CN113457007A

CN113457007A - Nerve stimulation electrode, manufacturing method thereof and nerve stimulation system

Info

Publication number: CN113457007A
Application number: CN202010244977.3A
Authority: CN
Inventors: 吕依蔓; 唐龙军; 何庆; 高伟; 徐永强
Original assignee: Shanghai Shenyi Medical Technology Co ltd
Current assignee: Shanghai Shenyi Medical Technology Co ltd
Priority date: 2020-03-31
Filing date: 2020-03-31
Publication date: 2021-10-01

Abstract

The invention provides a nerve stimulation electrode, a manufacturing method thereof and a nerve stimulation system, wherein the nerve stimulation electrode comprises a far-end electrode assembly, a middle-section lead and a near-end connector which are sequentially connected; the distal electrode assembly comprises a plurality of first electrodes arranged at intervals and a first lead electrically connected with the first electrodes; the proximal connector comprises a plurality of second electrodes arranged at intervals and a second lead electrically connected with the second electrodes; the middle section lead comprises a third lead, the far end of the third lead is connected with the near end of the first lead, and a first fixing ring is sleeved outside a first connecting part between the third lead and the first lead; the near end of the third wire is connected with the far end of the second wire, and a second fixing ring is sleeved outside a second connecting part between the third wire and the second wire. The invention ensures that the electrodes can be flexibly combined into the electrode structure according to the requirements, is convenient for manufacturing the electrodes with different sections and different structures, protects the electrode connection points and improves the mechanical property and the reliability of the electrode connection parts.

Description

Nerve stimulation electrode, manufacturing method thereof and nerve stimulation system

Technical Field

The invention relates to the technical field of implantable medical devices, in particular to a nerve stimulation electrode, a manufacturing method thereof and a nerve stimulation system.

Background

Implantable active medical devices are now widely used for the treatment of a variety of conditions, particularly physiological and psychological disorders, in a manner that provides superior and immediate therapeutic benefits over many conventional therapies. One of the implanted active instruments is a nerve electrical stimulator, which transmits pulse signals to nerve tissues through electrodes to improve normal skill operation of human body, for example, an implanted Deep Brain Stimulation (DBS) electrode can effectively improve limb control and coordination ability of Parkinson patients.

Parkinson's Disease (PD) is a common degenerative Disease of the nervous system, and drug therapy is the primary treatment modality in its early and middle stages. With the increasing dosage of the intervening drugs and the development of the disease, the risk of side effects of the drugs, the psychological burden of the patients and the drug resistance of the patients to the drugs are increased. In the middle and late stages of Parkinson's disease, surgical treatment is an effective supplement to drug treatment. The two main types of operation treatment are nucleus damage and deep brain nerve electrical stimulation. The deep brain nerve electrical stimulation is the first choice for surgical treatment because of small trauma, safety and effectiveness. The patient who passes through deep brain nerve electrical stimulation operation can obviously improve the limb control and coordination ability, and reduce the dosage of the medicine.

The deep brain electrical stimulation system is divided into an in-vivo implanted part and an in-vitro program-controlled part. The implanted portion in the body, as shown in fig. 1, is composed of three parts: an implantable pulse generator 10 (hereinafter IPG), an electrode extension lead 20 (hereinafter extension lead), and a neurostimulation electrode 30. The IPG 10 is used to provide electrical stimulation pulse signals to the neurostimulation electrodes 30; the extension lead 20 is used for connecting the nerve stimulation electrode 30 with the IPG 10; the neurostimulation electrode 30 is used for being implanted into human brain tissue and stimulating a predetermined treatment target area in the brain tissue.

After being implanted into a human body, the distal end of the nerve stimulation electrode 30 is placed at a predetermined treatment target region of the patient; fixing the nerve stimulation electrode 30 on the surface of the skull through a skull fixing device 40; the proximal connector of the nerve stimulation electrode 30 is connected to the distal end of the extension wire 20; the extension wire 20 extends through the subcutaneous tunnel to the vicinity of the clavicle; the proximal end of the extension wire 20 is connected to the IPG 10.

The existing electrode manufacturing process is an integral manufacturing process, and the manufacturing mode is not beneficial to carrying out different structural design and manufacturing according to the requirements of different parts of the electrode.

Disclosure of Invention

The invention aims to provide a nerve stimulation electrode, a manufacturing method thereof and a nerve stimulation system, which can ensure that the electrode flexibly combines an electrode structure according to requirements, facilitate the manufacturing of electrodes with different structures at different sections, protect electrode connection points and improve the mechanical property and reliability of electrode connection parts.

In order to achieve the above objects, the present invention provides a nerve stimulation electrode, comprising a distal electrode assembly, a middle lead and a proximal connector, which are connected in sequence;

the distal electrode assembly comprises a plurality of first electrodes arranged at intervals and a first lead electrically connected with the first electrodes;

the proximal connector comprises a plurality of second electrodes arranged at intervals and a second lead electrically connected with the second electrodes;

the middle section lead comprises a third lead, the far end of the third lead is connected with the near end of the first lead, and a first fixing ring is sleeved outside a first connecting part between the third lead and the first lead;

the near end of the third wire is connected with the far end of the second wire, and a second fixing ring is sleeved outside a second connecting part between the third wire and the second wire.

