Multi-conductive elastic electrode and connection method thereof

Abstract

The present invention relates to a multi-conductive elastic electrode and a connection method thereof. The multi-conductive elastic electrode comprises: a tube body containing 2n+1 lumens extending in the axial direction of the tube body, a central lumen located at the axial center of the tube body, and the remaining 2n peripheral lumens distributed around the central lumen; a signal receiving board containing a row of 2n solder pads on its upper surface; 2n wires, each inserted into the 2n peripheral lumens, with the proximal ends of the 2n wires alternately electrically connected to the 2n solder pads in a predetermined sequence; a filler tube interposed between the tube body and an inner single-lumen tube; an inner single-lumen tube with the signal receiving board located on the outer surface of the inner single-lumen tube; and an outer single-lumen tube encasing at least a portion of the tube body, the 2n wires interposed between the tube body and the signal receiving board, the filler tube, the signal receiving board, and the inner single-lumen tube; the above structure is integrated by heat fusion. The arrangement of the present invention prevents short circuits and increases durability.

Description

Technical Field

[0001] The invention relates to a multi-conducting elastic electrode and a connection method thereof. Background Art

[0002] Elastic electrodes for nerve stimulation have been widely used in the treatment of various diseases. Such electrodes need to be surgically implanted in different parts of the patient's body, such as the spine. Because they need to adapt to the deformation caused by the dynamic changes in various parts of the human body, such electrodes require very high flexibility. The currently commonly used method for preparing implantable electrodes and the method for connecting implantable electrodes to signal receiving boards are mainly perfusion methods. This method first uses physical methods to weld the wire to the electrode ring, and then fills the electrode ring with glue to obtain an electrode. The above steps are then repeated and directly physically connected to produce a stimulation electrode containing multiple electrodes. This method is relatively cumbersome and the resulting product is not flexible enough, so it has poor adaptability to the human body after implantation. At the same time, the connection between the implantable electrode and the signal receiving board is prone to a series of problems such as internal wire breakage and short circuits after the overall deformation of the electrode.

[0003] The above description of the background technology is only intended to facilitate an in-depth understanding of the technical solution of the present invention (such as the technical means used, the technical problems solved, and the technical effects produced), and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art. Summary of the Invention

[0004] The present invention provides a multi-conductive elastic electrode and a method for connecting it to a signal receiving board. The connection ends of the multi-conductive elastic electrode and the signal receiving board are integrally formed and highly flexible, providing good adaptability to the human body after implantation. This method for connecting the multi-conductive elastic electrode to the signal receiving board is simpler than traditional methods. This connection method reduces the risk of short circuits caused by contact between wires and the risk of disconnection due to unexpected movement, thereby enhancing the strength and conductivity of the wire connection.

[0005] The present invention relates to a method for connecting a multi-conductive elastic electrode, the method comprising the following steps: a) providing a tube body and a signal receiving board, wherein the tube body contains 2n+z lumens extending in the axial direction of the tube body, wherein one central lumen is located at the axial center of the tube body, and the remaining 2n peripheral lumens are distributed around the central lumen, and the 2n peripheral lumens respectively contain 2n wires, and the upper surface of the signal receiving board contains a row of 2n pads, where n is an integer greater than or equal to 1 and less than or equal to 8, and z is an integer greater than or equal to 1. an integer; b) electrically connecting the proximal ends of the 2n wires to the 2n solder pads alternately in a predetermined order; c) providing a stuffing tube, an inner single-lumen tube, and a core shaft; d) inserting the core shaft through the central lumen of the tube body, the stuffing tube, and the inner single-lumen tube, such that the stuffing tube is interposed between the tube body and the inner single-lumen tube, and the signal receiving board is located on the outer surface of the inner single-lumen tube; e) wrapping at least a portion of the tube body, the 2n wires interposed between the tube body and the signal receiving board, the stuffing tube, the signal receiving board, and the inner single-lumen tube with an outer single-lumen tube; and f) fixing the outer single-lumen tube.

[0006] In one embodiment, step b) further includes the following steps: b1) numbering the 2n wires in the 2n peripheral cavities as n odd wires and n even wires according to the first circumferential direction and the second circumferential direction of the tube body; b2) numbering the 2n solder pads as n odd solder pads and n even solder pads in the order from the distal end to the proximal end of the signal receiving board; b3) electrically connecting the n odd wires to the n odd solder pads, respectively, so that the n-1 odd wires except the first wire extend along the first side of the signal receiving board; b4) electrically connecting the n even wires to the n even solder pads, respectively, so that the n even wires extend along the second side of the signal receiving board.

[0007] In another embodiment, step d) is performed such that the 2n wires are wrapped around the filling tube and the axial center position of the filling tube is coaxially aligned with the axial center positions of the tube body and the axial center positions of the inner single lumen tube.

[0008] In another embodiment, step d) is performed such that the tube body, the filler tube, and the inner single lumen tube are contacted sequentially.

[0009] In another embodiment, step e) is performed such that the signal receiving plate is interposed between the inner single lumen tube and the outer single lumen tube.

[0010] In another embodiment, step f) further comprises the following steps: f1) putting a heat shrink tube on the outside of the outer single-lumen tube and heating it; f2) peeling off the heat shrink tube and pulling out the core shaft.

