Disclosure of Invention
The invention aims to provide a multi-conduction elastic electrode and a connection method of the multi-conduction elastic electrode and a signal receiving plate. The connecting end of the multi-conduction elastic electrode and the signal receiving plate are integrally formed, the flexibility is good, and the adaptability to the human body after being implanted into the human body is good. The connecting method of the multi-conduction elastic electrode and the signal receiving plate is simpler than the traditional method. The connecting method reduces the risk of short circuit caused by mutual contact of the wires and the risk of disconnection of the wires caused by 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 of a) providing a tube body and a signal receiving plate, wherein the tube body contains 2n+z tube cavities extending along the axial direction of the tube body, one central tube cavity is positioned at the axis position of the tube body, the other 2n outer circumferences Guan Qiang are distributed around the central tube cavity, 2n outer circumferences Guan Qiang respectively contain 2n wires, the upper surface of the signal receiving plate contains a row of 2n bonding pads, n is an integer which is greater than or equal to 1 and less than or equal to 8, z is an integer which is greater than or equal to 1, b) electrically connecting the proximal ends of the 2n wires to the 2n bonding pads in a preset sequence, c) providing a filling tube, an inner single-cavity tube and a mandrel, d) inserting the mandrel through the central tube cavity, the filling tube and the inner single-cavity tube, enabling the filling tube to be arranged between the tube and the inner single-cavity tube, and the signal receiving plate is positioned on the outer surface of the inner single-cavity tube, e) wrapping at least one part of the tube between the tube body, the inner single-cavity tube and the signal receiving plate, and f) fixing the signal receiving plate.
In one embodiment, step b) further includes the steps of b 1) numbering 2n wires within 2n outer circumferences Guan Qiang as n odd wires and n even wires according to a first circumferential direction and a second circumferential direction of the tube, b 2) numbering 2n pads as n odd pads and n even pads in order from the distal end to the proximal end of the signal receiving plate, b 3) electrically connecting the n odd wires to the n odd pads, respectively, such that n-1 odd wires other than the 1 st wire extend along a first side of the signal receiving plate, and b 4) electrically connecting the n even wires to the n even pads, respectively, such that the n even wires extend along a second side of the signal receiving plate.
In another embodiment, step d) is performed such that 2n wires encircle the filler tube and the axial location of the filler tube is coaxially aligned with the axial location of the tube body and the axial location of the inner single lumen tube.
In another embodiment, step d) is performed such that the tube body, filler tube and inner single lumen tube are contacted sequentially.
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.
In another embodiment, step f) further comprises the steps of f 1) sheathing a heat shrink tube over the exterior of the outer single lumen tube and heating, f 2) stripping the heat shrink tube and withdrawing the mandrel.
In another embodiment, the tube body, filler tube, inner single lumen tube and outer single lumen tube are made of a material selected from the group consisting of thermoplastic elastomer, thermoplastic polyurethane, the heat shrink tube is made of perfluoroethylene propylene copolymer, the mandrel is made of stainless steel material or nitinol wire and the mandrel surface is coated with polytetrafluoroethylene.
In another embodiment, the filler tube is polygonal in cross-section.
Another aspect of the invention relates to a multi-conductive elastic electrode comprising a tube body, wherein the tube body comprises 2n+z tube cavities extending along the axial direction of the tube body, one central tube cavity is positioned at the axial center position of the tube body, the other 2n outer tube cavities Guan Qiang are distributed around the central tube cavity, n is an integer which is greater than or equal to 1 and less than or equal to 8, z is an integer which is greater than or equal to 1, the upper surface of the signal receiving plate comprises a row of 2n bonding pads, 2n wires, the 2n wires are respectively inserted into the 2n outer tube cavities Guan Qiang, the proximal ends of the 2n wires are respectively and alternately electrically connected to the 2n bonding pads according to a preset sequence, the filler tube is arranged between the tube body and the inner single tube cavity, the signal receiving plate is positioned on the outer surface of the inner single tube cavity, the outer single tube cavity tube wraps at least one part of the tube body, the 2n wires arranged between the tube body and the signal receiving plate, the single tube cavity and the inner single tube cavity tube are a fusion tube.
