A connecting sheath and method of manufacturing the same, an electrode assembly

Abstract

This invention discloses a connecting sleeve, its manufacturing method, and an electrode assembly. The connecting sleeve, used at the connection point between an electrode lead and an extension lead, includes a sleeve body and a sealing portion. The sleeve body has a channel for accommodating the electrode lead and the extension lead, and the sleeve body has opposing first and second connecting ends. The sealing portion is disposed at the first and / or second connecting ends, forming a seal between the electrode lead and / or the extension lead at the first and / or second connecting ends respectively when the electrode lead and / or the extension lead are accommodated within the channel. By providing the sealing portion, the connecting sleeve can form a seal at both ends of the sleeve body when the electrode lead and the extension lead are connected within the channel, preventing tissue fluid from entering the channel through the gaps at both ends of the sleeve body. This prevents tissue fluid leakage into the channel from affecting the signal connection of the electrode lead and the extension lead, avoiding product malfunctions and other adverse effects.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to connecting sleeves and their manufacturing methods, and electrode assemblies. Background Technology

[0002] In most current DBS (Deep Brain Stimulation) systems, extension leads transmit signals by connecting the IPG (Implantable Pulse Generator) and electrode leads. The connection between the extension lead and the electrode leads is typically sealed and waterproofed by adding a protective sleeve and securing both ends with cable ties.

[0003] In the prior art, protective sleeves used for connecting extension wires and electrode wires are mostly made by adding raised O-shaped ribs to the outer wall or by having a smooth inner wall or raised O-shaped ribs on the inner wall. Moreover, the inner wall is mostly clearance-fitted with the extension wire or electrode wire to reduce the installation force when inserted into the protective sleeve.

[0004] (1) When O-shaped ribs are added to the outer wall of the protective sheath, on the one hand, the sutures cross the protruding ribs, and the doctor is not sure how many times to tie them, which can easily lead to them not being tied tightly; on the other hand, the exposed part of the sutures protrudes more from the outer surface of the sheath, which can easily cause the diameter of the body to increase after the extension wire is tied, affecting the patient's comfort.

[0005] (2) When the inner wall of the protective sleeve is smooth, the protective sleeve itself is in close fit with the extension wire or electrode wire. In the compression area after tying, gaps are easily formed, causing tissue fluid leakage and product failure.

[0006] (3) When there are O-shaped ribs on the inner wall of the protective sleeve, it is difficult to insert the electrode wire or extension wire due to the interference fit of the ribs.

[0007] To address at least one of the aforementioned problems, this application proposes a connecting sleeve, a connecting sleeve forming method, and an electrode assembly. Summary of the Invention

[0008] The purpose of this invention is to provide a connecting sheath and its manufacturing method, as well as an electrode assembly, for the convenience of doctors to identify the number of ligature loops, ensuring that the two ends of the sheath can be tied with a sufficient number of ligature loops to ensure the stability of the connecting sheath on the electrode wire and extension wire. At the same time, the ligature is contained in the first recess and / or the second recess to form a tightly wound structure, ensuring the stability of the ligature on the sheath and preventing the ligature from loosening during the winding process.

[0009] The objective of this invention is achieved through the following technical solution:

[0010] The present invention provides a connecting sleeve for use at the connection between an electrode wire and an extension wire, comprising a sleeve body and a wire bundle portion.

[0011] The inner side of the sleeve is provided with a channel for accommodating the electrode wire and the extension wire, and the sleeve has a first connecting end and a second connecting end opposite to each other.

[0012] The sealing portion is disposed at the first connection end and / or the second connection end, and is used to form a seal between the electrode wire and / or the extension wire at the first connection end and / or the second connection end respectively when the electrode wire and / or the extension wire are accommodated in the channel.

[0013] Preferably, the sealing portion includes a first skirt disposed at the first connecting end and / or a second skirt disposed at the second connecting end;

[0014] Wherein, the electrode wire is accommodated within the channel by the first skirt and forms a seal, and / or,

[0015] The extension wire is received within the channel by the second skirt and forms a seal.

[0016] Preferably, the first skirt has a first sealing section, and the second skirt has a second sealing section, wherein the first sealing section and the second sealing section respectively allow the electrode wire and the extension wire to enter the channel and form a seal.

[0017] Preferably, the electrode wire has a first connector end, and the extension wire has a second connector end that matches the first connector end, the first connector end and the second connector end cooperating in a channel between the first sealing section and the second sealing section.

