CN112402786A

CN112402786A - An implantable vagus nerve stimulator electrode

Info

Publication number: CN112402786A
Application number: CN202011092098.XA
Authority: CN
Inventors: 文雄伟; 夏泓玮; 余伟; 许扶; 胡海春
Original assignee: Tsinghua University; Beijing Pins Medical Co Ltd
Current assignee: Beijing Pinchi Medical Equipment Co ltd; Tsinghua University
Priority date: 2020-10-13
Filing date: 2020-10-13
Publication date: 2021-02-26
Anticipated expiration: 2040-10-13
Also published as: CN112402786B

Abstract

The embodiment of the invention discloses an implantable vagus nerve stimulator electrode, which comprises a spiral body, an electrode contact and a traction wire, wherein the spiral body is used for winding a vagus nerve; the electrode contact is embedded in the spiral body and provided with a stimulation surface exposed out of the inner surface of the spiral body, and the stimulation surface of the electrode contact is provided with a protruding structure which at least partially protrudes out of the inner surface of the spiral body and is used for contacting with the vagus nerve. Therefore, the electrode contact of the implanted vagus nerve stimulator electrode according to the embodiment of the present invention can make good contact with the vagus nerve through the protruding structure, so that the electrical impulse signal can be effectively transmitted to the vagus nerve.

Description

Implanted vagus nerve stimulator electrode

Technical Field

The invention relates to the field of medical equipment, in particular to an implantable vagus nerve stimulator electrode.

Background

The application of the vagus nerve electrical stimulation technology provides an auxiliary treatment means for patients with diseases such as epilepsy, depression, pain and the like. The stimulation contact of the electrode of the implanted vagus nerve stimulator is mostly a metal sheet, and in order to ensure the safety of the electrode implanted into the human body, some electrodes can adopt insulating materials to wrap the periphery of the electrode slice, and only the middle part of the electrode is exposed to output an electrical stimulation signal. However, the insulation surrounding the electrode pad creates a gap between the electrode and the vagus nerve, resulting in the output electrical signal not being effectively conducted to the vagus nerve under certain conditions.

Disclosure of Invention

In view of the above, embodiments of the present invention provide an implantable vagus nerve stimulator electrode capable of effectively conducting an electrical signal to the vagus nerve.

The implantable vagus nerve stimulator electrode provided by the embodiment of the present invention comprises a spiral body, an electrode contact and a pull wire; the spiral body is configured to wrap around the vagus nerve; the electrode contact is embedded in the spiral body and extends along the spiral body, the electrode contact is provided with a stimulation surface exposed out of the inner surface of the spiral body, the stimulation surface of the electrode contact is provided with a protruding structure, the protruding structure at least partially protrudes out of the inner surface of the spiral body, and the protruding structure is configured to be in contact with the vagus nerve; the traction wire is connected with the spiral body, and the traction wire is exposed out of two ends of the spiral body by a preset length.

Further, the protruding structure comprises an elastic member configured to be elastically deformable in a direction perpendicular to the stimulation surface.

Further, the elastic piece is a spring, and the axis of the spring extends along the spiral body.

Further, the spring is fixed on the stimulation surface of the electrode contact in a welding mode.

Further, the elastic piece is made of platinum, iridium or platinum-iridium alloy material.

Further, the protruding structure is a protruding point, and the protruding point protrudes from the stimulation surface of the electrode in the axial direction of the spiral body.

Further, the bump is formed by stamping on the electrode contact.

Furthermore, the number of the salient points is multiple, and the salient points are uniformly distributed on the electrode contact.

Further, the electrode contact is flat and annular, the electrode contact comprises a first section and a second section which are oppositely arranged, the distance between the first section and the second section is smaller than the thickness of the spiral body, the first section is embedded in the spiral body, and the stimulation surface is arranged on the second section.

Furthermore, the implanted vagus nerve stimulator electrode further comprises an insulating sleeve and a lead, wherein the lead is arranged in the insulating sleeve in a penetrating manner, and one end of the lead is electrically connected with the electrode contact.

The embodiment of the invention provides an implantable vagus nerve stimulator electrode, which comprises a spiral body, an electrode contact and a traction wire, wherein the spiral body is used for winding a vagus nerve; the electrode contact is embedded in the spiral body and provided with a stimulation surface exposed out of the inner surface of the spiral body, and the stimulation surface of the electrode contact is provided with a protruding structure which at least partially protrudes out of the inner surface of the spiral body and is used for contacting with the vagus nerve. Therefore, the electrode contact of the implanted vagus nerve stimulator electrode according to the embodiment of the present invention can make good contact with the vagus nerve through the protruding structure, so that the electrical impulse signal can be effectively transmitted to the vagus nerve.