In one embodiment, the 2n wires within the 2n outer circumferences Guan Qiang are numbered n odd wires and n even wires in the first circumferential direction and the second circumferential direction of the tube body, the 2n pads are numbered n odd pads and n even pads in the order of the distal end to the proximal end of the signal receiving plate, the n odd wires are electrically connected to the n odd pads, respectively, such that the n-1 odd wires other than the 1 st wire extend along the first side of the signal receiving plate, and the n even wires are electrically connected to the n even pads, respectively, such that the n even wires extend along the second side of the signal receiving plate.
In another embodiment, 2n wires surround the filler tube and the axial location of the filler tube is coaxially aligned with the axial location of the tube body and the axial location of the inner single lumen tube.
In another embodiment, the tube body, filler tube and inner single lumen tube are in sequential contact.
In another embodiment, the signal receiving plate is interposed between the inner single lumen tube and the outer single lumen tube.
In another embodiment, the tube body, filler tube, inner single lumen tube and outer single lumen tube are made of a material selected from the group consisting of thermoplastic elastomers, thermoplastic polyurethanes.
In another embodiment, the multi-conductive elastic electrode is provided with a marker ring that is closer to the proximal end of the multi-conductive elastic electrode relative to the signal receiving plate.
In another embodiment, the distal end of the multi-conductive elastic electrode is hemispherical.
In another embodiment, the outer side of the multi-conducting elastic electrode is provided with a positioning anchor.
Detailed Description
The inventive concept of the present invention includes a plurality of specific embodiments, and different embodiments have technical or application emphasis, and different embodiments can be combined and matched to meet different application scenarios and solve different application requirements. Therefore, the following description of specific embodiments should not be construed as limiting the technical solutions that the invention is intended to protect.
Hereinafter, various exemplary embodiments of the present invention will be described more specifically with reference to the accompanying drawings.
First, in order to more clearly describe embodiments of the present invention, "proximal end" and "distal end" are defined.
The end of the tool or instrument (e.g., forceps) that is closer to the physician when the physician is in normal operation with the tool or instrument (e.g., forceps) facing the patient is between the physician and the patient is referred to as the "proximal end" and the end that is farther from the physician (the end that is closer to the patient) is referred to as the "distal end". In other words, for example, when a physician holds the barrel to needle a patient, the tail of the barrel (where the physician 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".
The above definitions of "proximal end" and "distal end" are merely for convenience in describing embodiments of the present invention and are not limiting on 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 tube cross section, i.e. the circumferential direction around the tube axis.
The expression "radial direction" means a direction along the radius of the cross-section of the tubular body.
The expressions "first circumferential direction" and "second circumferential direction" mean circumferential directions of the tube body which are opposite to each other, for example clockwise and counterclockwise along the circumference of the tube body.
The expressions "first side of the signal receiving plate" and "second side of the signal receiving plate" mean one side and the other side, respectively, with respect to the longitudinal direction of the signal receiving plate.
The specific connection method of the multi-conduction elastic electrode and the signal receiving plate is as follows:
a) A tube and a signal receiving plate are provided. The tube body comprises 2n+1 tube cavities extending along the axial direction of the tube body, one central tube cavity is positioned at the axis of the tube body, the rest 2n outer circumferences Guan Qiang are distributed around the central tube cavity, and the 2n outer circumferences Guan Qiang respectively comprise 2n wires. For example, as shown in fig. 1, the tube body 100 includes 9 lumens extending along the axial direction of the tube body, one central lumen 110 is located at the axial position of the tube body 100, the remaining 8 outer circumferences Guan Qiang are distributed around the central lumen 110, and the 8 outer circumferences Guan Qiang respectively include 8 wires. Each outer perimeter Guan Qiang contains 1 wire, respectively, the first outer perimeter Guan Qiang contains a first wire 111, the second outer perimeter Guan Qiang contains a second wire 112, and the third outer perimeter Guan Qiang contains a third wire 113. The tube 100 may be made of a medical grade material such as Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), etc. The pipe body is formed by heating and stretching by using a special die in the preparation process. Therefore, such a tube has better thermoplasticity and elasticity. The outer diameter of the tube body 100 is 1mm to 3mm, preferably 1.1mm to 2.5mm. The inner diameter of the central lumen 110 is 0.3mm to 0.7mm, preferably 0.4mm to 0.6mm. The inner diameter of the peripheral lumens 101, 102, 103, etc. is 0.1mm to 0.3mm.