Optionally, the third wire is helical.

Optionally, the first fixing ring is a developing ring.

Optionally, a gap is provided in the visualization ring or the visualization ring extends in a non-closed ring shape around the circumference of the nerve stimulation electrode.

Optionally, the nerve stimulation electrode further comprises a guide wire, and the guide wire penetrates through the middle section lead.

Optionally, the proximal end of the first lead and the distal end of the third lead are both flat and have the same cross section, and the distal end of the second lead and the proximal end of the third lead are both flat and have the same cross section.

Optionally, the outside at first connection position still overlaps and is equipped with first insulating tube body, first solid fixed ring cover is located the outside of first insulating tube body, the outside at second connection position still overlaps and is equipped with the insulating tube body of second, solid fixed ring cover of second is located the outside of the insulating tube body of second.

Optionally, the second fixing ring is made of a metal material which is not a developing material.

To achieve the above object, the present invention further provides a neurostimulation system, which comprises a pulse generator, an extension lead and the neurostimulation electrode, wherein the distal end of the extension lead is connected with the proximal connector of the neurostimulation electrode, and the proximal end of the extension lead is connected with the pulse generator.

Optionally, a fastener matched with the second fixing ring is arranged at the distal end of the extension lead, and the fastener is used for pressing the second fixing ring.

To achieve the above object, the present invention also provides a method of manufacturing a nerve stimulation electrode, the method including:

respectively manufacturing a distal electrode assembly, a middle section lead and a proximal connector, wherein the distal electrode assembly comprises a plurality of first electrodes arranged at intervals and a first lead electrically connected with the first electrodes, and the proximal end of the first lead extends to the proximal end of the distal electrode assembly and is exposed; the proximal connector comprises a plurality of second electrodes arranged at intervals and a second lead electrically connected with the second electrodes, and the distal end of the second lead extends to the distal end of the proximal connector and is exposed; the middle section lead comprises a third lead, and the near end and the far end of the third lead respectively extend to the near end and the far end of the middle section lead and are exposed; and

connecting the near end of the first lead with the far end of the third lead, connecting the far end of the second lead with the near end of the third lead, sleeving a first fixing ring at a first connecting part between the first lead and the third lead, and sleeving a second fixing ring at a second connecting part between the second lead and the third lead.

Optionally, the proximal end of the first lead is connected to the distal end of the third lead by welding, and the distal end of the second lead is connected to the proximal end of the third lead.

Optionally, the method further includes:

after the first fixing ring is sleeved on the first connecting position, the first fixing ring is fixed on the far-end electrode assembly and the middle section lead in an injection molding or gluing mode;

after the second connecting part is sleeved with the second fixing ring, the second fixing ring is fixed on the proximal connector and the middle section wire in an injection molding or gluing mode.

Optionally, the method further includes:

sleeving a first insulating pipe body on the first connection position before sleeving the first fixing ring on the first connection position;

before the second connection portion is fitted with the second fixing ring, a second insulating tube body is fitted over the second connection portion.

Based on the same inventive concept, the invention also provides a manufacturing method of the nerve stimulation electrode, which comprises the following steps:

respectively manufacturing a distal electrode assembly, a middle section lead and a proximal connector, wherein the distal electrode assembly comprises a plurality of first electrodes arranged at intervals and a first lead electrically connected with the first electrodes, and the proximal end of the first lead extends to the proximal end of the distal electrode assembly and is exposed; the proximal connector comprises a plurality of second electrodes arranged at intervals and a second lead electrically connected with the second electrodes, and the distal end of the second lead extends to the distal end of the proximal connector and is exposed; the middle section lead comprises a third lead, and the near end and the far end of the third lead respectively extend to the near end and the far end of the middle section lead and are exposed;

sleeving a first fixing ring on the part, close to the distal end, of the third guide wire, and sleeving a second fixing ring on the part, close to the proximal end, of the third guide wire; and

and connecting the proximal end of the first lead with the distal end of the third lead, and connecting the distal end of the second lead with the proximal end of the third lead, so that the first fixing ring is sleeved on a first connecting part between the first lead and the third lead, and the second fixing ring is sleeved on a second connecting part between the second lead and the third lead.

Compared with the prior art, the nerve stimulation electrode, the manufacturing method thereof and the nerve stimulation system provided by the invention have the following advantages:

(1) according to the nerve stimulation electrode provided by the invention, the first fixing ring is sleeved at the first connecting part between the far-end electrode assembly and the middle-section lead, and the second fixing ring is sleeved at the second connecting part between the near-end connector and the middle-section lead, so that the first connecting part between the far-end electrode assembly and the middle-section lead can be protected by the first fixing ring, the first connecting part is effectively prevented from being broken due to stress caused by the first connecting part positioned at the stress release section, and the mechanical property and reliability of the first connecting part between the far-end electrode assembly and the middle-section lead are effectively improved. In a similar way, through the solid fixed ring of second can be to the second between proximal connector and the middle section wire connection position effect of playing the protection, effectively avoid producing the fracture because of the second is connected the position and is located the stress release section and atress, has effectively improved the mechanical properties and the reliability that the position was connected to the second between proximal connector and the middle section wire.