Drawings

The above and other objects, features and advantages of the present invention will become more apparent from the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

fig. 1 is a schematic perspective view of an implantable vagal nerve stimulator electrode according to an embodiment of the present invention;

FIG. 2 is a schematic side view of an implantable vagus nerve stimulator electrode according to an embodiment of the present invention;

FIG. 3 is a schematic diagram illustrating the operation of an implantable vagus nerve stimulator electrode according to an embodiment of the present invention;

FIG. 4 is a schematic diagram of an electrode contact and lead configuration according to an embodiment of the present invention;

FIG. 5 is a schematic perspective view of another implantable vagal nerve stimulator electrode according to an embodiment of the present invention;

FIG. 6 is a schematic side view of another implantable vagal nerve stimulator electrode according to an embodiment of the present invention;

FIG. 7 is a schematic cross-sectional view of another implantable vagal nerve stimulator electrode according to an embodiment of the present invention;

fig. 8 is a schematic diagram illustrating the operation of another implantable vagal nerve stimulator electrode according to an embodiment of the present invention.

Description of reference numerals:

1-spirochete; 2-electrode contact; 21-stimulating surface; 22-bumps; 23-a spring; 24-a first section; 25-a second stage; 3-a traction wire; 4-an insulating sleeve; 5-a wire; 6-vagus nerve.

Detailed Description

The present invention will be described below based on examples, but the present invention is not limited to only these examples. In the following detailed description of the present invention, certain specific details are set forth. It will be apparent to one skilled in the art that the present invention may be practiced without these specific details. Well-known methods, procedures, components and circuits have not been described in detail so as not to obscure the present invention.

Further, those of ordinary skill in the art will appreciate that the drawings provided herein are for illustrative purposes and are not necessarily drawn to scale.

Unless the context clearly requires otherwise, throughout the description, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, what is meant is "including, but not limited to".

In the description of the present invention, it is to be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.

Fig. 1 and 2 are a schematic perspective view and a side view of an implantable vagus nerve stimulator electrode according to an embodiment of the present invention, and fig. 3 is a schematic diagram illustrating the operation principle of the implantable vagus nerve stimulator electrode of fig. 1 and 2, wherein fig. 2 is a schematic diagram viewed along the axial direction of the spiral body 1, and a pull wire is omitted in fig. 3. As shown in fig. 1-3, the implantable vagal nerve stimulator electrode of the present embodiment includes a spiral 1, an electrode contact 2, and a pull wire 3. The spiral body 1 is used for winding on the vagus nerve 6, the electrode contact 2 is embedded in the spiral body 1 and extends along the spiral body 1, the electrode contact 2 is provided with a stimulation surface 21 exposed out of the inner surface of the spiral body 1, the stimulation surface 21 of the electrode contact 2 is provided with a protruding structure, and the protruding structure at least partially protrudes out of the inner surface of the spiral body 1 and is used for contacting the vagus nerve 6 and applying electric pulse stimulation.

The spiral body 1 is made of an insulating material, and preferably, the spiral body 1 is made of a biocompatible polymer organic material, such as medical silicon rubber, a polyurethane material, and the like. The inner diameter of the spirochete 1 is matched to the diameter of the vagus nerve 6 for good winding of the vagus nerve 6. When the implanted vagus nerve stimulator electrode is manufactured, the electrode contact 2 and the traction wire 3 can be placed into a mold, and the electrode contact and the traction wire are integrally formed by injection molding or other methods, so that the structural strength of the spiral body 1 can be improved

As shown in fig. 1 and 2, a traction wire 3 is connected to the spiral body 1 and is exposed to the outside from both ends of the spiral body 1 by a predetermined length, preferably 10-20mm, for winding the vagus nerve to fix the implantable vagus nerve stimulator electrode to the vagus nerve, so that the electrode can be better contacted with the vagus nerve. The pull wire 3 can extend from one end of the spiral body 1 along the spiral body 1 and penetrate out from the other end of the spiral body 1, and the function of improving the firmness of the spiral body 1 can be achieved. The pull wire 3 may be made of an organic polymer material with high biocompatibility, such as a polyester material such as polyethylene terephthalate.

The electrode contact 2 is made of metal materials with high biocompatibility, such as platinum, iridium, platinum-iridium alloy and the like, and the electrode contact 2 is used for applying electric pulse to the vagus nerve. The electrode contact 2 is fixedly connected with the spiral body 1, and the shape of the electrode contact 2 can be designed according to the shape of the spiral body 1. The electrode contact 2 may be in the form of a sheet, wire or other shape suitable for connection to the spiral 1 and application of electrical stimulation to the vagus nerve. The electrode contact 2 has certain flexibility, so that the vagus nerve can be wound conveniently after being combined with the spirochete 1.

