Introduction device comprising electroactive tips on a guide wire

Abstract

The invention relates to an introduction device comprising an electrically active tip on a guide wire. The catheter comprises: a hollow sheath; a guide wire extendable through the hollow sheath, wherein the guide wire comprises: a controllably bendable tip portion; a hollow tubular intermediate portion connected to the tip portion; a proximal electrical connection portion connected to the hollow tubular portion; at least a first electrical wire extending through the hollow tubular portion and connected at a first end thereof to a first circumferential conductor and at a second end thereof to a surface of the tip end; and a power supply connector, wherein the electrical connection portion is received in the power supply connector and a first terminal in the power supply connector contacts the first circumferential conductor.

Description

[0001] This application is a divisional application of the invention patent application with application number 201980004191.X (international application number PCT / US2019 / 029196), international application date of April 25, 2019, entitled "Introduction device including an electroactive terminal on a guidewire". Technical Field

[0002] This disclosure relates to the field of intraluminal guidewires and catheters, and more specifically, to the field of guidewires and catheters employing electroactive polymer tips. Background Technology

[0003] A guidewire is used to guide a second sheath, which is advanced along and over the guidewire, to a desired location within the body (e.g., the body of a mammal such as a human). In one application, the guidewire is introduced into a body lumen (i.e., a blood vessel) via an incision through the patient's skin and the wall of a cavity, and the introduced end or distal end of the guidewire is guided from there to a desired location within the lumen or to a desired location within a lumen branching from or into the lumen, wherein "the lumen" is the lumen into which the guidewire is introduced.

[0004] One problem with guidewire introduction systems is the limited ability to conform the distal end of the guidewire to the convoluted geometry of the lumen and to guide the distal end into intersecting lumens or into a branch lumen of the lumen where the distal end of the guidewire is located. To guide the distal end of the guidewire into a branch lumen, the distal end must be controllably moved from alignment with the lumen at the point of arrival at the branch lumen, allowing further movement of the guidewire into the body to allow the lead to enter and follow the branch lumen. In some cases, the location of the branch lumen is the destination of the distal end of the guidewire, intersecting the lumen where the distal end is located at a large angle (e.g., greater than 45 degrees, and in some cases greater than 90 degrees).

[0005] A method for controlling the orientation of a distal end of a guidewire includes incorporating an electroactive polymer, which is contacted by at least two electrical conductors located at at least two distinct positions on the electroactive polymer. By selectively biasing at least one electrical conductor, the orientation of the electroactive polymer portion of the guidewire can be controllably altered relative to the remainder of the guidewire. When the bias is removed, the segment of the guidewire containing the electroactive polymer returns to its free state. This is achieved by positioning the electroactive polymer segment of the guidewire at or as the distal end of the guidewire. The location of the distal end of the guidewire can be controllably positioned by the user of the guidewire.

[0006] Current guidewire systems suffer from several reliability and functional limitations due to their construction. The inherently limited physical range of motion of the distal end of the electroactive polymer segment restricts the ability to position the distal end of the guidewire at a high angle of incidence into an intersecting cavity with which the guidewire is currently being guided. Furthermore, because the conductors used to actuate the electroactive polymer segment must be connected to at least one of an electrical bias voltage or electrical ground to establish a bias on the electroactive polymer, hard-wiring the electroactive polymer portion of the guidewire to a voltage source and grounding limits user-controlled rotational actuation of the guidewire.

[0007] Furthermore, the guidewire geometry is very small, consisting of a rod or tube with a diameter of approximately 1 to 4 millimeters. The conductor that provides bias voltage to the electroactive polymer section must extend along or within the guidewire, and its connection to the surface of the electroactive polymer or to the electrodes contacting the surface of the electroactive polymer is small and fragile, resulting in frequent open circuits at the distal end of the guidewire that cannot be remotely controlled by the user. Summary of the Invention

[0008] This document provides, for example, a guidewire system incorporating an electroactive polymer portion, wherein the distal tip of the guidewire, positioned relative to the body of the guidewire, can be actuated by an angle greater than ninety degrees. WO 2017136729 A1 and U.S. Provisional Application No. 62 / 539,346 are incorporated herein by reference. Furthermore, the guidewire system is configured to rotate infinitely while maintaining a conductive path from a voltage source, electrical ground, or both, from a location outside the body of the guidewire to be introduced (e.g., on or near the proximal end of the guidewire) to the wall or side of the electroactive polymer. Additionally, improved connection paradigms between the electrical conductor and the electroactive polymer are provided.

[0009] On one hand, the catheter includes: a hollow sheath; a guidewire extending through the hollow sheath, wherein the guidewire includes: a controllably bendable terminal portion; a hollow tubular intermediate portion connected to the terminal portion; an electrical connection portion connected to the hollow tubular portion; at least a first wire extending through the hollow tubular portion and connected at a first end to a first circumferential conductor, and at a second end to a surface of the terminal end; and a power connector, wherein the electrical connection portion is received in the power connector, and a first terminal in the power connector contacts the first circumferential conductor.

[0010] In another embodiment, the conduit includes: a controllably bendable distal portion; a hollow tubular intermediate portion connected to the distal portion; a proximal electrical connection portion connected to the hollow tubular portion; at least one core extending through the hollow tubular portion and connected proximally to the proximal electrical connection portion and distally to a surface of the distal portion; and a power connector, wherein the electrical connection portion is received in the power connector, and a first terminal in the power connector contacts the proximal electrical connection portion. Attached Figure Description

[0011] To provide a detailed understanding of the foregoing features of this disclosure, a more specific description of the disclosure, which has been briefly summarized above, has been referenced to embodiments, some of which are illustrated in the accompanying drawings. However, it should be noted that the drawings illustrate exemplary embodiments only and should not be considered as limiting the scope of this disclosure, allowing for other equivalent embodiments.

