A channel module and an implantable neurostimulator

Abstract

The application relates to the technical field of medical products, and discloses a channel module and an implantable nerve stimulator. The channel module comprises a substrate, elastic conductive pieces and a module upper cover. The substrate is provided with a plurality of through holes for penetrating conductors. The elastic conductive pieces are installed on the substrate at intervals, and the elastic conductive pieces can be electrically connected to the conductors. The module upper cover is installed on the substrate and covers the elastic conductive pieces from above, and a channel for penetrating a wire is formed between the module upper cover and the elastic conductive pieces. The elastic conductive pieces replace the whole connector assembly in the prior art, the overall size of the channel module can be reduced, and the implantable nerve stimulator can be designed to be small.

Description

Technical Field

[0001] This application relates to the field of medical product technology, and in particular to a channel module and an implantable neurostimulator. Background Technology

[0002] Currently, for motor disorders such as Parkinson's disease, epilepsy, dystonia, and spinal cord pain, or mental illnesses such as depression, alcoholism, and obsessive-compulsive disorder, when the effectiveness of drug treatment declines, deep brain stimulation (DBS) or a combination of spinal cord stimulation can be used to improve treatment outcomes. Taking DBS as an example, its main implantable components are an IPG (intravascular coagulation) module, extension leads, and electrode leads. The main component that enables electrical connections between the IPG module, the extension leads, and the electrode leads is the channel module.

[0003] like Figure 1 As shown, current market channel modules are equipped with a connecting component 1', which includes a cover 11' and spring coils 12'. Multiple spring coils 12' are spaced apart within the channel 13' of the cover 11', and the spring coils 12' are arranged around the channel 13'. After the wire is inserted into the channel 13', the wire is electrically connected to the conductor of the pulse generator body through the spring coils 12'. However, the cover 11' and spring coils 12' are relatively large, which limits the overall size of the channel module and affects the miniaturization requirements of implantable neurostimulators. Utility Model Content

[0004] Based on the above, the purpose of this application is to provide a channel module and an implantable neurostimulator, which solves the problem that the large size of the connecting components limits the overall size of the channel module and affects the miniaturization requirements of the implantable neurostimulator.

[0005] To achieve the above objectives, this application adopts the following technical solution:

[0006] On the one hand, a channel module is provided, including:

[0007] A substrate having a plurality of through holes for passing conductors through it;

[0008] Multiple elastic conductive elements are spaced apart and mounted on the substrate, and the elastic conductive elements are electrically connected to the conductor;

[0009] A module cover is mounted on the substrate and covers the elastic conductive element, forming a channel between the module cover and the elastic conductive element for wires to pass through.

[0010] As a preferred technical solution for a channel module, the top of the elastic conductive element is provided with a recessed elastic arc-shaped wall, which is used to fit the wire.

[0011] As a preferred technical solution for a channel module, the elastic arc-shaped wall is provided with protrusions for fitting the wire.

[0012] As a preferred technical solution for a channel module, the elastic conductive element is provided with legs at both ends, and the legs are connected to the substrate.

[0013] As a preferred technical solution for a channel module, the legs are bonded, snapped, or welded to the substrate.

[0014] As a preferred technical solution for a channel module, the support foot is provided with a connection hole for the conductor to pass through, and the conductor can extend into the connection hole and be electrically connected to the support foot.

[0015] As a preferred technical solution for a channel module, the bottom of the elastic conductive element is disposed inside the substrate.

[0016] As a preferred technical solution for a channel module, there are two channels, which extend along a first direction and are spaced apart along a second direction, wherein the first direction is perpendicular to the second direction.

[0017] As a preferred technical solution for a channel module, the legs of the two channels that are close to each other are staggered along the first direction.

[0018] As a preferred technical solution for a channel module, the elastic conductive element is provided with a snap-fit ​​portion for snapping the wire.

[0019] As a preferred technical solution for a channel module, the elastic conductive element is provided with a guide portion at one end near the inlet of the channel, and the guide portion is used to provide guidance when the wire is inserted.