The upper surface of the signal receiving board comprises a row of 2n bonding pads, and n is an integer greater than or equal to 1 and less than or equal to 8. For example, as shown in fig. 2a and 2b, the upper surface of the signal receiving panel 200 includes a row of 8 pads and other components. Fig. 2b is a partial view of the pad-containing side of the signal receiving board 200, which includes 8 pads, i.e., a first pad 201, a second pad 202, and a third pad 203, in order from the distal end to the proximal end of the signal receiving board.
B) The proximal ends of the 2n wires are alternately electrically connected to the 2n pads, respectively, in a predetermined order. This step can be performed in several steps:
b1 According to the first circumferential direction and the second circumferential direction of the tube body, the 2n wires in the 2n outer circumferences Guan Qiang are numbered as n odd wires and n even wires. As shown in fig. 1, the counterclockwise direction facing the cross section of the tube body in fig. 1 is the first circumferential direction of the tube body, and the wires starting from the first wire 111 in the counterclockwise direction facing the cross section of the tube body are sequentially odd-numbered wires (e.g., the 1 st wire 111, the 3 rd wire 113, the 5 th wire, the 7 th wire). The clockwise direction in fig. 1 facing the cross section of the tube body is the second circumferential direction of the tube body, and the wires starting from the first wire 111 in the clockwise direction facing the cross section of the tube body are sequentially even numbered as even wires (e.g., the 2 nd wire 112, the 4 th wire, the 6 th wire, the 8 th wire).
B2 2n pads are numbered as n odd pads and n even pads in the order of the distal end to the proximal end of the signal receiving panel. As shown in fig. 2b, the 8 pads include 4 odd pads (1 st pad, 3 rd pad, 5 th pad, 7 th pad) and 4 even pads (2 nd pad, 4 th pad, 6 th pad, 8 th pad), wherein the first pad 201, the third pad 203, etc. are odd pads, and the second pad 202, etc. are even pads.
B3 N odd wires are electrically connected to the n odd pads, respectively, such that the n-1 odd wires other than the 1 st wire extend along the first side of the signal receiving board. The 1 st wire may be connected to the 1 st pad in any direction. Preferably, the 1 st wire extends in the axial direction of the tube body 100 and is connected to the 1 st pad. Connecting the 1 st wire with the 1 st pad in this way leaves room for other wires to extend. For example, as shown in fig. 3, the first wire 111 extends in the axial direction of the tube body 100 and is electrically connected to the first pad 201. The odd-numbered wires except for the first wire 111 extend along the signal receiving panel perpendicular to the plane shown in fig. 3 on the side other than the drawing and are electrically connected to the corresponding odd-numbered pads. For example, the third wire 113 is electrically connected to the third pad 203.
B4 N even conductors are electrically connected to the n even pads, respectively, such that the n even conductors extend along the second side of the signal receiving plate. For example, as shown in fig. 3, the second conductive line 112 extends along a side of the signal receiving board perpendicular to the plane shown in fig. 3 (partially obscured by the signal receiving board in fig. 3) and is electrically connected to the second pad 202.
