Introduction device that includes an electroactive tip in the guide wire

Abstract

The present invention provides guidewires and catheters that utilize electroactive polymer tip sections. [Solution] The catheter comprises a hollow sheath and a guidewire extending within the hollow sheath, the guidewire comprising a tip portion that can be controlledly bent, a hollow tubular intermediate portion connected to the tip portion, an electrical connection portion connected to the hollow tubular portion, at least one 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 the surface of the tip portion, and a power supply connector, the electrical connection portion being received by the power supply connector and the first terminal of the power supply connector in contact with the first circumferential conductor.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 664,753, filed Apr. 30, 2018, entitled "INTRODUCTION DEVICE INCLUDING AN ELECTROACTIVE TIP ON A GUIDEWIRE", which is incorporated herein by reference in its entirety.

[0002] This disclosure relates to the field of intravascular guidewires and catheters, and more particularly, to guidewires and catheters using electroactive polymer tip ends.

Background Art

[0003] A guidewire is used to guide an auxiliary sheath that is supplied to cover along the guidewire to a desired position within a body, such as within the body of a mammal, such as a human body. In one application, the guidewire is introduced into the lumen of the body, i.e., into a blood vessel, by incising the patient's skin and the lumen wall, from which the introduced end of the guidewire, i.e., the distal end, is guided to a desired position in the lumen or in a lumen that merges with or branches from the lumen into which the guidewire is introduced.

[0004] One problem associated with guidewire delivery systems is the limited ability to guide the distal end of the guidewire along a meandering lumen shape, and to guide the distal end into a crossing or branching lumen relative to the lumen where the distal end of the guidewire is located. To guide the distal end of the guidewire into a branching lumen, the distal end of the guidewire must be moved in a controllable manner from a state of alignment with the lumen where it reaches the branching point to a state of alignment where the guidewire enters and follows the branching lumen by moving the guidewire further into the body. In some cases, the branching lumen, where the target destination of the distal end of the guidewire is located, intersects the lumen where the distal end exists at a large angle, for example, greater than 45 degrees, and in some cases greater than 90 degrees.

[0005] One method for controlling the orientation of the distal end of a guidewire involves incorporating an electroactive polymer in which at least two conductors positioned at at least two different locations within the electroactive polymer are in contact. By selectively biasing at least one of the conductors, the orientation of the electroactive polymer portion of the guidewire can be controlled relative to the rest of the guidewire. When the bias is removed, the section of the guidewire containing the electroactive polymer returns to its free state. By positioning the electroactive polymer section of the guidewire at or as the distal end of the guidewire, the position of the distal tip of the guidewire can be controlled by the guidewire user.

[0006] These guidewire systems suffer from several limitations in reliability and functionality due to their construction. The range of motion of the distal end of the electroactive polymer section is inherently limited by its physical range, which limits its ability to position the distal end of the guidewire in a lumen where it intersects the lumen it is currently guiding at a large coupling angle. Furthermore, since the conductor used to actuate the electroactive polymer section must be connected to at least one of an electrical bias voltage or electrical ground to establish a bias across the electroactive polymer, the electroactive polymer portion of the guidewire is wired to a voltage source and ground, consequently limiting the user's rotational operation of the guidewire.

[0007] Furthermore, the guidewire is extremely small, consisting of a rod or tube with a diameter of approximately 1-4 mm. The conductor providing bias across the electroactive polymer section must extend along or within the guidewire, and the connections between the electroactive polymer surface and the conductor, or between the electrode in contact with the electroactive polymer surface and the conductor, are small and fragile, leading to frequent open-circuit conditions where the distal end of the guidewire cannot be remotely manipulated by the user. [Overview of the Initiative]

[0008] This specification provides a guidewire system incorporating an electroactive polymer section, wherein the positioning range of the distal end of the guidewire relative to the body of the guidewire is operable over angles greater than 90 degrees, such as the angles disclosed by reference in WO2017136729A1 and U.S. Provisional Patent Application No. 62 / 539,346. Furthermore, the guidewire system is configured to rotate indefinitely from an external position outside the body into which the guidewire will be introduced, such as the position of the proximal end of the guidewire or an adjacent position, while maintaining a conductive path between a voltage source, an electrical ground, or both, and the wall or side of the electroactive polymer. Furthermore, a typical example of an improved connection between a conductor and an electroactive polymer is provided.

