CN114914768A - Multi-conduction elastic electrode and connection method thereof - Google Patents
Multi-conduction elastic electrode and connection method thereof Download PDFInfo
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- CN114914768A CN114914768A CN202210645069.4A CN202210645069A CN114914768A CN 114914768 A CN114914768 A CN 114914768A CN 202210645069 A CN202210645069 A CN 202210645069A CN 114914768 A CN114914768 A CN 114914768A
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R43/00—Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01B—CABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
- H01B7/00—Insulated conductors or cables characterised by their form
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01B—CABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
- H01B7/00—Insulated conductors or cables characterised by their form
- H01B7/17—Protection against damage caused by external factors, e.g. sheaths or armouring
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/02—Contact members
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Abstract
The invention relates to a multi-conductive elastic electrode and a connecting method thereof, wherein the multi-conductive elastic electrode comprises: the device comprises a first pipe body and a second pipe body, wherein the first pipe body is connected with the second pipe body through 2n conducting wires, and the 2n conducting wires respectively pass through 2n peripheral pipe cavities of the first pipe body and the second pipe body and surround central pipe cavities of the first pipe body and the second pipe body; the filling pipe is arranged between the first pipe body and the second pipe body, and the axial position of the filling pipe is aligned with the axial position of the first pipe body and the axial position of the second pipe body; 2n conducting wires, wherein the 2n conducting wires surround the filler pipe; the single-cavity pipe wraps the end part of the first pipe body close to the filling pipe, the 2n conducting wires and the filling pipe between the first pipe body and the second pipe body, and the end part of the second pipe body close to the filling pipe; the first tube body, the filling tube, the second tube body and the single-cavity tube are integrated through hot melting. The arrangement of the present invention avoids the occurrence of short circuits and increases durability in use.
Description
Technical Field
The invention relates to a multi-conduction elastic electrode and a connection method thereof.
Background
Elastic electrodes for nerve stimulation have been widely used in the treatment of various diseases. Such electrodes need to be surgically implanted in various locations within the patient's body, such as the spine. Because the electrode needs to adapt to the deformation caused by the dynamic change of each part of the human body, the electrode has high requirement on flexibility. The currently widely used method for preparing the implanted electrode and the method for connecting the implanted electrode assembly are mainly perfusion methods. The method comprises the steps of welding a lead and an electrode ring by using a physical method, and then filling glue into the electrode ring to obtain an electrode. And repeating the steps and directly and physically butting to manufacture a stimulating electrode containing a plurality of electrodes. The method is complicated and the manufactured product has insufficient flexibility, so the method has poor adaptability to the human body after being implanted. Meanwhile, the connection between the parts of the implanted electrode is easy to cause a series of problems of internal lead fracture, short circuit and the like after the electrode is integrally deformed.
The above statements in the background are merely intended to facilitate a thorough understanding of the present disclosure (including the technical means used, technical problems solved and technical advantages brought about) and should not be taken as an acknowledgement or any form of suggestion that this information forms part of the prior art already known to a person skilled in the art.
Disclosure of Invention
The invention aims to provide a multi-conduction elastic electrode and a connection method thereof. The connecting ends among the parts of the multi-conduction elastic electrode are integrally formed, have good flexibility and have good adaptability to a human body after being implanted into the human body. Compared with the traditional method, the connection method of the multi-conduction elastic electrode is simpler. The connecting method reduces the risk of short circuit caused by mutual contact of the wires and the risk of disconnection of the wires due to unexpected movement, and enhances the strength and conductivity of wire connection.
The invention relates to a connecting method of a multi-conduction elastic electrode, which comprises the following steps: 1) a filler pipe is arranged between a first pipe body and a second pipe body, the first pipe body is connected with the second pipe body through 2n conducting wires, the 2n conducting wires respectively pass through 2n peripheral pipe cavities of the first pipe body and the second pipe body and surround central pipe cavities of the first pipe body and the second pipe body, so that the 2n conducting wires surround the filler pipe, and the axial center position of the filler pipe is aligned with the axial center position of the first pipe body and the axial center position of the second pipe body; 2) inserting the mandrel through the central tube cavity of the first tube body, the filler tube and the central tube cavity of the second tube body so that the first tube body, the filler tube and the second tube body are sequentially contacted; 3) wrapping the end part of the first pipe body close to the filler pipe, the 2n conducting wires and the filler pipe between the first pipe body and the second pipe body and the end part of the second pipe body close to the filler pipe by using a single-cavity pipe; 4) the first tube, the filler tube, the second tube and the single lumen tube are interconnected.
In one embodiment, step 1) further comprises the steps of: a) providing a first pipe body and a second pipe body, wherein the first pipe body and the second pipe body respectively contain 2n +1 pipe cavities extending along the axial direction of the pipe bodies, one central pipe cavity is positioned at the axis position of the pipe bodies, the rest 2n peripheral pipe cavities are distributed around the central pipe cavity, and n is an integer which is greater than or equal to 1 and less than or equal to 8; b) respectively cutting 2n cuts on the outer walls of the first pipe body and the second pipe body along the axial direction and the circumferential direction of the pipe bodies according to a preset cut sequence and a preset cut interval, wherein each cut exposes at least one peripheral pipe cavity; c) respectively inserting 2n leads into 2n peripheral tube cavities of the first tube body and the second tube body; d) one end of 2n wires is picked out of the tube body from 2n notches on the outer wall of the first tube body according to a preset picking sequence and is respectively and electrically connected with 2n head electrode rings, and the other end of 2n wires is picked out of the tube body from 2n notches on the outer wall of the second tube body according to a preset picking sequence and is respectively and electrically connected with 2n tail electrode rings.
In another embodiment, step d) further comprises the steps of: d1) picking out an end of the first wire in the first peripheral lumen from a first incision furthest from the distal end of the first tube; d2) sleeving a first head end electrode ring from the distal end of the first pipe body, so that the first head end electrode ring surrounds the first pipe body, covers the first cut and is electrically connected with the picked end of the first lead; d3) repeating the step d1) and the step d2) until the 2n th head end electrode ring covers the 2n th notch of the first tube body and is electrically connected with the picked-out end of the 2n th lead; d4) picking out the other end of the first guidewire in the first peripheral lumen from the first incision proximal to the distal end of the second tube; d5) sleeving a first tail end electrode ring from the proximal end of the second pipe body, so that the first tail end electrode ring surrounds the second pipe body, covers the first cut and is electrically connected with the other end, which is picked out by the first lead; d6) and d4) and d5) are repeated until the 2n tail electrode ring covers the 2n cut of the second tube body and is electrically connected with the other end of the 2n lead wire.
