A channel module, an extension lead, a stimulator and a neurostimulation system

Abstract

The utility model discloses a passageway module, extension wire, stimulator and nerve stimulation system, passageway module includes shell, the several conductive elements of accommodating in shell and the several sealing rings of interval setting with conductive element, and conductive element and sealing ring form the passageway that electrode wire inserts, sealing ring is equipped with at least one structural member made of shape memory material, and structural member keeps relaxed and releases sealing ring when being below certain temperature threshold value, and structural member contracts and drives sealing ring to contract towards the passageway and seals abuts to electrode wire when reaching or being higher than certain temperature threshold value. The utility model is used for guaranteeing the reliable sealing between each contact in passageway, and reducing the difficulty of electrode wire's plug -in.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a channel module, an extension wire, a stimulator and a nerve stimulation system. Background Technology

[0002] Currently, most mainstream IPGs on the market employ a sealed design for their connection to extension leads or electrode leads. This sealing structure consists of one or more silicone rubber sealing rings within the connection channel. The insert section of the electrode lead, which mates with this design, is typically a uniformly shaped cylindrical structure, achieving an effective seal through an interference fit with the sealing rings.

[0003] However, with the increasing demand for more contact points in deep brain stimulation (DBS) technology, more sealing rings are needed within the connection structure to ensure reliable sealing between each contact point. This directly results in each sealing ring generating corresponding insertion and extraction resistance. During the insertion of the electrode lead into the extension lead channel, the interference fit between multiple sealing rings and the lead surface will accumulate to generate insertion friction. This friction significantly increases the difficulty of the surgeon's operation, and excessive resistance can easily lead to incomplete electrode and extension lead insertion, thereby causing the risk of open circuits during surgery and directly affecting the success rate and treatment effect. Summary of the Invention

[0004] The purpose of this invention is to provide a channel module, an extension wire, a stimulator, and a nerve stimulation system to ensure reliable sealing between contacts within the extension wire channel and reduce the difficulty of inserting and removing electrode wires.

[0005] The objective of this utility model is achieved through the following technical solution: A channel module electrically connected to an implantable electrode wire, the channel module including a housing, a plurality of conductive elements housed within the housing, and a plurality of sealing rings spaced apart from the conductive elements, the conductive elements and the sealing rings forming a channel for insertion of the electrode wire; The sealing ring has at least one structural member made of shape memory material. The structural member remains relaxed and releases the sealing ring when the temperature is below a certain temperature threshold. When the temperature reaches or exceeds a certain temperature threshold, the structural member contracts and drives the sealing ring to contract toward the channel to seal against the electrode wire.

[0006] Preferably, the structural component is spiral, mesh, or ring-shaped; The shape memory material is a shape memory alloy or a shape memory polymer.

[0007] Preferably, the certain temperature threshold is greater than room temperature and less than or equal to the internal temperature of the human body.

[0008] Preferably, the sealing ring is made of a flexible material.

[0009] Preferably, the sealing ring is provided with at least one sealing rib protruding into the channel, and the structural member is disposed on the outer periphery of at least one of the sealing ribs; or the structural member is embedded in at least one of the sealing ribs and is covered by the sealing ribs.

[0010] Preferably, there are multiple sealing ribs, including a first rib and a second rib located at both ends of the inner hole of the sealing ring, and a main rib located between the first rib and the second rib; the structural member is disposed on the outer periphery of the main rib; or the structural member is embedded in the main rib and covered by the main rib, and when the structural member is below a certain temperature threshold, the main rib remains relaxed, and when the structural member reaches or exceeds a certain temperature threshold, the main rib contracts inward.

[0011] Preferably, stress relief cuts are provided on both sides of the main reinforcement; The inner wall of the main rib is coated with silicone oil.

[0012] Preferably, the sealing ring is stepped and includes a first adapter portion and a second adapter portion coaxially arranged, wherein the outer diameter of the first adapter portion is smaller than the outer diameter of the second adapter portion; The outer peripheral wall of the second adapter is provided with a protruding structure for engaging with the inner wall of the outer shell.

[0013] An implantable extension lead, wherein one end of the extension lead is provided with a channel module as described above.

[0014] An implantable stimulator, the stimulator having a channel module as described above.

[0015] A neural stimulation system includes: an electrode lead, a stimulator as described above, and an extension lead as described above, wherein one end of the electrode lead and the extension lead have a channel module, and the other end of the extension lead is electrically connected to the channel module of the stimulator.

