CN210114745U

CN210114745U - Nerve electrical stimulation electrode assembly and nerve electrical stimulation device

Info

Publication number: CN210114745U
Application number: CN201920576816.7U
Authority: CN
Inventors: 许扶; 郭剑
Original assignee: Beijing Pins Medical Co Ltd
Current assignee: Beijing Pins Medical Co Ltd
Priority date: 2019-04-25
Filing date: 2019-04-25
Publication date: 2020-02-28
Anticipated expiration: 2029-04-25

Abstract

The present application relates to a nerve electrical stimulation electrode assembly and a nerve electrical stimulation apparatus. The nerve electrical stimulation comprises soluble glue, an electrode catheter and a puncture tube. The electrode catheter includes a protection tube and a first fixing member including a first fixing portion and a first fixing wing. The first fixing part is fixedly sleeved on the protection tube. The first stationary vane includes a first fixed end and a first free end. The first fixed end is connected with one end of the first fixed part. The first free end is attached to the protective tube by the dissolvable glue. The puncture tube is sleeved on the electrode catheter. When the electrode catheter is implanted into a target tissue and reaches a target point, the soluble glue is gradually dissolved by contacting body fluid and loses viscosity, so that the first free end is automatically opened and embedded into the target tissue, and the electrode catheter and the target tissue are fixed. The fixing piece is not required to be fixed by a pipe sleeve, so that the problem that great inconvenience is caused to the operation of a doctor due to large friction force between the pipe sleeve and the electrode catheter fixing structure is solved.

Description

Nerve electrical stimulation electrode assembly and nerve electrical stimulation device

Technical Field

The application relates to the field of medical equipment, in particular to a nerve electrical stimulation electrode assembly and a nerve electrical stimulation device.

Background

The nerve electrical stimulation system is an active implantable medical device. Similar to the widely used cardiac pacemaker systems, the neurostimulation system is also comprised of a pulse generator that generates the stimulation signals and an electrode catheter that delivers the stimulation signals. The electrode catheter is implanted into a patient, a signal generated by the pulse generator stimulates a target nerve or a nerve nucleus through the electrode catheter, and the nerve is regulated and controlled in an electric stimulation mode to achieve the purpose of treating or improving disease symptoms. In order to achieve a long-term stable therapeutic effect, the positions of the stimulation contact point and the target point on the electrode catheter must be kept unchanged. Therefore, when the electrode catheter is implanted, effective measures should be taken to fix the electrode catheter and the human tissue. In other words, whether the permanent electrostimulation implantation procedure is successful depends on whether the implanted electrode catheter can be securely positioned at the target site without movement.

Currently, in neurostimulation systems using percutaneous puncture techniques for electrode implantation, such as implanted sacral nerve electrical stimulation systems, implanted spinal cord electrical stimulation systems, implanted dorsal root ganglion stimulation systems, etc., electrode catheters are fixed by means of their own fixation structures. After the electrode catheter is implanted into a human body through a puncture operation, the fixing structure of the electrode catheter is embedded into the tissue of the human body, so that the position of the electrode catheter is fixed. Such as those mentioned in patent applications US20030045919a1, CN105056397A, US20040230279a 1. The electrode catheter fixing structure mentioned in the above patent is a barb-like structure. In order to facilitate the puncture operation implantation of the electrode catheter, the barb-shaped fixing structure is compressed by the sleeve, and after the electrode catheter is implanted into the body and reaches a target position, the sleeve is taken out of the barb-shaped fixing structure of the electrode catheter. The friction between the sleeve and the fixing structure is large, so that great inconvenience is brought to the operation of a doctor.

SUMMERY OF THE UTILITY MODEL

Therefore, it is necessary to provide a nerve electrical stimulation electrode assembly and a nerve electrical stimulation device for solving the problem that great inconvenience is caused to the operation of a doctor due to the large friction force between the sleeve and the electrode catheter fixing structure.