In another embodiment, the electrode ring being electrically connected to the lead further comprises the steps of: riveting the metal ring at the selected end of the lead, wherein the riveted metal ring is arc-shaped and the curved surface of the riveted metal ring is consistent with the inner surface of the electrode ring; the metal ring is welded to the inner face of the electrode ring.
In another embodiment, step 4) comprises: 4a) sleeving heat-shrinkable tubes on the first tube body, the single-cavity tube and the second tube body and heating; 4b) and stripping the heat shrinkable tube and drawing out the mandrel.
In another embodiment, the cross-section of the filler tube is polygonal.
In another embodiment, the first tube, the filler tube, the second tube and the single lumen tube are made of a material selected from the group consisting of thermoplastic elastomers and thermoplastic polyurethanes, the heat shrinkable tube is made of perfluoroethylene propylene copolymer, the mandrel is made of stainless steel material or nitinol wire and the surface of the mandrel is coated with polytetrafluoroethylene.
Another aspect of the invention relates to a multi-pass elastomeric electrode, comprising: the device comprises a first pipe body and a second pipe body, wherein the first pipe body is connected with the second pipe body through 2n conducting wires, and the 2n conducting wires respectively pass through 2n peripheral pipe cavities of the first pipe body and the second pipe body and surround central pipe cavities of the first pipe body and the second pipe body; the filling pipe is arranged between the first pipe body and the second pipe body, and the axis position of the filling pipe is aligned with the axis position of the first pipe body and the axis position of the second pipe body; 2n conducting wires, wherein the 2n conducting wires surround the filler pipe; the single-cavity pipe wraps the end part of the first pipe body close to the filler pipe, the 2n conducting wires and the filler pipe between the first pipe body and the second pipe body, and the end part of the second pipe body close to the filler pipe; the first tube body, the filling tube, the second tube body and the single-cavity tube are integrated through hot melting.
In one embodiment, the first tube and the second tube respectively contain 2n +1 tube cavities extending along the axial direction of the tube, one central tube cavity is located at the axial center of the tube, the remaining 2n peripheral tube cavities are distributed around the central tube cavity, n is an integer greater than or equal to 1 and less than or equal to 8, and the 2n conducting wires are respectively inserted into the 2n peripheral tube cavities of the first tube and the second tube.
In another embodiment, the first and second tubes each comprise: 2n incisions, the 2n incisions being formed on an outer wall of the tube body in a predetermined order and at predetermined intervals in an axial direction and a circumferential direction of the tube body, each incision exposing one peripheral lumen; 2n wires inserted into the 2n peripheral lumens of the first and second tubes, respectively, and having exposed ends passing through the incisions on the peripheral lumens, respectively; and the 2n electrode rings are sequentially sleeved on the outer wall of the tube body at intervals and respectively cover 2n cuts, so that the electrode rings are respectively and electrically connected with the exposed ends of the 2n wires.
In another embodiment, the lead wires are electrically connected to the respective electrode rings through terminals.
In another embodiment, the terminal is a metal ring riveted into a circular arc shape, the curved surface of which conforms to and is welded to the inner face of the electrode ring.
In another embodiment, the multi-lead elastic electrode is provided with a marker ring that is closer to the proximal end of the multi-lead elastic electrode relative to the signal receiving plate.
In another embodiment, the distal end of the multi-lead elastic electrode is formed as a hemisphere.
In another embodiment, the outer side of the multi-lead elastic electrode is provided with a localizing anchor.
Drawings
FIG. 1a shows a partial perspective view of a tube and wire according to the present invention;
FIG. 1b shows a partial perspective view of a tube body, a filler tube and a wire according to the present invention;
FIG. 2 shows a schematic cross-sectional view of a filler tube and wire according to the present invention;
figure 3 shows a partial perspective view of a tubular body according to the invention;
FIG. 4 shows a partial perspective view of the tube and wire pick-up end according to the present invention;
FIG. 5a shows a perspective view of a wire and a metal ring according to the present invention;
FIG. 5b shows a perspective view of a wire and a riveted metal ring in accordance with the present invention;
FIG. 5c shows an enlarged perspective view of a wire and a riveted metal ring in accordance with the present invention;
FIG. 5d shows a perspective view of a wire, riveted metal ring and electrode ring according to the present invention;
FIG. 6a shows a partial perspective view of a mandrel, filler tube and wire in accordance with the present invention;
FIG. 6b shows a partial perspective view of a mandrel, filler tube, guide wire and single lumen tube according to the present invention;
fig. 7 shows an overall view of a multi-conductance elastic electrode according to the present invention.
List of reference numbers:
100: a first pipe body
111: first conductive line
112: second conductive line
113: third conducting wire
120: central tube cavity
121: a first peripheral lumen
122: second peripheral lumen
123: third peripheral lumen
131: first incision
132: second incision
133: third incision
141: the picking end of the first wire
142: the picking end of the second wire
151: metal ring
161: first electrode ring
200: the second tube body
300: filler pipe
400: core shaft
500: a single lumen tube.
Detailed Description
The invention concept of the invention comprises a plurality of specific implementation schemes, different implementation schemes have technical or application emphasis, and different implementation schemes can be combined and matched to meet different application scenes and solve different application requirements. Therefore, the following description of specific embodiments should not be construed as limiting the intended scope of the invention.
Hereinafter, various exemplary embodiments of the present invention will be described in more detail with reference to the accompanying drawings.
First, to more clearly describe embodiments of the present invention, the "proximal end" and "distal end" are defined.
When a physician is facing a patient to perform a typical operation with a tool or instrument (e.g., forceps) held in the hand and positioned between the physician and the patient, the end closer to the physician is referred to as the "proximal end" and the end further from the physician (the end closer to the patient) is referred to as the "distal end". In other words, for example, when a practitioner holds the syringe in the hand to inject a patient, the tail of the syringe (the area that the practitioner presses with the thumb) may be referred to as the "proximal end" and the portion of the needle may be referred to as the "distal end".
Additionally, the "leading electrode ring" represents all electrode rings closer to the patient relative to the filler tube, while the "trailing electrode ring" represents all electrode rings closer to the physician relative to the filler tube. Thus, if the first tubular body is closer to the patient relative to the filler tube and the second tubular body is closer to the physician relative to the filler tube, the "tip electrode ring" represents all of the electrode rings on the first tubular body and the "tail electrode ring" represents all of the electrode rings on the second tubular body. The "tip electrode rings" are sequentially represented as a first tip electrode ring, a second tip electrode ring … …, and a 2n tip electrode ring in a direction from the physician toward the patient, and the "trailing electrode rings" are sequentially represented as a first trailing electrode ring, a second trailing electrode ring … …, and a 2n trailing electrode ring in a direction from the patient toward the physician.