[0011] In another embodiment, the tube body, filling tube, inner single-lumen tube and outer single-lumen tube are made of a material selected from thermoplastic elastomers and thermoplastic polyurethanes, the heat shrink tube is made of perfluoroethylene propylene copolymer, the core shaft is made of stainless steel or nickel-titanium alloy wire and the surface of the core shaft is coated with polytetrafluoroethylene.

[0012] In another embodiment, the cross-section of the filling tube is polygonal.

[0013] Another aspect of the present invention relates to a multi-conductive elastic electrode, comprising: a tube body, wherein the tube body contains 2n+z lumens extending in the axial direction of the tube body, wherein one central lumen is located at the axial center of the tube body, and the remaining 2n peripheral lumens are distributed around the central lumen, where n is an integer greater than or equal to 1 and less than or equal to 8, and z is an integer greater than or equal to 1; a signal receiving board, wherein the upper surface of the signal receiving board contains a row of 2n solder pads; and 2n wires, wherein the 2n wires are connected to the electrode. The wires are respectively inserted into 2n peripheral tube lumens, and the proximal ends of the 2n wires are alternately and electrically connected to 2n welding pads in a predetermined order; a filler tube is interposed between the tube body and the inner single-lumen tube; the inner single-lumen tube, the signal receiving board is located on the outer surface of the inner single-lumen tube; the outer single-lumen tube, the outer single-lumen tube wraps at least a portion of the tube body, the 2n wires interposed between the tube body and the signal receiving board, the filler tube, the signal receiving board, and the inner single-lumen tube; the tube body, the filler tube, the inner single-lumen tube, and the outer single-lumen tube are hot-melt integrated.

[0014] In one embodiment, the 2n wires in the 2n peripheral lumens are numbered as n odd wires and n even wires in the first circumferential direction and the second circumferential direction of the tube body; the 2n solder pads are numbered as n odd solder pads and n even solder pads in the order from the distal end to the proximal end of the signal receiving board; the n odd wires are electrically connected to the n odd solder pads, respectively, so that the n-1 odd wires except the first wire extend along the first side of the signal receiving board; the n even wires are electrically connected to the n even solder pads, respectively, so that the n even wires extend along the second side of the signal receiving board.

[0015] In another embodiment, 2n wires are wrapped around the filling tube and the axial center position of the filling tube is coaxially aligned with the axial center position of the tube body and the axial center position of the inner single lumen tube.

[0016] In another embodiment, the tube body, filler tube, and inner single lumen tube are contacted sequentially.

[0017] In another embodiment, the signal receiving plate is interposed between the inner single lumen tube and the outer single lumen tube.

[0018] In another embodiment, the tube body, the filling tube, the inner single-lumen tube and the outer single-lumen tube are made of a material selected from thermoplastic elastomers and thermoplastic polyurethanes.

[0019] In another embodiment, the multi-conductive elastic electrode is provided with a marker ring, which is closer to the proximal end of the multi-conductive elastic electrode than to the signal receiving plate.

[0020] In another embodiment, the distal end of the multi-conductive elastic electrode is formed into a hemispherical shape.

[0021] In another embodiment, a positioning anchor is provided on the outer side of the multi-conductive elastic electrode. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 shows a cross-sectional view of a tube body according to the present invention;

[0023] Figure 2a shows a perspective view of a signal receiving board according to the present invention;

[0024] Figure 2b A partial view of a signal receiving board according to the present invention is shown;

[0025] Figure 3 It shows a schematic diagram of the connection between the wire and the signal receiving board according to the present invention;

[0026] Figure 4a A perspective view showing the tube body, the guide wire, the filler tube, the signal receiving plate and the inner single lumen tube according to the present invention is shown;

[0027] Figure 4b shows a cross-sectional view of a filler tube and a wire according to the present invention;

[0028] Figure 5 A perspective view of a multi-conductive elastic electrode according to the present invention is shown.

[0029] List of reference numerals:

[0030] 100: Pipe body

[0031] 101: First peripheral lumen

[0032] 102: Second peripheral lumen

[0033] 103: Third peripheral lumen

[0034] 110: Central lumen

[0035] 111: First conductor

[0036] 112: Second wire

[0037] 113: Third wire

[0038] 200: Signal receiving board

[0039] 201: First pad

[0040] 202: Second pad

[0041] 203: Third pad

[0042] 301: First connection end

[0043] 302: Second connection end

[0044] 303: Third connection port

[0045] 400: stuffing tube

[0046] 410: Inner single lumen tube

[0047] 500: External single lumen tube. DETAILED DESCRIPTION

[0048] The inventive concept of the present invention includes multiple specific implementation schemes, each with its own technical or application focus. Different implementation schemes can be combined and matched to meet different application scenarios and address different application needs. Therefore, the following description of specific implementation schemes should not be construed as limiting the technical solutions intended to be protected by the present invention.

[0049] Hereinafter, various exemplary embodiments of the present invention will be described in more detail with reference to the accompanying drawings.

[0050] First, in order to more clearly describe the embodiments of the present invention, the "proximal end" and the "distal end" are defined.

[0051] When a physician is facing a patient while holding a tool or instrument (e.g., forceps) and performing a normal operation, and the tool or instrument (e.g., forceps) is between the physician and the patient, the end closer to the physician is called the "proximal end," while the end farther from the physician (the end closer to the patient) is called the "distal end." In other words, for example, when a physician is holding a syringe to give a patient an injection, the tail of the syringe (the part the physician presses with their thumb) can be called the "proximal end," while the needle tip can be called the "distal end."