[0012] Figure 1 It is a schematic plan view of the catheter, including the external sheath and internal guidewire, as well as the electrical connections; Figure 2 yes Figure 1 A schematic cross-sectional view of the conduit; Figure 3 yes Figure 1 and Figure 2 Isometric view of the controlled bending tip of the catheter; Figure 4 yes Figure 1 and Figure 2 Side view of the guidewire; Figure 5 yes Figure 4 A partial view of the guidewire, showing the interconnection between the conductive wire and its controllably bent tip; Figure 6 yes Figure 6 The end view of the guidewire before it is connected to the controllable bending tip; Figure 7 It is an enlarged isometric view of the connection between the controllable bending tip and the middle part of the guidewire; Figure 8 This is an enlarged isometric view of the electrical connection portion of the guidewire; Figure 9 It is used for Figure 4 A three-dimensional isometric view of the power connector that powers the controllable bending portion of the guide wire. Figure 10 yes Figure 9 A cross-sectional view of the power connector; Figure 11 This is a partially enlarged side view of an alternative configuration in which the power supply is connected to the controllable bending tip of the guide wire. Figure 12 This is an enlarged side view of the alternative electrical connection portion of the guidewire; Figure 13 This is an enlarged isometric view of the alternative electrical connection portion of the guidewire, where the terminals have been removed; Figure 14 This is an enlarged isometric view of the alternative electrical connection portion of the guidewire; Figure 15 It is an isometric view of the steps involved in connecting the guidewire to the guide sheath; Figure 16 It is an isometric view of the steps involved in connecting the guidewire to the guide sheath; Figure 17 This is an isometric view of the guide wire and conduit, including the power connector, ready for use. Figure 18 This is a schematic plan view of another aspect of the catheter, which includes an outer sheath, an inner guidewire, and electrical connections; Figure 19 yes Figure 18 A plan view of the core or conical core of the catheter; Figure 20 yes Figure 18 A cross-sectional view of the outer sheath of the catheter, showing the tapered core and other components arranged in the outer sheath; Figure 21 It extends from the cone core to Figure 18 Isometric view of the conductive leads of the electroactive polymer portion of the conduit. Figure 22 yes Figure 18 A plan view of the outer sheath of the catheter; Figure 23 yes Figure 22 A schematic diagram of the outer sheath, showing the relative angular difference between some adjacent slots; Figure 24A and Figure 24B yes Figure 18 An enlarged end view of the catheter, showing the lead and... Figure 20 The connection of the electroactive polymer portion; Figure 25 yes Figure 18 A plan view of the proximal end of the outer sheath of the catheter, the inner guidewire, and the electrical connection components; Figure 26 yes Figure 18 A plan view of the terminal arrangement of the control box for the conduit; Figure 27 yes Figure 18 A plan view of the conical core of the catheter; Figure 28 It is the connection of the coil to Figure 27 An isometric view of one end of the guidewire; Figure 29 It is the connection of the coil to Figure 27 An isometric view of the second end of the guidewire; Figure 30 This is a view of the distal end of the outer sheath, the internal guidewire, and the electrical connection assembly, showing the coils integrated into the interior of the outer sheath; Figure 31 It is a view of the distal end of the outer sheath and the leads extending from it, wherein the electroactive polymer portion is adhered to the slots of the outer sheath; Figure 32 This is a view of the distal end of the outer sheath and the leads extending from it, wherein the electroactive polymer portion adheres to... Figure 31 The groove in the outer sheath, and the first side of the electroactive polymer portion has an insulating material between it and the outer sheath; Figure 33 This is a view of the distal end of the outer sheath and the leads extending from it, wherein the electroactive polymer portion adheres to... Figure 31 In the slot of the outer sheath, the lead wire is electrically connected to the first side of the electroactive polymer portion, and the outer sheath is electrically connected to the second side of the electroactive polymer portion; Figure 34 This is a view of the distal end of the outer sheath, where leads have been electrically connected to a first side of the electroactive polymer portion, and the outer sheath has been electrically connected to a second side of the electroactive polymer portion, and these portions are covered with sealant. Figure 35 This is a partial sectional view of another aspect of the guidewire; Figure 36 yes Figure 35 A schematic diagram illustrating the steps involved in assembling the guidewire; Figure 37 yes Figure 35 A schematic diagram of another step in the assembly of the guidewire; Figure 38 yes Figure 35 A schematic diagram of another step in the assembly of the guidewire; Figure 39 yes Figure 35 A partial plan view of the assembled guidewire; Figure 40 It is a plan view of a portion of the guidewire's connection section before the electrical connection section is constructed on it; Figure 41 The first part of the electrical connection is assembled onto the guide wire to electrically connect with... Figure 35 A plan view of the connection portion of a part of the guidewire after the first side of the electroactive polymer portion of the guidewire contacts the first conductor; Figure 42The second part of the electrical connection is assembled onto the guide wire to electrically connect with... Figure 35 A plan view of the connection portion of a part of the guidewire after the second side of the electroactive polymer portion of the guidewire contacts the second conductor; Figure 43 The connection detector of the electrical connection part is assembled in Figure 35 Plan view of the guidewire connection section after the guidewire is in place; Figure 44 yes Figure 35 A partial isometric view of the distal portion of a partially assembled guidewire, showing the electroactive polymer portion connected to the outer sheath of the guidewire; Figure 45 yes Figure 35 Another partial isometric view of the distal portion of the partially assembled guidewire, showing the space between the inner wall of the sheath and the filled electroactive polymer portion, which further covers the adjacent end of the outer sheath. Figure 46 yes Figure 35 Another partial isometric view of the distal portion of the partially assembled guidewire, showing the conductive adhesive covering the adjacent sides of the electrical connector and the electroactive polymer portion. Figure 47 yes Figure 35 Another partial isometric view of the distal portion of the guidewire; Figure 48 This is a schematic side view of a portion of the electroactive polymer, showing transmissive markers on its two opposing side surfaces; and Figure 49 yes Figure 48 A schematic side view of a portion of the electroactive polymer, showing a transmissive marker at its distal end.

[0013] For ease of understanding, the same reference numerals are used where possible to denote common elements in the figures. It is contemplated that elements and features of one embodiment can be advantageously incorporated into other embodiments without further description. Detailed Implementation

[0014] First refer to Figure 1 and 2 , Figure 1 The guidewire system 10 is shown, which includes Figure 2 The guidewire 12, a sheath 20 surrounding most of the length of the guidewire 12, and a power connector 21 are fully shown. The power connector 21 is disposable and located at the proximal end of the guidewire 12. The guidewire 12 consists of a hollow tubular shaft 14 forming the middle portion of the guidewire 12 and an electrical connection portion 16 forming the proximal end of the guidewire 12. Figure 2 and Figure 16 It comprises a guidewire 12 and a controllable bending portion 18 forming the distal end of the guidewire 12. Here, the guidewire 12 is shown extending along a generally straight path, and the bendable portion 18 is shown in its free state (i.e., without applied bias voltage), having a bend or fold 22. The bend 22 in Figure 2 The portion is shown as a continuous curve with a radius centered at point 24, and can be formed by stamping a controlled bending portion onto a circular or curved top rod to adapt the controlled bending portion to its bending surface. Alternatively, the bend 22 forming the pre-bent portion of the controlled bending portion 18 can be formed only along a small length of the controlled bending portion 18 (in other words, only along a portion of its length), such that a generally straight portion of the controlled bending portion 18 extends from one or both sides of the bend. Other bends are also conceived, such as compound bends comprising two or more bending angles along the length of the controlled bending portion 18.

[0015] like Figure 3 As shown, on one hand, the controllable bending portion 18 is constructed from an electroactive polymer portion 34 sandwiched between electrodes 36 and 38, with electrodes 36 and 38 directly formed on or bonded to opposite sides of the electroactive polymer portion 34.

[0016] By forming the controllable bending portion 18 to include a deviation from a straight path in its free state (e.g., by providing a bend or curve therein in its free state or in a non-energized state), the orientation of the tangent 32 at the end 30 of the controllable bending portion 18 can be determined from the position of the controllable bending portion 18 in relation to... Figure 1The tangent 33 at the connection point of the hollow tubular shaft 14 shown is arranged at an angle θ of approximately 0 to approximately 90 degrees. It is conceivable herein that the tangent 32 at the tip 30 of the controllable bending portion 18 can be arranged at an angle greater than 90 degrees from the tangent of the connection point of the controllable bending portion 18 with the hollow tubular shaft 14 or from the additional intermediate member therebetween. For example, if the tip 30 of the controllable bending portion is oriented at a 45-degree angle to the end of the hollow tubular shaft 14 in its free state, the tip 30 of the controllable bending portion 18 can be bent by an angle of + / - 45 degrees by the electro-actuation of its electro-actuable polymer. Therefore, the tip 30 can be oriented from 0 to 90 degrees relative to the connection point of the controllable bending portion 18 with the hollow tubular shaft 14 under operator control, i.e., the angle θ ranges from approximately 0 to approximately 90 degrees. If the controllable bending portion 18 can be controllably actuated between + / -60 degrees under the same pre-bending conditions, the angle θ can be controllably established between -15 and +105 degrees. By selecting the pre-bending bending angle and the bendability of the controllable bending portion, the operator or user of the guidewire system 10 can controllably select the desired orientation of the distal end 30 relative to the hollow tubular axis 14 to allow the distal end 30 of the guidewire 12 to be positioned to establish its location within the tortuous luminal anatomy, including into the branched lumen.