The above definitions of the "proximal end" and the "distal end" and the "leading electrode ring" and the "trailing electrode ring" are merely for convenience in describing embodiments of the present invention, and do not limit the structure of the present invention.
The expression "axial direction" means a direction substantially parallel to the axis of the tubular body.
The expression "circumferential direction" means a direction substantially perpendicular to both the axial direction and the radius of the cross-section of the tubular body, i.e. a circumferential direction around the axis of the tubular body.
The expression "a and B are identical" means that a and B are substantially equal, allowing a deviation of at most ± 5%.
The invention relates to a method for connecting a multi-conduction elastic electrode, which comprises the following steps:
1) the packing tube is arranged between the first tube body and the second tube body, the first tube body is connected with the second tube body through 2n conducting wires, the 2n conducting wires respectively penetrate through 2n peripheral tube cavities of the first tube body and the second tube body and surround the central tube cavities of the first tube body and the second tube body, and the 2n conducting wires surround the packing tube, and the axial center position of the packing tube is aligned with the axial center position of the first tube body and the axial center position of the second tube body. For example, as shown in fig. 1a, the first tube 100 and the second tube 200 have the same structure, and 8 wires (e.g., the first wire 111, the second wire 112, the third wire 113, etc.) are inserted into 8 corresponding peripheral lumens of the first tube 100 and the second tube 200, and extend in the axial direction of the tubes and are distributed around the axial center positions of the first tube 100 and the second tube 200. As shown in fig. 1b, filler tube 300 is inserted between first tube 100 and second tube 200 (not shown), 8 wires are wound around filler tube 300, and the axial position of filler tube 300 is aligned with the axial position of first tube 100 and the axial position of second tube 200 (i.e., central lumen). The first and second tubes 100, 200 may be made of medical grade materials such as Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), etc. The pipe body is prepared by heating and stretching a special die in the preparation process. Therefore, such a pipe body has better thermoplasticity and elasticity. The first and second tubes 100 and 200 have an outer diameter of 1 to 3mm, preferably 1.1 to 2.5 mm. The inner diameter of the central lumen 120 of the first and second tubes 100 and 200 is 0.3mm to 0.7mm, preferably 0.4mm to 0.6 mm. The inner diameters of the outer peripheral lumens 101, 102, 103, etc. of the first and second tubes 100, 200 are 0.1 to 0.3 mm.
The outer profile of the cross-section of the inserted packing tube 300 is polygonal, so it may be preferable to use each face of the polygonal packing tube to evenly separate the wires. For example, as shown in fig. 2, the cross-section of packing tube 300 is square, and 2 wires are placed on each side of the cross-section of packing tube 300, for example, first wire 111 and second wire 112 are placed on the top side of the cross-section of packing tube 300, so that 8 wires are spaced two by two. The placing mode of the conducting wires and the filling pipe can avoid the mutual cross winding interference between the conducting wires in the preparation process and after the finished product is obtained.
a) providing a first pipe body and a second pipe body, wherein the first pipe body and the second pipe body respectively comprise 2n +1 pipe cavities extending along the axial direction of the pipe bodies, one central pipe cavity is positioned at the axis position of the pipe bodies, the rest 2n peripheral pipe cavities are distributed around the central pipe cavity, and n is an integer which is more than or equal to 1 and less than or equal to 8. For example, as shown in fig. 1a and 1b, the first tube 100 and the second tube 200 respectively contain 9 lumens extending along the axial direction of the tubes, wherein 1 central lumen 120 is located at the axial position of the first tube 100 and the second tube 200 respectively, and the remaining 8 peripheral lumens (e.g., the first peripheral lumen 121, the second peripheral lumen 122, the third peripheral lumen 123, etc.) are distributed around the central lumen 120. The same numbered peripheral lumens of the first tube 100 and the second tube 200 are opposite to each other along the tube axial direction and include the same conducting wire, for example, the first peripheral lumen 121 of the first tube 100 is opposite to the first peripheral lumen (not shown) of the second tube 200 along the tube axial direction and includes the same first conducting wire 111.
b) 2n incisions are respectively cut in the outer walls of the first tube body and the second tube body along the axial direction and the circumferential direction of the tube bodies according to a preset incision sequence and a preset incision interval, and each incision exposes at least one peripheral tube cavity. For example, as shown in fig. 3, 8 incisions (only 3 of which are shown in fig. 3), such as a first incision 131, a second incision 132, a third incision 133, and the like from the proximal end, are cut on the outer wall of the first tube 100 in a predetermined incision sequence and a predetermined incision distance along the axial direction and the circumferential direction of the first tube 100. Each incision exposes at least one peripheral lumen, and 8 incisions expose at least 8 corresponding peripheral lumens, respectively. This step can be done on a tailored tube rotary cutting fixture. In this step, the tubular body is rotated by a predetermined angle in the circumferential direction after each cutting and displaced in the axial direction for another cutting, so that adjacent cuts are offset from each other in the circumferential direction and the axial direction. Preferably, the angle difference between the m +1 th cut and the m-th cut in the circumferential direction of the pipe body ism is an integer greater than or equal to 1 and less than 2 n. The predetermined sequence of cuts in the axial direction in this step is from one end of the tube to the other. E.g., from the proximal end to the distal end of the first tube 100. The distance between the m +1 th notch and the m-th notch in the axial direction of the pipe body is 0.5mm to 20mm, preferably 1mm to 18 mm. In this step, each cut is made such that each cut exposes at least one peripheral lumen, but not the central lumen.
When the second pipe 200 is cut, the order of the cuts in the axial direction is opposite to the order of the cuts in the axial direction of the first pipe 100. For example, when the first tube is100 from the proximal end, first, second, and third incisions 131, 132, 133, etc., are made, and second tube 200 from the distal end, first, second, and third incisions, etc. (not shown in the figures) are made. The incision of the second pipe 200 in the circumferential direction also coincides with the incision of the first pipe 100 in the circumferential direction. That is, it is preferable that the angle difference between the (m + 1) -th slit and the (m) -th slit on the second pipe body 200 in the circumferential direction of the pipe body isThe distance between the m +1 th notch and the m-th notch in the axial direction of the pipe body is 0.5mm to 20mm, preferably 1mm to 18 mm. In this step, each cut is made such that each cut exposes at least one peripheral lumen, but not the central lumen.