In the process of electric connection, the connection end of the wire and the corresponding bonding pad should penetrate through the whole length of the bonding pad to achieve the purpose of maximizing the electric connection area of the wire and the bonding pad. For example, as shown in fig. 3, the first connection end 301 of the first wire 111 is electrically connected to the first pad 201, and the first connection end 301 penetrates through the length of the first pad 201 in the axial direction of the pipe 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 penetrates through the length of the second pad 202 in the axial direction parallel to the surface of the signal receiving board 200 and perpendicular to 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 penetrates the length of the third pad 203 in the axial direction parallel to the surface of the signal receiving board 200 and perpendicular to the tube body 100.
C) A filler tube, an inner single lumen tube, and a mandrel are provided.
D) The core shaft is inserted through the central lumen of the tube body, the filler tube and the inner single-lumen tube, so that the filler tube is arranged between the tube body and the inner single-lumen tube, and the signal receiving plate is positioned on the outer surface of the inner single-lumen tube.
As shown in fig. 4a, the inner single-lumen tube 410 is placed on the lower surface of the signal receiving plate 200, and the axial position of the filler tube 400 is coaxially aligned with the axial position of the tube body 100 and the axial position of the inner single-lumen tube 410.
The cross section of the inserted filler tube is polygonal (fig. 4a is a schematic diagram of the finished product and does not represent the shape of the filler tube used in the manufacturing process), so that each side of the polygonal filler tube can be preferably used to uniformly separate the wires. For example, as shown in fig. 4b, the cross section of the filler tube 400 is square, and 2 wires are placed on each side of the cross section of the filler 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 filler tube 400 such that 8 wires are spaced apart from each other. The wire and the filler pipe are placed in a manner that the wire and the filler pipe can avoid the mutual cross winding interference between the wires in the preparation process and after the finished product.
The filler pipe and the inner single-cavity pipe are made of medical grade materials such as Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE) and the like by stretching through a special die in the heating process. The filler pipe has a side length of 0.6mm to 5mm, an inner hole diameter of 0.3mm to 4.5mm, preferably a side length of 0.8mm to 4.5mm, and an inner hole diameter of 0.5mm to 4.0mm when the filler pipe is square in cross section. 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.
The core shaft is made of stainless steel materials or nickel-titanium alloy wires, polytetrafluoroethylene can be coated or not coated on the surface of the core shaft, and the polytetrafluoroethylene coating can prevent the pipe body, the filler pipe and the inner single-cavity pipe from being adhered to the core shaft in the heat shrinkage process, so that the core shaft is pulled out after that. For example, as shown in fig. 4a, the mandrel is inserted through the central lumen 110 of the tube body 100 (obscured by the filler tube 400 in fig. 4 a), the filler tube 400, and the inner single-lumen tube 410, such that the tube body 100, the filler tube 400, and the inner single-lumen tube 410 are in sequential contact.
E) At least a portion of the tube body, 2n wires between the tube body and the signal receiving plate, the filler tube, the signal receiving plate and the inner single-lumen tube are wrapped with the outer single-lumen tube, so that the signal receiving plate is between the inner single-lumen tube and the outer single-lumen tube. For example, as shown in fig. 5, an outer single lumen tube 500 encloses the ends of the tube body 100, 8 wires between the tube body 100 and the signal receiving plate 200, the filler tube 400, the signal receiving plate 200, and the inner single lumen tube 410.
F) The outer single lumen tube is fixed. This step can be performed in several steps:
f1 A heat shrinkage tube is sleeved outside the outer single-cavity tube and heated. The size of the heat shrinkage tube is selected to enable the inner diameter of the heat shrinkage tube to be larger than the outer diameters of the tube body and the outer single-cavity tube, and the inner diameter of the heat shrinkage tube after heat shrinkage reaches the target outer diameter of the multi-conduction elastic electrode, and the heat shrinkage temperature of the heat shrinkage tube is selected to be larger than the melting points of the materials of the tube body, the filler tube, the inner single-cavity tube and the outer single-cavity tube. For example, an outer single lumen tube is first placed over all of the components shown in FIG. 4a, then a heat shrink tube (not shown) is placed over and heated to a temperature greater than or equal to the heat shrink temperature. When heating, the local annular heating device is adopted, the heating device is not moved, so that the electrode body moves to respectively and slowly heat the integral structure sleeved with the heat shrinkage pipe, the heat shrinkage pipe is subjected to heat shrinkage, and materials of the pipe body, the filling pipe, the inner single-cavity pipe and the outer single-cavity pipe are melted, so that the pipe body, the filling pipe, the inner single-cavity pipe and the outer single-cavity pipe are integrated. In addition, according to actual needs, different heat shrinkage tubes can be replaced to perform heat shrinkage for a plurality of times until the target outer diameter of the multi-conduction elastic electrode is reached.