[0017] In one aspect, the controllable bending portion 18 is configured as an electroactive polymer substrate in the form of a strip, with opposing electrical conductors on opposite sides of the strip. For example, as Figure 3 As shown, the strip 40 of the electroactive polymer portion 34 includes opposing main surfaces 44, 46 and two opposing secondary surfaces 48, wherein each secondary surface 48 spans between the two main surfaces 44, 46. Although the main surfaces 44, 46 are shown as having rectangular outlines, other outlines can be conceived in the plan view, such as triangles, truncated triangular polygons or other polygons, or curved side shapes. Each main surface 46, 48 is provided with a carbon layer 42 and a metal electrode 50 covering the carbon layer 42, which is pressed and attached to the electroactive polymer portion 34 by pressing against it. By making the carbon layer 42 on one main surface 44 or 46 thicker than the carbon layer 42 on the other main surface 44 or 46, the inherently different stresses in the carbon layer 42 cause the controllable bending portion 18 to inherently form a continuous bend along its length (e.g., ...). Figure 1 and Figure 2(As shown in the diagram). The relative thickness of the carbon layer 42 determines the total angular difference (angle θ) between the tangent 32 of the distal end 54 and the tangent 33 of the proximal end 56 of the controllable bending portion 18. By maintaining a constant thickness of each carbon layer 42 of varying thickness along the length from the proximal end 56 to the distal end 54 or the terminal end 30 of the controllable bending portion 18, a continuous curve centered at point 24 is inherently formed due to the constant difference in inherent stress between the two carbon layers 42 along the entire length from the proximal end 56 to the distal end 54 of the controllable bending portion 18. Each metal electrode 50 is disposed on the carbon layer 42 to form a highly conductive path, thereby distributing electricity along the length and width of each principal surface 44, 46, thus maintaining a uniform potential on each electrode 50. For example, the electrodes 50 may be formed from sputtered or vapor-deposited layers of gold, silver, palladium, or platinum, wherein each electrode has the same or nearly the same thickness. The carbon layer 42 may include carbon-based materials, such as carbon derived from carbides, carbon nanotubes, graphene, composites of carbon derived from carbides and polymer electrolyte components, and composites of carbon nanotubes and polymer electrolyte components.

[0018] Alternatively, the electrode 50 itself may be formed of a shape memory material (e.g., a nickel-titanium (NiTi) alloy or a NiTi-based alloy), for example, formed on the controlled bending portion 18 by sputtering, vapor deposition, or other deposition or adhesion methods. In this regard, for example, a thin layer of NiTi alloy formed by co-sponging a nickel and titanium target in a processing chamber is deposited on the main surfaces 44, 46 of the controlled bending portion 18. Subsequently, one or more desired bends, such as continuous curvature or sharp kink-type bends, are applied to the controlled bending portion. The controlled bending portion 18 is then cooled to a temperature sufficient to induce an internal phase change in the alloy (transforming the internal phase structure from austenite to martensite), and the controlled bending portion 18 is returned to a straight or near-straight configuration (e.g., Figure 3 As shown in the diagram, this allows it to be inserted into a delivery sheath or other sheath and to be heated back to the temperature at which the internal phase changes back to the austenitic phase while the controlled bending portion 18 is still within the sheath 20. Shape memory material can also be deposited onto the pre-bent controlled bending portion 18.

[0019] Shape memory alloys are also used here as electrode materials. When the distal end of the sheath is inserted into a body cavity or other body region, once the controllable bending portion is pushed outward from the distal end of the sheath, it will return to its bent shape before cooling and bending back to a flat or straight profile if no bias voltage or potential is applied to the electroactive polymer. Therefore, the profile of the controllable bending portion 18 can be altered by applying a bias voltage or potential to the electroactive polymer.

[0020] Now for reference Figure 4 and Figure 5This illustrates an example of a connection where the + and - terminals of a power source, such as a capacitor or battery, are connected to the opposite electrode 50. Here, the guidewire system 10 includes a guidewire 12, a sheath 20 surrounding most of the length of the guidewire 12, and a sheath located at... Figure 1 The power connector 21 is located at the proximal end of the guidewire system shown. (As shown) Figure 4 As shown, the guidewire 12 is configured to include a generally first tubular portion 60, a controllable bending portion 18, and a compliance member 62 disposed between a distal end 64 of the first tubular portion 60 and a proximal end 66 of the controllable bending portion 18, interconnecting the distal end 64 and the proximal end 66. Here, the compliance member 62 is configured as a helical spring having a winding 68 spaced along its length at approximately equal intervals between the first tubular portion 60 and the controllable bending portion 18. The compliance member 62 provides compliance support that can follow the tortuous anatomical structure of the body cavity when the guidewire assembly 10 is guided into the lumen. Additionally, for connecting the opposing electrode 50 to a power source, a first wire 70 ( Figure 5 ) is connected to one of the electrodes 50 and to a first terminal 72 located on the outer surface of the generally tubular portion 60 and extends between them, and a second wire 71 ( Figure 5 A second terminal 73 is connected to another of the electrodes 50 and located on the outer surface of the general tubular portion 60 and extends between them, the second terminal 73 being closer to the proximal end 84 of the general tubular portion 60 than the first terminal 72.

[0021] refer to Figure 5 and Figure 6 Each wire 70, 71 includes an outer insulating coating 86 and an inner conductive core 88, the inner conductive core 88 terminating at a generally flat trapezoidal portion 90 forming a terminal. Each of the wires 70, 71 is connected to one of the electrodes 50 on a controllable bending portion using a conductive adhesive 92 (e.g., gold paste), thereby providing a current connection between the wire 70, 71 and the terminal 90. Figure 7 and Figure 8As shown, once terminal 90 is attached to electrode 50 on either side of the electroactive polymer in the controllable bending portion 18, the electroactive polymer is further coated with polydimethylsiloxane (PDMS) and parylene. The opposing ends of wires 70, 71 pass through compliant member 62 and are connected to one of terminals 80, 82, for example, by attaching each conductive core 88 of wires 70, 72 to the corresponding terminal 80, 82 using conductive adhesive, and are received in the power connector 21. This can be achieved by providing holes through terminals 80, 82 and allowing the conductive core 88 to pass inward from the tubular sheath of terminals 80, 82 through the holes, or by means of other mechanisms. Terminals 80, 82 are circumferentially attached to the tubular portion 60 and spaced apart from each other in the longitudinal direction L of the tubular portion 60. Figure 4 As shown, the proximal end of the controllable bending portion 18 is adhered to the distal end of the compliant member 62 using an adhesive 94 (e.g., polyimide or UV curing agent), which also covers the conductive adhesive 92.

[0022] Now for reference Figure 9 and Figure 10 This illustrates an example of the connection between the power connector 21 and the controllable bending portion 18 of the guide wire 12. Here, the power connector 21 includes an outer, generally right-angled annular housing 100, in which an insert 96 is received. The insert 96 is constructed with a tapered inlet bore 102 leading to a conduit 104 having a slot opening 108 along its length. A cantilever portion 98 extends above and is spaced apart from the slot opening 108. The maximum outer diameter of the tapered inlet bore 102 is slightly larger than the inner diameter of the housing 100, and the sidewall 110 of the cantilever portion 98 is curved to mimic the curvature of the inner diameter of the housing 100, thereby allowing the insert 96 to be pressed into the housing 100 and centered within it. On the side surface of the cantilever portion 98 facing the slot opening 108, spaced apart and electrically insulated first terminals 112 and second terminals 114 are provided. The conduit 104 is sized to allow the proximal end of the guidewire 12 to enter therein and to allow the housing 100 and the guidewire 12 to rotate relative to each other. Here, power is connected via cable 106 to a DC power source, such as the output of a user-controllable variable-output AC-to-DC converter connected to an AC power source. Cable 106 includes two wires 116, 118 extending therein, and each of the wires 116, 118 is connected to one of the connection terminals 112, 114 to allow selective biasing of the electrodes 50 of the controllable bending portion 18.

[0023] The proximal end of the guide wire 12 is inserted into the housing 100 via a tapered inlet hole 102, thereby grounding the guide wire 12 against the base 120 of the conduit 104. The first terminal 112 and the second terminal 114 are constructed as strips of a conductive material such as copper, and each terminal includes a protrusion covering the slot opening 108. The first connecting terminal 112 and the second connecting terminal 114 are spaced apart from each other by a distance 124, such that the distance between the centers of their protrusions is the same as the distance between the centers of the first terminal 80 and the second terminal 82. This allows the proximal end of the guide wire 12 to move slightly outward and inward toward the housing 100 without disconnecting the circuit between the power supply and the electrode 50 on the electroactive polymer portion 34 of the controllable bending portion 18. Similarly, the circumferential extension of the terminals around the guide wire 12 and the rotational orientation of the guide wire 12 do not affect the circuitry passing through the housing 100. The guide wire 12 can be secured to the housing 100, for example, by press fitting into the conduit 104 or by applying an adhesive between the base 120 of the conduit 104 and the guide wire 12. Alternatively, the guide wire 12 does not need to be secured to the housing 100, and the guide wire 12 can rotate within the housing 100 without disrupting the contact between the connecting terminals 112, 114 and the terminals 80, 82.