The cuts to the first tube 100 and the second tube 200 can be performed simultaneously or separately and can be performed on the same or different rotary cutting tools for the tailored tubes. Preferably, the cuts of the first tube 100 and the second tube 200 are performed in turn on the same special tube rotary cutting tool to maintain the stability and similarity of the position and depth of the cuts of the first tube 100 and the second tube 200.
c) 2n wires are respectively inserted into 2n peripheral tube cavities of the first tube body and the second tube body. For example, as shown in fig. 1a, a first guide wire 111 is inserted into a first outer circumferential lumen 121 of the first tube 100 and a first outer circumferential lumen (not shown) of the second tube 200 corresponding thereto. The lead can be made of medical metal materials which can pass nuclear magnetism and have small resistance, such as platinum iridium alloy, MP35N, silver alloy and the like. Each wire has a diameter of 0.1mm to 1mm and a length of 10cm to 400cm, preferably a diameter of 0.12mm to 0.88mm and a length of 12cm to 95 cm.
d) One end of 2n wires is picked out of the tube body from 2n notches on the outer wall of the first tube body according to a preset picking sequence and is respectively and electrically connected with 2n head electrode rings, and the other end of 2n wires is picked out of the tube body from 2n notches on the outer wall of the second tube body according to a preset picking sequence and is respectively and electrically connected with 2n tail electrode rings. Step d) can be performed in the following steps:
d1) an end of the first wire in the first peripheral lumen is picked out starting with the first incision furthest from the distal end of the first tube. For example, as shown in fig. 4, the pullout end 141 of the first guidewire 111 in the first peripheral lumen 121 of the first tube 100 is pullout from the first incision 131 farthest from the distal end of the first tube 100.
d2) The first head electrode ring is sleeved on the distal end of the first tube body, so that the first head electrode ring surrounds the first tube body, covers the first cut and is electrically connected with the picked end of the first lead. Wherein the electrode ring is electrically connected to the wire further comprising the steps of: riveting the metal ring at the selected end of the lead, wherein the riveted metal ring is arc-shaped and the curved surface of the riveted metal ring is consistent with the inner surface of the electrode ring; the metal ring is welded to the inner face of the electrode ring.
For example, as shown in fig. 5a to 5d, the first electrode ring 161 is sleeved on the distal end of the first tube 100, such that the first electrode ring 161 surrounds the first tube 100 and covers the first notch 131, and is electrically connected to the picking end 141 of the first wire 111. Preferably, the inner diameter of the first electrode ring 161 is slightly larger than the diameter of the first tube 100. In order to facilitate the electrical connection between the picking end 141 of the first conductive wire 111 and the first electrode ring 161, one skilled in the art can adjust the length of the picking end as required. This step can be divided into the following steps:
d2a) first, as shown in fig. 5a, a metal ring 151 is fitted over the overhanging end 141 of the first lead 111 in the first peripheral lumen 121, and the metal ring 151 is swaged. The metal ring 151 has an outer diameter of 0.3mm to 3mm, a wall thickness of 0.01mm to 1mm, and a length of 0.5mm to 10mm, preferably an outer diameter of 0.8mm to 2.5mm, a wall thickness of 0.1mm to 0.8mm, and a length of 0.8mm to 8 mm. As shown in fig. 5b, the swaged metal ring 151 has an arc shape and a curved surface corresponding to the inner surface of the first electrode ring 161. The metal ring 151 is made of a medical metal material capable of passing nuclear magnetism, such as platinum-iridium alloy, titanium alloy, and the like, and is machined according to a specific size. In some embodiments, the swaged metal ring 151 can also have other shapes that increase the surface area of the wire to electrode ring weld. In other embodiments, other metal materials that increase the surface area of the wire-to-electrode ring weld may be used, or the metal ring may be riveted into other shapes that increase the surface area of the wire-to-electrode ring weld. For example, small metal pieces of various shapes can be introduced;
d2b) as shown in fig. 5c and 5d, the swaged metal ring 151 is welded to the inner surface of the first electrode ring 161, and the first electrode ring 161 is then slipped over the first tube 100 from the distal end of the first tube 100, covering the first notch 131. Thereby completing the electrical connection of the first wire 111 to the first electrode ring 161. The welding method of this step can be selected from tin soldering, resistance welding and laser welding;
d3) and d1) and d2) are repeated until the 2 n-th tip electrode ring covers the 2 n-th cut of the first pipe body and is electrically connected with the picked-out end of the 2 n-th lead. For example, steps d1) and d2) are repeated until the 8 th electrode ring of the first tube 100 overlies the 8 th cut of the first tube 100 from the proximal end to the distal end and is electrically connected to the picked end of the 8 th wire.
d4) The other end of the first guide wire in the first peripheral lumen is picked out starting from the first incision closest to the distal end of the second tube. For example, beginning with the first incision proximal to the distal end of the second tube 200, the other end of the first lead 111 in the first peripheral lumen is picked.
d5) And sleeving a first tail end electrode ring from the proximal end of the second pipe body, so that the first tail end electrode ring surrounds the second pipe body, covers the first cut and is electrically connected with the other end of the first lead wire, which is picked out. For example, a first tail electrode ring is sleeved on the proximal end of the second tube 200, such that the first tail electrode ring surrounds the second tube 200 and covers the first incision, and is electrically connected to the other end of the first wire 111.
d6) And d4) and d5) are repeated until the 2n tail electrode ring covers the 2n cut of the second tube body and is electrically connected with the other end of the 2n lead wire. For example, steps d4) and d5) are repeated until the 8 th trailing electrode ring covers the 8 th incision of the second tube 200 from the distal end to the proximal end and is electrically connected to the other end of the 8 th lead that is picked up. In some embodiments, steps d4), d5) and d6) are the same steps as steps d1), d2) and d3) performed at corresponding positions on the second tube 200, and therefore, the same parts as steps d1), d2) and d3) are not repeated herein.