[0020] As a preferred technical solution for a channel module, the guide portion is chamfered or has a guide arc surface.

[0021] On the other hand, an implantable neurostimulator is provided, comprising a pulse generator body and a channel module as described in any of the above. The channel module is mounted above the pulse generator body. The pulse generator body is provided with a conductor and a circuit board. One end of the conductor is electrically connected to the circuit board, and the other end passes through a through hole and is electrically connected to the elastic conductive element.

[0022] As a preferred technical solution for an implantable neurostimulator, the elastic conductive element is welded or pressed onto the conductor.

[0023] As a preferred technical solution for an implantable neurostimulator, the top of the pulse generator body is provided with an opening, the substrate is provided with a flange, the substrate is partially embedded in the opening and the flange overlaps the top of the pulse generator body.

[0024] The beneficial effects of this application are as follows:

[0025] This application provides a channel module and an implantable neurostimulator. During assembly, the conductor of the pulse generator body passes through the through hole of the substrate and is electrically connected to the elastic conductive element. When the wire is inserted into the channel, the elastic conductive element elastically abuts against the side wall of the wire, and the wire is electrically connected to the elastic conductive element. Thus, the wire is electrically connected to the conductor through the elastic conductive element, which meets the working requirements of the implantable neurostimulator. This application replaces the entire connector assembly in the prior art with an elastic conductive element, which can reduce the overall size of the channel module and enable the implantable neurostimulator to be miniaturized. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments of this application will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of this application and these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the structure of an implantable neurostimulator in the prior art;

[0028] Figure 2 This is a partial structural schematic diagram of the implantable neurostimulator provided in a specific embodiment of this application;

[0029] Figure 3 This is a partial structural schematic diagram of the channel module provided in a specific embodiment of this application;

[0030] Figure 4 This is a partial structural cross-sectional view of the channel module provided in the specific embodiments of this application;

[0031] Figure 5 This is a schematic diagram of the structure of the implantable neurostimulator provided in a specific embodiment of this application;

[0032] Figure 6 This is an exploded view of the structure of the implantable neurostimulator provided in the specific embodiments of this application.

[0033] The markings in the image are as follows:

[0034] 1' Connecting component; 11' Cover; 12' Spring ring; 13' Channel;

[0035] 100. Channel module; 200. Pulse generator body; 201. Conductor; 202. Circuit board; 203. Opening; 300. Wire; 400. Silicone cover;

[0036] 1. Substrate; 11. Through-hole; 12. Flanged edge;

[0037] 2. Elastic conductive component; 21. Elastic arc-shaped wall; 22. Support wall; 23. Support leg; 231. Connecting hole;

[0038] 3. Module top cover. Detailed Implementation

[0039] The present application will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the application and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present application, not the entire structure.

[0040] In the description of this application, unless otherwise expressly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0041] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0042] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. In addition, the terms "first" and "second" are used only for distinction in description and have no special meaning.

[0043] The technical field and related terms of the embodiments of this application are briefly described below.

[0044] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead transfer systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0045] Implantable neurostimulation systems consist of a stimulator implanted in the patient's body (i.e., an implantable neurostimulator) and a programmed device placed outside the patient's body. In other words, the stimulator is a medical device, or medical devices include stimulators. Related neuromodulation techniques primarily involve stereotactic surgery to implant electrodes (e.g., electrode wires) at specific sites (target points) in the body's tissues. Discharge pulses are then delivered through these electrodes to the target points, modulating the electrical activity and function of corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0046] As an example, a DBS includes an IPG (Implantable Pulse Generator), extension leads, and electrode leads. The IPG is connected to the electrode leads via the extension leads. The IPG is implanted in the patient's body, for example, in the chest or other internal locations.

[0047] As another example, DBS includes an IPG and electrode leads, with the IPG directly connected to the electrode leads. The IPG is implanted in the patient's head, for example, by creating a groove in the patient's skull and then placing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may protrude partially from the outer surface of the skull.