[0024] Now for reference Figure 11 and Figure 12 An alternative configuration for the electrical connection example to the electrode 50 of the controllable bending portion 18 is shown. Here, the wire 71 extends from the second terminal 82 at the middle portion 14 of the guide wire 12, and extends through the second terminal 82 and through the middle portions 14, 16 of the guide wire 12 (see...). Figure 2 ), and with Figure 7 and Figure 8 One of the electrodes 50 is connected to the controllable bending portion 18 in the same manner as shown. In comparison, with... Figure 7 and 8 Compared to the length of the wire 70 in the middle section, the length of the wire 70 is shortened, and the wire 70 is connected only between the first terminal 80 at the distal end of the electrical connection portion 16 and the other of the electrodes 50 of the controllable bending portion 18. Here, the intermediate portions 14 and 16 are both constructed of a conductive material (such as other biocompatible conductive portions of stainless steel). A portion 126 of the intermediate portion 14 serves as a second terminal. The end 128 of the wire 70 can be dog-legged so that it is biased against the interior of the intermediate portions 14 and 16 to allow sliding electrical contact between them.

[0025] Now for reference Figure 13 and Figure 14Examples of wires 70, 72 being attached to terminals 80, 82 are shown, each example being identical but spaced apart along the length of the guide wire 12. Here, the proximal end of the tubular shaft 14 of the guide wire 12 includes an electrical insulation adapter 130 comprising: a small-diameter portion 134 extending therein; and a large-diameter portion 132, wherein an annular shoulder 140 formed between the small-diameter portion 134 and the large-diameter portion 134 is spaced from the end of the guide wire 12. Wires 72, including insulation thereon, extend between the outer walls of the small-diameter portion 134 into a gap 138 formed between the annular end wall 136 and the annular shoulder 140 of the guide wire 12. A portion of the insulation on the portion of wire 72 extending into the gap 138 is stripped or removed to expose its conductive core. Terminals 82 are configured as cylindrical conductors and are located in the gap 138. The annular end wall 136 includes an insulating coating thereon, and a separate insulating washer is arranged between the annular end wall of the conductive wire and the conductive terminal 80. The large-diameter portion 132 is pressed or pushed along the direction of the wire 12 to secure the terminal, thereby allowing the large-diameter portion 132 to contact the conductive core of the wire 72 along its inner circumference to complete the connection of the wire 70 to the terminal (e.g., ...). Figure 14 (As shown in the diagram). Although connection examples have been described for a single terminal, it is demonstrated that the hollow adapter 130 has a hole extending through its large-diameter and small-diameter portions, through which the second wire 72 is pulled and inserted into the hole into the second small-diameter portion of the second adapter, with the second terminal located on the wire, and the second terminal 82 electrically connected to the conductive core of the second wire 72.

[0026] Now for reference Figures 15 to 17 The diagram illustrates the components of a guidewire system 10 with a guide tube 150. Initially, with the guidewire 12 removed from the power connector 21, the guide tube is introduced onto the guidewire from the end of the middle portion 16 of the guidewire and pushed in direction 152 to cover the guidewire 12. The guide tube 150 includes a manipulator 156 at its proximal end. Figure 16 As shown, the guide tube 150 and guide wire 12 are combined such that the intermediate portion 16 extends outward from the guide tube 150 at the end of the manipulator 156 of the guide tube 150. The intermediate portion 16 is then inserted into the hole of the power connector 21.

[0027] In this respect of introducing the device, such as Figure 18As shown, based on the additional construction of the guidewire and electroactive polymer, the introduction device 200 includes: a control and power module 218, which includes a power supply and control box 220; an electrical lead portion 222 having a flexible tubular protective sleeve 234 extending from the control and power module 220 and terminating in the junction box 228; and a guidewire 216 including a hollow sheath 240 formed from an outer sheath 260 formed as a thiopanthate tube 260 having a second end 264 receptacleable in the junction box 228 and a first end 262 at a distal end, the thiopanthate tube 260 selectively extending from the junction box 228 (see [link to documentation]). Figure 20 ).like Figure 20 and Figure 21 As shown, the hysteresis tube 260 includes a core formed by a tapered core 250, and an electroactive polymer portion 270 extends from its first end 262. In the configuration of this introduction device 200, a coil 280 is positioned at a certain location within the hysteresis tube 260 on a portion of the tapered core 250. A connection is made between the electroactive polymer portion 270 and the power supply to the control and power module 218 via the conductive tapered core 250 and the hysteresis tube 260, both of which are connected to their respective conductors in the electrical lead portion 222. The coil 280 provides a flexible support that, together with a suitable insulating coating, electrically insulates the hysteresis tube 260 and the tapered core 250 from each other in the region immediately adjacent to the electroactive polymer portion 270, where significant bending of the hysteresis tube 260 and the guide wire 250 can be expected. For example, the tapered core 250 is electrically connected to a first side 272 of the electroactive polymer portion 270, and the opposite second side 274 of the electroactive polymer portion 270 is electrically connected to the hyaluronic acid tube 260. For ease of introduction, the hyaluronic acid tube 260 may include a polymer sheath extending therefrom its first end 262 to its second end 264.

[0028] refer to Figure 19The diagram shows a portion of the conical core 250 along its length being removed. The conical core 250 includes: a main body portion 252 extending from its first end 254; and a conical portion 258 extending from its second end 256 in the direction of the first end 254. Here, approximately 15% of the length of the conical core 250 is formed by the conical portion 258, which extends continuously from the main body portion 252 at the junction point “J”, wherein the minimum outer diameter d of the conical portion 258 appears at its second end 256, and this minimum outer diameter d is approximately 30% of the outer diameter D of the main body portion 258 along its length. For example, in the case where the total length “L” of the conical core 250 is, for example, 200 cm (or two meters), the conical portion 258 extends a length “I” of 30 cm from the distal end 256 of the junction box 228 at its second end to the junction point J of the conical core 250. Furthermore, when the diameter D of the main body portion 252 is, for example, 0.20 mm, the tapered portion 258 tapers continuously (i.e. linearly) from the main body portion 252 at the junction J towards its distal end (second end 256), with the outer diameter decreasing from D to d along the length "I," such that the outer diameter "d" at the distal end 256 of the guidewire is approximately 0.064 mm. Although the taper of the tapered portion 258 is described here as a linear decrease in diameter along the length of the tapered portion 258, it is equally conceivable that the diameter decreases non-linearly along the length "I" from the main body portion 252 to the distal end 256. The taper of the tapered portion 258 of the tapered core 250 near its distal end 256 reduces the stiffness of the tapered core 250 at this point and also creates a clearance space between the tapered portion 258 and the inner diameter of the hysteresis tube 260 for receiving the conductive coil 280 therebetween.

[0029] refer to Figure 20 The image shows a sub-diameter tube 260, which includes: a tapered core 250 extending within and along the inner circumference 284 of the sub-diameter tube 260; and a coil 280 extending around a tapered portion 258 of the tapered core 250 adjacent to its distal end 256 and also located within the inner circumference 284 of the sub-diameter tube 260. Both the sub-diameter tube 260 and the tapered core 250 provide independent current paths to support the selective placement or maintenance of voltage signals or currents on thin electrodes, such as gold or silver layers, on opposing first and second sides 274 of the electroactive polymer portion 270. Here, conductive leads 300 (… Figure 21 It extends from the outer circumferential surface of the tapered portion 258 to connect to the first side 272 of the electroactive polymer portion 270. (As shown) Figure 21As shown, the conductive lead 300 includes: a generally flat first portion 302; a dog-leg portion 304 extending from and away from the distal second end 256 of the tapered portion 258 of the tapered core 250; a lead portion 306 extending from the dog-leg portion 304; and a generally flat second portion 310. The flat first portion 302 is in electrical contact with the tapered portion 258 of the guide wire 250 (e.g., by spot welding), and the second flat portion 310 is connected to a first side 272 of the electroactive polymer member 270, for example by adhering them to each other using a first conductive layer 384.