[0009] In one embodiment, the catheter comprises a hollow sheath and a guidewire extending through the hollow sheath, the guidewire comprising a tip portion that can be controlledly bent, a hollow tubular intermediate portion connected to the tip portion, an electrical connection portion connected to the hollow tubular portion, at least one 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 the surface of the tip portion, and a power supply connector, the electrical connection portion being received by the power supply connector and the first terminal of the power supply connector in contact with the first circumferential conductor.

[0010] In another embodiment, the catheter comprises a controllably bendable portion, a hollow tubular intermediate portion connected to a 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 at its proximal end to the proximal electrical connection portion and at its distal end to the surface of the tip end of the distal portion, and a power supply connector, the electrical connection portion being received by the power supply connector and a first terminal of the power supply connector in contact with the proximal electrical connection portion.

[0011] To allow for a more detailed understanding of the features of this disclosure described above, a more specific description of the disclosure, briefly summarized above, can be provided with reference to embodiments, some of which are shown in the accompanying drawings. However, it should be noted that the accompanying drawings show only exemplary embodiments and are therefore not intended to limit the scope, and other equally valid embodiments may be permitted. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic plan view of the catheter, including the outer sheath, inner guidewire, and electrical connections. [Figure 2] Figure 1 is a schematic cross-sectional view of the catheter. [Figure 3]Figures 1 and 2 are isometric views of the controllably bendable tip of the catheter. [Figure 4] Figures 1 and 2 are side views of the guide wire. [Figure 5] This is a partial view of the guide wire in Figure 4, showing the interconnection between the conductive wire and a controllably bendable tip. [Figure 6] Figure 6 shows the end of the wire before it is connected to a tip end that can be bent in a controllable manner. [Figure 7] This is an enlarged isometric view of the connection point between the controllably bendable tip and the middle section of the guide wire. [Figure 8] This is an enlarged isometric view of the electrical connection portion of the guide wire. [Figure 9] Figure 4 is an isometric view of a power supply connector for supplying power to a controllably bendable portion of a guide wire. [Figure 10] Figure 9 is a cross-sectional view of the power supply connector. [Figure 11] This is an enlarged side view showing, in partial cross-section, an alternative configuration in which a power supply is connected to the controllably bendable tip of a guide wire. [Figure 12] This is an enlarged side view of an alternative electrical connection section for the guide wire. [Figure 13] This is an enlarged isometric view of the alternative electrical connection portion of the guide wire with the terminals removed. [Figure 14] This is an enlarged isometric view of an alternative electrical connection point for a guide wire. [Figure 15] This is an isometric view showing the steps involved in connecting the guide wire into the guide sheath. [Figure 16] This is an isometric view showing the steps involved in connecting the guide wire into the guide sheath. [Figure 17] This is an isometric view of a usable guidewire and catheter, including the power supply connector. [Figure 18] This is a schematic plan view of a further embodiment of a catheter, including an outer sheath, an inner guidewire, and an electrical connection. [Figure 19] It is a plan view of the core or tapered core of the catheter of FIG. 18. [Figure 20] It is a cross-sectional view of the outer sheath of the catheter of FIG. 18, showing the tapered core and other components disposed therein. [Figure 21] It is an isometric view of a conductive lead extending from the tapered core to the electroactive polymer portion of the catheter of FIG. 18. [Figure 22] It is a plan view of the outer sheath of the catheter of FIG. 18. [Figure 23] It is a schematic view of the outer sheath of FIG. 22, showing the relative angle between specific adjacent slots therein. [Figure 24A] It is an enlarged end view of the catheter of FIG. 18, showing the connection between the lead of FIG. 20 and the electroactive polymer portion. [Figure 24B] It is an enlarged end view of the catheter of FIG. 18, showing the connection between the lead of FIG. 20 and the electroactive polymer portion. [Figure 25] It is a plan view of the proximal end