[0018] Preferably, the inner diameter of the first sealing section is d4, the inner diameter of the first connecting end is d5, and the outer diameter of the first joint end is greater than d4 and less than d5; and / or,

[0019] The inner diameter of the second sealing section is D4, the inner diameter of the second connecting end is D5, and the outer diameter of the second connector end is greater than D4 and less than D5.

[0020] Preferably, the first and / or second skirt hem are both made of implant-grade elastic material.

[0021] Preferably, the first skirt further includes a first connecting segment for connecting the first sealing segment to the first connecting end of the sleeve; and / or,

[0022] The second skirt also includes a second connecting section, which is used to connect the second sealing section to the second connecting end of the sleeve.

[0023] Preferably, the connecting sleeve further includes a wire harness portion, which is disposed circumferentially outside the first connecting end and / or the second connecting end of the sleeve body, for accommodating a tie wire, and the tie wire is used to bind and fix the sleeve body having the first connecting end and / or the second connecting end to the electrode wire and / or the extension wire.

[0024] The wire harness portion includes a first recess and / or a second recess disposed at the first connecting end and / or the second connecting end.

[0025] Preferably, the first recess is at least one ring-shaped inner groove located on the outer side of the first connecting end; and / or,

[0026] The second recess is at least one ring of second annular inner grooves provided on the outside of the second connecting end.

[0027] Preferably, the first annular groove and / or the second annular groove are circular or elliptical grooves formed along the outer surface of the sleeve.

[0028] Preferably, the first recess is at least one turn of a first spiral groove located on the outer side of the first connecting end; and / or,

[0029] The second recess is a second spiral groove located on the outer side of the second connecting end.

[0030] The present invention also provides a method for manufacturing a connecting sleeve, the method comprising:

[0031] Step S1: Form the sleeve by compression molding or injection molding, and form a first skirt and / or a second skirt at both ends of the sleeve;

[0032] Step S2: Place the first skirt and / or the second skirt into the channels at both ends of the sleeve.

[0033] Preferably, step S1 further includes:

[0034] Step S101: During the process of forming the sleeve, a first annular inner groove and / or a second annular inner groove are formed along the circumferential direction of the outer surface at both ends of the sleeve, or a first spiral inner groove and / or a second spiral inner groove are formed along the circumferential direction of the outer surface at both ends of the sleeve.

[0035] The present invention also provides an electrode assembly, including the aforementioned connecting sheath and binding wire.

[0036] Preferably, when the sleeve is tied and fixed to the electrode wire and / or extension wire, the binding wire in the first recess and / or the second recess does not protrude from the outer surface of the sleeve corresponding to the first connection end and / or the second connection end.

[0037] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0038] Therefore, by providing a sealing part, the connecting sleeve can form a seal at both ends of the sleeve when the electrode wire and the extension wire are connected in the channel, preventing tissue fluid from entering the channel through the gaps at both ends of the sleeve, preventing tissue fluid leakage into the channel from affecting the signal connection of the electrode wire and the extension wire, and avoiding adverse effects such as product failure.

[0039] Furthermore, when the connecting sheath is secured, the ligature is wound along the first and second recesses. This not only makes it easier for doctors to identify the number of ligature turns, ensuring that both ends of the sheath are secured with a sufficient number of ligature turns to guarantee the stability of the connecting sheath's position on the electrode leads and extension leads, but also ensures the stability of the ligature on the sheath by the tightly wound structure within the first and / or second recesses, preventing it from loosening during winding. At the same time, when the ligature is used to secure the first and second connecting ends, it applies a binding force to the sealing portion, improving the sealing effect at the end of the channel. This further prevents tissue fluid from entering the sheath through the gap between the first and / or second connecting ends, ensuring normal conductivity between the electrode leads and extension leads and avoiding adverse effects such as product malfunction. Attached Figure Description

[0040] Figure 1 This is a schematic diagram of a connecting sleeve provided in an embodiment of the present invention;

[0041] Figure 2 This is the present invention. Figure 1 A cross-sectional view of the connecting sleeve provided in the embodiment;

[0042] Figure 3 This is the present invention. Figure 2 A schematic diagram of the structure of the first connecting end of the connecting sleeve provided in the embodiment;

[0043] Figure 4 This is the present invention. Figure 2 A schematic diagram of the structure of the second connecting end of the connecting sleeve provided in the embodiment;