[0016] Compared with the prior art, the beneficial effects of this utility model include at least the following: By incorporating a shape-memory material structural component within the sealing ring, when the component's temperature falls below a certain threshold, it maintains an appropriate gap between the sealing ribs and the electrode leads. This effectively reduces frictional resistance during insertion, making electrode lead placement smoother and easier, thus simplifying the surgical procedure. When the component reaches or exceeds a certain temperature threshold, it deforms due to heat, causing the sealing ribs to contract inward and form a stable interference fit with the electrode leads. This ensures a reliable seal and also helps improve the surgeon's comfort, surgical success rate, and treatment outcomes. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the assembly structure of the sealing ring and conductive elements of the channel module according to an embodiment of this utility model; Figure 2 This is a schematic diagram of the connection structure between the pre-implantation electrode wire and the sealing ring according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the connection structure between the implanted electrode wire and the sealing ring according to an embodiment of the present invention; Figure 4 This is an embodiment of the present utility model. Figure 2 Enlarged schematic diagram of part A in the diagram; Figure 5 This is an embodiment of the present utility model. Figure 3 Enlarged schematic diagram of the structure of section B in the middle; Figure 6 This is a schematic diagram of the sealing ring structure according to an embodiment of the present invention; Figure 7 This is a schematic diagram of the structure of a structural component made of shape memory material according to an embodiment of the present invention; Figure 8 This is a cross-sectional view of the sealing ring and structural components according to an embodiment of the present invention. In the diagram: 100, channel module; 11, outer shell; 111, channel; 112, accommodating space; 113, hole; 12, limiting structure; 13, connecting block; 14, set screw; 15, water seal; 200, sealing ring; 21, first adapter; 22, second adapter; 23, protruding structure; 24, recessed groove; 25, inner hole; 26, first rib; 27, second rib; 28, main rib; 29, cutout; 300, conductive element; 301, metal shell; 302, contact spring; 31, limiting groove; 400, electrode wire; 500, structural component. Detailed Implementation

[0018] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided to make the present invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0019] The terms used to describe position and direction in this utility model are illustrated with the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this utility model. Example 1

[0020] like Figures 1 to 8 As shown, this utility model provides a channel module 100 that is electrically connected to an implantable electrode wire, including a plurality of conductive elements 300 housed in a housing 11 and a plurality of sealing rings 200 spaced apart from the conductive elements 300.

[0021] like Figure 1 As shown, an accommodating space 112 is formed inside the outer casing 11, and the sealing ring 200 and the conductive element 300 are alternately stacked in the accommodating space 112 along the axial direction of the outer casing 11. The conductive element 300 includes a metal housing 301 and a contact spring 302 housed in the metal housing 301.

[0022] The conductive element 300 and the sealing ring 200 form a channel 111 for inserting the electrode wire 400. The diameter of the accommodating space 112 is larger than the diameter of the channel 111, meaning that the channel 111 is inserted at the center of the accommodating space 112. A hole 113 communicating with the channel 111 is also formed inside the outer casing 11. This hole 113 communicates with the outside. The electrode wire 400 is inserted through the insertion port of the hole 113 and enters the channel 111. One end of the electrode wire 400 inserted into the channel 111 is provided with several contact terminals. When the electrode wire 400 is housed in the channel 111, the contact terminals are electrically connected to the contact spring 302 of the conductive element 300.

[0023] A limiting structure 12 is provided on the inner wall of the accommodating space 112, and a limiting groove 31 is provided on the metal housing 301 to cooperate with it. On the one hand, when the electrode wire 400 is not inserted into the conductive element 300, the limiting structure 12 can prevent the position of the conductive element 300 from moving. When the electrode wire 400 is inserted into the conductive element 300, the outer surface of the electrode wire 400 contacts the annular elastic member 32 and transmits the force of outward expansion to the annular elastic member 32, making the cooperation between the conductive element 300 and the limiting structure 12 more reliable and stable, and further improving the sealing of the cooperation part between the sealing ring 200 and the conductive element 300.

[0024] The sealing ring 200 is made of a flexible material, preferably a flexible polyurethane, silicone rubber or other polymer materials.

[0025] like Figure 6As shown, the sealing ring 200 is stepped and includes a first adapter portion 21 and a second adapter portion 22 coaxially arranged. The outer diameter of the first adapter portion 21 is smaller than the outer diameter of the second adapter portion 22. This structure facilitates a stable fit with the metal housing 301 of the conductive element 300, which is also stepped. A protruding structure 23 is provided on the outer peripheral wall of the second adapter portion 22. The protruding structure 23 can be a continuously distributed flange, multiple circumferentially distributed protrusions, or a protrusion on the entire annular outer surface. It is used to engage and position with the inner wall of the housing 11 or the accommodating space 112 to prevent the sealing ring 200 from rotating or axially shifting within the housing 11.

