Implantable lead and nerve stimulation system
By adding an adhesive layer between the shrinkage section of the outer tube and the locking ring and increasing the contact area, the problem of easy damage to the adhesive layer at the connection between the locking ring and the outer tube is solved, which enhances the connection strength and sealing performance of the implanted wire and extends its service life.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-02
- Publication Date
- 2026-03-27
AI Technical Summary
In the use of existing implantable leads, the adjacent placement of the locking ring and the outer sheath makes the adhesive layer prone to damage or separation, resulting in lead seal failure and reduced service life.
A shrinkage section is provided at one end of the outer tube near the first section, so that its outer diameter is smaller than the inner diameter of the locking ring. An adhesive layer is filled between the shrinkage section and the locking ring to enhance the connection strength, and the contact area is increased through surface structure features to enhance the bonding force.
It improves the connection strength between the middle section and the first end, reduces the risk of external force damage to the adhesive layer, prevents wire breakage or seal failure, and extends service life.
Smart Images
Figure CN224039787U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to implantable medical device technical field especially, implantable wire and nerve stimulation system. BACKGROUND
[0002] Electrical stimulation therapy technology is a technology that uses electrical current to stimulate nerves, muscles, or tissues in the human body to achieve treatment or relief of disease symptoms. This technology is widely used in pain management, nerve rehabilitation, muscle recovery, cardiac pacing and other medical fields. As a key component, implantable wire bears the core function of electrical signal transmission. The implantable wire includes a first segment, a second segment and an intermediate segment. The first segment is usually electrically connected to other functional modules, which provide stimulation signals for the implantable wire. Other functional modules are, for example, stimulators.
[0003] In the prior art, the first segment is arranged adjacent to the intermediate segment, one end of the first segment close to the intermediate segment is provided with a locking ring, the intermediate segment includes an outer sleeve, the locking ring and the outer sleeve are arranged adjacent to each other, a support tube and a guide wire wound on the outer surface of the support tube are arranged inside the locking ring and the outer sleeve, and an adhesive layer is filled between the support tube and the locking ring and the outer sleeve. The adhesive layer is used to connect the support tube, the locking ring and the outer sleeve together to form a seal. However, during use or bending of the implantable wire, the adhesive layer between the locking ring and the outer sleeve is torn and damaged or separated from the locking ring and the outer sleeve due to the adjacent arrangement of the locking ring and the outer sleeve, thereby causing damage to the implantable wire or seal failure, reducing the service life of the implantable wire.
[0004] Therefore, the existing implantable wire needs to be improved. SUMMARY
[0005] The utility model aims at providing a kind of implantable wire and nerve stimulation system, not only can enhance the connection strength between intermediate segment and first end, and also can prevent adhesive layer damage or separate from locking ring and outer sleeve, to avoid implantable wire damage or seal failure, while also can prolong the service life of implantable wire.
[0006] The utility model discloses the following technical solutions to achieve the purpose:
[0007] An implantable wire includes a first segment connected to other devices, a second segment extending in the opposite direction of the first segment, and an intermediate segment disposed between the first segment and the second segment.
[0008] The first section includes a plurality of first contacts and a locking ring, the locking ring is arranged at one end of the first section close to the intermediate section, the second section includes a plurality of second contacts, the first contacts and the second contacts are electrically connected by a plurality of guide wires, the intermediate section includes an outer sleeve, the guide wires extend through the outer sleeve;
[0009] The outer sleeve is provided with a contraction section at one end close to the first section, the outer diameter of the contraction section is less than or equal to the inner diameter of the locking ring, the contraction section is at least partially arranged in the cavity of the locking ring, and the implantable lead further includes an adhesive layer formed by an adhesive, at least part of the adhesive layer is filled between the contraction section and the locking ring.
[0010] Preferably, the contraction section is provided with a first surface structure feature, the first surface structure feature is used to increase the contact area between the contraction section and the adhesive layer, so as to enhance the bonding force between the contraction section and the adhesive layer.
[0011] Preferably, the first surface structure feature is arranged on the outer surface of the contraction section towards the locking ring, and at least part of the adhesive layer is located between the first surface structure feature and the locking ring; and / or,
[0012] The first surface structure feature penetrates the side wall of the contraction section, and at least part of the adhesive layer is located in the first surface structure feature and connected with the inner wall of the locking ring.
[0013] Preferably, the locking ring is provided with a second surface structure feature, the second surface structure feature is used to increase the contact area between the locking ring section and the adhesive layer, so as to enhance the bonding force between the contraction section, the locking ring and the adhesive layer.
[0014] Preferably, the second surface structure feature is arranged on the inner surface of the locking ring towards the contraction section, and at least part of the adhesive layer is located between the second surface structure feature and the contraction section; and / or,
[0015] The second surface structure feature penetrates the side wall of the locking ring, and at least part of the adhesive layer is located in the second surface structure feature.