[0030] The 260-volt sodium thiosulfate tube here is like... Figure 22 The thin-walled conductive sleeve shown, such as a biocompatible stainless steel tube, has a second tube end 264 that can be received in a junction box 228 and a first tube end 262 configured with a receiving slot 312, the slot height or width 314 of which is slightly greater than the thickness 316 of the electroactive polymer portion 270. Figure 20 By configuring the width 314 of the receiving slot 312 to be slightly larger than the thickness 316 of the electroactive polymer portion 270, the first side 272 of the electroactive polymer portion 270 can be spaced apart from and thus electrically insulated from the inner wall of the receiving slot 312. The sodium hypochlorite tube 260 also includes a plurality of transverse slots 318 cut inward from its opposite circumferential sides (see...). Figure 22 and Figure 23 This leaves a pair of opposing webs 320, which extend circumferentially between some pairs of slots in the paired slots. A transverse slot 318 is formed only in a portion of the submersible tube 260, adjacent to the second end 256 of the submersible tube and slightly spaced from the base of the receiving slot 312, and after assembly, this portion extends along the length of the submersible tube 260 by a distance slightly greater than the length of the tapered portion 258 of the tapered core 250 arranged in the submersible tube 260. The transverse slots 318 are progressive in terms of the circumferential span of the webs 320 and the spacing between the transverse slots 318. Here, the slots are laser-cut into the originally continuous tube of material including the submersible tube 260, but could be provided in other ways, such as physical cutting or milling, or pattern etching or other mechanisms. Considering, as Figure 24A and Figure 24BThe submersible tube 260 shown is in an unbent or untwisted state and has a centerline 322. Each pair of transverse slots 318 extends through the wall 324 of the submersible tube 260 at an angle perpendicular to (90 degrees to) the centerline 322. The depth of the cut, starting from the center of forming the circumferential span of each transverse slot 318, defines the circumferential span of the transverse slot 318 at the outer wall 324 of the submersible tube 260 and the remaining circumferential span of the web 320, which extends circumferentially between each end of each pair of directly opposite transverse slots 318.

[0031] Figure 22 A set of transverse slots 318 is depicted, wherein the slot frequency varies along the length of the centerline 322 of the hyaluronic acid tube 260 relative to the distance from its first end 262 (where the electroactive polymer portion 270 is received in the receiving slot 312) along the length of the hyaluronic acid tube 260. Here, there are four sets of slots 318a-d extending through the hyaluronic acid tube 260, each set of slots having different spacing, different slot depths, or a combination of both. The deepest transverse slots 318 are located in the first region of slots 318a adjacent to the first end 262 of the hyaluronic acid tube 260 and separated from the receiving slot 312, and these transverse slots 318 are also most closely spaced from each other along the length of the centerline 322 of the hyaluronic acid tube 260. The transverse slots 318 in the second set of slots 318 are arranged adjacent to the first set of slots 318a, such that the first set of slots 318a is located between the first end 262 of the submersible tube 260 and the second set of slots 318b. The transverse slots 318 in the second set of slots 318b are staggered along the length of the centerline 322 of the submersible tube 260, such that the transverse slots 318 adjacent to each other in the circumferential direction of the submersible tube 260 are not formed on opposite sides of the submersible tube 260 at a position of the same length as the centerline 322 of the submersible tube 260. Instead, they are linearly staggered in the direction of the centerline 322 of the submersible tube 260 at the same distance as the adjacent slots 318 in the first set of slots 318a in the length of the centerline 322 of the submersible tube 260. In the third set of slots 318c, the transverse slots 318 are again circumferentially opposite each other, and the spacing between them along the length of the centerline 322 of the submersible tube 260 is greater than the spacing between the first set of slots 318a or the second set of slots 318b, with the second set of slots 318b positioned between the first set of slots 318a and the third set of slots 318c. The fourth set of slots 318d extends through the submersible tube and is positioned further away from the first end 262 than the third set of slots 318c, and they comprise opposing pairs of transverse slots 318, each pair of transverse slots 318 having a gradually increasing spacing between them along the length of the centerline 322 of the submersible tube 260 in a direction away from the second end 256 of the submersible tube 260.

[0032] Furthermore, in some slot groups, their angular distribution relative to each other changes along the length of the submersible tube. For example, Figure 23 The angles of the sidewalls of two pairs of transverse slots 318, 318' directly adjacent to each other along the length of the submersible tube 260 are shown. Here, the bottom wall (solid line) of slot 318 extends at an angle A relative to the reference direction D1, and the bottom wall (dashed line) of the second set of slots 318' extends at an angle B relative to the reference direction A, where angle B is smaller than angle A. In the first set of slots 318a, the second set of slots 318b, and the third set of slots 318c, each adjacent transverse slot 318 is cut at a different angle relative to the reference direction, and in each set of slots 318a-c, the angular difference from one transverse slot 318 to the next transverse slot 318 along the length of the submersible tube 260 is the same. This causes the orientation of the transverse slot 318 to precess along the length of the submersible tube, and consequently, the position of the pivot formed by the web 320 also precesses circumferentially around the submersible tube 260 along its length, thus allowing for greater flexibility of the submersible tube 260. In this submersible tube, in the first to third sets of slots, the angular difference from transverse slot 318 to transverse slot 318' along the length of the submersible tube is the same and approximately 10 to 11.25 degrees. In each case, the direction of the angular change from transverse slot 318 to transverse slot 318' is the same. In the fourth set of slots 318d, each adjacent pair of transverse slots 318 is offset from the adjacent pair of transverse slots 318 by approximately 90 degrees. Additionally, with the spacing of the transverse slots 318 of the first set of slots 318a being 0.0013 inches, the first transverse slot 318 of the first set of slots 318a is spaced 0.200 mm from the base of slot 312 along the length of the tube. Slot 312 extends inwardly from the first end 262 of the subwoofer 260 by 0.400 mm, and the thickness of slot 312 is approximately 0.120 mm. The subwoofer 260 is constructed, for example, of stainless steel and has an outer circumference of approximately 0.0140 inches and an inner diameter of approximately 0.0100 inches.

[0033] like Figure 20 , Figure 22 and Figure 24A and Figure 24B As shown, for clarity, Figure 24A and Figure 24BA portion of the first set of slots 318a has been removed, and the hyaluronic acid tube 260 includes a continuous outer surface portion 326 extending between the base of slot 312 and the transverse slot 318 closest to the base of slot 312. A second end 256 of the tapered core 250 is located inside the hyaluronic acid tube 260 along its length, and a conductive lead 300 extends from this second end 256 to the first side 272 of the electroactive polymer portion 270. Slot 312 includes opposing first sidewalls 328 and second sidewalls 330, and the hyaluronic acid tube 260 is electrically connected to the first sidewall 328 by means of a conductive adhesive 332 or by other mechanism, and electrically insulated from the second sidewall 330 using a layer of insulating paste or adhesive 334. Therefore, as... Figure 22 As shown, no short circuit is formed between the first sidewall 328 and the second sidewall 330 of the receiving slot 312 in the first end 262 of the submersible tube 260.