2) The central tube cavity passing through the first tube body, the filler tube and the central tube cavity of the second tube body are inserted into the mandrel, so that the first tube body, the filler tube and the second tube body are contacted in sequence. For example, as shown in figure 6a, mandrel 400 is inserted through central lumen 120 of first tube 100, filler tube 300, and the central lumen of second tube 200 such that first tube 100, filler tube 300, and second tube 200 are in sequential contact. Because the mandrel 400 functions to support and retain the central lumen 120 of the first tube 100 and the central lumen of the second tube 200, the diameter of the mandrel 400 is less than or equal to the diameter of the central lumen 120. Preferably, one skilled in the art can select a diameter of mandrel 400 that facilitates insertion into central lumen 120 and is sufficient to support first tube 100 and second tube 200. Because mandrel 400 is cylindrical, filler tube 300 may be slightly deformed after insertion into mandrel 400. The mandrel 400 is made of stainless steel material or nitinol wire and the surface of the mandrel 400 may or may not be coated with teflon. The teflon coating can prevent the mandrel 400 from being adhered to the central lumen 120 of the first tube 100 and the central lumen of the second tube 200 during thermal shrinkage, thereby facilitating the subsequent extraction of the mandrel 400.
3) And wrapping the end part of the first pipe body close to the filler pipe, the 2n wires and the filler pipe between the first pipe body and the second pipe body and the end part of the second pipe body close to the filler pipe by using a single-cavity pipe. For example, as shown in fig. 6b, the end of the first tube 100 near the filler tube 300, the 8 wires between the first tube 100 and the second tube 200 and the filler tube 300 are wrapped with a single lumen tube 500, and the end of the second tube 200 near the filler tube 300 (not shown). The single lumen tube is made of a medical grade thermoplastic polyurethane material by drawing using a special die during heating. The single-cavity tube has an outer diameter of 1.0mm to 5.5mm and a wall thickness of 0.1mm to 2mm, preferably an outer diameter of 1.2mm to 5.0mm and a wall thickness of 0.15mm to 1.95 mm.
4) The first tube, the filler tube, the second tube and the single lumen tube are interconnected. This step can be divided into the following steps:
4a) and sleeving a heat-shrinkable tube on the outer parts of the first tube body, the single-cavity tube and the second tube body and heating. In this step, the heat shrink tubing wraps all structures, i.e.: 8 electrode rings on the first tube 100 and the second tube 200, respectively, and the outer walls of the first tube 100 and the second tube 200 and the single lumen tube 500 which are not covered by the electrode rings. The size of the heat-shrinkable tube is selected to enable the inner diameter of the heat-shrinkable tube to be larger than the outer diameters of the electrode ring, the tube body and the single cavity tube, and the material of the heat-shrinkable tube is selected to enable the heat-shrinkable temperature to be larger than the melting point of the materials of the tube body, the filler tube and the single cavity tube. The heat shrinkable tube is heated to a temperature greater than or equal to its heat-shrinking temperature. When heating, a local annular heating device is adopted, the heating device is not moved, and the first pipe body, the single-cavity pipe and the second pipe body are moved so as to respectively and slowly heat the integral structure sleeved with the heat shrinkable pipe. The heat shrinkable tube is heat shrunk and the materials of the tube body, the filler tube and the single-lumen tube are melted, so that the diameters of all the peripheral tube cavities of the first tube body 100 and the second tube body 200 are all reduced to be the same as the outer diameter of each wire, and the effect that all the peripheral tube cavities tightly wrap the corresponding wires is achieved. Similarly, in the single-cavity tube wrapped part, the melted single-cavity tube and the filler tube fill the gaps among the 8 leads, so that the effect of tightly wrapping all leads by the single-cavity tube and the filler tube is achieved. The outer wall of 8 head end electrode rings and first body 100, the space between the outer wall of 8 tail end electrode rings and second body 200 in addition also is filled by the fused body material to reach 8 head end electrode rings and first body 100, the effect that 8 tail end electrode rings and the outer wall of second body 200 closely laminated in addition. The gap between the central lumen 120 and the mandrel 400 is also filled with the heat-shrunk tube material. The first and second tubes 100 and 200 and the single lumen tube 500 therebetween are also integrated by the compression and filling of the above structure. The heat shrinkable tube is made of a perfluoroethylene propylene copolymer. The outer diameter of the heat-shrinkable tube is 1.6mm to 6.5mm, the wall thickness is 0.1mm to 2mm, preferably the outer diameter is 1.65mm to 6.0mm, and the wall thickness is 0.15mm to 1.95 mm;
in some cases, different heat shrinkable tubes can be replaced and heat shrunk for multiple times according to the size of the multi-conducting elastic electrode finished product.
4b) And stripping the heat shrinkable tube and drawing out the mandrel. After cooling the first tube 100, 8 head electrode rings on the first tube 100, the second tube 200, 8 tail electrode rings on the second tube 200, the single lumen tube and the heat shrinkable tube to fix the shape of the above integral structure, the heat shrinkable tube can be peeled off and the mandrel 400 can be pulled out. At this time, the central lumen 120 of the first tube 100 and the central lumen of the second tube 200 are hollow cavities and the shapes thereof are maintained due to the existence of the mandrel 400 during the heat shrinkage process. Due to the presence of mandrel 400 and the heat shrinking process, filler tube 300 also has a hollow shape inside that corresponds to central lumen 120 of first tube 100 and central lumen of second tube 200.
Preferably, the distal end of the first tube 100 needs to be closed after step 4 b). In this step, the distal tip of the first tube 100 is heat softened and cold set to close the distal end.
The multi-conduction elastic electrode can be prepared by the method. The multi-conductance elastic electrode includes: the device comprises a first pipe body and a second pipe body, wherein the first pipe body is connected with the second pipe body through 2n conducting wires, and the 2n conducting wires respectively pass through 2n peripheral pipe cavities of the first pipe body and the second pipe body and surround central pipe cavities of the first pipe body and the second pipe body; the filling pipe is arranged between the first pipe body and the second pipe body, and the axis position of the filling pipe is aligned with the axis position of the first pipe body and the axis position of the second pipe body; 2n conducting wires, wherein the 2n conducting wires surround the filler pipe; the single-cavity pipe wraps the end part of the first pipe body close to the filler pipe, the 2n conducting wires and the filler pipe between the first pipe body and the second pipe body, and the end part of the second pipe body close to the filler pipe; the first tube body, the filling tube, the second tube body and the single-cavity tube are integrated through hot melting.
The first body and the second body respectively contain 2n +1 tube cavities extending along the axial direction of the body, one of the central tube cavities is located at the axis position of the body, the rest 2n peripheral tube cavities are distributed around the central tube cavity, n is an integer larger than or equal to 1 and smaller than or equal to 8, and 2n wires are respectively inserted into the 2n peripheral tube cavities of the first body and the second body.