[0016] Preferably, the first surface structure feature and the second surface structure feature are oppositely arranged; and / or,
[0017] The first surface structure feature is a protrusion, a counterbore, a counterbore, a through hole or a through slot;
[0018] when the first surface structure feature is a protrusion, the distance between adjacent first surface structure features on the side closer to the locking ring is smaller than the distance between adjacent first surface structure features on the side farther from the locking ring;
[0019] when the first surface structure feature is a counterbore, a counterbore groove, a through hole, or a through groove, the caliber of the first surface structure feature on the side closer to the locking ring is smaller than the caliber of the first surface structure feature on the side farther from the locking ring; and / or,
[0020] the second surface structure feature is a protrusion, a counterbore, a counterbore groove, a through hole, or a through groove;
[0021] when the second surface structure feature is a protrusion, the distance between adjacent second surface structure features on the side closer to the contraction section is smaller than the distance between adjacent second surface structure features on the side farther from the contraction section;
[0022] when the second surface structure feature is a counterbore, a counterbore groove, a through hole, or a through groove, the caliber of the second surface structure feature on the side closer to the contraction section is smaller than the caliber of the second surface structure feature on the side farther from the contraction section.
[0023] Preferably, the implantable lead further comprises a support tube, the guide wire is wound on the outer surface of the support tube, and the adhesive layer fills at least part of the area outside the support tube to connect the support tube, the guide wire, the outer sleeve tube, and the locking ring together.
[0024] Preferably, the outer surface of the support tube is provided with third surface structure features for increasing the contact area between the support tube and the adhesive layer to enhance the bonding force between the support tube and the adhesive layer.
[0025] Preferably, the inner surface of the outer sleeve tube is provided with fourth surface structure features for increasing the contact area between the outer sleeve tube and the adhesive layer to enhance the bonding force between the outer sleeve tube and the adhesive layer.
[0026] Preferably, the outer diameter of one end of the contraction section toward the first section is smaller than the outer diameter of the other end of the contraction section away from the first section.
[0027] A neural stimulation system, comprising:
[0028] a stimulator;
[0029] The implantable lead according to any one of the preceding claims is one or both of an electrode lead and an extension lead.
[0030] When the implantable lead is an electrode lead, one end of the electrode lead is implanted into the patient, and the other end of the electrode lead is electrically connected to the stimulator;
[0031] When one of the implantable leads is an electrode lead and the other of the implantable leads is an extension lead, a second segment of the electrode lead is implanted into the patient, a first segment of the electrode lead is electrically connected to a second segment of the extension lead, and a first segment of the extension lead is electrically connected to the stimulator, so that the stimulator is electrically connected to the electrode lead through the extension lead.
[0032] Compared with the prior art, the implantable lead and the neural stimulation system have at least the following beneficial effects:
[0033] The implantable lead and the neural stimulation system have at least the following beneficial effects: BRIEF DESCRIPTION OF DRAWINGS
[0034] Figure 1 is a perspective structural schematic view of the implantable lead in the embodiment of the utility model.
[0035] Figure 2 is an exploded schematic view of the implantable lead in the embodiment of the utility model when the implantable lead is an electrode lead.
[0036] Figure 3 is a perspective structural schematic view of the implantable lead in the embodiment of the utility model. Figure 2 is a partial enlarged schematic view of A in FIG.
[0037] Figure 4 is a planar structural schematic view of the implantable lead in the embodiment of the utility model when the implantable lead is an electrode lead.
[0038] Figure 5 is a cross-sectional schematic view along A-A line in FIG. Figure 4
[0039] Figure 6 is a partial enlarged schematic view of B in FIG. Figure 5
[0040] is a perspective structural schematic view of a sleeve in the embodiment of the utility model. Figure 7
[0041] Figure 8 is another outer sleeve three-dimensional structure schematic view in the embodiment of the utility model.
[0042] In the drawing: 100, implantable lead; 1, first section; 11, first contact; 12, isolation ring; 13, locking ring; 131, second surface structure feature; 2, second section; 21, second contact; 22, insulating ring; 23, plug; 3, intermediate section; 31, outer sleeve; 311, contraction section; 312, first surface structure feature; 4, guide wire; 41, helical hole; 5, support tube; 6, adhesive layer. DETAILED DESCRIPTION
[0043] Example implementations will now be described more fully with reference to the accompanying drawings. Example implementations can be implemented in any number of ways, and are not limited to the embodiments described herein; rather, embodiments described herein provide a concrete example of how example implementations can be implemented. Like reference numerals refer to like elements throughout. Like elements will not be described in detail for each of the embodiments.