[0034] To connect the tapered core 250 and the hysteresis tube 260 to different power sources, such as different output terminals of a single DC power supply, a first end 254 of the tapered core 250 extends outward from a second end 264 of the hysteresis tube 260. Each of the tapered core 250 and the hysteresis tube 260 can be received in an opening 340 of the junction box 228. (Reference) Figure 25 The first dielectric sheath 342, the hollow connecting strip 344, the second dielectric sheath 346, and the dummy electrode 348 extend from the second end 264 of the hysteresis tube 260 in this order. A portion of the body portion 252 of the tapered core 250 extends through the first dielectric sheath 342, the hollow connecting strip 344, the second dielectric sheath 346, and the dummy electrode 348. The tapered core 250 is electrically connected to the hollow connecting strip 344 by means of an internal electrical connection, but not electrically connected to any of the first dielectric sheath 342, the second dielectric sheath 346, or the dummy electrode 348. The junction box includes a first terminal 350, a second terminal 352, a third terminal 354, and a fourth terminal 356, each of which is spaced apart from each other along an opening 340 in the junction box 228, and each of which includes a portion extending into the opening of the junction box 228. The distance between the portions of the first terminal 350 and the second terminal 352 extending inward from the opening 340 is at least as large as the length of the first dielectric sleeve 342; the distance between the portions of the second terminal 352 and the third terminal 354 extending inward from the opening 340 is at least as large as the length of the second dielectric sleeve 346; and the distance between the portions of the third terminal 354 and the fourth terminal 356 extending inward from the opening is the difference portion 348. The first end 254 of the tapered core 250 extends outward from the dummy electrode 348, and sets the interval between the end of the dummy electrode 348 and the base of the opening 340.

[0035] By inserting the virtual electrode 348 through which the conical core 250 extends, the second dielectric sleeve 346, the connecting strip 344, the first dielectric sleeve 342, and the portion of the hyaluronic acid tube 260 adjacent to its end 264 into the opening 240 and pushing it in until the end 254 of the conical core 250 engages the base of the opening 240, the first terminal 350 will make electrical contact with the outside of the hyaluronic acid tube 260, the second terminal 353 will make electrical contact with the hollow connecting strip 344, and thus the second terminal 353 will make electrical contact with the conical core 250 inside the hollow connecting strip 344, and the third terminal 354 and the fourth terminal 356 will both make electrical contact with the virtual electrode 348. By introducing current from one terminal of a power source (not shown) into one of the third terminals 354 and 356, and connecting the other of the third and fourth terminals 356 to another terminal of the power source, current flows through the dummy electrode 348, thereby indicating that the dummy electrode, along with the connected hysteresis tube 250, guide wire 260, and hollow connecting strip 344, are correctly positioned within the junction box 228 to allow voltage to be selectively applied to the first side 272 and the second side 274 of the electroactive polymer portion, respectively, via the tapered core 250 and the hysteresis tube 260. Four wires 360 to 366 extend from the control and power module 220 through the electrical lead portion 222 into the junction box 228. The first wire 360 ​​is connected to the first terminal 350, and the second wire 362 is connected to the second terminal 352. For example, a positive voltage can be supplied via the first wire 360, and a negative voltage or ground voltage can be supplied via the second wire 362, causing the electroactive polymer portion to bend in a first direction. Reversing these voltages will reverse the direction of bending. As previously described herein, the associated voltages supplied to the first side 272 and the second side 274 of the electroactive polymer portion 270 control the direction and extent of bending of the electroactive polymer portion in terms of both polarity (+ or -) and amplitude. The third wire 364 and the fourth wire 366 are connected to the third terminal 354 and the fourth terminal 356, respectively, and their opposite ends are connected to a power source (not shown) different from the power sources connected to the first wire 360 ​​and the second wire 362, such as the opposite poles (+, -) of a battery. When the third terminal 354 and the fourth terminal 356 simultaneously contact the dummy electrode 348, this completes the circuitry indicating that the junction box 228 is properly connected to the system, which can be indicated by illuminating an LED or other signal element in the circuitry.

[0036] Now for reference Figures 27 to 34 This illustrates a portion of the manufacturing sequence of the introduction device 200. To prevent a short circuit between the conical core 250 and the hyaluronic acid tube 260, the outer surface of the conical core is covered with an insulating coating. For example, parylene can be deposited on the conical core 250 by vapor deposition using an adhesion promoter to form an insulating coating 370 thereon. Figure 27Alternatively, the conical core 250 can be immersed in electrically insulating epoxy resin to form an insulating coating thereon, or other methods can be used to form the insulating coating. Then, as... Figure 28 and Figure 29 As shown, the coil 280 is slid on the portion of the tapered portion 258 directly adjacent to the second end 256 of the tapered core 250, and secured thereto with a non-conductive adhesive 372 (e.g., non-conductive acrylic adhesive) arranged between the inner diameter of the coil 260 and the outer circumference of the tapered portion 258, and on the coil 260. Then, as... Figure 21 As shown, the generally flat first portion 302 of the lead 300 is connected to the outer surface at the second end of the tapered core 250, which is achieved by partially removing the insulating coating 370 at the connection and then soldering or otherwise bonding them together.

[0037] Then, the first end 254 of the conical core 250, to which the lead wire 300 and coil 280 are attached, is fed into the first end 262 of the thiovanni 260 until the first end 254 of the conical core 250 extends outward from the second end 264 of the thiovanni 260, and the lead wire portion 306 extending from the dogleg portion 306 and the generally flattened second portion 310 of the lead wire extend outward from the first end 262 of the thiovanni 260. Figure 30 As shown, a non-conductive adhesive is used to form a non-conductive bonding layer 376 between the non-conductive adhesive 372 and at least the inner surface of the hyaluronic acid tube 260 adjacent to the first end 262 of the hyaluronic acid tube 260. This fixes the position of the tapered core 250 and the hyaluronic acid tube 260 relative to each other.

[0038] The electroactive polymer portion 270 is now fixed to the sodium hypotube 260. A coating of adhesive 378 is applied to the base 380 of the receiving slot 312, and the fixed end of the electroactive polymer portion 270 is inserted into the receiving slot 312 and contacts the adhesive 378, such that a gap exists between the portion of the electroactive polymer located in the receiving slot 312 and the opposing first sidewall 328 and second sidewall 330 of the receiving slot 312 (e.g., ...). Figure 31 (As shown in the diagram). The gap between the second side of the slot 312 and the electroactive polymer portion 270 is filled with an insulating filler 382, ​​wherein the filler 382 extends above the first end of the hysteresis tube 260, and the filler also covers the lead portion 306 of the lead 300, but exposes the generally flat second portion 310 (as shown in the diagram). Figure 32(As shown in the diagram). The exposed second flat portion 310 is then covered by a first conductive layer 384, which physically and electrically connects the flat portion 310 to the first side 272 of the electroactive polymer portion 270. A second conductive layer 386 fills the space between the first sidewall 328 of the receiving slot 312 and the second side 274 of the electroactive polymer portion 270, and extends outward along the second side 274 from the thiourea tube 260 to electrically connect the thiourea tube 260 to the second side 274 of the electroactive polymer portion (as shown in the diagram). Figure 33 (As shown in the diagram). The first conductive layer 384 and the second conductive layer 386 are constructed, for example, of conductive paste, conductive epoxy resin or another conductive adhesive material.

[0039] Next, the portion of the sodium hypotube 260 immediately adjacent to its first end 262, along with the first conductive layer 384, the second conductive layer 386, and the portion immediately adjacent to the electroactive polymer portion 270, is covered in a thin layer of sealant (e.g., silicone resin), then an adhesive (e.g., parylene) is applied, followed by a second sealant (e.g., silicone resin). Figure 34 Preferably, parylene is vapor-coated onto the relevant portion of the introduction device, while silicone resin can be applied to the relevant portion of the introduction device by dip coating.

[0040] To use the introduction device, the first dielectric sleeve 342, the hollow connecting strip 344, the second dielectric sleeve 346, and the dummy electrode 346 are slid onto the portion of the conical core 250 extending from the second end 264 of the sodium hypo tube 260 and secured thereto with adhesive. The first dielectric sleeve 342, the second dielectric sleeve 346, and the dummy electrode 346 are secured to the conical core 250 using a non-conductive adhesive, and the hollow connecting strip 344 and the conical core 250 are secured together using a conductive adhesive or press-fit connection to ensure electrical connection between them. The control box 220 is configured with buttons, levers, or other tactile elements that allow the operator to selectively apply a voltage of desired polarity and magnitude to the first side 272 and the second side 274 of the electroactive polymer portion by moving or pressing the tactile element, thereby achieving its relative... Figure 2 The effect shown by the electroactive polymer portion of the bendable portion 18.