(2) The nerve stimulation system provided by the invention comprises the nerve stimulation electrode, so that the nerve stimulation system provided by the invention has all the advantages of the nerve stimulation electrode, namely, the nerve stimulation electrode in the nerve stimulation system provided by the invention has the advantages that the first fixing ring is sleeved at the first connecting part between the distal electrode assembly and the middle section lead, and the second fixing ring is sleeved at the second connecting part between the proximal connector and the middle section lead, so that the first connecting part between the distal electrode assembly and the middle section lead can be protected by the first fixing ring, the first connecting part between the distal electrode assembly and the middle section lead is effectively prevented from being broken due to stress caused by the first connecting part positioned at the stress release section, and the mechanical property and the reliability of the first connecting part between the distal electrode assembly and the middle section lead are effectively improved. In a similar way, through the solid fixed ring of second can be to the second between proximal connector and the middle section wire connection position effect of playing the protection, effectively avoid producing the fracture because of the second is connected the position and is located the stress release section and atress, has effectively improved the mechanical properties and the reliability that the position was connected to the second between proximal connector and the middle section wire.

(3) The nerve stimulation electrode is divided into three modules, namely a far-end electrode assembly, a middle-section lead and a near-end connector, the far-end electrode assembly, the middle-section lead and the near-end connector are respectively manufactured firstly, then the near end of the far-end electrode assembly is connected with the far end of the middle-section lead, the far end of the near-end connector is connected with the near end of the middle-section lead, a first fixing ring is sleeved at a first connecting part between the far-end electrode assembly and the middle-section lead, and a second fixing ring is sleeved at a second connecting part between the near-end connector and the middle-section lead, so that the first connecting part between the far-end electrode assembly and the middle-section lead can be protected by the first fixing ring, stress fracture caused by the first connecting part being positioned at a stress release section is effectively avoided, and the mechanical property and reliability of the first connecting part between the far-end electrode assembly and the middle-section lead are effectively improved And (4) sex. In a similar way, through the solid fixed ring of second can be to the second between proximal connector and the middle section wire connection position effect of playing the protection, effectively avoid producing the fracture because of the second is connected the position and is located the stress release section and atress, has effectively improved the mechanical properties and the reliability that the position was connected to the second between proximal connector and the middle section wire. In addition, compared with the integral manufacturing process in the prior art, the manufacturing method of the nerve stimulation electrode provided by the invention is more convenient to adjust the internal structure of each section of the electrode according to the use requirement through a modularized assembly mode, is convenient to increase or design the structure meeting the requirement, is beneficial to reasonably arranging the process steps, and further can effectively reduce the production cost.

Drawings

FIG. 1 is a schematic illustration of an implantable brain neurostimulation electrode system (DSB) implanted in a body;

FIG. 2 is a schematic diagram of the overall structure of a neurostimulation electrode according to one embodiment of the invention;

FIG. 3 is a schematic view of a connection relationship between the distal electrode assembly and the middle lead when the first fixing ring is not sleeved on the nerve stimulating electrode according to an embodiment of the present invention;

FIG. 4 is a schematic view of a connection relationship between the distal electrode assembly and the middle lead after the first fixing ring is sleeved on the nerve stimulating electrode according to an embodiment of the present invention;

fig. 5 is a schematic structural view illustrating a connection relationship between the middle lead and the proximal connector when the second fixing ring is not sleeved on the nerve stimulating electrode according to an embodiment of the present invention;

fig. 6 is a schematic structural view illustrating a connection relationship between the middle lead and the proximal connector after the second fixing ring is sleeved on the nerve stimulating electrode according to an embodiment of the present invention;

FIG. 7 is a schematic structural diagram of a neurostimulation system in one embodiment of the invention;

FIG. 8 is a schematic diagram of the connection between the proximal connector and the extension lead in the neurostimulation system, according to one embodiment of the present invention;

FIG. 9 is a flow chart of a method of manufacturing a neurostimulation electrode according to one embodiment of the invention;

fig. 10 is a flowchart of a method of manufacturing a neurostimulation electrode according to another embodiment of the invention.

Wherein the reference numbers are as follows:

a pulse generator-10; an extension wire-20; a nerve stimulation electrode-30; -a fixture-40; a distal electrode assembly-31; a middle section lead-32; a proximal connector-33; a first electrode-311; a first conductive line-312; a second electrode-331; a second conductive line-332; a third conductive line-321; a first connection site-341; a first retaining ring-34; second junction-351; a second retaining ring-35; fastener-21; a guidewire-36.