portions of the outer sheath and the inner guide wire of the catheter of FIG. 18, as well as the electrical connection components. [Figure 26] It is a plan view showing the terminal arrangement of the control box of the catheter of FIG. 18. [Figure 27] It is a plan view of the tapered core of the catheter of FIG. 18. [Figure 28] It is an isometric view showing one end of the coil adhered to the guide wire of FIG. 27. [Figure 29] It is an isometric view showing the second end of the coil adhered to the guide wire of FIG. 27. [Figure 30] It is a view of the distal end portions of the outer sheath and the inner guide wire, as well as the electrical connection components, showing the coil adhered inside the outer sheath. [Figure 31] It is a view of the distal end of the outer sheath and the lead extending therefrom, with the electroactive polymer portion adhered within the slot of the outer sheath. [Figure 32]Figure 31 shows the distal end of the outer sheath and the lead extending therefrom, with an insulating material between the first side of the electroactive polymer portion and the outer sheath, in a state where the electroactive polymer portion is bonded within the slot of the outer sheath. [Figure 33] Figure 31 shows the distal end of the outer sheath and the lead extending therefrom, with the electroactive polymer portion bonded to the slot of the outer sheath, the lead electrically connected to the first side of the electroactive polymer portion, and the outer sheath electrically connected to the second side of the electroactive polymer portion. [Figure 34] This is a diagram of the distal end of the outer sheath, where the lead is electrically connected to the first side of the electroactive polymer portion, the outer sheath is electrically connected to the second side of the electroactive polymer portion, and these portions are covered with capsule material. [Figure 35] This is a plan view showing a further aspect of the guide wire in a partial cross-section. [Figure 36] Figure 35 is a schematic diagram showing the steps involved in assembling the guide wire. [Figure 37] Figure 35 is a schematic diagram showing further steps in assembling the guide wire. [Figure 38] Figure 35 is a schematic diagram showing further steps in assembling the guide wire. [Figure 39] Figure 35 is a partially assembled plan view of the guide wire. [Figure 40] This is a plan view showing a portion of the connection area of ​​a guide wire before the electrical connection part is formed into the guide wire. [Figure 41] Figure 35 is a plan view showing a portion of the guidewire connection after the first portion of the electrical connection has been assembled to the guidewire in order to electrically connect it to the first conductor that is in contact with the first side of the electroactive polymer portion of the guidewire. [Figure 42]This is a plan view showing a portion of the guidewire connection after the second portion of the electrical connection has been assembled to the guidewire in order to electrically connect it to the second conductor that is in contact with the second side of the electroactive polymer portion of the guidewire shown in Figure 35. [Figure 43] Figure 35 is a plan view showing the connection portion of the guide wire after the connection detector of the electrical connection portion has been assembled to the guide wire. [Figure 44] Figure 35 is a partial isometric view of the distal end portion of a partially assembled guidewire, showing the electroactive polymer portion connected to the outer sheath of the guidewire. [Figure 45] Figure 35 is a further partial isometric view showing the distal end portion of a partially assembled guidewire, with the space between the inner wall of the sheath and the electroactive polymer portion filled, and the adjacent end of the outer sheath further covered by this filling. [Figure 46] Figure 35 is a further partial isometric view of the distal end portion of the partially assembled guidewire, showing the conductive adhesive covering the adjacent sides of the electrical connector and electroactive polymer portion. [Figure 47] Figure 35 is a further isometric view of the distal end portion of the guidewire. [Figure 48] This is a schematic side view showing a portion of the electroactive polymer section, with a radiopaque marker on the opposite side. [Figure 49] This is a schematic side view showing a portion of the electroactive polymer portion of Figure 48, which has a radiopaque marker at its tip. [Modes for carrying out the invention]

[0013] For the sake of clarity, the same reference numerals are used to indicate the same elements common to multiple drawings, where possible. Elements and features of one embodiment may be incorporated into other embodiments for the benefit of purposes without further mention.