[0052] The above definitions of “proximal end” and “distal end” are only for the convenience of describing the embodiments of the present invention, and do not limit the structure of the present invention.

[0053] The expression "axial direction" means a direction substantially parallel to the axis of the tube body.

[0054] The expression "circumferential direction" means a direction substantially perpendicular to both the axial direction and the radius of the cross section of the tube body, ie a circumferential direction around the axis of the tube body.

[0055] The expression "radial direction" means a direction along the radius of the cross section of the tube body.

[0056] The expressions “first circumferential direction” and “second circumferential direction” mean mutually opposite circumferential directions of the tube body, for example a clockwise direction and a counterclockwise direction along the circumference of the tube body.

[0057] The expressions “a first side of the signal receiving board” and “a second side of the signal receiving board” respectively mean one side and the other side with respect to the longitudinal direction of the signal receiving board.

[0058] The specific connection method of the multi-conductive elastic electrode and the signal receiving board of the present invention is as follows:

[0059] a) Provide a tube body and a signal receiving board. The tube body contains 2n+1 lumens extending along the axial direction of the tube body, one of which is located at the axial center of the tube body, and the remaining 2n peripheral lumens are distributed around the central lumen, each of which contains 2n wires. For example Figure 1 As shown, the tubular body 100 contains 9 tubular lumens extending in the axial direction of the tubular body, wherein a central tubular lumen 110 is located at the axial center of the tubular body 100, and the remaining 8 peripheral tubular lumens are distributed around the central tubular lumen 110, and the 8 peripheral tubular lumens respectively contain 8 wires. Each peripheral tubular lumen contains a corresponding wire: the first peripheral tubular lumen 101 contains the first wire 111, the second peripheral tubular lumen 102 contains the second wire 112, and the third peripheral tubular lumen 103 contains the third wire 113. This tubular body 100 can be made of medical-grade materials such as thermoplastic polyurethane (TPU) and thermoplastic elastomer (TPE). This type of tubular body uses a special mold during the preparation process and is heated and stretched. Therefore, this type of tubular body has good thermoplasticity and elasticity. The outer diameter of the tubular body 100 is 1 mm to 3 mm, preferably 1.1 mm to 2.5 mm. The inner diameter of the central lumen 110 is 0.3 mm to 0.7 mm, preferably 0.4 mm to 0.6 mm. The inner diameters of the peripheral lumens 101, 102, 103, etc. are 0.1 mm to 0.3 mm.

[0060] The upper surface of the signal receiving board includes a row of 2n pads, where n is an integer greater than or equal to 1 and less than or equal to 8. For example Figure 2a 、 Figure 2b As shown, the upper surface of the signal receiving board 200 includes a row of 8 pads and other components. Figure 2b The figure shows a partial view of the side of the signal receiving board 200 including the pads, which includes eight pads, namely, a first pad 201 , a second pad 202 and a third pad 203 , from the distal end to the proximal end of the signal receiving board.

[0061] b) Alternately and electrically connect the proximal ends of the 2n wires to the 2n pads in a predetermined order. This step can be divided into the following steps:

[0062] b1) According to the first circumferential direction and the second circumferential direction of the tube body, the 2n wires in the 2n peripheral lumens are numbered as n odd-numbered wires and n even-numbered wires. Figure 1 As shown, Figure 1 The counterclockwise direction facing the cross section of the tube body is the first circumferential direction of the tube body. Starting from the first wire 111, the wires along the counterclockwise direction facing the cross section of the tube body are numbered in sequence as odd-numbered wires (for example, the first wire 111, the third wire 113, the fifth wire, and the seventh wire). Figure 1 The clockwise direction facing the cross section of the tube body is the second circumferential direction of the tube body. Starting from the first wire 111, the wires along the clockwise direction facing the cross section of the tube body are numbered in sequence as even-numbered wires (for example, the second wire 112, the fourth wire, the sixth wire, and the eighth wire).

[0063] b2) Number the 2n pads into n odd pads and n even pads in the order from the distal end to the proximal end of the signal receiving board. Figure 2b As shown, the 8 pads include 4 odd pads (the 1st pad, the 3rd pad, the 5th pad, and the 7th pad) and 4 even pads (the 2nd pad, the 4th pad, the 6th pad, and the 8th pad), among which the first pad 201 and the third pad 203 are odd pads, and the second pad 202 and the like are even pads.

[0064] b3) Electrically connect n odd-numbered wires to n odd-numbered pads, respectively, so that n-1 odd-numbered wires, excluding the first wire, extend along the first side of the signal receiving board. The first wire can be connected to the first pad in any direction. Preferably, the first wire extends along the axial direction of the tube body 100 and is connected to the first pad. Connecting the first wire to the first pad in this way can leave space for the other wires to extend. For example Figure 3 As shown, the first wire 111 extends along the axial direction of the tube body 100 and is electrically connected to the first pad 201. The odd-numbered wires except the first wire 111 are connected along the signal receiving board perpendicular to the Figure 3 The plane shown extends toward the side outside the figure and is electrically connected to the corresponding odd-numbered pads. For example, the third conductive line 113 is electrically connected to the third pad 203.

[0065] b4) electrically connecting n even-numbered wires to n even-numbered pads, respectively, so that the n even-numbered wires extend along the second side of the signal receiving board. Figure 3 As shown, the second wire 112 is perpendicular to the signal receiving board. Figure 3 The plane shown extends to the side of the figure (in Figure 3 The second pad 202 is electrically connected to the second pad 202.