Detailed Description

The neurostimulation electrode, the manufacturing method thereof and the neurostimulation system provided by the invention are further described in detail in the following with reference to the attached drawings 1 to 10 and the detailed description. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are all used in a non-precise scale for the purpose of facilitating and distinctly aiding in the description of the embodiments of the present invention. To make the objects, features and advantages of the present invention comprehensible, reference is made to the accompanying drawings. It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the implementation conditions of the present invention, so that the present invention has no technical significance, and any structural modification, ratio relationship change or size adjustment should still fall within the scope of the present invention without affecting the efficacy and the achievable purpose of the present invention.

It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential", and the like, indicate orientations and positional relationships based on the orientations and positional relationships shown in the drawings, and are used merely for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore, should not be construed as limiting the present invention. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "fixed" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral part; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

The core idea of the invention is to provide a nerve stimulation electrode, a manufacturing method thereof and a nerve stimulation system, which can ensure that the electrode flexibly combines the electrode structure according to the requirements, facilitate the manufacture of electrodes with different structures at different sections, protect the electrode connection point and improve the mechanical property and reliability of the electrode connection part. In the present invention, the distal end refers to an end close to the site to be stimulated, and the proximal end refers to an end far from the site to be stimulated.

To achieve the above-mentioned idea, the present invention provides a neurostimulation electrode, please refer to fig. 2, which schematically shows an overall structure diagram of the neurostimulation electrode according to an embodiment of the present invention, as shown in fig. 2, the neurostimulation electrode comprises a distal electrode assembly 31, a middle lead 32 and a proximal connector 33, which are connected in sequence. Wherein, the proximal end of the proximal connector 33 is used for connecting the pulse generator 10, and the pulse signal generated by the pulse generator 10 can be input into the proximal connector 33 and transmitted to the distal electrode assembly 31 through the middle wire 32. The middle lead 32 not only serves to connect the distal electrode assembly 31 and the proximal connector 33, but also serves to adjust the overall length of the neurostimulation electrode according to the patient and the implanted site. The distal electrode assembly 31 is used to contact and send stimulation signals to the site to be stimulated.

Preferably, as shown in fig. 2, the nerve stimulation electrode further includes a guide wire 36 that extends through the mid-section wire 32. In this embodiment, the guide wire 36 is a stainless steel wire or a tungsten wire. Therefore, the guide wire 36 is arranged in the middle section lead 32 to improve the conveying performance of the middle section lead 32, so that the nerve stimulation electrode can be implanted into a human body more conveniently.

Referring to fig. 2 and fig. 3, fig. 3 is a schematic view illustrating a connection relationship between the distal electrode assembly 31 and the middle lead 32 when the first fixing ring 34 is not sleeved on the neurostimulation electrode according to an embodiment of the present invention. As shown in fig. 2 and 3, the distal electrode assembly 31 includes a plurality of first electrodes 311 disposed at intervals and a first conductive wire 312 electrically connected to the first electrodes 311, and the plurality of first electrodes 311 are insulated from each other. The first wire 312 includes a plurality of first electrode wires, the plurality of first electrode wires are insulated from each other, and distal ends of the first electrode wires are connected to the first electrodes 311 in a one-to-one correspondence manner. The first electrode 311 may be made of an electrically conductive biocompatible material, such as platinum or platinum-iridium alloy, or a material coated with platinum or platinum-iridium alloy, and may be electrically connected to the first electrode wire by resistance spot welding or laser spot welding. The first electrode 311 may be a ring electrode, a hemispherical electrode, or an arc electrode.

Referring to fig. 3 and 4, fig. 4 is a schematic view illustrating a connection relationship between the distal electrode assembly 31 and the middle lead 32 after the first fixing ring 34 is sleeved on the nerve stimulating electrode according to an embodiment of the present invention. As shown in fig. 3 and 4, the middle section wire 32 includes a third wire 321, a distal end of the third wire 321 is connected to a proximal end of the first wire 312, a first fixing ring 34 is sleeved outside a first connection portion 341 between the third wire 321 and the first wire 312, and the first fixing ring 34 is made of a metal material. Because the distal electrode assembly 31 has a relatively high stiffness and is hard to bend when being stressed, and the first fixing ring 34 is made of a metal material, such as platinum-iridium alloy or stainless steel, when being stressed, the metal material of the first fixing ring 34 can sufficiently share the stress, so as to better protect the first connection portion 341, and thus, the first fixing ring 34 is sleeved on the first connection portion 341 between the distal electrode assembly 31 and the middle section wire 32, and the first fixing ring 34 can cover the first connection portion 341, thereby protecting the first connection portion 341, effectively avoiding the fracture caused by the stress when the connection portion is located at the stress release section, and effectively improving the mechanical properties and reliability of the first connection portion 341 between the distal electrode assembly 31 and the middle section wire 32. The third wire 321 includes a plurality of third wire electrodes, the plurality of third wire electrodes are insulated from each other, and distal ends of the third wire electrodes are connected to proximal ends of the first wire electrodes in a one-to-one correspondence manner.