[0014] Referring first to Figures 1 and 2, Figure 1 shows a guidewire system 10, which includes a guidewire 12, the entirety of which is shown in Figure 2, a sheath 20 enclosing most of the length of the guidewire 12, and a power supply connector 21 disposed to cover the proximal end of the guidewire 12. The guidewire 12 consists of a hollow tubular shaft 14 forming its middle portion, an electrical connection portion 16 (Figures 2 and 16) forming its proximal end, and a controllably bendable portion 18 forming the distal end of the guidewire 12. Here, the guidewire 12 is shown extending in a generally straight path, and the bendable portion 18 in a free state, i.e., without electrical bias applied throughout, is shown having a curved portion or bend 22 therein. The bend 22 is shown in Figure 2 as a continuous curved portion with a radius centered on a point 24, and may be formed by pressing the controllably bendable portion onto a round or curved mandrel and making the controllably bendable portion conform to the curved surface. Alternatively, the bend 22 forming a pre-bent portion of the controllable bendable portion 18 may be formed along only a short length of the controllable bendable portion 18, in other words, over only a portion of the length of that portion, such that a generally linear section of the controllable bendable portion 18 extends from one or both sides of the bend. Other bends, such as compound bends involving two or more bending angles along the length of the controllable bendable portion 18, are also conceivable.

[0015] As shown in Figure 3, in one embodiment, the controllably bendable portion 18 consists of an electroactive polymer portion 34 sandwiched between electrodes 36, 38 that are directly formed on or bonded to the opposite side of the electroactive polymer portion 34.

[0016] By forming the controllably bendable portion 18 to include a deviation from its free-state straight path, such as by imparting a bend or curve to the controllably bendable portion 18 in a free or unenergized state, the orientation of the tangent 32 to the end of the tip 30 of the controllably bendable portion 18 can be positioned at an angle θ of approximately 0 to approximately 90 degrees from the tangent 33 to the controllably bendable portion 18 at the connection point with the hollow tubular shaft 14 shown in Figure 1. In this specification, it is intended that the tangent 32 to the end of the tip 30 of the controllably bendable portion 18 can be positioned at an angle greater than 90 degrees from the tangent to the connection point between the controllably bendable portion 18 and the hollow tubular shaft 14, or to an additional intermediate member between them. For example, if the end of the tip 30 of the controllably bendable portion is oriented at a 45-degree angle from the orientation of the end of the hollow tubular shaft 14 in its free state, and the end of the tip 30 of the controllably bendable portion 18 can be bent over an angle of + / - 45 degrees by electrically acting its electrically actuated polymer, then the end of the tip 30 can be oriented at 0 to 90 degrees with respect to the connection point between the controllably bendable portion 18 and the hollow tubular shaft 14 under the control of the operator, i.e., the angle θ range is approximately 0 to 90 degrees. If, under the same pre-bending conditions, the controllably bendable portion 18 can be actuated in a controllable manner at + / - 60 degrees, then the angle θ can be established in a controllable manner at -15 to +105 degrees. By pre-selecting the bending angle and flexibility of the controllably bendable portion, the operator or user of the guidewire system 10 can controllably select the desired orientation of the tip 30 end relative to the hollow tubular shaft 14, thereby positioning the tip 30 end of the guidewire 12 to establish its arrangement in tortuous lumen tissue, including within branched lumens.