[0044] Figure 5 This is the present invention. Figure 1 A three-dimensional structural diagram showing the first and second skirts of the connecting sleeve located outside the channel, provided in the embodiment;

[0045] Figure 6 This is the present invention. Figure 5 A cross-sectional view of the connecting sleeve provided in the embodiment;

[0046] Figure 7 This is a schematic diagram of another connecting sleeve provided in an embodiment of the present invention;

[0047] Figure 8 This is a schematic diagram of an assembly structure of a connecting component provided in an embodiment of the present invention;

[0048] Figure 9 This is the present invention. Figure 8 A schematic diagram of the disassembly structure of the connecting component provided in the embodiment.

[0049] In the picture:

[0050] 1. Sleeve body;

[0051] 101. First connecting end; 1011. First annular groove position; 1012. First spiral groove position;

[0052] 102. Second connecting end; 1021. Second annular groove position; 1022. Second spiral groove position;

[0053] 103. Passage;

[0054] 2. Electrode wires; 201. First connector end;

[0055] 3. Extension wire; 301. Second connector end;

[0056] 4. First skirt; 401. First sealing section; 402. First connecting section;

[0057] 5. Second skirt; 501. Second sealing section; 502. Second connecting section. Detailed Implementation

[0058] 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, they are provided to make the 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.

[0059] The terms used to express position and direction in this invention are illustrated with reference to the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this invention.

[0060] Firstly, referring to Figures 1 to 9 This invention provides a connecting sleeve for use at the connection between the electrode wire 2 and the extension wire 3, comprising a sleeve body 1 and a sealing portion. Further, the connecting sleeve may also include a wire harness portion. The sleeve body 1 can be a hollow tube, and there are no specific limitations on the material of the sleeve body 1; materials commonly used in the art can be used, such as medical-grade polyurethane or silicone rubber.

[0061] Specifically, the inner side of the sleeve 1 is provided with a channel 103 for accommodating the electrode wire 2 and the extension wire 3. The channel 103 can be the inner cavity of a hollow tube. The sleeve 1 has a first connecting end 101 and a second connecting end 102. The sleeve 1 can be configured with a structure that is large at one end and small at the other end. Specifically, in this application, the first connecting end 101 can be the small port of the sleeve 1, and the second connecting end 102 can be the large port of the sleeve 1. This application is described using this method as an example.

[0062] A sealing portion is provided at the first connecting end 101 and / or the second connecting end 102, for forming a seal between the electrode wire 2 and / or the extension wire 3 at the first connecting end 101 and / or the second connecting end 102, respectively, when the electrode wire 2 and / or the extension wire 3 are accommodated within the channel 103. Specifically, after the electrode wire 2 and / or the extension wire 3 are inserted into the channel 103, the two ends of the sleeve 1 can respectively form a first sealing surface (not shown in the figure) and / or a second sealing surface (not shown in the figure) between the electrode wire 2 and / or the extension wire 3.

[0063] Therefore, by providing a sealing part, the connecting sleeve can form a seal at both ends of the sleeve 1 when the electrode wire 2 and the extension wire 3 are connected in the channel 103, preventing tissue fluid at the implantation site from entering the channel 103 through the gap at both ends of the sleeve 1, preventing tissue fluid leakage into the channel 103 from affecting the signal connection of the electrode wire 2 and the extension wire 3, and avoiding adverse effects such as product failure.

[0064] In some alternative embodiments, refer to Figures 1 to 6 The sealing portion includes a first skirt 4 disposed at the first connecting end 101 and / or a second skirt 5 disposed at the second connecting end 102; wherein the electrode wire 2 is accommodated within the channel 103 via the first skirt 4 and forms a seal, and / or the extension wire 3 is accommodated within the channel 103 via the second skirt 5 and forms a seal. Both the first skirt 4 and / or the second skirt 5 are made of implant-grade elastic material and can be integrally formed with the sheath 1. The first skirt 4 and / or the second skirt 5 can expand and contract, facilitating the formation of a seal between the electrode wire 2 and / or the extension wire 3 and the skirt. The first skirt 4 and the second skirt 5 respectively correspond to the outer surfaces of the electrode wire 2 and the extension wire 3 on both sides of the connection point, forming sealing surfaces at both ends of the sheath 1, preventing tissue fluid leakage due to gaps at the ends of the sheath 1 during use.