[0044] The words expressing position and direction described in the utility model are all explained by taking the drawings as examples, but changes can also be made according to needs, and the changes made are all included in the protection scope of the utility model.
[0045] Referring to Figures 1 to 8 The utility model provides a kind of implantable lead 100, implantable lead 100 includes the first section 1 connected with other equipment, the second section 2 extending in the opposite direction of first section 1 and the intermediate section 3 being arranged between first section 1 and second section 2.The first section 1 can be electrically connected with other functional modules, other functional modules can include stimulator (not shown), and the first section 1 can be inserted into stimulator, so that the first contact 11 of the first section 1 is electrically connected with stimulator.
[0046] Implantable lead 100 can be one or both of electrode lead and extension lead.That is, implantable lead 100 can be electrode lead, and implantable lead 100 can also be extension lead.The structure of electrode lead and extension lead is similar, and the difference between the two is that the second section 2 of electrode lead can be implanted into patient's body, the first section 1 of electrode lead can be electrically connected with stimulator or the second section 2 of extension lead, while the second section 2 of extension lead can only be electrically connected with the first section 1 of electrode lead, and the first section 1 of extension lead can only be electrically connected with stimulator.The structure of the first section 1 of electrode lead and the first section 1 of extension lead is same or similar, the structure of the intermediate section 3 of electrode lead and the intermediate section 3 of extension lead is same or similar, and the structure of the second section 2 of electrode lead and the second section 2 of extension lead is different.
[0047] In the embodiment, the implantable lead 100 is taken as an electrode lead for description.
[0048] With reference to Figure 1 , Figure 4 , the first section 1 and the second section 2 can be respectively arranged at two ends of the intermediate section 3, and the intermediate section 3 serves to connect the first section 1 and the second section 2. The intermediate section 3 is used to transmit the stimulation signal of the first section 1 to the second section 2, that is, the guide wire 4 in the intermediate section 3 transmits the stimulation signal of the first section 1 to the second section 2, and the second section 2 performs electrical stimulation on the affected part of the patient. In the case that the length of the second section 2 is certain, the length of the intermediate section 3 determines the overall length of the implantable lead 100, so as to ensure that the second section 2 can be implanted into the patient's body at a deep enough position.
[0049] Specifically, with reference to Figure 1 , Figure 2 , Figure 3 , Figure 4 , the first section 1 can include a plurality of first contacts 11 and a locking ring 13, that is, the first section 1 is provided with one or more first contacts 11. In the embodiment, the first section 1 can be provided with a plurality of first contacts 11, and the stimulator can provide a plurality of stimulation signals through the plurality of first contacts 11. The plurality of first contacts 11 are arranged at intervals to avoid mutual interference between the first contacts 11, so as to avoid mutual interference between the stimulation signals of the stimulator. The first contacts 11 of the first section 1 can be one or more of a sheet shape or a ring shape, which can be arranged according to actual needs. In the embodiment, the first contacts 11 of the first section 1 are in the form of a ring.
[0050] The locking ring 13 is arranged at one end of the first section 1 close to the intermediate section 3. In use, when the implantable lead 100 is inserted into other functional modules, the screw on the functional module can also press on the locking ring 13 to fix the implantable lead 100 and the functional module together. The locking ring 13 is made of a material with high structural strength, and the material of the locking ring 13 is preferably a metal material, so as to ensure that the locking ring 13 has sufficient structural strength. An isolation ring 12 can be arranged between the locking ring 13 and the first contacts 11, and the isolation ring 12 can ensure that the locking ring 13 and the first contacts 11 are insulated.
[0051] With reference to Figure 1 , Figure 2 , Figure 4When the implantable lead 100 is an electrode lead, the second section 2 can include a plurality of second contacts 21, i.e. the second section 2 is provided with one or more second contacts 21. In the present embodiment, the second section 2 can be provided with a plurality of second contacts 21, which can be used to electrically stimulate a plurality of affected areas of the patient. The second contacts 21 are exposed to the outer surface of the second section 2 to ensure that the second contacts 21 can have good contact with the affected areas of the patient, thereby ensuring that the second contacts 21 can electrically stimulate the affected areas of the patient. The second contacts 21 of the second section 2 can be in one or more of a sheet shape or a ring shape, which can be provided as needed.
[0052] With reference to Figure 2 , Figure 5 , the first contacts 11 and the second contacts 21 can be electrically connected by a plurality of guide wires 4, which are preferably helically wound along the axial direction of the implantable lead 100 and form helical holes 41. When the first contacts 11 are in the form of a ring, the first contacts 11 can be sleeved on the outside of the helically wound guide wires 4. The number of first contacts 11, the number of second contacts 21 and the number of guide wires 4 are preferably the same, and the first contacts 11, the second contacts 21 and the guide wires 4 are one-to-one correspondingly arranged, i.e. one end of one guide wire 4 is connected to one first contact 11 and the other end is connected to one second contact 21.