[0017] In one embodiment as described herein, a controllably bendable portion 18 is configured to have a strip-shaped electroactive polymer base having a conductor facing the other side of the strip. For example, as shown in Figure 3, the strip 40 of the electroactive polymer portion 34 includes opposing main faces 44, 46 and opposing secondary faces 48, each secondary face 48 extending between the two main faces 44, 46. The main faces 44, 46 are shown as having a rectangular profile, but other profiles in plan view are contemplated, such as a triangle, a truncated triangular polygon, or other polygon, or a shape with curved edges. Each main face 46, 48 is provided with a carbon layer 42 pressed and bonded thereto by being pressed against the electroactive polymer portion 34, and a metal electrode 50 that lies on top of the carbon layer 42. By forming one carbon layer 42 on one main surface 44 or 46 to be thicker than the carbon layer on the other main surface 44 or 46, the inherent stress difference of the carbon layers 42 causes the controllably bendable portion 18 to inherently form a continuous curved section along its length as shown in Figures 1 and 2. The relative thickness of the carbon layers 42 defines the total angular difference (angle θ) between the tangent 32 to the distal end 54 of the controllably bendable portion 18 and the tangent 33 to the proximal end 56 of the controllably bendable portion 18. By maintaining a constant thickness for each carbon layer 42 of different thicknesses along its length from the proximal end 56 to the distal end 54 or tip end 30 of the controllably bendable portion 18, the difference in internal stress between the two carbon layers 42 remains constant along its length from the proximal end 56 to the distal end 54, resulting in the inherent formation of a continuous curved section centered on point 24. Each metal electrode 50 is positioned on the carbon layer 42 to form highly conductive paths for distributing electricity across the length and width of each main surface 44, 46, thereby maintaining a uniform voltage potential across each electrode 50. For example, the electrodes 50 may be formed from sputtered or vapor-deposited layers of gold, silver, palladium, or platinum, with each electrode having the same or nearly the same thickness.The carbon layer 42 may also contain carbon-based materials such as carbide-derived carbon, carbon nanotubes, graphene, composites of carbide-derived carbon and polymer electrolyte members, and composites of carbon nanotubes and polymer electrolyte members.

[0018] Alternatively, the electrode 50 itself may be formed from a shape memory material, such as a NiTi alloy or a NiTi-based alloy, which is formed on the controllably bendable portion 18 by sputtering, vapor deposition, or other deposition or bonding methods. In this embodiment, for example, a thin layer of NiTi alloy formed by co-sputtering nickel and titanium targets in a processing chamber is deposited on the main surfaces 44, 46 of the controllably bendable portion 18. Thereafter, one or more desired bends, such as a continuous curve or a sharp kink-type bend, are applied to the controllably bendable portion. The controllably bendable portion 18 is then cooled to a temperature sufficient to change the internal phase of the alloy, changing the structure of the internal phase from austenite to martensite, and the controllably bendable portion 18 returns to a straight or nearly straight configuration as shown in Figure 3, thereby making it possible to insert into a delivery sheath or other sheath, and while the controllably bendable portion 18 is still inside the sheath 20, it is possible to reheat it to a temperature at which the internal phase changes again to the austenite phase. The shape memory material can also be deposited on a pre-bent, controllably bendable portion 18.

[0019] Here, the shape memory alloy material also acts as an electrode material. When the distal end of the sheath is inserted into a body lumen or other body region, the controllably bendable portion is pushed outward from the distal end of the sheath, and if no bias or potential is applied across the electroactive polymer, the controllably bendable portion will return to its curved shape before it cooled and was bent back to a flat or straight profile. Thus, by applying a bias or potential across the electroactive polymer, the profile of the controllably bendable portion 18 can be altered.

[0020] Referring here to Figures 4 and 5, a typical example of a connection for connecting the + and - terminals of a power source, such as a capacitor or battery, to opposing electrodes 50 is shown. As shown in Figure 1, the guidewire system 10 here includes a guidewire 12, a sheath 20 enclosing most of the length of the guidewire 12, and a power supply connector 21 located at the proximal end of the guidewire system. As shown in Figure 4, the guidewire 12 is configured to include, overall, a first tubular portion 60, a controllably bendable portion 18, and a flexible member 62 disposed between the distal end 64 of the first tubular portion 60 and the proximal end 66 of the controllably bendable portion 18, and interconnecting them. Here the flexible member 62 is configured as a coil spring having windings 68 spaced at approximately equal pitches along its length between the tubular first portion 60 and the controllably bendable portion 18. The flexible member 62 provides flexible support that allows the guidewire assembly 10 to follow the meandering tissue of the body lumen as it is guided into the lumen. Furthermore, to connect the opposing electrodes 50 to the power source, a first wire 70 (Figure 5) is connected to one electrode 50 and a first terminal 72 located on the outer surface of the generally tubular portion 60, extending between them, and a second wire 71 (Figure 5) is connected to the other electrode 50 and a second terminal 73 located on the outer surface of the generally tubular portion 60, closer to the proximal end 84 of the generally tubular portion 60 than the first terminal 72, extending between them.