Referring to fig. 2 and 5, fig. 5 is a schematic view illustrating a connection relationship between the middle lead 32 and the proximal connector 33 when the second fixing ring 35 is not sleeved on the nerve stimulating electrode according to an embodiment of the present invention. As shown in fig. 2 and 5, the proximal connector 33 includes a plurality of second electrodes 331 spaced apart from each other and a second wire 332 electrically connected to the second electrodes 331, wherein the second electrodes 331 are insulated from each other. The second wire 332 comprises a plurality of second wire electrodes, the second wire electrodes are insulated from one another, the proximal ends of the second wire electrodes are connected with the second electrodes 331 in a one-to-one correspondence manner, and the distal ends of the second wire electrodes are connected with the proximal ends of the third wire electrodes in a one-to-one correspondence manner. The second electrode 331 may be made of an electrically conductive biocompatible material, such as platinum or platinum-iridium alloy, or a material coated with platinum or platinum-iridium alloy, and may be electrically connected to the second electrode wire by resistance spot welding or laser spot welding. The second electrode 331 may be a ring electrode, a partial electrode, or a segmented electrode.

Referring to fig. 5 and fig. 6, fig. 6 is a schematic view showing a connection relationship between the middle lead 32 and the proximal connector 33 after the second fixing ring 35 is sleeved on the nerve stimulating electrode according to an embodiment of the present invention. As shown in fig. 5 and 6, a proximal end of the third wire 321 is connected to a distal end of the second wire 332, a second fixing ring 35 is sleeved outside a second connection portion 351 between the third wire 321 and the second wire 332, and the second fixing ring 35 is made of a metal material. Because the rigidity of the proximal connector 33 is large, the portion is difficult to bend due to stress, and the second fixing ring 35 is made of a metal material, such as platinum-iridium alloy or stainless steel, which has a better mechanical property, when the proximal connector 33 is stressed, the metal material of the second fixing ring 35 can fully share the stress, and the second connecting portion 351 can be better protected, so that the second fixing ring 35 is sleeved on the second connecting portion 351 between the proximal connector 33 and the middle section wire 32, the second fixing ring 35 can cover the second connecting portion 351, and further the second connecting portion 351 can be protected, so that the fracture due to stress of the connecting portion located in the stress release section is effectively avoided, and the mechanical property and reliability of the second connecting portion 351 between the proximal connector 33 and the middle section wire 32 are effectively improved.

Preferably, the third wire 321 is spiral, that is, the third wire 321 spirally extends along the axial direction thereof. Therefore, the third conductor 321 is arranged in a spiral shape, so that the mechanical property of the middle section conductor 32 can be effectively improved.

Preferably, the first fixing ring 34 is a developing ring, so that the first fixing ring 34 functions as a developing position. Thus, by observing the position of the visualization ring, the physician can easily determine whether the distal electrode assembly 31 has reached the target site for electrical stimulation therapy. More preferably, a notch is provided in the visualization ring or the visualization ring is in a non-closed ring shape around the circumferential extension of the nerve stimulation electrode, for example, the projection of the visualization ring on the cross section of the distal electrode assembly 31 is 3/4 circles or 2/3 circles. Therefore, the circumferential position of the first electrode 311 can be conveniently determined during operation through the circumferential position of the developing ring, so that a doctor can conveniently confirm the corresponding direction of the used first electrode 311 and perform accurate electrostimulation treatment on a patient. The trapezoidal notches in the first fixing ring 34 shown in fig. 2 and 4 are provided for the purpose of directional development, and in other embodiments, the notches in the first fixing ring 34 may have other shapes, such as circular, oval, square, etc. In addition, the notch provided in the first fixing ring 34 also facilitates the first fixing ring 34 to be caught on the proximal end of the distal electrode assembly 31. Specifically, the first fixing ring 34 is made of a developing material, and preferably may be made of a material having a large attenuation to absorption of X-rays, such as tantalum, platinum-iridium alloy, platinum-tungsten alloy, or barium, or a polymer containing tantalum, platinum-iridium alloy, platinum-tungsten alloy, or barium.

Since the second fixing ring 35 is not required to be developed, the second fixing ring 35 is preferably made of a metal material that is not a developing material, and since the second fixing ring is a multi-component connection portion, the second fixing ring 35 is preferably made of a material having a good mechanical property such as stainless steel in order to avoid stress concentration and improve mechanical property and reliability. In addition, a notch may also be provided in the second fixing ring 35, that is, the second fixing ring 35 is in a non-closed ring shape around the circumferential extension of the neurostimulation electrode, so that the notch can facilitate the second fixing ring 35 to be clamped on the distal end of the proximal connector 33. Preferably, the second fixing ring 35 is not provided with a notch, so that the fixing effect on the connecting part is better, and the mechanical property and the reliability are better.