[0053] With reference to Figure 1 , Figure 2 , Figure 5 , the intermediate section 3 can include an outer sleeve 31, which can be in the form of a hollow cylinder as a whole, and the guide wires 4 extend through the outer sleeve 31, i.e. at least part of the guide wires 4 are inside the outer sleeve 31. The outer sleeve 31 is in direct contact with the patient, and the outer sleeve 31 can protect the guide wires 4 from physical and chemical damage. The outer sleeve 31 also has biocompatibility, ensuring that no immune response or other adverse reactions will occur when in contact with the patient. The material of the outer sleeve 31 is made of high polymer materials, such as medical grade silicone, polyurethane, PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene copolymer) or TPE (thermoplastic elastomer), etc., to ensure that the outer sleeve 31 has sufficient strength while maintaining a certain flexibility to adapt to the stretching, compression and other stresses in the implant environment.
[0054] As a preferred mode, with reference to Figure 1 , Figure 2 , Figure 3The first section 1 can further comprise a plurality of isolation rings 12, i.e. the first section 1 is provided with one or more isolation rings 12. In the present embodiment, the number of isolation rings 12 is plural, and the isolation rings 12 are distributed at intervals from the first contacts 11 so that the first contacts 11 are distributed at intervals from each other, and the mutual insulation of the first contacts 11 can be ensured. The isolation rings 12 are preferably annular in shape. The plurality of isolation rings 12 and the plurality of first contacts 11 can be arranged in close proximity to each other.
[0055] With reference to Figure 1 , Figure 2 When the implantable lead 100 is an electrode lead, the second section 2 can further comprise a plug 23 and a plurality of insulation rings 22. The plug 23 can be arranged at one end of the second section 2 away from the middle section 3, and the end of the plug 23 facing the patient is a smooth end face, such as a hemispherical boss. The plug 23 not only has a plugging effect on the second section 2 to prevent the patient's tissue fluid from entering the interior of the second section 2, but also can reduce the damage to the human tissue when the implantable lead 100 is inserted. The insulation rings 22 are distributed at intervals from the second contacts 21 so that the second contacts 21 are distributed at intervals from each other, and the mutual insulation of the second contacts 21 can be ensured. The insulation rings 22 are preferably annular in shape. The plurality of insulation rings 22 and the plurality of second contacts 21 can be arranged in close proximity to each other.
[0056] With reference to Figure 2 , Figure 3 , Figure 6 , Figure 7 , Figure 8 The outer sleeve 31 is provided with a contraction section 311 at one end close to the first section 1, the outer diameter of the contraction section 311 is less than or equal to the inner diameter of the locking ring 13, and the contraction section 311 can be at least partially arranged in the cavity of the locking ring 13. The contraction section 311 not only enhances the connection strength between the middle section 3 and the first end, but also positions the locking ring 13, so that the first section 1 and the middle section 3 can be coaxially arranged, and the alignment and installation of the first section 1 and the middle section 3 are facilitated.
[0057] The contraction section 311 and the outer sleeve 31 can be integrally formed, or the contraction section 311 and the outer sleeve 31 can be separate. In the present embodiment, the contraction section 311 and the outer sleeve 31 are integrally formed, and the contraction section 311 is more preferably formed by the outer sleeve 31, for example, the contraction section 311 can be formed by the outer sleeve 31 through heat shrinkage.
[0058] With reference to Figure 2 , Figure 3 , Figure 6The implantable lead 100 can further comprise an adhesive layer 6 formed by an adhesive, and at least part of the adhesive layer 6 can be filled between the shrinkable section 311 and the locking ring 13 to connect the shrinkable section 311 and the locking ring 13 together to form a sealed structure. The adhesive layer 6 can be formed by solidifying a liquid adhesive, for example, by physical or chemical solidification. In some embodiments, the adhesive layer 6 can also be formed by a solid adhesive.
[0059] As a preferred mode, the implantable lead 100 can further comprise a support tube 5, the guide wire 4 can be wound around the outer surface of the support tube 5, and the support tube 5 can be arranged in the helical hole 41 of the guide wire 4 in the first section 1. The material of the support tube 5 is preferably a non-metal material. The support tube 5 has a supporting effect on the helical guide wire 4, thereby improving the structural strength of the implantable lead 100. The adhesive layer 6 can be filled in the area outside at least part of the support tube 5 to connect the support tube 5, the guide wire 4, the shrinkable section 311 and the locking ring 13 together to form a sealed structure.