[0021] Referring to Figures 5 and 6, each of the wires 70, 71 includes an outer insulating coating 86 and an internal conductive core 88 terminated at a generally flat trapezoidal portion 90 that forms a terminal. One end of each wire 70, 71 is connected by a conductive adhesive 92 (such as gold paste) to one of the electrodes 50 on a controllably bendable portion, thereby providing an electrical current connection between the wires 70, 71 and the terminal 90. As shown in Figures 7 and 8, once the terminal 90 is attached to the electrodes 50 on both sides of the electroactive polymer of the controllably bendable portion 18, the electroactive polymer is further coated with polydimethylsiloxane (PDMS) and parylene, and the opposite ends of the wires 70, 71 are passed through a flexible member 62 and connected to one of the terminals 80, 82 to be received by the power supply connector 21, by attaching each of the conductive cores 88 of the wires 70, 72 to their respective terminals 80, 82 using a conductive adhesive. This can be achieved by drilling holes through terminals 80 and 82, inserting a conductive core 88 inside the tubular covering of terminals 80 and 82 and passing it through the holes, or by other mechanisms. Terminals 80 and 82 surround the tubular portion 60 and are spaced apart from each other along the length L of the tubular portion 60. As shown in Figure 4, the proximal end of the controllably bendable portion 18 is bonded to the distal end of the flexible member 62 using an adhesive 94 (e.g., polyimide or UV curing agent), and this adhesive 94 also covers the conductive adhesive 92.

[0022] Referring here to Figures 9 and 10, a typical example of the connection between the power supply connector 21 and the controllably bendable portion 18 of the guide wire 12 is shown. Here, the power supply connector 21 includes an outer, roughly exact annular housing 100 and an insert 96 that is received therein, the insert 96 consisting of a tapering inlet bore 102 leading to a conduit 104 having a slot opening 108 along its length, and a cantilevered portion 98 extending spaced above the slot opening 108. The maximum outer diameter of the tapering inlet bore 102 is slightly larger than the inner diameter of the housing 100, and the side walls 110 of the cantilevered portion 98 are curved to mimic the curvature of the inner diameter of the housing 100, thus allowing the insert 96 to be pressed into the housing 100 and positioned centrally within the housing 100. A first terminal 112 and a second terminal 114, spaced apart and electrically insulated from each other, are provided on the side of the cantilevered portion 98 facing the slot opening 108. The conduit 104 is sized to accommodate the proximal end of the guidewire 12 and to allow the housing 100 and the guidewire 12 to rotate relative to each other. The power supply unit is connected via cable 106 to the output of a user-controllable AC-DC converter with variable output, for example, connected to an AC power source, to a DC power source. Cable 106 includes two wires 116 and 118 extending therein, one of which is connected to one of the connection terminals 112 and 114, allowing for selective biasing of the electrodes 50 of the controllably bendable portion 18.

[0023] The proximal end of the guidewire 12 is inserted into the housing 100 via a tapered entrance bore 102, where the guidewire 12 is grounded to the base 120 of the conduit 104. The first and second terminals 112, 114 are configured as strips of a conductive material such as copper, each including a convex portion that lies above the slot opening 108. The first and second connecting terminals 112, 114 are spaced apart by a distance 124 such that the centers of their convex portions are spaced apart by the same distance as the distance between the centers of the first and second terminals 80, 82. This allows the proximal end of the guidewire 12 to be moved slightly outward and inward from the housing 100 without breaking the electrical circuit between the power source and the electrodes 50 of the electroactive polymer portion 34 of the controllably bendable portion 18. Similarly, since the terminals extend circumferentially around the guidewire 12, the rotational orientation of the guidewire 12 does not affect the electrical circuit through the housing 100. The guide wire 12 may be fixed to the housing 100 by crimping it to the conduit 104, or an adhesive may be applied between the base 120 of the conduit 104 and the guide wire 12. Alternatively, the guide wire 12 does not need to be fixed to the housing 100, and the guide wire 12 may rotate within it without obstructing contact between the connection terminals 112, 114 and terminals 80, 82.