Preferably, the proximal end of the first wire 312 and the distal end of the third wire 321 are both flat and have the same cross-section, and the distal end of the second wire 332 and the proximal end of the third wire 321 are both flat and have the same cross-section. Here, the same cross section means that both cross sections have the same shape and area. Since the proximal end of the first wire 312 and the distal end of the third wire 321 are both flat and have the same cross section, when the first wire 312 and the third wire 321 are connected, the connection ends of the first wire 312 and the third wire 321 can be aligned conveniently, so that the connection stability between the first wire 312 and the third wire 321 can be further improved. Similarly, since the distal end of the second wire 332 and the proximal end of the third wire 321 are both flat and have the same cross section, when the second wire 332 is connected to the third wire 321, the connection ends of the second wire 332 and the third wire 321 can be aligned conveniently, so as to further improve the stability of the connection between the second wire 332 and the third wire 321.

Preferably, a first insulating tube (not shown) is further sleeved outside the first connection portion 341 between the third conductive wire 321 and the first conductive wire 312, the first fixing ring 34 is further sleeved outside the first insulating tube, a second insulating tube (not shown) is further sleeved outside the second connection portion 351 between the third conductive wire 321 and the second conductive wire 332, and the second fixing ring 35 is further sleeved outside the second insulating tube. Therefore, the first connection portion 341 is covered with the first insulating tube, and the first fixing ring 34 is covered with the first insulating tube, so that the first connection portion 341 can be further protected by the first insulating tube, and in addition, the insulation of the neurostimulation electrode at the first connection portion 341 can be improved and the short circuit of the circuit can be prevented because the first insulating tube is made of an insulating material. Similarly, the second insulating tube is sleeved on the second connection portion 351, and the second fixing ring 35 is sleeved on the outside of the second insulating tube, so that the second connection portion 351 can be further protected by the second insulating tube, and the second insulating tube is made of an insulating material, so that the insulation of the nerve stimulation electrode at the second connection portion 351 can be improved, and a short circuit of the circuit can be prevented.

The material of the first insulating tube may be the same as the insulating material of the distal electrode assembly 31 (i.e., the sleeve outside the distal electrode assembly 31), or may be different from the insulating material of the distal electrode assembly 31, and the material of the first insulating tube may be an insulating material such as TPU or silicone. The material of the second insulating tube may be the same as the insulating material of the proximal connector 33 (i.e., the sleeve outside the proximal connector 33), or may be different from the insulating material of the proximal connector 33, and the material of the second insulating tube may be an insulating material such as TPU or silica gel. As will be understood by those skilled in the art, the material of the first insulating pipe body and the second insulating pipe body may be other insulating materials besides TPU and silicone rubber.

To achieve the above-mentioned idea, the present invention further provides a neurostimulation system, please refer to fig. 7, which schematically shows a structural schematic diagram of the neurostimulation system provided by an embodiment of the present invention, as shown in fig. 7, the neurostimulation system includes the neurostimulation electrode, the pulse generator 10 and the extension wire 20, the distal end of the extension wire 20 is connected to the proximal end connector 33 of the neurostimulation electrode, and the proximal end of the extension wire 20 is connected to the pulse generator 10. Because the first fixing ring 34 is sleeved on the first connection part 341 between the far-end electrode assembly 31 and the middle section lead 32, and the second fixing ring 35 is sleeved on the second connection part 351 between the near-end connector 33 and the middle section lead 32, the first connection part 341 between the far-end electrode assembly 31 and the middle section lead 32 can be protected by the first fixing ring 34, the first connection part 341 is effectively prevented from being broken due to stress caused by the first connection part 341 being positioned in the stress release section, and the mechanical property and reliability of the first connection part 341 between the far-end electrode assembly 31 and the middle section lead 32 are effectively improved. Similarly, through the fixed ring 35 of second can play the effect of protection to second connection position 351 between proximal connector 33 and middle section wire 32, effectively avoid producing the fracture because of second connection position 351 is located the stress release section and the atress, effectively improved the mechanical properties and the reliability of second connection position 351 between proximal connector 33 and middle section wire 32.

Preferably, referring to fig. 8, which schematically shows a connection relationship between the proximal connector 33 and the extension lead 20 in the neurostimulation system provided by the embodiment of the invention, as shown in fig. 8, the distal end of the extension lead 20 is provided with a fastener 21 matched with the second fixing ring 35, and the fastener 21 can press the second fixing ring 35. Thus, by providing the fastener 21 at the distal end of the extension wire 20 to be fitted with the second fixing ring 35, the proximal connector 33 can be firmly fixed in the distal end of the extension wire 20 by the fastener 21, and the proximal connector 33 is effectively prevented from coming off the distal end of the extension wire 20. When the fastening member 21 is fixed, a certain pressure can be applied to the second fixing ring 35, but the pressure is within the bearing range of the second fixing ring 35, and the second fixing ring 35 and the second insulating tube can simultaneously protect the second connection portion 351 between the proximal connector 33 and the middle section wire 32, thereby effectively ensuring the mechanical property and reliability of the second connection portion 351.