[0026] like Figure 8 As shown, the sealing ring 200 is provided with at least one sealing rib protruding towards the channel 111, that is, multiple annular sealing ribs are provided on the inner hole 25 wall of the sealing ring 200. Specifically, it includes a first rib 26 and a second rib 27 located at both ends of the inner hole 25, and a main rib 28 located between them. Dynamic sealing can be performed on one of the main rib 28, the first rib 26, or the second rib 27 as needed, without limitation. In this embodiment, the main rib 28 is preferably used as the dynamic sealing location, and radial stress relief cuts 29 are provided on both sides of the main rib 28, making it easier for the main rib 28 to produce uniform, axial deformation when subjected to radial compression, while releasing stress and preventing root tearing.

[0027] like Figure 1 and 6 As shown, a structural component 500 made of shape memory material is provided on the sealing ring 200. The structural component 500 is located on the outer periphery of at least one sealing rib, or on the outer periphery of the main rib 28. A recessed groove 24 is formed inwardly on the outer peripheral wall of the sealing ring 200, and the structural component 500 is tightly embedded in the recessed groove 24. Dynamic sealing can also be achieved based on the selected first rib 26 or second rib 27, in which case the structural component 500 can also be located on the outer periphery of the first rib 26 or the second rib 27. In other words, the position of the structural component 500 is set according to the corresponding rib position, as long as the inward contraction of the rib is achieved. The sealing ring 200 and the structural component 500 are assembled into a single unit after pre-fabrication and machining.

[0028] like Figure 7 As shown, the shape of structural component 500 can be spiral, mesh, or ring-shaped, and it is made of SMA material, such as metal round wire, flat wire winding, weaving, laser cutting, or CNC forming; and the shape memory material can be Ni-Ti based, Ag based, Au based, Co based, or other shape memory alloys, or polyurethane polymer, epoxy resin polymer, or other shape memory polymer materials.

[0029] In this embodiment, the shape memory structural component 500 can change by being in a relaxed and expandable state when the temperature is below a certain temperature threshold, and in a contracted state when the temperature reaches or exceeds the certain temperature threshold. The set certain temperature threshold is greater than room temperature and less than or equal to the internal temperature of the human body, so that the structural component 500 remains relaxed when located outside the human body, i.e., in a room temperature environment; when the structural component 500 is located inside the human body, the shape memory structural component 500 reaches or exceeds the certain temperature threshold and contracts. The certain temperature threshold can be human body temperature, for example, set between 36°C and 38°C. Of course, the temperature range depends on the part of the body requiring medical treatment and is subject to error. Furthermore, in some embodiments, it does not specifically refer to human body temperature; any environment or temperature that can cause the structural component 500 to deform is within the protection range.

[0030] like Figure 2 and 4 As shown, when the electrode wire 400 is inserted into the channel 111 of the channel module 100, and the ambient temperature is below a certain temperature threshold of the shape memory structure 500, the strength of the structure 500 is low, and it is in a relaxed state, exerting almost no constraint on the main body of the sealing ring 200. Therefore, the sealing ring 200, especially the main rib 28, remains in a naturally relaxed state. At this time, the inner diameter of the main rib 28 is slightly larger than or equal to the outer diameter of the electrode wire 400, forming a clearance fit or a slight interference fit. This significantly reduces the friction of the electrode wire 400 during insertion, making the doctor's operation easier.

[0031] like Figure 3 and 5 As shown, when the channel module 100 and the electrode wire 400 are implanted into the human body, the temperature of the entire structure rises to body temperature. When the temperature reaches and exceeds a certain temperature threshold of the shape memory structure 500, the structure 500 restores its preset memory shape, generating a contraction force, which is transmitted to the sealing ring 200 through the wall of the recessed groove 24 and concentrated on the area of ​​the main rib 28. At the same time, under the stress relief cuts 29 on both sides of the main rib 28, this contraction force forces the main rib 28 to contract uniformly towards the channel 111, reducing its inner diameter. At this time, the main rib 28 and the surface of the electrode wire 400 form a stable interference fit, thereby achieving a reliable seal.

[0032] To further reduce the insertion resistance of the electrode wire 400, an absorbable silicone oil can be coated on the inner wall of the main rib position 28 before assembly. On the one hand, this reduces the coefficient of friction between the sealing rib and the electrode wire 400 during insertion and extraction, thereby reducing the insertion and extraction force. On the other hand, after implantation, the silicone oil is absorbed by the sealing ring 200, increasing the coefficient of friction and thus increasing the frictional force, ensuring the reliability of the seal.

[0033] In addition, such as Figure 1 As shown, within the accommodating space 112, and at the tail end where the sealing ring 200 and conductive element 300 are alternately stacked, a connecting block 13 and a set screw 14 are used for fixation. One end of the connecting block 13 engages with the last sealing ring 200, and the other end also engages with another sealing ring 200. The set screw 14 is screwed into the side wall of the housing 11 and threaded onto the connecting block 13. The connecting block 13 is hollow inside and allows the electrode wire 400 to pass through. After the electrode wire 400 passes into the channel module 100, the set screw 14 can be screwed into the connecting block 13 to press and fix the electrode wire 400. A water seal 15 can be provided at the interface between the set screw 14 and the housing 11 to ensure the sealing of the housing 11 itself.