The heat-shrinkable tube is made of perfluoroethylene propylene copolymer. The heat shrinkable tube has an outer diameter of 1.6mm to 6.5mm, 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.
F2 Peeling the heat shrinkage tube and drawing out the mandrel. As shown in fig. 5, after the heat shrink tube is peeled off, the outer single lumen tube 500 is compatible with the tube body. Under the wrapping of the heat shrinkage tube and the local heating, the part of the outer single-cavity tube 500 sleeved on the tube body 100 before heating is fused with the tube body 100, and the diameter of the joint of the outer single-cavity tube 500 and the tube body 100 is similar to the original diameter of the tube body 100. Because the outer single lumen 500 is wrapped with different components at different locations, heat shrinking may result in different diameters in different areas of the outer single lumen 500 as shown in fig. 5. The filler tube 400, the inner single lumen tube 410 and the central lumen 110 of the tube body 100 are axially aligned and fused with the assistance of the mandrel, thereby obtaining the multi-conductive elastic electrode finished structure as shown in fig. 5.
The multi-conduction elastic electrode can be prepared by the method. The multi-conductive elastic electrode includes a tube body connected to an outer single-lumen tube, which is internally wrapped with a signal receiving plate, 2n wires, a filler tube 400, and an inner single-lumen tube 410. As shown in fig. 5, the multi-conductive elastic electrode includes a tube body 100, the tube body 100 is connected with an outer single-lumen tube 500, the signal receiving plate 200,8 wires 111, 112, 113, etc. are wrapped inside the outer single-lumen tube 500, a filler tube 400, and an inner single-lumen tube 410.
The tube body comprises 2n+1 tube cavities extending along the axial direction of the tube body, wherein one central tube cavity is positioned at the axial center of the tube body, the other 2n outer circumferences Guan Qiang are distributed around the central tube 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. 1 and 5, the tube 100 includes 1 central lumen and 8 outer circumferences Guan Qiang, such as a first outer circumference Guan Qiang 101, a second outer circumference Guan Qiang 102, a third outer circumference Guan Qiang 103, and so on. The 8 outer circumferences Guan Qiang are distributed around the central lumen (obscured by the filler tube 400 in fig. 5).
The upper surface of the signal receiving plate comprises a row of 2n bonding pads. For example, as shown in fig. 2b and fig. 5, 8 pads, such as a first pad 201, a second pad 202, a third pad 203, etc., are distributed on the upper surface of the signal receiving board 200.
The 2n wires are respectively inserted into the 2n outer circumferences Guan Qiang, and proximal ends of the 2n wires are respectively and alternately electrically connected to the 2n pads in a predetermined order. The 2n wires in the 2n outer circumferences Guan Qiang are numbered as n odd wires and n even wires according to the first circumferential direction and the second circumferential direction of the tube. The 2n pads are numbered n odd pads and n even pads in the order of the distal end to the proximal end of the signal receiving panel. The n odd wires are electrically connected to the n odd pads, respectively, such that the n-1 odd wires other than the 1 st wire extend along the first side of the signal receiving board. The n even wires are electrically connected to the n even pads, respectively, such that the n even wires extend along the second side of the signal receiving plate.