[0060] At least part of the support tube 5 can be arranged in the first section 1, at least part of the support tube 5 can also be arranged in the middle section 3, and at least part of the support tube 5 can also be arranged in the second section 2. The number of support tubes 5 can be one or more. In this embodiment, the number of support tubes 5 is two, one of which can be arranged in the outer sleeve 31 near the first section 1 and the first section 1, and the other of which can be arranged in the outer sleeve 31 near the second section 2 and the second section 2.
[0061] As a preferred mode, the shrinkable section 311 as a whole can be a part of a taper, and the outer diameter of one end of the shrinkable section 311 facing the first section 1 can be smaller than the outer diameter of the other end of the shrinkable section 311 facing away from the first section 1. This not only facilitates the installation of the shrinkable section 311 in the locking ring 13, thereby reducing the assembly difficulty and improving the assembly efficiency, but also allows the outer surface of the shrinkable section 311 to have a gap with the inner surface of the locking ring 13. Part of the adhesive layer 6 can be filled in the gap between the outer surface of the shrinkable section 311 and the inner surface of the locking ring 13, which can increase the contact area between the adhesive layer 6 and the shrinkable section 311 and the locking ring 13, thereby improving the bonding force between the adhesive layer 6 and the shrinkable section 311 and the locking ring 13, and improving the adhesive reliability of the adhesive layer 6, thereby ensuring the sealing performance of the implantable lead 100 and prolonging the service life of the implantable lead 100. At the same time, the outer diameter of the other end of the shrinkable section 311 facing away from the first section 1 can be large, which can prevent the shrinkable section 311 from being offset in the locking ring 13, and can ensure the coaxiality between the shrinkable section 311 and the locking ring 13. Thus, the outer surface of the outer sleeve 31 and the outer surface of the locking ring 13 can be flush or substantially flush.
[0062] In the present application, by setting a shrink section 311 on the outer sleeve 31 close to the first end of the first section 1, the outer diameter of the shrink section 311 is less than or equal to the inner diameter of the locking ring 13, and the shrink section 311 is arranged in the cavity of the locking ring 13, so that not only the connection strength between the middle section 3 and the first end can be enhanced, but also the bending degree of the connection between the locking ring 13 and the shrink section 311 can be reduced during the use of the implantable lead 100, and the external force on the adhesive layer 6 at this position can be reduced, so as to prevent the adhesive layer 6 from being damaged or separated from the locking ring 13 and the shrink section 311 of the outer sleeve 31, thereby avoiding damage or sealing failure of the implantable lead 100, and prolonging the service life of the implantable lead 100.
[0063] In a specific embodiment, the shrink section 311 can be provided with a first surface structure feature 312, which is used to increase the contact area between the shrink section 311 and the adhesive layer 6, so as to enhance the bonding force between the shrink section 311 and the adhesive layer 6, thereby further improving the bonding reliability of the adhesive layer 6, and further ensuring the sealing performance of the implantable lead 100 and prolonging the service life of the implantable lead 100.
[0064] Specifically, referring to Figure 7 , the first surface structure feature 312 can be arranged on the outer surface of the shrink section 311 facing the locking ring 13, the first surface structure feature 312 does not penetrate the side wall of the shrink section 311, and at least part of the adhesive layer 6 is located between the first surface structure feature 312 and the locking ring 13, so as to improve the bonding force between the adhesive layer 6 and the shrink section 311 and the locking ring 13, improve the bonding reliability of the adhesive layer 6, and further ensure the sealing performance of the implantable lead 100 and prolong the service life of the implantable lead 100. The first surface structure feature 312 can be in the shape of uneven lines, counterbores, grooves, etc., and the uneven lines can be, for example, protrusions.
[0065] As an example, the first surface structure feature 312 can be uneven lines, and the outer surface of the shrink section 311 facing the locking ring 13 can be laser etched to form lines, thereby increasing the roughness of the surface of the shrink section 311. Of course, lines can also be formed on the outer surface of the shrink section 311 facing the locking ring 13 by other means, such as chemical etching. The outer surface of the shrink section 311 facing the locking ring 13 can also be subjected to plasma treatment to make the outer surface of the shrink section 311 facing the locking ring 13 rough, so as to increase the surface energy.
[0066] Referring to Figure 7, the first surface structure feature 312 can also penetrate the side wall of the shrinkage section 311, and at least part of the adhesive layer 6 can be located in the first surface structure feature 312 and connected with the inner wall of the locking ring 13. The first surface structure feature 312 can be in the shape of a through hole, a through groove, etc. In this way, the bonding force between the adhesive layer 6 and the shrinkage section 311 and the locking ring 13 can be improved, the bonding reliability of the adhesive layer 6 can be improved, and thus the sealing performance of the implantable lead 100 is ensured and the service life of the implantable lead 100 is prolonged.