The utility model provides a nerve electrical stimulation electrode subassembly includes soluble glue, electrode conduit and puncture tube. The electrode catheter includes a protection tube and a first fixing member. The protective tube is provided with a connecting end and a stimulating end which are oppositely arranged, the connecting end is used for being connected with the pulse generator, and the stimulating end is used for stimulating a target spot. The first fixing piece comprises a first fixing part and a first fixing wing. The first fixing part is fixedly sleeved on the protection tube. The first stationary vane includes a first fixed end and a first free end. The first fixed end is connected with one end of the first fixed part. The first free end is adapted to be attachable to the protective tube by the dissolvable adhesive. The puncture pipe sleeve is arranged on the electrode catheter and used for assisting the electrode catheter to be implanted into a target point.

The nerve electrical stimulation assembly enables the first free end to be adhered to the protection tube through soluble glue, so that the first fixing piece of the electrode catheter is fixed to the protection tube. When the electrode catheter is implanted into a target tissue and reaches a target point, the soluble glue is gradually dissolved by contacting with body fluid and loses viscosity, so that the first free end is automatically opened and embedded into the target tissue, and the electrode catheter and the target tissue are fixed. The free end of the fixing piece is not required to be fixed by a pipe sleeve, so that the problem of great inconvenience for the operation of a doctor due to large friction force between the sleeve and the electrode catheter fixing structure is solved.

Drawings

FIG. 1 is a block diagram of an electrode catheter of a neurostimulation electrode assembly provided in an embodiment of the present application;

FIG. 2 is a diagram of a structure of an electrode catheter of a neurostimulation electrode assembly according to another embodiment of the present application;

fig. 3 is an enlarged schematic view of a first fixing portion and a soluble glue according to an embodiment of the disclosure;

fig. 4 is an enlarged view of a first fixing portion and a soluble glue according to another embodiment of the present disclosure;

FIG. 5 is a flow chart of a method for manufacturing a nerve electrode assembly according to an embodiment of the present application;

FIG. 6 is a schematic view of a nerve electrode assembly implantation process provided by an embodiment of the present application;

fig. 7 is a flowchart of a method for implanting a nerve electrode assembly according to an embodiment of the present disclosure.

The reference numbers illustrate:

the nerve electrical stimulation electrode assembly 10, the electrode catheter 100, the protective tube 110, the connecting end 113, the stimulating end 115, the connecting contact 114, the stimulating contact 116, the target mark 117, the handheld element 119, the first fixing member 120, the first fixing portion 121, the first fixing wing 122, the first fixing end 1221, the first free end 1222, the X-ray development mark 123, the fixing piece 124, the second fixing member 130, the second fixing portion 131, the second fixing wing 132, the second fixing end 1321, the second free end 1322, the first fixing area 125, the second fixing area 126, the soluble glue 140, the puncture tube 200, the target tissue 300, the target point 310, the nerve electrical stimulation device 40 and the pulse generator 410.

Detailed Description

Referring to fig. 1, the present application provides a neurostimulation electrode assembly 10 including a dissolvable gel 140, an electrode catheter 100, and a puncture tube 200. The electrode catheter 100 includes a protective tube 110 and a first fixing member 120. The protective tube 110 has a connection end 113 and a stimulation end 115 arranged opposite to each other, the connection end 113 being adapted for connection to a pulse generator and the stimulation end 115 being adapted for stimulating a target. The first fixing member 120 includes a first fixing portion 121 and a first fixing wing 122. The first fixing portion 121 is fixedly sleeved on the protection tube 110. The first stationary wing 122 includes a first fixed end 1221 and a first free end 1222. The first fixing end 1221 is connected to one end of the first fixing portion 121. The first free end 1222 can be adhered to the protective tube 110 by the soluble glue 140. The puncture tube 200 is sleeved on the electrode catheter 100 and is used for assisting the electrode catheter 100 to be implanted to a target point. It should be understood that the penetration tube 200 is a hollow structure. And the inner diameter of the puncture tube 200 is greater than the outer diameter of the electrode catheter 100 so that the puncture tube 200 is fitted over the electrode catheter 100.