For example, as shown in fig. 1 and 5, the first wire 111 corresponds to the first outer periphery Guan Qiang 101, the second wire 112 corresponds to the second outer periphery Guan Qiang 102, and the third wire 113 corresponds to the third outer periphery Guan Qiang. The counterclockwise direction facing the cross section of the tube in fig. 1 is the first circumferential direction of the tube, and the odd-numbered wires, such as the third wire 113, are sequentially odd-numbered from the first wire 111 in the counterclockwise direction facing the cross section of the tube. The clockwise direction in fig. 1 facing the cross section of the tube is the second circumferential direction of the tube, and the even-numbered wires, such as the second wire 112, are sequentially from the first wire 111 in the clockwise direction in fig. 1 facing the cross section of the tube.
The 1 st wire may be connected to the 1 st pad from different directions. Preferably, the 1 st wire extends in the axial direction of the tube body 100 and is connected to the 1 st pad. Connecting the 1 st wire with the 1 st pad in this way leaves room for other wires to extend. For example, as shown in fig. 5, the first wire 111 extends in the axial direction of the tube body 100 and is electrically connected to the first pad 201. The odd-numbered wires except for the first wire 111 extend along the signal receiving panel perpendicular to the plane shown in fig. 5 on the side other than the drawing and are electrically connected to the corresponding odd-numbered pads. The even-numbered wires extend along one side of the signal receiving panel perpendicular to the plane shown in fig. 5 and are electrically connected to the corresponding even-numbered pads. For example, the third conductive line 113 extends along a side of the signal receiving panel perpendicular to the plane shown in fig. 5 outside the drawing and is electrically connected to the third pad 203. The second conductive line 112 extends along a side of the signal receiving panel perpendicular to the plane shown in fig. 3 (partially obscured by the signal receiving panel in fig. 3) and is electrically connected to the second pad 202. Meanwhile, as described above with reference to fig. 3, the connection ends of the wires and the pads corresponding thereto should extend through the entire length of the pads to maximize the electrical connection area between the wires and the pads. The method for electrically connecting the lead and the bonding pad ensures that the lead does not need to be wound on the signal receiving plate and the inner single-cavity tube before being electrically connected with the bonding pad, and the lead is not crossed or wound on the premise of increasing the contact surface of the lead and the corresponding bonding pad as far as possible. Therefore, the wire and pad connection method can reduce the risk of wire short circuit and the like and strengthen the strength and conductivity of wire connection.
The filler pipe is arranged between the pipe body and the inner single-cavity pipe, and the signal receiving plate is positioned on the outer surface of the inner single-cavity pipe. For example, as shown in fig. 5, the filler tube 400 is interposed between the tube body 100 and the inner single-lumen tube 410, and the signal receiving plate 200 is located on the outer surface of the inner single-lumen tube 410. Because the mandrel is used to penetrate the tube body 100, the filler tube 400 and the inner single-cavity tube 410 in the preparation process, the three components achieve the effect of aligning the axes after the mandrel is hot melted and extracted, and the three components are fixed into a whole through the hot melting. The filler pipe is polygonal in the preparation process, but the shape of the finished product of the filler pipe can be changed after the filler pipe is heat-shrunk under the support of a central mandrel. The filler tube 400 shown in fig. 5 is partially cylindrical, but it represents only one embodiment and should not be construed as limiting the technical solution that the invention is intended to protect.