First body and second body include respectively: 2n incisions, the 2n incisions being formed on an outer wall of the tube body in a predetermined order and at predetermined intervals in an axial direction and a circumferential direction of the tube body, each incision exposing one peripheral lumen; 2n wires inserted into the 2n peripheral lumens of the first and second tubes, respectively, and having exposed ends passing through the incisions on the peripheral lumens, respectively; and the 2n electrode rings are sequentially sleeved on the outer wall of the tube body at intervals and respectively cover the 2n cuts, so that the exposed ends of the 2n wires are electrically connected.
For example, as shown in fig. 1a, the first tube 100 and the second tube 200 are connected by 8 wires (e.g., the first wire 111, the second wire 112, the third wire 113, etc.), and the 8 wires respectively pass through 8 peripheral lumens of the first tube 100 and the second tube 200 and surround the central lumen 120 of the first tube 100 and the second tube 200. As shown in fig. 1b, filler tube 300 is interposed between first tubular body 100 and second tubular body 200, and the axial position of filler tube 300 is aligned with the axial position of first tubular body 100 and the axial position of second tubular body 200. The 8 wires surround the filler tube 300. As shown in fig. 6b, the single lumen tube 500 encloses the end of the first tube 100 near the filler tube 300, the 8 wires between the first tube 100 and the second tube 200 and the filler tube 300, and the end of the second tube 200 near the filler tube 300. The first tube body 100, the filler tube 300, the second tube body 200 and the single-cavity tube 500 are integrated by hot melting.
As shown in fig. 1a, the first tube 100 and the second tube 200 respectively include 9 lumens extending along the axial direction of the tubes, wherein a central lumen (e.g., the central lumen 120) is located at the axial position of the first tube 100, the remaining 8 peripheral lumens are distributed around the central lumen 120, and the 8 wires are respectively inserted into the 8 peripheral lumens of the first tube 100 and the second tube 200.
As shown in fig. 4, the first tube 100 and the second tube 200 respectively include: 8 incisions. The 8 incisions, each exposing one peripheral lumen, for example, the first incision 131 exposes the first peripheral lumen 121, are formed on the outer walls of the first and second tubes 100 and 200 in a predetermined order and at predetermined intervals in the axial and circumferential directions of the tubes. The 8 wires are inserted into the 8 peripheral lumens of the first and second tubes 100 and 200, respectively, and have exposed ends passing through the incisions on the peripheral lumens, respectively, e.g., the first wire 111 has a pick-out end 141 passing through the first incision 131. As shown in fig. 7, the first tube 100 and the second tube 200 each have 8 electrode rings, which are sequentially fitted around the outer wall of the tube at intervals and cover 8 cuts, respectively, to be electrically connected to the exposed ends of the 8 wires, respectively.
In addition, the multi-conductance elastic electrode may be provided with a marker ring near the proximal end of the multi-conductance elastic electrode, the outer side of the marker ring (the side near the proximal end) may be reduced in length as needed, but the inner side of the marker ring (the side near the distal end) may not be cut short. The distal end of the multi-lead elastic electrode can be formed into a hemispherical shape, so that the electrode can be conveniently inserted into the vertebral cavity and sealed. The outer side of the multi-conduction elastic electrode can be provided with a positioning anchor, and the positioning anchor is used for fixing the positioning anchor to the interspinal ligament tissue through sewing by using a sewing thread and is used for fixing the electrode without moving after the electrode is implanted.
The advantageous effects of the above-described method of the present invention and the multi-conductive elastic electrode manufactured by the method are as follows:
1) by arranging 2n leads in 2n peripheral tube cavities of the tube body at the same time, the leads are sufficiently isolated from each other without the risk of contact, and signal interference is avoided; although the wires are insulated enameled wires and are not conductive when being contacted with each other, the friction or the compression of the electrodes in the using process increases the risk of short circuit, the arrangement of the invention reduces the mutual friction of the wires in the using process, avoids the occurrence of short circuit and increases the using durability; in addition, the non-winding distance of the lead is shortest, so that the appearance is improved, and the impedance is reduced;
2) the perfusion method conventionally used in the prior art is not needed, the method is simpler to operate, the flexibility of the product is improved, and the product can be implanted into the human body and has better adaptability with the corresponding part of the human body;
3) the tube body of the multi-conducting elastic electrode is integrally formed, the product strength is improved, the tube body is tightly wrapped with the lead in the peripheral tube cavity after thermal shrinkage treatment, and the lead is prevented from undesirably moving in the peripheral tube cavity and being disconnected from the electrode ring;
4) after the thermal shrinkage treatment, a gap between the electrode ring and the outer wall of the tube body is filled with a molten tube body material, so that the electrode ring is prevented from moving on the outer wall of the tube body undesirably and being disconnected from a lead;
5) gaps among the tube body, the filling tube and the single-cavity tube are filled with materials after thermal shrinkage, so that the risk of failure of the whole electrode caused by leakage of liquid (blood, tissue fluid and the like) in a human body and contact with an internal lead after the electrode is implanted into the human body is effectively reduced;
6) because the packing tube with the polygonal cross section is used, the wire part between the first tube body and the second tube body can be uniformly distributed around the periphery of the packing tube, so that the cross winding interference or accidental short circuit between wires in the preparation process and after the finished product can be avoided;
7) since the material of, for example, MP35N as a wire is inferior in soldering property by itself, it is more difficult to secure the soldering if its soldering point is small. After the riveted metal ring is introduced between the lead and the electrode ring, the contact area of the welding part can be obviously improved, and further the welding firmness is enhanced.
Example 1
2 9 hole tube bodies are provided, one central tube cavity in the 9 holes is positioned at the axis position of the 9 hole tube bodies, and the other 8 peripheral tube cavities are uniformly distributed around the central tube cavity. The tube body is made of thermoplastic polyurethane. The external diameter of body is 1.3mm, and the internal diameter of every periphery lumen is 0.21mm, and the internal diameter of central lumen is 0.51 mm.
And respectively cutting 8 cuts on the outer walls of the 2 tubes along the axial direction and the circumferential direction of the tubes according to a preset cut sequence and a preset cut interval, wherein each cut exposes at least one peripheral tube cavity.
