) is provided with a circuit board electrically connected to the first conductor (123).

2. The implantable neurostimulator according to claim 1, wherein The channel module (1) further comprises an annular insulating seat (13), the connecting channel (11) passes through the annular insulating seat (13), and a plurality of the first conductive sheets (121) are arranged on the inner wall of the annular insulating seat (13).

3. The implantable neurostimulator according to claim 2, wherein: The channel module (1) further comprises a plurality of annular insulating seats (13), the connecting components (12) being mounted on the annular insulating seats (13) in a one-to-one correspondence, and the plurality of annular insulating seats (13) being spliced ​​in sequence along the axial direction of the connecting channel (11).

4. The implantable neurostimulator according to claim 3, wherein One of the two opposite side walls of the adjacent annular insulating seat (13) is provided with a positioning column (131), and the other is provided with a positioning hole (132), and the positioning column (131) can extend into the positioning hole (132).

5. The implantable neurostimulator according to claim 1, wherein The implantable neurostimulator further comprises a feedthrough component (4), wherein the feedthrough component (4) is mounted on the main body (2), one side of the feedthrough component (4) is electrically connected to the first conductor (123), and the other side of the feedthrough component (4) is electrically connected to the circuit board.

6. The implantable neurostimulator according to claim 3, wherein: The connecting assembly (12) further comprises an annular pressing piece (122), the annular pressing piece (122) being mounted on the annular insulating seat (13), the annular pressing piece (122) being provided with a plurality of crimping portions (1221) around the annular pressing piece (122), the plurality of crimping portions (1221) corresponding one-to-one to the plurality of first conductive sheets (121), the crimping portions (1221) being capable of crimping the first conductive sheets (121) onto the inner wall of the annular insulating seat (13).

7. The implantable neurostimulator according to claim 6, wherein: The inner wall of the annular insulating seat (13) is provided with a first mounting groove (133), and the first conductive sheet (121) can be embedded in the first mounting groove (133).

8. The implantable neurostimulator according to claim 7, wherein: Step portions (1211) are provided at both ends of the first conductive sheet (121), the step portion (1211) at one end of the first conductive sheet (121) is clamped to the inner wall of the first mounting groove (133), and the crimping portion (1221) is crimped to the step portion (1211) at the other end of the first conductive sheet (121).

9. The implantable neurostimulator according to claim 6, wherein: The inner wall of the annular insulating seat (13) is provided with a second mounting groove (134), and the annular pressing piece (122) can be embedded in the second mounting groove (134).

10. The implantable neurostimulator according to claim 3, wherein: The annular insulating seat (13) is provided with a first avoidance portion (135), and the first conductor (123) can pass through the first avoidance portion (135) and be electrically connected to the first conductive sheet (121).

11. The implantable neurostimulator according to claim 10, wherein: The first avoidance portion (135) is a avoidance hole, and the avoidance hole is provided on the side wall of the annular insulating seat (13); or The first avoidance portion (135) is a avoidance groove, and the avoidance groove is provided on the end surface of the annular insulating seat (13).

12. The implantable neurostimulator according to claim 10, wherein: The first conductive sheet (121) is elastic, and a middle portion of the first conductive sheet (121) is bent in a direction close to the axis of the connecting channel (11).

13. A guide wire comprising a connection end for docking with an implantable neurostimulator, characterized in that: The connecting end includes at least one docking component, and the docking component includes a plurality of second conductive sheets (33) and a plurality of guide wires (32). The plurality of second conductive sheets (33) are arranged in a ring at intervals along the circumference of the wire. The plurality of guide wires (32) correspond to the plurality of second conductive sheets (33) one by one, and the guide wires (32) electrically connect the second conductive sheets (33) with the other end of the wire.

14. The guide wire according to claim 13, characterized in that The docking assembly further comprises an insulating ring (31), a plurality of second conductive sheets (33) are arranged at intervals on the outer wall of the insulating ring (31), and the guide wire (32) is passed through the insulating ring (31).

15. The guide wire according to claim 14, characterized in that There are a plurality of insulating rings (31), and the plurality of insulating rings (31) are connected in sequence along the axial direction of the insulating ring (31).

16. The guide wire according to claim 14, characterized in that The outer wall of the insulating ring (31) is provided with a third installation groove (311), and both ends of the second conductive sheet (33) are clamped in the third installation groove (311).

17. The guide wire according to claim 14, characterized in that The second conductive piece (33) is elastic, a middle portion of the second conductive piece (33) is bent in an axial direction away from the insulating ring (31), and the second conductive piece (33) elastically protrudes from the outer wall of the insulating ring (31).

18. A neurostimulator system, characterized in that: The implantable neurostimulator comprises an implantable neurostimulator and a lead, wherein the implantable neurostimulator comprises a channel module (1) and a main body (2), wherein the channel module (1) comprises at least one connecting component (12), wherein at least one connecting component (12) forms a connecting channel (11), wherein the connecting component (12) comprises a plurality of first conductive sheets (121) and a plurality of first conductors (123), wherein the plurality of first conductors (123) correspond one-to-one to the plurality of first conductive sheets (121), wherein the first conductors (123) are electrically connected to the first conductive sheets (121), and wherein the plurality of first conductive sheets (121) are arranged in the connecting channel (11) at intervals along the circumference of the connecting channel (11); and wherein the main body (2) is provided with a circuit board electrically connected to the first conductors (123); The lead comprises a connection end for docking with an implantable neurostimulator, the connection end comprises at least one docking assembly, the docking assembly comprises a plurality of second conductive sheets (33) and a plurality of guide wires (32), the second conductive sheets (33) and the first conductive sheets (121) correspond one to one, the plurality of second conductive sheets (33) are arranged in a ring at intervals along the circumference of the lead, the plurality of guide wires (32) and the plurality of second conductive sheets (33) correspond one to one, and the guide wires (32) electrically connect the second conductive sheets (33) to the other end of the lead; The wire can be plugged into the connection channel (11) to electrically connect the first conductive sheet (121) to the second conductive sheet (33).

19. A method for assembling a neurostimulator system, characterized in that: The following steps are involved: S1, assemble the implantable neurostimulator; S2, assemble the wires; S3, the lead is plugged into the implantable neurostimulator; The S1 step includes a channel module assembly method, and the channel module assembly method includes the following steps: S11, electrically connecting the first conductive sheet (121) and the first conductor (123); S12, installing the first conductive sheet (121) in a plurality of first installation grooves (133) of the annular insulating seat (13); S13, embedding the annular pressing piece (122) into the second mounting groove (134) of the annular insulating seat (13) through one end of the annular insulating seat (13), until the crimping portion (1221) of the annular pressing piece (122) is crimped onto the plurality of first conductive sheets (121), and the annular pressing piece (122) is connected to the annular insulating seat (13); S14, sequentially connecting the plurality of annular insulating seats (13) assembled with the connection components (12).

20. The method for assembling a neurostimulator system according to claim 19, wherein: The S2 step includes a wire assembly method, which includes the following steps: S21, installing a plurality of second conductive sheets (33) in a plurality of third installation grooves (311) in the insulating ring (31); S22, electrically connecting the second conductive sheet (33) and the guide wire (32), and assembling the insulating ring (31) with the second conductive sheet (33) and the guide wire (32) to form a docking assembly; S23, connecting the outer sleeve (35) and the plurality of docking assemblies in sequence, and then filling the inner portions of the outer sleeve (35) and the plurality of docking assemblies with glue; S24, install the guide head (34).

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