The outer single-cavity tube wraps at least one part of the tube body, 2n wires between the tube body and the signal receiving plate, a filling tube, the signal receiving plate and the inner single-cavity tube, and the 2n wires encircle the filling tube. For example, as shown in fig. 5, an outer single-lumen tube 500 encloses the end portion of the tube body 100, 8 wires such as 111, 112 and 113 interposed between the tube body 100 and the signal receiving plate 200, a filler tube 400, the signal receiving plate 200 and an inner single-lumen tube 410. The 8 wires are routed around the filler tube 400 as shown in fig. 5 and extend to respective corresponding pads. Because the outer single-lumen tube 500 is integrally formed by integrally wrapping the heat shrinkage tube after wrapping the end of the tube body 100 in the preparation process, the junction between the tube body 100 and the rest of the outer single-lumen tube 500 is shown in the finished product shown in fig. 5 without obvious marks. That is, the portion of the outer single lumen tube 500 surrounding the end of the tube body 100 is thermally fused with the tube body 100 during the manufacturing process. The body 100, filler tube 400, inner single lumen tube 410 and outer single lumen tube 500 thus form an interconnected unitary structure. The tube body, the filling tube, the inner single-cavity tube and the outer single-cavity tube are made of materials selected from thermoplastic elastomer and thermoplastic polyurethane.
In addition, the multi-conductive elastic electrode may be provided with a flag ring that is closer to the proximal end of the multi-conductive elastic electrode with respect to the signal receiving plate, the outside of the flag ring (the side near the proximal end) may be reduced in length according to actual needs, but the inside of the flag ring (the side near the signal receiving plate) may not be shortened. The distal end of the multi-pass resilient electrode may be formed as a hemisphere to facilitate insertion and sealing of the electrode into the vertebral cavity. The outside of the multi-conduction elastic electrode can be provided with a positioning anchor, and the positioning anchor is used for fixing the positioning anchor in the inter-spinal ligament tissue by suture lines, so that the electrode can not float after being implanted.
The multi-conduction elastic electrode and the connecting method thereof have the following beneficial effects:
1) By arranging 2n wires in 2n peripheral lumens of the tube body simultaneously, the wires are sufficiently isolated from each other without risk of contact, so that signal interference is avoided; although the wires are insulated enameled wires and are not conductive when being contacted with each other, friction or compression in the use process of the electrode increases the risk of short circuit, the arrangement of the invention reduces the mutual friction of the wires in the use process, avoids the occurrence of short circuit and increases the use durability;
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 a human body to have good adaptability with the corresponding part of the human body;
3) The tube body, the filling tube, the inner single-cavity tube and the outer single-cavity tube of the multi-conduction elastic electrode form a whole, the strength of the product is improved, the outer tube cavity of the tube body tightly wraps the wire after heat shrinkage treatment, the wire is prevented from undesirably moving in the outer periphery Guan Qiang and being disconnected, the outer single-cavity tube, the filling tube and the inner single-cavity tube tightly wrap the wire and the signal receiving plate after heat shrinkage treatment, and the wire or the signal receiving plate is prevented from being disconnected due to unexpected movement;
4) The gaps among the heat-shrinkable tube body, the filler tube, the inner single-cavity tube and the outer single-cavity tube are filled with materials, so that the risk of failure of the whole electrode caused by leakage of in-vivo liquid (blood, tissue liquid and the like) and contact with an internal lead or a signal receiving plate after the electrode is implanted into a human body is effectively reduced;
5) The filler pipe with the polygonal cross section is used, so that the lead parts between the signal receiving plate and the pipe body can be uniformly distributed around the periphery of the filler pipe, and the inter-cross winding interference or accidental short circuit between leads in the preparation process and after the finished product can be avoided;
6) Because the 2n wires are numbered as n odd wires and n even wires according to the first circumferential direction and the second circumferential direction of the tube body, and are alternately and electrically connected to the 2n bonding pads, a fishbone-like structure is formed, and cross winding interference or accidental short circuit of adjacent wires is further avoided.
Example 1
Providing a 9-hole tube body, wherein one central lumen in 9 holes is positioned at the axial center of the 9-hole tube body, and the rest 8 peripheral Guan Qiang are uniformly distributed around the central lumen. One wire is located within each outer perimeter Guan Qiang. The number of the peripheral tube cavity at the uppermost end of the cross section of the tube body is first periphery Guan Qiang, and the wires in the peripheral tube cavity are first wires. The peripheral lumens facing in the counterclockwise direction of the tube cross section and their corresponding wires are numbered in order from 3 and the peripheral lumens facing in the clockwise direction of the tube cross section and their corresponding wires are numbered in order from 2 and the peripheral lumens facing in the clockwise direction of the tube cross section and their corresponding wires are numbered in order from 3 and the wires are numbered in order from 2. The outer diameter of the tube is 1.3mm, the inner diameter of each outer circumference Guan Qiang is 0.21mm, and the inner diameter of the central lumen is 0.51mm. The pipe body is made of thermoplastic polyurethane. The wire is made of MP35N material. Each wire had a diameter of 0.15mm.