Firstly, each pipe body is respectively arranged on a special incision tool, and the pipe bodies can freely move on the tool in the axial direction and the circumferential direction of the pipe bodies. After the proximal and distal ends of the tube are identified, a first positional cut is optionally selected in the outer wall of the proximal end of the first tube. Thereafter, the first tube may be rotated clockwise 45 ° in the circumferential direction and moved 7mm in the axial direction toward the distal end to select a second position cut, then rotated 90 ° counterclockwise in the circumferential direction and moved 7mm in the axial direction toward the distal end to select a third position cut, then rotated 135 ° clockwise in the circumferential direction and moved 7mm in the axial direction toward the distal end to select a fourth position cut, then rotated 180 ° counterclockwise in the circumferential direction and moved 7mm in the axial direction toward the distal end to select a fifth position cut, then rotated 225 ° clockwise in the circumferential direction and moved 7mm in the axial direction toward the distal end to select a sixth position cut, then rotated 270 ° clockwise in the circumferential direction and moved 7mm in the axial direction toward the distal end to select a seventh position cut, the first tube was then rotated clockwise 315 ° in the circumferential direction and moved 7mm in the axial direction toward the distal end to select the eighth positional cut. Similarly, the second tube is cut. The incision step is the same as the first tube incision step, but in the opposite direction, i.e., the incision is initiated from the distal end to the proximal end of the second tube. Each cut was 0.3mm deep in this step and was parallel to the circumferential direction of the tube.
And respectively inserting 1 wire into each corresponding peripheral cavity of the two pipe bodies, so that the wires can be basically parallel to the axial direction of the pipe bodies and do not intersect with each other. The wire is made of MP35N material. Each wire has a diameter of 0.15 mm.
A first incision in the first tube furthest from the distal end begins by picking an end of the first wire in the first peripheral lumen. And riveting the metal ring at the selected end of the first lead in the first peripheral tube cavity, wherein the riveted metal ring is in a circular arc shape, and the curved surface of the riveted metal ring is consistent with the inner surface of the electrode ring. The metal ring is made of platinum-iridium alloy. The outer diameter of the metal ring is 0.33mm, the inner diameter is 0.21mm, and the length is 1.5 mm. The swaged metal ring is resistance welded to the inner surface of the first tip electrode ring, and then the first tip electrode ring is fitted over the first tube from the distal end of the first tube and covers the first cutout, thereby completing the electrical connection of the first wire to the first tip electrode ring. Repeating the steps from the proximal end to the distal end to pick up the wire, weld the electrode ring and the wire until the 8 th head electrode ring covers the 8 th cut from the proximal end to the distal end of the first tube body and is electrically connected with the pick-up end of the 8 th wire.
The other end of the first wire in the first peripheral lumen is singled out beginning at a first incision in the second tube proximal to the distal end. And riveting the metal ring at the selected end of the first lead in the first peripheral tube cavity of the second tube body, wherein the riveted metal ring is arc-shaped, and the curved surface of the riveted metal ring is consistent with the inner surface of the electrode ring. The metal ring is made of platinum-iridium alloy. The outer diameter of the metal ring is 0.33mm, the inner diameter is 0.21mm, and the length is 1.5 mm. And (3) resistance welding the riveted metal ring to the inner surface of the first tail end electrode ring, and then sleeving the first tail end electrode ring on the second pipe body from the proximal end of the second pipe body and covering the first tail end electrode ring on the first notch, so that the first lead is electrically connected with the first tail end electrode ring. And repeating the steps from the distal end to the proximal end to pick up the wire and weld the electrode ring and the wire until the 8 th tail end electrode ring covers the 8 th cut from the distal end to the proximal end of the second tube body and is electrically connected with the picking end of the 8 th wire.
Then, a filler pipe is arranged between the first pipe body and the second pipe body, the part, between the first pipe body and the second pipe body, of the 2n conducting wires surrounds the filler pipe, the axial center position of the filler pipe is aligned with the axial center position of the first pipe body and the axial center position of the second pipe body, a mandrel is inserted into the central pipe cavity of the first pipe body, the filler pipe and the central pipe cavity of the second pipe body, and the first pipe body, the filler pipe and the second pipe body are sequentially contacted. In this step, the mandrel extends through the entire length of the multi-conductive elastic electrode. The diameter of the mandrel is 0.50 mm. The mandrel is made of stainless steel and the surface of the mandrel is coated with polytetrafluoroethylene.
And completely covering the corresponding cut of each electrode ring, and prepressing 8 electrode rings on each pipe body to reduce the diameter of each electrode ring. Then 8 electrode rings on each tube body are forged, so that the outer diameter of each electrode ring is consistent with that of the tube body, and each electrode ring is fixed on the outer wall of the tube body through forging.
And wrapping the end part of the first pipe body close to the filler pipe, the 2n wires and the filler pipe between the first pipe body and the second pipe body and the end part of the second pipe body close to the filler pipe by using a single-cavity pipe. The single-cavity tube has an outer diameter of 2.3mm and an inner diameter of 1.7 mm.
And (3) sleeving heat shrinkable tubes on 8 electrode rings of each of the two tube bodies, the outer wall of the tube body which is not covered by the electrode rings and the outer wall of the single-cavity tube wholly or partially according to actual conditions, and slowly heating to the temperature which is more than or equal to the heat shrinkage temperature of the heat shrinkable tubes respectively. And at the temperature, the heat-shrinkable tube is subjected to heat shrinkage, and the materials of the two tube bodies, the filler tube and the single-cavity tube are melted, so that all peripheral tube cavities of the first tube body and the second tube body are tightly wrapped by corresponding wires, and the melted single-cavity tube and the filler tube are filled in the gaps among the 8 wires to tightly wrap all the wires. The gaps between the 8 head end electrode rings and the outer wall of the first tube body and between the 8 tail end electrode rings and the outer wall of the second tube body are also filled with molten tube body materials, so that the electrode rings are tightly attached to the outer wall of the tube body. The first and second tubes and the single lumen tube therebetween are also integrated by the compression and filling of the structure. And then, cooling the heat-shrinkable tube and the two tube bodies, the single cavity tube and the electrode ring which are wrapped by the heat-shrinkable tube. The heat shrinkable tube is made of a perfluoroethylene propylene copolymer. The outer diameter of the heat-shrinkable tube is 2.8mm, and the wall thickness is 0.2 mm. The heat shrink tube is then peeled off and the mandrel is withdrawn. Finally, the distal tip of the first tube is heat softened and cold set to close the tip.
Although the present invention has been described with reference to the accompanying drawings and examples, it will be apparent to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention and not limited to the exemplary embodiments disclosed herein. Accordingly, it should be noted that the changes or modifications fall within the scope of the claims of the present invention, and the scope of the present invention should be construed based on the appended claims.