[0065] In this embodiment, refer to Figure 3 and Figure 4The first skirt 4 has a first sealing end 401, and the second skirt 5 has a second sealing section 501. The first sealing section 401 and the second sealing section 501 respectively allow the electrode wire 2 and the extension wire 3 to enter the channel 103 and form a seal. Specifically, the first sealing section 401 and the second sealing section 501 can be cylindrical structures. When the electrode wire 2 and the extension wire 3 are inserted into the channel 103 and connected, the electrode wire 2 on the outside of the connection will form a first sealing surface with the inner wall of the first sealing section 401, and the extension wire 3 on the outside of the connection will form a second sealing surface with the inner wall of the second sealing section 501. Thus, a cylindrical sealing surface of a certain width will be formed at both ends of the sleeve 1, ensuring the sealing effect of the sealing surfaces at both ends of the sleeve 1.

[0066] It should be noted that the shapes of the first sealing section 401 and the second sealing section 501 can also be set as, for example, a conical cylindrical structure, or a combination of a conical cylinder and a cylindrical cylinder, as long as it can ensure that when the electrode wire 2 and the extension wire 3 are inserted into both ends of the sleeve 1, the first sealing section 401 and the second sealing section 501 can be opened and a sealing surface can be formed.

[0067] As a preferred method, refer to Figure 9 The electrode lead 2 has a first connector end 201, and the extension lead 3 has a second connector end 301 that matches the first connector end 201. The first connector end 201 and the second connector end 301 are engaged within the channel 103 between the first sealing section 401 and the second sealing section 501. In this way, the connection point of the two connector ends can be located between the first sealing surface and the second sealing surface, thereby isolating the connection point of the two connector ends from external tissue fluid.

[0068] Furthermore, refer to Figure 3 and Figure 4 The inner diameter of the first sealing section 401 is d4, the inner diameter of the first connecting end 101 is d5, and the outer diameter of the first connector end 201 is greater than d4 and less than d5. After the first connector end 201 passes through the first skirt 4, the first sealing section 401 can be opened, allowing it to adhere to the outer surface of the first connector end 201 of the electrode wire 2 and form a seal. And / or,

[0069] The inner diameter of the second sealing section 501 is D4, the inner diameter of the second connecting end 102 is D5, and the outer diameter of the second connector end 301 is greater than D4 and less than D5. After the second connector end 301 passes through the second skirt 5, the second sealing section 501 can be opened so that the second sealing section 501 can be attached to the outer surface of the second connector end 301 of the extension wire 3 to form a seal.

[0070] In this embodiment, the first skirt 4 may further include a first connecting segment 402, which is used to connect the first sealing segment 401 to the first connecting end 101 of the sleeve 1; and / or, the second skirt 5 may further include a second connecting segment 502, which is used to connect the second sealing segment 501 of the sleeve 1 to the second connecting end 102. Specifically, the first connecting segment 402 is formed in a uniform transition manner from the first connecting end 101 to the skirt of the first sealing segment 401, and the second connecting segment 502 is formed in a uniform transition manner from the second connecting end 102 to the skirt of the second sealing segment 501. For example, the first connecting segment 402 and the second connecting segment 502 are conical or flared. The first connecting segment 402 and the second connecting segment 502 are integrally formed with the first sealing segment 401 and the second sealing segment 501, respectively. That is, the sleeve 1 is integrally formed with the first skirt 4 and the second skirt 5 in a uniform transition manner, which makes the overall strength of the connecting sleeve higher and the service life of the connecting sleeve longer. In practical applications, the sleeve 1 and the first skirt 4 and the second skirt 5 can be processed by methods including but not limited to molding or injection molding.

[0071] In some alternative embodiments, refer to Figures 1 to 7 The connecting sheath may also include a suture bundle, which is arranged circumferentially around the outer side of the first connecting end 101 and / or the second connecting end 102 of the sheath body 1. The suture bundle is used to hold the sheath body 1 with the first connecting end 101 and / or the second connecting end 102 and to tie and fix it to the electrode lead 2 and / or the extension lead 3. The suture bundle may be selected from surgical sutures with good antibacterial properties and chemical stability, including but not limited to polypropylene, so that the sheath body 1 can remain stable in the tissue for a long time after being tied and fixed.

[0072] The wire harness portion includes a first recess and / or a second recess disposed at the first connecting end 101 and / or the second connecting end 102. Specifically, after the tying wire binds and fixes the sleeve 1 to the electrode wire 2 and / or the extension wire 3 along the first recess and / or the second recess of the first connecting end 101 and / or the second connecting end 102, the tying wire is only wound within the first recess and / or the second recess, and the tying wire is located within the wire harness portion.