A signal receiving board is also provided, and the upper surface of the signal receiving board comprises a row of 8 bonding pads and other parts. The 8 pads are numbered sequentially from 1 in the order of the distal end to the proximal end of the signal receiving panel.
The first wire extends along the axial direction of the tube body and is connected to the first pad. The 3 odd wires except the first wire are extended along one side of the signal receiving board and electrically connected to the odd pads having the same number as the first wire. The 4 even-numbered wires extend along the second side of the signal receiving panel and are electrically connected to the even-numbered pads of the same number. When in soldering connection, the near end of each wire is pressed with a platinum iridium alloy terminal with the thickness of 1mm, and the terminal and the wire together with the connecting end of the bonding pad with the same number corresponding to the terminal penetrate through the whole length of the bonding pad.
A filling pipe is arranged between the pipe body and the signal receiving plate, and an inner single-cavity pipe is arranged on the lower surface of the signal receiving plate, so that 8 wires encircle the filling pipe, and the axis position of the filling pipe is coaxially aligned with the axis position of the pipe body and the axis position of the inner single-cavity pipe. The cross section of the inserted filling pipe is square, and 2 wires are placed on each side surface of the square filling pipe, so that 8 wires are separated from each other. The filler pipe and the inner single-cavity pipe are made of medical thermoplastic polyurethane through stretching by using a special die in the heating process. The side length of the filler pipe is 1mm, and the inner diameter of the filler pipe is 0.6mm. The outer diameter of the inner single-cavity tube is 0.65mm, and the inner diameter is 0.55mm.
The mandrel is inserted through the central lumen, the filler tube and the inner single-lumen tube of the tube body, so that the tube body, the filler tube and the inner single-lumen tube are sequentially contacted. The mandrel is made of stainless steel materials, and polytetrafluoroethylene is coated on the surface of the mandrel.
The end part of the pipe body, which is close to the filling pipe, is wrapped by the outer single-cavity pipe, 8 wires between the pipe body and the signal receiving plate, the filling pipe, the signal receiving plate and the inner single-cavity pipe are used, so that the signal receiving plate is arranged between the inner single-cavity pipe and the outer single-cavity pipe, and the outer single-cavity pipe has the outer diameter of 2.3mm and the inner diameter of 1.7mm.
And (3) sleeving heat shrinkage tubes on the outer parts of the outer single-cavity tubes wholly or partially according to actual conditions, and then respectively heating the heat shrinkage tubes slowly to a temperature higher than the heat shrinkage temperature of the heat shrinkage tubes. The heat shrinkage tube is subjected to heat shrinkage, and materials of the tube body, the filling tube, the inner single-cavity tube and the outer single-cavity tube are melted, so that the outer single-cavity tube and the tube body are integrated. The corresponding part of the tube body is contacted with the filling tube in the outer single-cavity tube, and the filling tube and the inner single-cavity tube are correspondingly integrated. The heat-shrinkable tube is made of perfluoroethylene propylene copolymer. The external diameter of the heat-shrinkable tube is 2.8mm, and the wall thickness is 0.2mm.
And stripping the heat shrinkage tube after cooling the integral structure, and extracting the mandrel. The filling pipe, the inner single-cavity pipe and the central pipe cavity of the pipe body are aligned and fused with each other with the assistance of the mandrel, so that the multi-conduction elastic electrode finished product structure shown in fig. 5 is obtained.
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 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 construed based on the appended claims.