Fig. 4 is a schematic structural view of an electrode contact 2 and a lead wire 5 according to an embodiment of the present invention. As shown in fig. 3 and 4, in some embodiments, the electrode contact 2 may be a flat ring shape, and the electrode contact 2 in the flat ring shape may be a continuous ring-shaped conductor, or may be a strip-shaped electrode contact 2 connected in an end-to-end manner to form a ring shape (as shown in fig. 4). The electrode contact 2 comprises a first section 24 and a second section 25 which are oppositely arranged, the distance between each point on the first section 24 and the second section 25 is basically equal within a tolerance range, and the distance between the first section 24 and the second section 25 is smaller than the thickness of the spiral body 1. That is, the first section 24 and the second section 25 are arranged along the spiral body 1 in substantially the same posture, and the spiral body 1 has the electrode contact 2 of the double layer in the wall thereof. The first section 24 is completely embedded in the spiral body 1, the first section 24 is farther away from the axis of the spiral body 1 than the second section 25, the stimulation surface 21 is an end surface of the second section 25 facing the axis of the spiral body 1, and the stimulation surface 21 is exposed out of the spiral body 1, that is, the material of the spiral body 1 does not cover the stimulation surface 21. The flat annular electrode contact 2 is arranged, so that compared with the single-layer sheet electrode contact 2, the connection strength of the electrode contact 2 and the spiral body 1 can be increased, and the electrode contact 2 is prevented from falling off.

Referring to fig. 1, the implantable vagal stimulator electrode further includes an insulating sleeve 4 and a lead 5, one end of the lead 5 being electrically connected to the electrode contact 2 for transmitting an electrical signal to the electrode contact 2. As shown in fig. 4, when the electrode contacts 2 in the form of a strip are joined end to form a flat ring shape, the conductive wire 5 may be placed between both ends of the stacked electrode contacts 2 such that the electrode contacts 2 wrap the ends of the conductive wire 5 to achieve a firm electrical connection. The lead 5 is arranged in the insulating sleeve 4 in a penetrating way, and the part of the insulating sleeve 4 connected with the spiral body 1 can be bonded by adhesive, so that the stimulation effect on the target vagus nerve is prevented from being influenced by applying electric signals to other parts in the human body in the transmission process. The insulating sleeve 4 can be made of medical silicon rubber, polyurethane and other materials with good biocompatibility. Preferably, the outer surface of the insulating sleeve 4 may be coated with a lubricant having good biocompatibility. The insulating sleeve 4 and the lead 5 have certain flexibility, so that the implanted vagus nerve stimulator electrode can be conveniently arranged in the body.

Referring to fig. 1-4, in an alternative embodiment, the protruding structure is a protruding point 22, and the protruding point 22 protrudes from the stimulating surface 21 in the axial direction of the spiral body 1, that is, the protruding point 22 protrudes from the inner surface of the spiral body 1. The bumps 22 may include one or more, and it is to be understood that the present invention is not limited to the number, shape, size, and arrangement of the bumps 22, as the bumps 22 are preferably capable of making good contact with the vagus nerve 6 and applying electrical impulse stimulation. Preferably, the projections 22 are included in a plurality and are evenly distributed on the stimulation surface 21 to increase the contact area of the electrode contact 2 with the vagus nerve 6 to effectively conduct the electrical impulse to the vagus nerve 6.

Referring to fig. 3, after the electrode contact 2 is placed into the spiral body 1, the spiral body 1 wraps the edge of the stimulation surface 21, and the salient points 22 protrude out of the inner surface of the spiral body 1. In use, the spirochete 1 is wrapped around the vagus nerve 6, the projections 22 are brought into contact with the vagus nerve 6, and a corresponding electrical stimulus is applied to the vagus nerve 6.

The bumps 22 may be formed by stamping on the electrode contacts 2, which facilitates processing and also helps to ensure the structural strength of the bumps 22. Of course, the bump 22 may be formed on the stimulation surface 21 of the electrode contact 2 by adding a material, for example, by soldering, plating, or the like; alternatively, the bump 22 may be formed by reducing the material, for example, the thick electrode contact 2 may be reduced in thickness by etching or the like to form the bump 22.

Fig. 5-8 are schematic diagrams of another implantable vagal nerve stimulator electrode according to an embodiment of the present invention. In another alternative embodiment, as shown in fig. 5-8, the projection arrangement includes a resilient member. The elastic member is fixed to the stimulation surface 21 and protrudes at least partially over the inner surface of the spiral 1 to achieve a good contact with the vagus nerve 6. The form of the elastic member includes, but is not limited to, a coil spring 23, a spring plate, an elastic porous structure, etc., and it is understood that a conductive elastic member capable of elastic deformation to some extent in a direction perpendicular to the stimulating surface 21 may be used. Preferably, the elastic member is made of a material with high biocompatibility, such as platinum, iridium, platinum-iridium alloy, and the like. For example, the elastic member in fig. 5-8 is a spring 23, and the axis of the spring 23 extends along the spiral body 1. The spring 23 may be fixed to the stimulation surface 21 of the electrode contact 2 by welding. The elastic piece can be fixed with the electrode contact 2 after the electrode contact 2 is arranged in the spiral body 1; or the electrode contact 2 can be fixed with the electrode contact 2 before the electrode contact 2 is connected with the spiral body 1, and then the electrode contact 2 connected with the elastic member is arranged in the spiral body 1.