[0073] Therefore, when the connecting sheath is tied, the ligature is wound along the first and second recesses. This not only makes it easier for doctors to identify the number of ligature turns, ensuring that the sheath 1 can be tied with a sufficient number of ligature turns to ensure the stability of the connecting sheath on the electrode wire 2 and the extension wire 3, but also ensures the stability of the ligature on the sheath 1 by tying the ligature within the first and / or second recesses, preventing the ligature from coming loose during the winding process. At the same time, when the ligature is used to tie the first connecting end 101 and the second connecting end 102, the ligature can apply a binding force to the sealing part, improving the sealing effect at the end of the channel 103, further preventing tissue fluid from entering the sheath 1 through the gap between the first connecting end 101 and / or the second connecting end 102, so that the electrode wire 2 and the extension wire 3 can conduct normally, avoiding adverse effects such as product failure.

[0074] As a preferred method, refer to Figures 1 to 6 The first recess is at least one ring of first annular inner groove positions 1011 disposed on the outer side of the first connecting end 101. And / or, the second recess is at least one ring of second annular inner groove positions 1021 disposed on the outer side of the second connecting end 102. In practical applications, at least one loop of binding wire is tied within each first annular inner groove position 1011 and each second annular inner groove position 1021.

[0075] Therefore, by setting annular grooves at both ends of the sleeve 1 of the connecting sheath, the ligating suture is wound along the annular grooves at both ends when the connecting sheath is tied. This not only makes it easier for doctors to identify the number of ligating turns, ensuring that the sleeve 1 can be tied with a sufficient number of ligating turns to guarantee the stability of the connecting sheath, but also ensures the stability of the ligating suture on the sleeve 1 by the tightly wound structure within the annular grooves, preventing the ligating suture from loosening during the winding process. After the sleeve 1 is tied with the ligating suture, it will not bulge out from the outer surface of the connecting sheath, preventing the connecting sheath from becoming loose after tying. The overall circumference increases, especially after implantation into the tissue, which can avoid increasing the patient's foreign body sensation and affecting the patient's comfort. At the same time, when the first connecting end 101 and the second connecting end 102 are tied with a ligature along the annular inner groove, the ligature can apply a binding force to the sealing part, improve the sealing effect of the end of the channel 103, and further prevent tissue fluid at the implantation site from entering the sleeve 1 through the gap between the first connecting end 101 and / or the second connecting end 102 of the sleeve 1, so that the electrode wire 2 and the extension wire 3 can conduct normally, avoiding adverse effects such as product failure.

[0076] It should be noted that in practical applications, the number of rings in the first annular inner groove position 1011 and the second annular inner groove position 1021 can be increased or decreased according to the actual application scenario. The number of binding wires tied in each first annular inner groove position 1011 and the second annular inner groove position 1021 can also be increased or decreased according to the actual application scenario. However, it is necessary to ensure the stability of the position of the sleeve 1 on the electrode wire 2 and the extension wire 3, and at the same time, it is necessary to prevent the binding wires from protruding from the outer surface of the sleeve 1 and to prevent the circumference of the connecting sheath from increasing.

[0077] In a specific application, the first annular groove 1011 and / or the second annular groove 1021 are circular or elliptical grooves (not shown in the figure) formed along the outer surface of the sleeve 1. Specifically, when the first annular groove 1011 and / or the second annular groove 1021 are circular grooves on the sleeve 1, the plane of the aforementioned annular groove is parallel to the plane of the end of the sleeve 1; when the first annular groove 1011 and / or the second annular groove 1021 are elliptical grooves on the sleeve 1, the plane of the aforementioned annular groove intersects with the plane of the end of the sleeve 1. However, regardless of whether the annular groove is a circular or elliptical groove, the tying wire can be wound along its interior to secure both ends of the sleeve 1, preventing the tying wire from protruding from the outer surface of the end of the sleeve 1, preventing the sleeve 1 from reducing patient comfort inside the patient's tissue, and improving the sealing effect of the sealing parts at both ends of the sleeve 1.