[0024] Referring here to Figures 11 and 12, an alternative configuration of a typical example of electrical connection to the electrodes 50 of the controllably bendable portion 18 is shown. Here, the wire 71 extends from a second terminal 82 in the intermediate portion 14 of the guidewire 12, passes through there, extends through the intermediate portions 14 and 16 of the guidewire 12 (see Figure 2), and connects to one of the electrodes 50 on the controllably bendable portion 18 in the same manner as shown in Figures 7 and 8. In contrast, the wire 70 is shortened compared to its length in Figures 7 and 8 and connects only between a first terminal 80 at the distal end of the electrical connection portion 16 and the other electrode 50 of the controllably bendable portion 18. Here, both intermediate portions 14 and 16 are made of a conductive material, such as stainless steel of other biocompatible conductive portions. A portion 126 of the intermediate portion 14 serves as the second terminal. The end 128 of the wire 70 may be bent into a dog-leg shape so as to bias the inner portion of the intermediate sections 14, 16 and enable sliding electrical contact between them.

[0025] Referring here to Figures 13 and 14, typical examples of connections for attaching wires 70 and 72 to terminals 80 and 82 are shown, which are the same for each 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 which includes a partially extending small-diameter portion 134 and a large-diameter portion 132, where an annular edge 140 formed between the small-diameter portion and the large-diameter portions 134 and 132 is spaced apart from the end of the guide wire 12. Above this, the wire 72, which includes an insulator, extends between the outer wall of the small-diameter portion 134 and enters a gap 138 formed between the annular end wall 136 of the guide wire 12 and the annular edge 140. A portion of the insulator on the portion of the wire 72 extending into the gap 138 is stripped or removed to expose its conductive core. The terminal 82 is configured as a cylindrical conductor and is positioned in the gap 138. The annular end wall 136 includes an insulating coating thereon, and a separate insulating washer is provided between the annular end wall of the conductive guidewire and the conductive terminal 80. As shown in Figure 14, the large-diameter portion 132 is pushed or pressed in the direction of the guidewire 12 to secure the terminal, contacting the conductive core of the wire 72 along its inner circumference to complete the connection between the wire 70 and the terminal. While a typical example of this connection has been described in terms of a single terminal, a hollow adapter 130 having a bore extending across its large and small-diameter portions can be provided through which the second wire 72 is drawn, and the second terminal 82 can be electrically connected to the conductive core of the second wire 72 by inserting the second small-diameter portion of the second adapter into the bore with the second terminal on it.

[0026] Referring now to Figures 15-17, the assembly of the guidewire system 10 and guide tube 150 is shown. First, with the guidewire 12 removed from the power supply connector 21, the guide sheath is introduced over the guidewire from the end of its intermediate section 16 and pushed in the direction 152 so that it is over the guidewire 12. The guide tube 150 includes a manipulator 156 at its proximal end. As shown in Figure 16, the guide tube 150 and the guidewire 12 are integrated such that the intermediate section 16 extends outward from the guide tube 150 at the end of its manipulator 156. The intermediate section 16 is then inserted into the bore of the power supply connector 21.

[0027] As shown in Figure 18, in this embodiment of the introduction device, the further configuration of the introduction device 200 based on the guidewire and electroactive polymer includes a power and control box 220, a control and power module 218 having a flexible tubular protective cover 234 thereon and an electrical lead portion 222 extending from the control and power module 220 and terminating in a connection box 228, and a guidewire 216 including a hollow sheath 240 formed from an outer sheath that is formed as a hypotube 260 having a second end 264 receivable into the connection box 228 and a first end 262 distal thereto, the hypotube 260 selectively extending from the connection box 228 (see Figure 20). As shown in Figures 20 and 21, the hypotube 260 includes therein a core formed from a tapered core 250 and an electroactive polymer portion 270 extending from its first end 262. In the configuration of this introduction device 200, the coil 280 is positioned on a portion of the tapered core 250 within the hypo tube 260. The connection between the electroactive polymer portion 270 and the power supply of the control and power module 218 is made via the conductive tapered core 250 and the hypo tube 260, each connected to a separate conductor within the electrical lead portion 222, with the coil 280 providing flexible support, which, along with a suitable insulating coating, electrically insulates the hypo tube 260 and the tapered core 250 from each other in the area immediately adjacent to the electroactive polymer portion 270 where significant bending of the hypo tube 260 and guide wire 250 is expected. For example, the tapered core 250 is electrically connected to the 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 hypo tube 260. To facilitate installation, the hypotube 260 may include a polymer sheath extending over it from a first end 262 to its second end 264.