Referring to fig. 8, in use, the spiral 1 is wrapped around the vagus nerve 6 and the protruding spring 23 contacts the vagus nerve 6 to deliver electrical stimulation to the vagus nerve 6. The spring 23 is also capable of elastically deforming in a direction perpendicular to the stimulation surface 21, depending on the thickness of the vagus nerve 6, thereby enabling the implantable vagus nerve stimulator electrode to adapt to vagus nerves of different thicknesses to achieve good contact with the vagus nerves.

The implantable vagus nerve stimulator electrode comprises a spiral body, an electrode contact and a traction wire, wherein the spiral body is used for winding the vagus nerve, and the traction wire is connected with the spiral body and is exposed out of two ends of the spiral body by a preset length; the electrode contact is embedded in the spiral body and provided with a stimulation surface exposed out of the inner surface of the spiral body, and the stimulation surface of the electrode contact is provided with a protruding structure which at least partially protrudes out of the inner surface of the spiral body and is used for contacting with the vagus nerve. Therefore, the electrode contact of the implanted vagus nerve stimulator electrode according to the embodiment of the present invention can make good contact with the vagus nerve through the protruding structure, so that the electrical impulse signal can be effectively transmitted to the vagus nerve.

An implantable vagus nerve stimulator electrode is disclosed, the electrode structure is not limited to use for vagus nerve stimulation, but may be used for other types of electrical stimulation therapy (e.g., spinal cord stimulation, peripheral nerve stimulation, pelvic nerve stimulation, gastric nerve stimulation, etc.), stimulation of at least one muscle or muscle group, stimulation of at least one organ such as the stimulation of the gastric system, stimulation accompanying gene therapy, stimulation of blood vessels, and generally stimulation of any tissue of a patient. The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An implantable vagal stimulator electrode comprising:

a spirochete (1) configured to wrap around a vagus nerve (6);

the electrode contact (2) is embedded in the spiral body (1) and extends along the spiral body (1), the electrode contact (2) is provided with a stimulation surface (21) exposed out of the inner surface of the spiral body (1), the stimulation surface (21) of the electrode contact (2) is provided with a protruding structure, the protruding structure at least partially protrudes out of the inner surface of the spiral body (1), and the protruding structure is configured to be in contact with the vagus nerve (6); and

the traction wire (3) is connected with the spiral body (1), and the traction wire (3) is exposed out of two ends of the spiral body (1) by a preset length.

2. The implantable vagal stimulator electrode according to claim 1, wherein the protruding structure comprises a resilient member configured to be elastically deformable in a direction perpendicular to the stimulation surface (21).

3. The implantable vagal nerve stimulator electrode according to claim 2, wherein the resilient member is a spring (23), the axis of the spring (23) extending along the helical body (1).

4. The implantable vagal nerve stimulator electrode according to claim 3, characterized in that the spring (23) is fixed to the stimulation face (21) of the electrode contact (2) by means of welding.

5. The implantable vagal stimulator electrode according to claim 2, wherein the resilient member is made of platinum, iridium, or a platinum-iridium alloy material.

6. The implantable vagal nerve stimulator electrode according to claim 1, wherein the protruding structure is a bump (22), the bump (22) protruding from the stimulation surface (21) of the electrode in the axial direction of the spiral body (1).

7. The implantable vagal nerve stimulator electrode according to claim 6, wherein the bumps (22) are formed by stamping on the electrode contacts (2).

8. The implantable vagal nerve stimulator electrode according to claim 6, wherein the plurality of bumps (22) is a plurality, and the plurality of bumps (22) are evenly distributed on the electrode contact (2).

9. The implantable vagus nerve stimulator electrode according to claim 1, wherein the electrode contact (2) is in the shape of a flat ring, the electrode contact (2) comprises a first segment (24) and a second segment (25) disposed opposite to each other, the distance between the first segment (24) and the second segment (25) is less than the thickness of the spiral body (1), the first segment (24) is embedded in the spiral body (1), and the stimulation surface (21) is disposed on the second segment (25).

10. The implantable vagal nerve stimulator electrode according to claim 1, further comprising:

an insulating sleeve (4); and

and the lead (5) is arranged in the insulating sleeve (4) in a penetrating manner, and one end of the lead (5) is electrically connected with the electrode contact (2).