[0066] During electrical connection, the connection end of the wire and its corresponding pad should run through the entire length of the pad to maximize the electrical connection area between the wire and the pad. Figure 3 As shown, the first connection end 301 of the first wire 111 is electrically connected to the first pad 201, and the first connection end 301 extends through the length of the first pad 201 in the axial direction of the tube body 100. The second connection end 302 of the second wire is electrically connected to the second pad 202, and the second connection end 302 extends through the length of the second pad 202 in a direction parallel to the surface of the signal receiving board 200 and perpendicular to the axial direction of the tube body 100. The third connection end 303 of the third wire is electrically connected to the third pad 203, and the third connection end 303 extends through the length of the third pad 203 in a direction parallel to the surface of the signal receiving board 200 and perpendicular to the axial direction of the tube body 100.

[0067] c) Provide a stuffing tube, an inner single lumen tube, and a core shaft.

[0068] d) inserting a core shaft through the central lumen of the tube body, the filling tube and the inner single-lumen tube, so that the filling tube is interposed between the tube body and the inner single-lumen tube, and the signal receiving board is located on the outer surface of the inner single-lumen tube.

[0069] like Figure 4a As shown, the inner single-lumen tube 410 is placed on the lower surface of the signal receiving board 200 , and the axis of the filling tube 400 is coaxially aligned with the axis of the tube body 100 and the axis of the inner single-lumen tube 410 .

[0070] The cross section of the inserted filling tube is polygonal ( Figure 4a This is a finished product diagram and does not represent the shape of the filler tube used in the preparation process), so it is preferable to use each side of the polygonal filler tube to evenly separate the wires. Figure 4b As shown, the cross-section of the filling tube 400 is square. Two wires are placed on each side of the cross-section of the filling tube 400. For example, the first wire 111 and the second wire 112 are placed on the upper side of the cross-section of the filling tube 400, so that the eight wires are spaced apart. This arrangement of the wires and the filling tube prevents cross-entanglement and interference between the wires during the manufacturing process and after the product is finished.

[0071] The stuffing tube and inner single-lumen tube are made of medical-grade materials such as thermoplastic polyurethane (TPU) and thermoplastic elastomer (TPE) by stretching them in a special mold during heating. When the stuffing tube has a square cross-section, its side length is 0.6mm to 5mm and its inner hole diameter is 0.3mm to 4.5mm, preferably 0.8mm to 4.5mm and its inner hole diameter is 0.5mm to 4.0mm. The outer single-lumen 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 1.95mm.

[0072] The core shaft is made of stainless steel or nickel-titanium alloy wire and the surface of the core shaft may be coated with or not coated with polytetrafluoroethylene. The polytetrafluoroethylene coating can prevent the tube body, the filling tube and the inner single-lumen tube from adhering to the core shaft during the heat shrinking process, thereby facilitating the subsequent removal of the core shaft. Figure 4a As shown, the central lumen 110 (at Figure 4a The filling tube 400 and the inner single-lumen tube 410 are inserted into the core shaft so that the tube body 100, the filling tube 400 and the inner single-lumen tube 410 are in contact with each other in sequence.

[0073] e) Wrapping at least a portion of the tube body, the 2n wires between the tube body and the signal receiving board, the filler tube, the signal receiving board, and the inner single-lumen tube with an outer single-lumen tube, so that the signal receiving board is between the inner single-lumen tube and the outer single-lumen tube. Figure 5 As shown, the outer single-lumen tube 500 wraps the end of the tube body 100 , the eight wires between the tube body 100 and the signal receiving board 200 , the filler tube 400 , the signal receiving board 200 and the inner single-lumen tube 410 .

[0074] f) Fix the outer single-lumen tube. This step can be divided into the following steps:

[0075] f1) Cover the outer single-lumen tube with a heat shrink tubing and heat it. The size of the heat shrink tubing is selected so that its inner diameter is larger than the outer diameter of the tube body and the outer single-lumen tube and the inner diameter after heat shrinkage reaches the target outer diameter of the multi-conducting elastic electrode. The material of the heat shrink tubing is selected so that its heat shrinking temperature is larger than the melting point of the material of the tube body, the filler tube, the inner single-lumen tube and the outer single-lumen tube. For example, Figure 4a All components shown are first covered with an outer single-lumen tube, followed by a heat-shrink tubing (not shown) and heated to a temperature equal to or greater than its shrinkage temperature. During heating, a localized annular heating device is employed. While the heating device remains stationary, the electrode body is moved, thereby slowly heating the entire structure covered with the heat-shrink tubing. The heat-shrink tubing shrinks, and the material of the tubing, filler tube, inner single-lumen tube, and outer single-lumen tube melts, allowing the tubing, filler tube, inner single-lumen tube, and outer single-lumen tube to become one. Furthermore, as needed, different heat-shrink tubings can be replaced and heat-shrunk multiple times until the target outer diameter of the multi-conducting elastic electrode is achieved.

[0076] The heat shrink tube is made of perfluoroethylene propylene copolymer, has an outer diameter of 1.6mm to 6.5mm, and a wall thickness of 0.1mm to 2mm, preferably an outer diameter of 1.65mm to 6.0mm, and a wall thickness of 0.15mm to 1.95mm.