[0078] As a preferred method, refer to Figure 7 The first recess is at least one turn of a first spiral groove 1012 located on the outer side of the first connecting end 101. And / or, the second recess is at least one turn of a second spiral groove 1022 located on the outer side of the second connecting end 102. In practical applications, at least one turn of binding wire is tied within each first spiral groove 1012 and each second spiral groove 1022.

[0079] Therefore, by setting spiral grooves at both ends of the sleeve 1 of the connecting sheath, the ligating suture is wound along the spiral grooves at both ends when the connecting sheath is tied. This not only makes it easier for doctors to identify the number of ligating turns, ensuring that the sleeve 1 has enough ligating turns to guarantee the stability of the connecting sheath, but also ensures the stability of the ligating suture on the sleeve 1 by the tightly wound structure within the annular grooves. This prevents the ligating suture from coming loose during the winding process. After the sleeve 1 is tied with the ligating suture, it will not bulge out from the outer surface of the connecting sheath, preventing the connecting sheath from becoming loose after tying. The overall circumference increases, especially after implantation into the tissue, which can avoid increasing the patient's foreign body sensation and affecting the patient's comfort. At the same time, when the first connecting end 101 and the second connecting end 102 are tied with a ligature along the spiral groove, the ligature can apply a binding force to the sealing part, improve the sealing effect of the end of the channel 103, and further prevent tissue fluid at the implantation site from entering the sleeve 1 through the gap between the first connecting end 101 and / or the second connecting end 102 of the sleeve 1, so that the electrode wire 2 and the extension wire 3 can conduct normally, avoiding adverse effects such as product failure.

[0080] It should be noted that in practical applications, the number of turns of the first spiral groove position 1012 and the second spiral groove position 1022 can be increased according to the actual application scenario. The number of binding wires tied in each first spiral groove position 1012 and the second spiral groove position 1022 can also be increased or decreased according to the actual application scenario. However, it is necessary to ensure the stability of the sleeve 1 on the electrode wire 2 and the extension wire 3, and at the same time, prevent the binding wires from protruding from the outer surface of the sleeve 1 and prevent the circumference of the connecting sheath from increasing.

[0081] Furthermore, in other embodiments, the first and second recesses can also be a combination of annular grooves and threaded grooves. For example, the first recess is an annular groove and the second recess is a threaded groove, or the first recess is a threaded groove and the second recess is an annular groove. In this way, the combination of annular and threaded grooves can secure both ends of the sleeve 1 to the electrode wire 2 and the extension wire 3. This also essentially achieves the advantages of maintaining a stable relative position of the ligature to the sheath when using either annular or threaded grooves simultaneously, making it easier for doctors to identify the number of ligature loops, avoiding an increase in ligature diameter that could affect patient comfort, and further improving the sealing effect of the sealing portion.

[0082] In other embodiments, refer to Figure 3 and Figure 4 Alternatively, the sealing portion, including the first skirt 4 disposed at the first connecting end 101 and the second skirt 5 disposed at the second connecting end 102, can be combined with the wire harness portion, including the first recess and the second recess disposed at the first connecting end 101 and the second connecting end 102; see details below. Figure 3The sleeve body 1 has a central axis. The length of the first skirt 4 along the central axis of the sleeve body 1 is L3. The length between the end of the first recess near the middle of the sleeve body 1 and the end of the first connecting end 101 of the sleeve body 1 is L4, where L3 ≥ L4. See the attached document for details. Figure 4 The length of the second skirt 5 along the central axis of the sleeve 1 is L5, and the length between the end of the second recess near the middle of the sleeve 1 and the end of the second connecting end 102 of the sleeve 1 is L6, where L5 ≥ L6. Therefore, when the binding wire is used to bind the sleeve 1 along the first and second recesses, the binding areas of all the binding wires are located on the outer sides of the first skirt 4 and the second skirt 5, respectively. The binding force of the binding wire is applied entirely to the first skirt 4 and the second skirt 5. While fixing the sleeve 1, the binding effect of all the binding wires is fully utilized, further improving the sealing effect between the skirt and the conductor, resulting in better sealing and a more reliable sealing effect.

[0083] Secondly, the present invention also provides a method for manufacturing a connecting sleeve, the method comprising steps S1 and S2.

[0084] Step S1: The sleeve 1 is formed by compression molding or injection molding, and a first skirt 4 and / or a second skirt 5 are formed at both ends of the sleeve 1. Step S1 further includes step S101: During the formation of the sleeve 1, a first annular inner groove position 1011 and / or a second annular inner groove position 1021 are formed circumferentially along the outer surface of both ends of the sleeve 1, or a first spiral inner groove position 1012 and / or a second spiral inner groove position 1022 are formed circumferentially along the outer surface of both ends of the sleeve 1.