The above-mentioned nerve electrical stimulation electrode assembly 10 adheres the first free end 1222 to the protective tube 110 by the soluble glue 140 so that the first fixing member 120 of the electrode catheter 100 is fixed to the protective tube 110. After the electrode catheter 100 is implanted into a target tissue and reaches the target site, the soluble glue 140 gradually dissolves in contact with body fluid and loses viscosity, so that the first free end 1222 is automatically opened to be embedded into the target tissue, and the electrode catheter 100 is fixed with the target tissue. The free end of the fixing member is not fixed by using a sleeve, thereby solving the problem of great inconvenience to the doctor in the operation due to the large friction force between the sleeve and the fixing structure of the electrode catheter 100.

In one embodiment, the protective tube 110 is a hollow cannula structure that encloses a lumen. The stimulating end 115 is a closed structure, and the head of the stimulating end 115 can be a smooth curved surface, which is beneficial to implanting into a target tissue and stimulating a target spot. The connecting end 113 is an open structure so that a steel wire can be inserted into the connecting end to facilitate surgical operation.

In one embodiment, the connecting terminal 113 includes a plurality of connecting contacts 114, the stimulating terminal 115 includes a plurality of stimulating contacts 116, the number of the connecting contacts 114 is equal to that of the stimulating contacts 116, and the connecting contacts 114 are electrically connected with the stimulating contacts 116 in a one-to-one correspondence through wires.

In the above embodiment, the plurality of connection contacts 114 are used to receive different pulse signals or pulse signals of different time periods from the pulse generator. The pulse signals received by the plurality of connecting contacts 114 are conducted to different stimulating contacts 116 through different wires, so that different pulse signals or pulse signals with different time periods are transmitted to a target point, and a therapeutic effect is achieved. It should be understood that adjacent ones of the connection contacts 114 and adjacent ones of the stimulation contacts 116 are electrically isolated from one another.

In one embodiment, the connection contact 114 may be a ring-shaped structure embedded in the protective tube 110. The connection contacts 114 may be composed of an electrically conductive, biocompatible material, such as stainless steel, cobalt alloy, titanium alloy, tantalum, platinum-iridium alloy, and the like. In another embodiment, the stimulating contact 116 may be a ring-shaped structure. The stimulation contacts 116 may be electrically connected to the leads by resistance spot welding or laser spot welding. The stimulation contacts 116 may be composed of an electrically conductive biocompatible material, such as platinum or a platinum-iridium alloy, or a material having a surface coated with a platinum or platinum-iridium alloy coating.

In one embodiment, the wire extends through the lumen of the protective tube 110. The conducting wire can be a plurality of spiral wires or stranded wires and is insulated from each other. Each of the conductors is connected at both ends to a connection contact 114 and a stimulation contact 116, respectively. The lead may transmit the electrical pulse signal received by the connection terminal 113 from the pulse generator to the stimulation terminal 115.

In one embodiment, in a free state (no external force is applied), the first free end 1222 of the first fixing wing 122 is tilted and opened away from the protective tube 110, surrounding an opening. It is understood that when the opening is directed toward the connection end 113, the electrode catheter 100 is prevented from moving toward the connection end 113 after being implanted into the target tissue. When the opening is directed toward the stimulating end 115, the electrode catheter 100 may be prevented from moving toward the stimulating end 115 after being implanted into the target tissue. The first fixing element 120 has a one-way contractibility, and the first free end 1222 of the first fixing wing 122 can be completely compressed and attached to the protection tube 110 under a stressed condition. After the first free end 1222 is attached to the protective tube 110, the first free end 1222 may be adhered to the protective tube 110 by the soluble glue 140, and then the external force is removed. After the electrode catheter 100 is implanted into a target tissue, the soluble glue 140 is decomposed and loses viscosity when encountering body fluid, and the first free end 1222 is automatically tilted and opened and embedded into the target tissue to fix the electrode catheter 100. The first free end 1222 is fixed without using a sleeve, thereby solving the problem of great inconvenience to the doctor in the operation due to the large friction force between the sleeve and the fixed structure of the electrode catheter 100.