[0077] f2) Peel off the heat shrink tube and pull out the core shaft. Figure 5As shown in the figure, after the heat shrink tube is peeled off, the outer single lumen tube 500 is fused with the corresponding tube body. Under the wrapping and local heating of the heat shrink tube, the part of the outer single lumen tube 500 that was wrapped on the tube body 100 before heating is fused with the tube body 100, and the diameter of the connection between the outer single lumen tube 500 and the tube body 100 is similar to the original diameter of the tube body 100. Because the outer single lumen tube 500 wraps different components at different positions, the outer single lumen tube 500 will be fused after heat shrinking. Figure 5 The filling tube 400, the inner single lumen tube 410 and the central lumen 110 of the tube body 100 are aligned and integrated with each other with the aid of the mandrel, thereby obtaining the following: Figure 5 The finished structure of the multi-conductive elastic electrode is shown.

[0078] The multi-conducting elastic electrode of the present invention can be prepared by the above method. The multi-conducting elastic electrode includes a tube body connected to an outer single-lumen tube, the outer single-lumen tube internally enclosing a signal receiving board, 2n wires, a filler tube 400, and an inner single-lumen tube 410. Figure 5 As shown, the multi-conductive elastic electrode includes a tube body 100 , which is connected to an outer single-lumen tube 500 , which contains a signal receiving board 200 , 8 wires 111 , 112 , 113 , etc., a filler tube 400 , and an inner single-lumen tube 410 .

[0079] The tube body contains 2n+1 lumens extending along the axial direction of the tube body, wherein a central lumen is located at the axial center of the tube body, and the remaining 2n peripheral lumens are distributed around the central lumen, where n is an integer greater than or equal to 1 and less than or equal to 8. Figure 1 and Figure 5 As shown, the tubular body 100 includes a central lumen and eight peripheral lumens, such as a first peripheral lumen 101, a second peripheral lumen 102, a third peripheral lumen 103, etc. These eight peripheral lumens surround the central lumen ( Figure 5 (obscured by the filler tube 400).

[0080] The upper surface of the signal receiving board contains a row of 2n pads. Figure 2b and Figure 5 As shown, eight pads, including a first pad 201 , a second pad 202 , and a third pad 203 , are distributed on the upper surface of the signal receiving board 200 .

[0081] The 2n wires are respectively inserted into the 2n peripheral lumens, and the proximal ends of the 2n wires are respectively electrically connected to the 2n pads in a predetermined order. According to the first circumferential direction and the second circumferential direction of the tube body, the 2n wires in the 2n peripheral lumens are numbered as n odd wires and n even wires. According to the order from the distal end to the proximal end of the signal receiving board, the 2n pads are numbered as n odd pads and n even pads. The n odd wires are respectively electrically connected to the n odd pads, so that the n-1 odd wires except the first wire extend along the first side of the signal receiving board. The n even wires are respectively electrically connected to the n even pads, so that the n even wires extend along the second side of the signal receiving board.

[0082] For example Figure 1 and Figure 5 As shown, the first guide wire 111 corresponds to the first peripheral lumen 101 , the second guide wire 112 corresponds to the second peripheral lumen 102 , and the third guide wire 113 corresponds to the third peripheral lumen 103 . Figure 1 The counterclockwise direction facing the cross section of the tube body is the first circumferential direction of the tube body, and starting from the first wire 111 , the odd-numbered wires are sequentially numbered in the counterclockwise direction facing the cross section of the tube body, such as the third wire 113 . Figure 1 The clockwise direction of the middle surface facing the cross section of the tube body is the second circumferential direction of the tube body, starting from the first wire 111 along Figure 1 The even-numbered wires are numbered in the clockwise direction facing the cross section of the tube body, such as the second wire 112.

[0083] The first wire can be connected to the first pad from different directions. Preferably, the first wire extends along the axial direction of the tube body 100 and is connected to the first pad. Connecting the first wire to the first pad can leave space for other wires to extend. For example Figure 5 As shown, the first wire 111 extends along the axial direction of the tube body 100 and is electrically connected to the first pad 201. The odd-numbered wires except the first wire 111 are connected along the signal receiving board perpendicular to the Figure 5 The plane shown extends to the side outside the figure and is electrically connected to the corresponding odd-numbered pads. The even-numbered wires run perpendicular to the signal receiving board. Figure 5 The plane shown in the figure extends to the side and is electrically connected to the corresponding even-numbered pads. For example, the third wire 113 extends perpendicular to the signal receiving board. Figure 5 The plane shown in the figure extends to the side outside the figure and is electrically connected to the third pad 203. The second wire 112 is perpendicular to the signal receiving board. Figure 3 The plane shown extends to the side of the figure (in Figure 3 (partially blocked by the signal receiving board) and electrically connected to the second pad 202. Figure 3As described above, the connection end between the wire and its corresponding pad should extend through the entire length of the pad to maximize the electrical connection area between the wire and the pad. This method of electrically connecting the wire to the pad eliminates the need for the wire to be wrapped around the signal receiving board and the inner single-lumen tube before being electrically connected to the pad. Furthermore, while maximizing the contact surface between the wire and the corresponding pad, the wires are prevented from crossing or becoming entangled. Therefore, the wire-to-pad connection method of the present invention reduces the risk of short circuits and enhances the strength and conductivity of the wire connection.