[0085] Step S2: Place the first skirt 4 and / or the second skirt 5 into the channels 103 at both ends of the sleeve 1 respectively.

[0086] Specifically, the sheath manufactured by molding or injection molding has an annular or spiral groove on the outer surface of the end of the sheath body 1, and a skirt is formed at the end. When the connecting sheath manufactured by this method is used, the electrode wire 2 and the extension wire 3 can be passed through the first skirt 4 and the second skirt 5 respectively to form a seal at both ends of the sheath body 1. While binding the sheath body 1 along the annular or spiral groove, binding force can be applied to the first skirt 4 and the second skirt 5 respectively to further improve the sealing effect at both ends of the connecting sheath.

[0087] Therefore, by setting annular or spiral grooves at both ends of the sleeve 1 of the connecting sheath, when the connecting sheath is tied with ligatures, the ligatures are wound along the annular or spiral grooves at both ends. This not only makes it easier for doctors to identify the number of ligature turns, ensuring that the sleeve 1 has enough ligature turns to guarantee the stability of the connecting sheath, but also ensures the stability of the ligatures on the sleeve 1 by forming a tight winding structure within the annular or spiral grooves, preventing the ligatures from coming loose during winding. Furthermore, the sleeve 1 will not bulge out from the outer surface of the connecting sheath after being tied with ligatures. To prevent the overall circumference of the connecting sheath from increasing after tying, especially after implantation into the tissue, it can avoid increasing the patient's foreign body sensation and affecting the patient's comfort. At the same time, when the first connecting end 101 and the second connecting end 102 are tied with ligatures along the annular or spiral groove, the ligatures can apply tying force to the sealing part, improve the sealing effect of the end of the channel 103, and further prevent tissue fluid from entering the sheath 1 through the gap between the first connecting end 101 and / or the second connecting end 102 of the sheath 1, so that the electrode wire 2 and the extension wire 3 can conduct normally, avoiding adverse effects such as product failure.

[0088] Thirdly, referring to Figure 8 and Figure 9 The present invention also provides an electrode assembly, including a connecting sheath and a binding wire.

[0089] Specifically, the connecting component may also include electrode lead 2 and extension lead 3. Using the connecting sheath can seal and isolate the connection between electrode lead 2 and extension lead 3 from the outside, keeping the position of the ligature relative to the connecting sheath stable. This allows doctors to easily identify the number of ligature loops and avoids the ligature diameter from increasing and affecting patient comfort.

[0090] Therefore, the electrode assembly uses a connecting sleeve with a sealing part, which can form a seal at both ends of the sleeve 1 when the electrode wire 2 and the extension wire 3 are connected in the channel 103, preventing tissue fluid at the implantation site from entering the channel 103 through the gap at both ends of the sleeve 1, preventing tissue fluid leakage into the channel 103 from affecting the signal connection of the electrode wire 2 and the extension wire 3, and avoiding adverse effects such as product failure.

[0091] In some alternative embodiments, refer to Figure 8 and Figure 9When the sleeve 1 is secured to the electrode lead 2 and / or extension lead 3, the tying wires within the first and / or second recesses do not protrude from the outer surface of the sleeve 1 corresponding to the first connecting end 101 and / or the second connecting end 102. Therefore, during the process of securing the sleeve 1 by binding the tying wires along the first and / or second recesses to form a tightly wound structure, the tying wires will not protrude from the outer surface of the connecting sheath after binding, preventing the overall circumference of the connecting sheath from increasing. This is especially beneficial after implantation into tissues, avoiding increased foreign body sensation and improving patient comfort.

[0092] 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 variations to the above embodiments within the scope of the invention without departing from the principles and spirit of the invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. A connecting sleeve for use at the connection between the electrode wire (2) and the extension wire (3), characterized in that, include: The sleeve (1) has a channel (103) inside for accommodating the electrode wire (2) and the extension wire (3), and the sleeve (1) has a first connecting end (101) and a second connecting end (102) opposite to each other. A sealing portion is provided at the first connection end (101) and / or the second connection end (102) for forming a seal between the electrode wire (2) and / or the extension wire (3) at the first connection end (101) and / or the second connection end (102) respectively when the electrode wire (2) and / or the extension wire (3) are accommodated in the channel (103).