[0034] This embodiment provides an implantable extension lead. One end of the extension lead is provided with the aforementioned channel module 100. The channel module 100 is used to connect to the end of an electrode lead 400 with contact terminals. When the extension lead is implanted in the human body, its channel module 100 can automatically seal the electrode lead 400 connected to it under the action of body temperature.

[0035] This embodiment provides an implantable stimulator, such as a spinal cord stimulator or a deep brain stimulator. The stimulator has one or more of the aforementioned channel modules 100. These channel modules 100 are used to directly connect to electrode leads 400, or to connect to the other end of an extension lead. Electrical pulses generated by the stimulator are transmitted to the electrode leads 400 through conductive elements 300 within the channel modules 100.

[0036] This invention also provides a nerve stimulation system, including an electrode lead 400, the aforementioned stimulator, and the aforementioned extension lead. The electrode lead 400 has multiple stimulation electrodes distributed on it, and its tail end is electrically connected to one end of the extension lead having a channel module 100. The other end of the extension lead is electrically connected to the channel module 100 of the stimulator. Example 2

[0037] The main difference between this embodiment and Embodiment 1 lies in the arrangement of the shape memory structure 500 and the structure of the sealing ring 200. The structure 500 is embedded within and covered by at least one sealing rib, specifically, the structure 500 is embedded within and covered by the main rib 28, meaning it is completely encased in flexible material and isolated from the external environment. This structure provides more uniform contraction force and, due to complete encapsulation, avoids any potential interaction with the human body and environment, as well as the risk of displacement or detachment of the electrode wire 400. Specifically, the shape memory structure 500 can be pre-prepared, and then the sealing ring 200 covering the shape memory structure 500 can be formed by overmolding. Alternatively, for the structure 500 in the above embodiment, a water seal with slits can be formed directly using a polymer with shape memory properties.

[0038] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and alterations to the above embodiments within the scope of the present invention without departing from the principles and spirit of the present invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. A channel module electrically connected to an implantable electrode lead, characterized in that, The channel module includes a housing, a plurality of conductive elements housed within the housing, and a plurality of sealing rings spaced apart from the conductive elements. The conductive elements and the sealing rings form a channel for inserting the electrode wires. The sealing ring has at least one structural member made of shape memory material. The structural member remains relaxed and releases the sealing ring when the temperature is below a certain temperature threshold. When the temperature reaches or exceeds a certain temperature threshold, the structural member contracts and drives the sealing ring to contract toward the channel to seal against the electrode wire.

2. The channel module according to claim 1, characterized in that: The shape of the structural component is spiral, mesh, or ring-shaped; The shape memory material is a shape memory alloy or a shape memory polymer.

3. The channel module according to claim 1, characterized in that: The specified temperature threshold is greater than room temperature and less than or equal to the internal temperature of the human body.

4. The channel module according to claim 1, characterized in that: The sealing ring is made of a flexible material.

5. The channel module according to claim 1, characterized in that: The sealing ring is provided with at least one sealing rib protruding into the channel, and the structural member is disposed on the outer periphery of at least one of the sealing ribs; or the structural member is embedded in at least one of the sealing ribs and is covered by the sealing ribs.

6. The channel module according to claim 5, characterized in that: The sealing ribs are multiple, including a first rib and a second rib located at both ends of the inner hole of the sealing ring, and a main rib located between the first rib and the second rib; the structural member is disposed on the outer periphery of the main rib; or the structural member is embedded in the main rib and covered by the main rib, and when the structural member is below a certain temperature threshold, the main rib remains relaxed, and when the structural member reaches or exceeds a certain temperature threshold, the main rib contracts inward.

7. The channel module according to claim 6, characterized in that: Stress relief cuts are provided on both sides of the main reinforcement; The inner wall of the main rib is coated with silicone oil.

8. The channel module according to claim 2, characterized in that: The sealing ring is stepped and includes a first adapter and a second adapter arranged coaxially, wherein the outer diameter of the first adapter is smaller than the outer diameter of the second adapter. The outer peripheral wall of the second adapter is provided with a protruding structure for engaging with the inner wall of the outer shell.

9. An implantable extension lead, characterized in that, One end of the extension conductor is provided with a channel module as described in any one of claims 1 to 8.

10. An implantable stimulator, comprising: The stimulator is provided with a channel module as described in any one of claims 1 to 8.

11. A neural stimulation system, comprising: include: The electrode leads, the stimulator as described in claim 10, and the extension leads as described in claim 9, wherein one end of the electrode leads and the extension leads having a channel module is electrically connected, and the other end of the extension leads is electrically connected to the channel module of the stimulator.

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