[0048] In this system, the IPG responds to programmed commands sent by a programmable device, relying on sealed batteries and circuits to provide controllable electrical stimulation therapy (or electrical stimulation energy) to tissues within the body. The IPG delivers one or more controllable specific electrical stimuli to specific areas of tissues within the body via electrode leads.

[0049] In some embodiments, the extension wire is used in conjunction with the IPG as a medium for transmitting electrical stimulation, thereby transmitting the electrical stimulation generated by the IPG to the electrode wire.

[0050] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Therefore, non-pulsed signal electrical stimulation can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms.

[0051] After receiving electrical stimulation from the IPG or extension leads, the electrode leads deliver the stimulation to specific areas of tissue within the body via multiple electrode contacts. The stimulator may have one or more electrode leads on one or both sides, with multiple electrode contacts on each lead. These contacts may be evenly or non-uniformly arranged circumferentially on the electrode leads. As an example, the electrode contacts may be arranged in a 4x3 array (a total of 12 contacts) circumferentially on the electrode leads. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts. The electrode contacts may be in shapes such as sheet-like, ring-like, or dot-like.

[0052] In some embodiments, the stimulated tissue may be the patient's brain tissue, and the stimulated site may be a specific location within the brain tissue. Generally, the stimulated site differs depending on the patient's disease type, and the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation pathways (single-channel or multi-channel), and the stimulation parameters (values) also vary.

[0053] This application does not limit the applicable disease types, but can be any disease type applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, or functional electrical stimulation. Among these, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility 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 impairments.

[0054] In this embodiment of the application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, with different stimulation parameters corresponding to different electrical stimuli). Alternatively, the stimulator can sense the patient's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue adjusting the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0055] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact #2 and electrode contact #3), frequency (e.g., the number of electrical stimulation pulse signals per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty refers to 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), physician control upper and lower limits (the range that the physician can adjust), and patient control upper and lower limits (the range that the patient can adjust independently).

[0056] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0057] Programmable devices can include physician-controlled devices (i.e., devices used by physicians) and / or patient-controlled devices (i.e., devices used by patients). Physician-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. Patient-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; patient-controlled devices can also be other electronic devices with programming functions (e.g., chargers with programming functions, electrophysiological acquisition devices, etc.).

[0058] like Figures 2-4As shown, this embodiment provides a channel module 100, which includes a substrate 1, an elastic conductive element 2, and a module cover 3. The substrate 1 is provided with a plurality of through holes 11 for passing through conductors 201. A plurality of elastic conductive elements 2 are spaced apart on the substrate 1 and can be electrically connected to conductors 201. The module cover 3 is mounted on the substrate 1 and covers the elastic conductive elements 2, forming a channel for passing through wires 300 between the module cover 3 and the elastic conductive elements 2. During assembly, the conductor 201 of the pulse generator body 200 passes through the through hole 11 of the substrate 1 and is electrically connected to the elastic conductive element 2. When the wire 300 is inserted into the channel, the elastic conductive element 2 elastically abuts against the side wall of the wire 300, and the wire 300 is electrically connected to the elastic conductive element 2. Thus, the wire 300 is electrically connected to the conductor 201 through the elastic conductive element 2, which meets the working requirements of the implantable neurostimulator. This application replaces the entire connector assembly in the prior art with the elastic conductive element 2, which can reduce the overall size of the channel module 100 and enable the implantable neurostimulator to be miniaturized.

[0059] In this embodiment, the channel module 100 reduces the upper space requirement caused by the complete connector assembly in the height direction, and reduces the lower space requirement caused by the connection between the connector assembly and the feed conductor 201, thereby minimizing the height of the module channel and reducing the height dimension of the channel module 100.

[0060] In this embodiment, the substrate 1 and the module cover 3 are insulators. The substrate 1 and the module cover 3 wrap the elastic conductive element 2 to form a module channel. The materials of the substrate 1 and the module cover 3 can be insulating materials such as ceramics and plastics.