In one embodiment, the material of the first fixing member 120 may be a material with good contractility, such as polyurethane, silicone rubber, or polyurethane-silicone rubber polymer. In the above embodiment, the first fixing part 121 is sleeved on the protective tube 110 and may be fixed by bonding or welding, and then the first fixing part 120 of the electrode catheter 100 and the protective tube 110 are completely dried.

Referring to fig. 2, in one embodiment, the protective tube 110 further includes at least one second fixing member 130. Each of the second fixing pieces 130 includes a second fixing portion 131 and two second fixing wings 132. The second fixing portion 131 is fixedly sleeved on the protection tube 110. The two fixing wings are respectively disposed at two opposite ends of the second fixing portion 131. Each of the second stationary wings 132 includes a second fixed end 1321 and a second free end 1322. The second fixing end 1321 is disposed on the second fixing portion 131. The second free end 1322 can be adhered to the protective tube 110 by the soluble glue 140.

In a free state (no external force is applied), each of the second free ends 1322 is tilted and opened away from the protective tube 110 to surround and form an opening. One of the second free ends 1322 is formed to have an opening direction toward the connection end 113 of the protective tube 110, and the other of the second free ends 1322 is formed to have an opening direction toward the stimulation end 115 of the protective tube 110. Under the stress state, the two second free ends 1322 are contracted and respectively attached to the protection tube 110. And then, the two second free ends 1322 are respectively adhered to the protective tube 110 by the soluble glue 140, and after the soluble glue 140 is completely cured, the applied external force is removed, so that the two second free ends 1322 are adhered to the protective tube 110 by the soluble glue 140. After the electrode catheter 100 is implanted into the target tissue, the soluble glue 140 contacts with body fluid, gradually dissolves and loses viscosity, and the two second free ends 1322 are respectively opened towards the stimulating end 115 and the connecting end 113 and are embedded in the target tissue, so that the electrode catheter 100 is fixed to the target tissue. The two free ends are oriented in opposite directions, i.e., the electrode catheter 100 is prevented from moving toward the connecting end 113 and the electrode catheter 100 is prevented from moving toward the stimulating end 115, further fixing the position of the electrode catheter 100 in the target tissue.

In one embodiment, the protective tube 110 includes two first fasteners 120. The first fixing element 120 is disposed on two sides of the second fixing element 130, and the two first free ends 1222 are opposite in orientation. In this embodiment, the two first free ends 1222 are oriented in opposite directions, which prevents the electrode catheter 100 from moving toward the connecting end 113 and the electrode catheter 100 from moving toward the stimulating end 115, further fixing the position of the electrode catheter 100 in the target tissue. Referring to fig. 2, in one embodiment, the protective tube 110 includes two first fixing members 120 and one second fixing member 130. One of the first free ends 1222 is oriented in the same direction as the second free end 1322, and the other of the first free ends 1222 is oriented in the same direction as the second free end 1322. This arrangement may further enhance the fixation of the position of the electrode catheter 100 in the target tissue, preventing the electrode catheter 100 from moving toward the stimulating end 115 or the connecting end 113.

In one embodiment, the protective tube 110 includes a plurality of the first fasteners 120. In the axial direction of the protective tube 110, at least one of the first free ends 1222 is oriented opposite to the other first free ends 1222.

Referring again to fig. 1, in one embodiment, the protective tube 110 is divided into a first securing region 125 and a second securing region 126. The first fixing sections 125 and the second fixing sections 126 are provided with the same number of first fixing sections 120. The first free end 1222 at the first fixed area 125 is oriented opposite the first free end 1222 at the second fixed area 126. In one embodiment, the first fixing section 125 is close to the connecting end 113, and the first free end 1222 of the first fixing member 120 located at the first fixing section 125 faces the stimulating end 115 and engages with the target tissue after the first free end 1222 located at the first fixing section 125 is expanded, so as to prevent the electrode catheter 100 from moving towards the stimulating end 115. The second fixing section 126 is adjacent to the stimulation end 115, and the first free end 1222 of the first fixing element 120 at the second fixing section 126 faces the connection end 113 and engages with the target tissue after the first free end 1222 at the second fixing section 126 is expanded, thereby preventing the electrode catheter 100 from moving toward the connection end 113. The first fixing sections 125 and the second fixing sections 126 have the same number of first fixing elements 120, so that after the first free end 1222 is expanded to be engaged with the target tissue, the electrode catheter 100 is uniformly stressed and prevented from moving towards both ends, and the fixing effect is better.

Referring to fig. 3, in one embodiment, the first fixing wing 122 includes a plurality of fixing pieces 124, and the plurality of fixing pieces 124 are spaced around the first fixing portion 121. The fixing pieces 124 uniformly arranged around the first fixing portion 121 can facilitate the first fixing wings 122 to be embedded in the target tissue, and are not easy to fall off. Moreover, the structure of the plurality of fixing pieces 124 can increase the adhesive area, so that the soluble glue 140 can adhere to the first fixing wing 122 and the protection tube 110.

In one embodiment, the plurality of fixing pieces 124 are attached to the protective tube 110, and the soluble glue 140 is spot-coated on the edges of the fixing pieces 124. In another embodiment, the soluble glue 140 may be spot-coated on the edge of the fixing piece 124 and the protective tube 110. The soluble glue 140 is applied to the edge of the fixing plate 124 in a spot manner, so that the soluble glue 140 is in contact with body fluid after the electrode catheter 100 is implanted into a target tissue, the contact area between the soluble glue 140 and the body fluid is increased, and the first free end 1222 can be opened as soon as possible and can be conveniently embedded in the target tissue.

Referring to fig. 4, in one embodiment, the soluble glue 140 is coated on the outside of the first fixing wing 122 to form a film surrounding the first fixing wing 122, and the first free end 1222 can be adhered to the protective tube 110 by the soluble glue 140. In another embodiment, the dissolvable glue 140 surrounds the anchor sheets 124 to form a protective film in the gap between two adjacent anchor sheets 124. The wrapping area of the soluble glue 140 may be increased, and the contact area of the soluble glue 140 with the body fluid is increased after the electrode catheter 100 is implanted into the target tissue, thereby accelerating the dissolution speed of the soluble glue 140, making the stator 124 more easily opened, and accelerating the fixation of the electrode catheter 100 in the target tissue. Referring again to fig. 1, in one embodiment, the electrode catheter 100 further includes a target mark 117 disposed between the connecting end 113 and the first fixing member 120; when the target mark 117 is aligned with the end of the puncture tube 200, the stimulating end 115 of the electrode catheter 100 reaches the target point.

In the above embodiment, the target mark 117 is used for monitoring the puncture depth when the electrode catheter 100 is implanted. The target mark 117 may be a color or a structure that is clearly distinguishable by being etched, brushed, stuck, fixed on the protective tube 110. For example, white stripes may be painted or white tape may be stuck on the protective tube 110. During the implantation of the electrode catheter 100 into the target tissue, the puncture tube 200 is inserted into the target tissue, and the piercing end of the puncture tube 200 is located at the target site. The other end of the puncture tube 200 is exposed outside the target tissue. The electrode catheter 100 is inserted into the puncture tube 200, and when the target mark 117 of the protective tube 110 is aligned with the end of the puncture tube 200 located outside the target tissue, the stimulating end 115 of the electrode catheter 100 reaches the target point, thereby facilitating real-time monitoring of the puncture depth and ensuring that the stimulating end 115 of the electrode catheter 100 reaches the target point, so as to achieve a therapeutic effect.

In one embodiment, the electrode catheter 100 further includes two radiographic markers 123 respectively disposed at the beginning and the end of the fixing member for positioning the first fixing member 120. The X-ray imaging marker 123 is used for determining the position of the first fixing member 120 under X-ray after the electrode catheter 100 is implanted. The X-ray development mark 123 is made of a material having a large attenuation to the absorption of X-rays, such as tantalum, platinum-iridium alloy, or barium-containing, tungsten-containing, bismuth-containing polymer.

In one embodiment, the electrode catheter 100 further includes a handheld element 119, and the handheld element 119 is disposed at the connection end 113 to assist in implanting the electrode catheter 100. The connection end 113 of the protective tube 110 has an open structure into which the grip element 119 can be inserted. The hand-held element 119 serves to enhance the rigidity of the electrode, facilitate implantation of the electrode catheter 100 into the target tissue, and facilitate the surgical operation. After the electrode catheter 100 is implanted into the target tissue, the hand-held element 119 may be removed from the electrode catheter 100, and detached from the electrode catheter 100.

In one embodiment, the material of the soluble glue 140 is starch, dextrin, cellulose, polyvinylpyrrolidone or N-vinyl amide polymer. The material has the characteristics of in vivo dissolubility or in vivo degradability, good biocompatibility and water-soluble polymers, and can be gradually dissolved or decomposed to lose viscosity after the target tissue is contacted with body fluid for a period of time, so that the first free end 1222 or the second free end 1322 is completely unfolded and embedded into the target tissue, and the electrode catheter 100 is fixed with the target tissue.

In one embodiment, the soluble glue 140 may be a polyvinylpyrrolidone solution (PVP). The polyvinylpyrrolidone solution (PVP) has excellent dissolving performance and physiological compatibility, the larger the molecular weight K value is, the larger the viscosity is, the stronger the adhesiveness is, and the slower the dissolving rate is. In one embodiment, a polyvinylpyrrolidone K value of 90 is used. A polyvinylpyrrolidone solution may be sequentially spot-coated on the side (edge) of each of the fixing pieces 124 and the protective tube 110, and after PVP is completely cured, the fixing pieces 124 are adhered to the protective tube 110 by removing the applied external force.

In one embodiment, the material of the protective tube 110 is polyurethane, silicon rubber, or polyurethane-silicon rubber polymer. The material of the fixing member may also be polyurethane, silicone rubber or polyurethane-silicone rubber polymer. The polyurethane, silicon rubber or polyurethane-silicon rubber polymer material has good bondability with the soluble glue 140, so that the free end of the fixing wing is conveniently adhered to the protection tube 110 through the soluble glue 140.

In one embodiment, the amount of the soluble glue 140 is used to ensure that the first fixing wing 122 or the second fixing wing 132 can be compressed completely and attached to the protection tube 110. And after the electrode catheter 100 is implanted into a target tissue, the soluble glue 140 loses viscosity, and the time required for the first fixing wing 122 or the second fixing wing 132 to be fully opened is less than 12 hours.

The present application also provides a nerve electrical stimulation apparatus 40. The electrical nerve stimulation device 40 comprises the electrical nerve stimulation electrode assembly 10 and further comprises a pulse generator 410. The pulse generator 410 is disposed at the connection terminal 113. The pulse generator 410 is capable of transmitting an electrical pulse signal. The electric pulse signal reaches the stimulating end 115 through the connecting end 113 so as to stimulate a target spot, and the target spot nerve is regulated and controlled in an electric stimulation mode so as to achieve the purpose of treating or improving disease symptoms.

Referring to fig. 5, the present application also provides a method 20 for preparing the electrical nerve stimulation electrode assembly 10. The preparation method 20 comprises the following steps:

s210, the first fixing portion 121 of the first fixing member 120 is sleeved on and fixed to the protection tube 110;

s220 applying an external force to the first fixing wing 122 of the first fixing member 120 to make the first free end 1222 attached to the protective tube 110;

s230 coating the soluble glue 140 between the first free end 1222 and the protective tube 110;

s240, after the soluble glue 140 is cured, the applied external force is removed, so that the first free end 1222 is attached to the protective tube 110.

In one embodiment, the step S210 specifically includes sleeving the first fixing part 121 of the first fixing member 120 on the protective tube 110, and thermally fusing the first fixing part 121 and the protective tube 110 together by using a heat gun at 150 ℃. Then, the first fixing member 120 and the protection pipe 110 are ultrasonically cleaned (or plasma cleaned) in a solvent of alcohol or isopropyl alcohol, and impurities and oil stains on the surface are cleaned. After cleaning, the first fixing member 120 and the protection pipe 110 are completely dried by using a blast drying oven. The step S220 is then performed to apply an external force to the first free end 1222 of the first fixed wing 122, so that the first free end 1222 is completely compressed and attached to the protective tube 110. The soluble glue 140 used in step S230 may be a polyvinylpyrrolidone solution (PVP) having excellent solubility and physiological compatibility, wherein the larger the molecular weight K value, the larger the viscosity, the stronger the adhesiveness, and the slower the dissolution rate, and the polyvinylpyrrolidone K value used in this embodiment is 90. A polyvinylpyrrolidone solution is sequentially dispensed on the side of each of the first free ends 1222 and the protective tube 110, and after PVP is completely cured, the applied external force is removed, and the first fixing wing 122 and the protective tube 110 are adhered together.

It should be understood that the first fixing member 120 and the second fixing member 130 are the same in function and the same in material but different in function in the present application, and thus, the manner of fixing the second fixing member 130 to the protective pipe 110 is the same as the manner of fixing the first fixing member 120 to the protective pipe 110. The operation process of adhering the second free end 1322 to the protective tube 110 using the soluble glue 140 is the same as the operation process of adhering the first free end 1222 to the protective tube 110 using the soluble glue 140, and is not repeated.

Referring to fig. 6 and 7, a method 30 of implanting a neurostimulation electrode assembly is also provided. The implantation method 30 comprises the steps of:

s310, inserting the puncture tube 200 into the target tissue 300, and enabling the puncture end of the puncture tube 200 to be located at the target point position 310;

s320 inserting the electrode catheter 100 into the puncture tube 200 such that the stimulating end 115 of the electrode catheter 100 is located at the target site;

s330, pulling out the puncture tube 200;

s340, after the soluble glue 140 loses its adhesiveness, the first fixing wings 122 of the first fixing member 120 automatically open and are embedded into the target tissue 300.

In one embodiment, the implantation method 30 may further include, after the step S340, a step S350 of detecting the position of the first fixing member 120 through X-ray visualization so as to monitor the position of the first fixing member 120 in the target tissue 300.

In one embodiment, the step S310 specifically includes placing the puncture needle with the score line into the target tissue 300 to find the target site 310, where the score line of the puncture needle is exposed to the target tissue 300. The puncture tube 200 is then inserted into the target tissue 300 along the puncture needle such that the end of the puncture tube 200 exposed to the target tissue 300 is aligned with the score line of the puncture needle, and the piercing end of the puncture tube 200 is located at the target site 310. The puncture needle is then withdrawn and the step S320 is performed to insert the electrode catheter 100 into the puncture tube 200, such that the stimulation end 115 of the electrode catheter 100 is located at the target position 310, i.e., the target mark 117 of the electrode catheter 100 is aligned with the end of the puncture tube 200 exposed to the target tissue 300. It should be understood that the first free end 1222 of the first fixing wing 122 in the electrode catheter 100 in the step S320 is in a compressed state, and is attached to the protective tube 110. Then, the puncture tube 200 is pulled out in step S330. Finally, after the soluble glue 140 loses its adhesiveness, the first fixing wing 122 of the first fixing member 120 automatically opens to be embedded into the target tissue 300 in the step S340. It is necessary to keep the electrode catheter 100 in place for 5 minutes in the step S340 to ensure that the soluble gel 140 comes into contact with the body fluid to start dissolving. After the soluble 140 glue is gradually dissolved, the first free ends 1222 are all automatically opened to be embedded into the target tissue 300, so that the electrode catheter 100 is completely fixed with the target tissue 300. The free end of the fixing piece is not required to be fixed by a pipe sleeve, so that the problem of great inconvenience for the operation of a doctor due to large friction force between the sleeve and the electrode catheter fixing structure is solved.

It should be understood that the "first fixing member 120" described in the above-mentioned implantation method 30 may also be the second fixing member 130, and correspondingly, the "first fixing wing 122" may also be the second fixing wing 132.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims

1. An electrostimulation electrode assembly for a nerve, comprising:

a soluble gum (140);

an electrode catheter (100) comprising:

a protective tube (110) having a connection end (113) and a stimulation end (115) arranged opposite to each other, the connection end (113) being adapted to be connected to a pulse generator, the stimulation end (115) being adapted to stimulate a target;

a first fixture (120) comprising:

the first fixing part (121), the first fixing part (121) is fixedly sleeved on the protection tube (110);

a first fixing wing (122), the first fixing wing (122) including a first fixed end (1221) and a first free end (1222), the first fixed end (1221) being connected with one end of the first fixing portion (121), the first free end (1222) being capable of adhering to the protective tube (110) by the soluble glue (140);

the puncture tube (200) is sleeved on the electrode catheter (100) and used for assisting the electrode catheter (100) in implanting a target point.

2. The electrical nerve stimulation electrode assembly of claim 1, wherein the protective tube further comprises at least one second fixing member (130), each of the second fixing members (130) comprising:

the second fixing part (131), the said second fixing part (131) is fixed and sleeved on the said protective pipe (110);

two second stationary vanes (132) respectively disposed at opposite ends of the second fixing portion (131), each of the second stationary vanes (132) includes a second fixing end (1321) and a second free end (1322), the second fixing end (1321) is disposed at the second fixing portion (131), and the second free end (1322) can be adhered to the protection pipe (110) by the soluble glue (140).

3. The electrical nerve stimulation electrode assembly according to claim 2, wherein the protection tube (110) includes two first fixing members (120), the first fixing members (120) are respectively disposed at both sides of the second fixing member (130), and the two first free ends (1222) are oppositely oriented.

4. The electrical nerve stimulation electrode assembly according to claim 1, wherein the protection tube includes a plurality of the first fixing members (120), and at least one of the first free ends (1222) is oriented in an opposite direction to the other first free ends (1222) in an axial direction of the protection tube (110).

5. The electrical nerve stimulation electrode assembly according to claim 1, wherein the protection tube is divided into a first fixing section (125) and a second fixing section (126), the first fixing section (125) and the second fixing section (126) are provided with the same number of the first fixing members (120), and the first free end (1222) at the first fixing section (125) is oriented in an opposite direction to the first free end (1222) at the second fixing section (126).

6. The electrical nerve stimulation electrode assembly of claim 1, wherein the first fixing wing (122) includes a plurality of fixing tabs (124), the plurality of fixing tabs (124) being spaced around the first fixing portion (121).

7. The neurostimulation electrode assembly as claimed in claim 6, wherein the plurality of fixing pieces (124) are attached to the protection tube (110), and the soluble glue (140) is spot-coated on the edges of the fixing pieces (124).

8. The electrostimulation electrode assembly of a nerve according to claim 1, characterised in that the soluble glue (140) is applied on the outside of the first fixed wing (122) forming a thin film surrounding the first fixed wing (122).

9. The neurostimulation electrode assembly according to claim 1, wherein the connecting end (113) comprises a plurality of connecting contacts (114), the stimulating end (115) comprises a plurality of stimulating contacts (116), the number of the connecting contacts (114) is equal to that of the stimulating contacts (116), and the connecting contacts (114) are electrically connected with the stimulating contacts (116) in a one-to-one correspondence through conducting wires.

10. A nerve stimulation device comprising the nerve stimulation electrode assembly as claimed in any one of claims 1 to 9, further comprising a pulse generator (410) disposed at the connection end (113), the pulse generator (410) being capable of emitting electrical pulse signals which pass through the connection end (113) to the stimulation end (115) to stimulate a target site.