2. The connecting sleeve according to claim 1, characterized in that, The sealing part includes a first skirt (4) disposed at the first connecting end (101) and / or a second skirt (5) disposed at the second connecting end (102); Wherein, the electrode wire (2) is accommodated within the channel (103) through the first skirt (4) and forms a seal, and / or, The extension wire (3) is received within the channel (103) by the second skirt (5) and forms a seal.

3. The connecting sleeve according to claim 2, characterized in that, The first skirt (4) has a first sealing section (401), and the second skirt (5) has a second sealing section (501). The first sealing section (401) and the second sealing section (501) respectively allow the electrode wire (2) and the extension wire (3) to enter the channel (103) and form a seal.

4. The connecting sleeve according to claim 3, characterized in that, The electrode wire (2) has a first connector end (201), and the extension wire (3) has a second connector end (301) that matches the first connector end (201). The first connector end (201) and the second connector end (301) are engaged in a channel (103) between the first sealing section (401) and the second sealing section (501).

5. The connecting sleeve according to claim 4, characterized in that, The inner diameter of the first sealing section (401) is d4, the inner diameter of the first connecting end (101) is d5, and the outer diameter of the first joint end (201) is greater than d4 and less than d5; and / or, The inner diameter of the second sealing section (501) is D4, the inner diameter of the second connecting end (102) is D5, and the outer diameter of the second connector end (301) is greater than D4 and less than D5.

6. The connecting sleeve according to claim 2, characterized in that, The first skirt (4) and / or the second skirt (5) are both made of implant-grade elastic material.

7. The connecting sleeve according to claim 4, characterized in that, The first skirt (4) further includes a first connecting segment (402), which is used to connect the first sealing segment (401) to the first connecting end (101) of the sleeve (1); and / or, The second skirt (5) also includes a second connecting section (502), which is used to connect the second sealing section (501) to the second connecting end (102) of the sleeve (1).

8. The connecting sleeve according to claim 1, characterized in that, The connecting sleeve also includes a wire harness, which is arranged circumferentially around the sleeve body (1) outside the first connecting end (101) and / or the second connecting end (102) for accommodating a tie wire, and the tie wire is used to bind and fix the sleeve body (1) having the first connecting end (101) and / or the second connecting end (102) to the electrode wire (2) and / or the extension wire (3). The wire harness portion includes a first recess and / or a second recess disposed at the first connecting end (101) and / or the second connecting end (102).

9. The connecting sleeve according to claim 8, characterized in that, The first recess is at least one ring of first annular inner groove positions (1011) provided on the outer side of the first connecting end (101); and / or, The second recess is at least one second annular inner groove (1021) provided on the outside of the second connecting end (102).

10. The connecting sleeve according to claim 9, characterized in that, The first annular groove (1011) and / or the second annular groove (1021) are circular or elliptical grooves provided along the outer surface of the sleeve (1).

11. The connecting sleeve according to claim 8, characterized in that, The first recess is at least one spiral groove (1012) disposed on the outer side of the first connecting end (101); and / or, The second recess is at least one second spiral groove (1022) provided on the outside of the second connecting end (102).

12. A method for manufacturing a connecting sheath, characterized in that, The manufacturing method includes: Step S1: Form the sleeve (1) by compression molding or injection molding, and form a first skirt (4) and / or a second skirt (5) at both ends of the sleeve (1); Step S2: Place the first skirt (4) and / or the second skirt (5) into the channels (103) at both ends of the sleeve (1).

13. The method for manufacturing the connecting sleeve according to claim 13, characterized in that, Step S1 also includes: Step S101: During the process of forming the sleeve (1), a first annular inner groove position (1011) and / or a second annular inner groove position (1021) are formed along the circumferential direction of the outer surface at both ends of the sleeve (1), or a first spiral inner groove position (1012) and / or a second spiral inner groove position (1022) are formed along the circumferential direction of the outer surface at both ends of the sleeve (1).

14. A connecting component, characterized in that, Includes the connecting sheath and cable tie as described in any one of claims 1 to 11.

15. The connection component according to claim 14, characterized in that, When the connecting sleeve according to any one of claims 8 to 11 is tied and fixed on the electrode wire (2) and / or extension wire (3), the binding wire in the first recess and / or the second recess does not protrude from the outer surface of the sleeve (1) corresponding to the first connecting end (101) and / or the second connecting end (102).

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