[0041] Now for reference Figures 35 to 49 This illustrates another configuration of the guidewire device, which utilizes a control and power module 218, a core 250 configured to extend within a hysteresis tube 260, an electroactive polymer portion 270, and regarding... Figures 18 to 24A and Figure 24BOther components of the device shown and described herein, wherein the electrical connection between the power source and the opposing first side 272 and second side 274 of the electroactive polymer portion is provided by a dedicated conductor surrounded by an insulator, so that the tapered core 250 and the hysteresis tube 260 do not need to be electrically insulated from each other.

[0042] like Figure 35 As shown, a portion of the hyaluronic acid tube 260 adjacent to its first end 262 is shown in cross-section to reveal its internal details. A first conductor 400 and a second conductor 402 extend within the hyaluronic acid tube 260. The first conductor 400 has a conductive core and surrounding insulator, and the second conductor 402 has a conductive core and surrounding insulator. The conductive portion of the first conductor 400 is electrically connected to a first side 272 of the electroactive polymer portion 270, and the conductive portion of the second conductor 274 is connected to a second side 274 of the electroactive polymer portion 270. Here, the conductive portion of the conductor is constructed of a base metal (e.g., stainless steel) and covered with a thin layer of gold, but other conductive material coverings (e.g., silver, copper, cobalt, rhenium, or ruthenium) can be used as conductors.

[0043] The first conductor 400 and the second conductor 402 are electrically connected, respectively, to a first side 272 and a second side 274 of the electroactive polymer portion 270 using conductive adhesive. Each conductor passes through the interior of the hysteresis tube 260 from its connection with the electroactive polymer portion and extends outward from a second end 264 of the hysteresis tube 260, where it connects to a conductor of an electrical connection portion 404, which can be received in a junction box 228 of the control and power module 218 (as previously described herein).

[0044] Using conductors 400 and 402 as current-carrying paths to apply the desired voltage to the first side 272 and the second side 274 of the electroactive polymer portion 270 makes the assembly of the catheter or guidewire, consisting of the tapered core 250, the hypo tube 260, the electroactive polymer portion 270, the conductors 400 and 402, and the connecting portion, relatively simple. For assembling the catheter or guidewire, a connecting plate 410 with the same diameter as the body portion 252 of the tapered core 240 is used. Figure 36 The heat shrink tubing 414 extends through the hyaluronic acid tube 260, such that its end 412 extends outward from the first end of the hyaluronic acid tube 260. Conductors 400 and 402 are placed on opposite sides of the conical core adjacent to its first end 254, and heat shrink tubing 414 extends thereon, such that the first end 254 of the conical core 250 extends inward from the first open end 416 of the heat shrink tubing 414, and the end 412 of the bonding plate 410 extends inward from the second open end 418 of the heat shrink tubing 414. The heat shrink tubing 414 is then heated to shrink radially, physically securing the conductors 400 and 402, the bonding plate 410, and the first end 254 of the conical core together (e.g., Figure 37(As shown in the diagram). Prior to this operation, the portions of conductors 400, 402 extending between the heat-shrink tubing 414 and the tapered core can be flattened to form a flat region similar to the flat portion 302 of the conductive lead 300, or terminals (not shown) can be connected to each of conductors 400, 402. These operations can be performed once the conductors have been pulled through the hysteresis tube 260 and exposed outward from the second end 264 of the hysteresis tube 260.

[0045] Then, pull the end 412 of the connecting plate 410 in the direction from the first end 262 of the sodium hypochlorite tube toward the second end (as shown in the image). Figure 38 As shown in the diagram, heat shrink tubing 410 is positioned on the outside of the second end 264 of the hyaluronic acid tube 260. Then, an adhesive such as acrylic resin is injected into the opposing first end 262 and second end 264 of the hyaluronic acid tube 260 to form a first adhesive strip 420 extending around the outside of the conical core 250 and conductors 400, 402 and the inside of the hyaluronic acid tube 260 just inward from the second end 264, and a second adhesive strip 422 extending around the outside of the conical core 250 and conductors 400, 402 and the inside of the hyaluronic acid tube 260 just inward from the first end 262, the conductors 400, 402 extending through the first adhesive strip 420 and along the sidewall of the receiving slot 312.

[0046] Then, an insulating tube is used to cover the portion of the conical core 250 extending outward from the second end 264 of the thiocyanate tube 260. This insulating tube is heated above its solidus temperature and allowed to reflow and adhere to the outer surface of the conical core 250, where the conductor is disposable. The electrical connection portion 404 is then formed by removing the insulating covering at the ends 406 and 408 of the conductors 400 and 402. Figure 40Next, the first thin-walled tubular insulator 424 is slid across the exposed portion of the conical core 250. A conductive paste, such as gold paste, is disposed inside the first thin-walled conductor 426. When the first thin-walled conductor 426 slides across the exposed portion of the conical core 250 to abut the first thin-walled tubular insulator 424, the exposed conductive portion of the first conductor 400 is connected to the first thin-walled conductor 426 via the paste. Then, the second thin-walled tubular insulator 428 slides across the exposed portion of the conical core 250 to abut the first thin-walled conductor 426. A conductive paste, such as gold paste, is disposed inside the second thin-walled conductor 430. When the second thin-walled conductor 430 slides across the exposed portion of the conical core 250 to abut the second thin-walled tubular insulator 428, the exposed conductive portion of the second conductor 402 is connected to the second thin-walled conductor 430 via the paste. Then, the third thin-walled tubular insulator 432 slides on the exposed portion of the conical core 250, and the thin-walled detection connector 434, which functions identically to the dummy electrode 348, slides on the exposed portion of the conical core 250 to abut the third thin-walled tubular insulator 432 and is adhered thereto with adhesive. This completes the assembly of the electrical connection portion 404. The connection portion 404 is configured to be received in and operate with the junction box 228 previously described herein, wherein when properly inserted into the opening in the junction box 228, the first thin-walled conductor 426 contacts the first terminal 350, the second thin-walled conductor 430 contacts the second terminal 352, and the thin-walled detection connector 434 contacts the third terminal 354 and the fourth terminal 356, each of which is spaced apart from each other along the opening 340 in the junction box 228, and each of which includes a portion extending into the opening of the junction box 228. Therefore, the voltage applied to the first terminal 350 is applied to the first side 272 of the electroactive polymer portion 270, the voltage applied to the second terminal 352 is applied to the second side 274 of the electroactive polymer portion 270, and the connection detection circuit is completed when the thin-walled detection connector 434 contacts the third terminal 354 and the fourth terminal 356.