Claims (15)
1. A method of connecting a multi-conductance elastic electrode, the method comprising:
1) a filler pipe is arranged between a first pipe body and a second pipe body, the first pipe body is connected with the second pipe body through 2n conducting wires, the 2n conducting wires respectively pass through 2n peripheral pipe cavities of the first pipe body and the second pipe body and surround central pipe cavities of the first pipe body and the second pipe body, so that the 2n conducting wires surround the filler pipe, and the axial center position of the filler pipe is aligned with the axial center position of the first pipe body and the axial center position of the second pipe body;
2) inserting the mandrel through the central tube cavity of the first tube body, the filler tube and the central tube cavity of the second tube body so that the first tube body, the filler tube and the second tube body are sequentially contacted;
3) wrapping the end part of the first pipe body close to the filler pipe, the 2n conducting wires and the filler pipe between the first pipe body and the second pipe body and the end part of the second pipe body close to the filler pipe by using a single-cavity pipe;
4) the first tube, the filler tube, the second tube and the single lumen tube are interconnected.
2. The method for connecting multiple-conductance elastic electrodes according to claim 1, wherein the step 1) further comprises:
a) providing a first pipe body and a second pipe body, wherein the first pipe body and the second pipe body respectively contain 2n +1 pipe cavities extending along the axial direction of the pipe bodies, one central pipe cavity is positioned at the axis position of the pipe bodies, the rest 2n peripheral pipe cavities are distributed around the central pipe cavity, and n is an integer which is greater than or equal to 1 and less than or equal to 8;
b) respectively cutting 2n cuts on the outer walls of the first pipe body and the second pipe body along the axial direction and the circumferential direction of the pipe bodies according to a preset cut sequence and a preset cut interval, wherein each cut exposes at least one peripheral pipe cavity;
c) respectively inserting 2n leads into 2n peripheral tube cavities of the first tube body and the second tube body;
d) one end of 2n wires is picked out of the tube body from 2n notches on the outer wall of the first tube body according to a preset picking sequence and is respectively and electrically connected with 2n head electrode rings, and the other end of 2n wires is picked out of the tube body from 2n notches on the outer wall of the second tube body according to a preset picking sequence and is respectively and electrically connected with 2n tail electrode rings.
3. The method of claim 2, wherein step d) further comprises:
d1) picking out an end of the first guidewire in the first peripheral lumen from a first incision furthest from the distal end of the first tube;
d2) sleeving a first head end electrode ring from the distal end of the first pipe body, so that the first head end electrode ring surrounds the first pipe body, covers the first cut and is electrically connected with the picked end of the first lead;
d3) repeating the steps d1) and d2) until the 2n th tip electrode ring covers the 2n th cut of the first pipe body and is electrically connected with the picked-out end of the 2n th lead;
d4) picking out the other end of the first guidewire in the first peripheral lumen from the first incision proximal to the distal end of the second tube;
d5) sleeving a first tail end electrode ring from the proximal end of the second pipe body, so that the first tail end electrode ring surrounds the second pipe body, covers the first cut and is electrically connected with the other end, which is picked out by the first lead;
d6) and d4) and d5) are repeated until the 2n tail electrode ring covers the 2n cut of the second tube body and is electrically connected with the other end of the 2n lead wire.
4. The method of claim 3, wherein the step of electrically connecting the electrode ring to the conductive wire further comprises:
riveting the metal ring at the selected end of the lead, wherein the riveted metal ring is arc-shaped and the curved surface of the riveted metal ring is consistent with the inner surface of the electrode ring;
welding the metal ring to the inner face of the electrode ring.
5. The method for connecting a multi-conductive elastic electrode according to claim 1, wherein the step 4) comprises:
4a) sleeving heat-shrinkable tubes on the first tube body, the single-cavity tube and the second tube body and heating;
4b) and stripping the heat shrinkable tube and drawing out the mandrel.
6. The method of claim 1, wherein the cross-section of the filler tube is polygonal.
7. The method of claim 5, wherein the first tube, the filler tube, the second tube and the single lumen tube are made of a material selected from the group consisting of thermoplastic elastomer and thermoplastic polyurethane, the heat shrinkable tube is made of perfluoroethylene propylene copolymer, the mandrel is made of stainless steel or nitinol wire and the surface of the mandrel is coated with teflon.
8. A multi-conductive spring electrode, comprising:
-a first tube and a second tube connected by 2n wires, said 2n wires passing through 2n peripheral lumens of the first and second tubes respectively and surrounding central lumens of the first and second tubes;
-a filler tube interposed between the first tube body and the second tube body, and having an axial position aligned with an axial position of the first tube body and an axial position of the second tube body;
-2n wires, said 2n wires surrounding a filler tube;
-a single lumen tube enclosing the end of the first tube body near the filler tube, the 2n wires and the filler tube between the first tube body and the second tube body, and the end of the second tube body near the filler tube;
the first tube body, the filling tube, the second tube body and the single-cavity tube are integrated through hot melting.
9. The multi-conductance elastic electrode of claim 8, wherein the first tube and the second tube respectively contain 2n +1 tube cavities extending along the axial direction of the tube, one central tube cavity is located at the axial center of the tube, the remaining 2n peripheral tube cavities are distributed around the central tube cavity, n is an integer greater than or equal to 1 and less than or equal to 8, and the 2n wires are respectively inserted into the 2n peripheral tube cavities of the first tube and the second tube.
10. The multi-conductance elastic electrode of claim 8, wherein the first and second tubes respectively comprise:
-2n incisions formed on the outer wall of the tubular body in a predetermined order and at predetermined intervals in the axial direction and in the circumferential direction of the tubular body, each incision exposing one peripheral lumen;
-2n wires inserted into the 2n peripheral lumens of the first and second tubes, respectively, and having exposed ends passing through the incisions in the peripheral lumens, respectively;
and 2n electrode rings, wherein the 2n electrode rings are sequentially sleeved on the outer wall of the tube body at intervals and respectively cover 2n cuts so as to be respectively electrically connected with the exposed ends of the 2n wires.
11. The multi-conductance elastic electrode of claim 10, wherein the lead wires are electrically connected to the respective electrode rings through terminals.
12. The multi-conductance elastic electrode of claim 11, wherein the terminal is a metal ring riveted into a circular arc shape, and a curved surface thereof is conformed to and welded to an inner face of the electrode ring.
13. The multi-conductance elastic electrode of claim 8, wherein the multi-conductance elastic electrode is provided with a marker ring near a proximal end of the multi-conductance elastic electrode.
14. The multi-lead elastic electrode of claim 8, wherein the distal end of the multi-lead elastic electrode is formed in a hemispherical shape.
15. The multi-conductance elastic electrode of claim 8, wherein a positioning anchor is disposed on an outer side of the multi-conductance elastic electrode.
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