[0061] In this embodiment, the top of the elastic conductive element 2 is provided with a recessed elastic arc-shaped wall 21, which is used to fit the wire 300. After the wire 300 is inserted into the channel, the elastic arc-shaped wall 21 can deform under pressure, and the elastic arc-shaped wall 21 can better fit the side wall of the wire 300, increase the contact area with the wire 300, and thus increase the reliability of the electrical connection.

[0062] Preferably, the elastic arc-shaped wall 21 is provided with protrusions for fitting the wire 300. After the wire 300 is inserted into the channel, the protrusions contact the contacts of the wire 300 to achieve electrical connection, thereby improving the reliability of the connection between the wire 300 and the elastic conductive element 2.

[0063] More preferably, the elastic conductive element 2 is provided with a snap-fit ​​part for snapping the wire 300. The snap-fit ​​part can be a slot or buckle provided on the elastic arc-shaped wall 21. After the wire 300 is inserted into the channel, the slot or buckle can snap onto the side wall of the wire 300, which improves the connection stability between the wire 300 and the channel and makes the wire 300 less likely to fall off.

[0064] To prevent the sidewall of the wire 300 from being scratched by the elastic conductive element 2 during insertion, preferably, a guide portion is provided at one end of the elastic conductive element 2 near the inlet of the channel. The guide portion provides guidance during insertion of the wire 300, improving the ease of insertion. The guide portion is chamfered or has a guide arc surface, and its function is to prevent the wire 300 from being scratched.

[0065] Furthermore, the elastic conductive element 2 is provided with legs 23 at both ends, and the legs 23 are connected to the substrate 1. The elastic conductive element 2 is connected to the substrate 1 by the two legs 23, which improves the connection stability. Specifically, the legs 23 can be connected to the substrate 1 by adhesive, snap-fit, or welding.

[0066] In other embodiments, the bottom of the elastic conductive element 2 is disposed inside the substrate 1. The elastic conductive element 2 and the substrate 1 can be integrally molded using an injection molding process, further reducing the dimension of the channel module 100 along the height direction.

[0067] In this embodiment, support walls 22 are also provided at both ends of the elastic arc-shaped wall 21, and the elastic arc-shaped wall 21 is connected to two legs 23 through the two support walls 22. The elastic conductive element 2 is made of an elastic conductor 201, and the material of the elastic conductive element 2 can be stainless steel, pure titanium, nickel-titanium alloy, etc., and the main forming method is laser cutting or stamping.

[0068] Preferably, the support leg 23 is provided with a connection hole 231 for the conductor 201 to pass through, and the conductor 201 can extend into the connection hole 231 and be electrically connected to the support leg 23. On the one hand, when installing the elastic conductive element 2, the conductor 201 passes through the connection hole 231 of the support leg 23, realizing the positioning and assembly of the elastic conductive element 2; on the other hand, the conductor 201 is electrically connected to the connection hole 231, realizing the electrical connection between the conductor 201 and the elastic conductive element 2.

[0069] In other embodiments, the elastic conductive element 2 may also be pressed onto the conductor 201 to achieve an electrical connection between the two.

[0070] In this embodiment, there are two channels extending along a first direction and spaced apart along a second direction. The first direction is perpendicular to the second direction, so that the channel module 100 can be connected to two wires 300. In this embodiment, the first direction is X and the second direction is Y.

[0071] Preferably, the legs 23 of the two channels are staggered along the first direction on the side closest to each other. The staggered arrangement of the elastic conductive elements 2 of the two channels can improve the space utilization inside the channel module 100 and further reduce the size of the channel module 100 along the second direction.

[0072] like Figure 2 , Figure 5 and Figure 6 As shown, this embodiment also provides an implantable neurostimulator, including a pulse generator body 200 and the aforementioned channel module 100. The channel module 100 is mounted above the pulse generator body 200. The pulse generator body 200 is provided with a conductor 201 and a circuit board 202. One end of the conductor 201 is electrically connected to the circuit board 202, and the other end passes through a through hole 11 and is electrically connected to the elastic conductive element 2. By employing the aforementioned channel module 100, this implantable neurostimulator can reduce its height dimension while ensuring basic functions, achieving a miniaturized design of the implantable neurostimulator. The substrate 1 is connected to the top of the pulse generator body 200.