To achieve the above-mentioned idea, the present invention further provides a method for manufacturing a neurostimulation electrode, referring to fig. 9, which schematically shows a flowchart of a method for manufacturing a neurostimulation electrode according to an embodiment of the present invention, and as shown in fig. 9, the method for manufacturing a neurostimulation electrode comprises the following steps:

step S110: respectively manufacturing a distal electrode assembly, a middle section lead and a proximal connector, wherein the distal electrode assembly comprises a plurality of first electrodes arranged at intervals and a first lead electrically connected with the first electrodes, and the proximal end of the first lead extends to the proximal end of the distal electrode assembly and is exposed; the proximal connector comprises a plurality of second electrodes arranged at intervals and a second lead electrically connected with the second electrodes, and the distal end of the second lead extends to the distal end of the proximal connector and is exposed; the middle section wire comprises a third wire, and the near end and the far end of the third wire respectively extend to the near end and the far end of the middle section wire and are exposed.

Step S120: connecting the near end of the first lead with the far end of the third lead, connecting the far end of the second lead with the near end of the third lead, sleeving a first fixing ring at a first connecting part between the first lead and the third lead, and sleeving a second fixing ring at a second connecting part between the second lead and the third lead.

Therefore, the manufacturing method of the nerve stimulation electrode provided by the invention comprises the steps of dividing the nerve stimulation electrode into three modules, namely a far-end electrode assembly, a middle-section lead and a near-end connector, respectively manufacturing the far-end electrode assembly, the middle-section lead and the near-end connector, then connecting the near end of the far-end electrode assembly with the far end of the middle-section lead, connecting the far end of the near-end connector with the near end of the middle-section lead, sleeving a first fixing ring at a first connecting part between the far-end electrode assembly and the middle-section lead, sleeving a second fixing ring at a second connecting part between the near-end connector and the middle-section lead, protecting the first connecting part between the far-end electrode assembly and the middle-section lead by the first fixing ring, and effectively avoiding the first connecting part from being broken due to stress caused by the first connecting part being positioned at a stress release section, the mechanical property and reliability of the first connecting part between the far-end electrode assembly and the middle section lead are effectively improved. In a similar way, through the solid fixed ring of second can be to the second between proximal connector and the middle section wire connection position effect of playing the protection, effectively avoid producing the fracture because of the second is connected the position and is located the stress release section and atress, has effectively improved the mechanical properties and the reliability that the position was connected to the second between proximal connector and the middle section wire. In addition, compared with the integral manufacturing process in the prior art, the manufacturing method of the nerve stimulation electrode provided by the invention is more convenient to adjust the structure of each section of the nerve stimulation electrode according to the use requirement through a modularized assembly mode, is convenient to increase or design a structure module meeting the requirement, is beneficial to reasonably arranging process steps, and further can effectively reduce the production cost.

Preferably, the proximal end of the first lead is connected to the distal end of the third lead, and the distal end of the second lead is connected to the proximal end of the third lead by welding. Specifically, the proximal end of the first lead may be connected to the distal end of the third lead by resistance welding or laser welding, and the distal end of the second lead may be connected to the proximal end of the third lead.

Preferably, the method further comprises:

the second connection position is sleeved with the second fixing ring, and then the second fixing ring is fixed on the proximal connector and the middle section wire in an injection molding or gluing mode.

Therefore, the first fixing ring is fixed on the far-end electrode assembly and the middle section lead in an injection molding or gluing mode, the connection stability between the first fixing ring and the far-end electrode assembly and between the first fixing ring and the middle section lead can be further improved, and the protection effect of the first fixing ring on the first connection part is further improved. In a similar way, will through adopting the mode of moulding plastics or gluing the solid fixed ring of second is fixed in on proximal connector and the middle section wire, can further improve the solid fixed ring of second with the proximal connector with the stability of connecting between the middle section wire further improves the guard action at position is connected to the second.

Preferably, the method further comprises:

Therefore, before the first fixing ring is sleeved on the first connecting part, the first insulating pipe body is sleeved on the first connecting part, and then the first fixing ring is sleeved on the first connecting part, so that the first connecting part can be further protected through the first insulating pipe body. Similarly, before the second connection position is sleeved with the second fixing ring, the second connection position is sleeved with the second insulating pipe, and then the second fixing ring is sleeved, so that the second connection position can be further protected by the second insulating pipe, and the second insulating pipe is insulated, so that the insulativity of the nerve stimulation electrode at the second connection position can be improved, and the short circuit of the circuit is prevented.

Based on the same inventive concept, the present invention provides another method for manufacturing a neurostimulation electrode, please refer to fig. 10, which schematically shows a flow chart of the method for manufacturing the neurostimulation electrode according to another embodiment of the present invention, as shown in fig. 10, the method for manufacturing the neurostimulation electrode comprises the following steps:

step S210, respectively manufacturing a distal electrode assembly, a middle section lead and a proximal connector, wherein the distal electrode assembly comprises a plurality of first electrodes arranged at intervals and first leads electrically connected with the first electrodes, and the proximal ends of the first leads extend to the proximal end of the distal electrode assembly and are exposed; the proximal connector comprises a plurality of second electrodes arranged at intervals and a second lead electrically connected with the second electrodes, and the distal end of the second lead extends to the distal end of the proximal connector and is exposed; the middle section lead comprises a third lead, and the near end and the far end of the third lead respectively extend to the near end and the far end of the middle section lead and are exposed;

step S220, sleeving a first fixing ring on the portion of the third guide wire near the distal end, and sleeving a second fixing ring on the portion of the third guide wire near the proximal end; and

step S230, connecting the proximal end of the first wire to the distal end of the third wire, and connecting the distal end of the second wire to the proximal end of the third wire, so that the first fixing ring is sleeved on the first connection portion between the first wire and the third wire, and the second fixing ring is sleeved on the second connection portion between the second wire and the third wire.