[0084] The filler tube is located between the tube body and the inner single-lumen tube, and the signal receiving plate is located on the outer surface of the inner single-lumen tube. Figure 5 As shown, the filler tube 400 is interposed between the tube body 100 and the inner single-lumen tube 410, and the signal receiving board 200 is located on the outer surface of the inner single-lumen tube 410. Because a mandrel is used during the manufacturing process to penetrate the tube body 100, filler tube 400, and inner single-lumen tube 410, these three components are aligned axially after heat-seal and removal of the mandrel, and are heat-sealably fixed together. The filler tube is polygonal during the manufacturing process, but its shape changes after heat shrinkage due to the support of the central mandrel. Figure 5 The filler tube 400 shown is partially cylindrical, but this only represents one embodiment and should not be understood as limiting the technical solution that the present invention is intended to protect.

[0085] The outer single-lumen tube wraps at least a portion of the tube body, the 2n wires between the tube body and the signal receiving board, the filling tube, the signal receiving board and the inner single-lumen tube, and the 2n wires surround the filling tube. Figure 5 As shown, the outer single-lumen tube 500 wraps the end portion of the tube body 100, the eight wires 111, 112 and 113 between the tube body 100 and the signal receiving board 200, the filling tube 400, the signal receiving board 200 and the inner single-lumen tube 410. The eight wires are arranged as follows: Figure 5 As shown in the figure, the outer single cavity tube 500 is wrapped with a heat shrink tube after wrapping the end of the tube body 100 and is heat-shrink-molded as a whole. Figure 5 The finished product shown shows no obvious signs of the junction between the tubular body 100 and the rest of the outer single-lumen tube 500. In other words, the portion of the outer single-lumen tube 500 that wraps around the end of the tubular body 100 is thermally fused to the tubular body 100 during the manufacturing process. The tubular body 100, filler tube 400, inner single-lumen tube 410, and outer single-lumen tube 500 thus form an interconnected, integrated structure. The tubular body, filler tube, inner single-lumen tube, and outer single-lumen tube are made of a material selected from thermoplastic elastomers and thermoplastic polyurethanes.

[0086] In addition, the multi-conducting elastic electrode can be provided with a marker ring, which is closer to the proximal end of the multi-conducting elastic electrode relative to the signal receiving plate. The outer side of the marker ring (the side close to the proximal end) can be shortened according to actual needs, but the inner side of the marker ring (the side close to the signal receiving plate) cannot be shortened. The distal end of the multi-conducting elastic electrode can be formed into a hemispherical shape to facilitate electrode insertion and sealing in the vertebral cavity. The outer side of the multi-conducting elastic electrode can be provided with a positioning anchor. The function of the positioning anchor is to suture and fix the positioning anchor to the intervertebral ligament tissue with sutures to prevent the electrode from moving after implantation.

[0087] The advantageous effects of the multi-conductive elastic electrode and the connection method thereof of the present invention are as follows:

[0088] 1) By simultaneously arranging 2n wires within the 2n peripheral lumens of the tube body, the wires are fully isolated from each other and there is no risk of contact, thus avoiding signal interference. Although the wires themselves are insulated enameled wires and will not conduct electricity when in contact with each other, friction or pressure during electrode use increases the risk of short circuits. The arrangement of the present invention reduces friction between the wires during use, avoiding the occurrence of short circuits and increasing durability. In addition, since the wires are not entangled and the distance is minimized, the appearance is improved and the impedance is reduced.

[0089] 2) No need to use the perfusion method commonly used in the prior art, the method is simpler to operate and the product flexibility is improved, and it can have better adaptability to the corresponding parts of the human body when implanted in the human body;

[0090] 3) The tube body, filler tube, inner single-lumen tube, and outer single-lumen tube of the multi-conducting elastic electrode are integrated into one body, which improves product strength. After heat shrinking, the outer lumen of the tube body tightly wraps the wire, preventing the wire from moving unexpectedly in the outer lumen and becoming disconnected. After heat shrinking, the outer single-lumen tube, filler tube, and inner single-lumen tube tightly wrap the wire and signal receiving board, preventing the wire or signal receiving board from becoming disconnected due to unexpected movement.

[0091] 4) After heat shrinkage, the gaps between the tube body, filler tube, inner single-lumen tube, and outer single-lumen tube are filled with material, effectively reducing the risk of the entire electrode failing due to leakage of body fluids (blood, tissue fluid, etc.) and contact with internal wires or signal receiving boards after the electrode is implanted in the human body;

[0092] 5) Due to the use of a polygonal cross-section filler tube, the wires between the signal receiving board and the tube body can be evenly distributed around the outer circumference of the filler tube, thus avoiding cross-entanglement interference or accidental short circuits between the wires during the preparation process and after the finished product;

[0093] 6) Since the 2n wires are numbered as n odd-numbered wires and n even-numbered wires according to the first circumferential direction and the second circumferential direction of the tube body, and are alternately electrically connected to the 2n pads, a fishbone-like structure is formed, which further avoids cross-entanglement interference or accidental short circuit of adjacent wires.

[0094] Example 1

[0095] A 9-hole tube body is provided, wherein one of the central lumens in the 9 holes is located at the axial center of the 9-hole tube body, and the remaining 8 peripheral lumens are evenly distributed around the central lumen. There is a wire in each peripheral lumen. The peripheral lumen at the top of the tube cross section is numbered as the first peripheral lumen, and the wire therein is the first wire. Starting from the first peripheral lumen, the peripheral lumens and their corresponding wires in the counterclockwise direction facing the tube cross section are numbered in sequence from 3 by odd numbers (excluding the first wire), and starting from the first peripheral lumen, the peripheral lumens and their corresponding wires in the clockwise direction facing the tube cross section are numbered in sequence from 2 by even numbers (excluding the first wire). The outer diameter of the tube body is 1.3mm, the inner diameter of each peripheral lumen is 0.21mm, and the inner diameter of the central lumen is 0.51mm. The above-mentioned tube body is made of thermoplastic polyurethane. The wires are made of MP35N material. The diameter of each wire is 0.15mm.