[0073] In this embodiment, as Figure 3 As shown, the elastic conductive element 2 is welded or pressed onto the conductor 201, thereby achieving an electrical connection between the elastic conductive element 2 and the conductor 201.

[0074] like Figure 5 and Figure 6 As shown, the implantable neurostimulator also includes a head, which includes a silicone cover 400 and a channel module 100. The silicone cover 400 covers the outside of the channel module 100 to form a seal.

[0075] In this embodiment, the top of the pulse generator body 200 is provided with an opening 203, and the substrate 1 is provided with a flange 12. The substrate 1 is partially embedded in the opening 203 and the flange 12 overlaps the top of the pulse generator body 200, which improves the assembly accuracy and assembly strength of the substrate 1 and the pulse generator body 200.

[0076] Note that the above are merely preferred embodiments and the technical principles employed in this application. Those skilled in the art will understand that this application is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of this application. Therefore, although this application has been described in detail through the above embodiments, this application is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of this application, the scope of which is determined by the scope of the appended claims.

Claims

1. A channel module, characterized in that, include: The substrate (1) is provided with a plurality of through holes (11) for passing through conductors (201); Multiple elastic conductive elements (2) are spaced apart on the substrate (1) and the elastic conductive elements (2) are electrically connected to the conductor (201); A module cover (3) is mounted on the substrate (1) and covers the elastic conductive element (2), forming a channel between the module cover (3) and the elastic conductive element (2) for the wire (300) to pass through.

2. The channel module according to claim 1, characterized in that, The top of the elastic conductive element (2) is provided with a recessed elastic arc-shaped wall (21), which is used to fit the wire (300).

3. The channel module according to claim 2, characterized in that, The elastic arc-shaped wall (21) is provided with protrusions for fitting the conductor (300).

4. The channel module according to claim 1, characterized in that, The elastic conductive element (2) has legs (23) at both ends, and the legs (23) are connected to the substrate (1).

5. The channel module according to claim 4, characterized in that, The support leg (23) is bonded, snapped or welded to the substrate (1).

6. The channel module according to claim 4, characterized in that, The support leg (23) is provided with a connection hole (231) for the conductor (201) to pass through, and the conductor (201) can extend into the connection hole (231) and be electrically connected to the support leg (23).

7. The channel module according to claim 1, characterized in that, The bottom of the elastic conductive element (2) is disposed inside the substrate (1).

8. The channel module according to claim 4, characterized in that, There are two channels, which extend along a first direction and are spaced apart along a second direction, with the first direction perpendicular to the second direction.

9. The channel module according to claim 8, characterized in that, The legs (23) of the two channels are staggered along the first direction, with the legs (23) on one side of each other being close to each other.

10. The channel module according to claim 7, characterized in that, The elastic conductive element (2) is provided with a snap-fit ​​portion for snapping the wire (300).

11. The channel module according to claim 7, characterized in that, The elastic conductive element (2) has a guide portion at one end near the inlet of the channel, which is used to guide the wire (300) when it is inserted.

12. The channel module according to claim 11, characterized in that, The guide portion is a chamfered or guide arc surface.

13. An implantable neurostimulator, characterized in that, The device includes a pulse generator body (200) and a channel module as described in any one of claims 1-12. The channel module is mounted above the pulse generator body (200). The pulse generator body (200) is provided with a conductor (201) and a circuit board (202). One end of the conductor (201) is electrically connected to the circuit board (202), and the other end passes through a through hole (11) and is electrically connected to the elastic conductive element (2).

14. The implantable neurostimulator according to claim 13, characterized in that, The elastic conductive element (2) is welded or pressed onto the conductor (201).

15. The implantable neurostimulator according to claim 13, characterized in that, The pulse generator body (200) has an opening (203) at the top, and the substrate (1) has a flange (12). The substrate (1) is partially embedded in the opening (203) and the flange (12) overlaps the top of the pulse generator body (200).

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