[0047] By inserting one end of the electroactive polymer portion 270 into the receiving slot 312, the electroactive polymer portion 270 is secured in the receiving slot 312, wherein the first sidewall 328 and the second sidewall 330, as well as the base of the receiving slot 312, are covered with an adhesive such as an acrylic adhesive to contact the adhesive, which forms a fixing layer 440 after curing. When the end of the electroactive polymer portion 270 is inserted into the receiving slot 312, its flat terminals 436, 438 ( Figure 44 The first side 272 and the second side 274 of the electroactive polymer portion 270 are located opposite each other. Next, portions of the first side 272 and the second side 274 of the electroactive polymer portion 270 are connected to the inner wall of the sodium hypochlorite tube 260. Figure 44The open areas 442 and 444 between them are filled with adhesive to form plugs 446 and 448. Figure 45 The plugs can be formed, for example, of an acrylic adhesive, which, upon curing, forms plugs 446 and 448. Next, the flat terminal portions 436 and 438 are electrically connected and secured to a first side 272 and a second side 274 of the electroactive polymer portion, respectively, using conductive blocks 456 and 452. The conductive blocks may include, for example, cured conductive epoxy resin or, for example, gold-filled epoxy resin. Figure 46 Then, the exposed portion of the first end 262 of the sodium hypotube 260, the adjacent portions of the first side 272 and the second side 274 of the electroactive polymer portion 270 are covered with a layer of sealant 454, 456, the sealants 454, 456 being composed of, for example, silicone resin adhesive. Next, as... Figure 48 As shown, radiopaque marker plates 460 and 462 are attached to opposing first sides 272 and second sides 274 of the electroactive polymer portion 270. The marker plates 460 and 462 are, for example, made of a platinum-iridium alloy and are arranged slightly inward toward the distal end 464 of the electroactive polymer portion 270 on the opposing first sides 272 and second sides 274. Each marker plate 460 and 462 is arranged such that it is less than one millimeter from the distal end 464 of the electroactive polymer portion 270, and each has a length less than one millimeter. For example, the length is 0.5 millimeters. Alternatively, in addition to or instead of the marker plates 462 and 464, the distal end 464 of the electroactive polymer portion 272 may be coated with a radiopaque layer 466, such as a platinum-iridium alloy or a gold layer. Subsequently, the adjacent portions of the electroactive polymer portion 272, sealants 454 and 456, and the hypotube 260 are immersed in a silicone dispersion to coat the silicone dispersion. Then, the hypotube 260, along with the immersed electroactive polymer and the sealants 452 and 454 extending therefrom, are vapor-phase coated with a coating such as parylene. The vapor-phase coated electroactive polymer portion 272, sealants 454 and 456, and the adjacent portions of the hypotube 460 are immersed in a silicone dispersion to coat the silicone dispersion. The hypotube 260, the immersed electroactive polymer, and sealants 452 and 454 are then again coated with a vapor-phase coating such as parylene. Finally, the parylene coating is covered with a hydrophilic coating to complete the assembly of the conduit or guidewire portion of the system.

Claims

1. A catheter comprising: Hollow sheath; A guidewire, which extends through the hollow sheath, comprises: The distal portion that can be bent in a controlled manner; A hollow tubular middle portion connected to the distal portion; A proximal electrical connection portion connected to the hollow tubular intermediate portion, the proximal electrical connection portion further comprising at least a first circumferential conductor having a first end and a second circumferential conductor having a second end, wherein the first end and the second end are spaced apart from each other in the axial direction of the proximal electrical connection portion and each has a circumferential conductive surface extending in the axial direction. At least one core extending through the hollow tubular intermediate portion and having a proximal end and a distal end, the proximal end being connected to the proximal electrical connection portion, and the distal end being connected to the surface of the distal end of the distal portion; and A power connector comprising: a cantilever portion including a first terminal extending from the cantilever portion, wherein a proximal electrical connection portion is received in the power connector and the first terminal contacts a first circumferential conductor of the proximal electrical connection portion; and a tapered inlet aperture extending from the cantilever portion away from the first terminal. The controllable bending distal portion includes: An electroactive polymer core having opposing first and second surfaces; A first carbon layer and a second carbon layer, wherein the first carbon layer is formed on the first surface and the second carbon layer is formed on the second surface.

2. The catheter according to claim 1, further comprising: A first conductive wire extends through the hollow tubular middle portion and connects to the first circumferential conductor at its proximal end, and connects to the surface of the distal end other than the surface connected to the core at its distal end. and The second conductive wire extends accordingly through the hollow tubular middle portion and connects to the second circumferential conductor at its proximal end, and connects to the surface of the distal end other than the surface connected to the core and the first conductive wire. The cantilever portion of the power connector further includes a second terminal extending from the cantilever portion, wherein the first terminal and the second terminal are electrically insulated from each other.

3. The catheter according to claim 1, wherein, The distal end of the guidewire is pre-bent, and the first electrode and the second electrode are formed of a shape memory material that remembers the shape of the pre-bent.

4. The catheter according to claim 1, wherein, The controllable bending distal portion includes: Electroactive polymer core, the electroactive polymer core having The first and second sides are opposite; and A first carbon layer and a second carbon layer, wherein the first carbon layer is formed on the first surface and the second carbon layer is formed on the second surface.

5. The catheter according to claim 4, wherein, The thicknesses of the first carbon layer and the second carbon layer are different.

6. The catheter according to claim 4, further comprising a first metal layer on the first carbon layer and a second metal layer on the second carbon layer.

7. The catheter according to claim 1, wherein, The hollow tubular middle section is the first conductor, while the core is the second conductor.

8. The catheter according to claim 1, wherein, The hollow tubular central portion also includes patterned laser cuts around its outer surface.

9. The catheter according to claim 1, wherein, The core also includes a coil tube surrounding at least a portion of its distal end.

10. The catheter according to claim 1, wherein, The core also includes a tapered portion at its distal end.

11. The catheter according to claim 1, wherein, The power connector further includes a first connection terminal and a second connection terminal. The first connection terminal includes a first protrusion, and the second connection terminal includes a second protrusion. The distance between the first protrusion and the second protrusion is the same as the distance between the first circumferential conductor and the second circumferential conductor in the axial direction of the proximal electrical connection portion.

12. A guidewire comprising: The distal portion that can be bent in a controlled manner; A hollow tubular middle portion connected to the distal portion; A proximal electrical connection portion connected to the hollow tubular portion, the proximal electrical connection portion further comprising at least a first circumferential conductor having a first end and a second circumferential conductor having a second end, wherein the first end and the second end are spaced apart from each other in the axial direction of the proximal electrical connection portion and each has a circumferential conductive surface extending in the axial direction. At least one core extending through the hollow tubular portion and including a proximal end and a distal end, the proximal end being connected to the proximal electrical connection portion and the distal end being connected to the surface of the distal end of the distal portion, wherein the controllably bent distal portion has a pre-bent shape when no electrical bias is applied to the core; as well as A power connector comprising: a first terminal, wherein an electrical connection portion is received within the power connector and the first terminal contacts one of a first circumferential conductor and a second circumferential conductor of the proximal electrical connection portion; and a tapered inlet aperture extending from the cantilever portion away from the first terminal. The controllable bending distal portion includes: An electroactive polymer core having opposing first and second surfaces; A first carbon layer and a second carbon layer, wherein the first carbon layer is formed on the first surface and the second carbon layer is formed on the second surface.

13. The guidewire according to claim 12, wherein, The hollow tubular middle section is the first conductor, while the core is the second conductor.

14. The guidewire according to claim 12, wherein, The hollow tubular central portion also includes patterned laser cuts around its outer surface.

15. The guidewire according to claim 12, wherein, The core also includes a coil tube surrounding at least a portion of its distal end.

16. The guidewire according to claim 12, wherein, The core also includes a tapered portion at its distal end.

17. The guidewire according to claim 12, wherein, The power connector further includes a first connection terminal and a second connection terminal. The first connection terminal includes a first protrusion, and the second connection terminal includes a second protrusion. The distance between the first protrusion and the second protrusion is the same as the distance between the first circumferential conductor and the second circumferential conductor in the axial direction of the proximal electrical connection portion.

18. The guidewire according to claim 17, further comprising: A first conductive wire extends through the hollow tubular portion and is connected to the first circumferential conductor at its proximal end, and to the surface of the distal end other than the surface connected to the core at its distal end. and The second conductive wire extends through the hollow tubular portion and connects to the second circumferential conductor at its proximal end, and connects to the surface of the distal end other than the surface connected to the core and the first conductive wire.

19. The guidewire of claim 12, wherein the distal end of the guidewire is pre-bent.

20. The guidewire according to claim 12, wherein, The controllable bending distal portion includes: An electroactive polymer core having opposing first and second surfaces; A first carbon layer and a second carbon layer, wherein the first carbon layer is formed on the first surface and the second carbon layer is formed on the second surface.

21. The guidewire according to claim 20, wherein, The first carbon layer and the second carbon layer have different thicknesses.

22. The guidewire of claim 20, further comprising a first metal layer on the first carbon layer and a second metal layer on the second carbon layer.

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