[0067] When the first surface structure feature 312 is a protrusion, the distance between adjacent first surface structure features 312 on the side close to the locking ring 13 is smaller than the distance between adjacent first surface structure features 312 on the side away from the locking ring 13, that is, the first surface structure feature 312 as a whole can be in the shape of an inverted buckle with a small upper part and a large lower part. When the adhesive layer 6 is filled in the first surface structure feature 312, the bonding force between the adhesive layer 6 and the first surface structure feature 312 can be greatly improved.
[0068] When the first surface structure feature 312 is a counterbore, a counterbore groove, a through hole or a through groove, the caliber of the first surface structure feature 312 on the side close to the locking ring 13 is preferably smaller than the caliber of the first surface structure feature 312 on the side away from the locking ring 13, that is, the first surface structure feature 312 as a whole can be in the shape of an inverted buckle with a small upper part and a large lower part. When the adhesive layer 6 is filled in the first surface structure feature 312, the bonding force between the adhesive layer 6 and the first surface structure feature 312 can be greatly improved.
[0069] In a specific embodiment, with reference to Figure 1 , Figure 2 , Figure 3 , the locking ring 13 can be provided with a second surface structure feature 131, the second surface structure feature 131 is used to increase the contact area between the locking ring 13 and the adhesive layer 6, to enhance the bonding force between the shrinkage section 311, the locking ring 13 and the adhesive layer 6, to improve the bonding reliability of the adhesive layer 6, and thus to ensure the sealing performance of the implantable lead 100 and to prolong the service life of the implantable lead 100.
[0070] The second surface structure feature 131 can be provided on the inner surface of the locking ring 13 facing the shrinkage section 311, the second surface structure feature 131 does not penetrate the side wall of the locking ring 13, and at least part of the adhesive layer 6 is located between the second surface structure feature 131 and the shrinkage section 311. The second surface structure feature 131 can be in the shape of a concave-convex pattern, a counterbore, a counterbore groove, etc. The concave-convex pattern is, for example, a protrusion.
[0071] The second surface structure feature 131 can also penetrate the side wall of the locking ring 13, and at least part of the adhesive layer 6 is located in the second surface structure feature 131. The second surface structure feature 131 can be in the shape of a through hole, a through groove, etc.
[0072] When the second surface structure feature 131 is a protrusion, the distance between adjacent second surface structure features 131 on the side close to the contraction section 311 is smaller than the distance between adjacent second surface structure features 131 on the side away from the contraction section 311, that is, the second surface structure feature 131 as a whole can have an inverted cup shape with the upper part being smaller and the lower part being larger. When the adhesive layer 6 is filled in the second surface structure feature 131, the bonding force between the adhesive layer 6 and the second surface structure feature 131 can be greatly improved.
[0073] When the second surface structure feature 131 is a counterbore, a sink groove, a through hole or a through groove, the caliber of the second surface structure feature 131 on the side close to the contraction section 311 is preferably smaller than the caliber of the second surface structure feature 131 on the side away from the contraction section 311, that is, the second surface structure feature 131 as a whole can have an inverted cup shape with the upper part being smaller and the lower part being larger. When the adhesive layer 6 is filled in the second surface structure feature 131, the bonding force between the adhesive layer 6 and the second surface structure feature 131 can be greatly improved.
[0074] As a preferred mode, the first surface structure feature 312 and the second surface structure feature 131 are preferably oppositely arranged, which can increase the thickness of the adhesive layer 6 between the contraction section 311 and the locking ring 13, further improve the bonding force between the adhesive layer 6 and the contraction section 311 and the locking ring 13, improve the bonding reliability of the adhesive layer 6, and further ensure the sealing performance of the implantable lead 100 and prolong the service life of the implantable lead 100.
[0075] In a specific embodiment, the outer surface of the support tube 5 can be provided with third surface structure features (not shown), which are used to increase the contact area between the support tube 5 and the adhesive layer 6 to enhance the bonding force between the support tube 5 and the adhesive layer 6, and also improve the bonding reliability of the adhesive layer 6.
[0076] The third surface structure features can be arranged on the outer surface of the support tube 5 facing the guide wire 4, and the third surface structure features do not penetrate the side wall of the support tube 5. The third surface structure features can have shapes such as uneven lines, counterbores, sink grooves, etc. The uneven lines can be protrusions, for example.
[0077] The third surface structure features can also penetrate the side wall of the support tube 5, and at least part of the adhesive layer 6 is located in the third surface structure features. The third surface structure features can have shapes such as through holes and through grooves.
[0078] When the third surface structure features are protrusions, the distance between adjacent third surface structure features on the side closer to the guide wire 4 is smaller than the distance between adjacent third surface structure features on the side farther from the guide wire 4, that is, the third surface structure features as a whole can have an inverted shape with the upper part being smaller and the lower part being larger. When the adhesive layer 6 is filled in the third surface structure features, the bonding force between the adhesive layer 6 and the third surface structure features can be greatly improved.