[0096] A signal receiving board is also provided, and the upper surface of the signal receiving board includes a row of 8 solder pads and other components. The 8 solder pads are numbered starting from 1 in order from the distal end to the proximal end of the signal receiving board.

[0097] The first wire extends along the axial direction of the tube and connects to the first pad. The three odd-numbered wires, excluding the first wire, extend along one side of the signal receiving board and electrically connect to the odd-numbered pads with the same numbers. The four even-numbered wires extend along the second side of the signal receiving board and electrically connect to the even-numbered pads with the same numbers. When soldering, press a 1mm platinum-iridium alloy terminal onto the proximal end of each wire. Then, connect the terminal and wire together to the corresponding pad with the same number and extend the entire length of the pad.

[0098] A stuffing tube is placed between the tube body and the signal receiving plate, and an inner single-lumen tube is placed on the lower surface of the signal receiving plate, so that eight wires surround the stuffing tube and the axis of the stuffing tube is coaxially aligned with the axis of the tube body and the axis of the inner single-lumen tube. The cross-section of the stuffing tube is square, and two wires are placed on each side of this square stuffing tube, so that the eight wires are separated by twos. The stuffing tube and the inner single-lumen tube are made of medical-grade thermoplastic polyurethane by stretching using a special mold during the heating process. The stuffing tube has a side length of 1mm and an inner diameter of 0.6mm. The outer diameter of the inner single-lumen tube is 0.65mm and the inner diameter is 0.55mm.

[0099] A core shaft is inserted through the central lumen of the tube body, the filling tube and the inner single lumen tube, so that the tube body, the filling tube and the inner single lumen tube are in contact with each other in sequence. The core shaft is made of stainless steel and its surface is coated with polytetrafluoroethylene.

[0100] An outer single-lumen tube is used to wrap the end portion of the tube body close to the filling tube, the eight wires between the tube body and the signal receiving board, the filling tube, the signal receiving board and the inner single-lumen tube, so that the signal receiving board is located between the inner single-lumen tube and the outer single-lumen tube. The outer single-lumen tube has an outer diameter of 2.3 mm and an inner diameter of 1.7 mm.

[0101] After applying heat shrink tubing to the outer single-lumen tube, either entirely or partially, depending on the actual situation, the outer tube is slowly heated to a temperature above the shrinking temperature of the heat shrink tubing. The heat shrink tubing shrinks, and the materials of the tube body, filler tube, inner single-lumen tube, and outer single-lumen tube melt, allowing the outer single-lumen tube to fuse with the tube body. The filler tube, filler tube, and inner single-lumen tube within the outer single-lumen tube, where the corresponding portion of the tube body contacts it, also fuse accordingly. The heat shrink tubing is made of perfluoroethylene propylene copolymer. It has an outer diameter of 2.8 mm and a wall thickness of 0.2 mm.

[0102] After the whole structure is cooled, the heat shrink tube is peeled off and the mandrel is pulled out. With the help of the mandrel, the filling tube, the inner single lumen tube and the central lumen of the tube body are aligned and fused together, thus obtaining the following Figure 5 The finished structure of the multi-conductive elastic electrode is shown.

[0103] 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 present invention and are not limited to the exemplary embodiments disclosed herein. Accordingly, it should be noted that such changes or modifications fall within the scope of the claims of the present invention, and the scope of the present invention should be interpreted based on the appended claims.

Claims

1. A method for connecting multiple conductive elastic electrodes, characterized in that: The connection method comprises: a) providing a tube body and a signal receiving board, wherein the tube body contains 2n+z lumens extending in the axial direction of the tube body and wires located in the peripheral lumens, and the upper surface of the signal receiving board contains 2n solder pads, where n and z are integers greater than or equal to 1; b) electrically connecting the proximal ends of the wires to the pads alternately in a predetermined order; c) providing a stuffing tube, an inner single lumen tube, and a mandrel; d) inserting a core shaft through the central lumen of the tube body, the filler tube, and the inner single lumen tube; e) wrapping at least a portion of the tube body, the wire between the tube body and the signal receiving board, the filler tube, the signal receiving board, and the inner single-lumen tube with an outer single-lumen tube; f) Fix the outer single lumen tube.

2. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: In step a), a central lumen is located at the axial center of the tube body, and the remaining 2n peripheral lumens are distributed around the central lumen. The 2n peripheral lumens respectively contain 2n wires, and the upper surface of the signal receiving board contains a row of 2n solder pads.

3. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: n is an integer less than or equal to 8.

4. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: In step b), the proximal ends of the 2n wires are electrically connected to the 2n pads alternately in a predetermined order.

5. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: In step d), the filling tube is interposed between the tube body and the inner single-lumen tube, and the signal receiving plate is located on the outer surface of the inner single-lumen tube.

6. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: In step e), an outer single-lumen tube is used to wrap at least a portion of the tube body, the 2n wires between the tube body and the signal receiving board, the filler tube, the signal receiving board, and the inner single-lumen tube.

7. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: Step b) further comprises: b1) numbering the 2n wires in the 2n peripheral lumens into n odd-numbered wires and n even-numbered wires according to a first circumferential direction and a second circumferential direction of the tube body; b2) numbering the 2n pads into n odd-numbered pads and n even-numbered pads in order from the distal end to the proximal end of the signal receiving board; b3) electrically connecting the n odd-numbered wires to the n odd-numbered pads, respectively, so that n-1 odd-numbered wires excluding the first wire extend along the first side of the signal receiving board; b4) electrically connecting the n even-numbered wires to the n even-numbered pads, respectively, so that the n even-numbered wires extend along the second side of the signal receiving board.

8. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: Step d) is performed so that the 2n wires surround the filling tube and the axis of the filling tube is coaxially aligned with the axis of the tube body and the axis of the inner single-lumen tube.

9. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: Step d) is performed so that the tube body, the filler tube and the inner single-lumen tube are contacted in sequence.

10. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: Step e) is performed so that the signal receiving plate is interposed between the inner single-lumen tube and the outer single-lumen tube.

11. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: Step f) further comprises: f1) Put a heat shrink tubing on the outer single lumen tube and heat it; f2) Peel off the heat shrink tubing and pull out the core shaft.

12. The method for connecting multiple conductive elastic electrodes according to claim 11, wherein: The tube body, filler tube, inner single-lumen tube and outer single-lumen tube are made of materials selected from thermoplastic elastomers and thermoplastic polyurethanes, the heat shrink tube is made of perfluoroethylene propylene copolymer, the core shaft is made of stainless steel or nickel-titanium alloy wire, and the surface of the core shaft is coated with polytetrafluoroethylene.

13. The method for connecting multiple conductive elastic electrodes according to claim 1, wherein: The cross section of the stuffing tube is polygonal.

14. A multi-conducting elastic electrode, characterized in that: The multi-conductive elastic electrode comprises: - a tubular body, wherein the tubular body contains 2n+z lumens extending in the axial direction of the tubular body, where n and z are integers greater than or equal to 1; - a signal receiving board, wherein the upper surface of the signal receiving board comprises 2n solder pads; - a wire, the wire being inserted into the peripheral lumen, the proximal ends of the wire being electrically connected to the pads alternately in a predetermined sequence; - stuffing tube; -Inner single lumen tube; - an outer single-lumen tube, the outer single-lumen tube enclosing at least a portion of the tube body, the wire between the tube body and the signal receiving board, the filler tube, the signal receiving board, and the inner single-lumen tube; The tube body, the filling tube, the inner single-lumen tube and the outer single-lumen tube are integrated by hot melting.

15. The multi-conductive elastic electrode according to claim 14, characterized in that: One central lumen is located at the axial center of the tube body, and the remaining 2n peripheral lumens are distributed around the central lumen.

16. The multi-conductive elastic electrode according to claim 14, characterized in that: n is an integer less than or equal to 8.

17. The multi-conductive elastic electrode according to claim 14, characterized in that: The upper surface of the signal receiving board includes a row of 2n solder pads.

18. The multi-conductive elastic electrode according to claim 14, characterized in that: The wires are 2n wires, which are respectively inserted into 2n peripheral lumens, and the proximal ends of the 2n wires are respectively and alternately electrically connected to 2n pads in a predetermined order.

19. The multi-conductive elastic electrode according to claim 14, characterized in that: The filling tube is located between the tube body and the inner single-lumen tube, and the signal receiving plate is located on the outer surface of the inner single-lumen tube.

20. The multi-conductive elastic electrode according to claim 14, characterized in that: - According to the first circumferential direction and the second circumferential direction of the tube body, the 2n wires in the 2n peripheral lumens are numbered as n odd-numbered wires and n even-numbered wires; - In order from the distal end to the proximal end of the signal receiving board, the 2n pads are numbered as n odd pads and n even pads; - n odd-numbered wires are electrically connected to n odd-numbered pads, respectively, so that n-1 odd-numbered wires except the first wire extend along the first side of the signal receiving board; - n even-numbered wires are electrically connected to n even-numbered pads, respectively, so that the n even-numbered wires extend along the second side of the signal receiving board.

21. The multi-conductive elastic electrode according to claim 14, characterized in that: 2n wires surround the stuffing tube, and the axial center position of the stuffing tube is coaxially aligned with the axial center position of the tube body and the axial center position of the inner single-lumen tube.

22. The multi-conductive elastic electrode according to claim 14, characterized in that: The tube body, the filler tube and the inner single-lumen tube are contacted in sequence.

23. The multi-conductive elastic electrode according to claim 14, characterized in that: The signal receiving plate is located between the inner single-lumen tube and the outer single-lumen tube.

24. The multi-conductive elastic electrode according to claim 14, characterized in that: The tube body, the filling tube, the inner single-lumen tube and the outer single-lumen tube are made of a material selected from thermoplastic elastomer and thermoplastic polyurethane.

25. The multi-conductive elastic electrode according to claim 14, characterized in that: The multi-conductive elastic electrode is provided with a marking ring, and the marking ring is closer to the proximal end of the multi-conductive elastic electrode relative to the signal receiving plate.

26. The multi-conductive elastic electrode according to claim 14, characterized in that: The distal end of the multi-conductive elastic electrode is formed in a hemispherical shape.

27. The multi-conductive elastic electrode according to claim 14, characterized in that: Positioning anchors are arranged on the outer sides of the multi-conductive elastic electrodes.

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