Compared with the manufacturing method shown in fig. 9, in the manufacturing method of this embodiment, before the proximal end of the first lead is connected to the distal end of the third lead, a first fixing ring is sleeved on the portion, close to the distal end, of the third lead, so that the first fixing ring can be more conveniently sleeved on the first connection portion after the proximal end of the first lead is connected to the distal end of the third lead. Similarly, before the distal end of the second lead is connected to the proximal end of the third lead, the second fixing ring is sleeved on the portion, close to the proximal end, of the third lead, so that the second fixing ring can be more conveniently sleeved on the second connection portion after the distal end of the second lead is connected to the proximal end of the third lead.

In summary, compared with the prior art, the neurostimulation electrode, the manufacturing method thereof and the neurostimulation system provided by the invention have the following advantages:

(2) The nerve stimulation system provided by the invention comprises the nerve stimulation electrode, so that the nerve stimulation system provided by the invention has all the advantages of the nerve stimulation electrode, namely, the nerve stimulation electrode in the nerve stimulation system provided by the invention has the advantages that the first fixing ring is sleeved at the first connecting part between the distal electrode assembly and the middle section lead, and the second fixing ring is sleeved at the second connecting part between the proximal connector and the middle section lead, so that the first connecting part between the distal electrode assembly and the middle section lead can be protected by the first fixing ring, the first connecting part between the distal electrode assembly and the middle section lead is effectively prevented from being broken due to stress of the first connecting part at the stress release section, and the mechanical property and reliability of the first connecting part between the distal electrode assembly and the middle section lead are effectively improved. In a similar way, through the solid fixed ring of second can be to the second between proximal connector and the middle section wire connection position effect of playing the protection, effectively avoid producing the fracture because of the second is connected the position and is located the stress release section and atress, has effectively improved the mechanical properties and the reliability that the position was connected to the second between proximal connector and the middle section wire.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims. It will be apparent to those skilled in the art that various changes and modifications may be made in the invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. The nerve stimulation electrode is characterized by comprising a distal electrode assembly, a middle section lead and a proximal connector which are connected in sequence;

2. The neurostimulation electrode of claim 1, wherein the third wire is helical.

3. The neurostimulation electrode of claim 1, wherein the first fixation ring is a visualization ring.

4. The neurostimulation electrode according to claim 3, wherein the visualization ring is provided with a gap or is in a non-closed annular shape around the circumferential extension of the neurostimulation electrode.

5. The neurostimulation electrode of claim 1, further comprising a guide wire extending through the mid-section wire.

6. The neurostimulation electrode of claim 1, wherein the proximal end of the first wire and the distal end of the third wire are both flat and have the same cross-section, and wherein the distal end of the second wire and the proximal end of the third wire are both flat and have the same cross-section.

7. The neurostimulation electrode according to claim 1, wherein a first insulating tube body is further sleeved outside the first connection portion, the first fixing ring is sleeved outside the first insulating tube body, a second insulating tube body is further sleeved outside the second connection portion, and the second fixing ring is sleeved outside the second insulating tube body.

8. The neurostimulation electrode according to claim 1, wherein the material of the second fixing ring is a metal material which is not a developing material.

9. A neurostimulation system comprising a pulse generator, an extension lead and a neurostimulation electrode as claimed in any one of claims 1 to 8, the distal end of the extension lead being connected to the proximal connector of the neurostimulation electrode and the proximal end of the extension lead being connected to the pulse generator.

10. The neurostimulation system of claim 9, wherein the distal end of the extension wire is provided with a fastener that mates with the second fixation ring, the fastener for compressing the second fixation ring.

11. A method of manufacturing a neurostimulation electrode, comprising:

12. The method of manufacturing a neurostimulation electrode according to claim 11, wherein the proximal end of the first lead is connected with the distal end of the third lead, and the distal end of the second lead is connected with the proximal end of the third lead by welding.

13. The method of manufacturing a neurostimulation electrode according to claim 11, wherein the method further comprises:

after the first fixing ring is sleeved on the first connecting position, the first fixing ring is fixed on the distal electrode assembly and the middle section lead in an injection molding or gluing mode;

after the second fixing ring is sleeved on the second connecting position, the second fixing ring is fixed on the proximal connector and the middle section wire in an injection molding or gluing mode.

14. The method of manufacturing a neurostimulation electrode according to claim 11, wherein the method further comprises:

15. A method of manufacturing a neurostimulation electrode, comprising: