CN109908467B - Nerve electric stimulation electrode assembly and preparation method thereof - Google Patents
Nerve electric stimulation electrode assembly and preparation method thereof Download PDFInfo
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- CN109908467B CN109908467B CN201910339477.5A CN201910339477A CN109908467B CN 109908467 B CN109908467 B CN 109908467B CN 201910339477 A CN201910339477 A CN 201910339477A CN 109908467 B CN109908467 B CN 109908467B
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Abstract
The application relates to a nerve electric stimulation electrode assembly and a preparation method thereof. The nerve electrical stimulation electrode assembly comprises a soluble glue, an electrode catheter and a puncture tube. The electrode catheter includes a protective tube and a first fixture including a first fixing portion and a first fixing wing. The first fixing part is fixedly sleeved on the protection tube. The first fixed wing comprises 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 adhered to the protective tube by the soluble glue. The puncture tube is sleeved on the electrode catheter. After the electrode catheter is implanted into target tissue and reaches a target point, the soluble glue is gradually dissolved to lose viscosity, so that the first free end is automatically opened and embedded into the target tissue, and the fixation of the electrode catheter and the target tissue is realized. The fixing piece is not required to be fixed by using the sleeve, so that the problem that great inconvenience is caused to the operation of a doctor due to large friction force between the sleeve and the electrode catheter fixing structure is solved.
Description
Technical Field
The application relates to the field of medical equipment, in particular to a nerve electric stimulation electrode assembly and a preparation method thereof.
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 composed of a pulse generator that generates a stimulation signal and an electrode catheter that delivers the stimulation signal. The electrode catheter is implanted into a patient, the target nerve or nerve nuclear cluster is stimulated by the signal generated by the pulse generator through the electrode catheter, and the nerve is regulated and controlled in an electric stimulation mode so as to achieve the aim of treating or improving disease symptoms. To achieve a long-term stable therapeutic effect, the stimulation contacts and target sites on the electrode catheter must be kept unchanged. Therefore, when the electrode catheter is implanted, effective measures are taken to fix the electrode catheter with human tissues. In other words, whether the permanent neurostimulation implantation procedure is successful depends on whether the implanted electrode catheter can be securely located at the target site without movement.
Currently, in nerve stimulation systems using percutaneous puncture techniques for electrode implantation, such as implantable sacral nerve stimulation systems, implantable spinal cord electrical stimulation systems, implantable dorsal root ganglion stimulation systems, etc., the electrode catheter is fixed by its own fixation structure. After the electrode catheter is implanted into a human body through a puncture operation, the self fixing structure of the electrode catheter is embedded into human tissue, so that the position of the electrode catheter is fixed. Such as the related devices mentioned in patent applications US20030045919A1, CN105056397A, US20040230279 A1. 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 the target point position, the sleeve is taken out of the barb-shaped fixing structure of the electrode catheter. Because the friction force between the sleeve and the fixed structure is large, great inconvenience is caused to the operation of doctors.
Disclosure of Invention
Based on the above, it is necessary to provide a nerve electro-stimulation electrode assembly and a method for manufacturing the same, which solve the problem that the operation of a doctor is very inconvenient due to the large friction force between the cannula and the electrode catheter fixing structure.
The nerve electro-stimulation electrode assembly provided by the application comprises soluble glue, an electrode catheter and a puncture tube. The electrode catheter includes a protective tube and a first fixture. The protection 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 point. 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 fixed wing comprises 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 can be adhered to the protective tube by the soluble glue. The puncture tube is sleeved on the electrode catheter and is used for assisting the implantation of the electrode catheter to a target point.
The nerve electro-stimulation component adheres the first free end to the protection tube through soluble glue, so that the first fixing piece of the electrode catheter is fixed to the protection tube. After the electrode catheter is implanted into target tissue and reaches a target point, the soluble glue is gradually dissolved 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 fixed without using 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 sleeve and the electrode catheter fixing structure is solved.
Drawings
FIG. 1 is a block diagram of an electrode catheter of a nerve electro-stimulation electrode assembly according to an embodiment of the present application;
FIG. 2 is a diagram showing the structure of an electrode catheter of a nerve electro-stimulation 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 adhesive according to an embodiment of the present application;
FIG. 4 is an enlarged view of a first fixing portion and a soluble adhesive according to another embodiment of the present application;
FIG. 5 is a flowchart of a method for fabricating a neural electrode assembly according to an embodiment of the present application;
FIG. 6 is a schematic diagram illustrating an implantation process of a neural electrode assembly according to an embodiment of the present application;
fig. 7 is a flowchart of a neural electrode assembly implantation method according to an embodiment of the present application.
Reference numerals illustrate:
The nerve stimulating 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 developing 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 spot 310, the nerve stimulating device 40, and the pulse generator 410.
Detailed Description
Referring to fig. 1, the nerve electro-stimulation electrode assembly 10 provided by the present application includes a soluble gel 140, an electrode catheter 100 and a puncture tube 200. The electrode catheter 100 includes a protection 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 to be connected to a pulse generator, the stimulation end 115 being adapted to stimulate a target site. 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 blade 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 part 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 implantation of the electrode catheter 100 to a target site. It should be appreciated that the described lance 200 is hollow in structure. And the inner diameter of the puncture tube 200 is larger than the outer diameter of the electrode catheter 100, so that the puncture tube 200 is sleeved on the electrode catheter 100.
The nerve stimulating electrode assembly 10 described above 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 the target tissue and reaches the target site, the soluble glue 140 is gradually dissolved by contacting with body fluid, and loses viscosity, so that the first free end 1222 is automatically opened and embedded into the target tissue, and the electrode catheter 100 and the target tissue are fixed. The free end of the fixing member is not fixed by using a tube sleeve, thus solving the problem of great inconvenience to the doctor's operation due to the great friction between the tube sleeve and the fixing structure of the electrode catheter 100.
In one embodiment, the protective tube 110 is an hollow sleeve structure surrounding a lumen. The stimulating end 115 is in a closed structure, and the head of the stimulating end 115 can be in a smooth curved surface, which is beneficial to implantation into target tissues and target point stimulation. The connection end 113 is of an open structure to facilitate the insertion of a wire therein for facilitating the surgical operation.
In one embodiment, the connection terminal 113 includes a plurality of connection contacts 114, the stimulation terminal 115 includes a plurality of stimulation contacts 116, the connection contacts 114 are equal in number to the stimulation contacts 116, and the connection contacts 114 are electrically connected to the stimulation contacts 116 through wires in a one-to-one correspondence.
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 connection contacts 114 are conducted to different stimulation contacts 116 through different wires, so as to realize that different pulse signals or pulse signals in different time periods are delivered to a target point, and achieve a therapeutic effect. It should be appreciated 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, and is inlaid in the protection tube 110. The connection contact 114 may be composed of a conductive biocompatible material, such as stainless steel, cobalt alloy, titanium alloy, tantalum, platinum iridium alloy, and the like. In another embodiment, the stimulation contacts 116 may be annular structures. The stimulation contacts 116 may be electrically connected to the wires by resistance spot welding or laser spot welding. The stimulation contacts 116 may be composed of a conductive biocompatible material, such as platinum or a platinum iridium alloy, or a material coated with a platinum or platinum iridium alloy coating on the surface.
In one embodiment, the guide wire extends through the lumen of the protective tube 110. The wires may be a plurality of spiral wires or stranded wires and are insulated from each other. Each wire is connected at both ends to a connection contact 114 and a stimulation contact 116, respectively. The leads may transmit electrical pulse signals 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 applied state), the first free end 1222 of the first fixing wing 122 is turned up and opened in a direction away from the protection pipe 110, surrounding an opening. It should be appreciated that when the opening direction is toward the connection end 113, the electrode catheter 100 may be prevented from moving toward the connection end 113 after implantation into the target tissue. When the opening direction is toward the stimulation end 115, the electrode catheter 100 may be prevented from moving toward the stimulation end 115 after implantation into the target tissue. The first fixing member 120 has a unidirectional contractibility, and the first free end 1222 of the first fixing wing 122 can be completely compressed to fit the protection tube 110 in a stressed state. After the first free end 1222 is attached to the protection pipe 110, the first free end 1222 is adhered to the protection pipe 110 by the soluble glue 140, and then the external force is removed. After the electrode catheter 100 is implanted into the target tissue, the soluble glue 140 is decomposed by body fluid to lose viscosity, and the first free end 1222 is automatically tilted and opened to be embedded into the target tissue, so as to fix the electrode catheter 100. The first free end 1222 is fixed without using a socket, thus solving the problem of great inconvenience to the doctor's operation due to the great friction between the socket and the fixed structure of the electrode catheter 100.
In one embodiment, the material of the first fixing member 120 may be a material having 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 protection tube 110 and may be fixed by bonding or welding, and then the first fixing part 120 of the electrode catheter 100 and the protection tube 110 are completely dried.
Referring to fig. 2, in one embodiment, the protection tube 110 further includes at least one second fixing member 130. Each of the second fixing members 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 fixing 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 the free state (no external force applied state), each of the second free ends 1322 is tilted and opened in a direction away from the protection tube 110, surrounding an opening. One of the second free ends 1322 is formed with an opening direction toward the connection end 113 of the protection tube 110, and the other of the second free ends 1322 is formed with an opening direction toward the stimulation end 115 of the protection tube 110. In the stressed state, the two second free ends 1322 shrink and respectively fit to the protection tube 110. The two second free ends 1322 are then adhered to the protection tube 110 by the soluble glue 140, respectively, 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 protection tube 110 by the soluble glue 140. After the electrode catheter 100 is implanted into the target tissue, the soluble glue 140 contacts the body fluid and gradually dissolves to lose viscosity, and the two second free ends 1322 are respectively opened toward the stimulating end 115 and the connecting end 113 and are engaged with the target tissue, so that the electrode catheter 100 is fixed to the target tissue. The two free ends face in opposite directions, i.e. the electrode catheter 100 is prevented from moving towards the connection end 113, and the electrode catheter 100 is prevented from moving towards the stimulation end 115, further fixing the position of the electrode catheter 100 in the target tissue.
In one embodiment, the protective tube 110 includes two of the first fixtures 120. The first fixing members 120 are disposed on two sides of the second fixing member 130, and the two first free ends 1222 are opposite to each other. In this embodiment, the two first free ends 1222 are oriented in opposite directions, i.e., the electrode catheter 100 is prevented from moving toward the connection end 113, and the electrode catheter 100 is prevented from moving toward the stimulation end 115, further fixing the position of the electrode catheter 100 in the target tissue. Referring to fig. 2, in one embodiment, the protection 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 one of the second free ends 1322, and the other of the first free ends 1222 is oriented in the same direction as the other of the second free ends 1322. This arrangement may further enhance fixation of the position of the electrode catheter 100 in the target tissue, preventing movement of the electrode catheter 100 towards the stimulation end 115 or the connection end 113.
In one embodiment, the protective tube 110 includes a plurality of the first fixtures 120. Along the axial direction of the protection 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 fixed zone 125 and a second fixed zone 126. The first fixing sections 125 and the second fixing sections 126 are provided in the same number of the first fixing members 120. The first free end 1222 at the first fixed region 125 is oriented opposite the first free end 1222 at the second fixed region 126. In one embodiment, the first fixing portion 125 is adjacent to the connection end 113, the first free end 1222 of the first fixing member 120 located in the first fixing portion 125 faces the stimulation end 115, and after the first free end 1222 located in the first fixing portion 125 is opened, the first free end 1222 is engaged with a target tissue to prevent the electrode catheter 100 from moving toward the stimulation end 115. The second fixing portion 126 is close to the stimulating end 115, the first free end 1222 of the first fixing member 120 located in the second fixing portion 126 faces the connecting end 113, and after the first free end 1222 located in the second fixing portion 126 is opened, the first free end 1222 is engaged with a target tissue, so as to prevent the electrode catheter 100 from moving toward the connecting end 113. The number of the first fixing members 120 in the first fixing region 125 is the same as that of the second fixing members 126, so that after the first free end 1222 is expanded and embedded in the target tissue, the stress of the electrode catheter 100 is uniform, and the electrode catheter is prevented from moving towards the two ends, so that 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 plurality of fixing pieces 124 uniformly disposed around the first fixing portion 121 may facilitate the first fixing wing 122 to be engaged with the target tissue, so as not to be easily removed. And the plurality of fixing pieces 124 may have a structure to increase an adhesive area, so that the soluble glue 140 adheres to the first fixing wing 122 and the protection tube 110.
In one embodiment, the fixing sheets 124 are attached to the protecting tube 110, and the soluble glue 140 is applied to the edges of the fixing sheets 124. In another embodiment, the soluble glue 140 may be dispensed on the edge of the fixing piece 124 and the protection tube 110. The soluble glue 140 is applied to the edge of the fixing piece 124, so that after the electrode catheter 100 is implanted into the target tissue, the soluble glue 140 contacts with the body fluid, so that the contact area between the soluble glue 140 and the body fluid is increased, and the first free end 1222 is opened as soon as possible and is embedded into the target tissue.
Referring to fig. 4, in one embodiment, the soluble glue 140 is applied to the exterior of the first stationary blade 122 to form a film that surrounds the first stationary blade 122, and the first free end 1222 is adhered to the protective tube 110 by the soluble glue 140. In another embodiment, the soluble glue 140 surrounds the fixing sheets 124 to form a protective film at a gap between two adjacent fixing sheets 124. The wrapping area of the soluble glue 140 may be increased, and after the electrode catheter 100 is implanted into the target tissue, the contact area between the soluble glue 140 and the body fluid is increased, so as to accelerate the dissolution speed of the soluble glue 140, so that the fixing piece 124 is easier to open, and the fixation of the electrode catheter 100 in the target tissue is accelerated. Referring to fig. 1 again, in one embodiment, the electrode catheter 100 further includes a target mark 117 disposed between the connection end 113 and the first fixing member 120; with the target mark 117 aligned with the end of the lance 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 penetration depth when the electrode catheter 100 is implanted. The target mark 117 may be a color or a structure that is provided on the protective tube 110 by etching, brushing, pasting, or fixing. For example, white stripes or paste white stripes or the like may be brushed on the protection tube 110. During implantation of the electrode catheter 100 into the target tissue, the penetrating tube 200 is inserted into the target tissue, and the penetrating end of the penetrating tube 200 is positioned at a target site. The other end of the penetration tube 200 is exposed to the outside of the target tissue. The electrode catheter 100 is then inserted into the puncture tube 200, and when the target mark 117 of the protection tube 110 is aligned with the end portion of the puncture tube 200 located outside the target tissue, the stimulating end 115 of the electrode catheter 100 reaches the target point, so that the puncture depth is monitored in real time, and the stimulating end 115 of the electrode catheter 100 is ensured to reach the target point, so as to achieve the therapeutic effect.
In one embodiment, the electrode catheter 100 further includes two X-ray developing marks 123 disposed at the start and end portions of the fixing element, respectively, for positioning the first fixing element 120. The X-ray developing mark 123 is used to determine the position of the first fixing member 120 under X-rays after the implantation of the electrode catheter 100. The X-ray developing mark 123 is made of a material having a large attenuation to X-ray absorption, such as tantalum, platinum iridium alloy, or a polymer containing barium, tungsten, bismuth, or the like.
In one embodiment, the electrode catheter 100 further comprises a hand-held element 119, the hand-held element 119 being disposed at the connection end 113 for assisting in implantation of the electrode catheter 100. The connecting end 113 of the protective tube 110 has an opening structure, and the holding member 119 can be inserted into the opening. The hand-held element 119 is used to enhance the rigidity of the electrode, facilitate implantation of the electrode catheter 100 into the target tissue, and facilitate surgical procedures. After the electrode catheter 100 is implanted in the target tissue, the hand-held element 119 may be removed from the electrode catheter 100 and disengaged from the electrode catheter 100.
In one embodiment, the material of the soluble glue 140 is starch, dextrin, cellulose, polyvinylpyrrolidone or N-vinylamide-based polymer. The material has the characteristics of in vivo dissolvable or in vivo degradable, good biocompatibility and water-soluble polymer, and can be gradually dissolved or decomposed to lose viscosity after contacting the target tissue 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 fixation of the electrode catheter 100 and the target tissue is realized.
In one embodiment, the soluble gum 140 may be a polyvinylpyrrolidone solution (PVP). The polyvinylpyrrolidone solution (PVP) has excellent dissolution performance and physiological compatibility, and the higher the molecular weight K value is, the higher the viscosity is, the higher the adhesiveness is, and the slower the dissolution rate is. The polyvinylpyrrolidone used in one embodiment has a K value of 90. The polyvinylpyrrolidone solution may be sequentially dispensed on the side surface (edge) of each fixing piece 124 and the protection tube 110, and after the PVP is completely cured, the external force applied is removed, and the fixing pieces 124 and the protection tube 110 are adhered together.
In one embodiment, the material of the protective tube 110 is polyurethane, silicone rubber, or polyurethane-silicone rubber polymer. The material of the fixing piece can also be polyurethane, silicon rubber or polyurethane-silicon rubber polymer. The polyurethane, silicone rubber or polyurethane-silicone rubber polymer material has good tackiness with the soluble glue 140, so that the free ends of the fixing wings are adhered to the protection tube 110 through the soluble glue 140.
In one embodiment, the soluble glue 140 is used in an amount to ensure that the first fixing wing 122 or the second fixing wing 132 can be fully compressed and attached to the protection tube 110. And the soluble glue 140 loses viscosity after the electrode catheter 100 is implanted into the target tissue, the time required for the first fixing wing 122 or the second fixing wing 132 to be fully opened is less than 12 hours.
Referring to fig. 5, the present application also provides a method 20 for preparing the nerve stimulating electrode assembly 10. The preparation method 20 comprises the following steps:
S210, sleeving and fixing the first fixing part 121 of the first fixing piece 120 on the protection tube 110;
S220, applying an external force to the first fixing wings 122 of the first fixing piece 120 to enable the first free ends 1222 to be attached to the protection pipe 110;
s230, coating the soluble glue 140 between the first free end 1222 and the protective tube 110;
After the soluble glue 140 is cured in S240, the applied external force is removed, so that the first free end 1222 is attached to the protection pipe 110.
In one embodiment, the step S210 specifically includes sleeving the first fixing portion 121 of the first fixing member 120 on the protection tube 110, and fixing the first fixing portion 121 and the protection tube 110 together by hot-melting with a hot-air gun at 150 ℃. Then, the first fixing member 120 and the protecting tube 110 are ultrasonically cleaned (or plasma cleaned) in a solvent of alcohol or isopropyl alcohol, and impurities and greasy dirt on the surface are cleaned. After cleaning, the first fixing member 120 and the protection pipe 110 are completely dried by a forced air drying oven. The step S220 is then performed to apply an external force to the first free end 1222 of the first fixing wing 122, so that the first free end 1222 is fully compressed and attached to the protection pipe 110. The soluble gel 140 used in the step S230 may be a polyvinylpyrrolidone solution (PVP), which has excellent dissolution performance and physiological compatibility, and the greater the molecular weight K value, the greater the viscosity, the stronger the adhesiveness, and the slower the dissolution rate, and the polyvinylpyrrolidone K value used in this embodiment is 90. The polyvinylpyrrolidone solution is sequentially dispensed on the side surface of each of the first free ends 1222 and the protection tube 110, and after the PVP is completely cured, the applied external force is removed, and the first fixing wings 122 are adhered to the protection tube 110.
It should be understood that the first fixing member 120 and the second fixing member 130 are configured to have the same function and the same material but only have different functions in the present application, and thus, the second fixing member 130 is fixed to the protection tube 110 in the same manner as the first fixing member 120 is fixed to the protection tube 110. The operation of adhering the second free end 1322 to the protection tube 110 using the soluble glue 140 is the same as the operation of adhering the first free end 1222 to the protection tube 110 using the soluble glue 140, and will not be described.
Referring to fig. 6 and 7, the present application also provides a method 30 for implanting a neural electro-stimulation electrode assembly. The implantation method 30 includes 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 positioned at a target position 310;
S320, inserting the electrode catheter 100 into the puncture tube 200, so that the stimulation end 115 of the electrode catheter 100 is positioned at the target site;
s330, pulling out the puncture tube 200;
S340, after the soluble glue 140 loses the adhesiveness, the first fixing wing 122 of the first fixing member 120 is automatically opened and embedded into the target tissue 300.
In one embodiment, the implantation method 30 may further comprise a step S350 of detecting the position of the first fixture 120 by X-ray visualization after the step S340, so as to monitor the position of the first fixture 120 in the target tissue 300.
In one embodiment, the step S310 specifically includes placing a puncture needle with a 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 lance 200 is then inserted into the target tissue 300 along the needle such that the end of the lance 200 exposed to the target tissue 300 is aligned with the line of the needle where the penetrating end of the lance 200 is at the target site 310. The puncture needle is then pulled out and the step S320 is performed to insert the electrode catheter 100 into the puncture tube 200, so that the stimulating end 115 of the electrode catheter 100 is located at the target site 310, that is, 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 appreciated that the first free ends 1222 of the first fixing wings 122 of the electrode catheter 100 in step S320 are in a compressed state and fit over the protection tube 110. The step S330 is performed to withdraw the puncture tube 200. Finally, the step S340 is performed, and after the soluble glue 140 loses its adhesiveness, the first fixing wings 122 of the first fixing member 120 are automatically opened and embedded in the target tissue 300. It is necessary to keep the position of the electrode catheter 100 for 5 minutes in the step S340 to ensure that the soluble gel 140 is contacted with body fluid to begin dissolution. After the soluble 140 glue is gradually dissolved, the first free ends 1222 are automatically opened and embedded into the target tissue 300, so as to achieve complete fixation of the electrode catheter 100 and the target tissue 300. The free end of the fixing piece is fixed without using 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 sleeve and the electrode catheter fixing structure is solved.
It should be appreciated that the "first fixing member 120" described in the 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.
In one embodiment, the present application also provides a nerve electrical stimulation device 40. The nerve electro-stimulation device 40 includes the nerve electro-stimulation electrode assembly 10 described above, and also includes 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 point, and the target point nerve is regulated and controlled in an electric stimulation mode so as to achieve the purpose of treating or improving disease symptoms.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (9)
1. A nerve electrical stimulation electrode assembly, comprising:
A soluble glue (140);
An electrode catheter (100), comprising:
a protective tube (110) having oppositely disposed connection ends (113) and stimulation ends (115), the connection ends (113) for connection to a pulse generator, the stimulation ends (115) for stimulating a target;
a first mount (120) comprising:
a first fixing part (121), wherein the first fixing part (121) is fixedly sleeved on the protection tube (110);
-a first stationary wing (122), the first stationary wing (122) comprising a first fixed end (1221) and a first free end (1222), the first fixed end (1221) being connected to one end of the first stationary part (121), the first free end (1222) being capable of being adhered to the protective tube (110) by the soluble glue (140), the first free end (1222) of the first stationary wing (122) being in a compressed state;
the puncture tube (200) is sleeved on the electrode catheter (100) and is used for assisting the electrode catheter (100) to be implanted into a target point;
the protection tube is divided into a first fixing area (125) and a second fixing area (126), the number of the first fixing pieces (120) arranged in the first fixing area (125) and the second fixing area (126) is the same, and the first free ends (1222) positioned in the first fixing area (125) and the first free ends (1222) positioned in the second fixing area (126) are opposite;
After the electrode catheter (100) is implanted into the target site, the soluble glue (140) is dissolved, the first free end (1222) of the first fixing wing (122) is converted from a compressed state to an open state, and the first free end (1222) is embedded into the target site in the state conversion process, so that the electrode catheter (100) is fixed on the target site.
2. The nerve stimulating electrode assembly of claim 1, wherein the protective tube further comprises at least one second securing member (130), each second securing member (130) comprising:
the second fixing part (131) is fixedly sleeved on the protection tube (110);
two second fixed wings (132) set up respectively in the both ends that second fixed part (131) are relative, every second fixed wing (132) include second stiff end (1321) and second free end (1322), second stiff end (1321) set up in second fixed part (130), second free end (1322) can pass through soluble glue (140) adhesion in protection tube (110).
3. The nerve stimulating electrode assembly of claim 2, wherein the protective tube (110) includes two first fixing members (120), the first fixing members (120) are disposed on two sides of the second fixing member (130), respectively, and the two first free ends (1222) are opposite in orientation.
4. The nerve stimulating electrode assembly of claim 1, wherein the protective tube includes a plurality of the first fixing members (120), at least one of the first free ends (1222) being oriented opposite to the other first free ends (1222) along the axial direction of the protective tube (110).
5. The nerve stimulating electrode assembly of claim 1, wherein the first fixing wing (122) includes a plurality of fixing pieces (124), the plurality of fixing pieces (124) are spaced around the first fixing portion (121), the plurality of fixing pieces (124) are attached to the protective tube (110), and the soluble glue (140) is spot-coated on an edge of the fixing piece (124).
6. The nerve stimulating electrode assembly of claim 1, wherein the soluble glue (140) is applied to the exterior of the first fixed wing (122) to form a film surrounding the first fixed wing (122), the first free end (1222) being capable of adhering to the protective tube (110) through the soluble glue (140).
7. The neural stimulation electrode assembly of claim 1, wherein the material of the soluble glue (140) is starch, dextrin, cellulose, polyvinylpyrrolidone or N-vinylamide-based polymer.
8. The nerve stimulating electrode assembly of claim 1, wherein the material of the first anchor (120) is polyurethane, silicone rubber or polyurethane-silicone rubber polymer.
9. A method of preparing a neural electrical stimulation electrode assembly as claimed in any of claims 1-8, comprising the steps of:
sleeving and fixing a first fixing part (121) of the first fixing piece (120) on the protection tube (110);
Applying an external force to a first fixing wing (122) of the first fixing member (120) to enable the first free end (1222) to be attached to the protection pipe (110);
-applying the soluble glue (140) between the first free end (1222) and the protective tube (110);
After the soluble glue (140) cures, the applied external force is removed such that the first free end (1222) fits the protective tube (110).
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| CN111686369B (en) * | 2020-06-22 | 2024-02-27 | 山东大学齐鲁医院 | Barb device and system for preventing sacral nerve stimulating electrode from inward displacement |
| CN115054827A (en) * | 2022-07-19 | 2022-09-16 | 苏州景昱医疗器械有限公司 | Delivery module and electrical stimulation device |
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