[0079] When the third surface structure features are countersunk holes, grooves, through holes or through grooves, the diameter of the third surface structure features on the side closer to the guide wire 4 is preferably smaller than the diameter of the third surface structure features on the side farther from the guide wire 4, that is, the third surface structure features as a whole can have an inverted shape with the upper part being smaller and the lower part being larger. When the adhesive layer 6 is filled in the third surface structure features, the bonding force between the adhesive layer 6 and the third surface structure features can be greatly improved.
[0080] As a preferred mode, the inner surface of the outer sleeve 31 is provided with fourth surface structure features (not shown), which are used to increase the contact area between the outer sleeve 31 and the adhesive layer 6, thereby enhancing the bonding force between the outer sleeve 31 and the adhesive layer 6, and also improving the bonding reliability of the adhesive layer 6, so as to improve the bonding force between the outer sleeve 31, the guide wire 4 and the adhesive layer 6. The fourth surface structure features can be provided on the inner surface of the outer sleeve 31 facing the guide wire 4, the fourth surface structure features do not penetrate the side wall of the outer sleeve 31, and the fourth surface structure features can have shapes such as uneven lines, countersunk holes, grooves, etc. The uneven lines can be protrusions, for example.
[0081] When the fourth surface structure features are protrusions, the distance between adjacent fourth surface structure features on the side closer to the guide wire 4 is smaller than the distance between adjacent fourth surface structure features on the side farther from the guide wire 4, that is, the fourth surface structure features as a whole can have an inverted shape with the upper part being smaller and the lower part being larger. When the adhesive layer 6 is filled in the fourth surface structure features, the bonding force between the adhesive layer 6 and the fourth surface structure features can be greatly improved.
[0082] When the fourth surface structure features are countersunk holes or grooves, the diameter of the fourth surface structure features on the side closer to the guide wire 4 is preferably smaller than the diameter of the fourth surface structure features on the side farther from the guide wire 4, that is, the fourth surface structure features as a whole can have an inverted shape with the upper part being smaller and the lower part being larger. When the adhesive layer 6 is filled in the fourth surface structure features, the bonding force between the adhesive layer 6 and the fourth surface structure features can be greatly improved.
[0083] The first surface structure features 312, the second surface structure features 131, the third surface structure features and the fourth surface structure features can be formed by the same or similar process, or can be formed by different processes, which can be selected according to actual needs.
[0084] The utility model also provides a nerve stimulation system, nerve stimulation system can include stimulator and above-mentioned implantable lead wire 100, implantable lead wire 100 can be one or two of electrode lead wire and extension lead wire.
[0085] When implantable lead wire 100 is electrode lead wire, the second section 2 of electrode lead wire can be implanted in patient's body, and the first section 1 of electrode lead wire is electrically connected with the stimulator. In use, the user holds the middle section 3 of electrode lead wire close to one end of the first section 1 of electrode lead wire to insert the first section 1 of electrode lead wire into the stimulator. The stimulator can be a pulse generator, which transmits the stimulation signal to the affected part of the patient through the implantable lead wire 100, and the second contact 21 of the second section 2 electrically stimulates the affected part of the patient.
[0086] When one implantable lead wire 100 is electrode lead wire and the other implantable lead wire 100 is extension lead wire, the second section 2 of electrode lead wire can be implanted in patient's body, the first section 1 of electrode lead wire can be electrically connected with the second section 2 of extension lead wire, and the first section 1 of extension lead wire can be electrically connected with the stimulator, so that the stimulator is electrically connected with the electrode lead wire through the extension lead wire. In use, the user holds the middle section 3 of electrode lead wire close to one end of the first section 1 of electrode lead wire to insert the first section 1 of electrode lead wire into the second section 2 of extension lead wire. The user holds the middle section 3 of extension lead wire close to one end of the first section 1 of extension lead wire to insert the first section 1 of extension lead wire into the stimulator, and the first section 1 of extension lead wire can be electrically connected with the stimulator. The extension lead wire can transmit the stimulation signal of the stimulator to the first contact 11 of the first section 1 of electrode lead wire, the first contact 11 of the first section 1 of electrode lead wire transmits the stimulation signal to the second contact 21 of the second section 2 of electrode lead wire through the guide wire 4, and the second contact 21 of the second section 2 of electrode lead wire electrically stimulates the affected part of the patient.
[0087] Although the embodiments of the utility model have been shown and described above, it should be understood that the above-mentioned embodiments are exemplary and cannot be understood as limiting the utility model. Those skilled in the art can change, modify, replace and transform the above-mentioned embodiments without departing from the principles and purposes of the utility model in the range of the utility model, and all these changes should belong to the protection scope of the utility model claim.
Claims
1. An implantable lead, characterized in that, The implantable lead includes a first section for connecting with other devices, a second section extending in an opposite direction of the first section, and an intermediate section disposed between the first section and the second section; The first section includes a plurality of first contacts and a locking ring disposed at one end of the first section close to the intermediate section, the second section includes a plurality of second contacts, the first contacts and the second contacts are electrically connected by a plurality of guide wires, and the intermediate section includes an outer sleeve, the guide wires extend through the outer sleeve; The outer sleeve is provided with a contraction section at one end close to the first section, the outer diameter of the contraction section is less than or equal to the inner diameter of the locking ring, the contraction section is at least partially disposed in the cavity of the locking ring, and the implantable lead further includes an adhesive layer formed by an adhesive, at least part of the adhesive layer is filled between the contraction section and the locking ring.
2. The implantable lead of claim 1, wherein, The contraction section is provided with a first surface structure feature for increasing the contact area between the contraction section and the adhesive layer to enhance the bonding force between the contraction section and the adhesive layer.
3. The implantable lead of claim 2, wherein, The first surface structure feature is disposed on the outer surface of the contraction section towards the locking ring, and at least part of the adhesive layer is located between the first surface structure feature and the locking ring; And / or, The first surface structure feature penetrates through the side wall of the contraction section, and at least part of the adhesive layer is located in the first surface structure feature and connected with the inner wall of the locking ring.
4. The implantable lead of claim 2, wherein, The locking ring is provided with a second surface structure feature for increasing the contact area between the locking ring section and the adhesive layer to enhance the bonding force between the contraction section, the locking ring and the adhesive layer.
5. The implantable lead of claim 4, wherein the first and second electrodes are configured to be positioned on opposite sides of the left atrial appendage. The second surface structure feature is disposed on the inner surface of the locking ring towards the contraction section, and at least part of the adhesive layer is located between the second surface structure feature and the contraction section; And / or, The second surface structure feature penetrates through the side wall of the locking ring, and at least part of the adhesive layer is located in the second surface structure feature.
6. The implantable lead of claim 4, wherein the distal electrode is configured to be positioned in the right atrium of the heart. The first surface structure feature and the second surface structure feature are oppositely arranged; and / or, The first surface structure feature is a protrusion, a counter bore, a counter slot, a through hole or a through slot; When the first surface structure feature is a protrusion, the distance between adjacent first surface structure features close to the locking ring is less than the distance between adjacent first surface structure features away from the locking ring; When the first surface structure feature is a counter bore, a counter slot, a through hole or a through slot, the caliber of the first surface structure feature close to the locking ring is less than the caliber of the first surface structure feature away from the locking ring; and / or, The second surface structure feature is a protrusion, a counter bore, a counter slot, a through hole or a through slot; When the second surface structure feature is a protrusion, the distance between adjacent second surface structure features close to the contraction section is less than the distance between adjacent second surface structure features away from the contraction section; When the second surface structure feature is a counterbore, a counterbore, a through hole or a through groove, the caliber of the second surface structure feature near one side of the contraction section is smaller than the caliber of the second surface structure feature away from the other side of the contraction section.
7. The implantable lead of claim 1, wherein the lead body comprises a first portion and a second portion, the first portion comprising the first electrode and the second portion comprising the second electrode. The implantable lead further comprises a support tube, the guide wire is wound on the outer surface of the support tube, and the adhesive layer fills at least part of the area outside the support tube to connect the support tube, the guide wire, the outer sleeve and the locking ring together.
8. The implantable lead of claim 7, wherein the distal electrode is configured to be positioned in the right atrium of the heart. The outer surface of the support tube is provided with third surface structure features for increasing the contact area between the support tube and the adhesive layer to enhance the bonding force between the support tube and the adhesive layer.
9. The implantable lead of claim 1, wherein, The inner surface of the outer sleeve is provided with fourth surface structure features for increasing the contact area between the outer sleeve and the adhesive layer to enhance the bonding force between the outer sleeve and the adhesive layer.
10. The implantable lead of claim 1, wherein, The outer diameter of one end of the contraction section towards the first section is smaller than the outer diameter of the other end of the contraction section away from the first section.
11. A neural stimulation system, comprising: Comprise: a stimulator; The implantable lead according to any one of claims 1 to 10, wherein the implantable lead is one or both of an electrode lead and an extension lead; When the implantable lead is an electrode lead, one end of the electrode lead is implanted into the patient's body, and the other end of the electrode lead is electrically connected to the stimulator; When one of the implantable leads is an electrode lead and the other is an extension lead, the second section of the electrode lead is implanted into the patient's body, the first section of the electrode lead is electrically connected to the second section of the extension lead, and the first section of the extension lead is electrically connected to the stimulator, so that the stimulator is electrically connected to the electrode lead through the extension lead.