[0028] Referring to Figure 19, the tapered core 250 is shown with a portion removed along its length. The tapered core 250 includes a main portion 252 extending from its first end 254 and a tapered portion 258 extending from its second end 256 toward the first end 254. Here, approximately 15% of the length of the tapered core 250 is formed from the tapered portion 258 that extends continuously from the main portion 252 at the joint "J", and the minimum outer diameter d of the tapered portion 258 that occurs at its second end 256 is approximately 30% of the outer diameter D of the main portion 258 along its length. For example, if the total length "L" of the tapered core 250 is, for example, 200 cm (i.e., 2 meters), the tapered portion 258 will extend for a length "l" of 30 cm distal to the joint J of the tapered core 250 from the connection box 228 of its second end 256. Furthermore, if the diameter D of the main portion 252 is, for example, 0.20 mm, the tapered portion 258 will taper over a length "l" from the main portion 252 of the joint J to its distal second end 256 such that the outer diameter decreases continuously, i.e., linearly (from D to d), so that the outer diameter "d" at the distal end 256 of the guidewire is approximately 0.064 mm. Although the tapering of the tapered portion 258 has been described herein as occurring as a linear reduction in diameter along the length of the tapered portion 258, a similar reduction in diameter along a length "l" from the main portion 252 to the distal end 256 is also intended. The tapering of the tapered portion 258 of the tapered core 250 adjacent to the distal end 256 reduces the rigidity of the tapered core 250 therein, and also creates a clearance space between the tapered portion 258 and the inner diameter of the hypo tube 260, allowing for the conductive coil 280 to be accommodated between them.

[0029] Referring to Figure 20, the hypotube 260 is shown in cross-section, with a tapered core 250 extending along it within its inner circumference, and a coil 280 also extending within its inner circumference, around a portion of its tapered portion 258 adjacent to its distal end 256. The hypotube 260 and the tapered core 250 each provide separate current paths, supporting the selective application or maintenance of a voltage signal or current to thin electrodes, such as gold or silver layers, on the opposite first and second sides 272, 274 of the electroactive polymer portion 270. Here, a conductive lead 300 (Figure 21) extends from the outer circumferential surface of the tapered portion 258 and connects to the first side 272 of the electroactive polymer portion 270. As shown in Figure 21, the conductive lead 300 includes a first generally flat portion 302, a dogleg-shaped portion 304 extending therefrom and separating from the distal second end 256 of the tapered portion 258 of the tapered core 250, a lead portion 306 extending from the dogleg-shaped portion 304, and a second generally flat portion 310. The flat first portion 302 is electrically in contact with the tapered portion 258 of the guide wire 250 by spot welding, etc., and the second flat portion 310 is connected to the first side 272 of the electroactive polymer member 270 by bonding them together with a first conductive layer 384, etc.

[0030] Here, the hypotube 260 is a thin-walled conductive sleeve as shown in Figure 22, and is a biocompatible stainless steel tube having, for example, a second tube end 264 that can be received into a connection box 228, and a first tube end 262 configured to have a receiving slot 312 having a slot height or width slightly larger 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 the inner wall of the receiving slot 312 and thus electrically insulated from it. The hypotube 260 further includes a plurality of cross-cut slots 318 (see Figures 22 and 23) cut inward from its opposing circumferential sides, leaving pairs of opposing webs 320 extending circumferentially between some pairs of slots. The cross-cut slots 318 are formed only in a portion of the hypo tube 260, which is adjacent to its second end 256 and slightly spaced from the base of the receiving slot 312, and extends along the length of the hypo tube 260 for a distance slightly longer than the length of the tapered portion 258 of the tapered core 250 which will be placed therein after assembly, and the cross-cut slots 318 gradually increase in both the size of the circumferential span of the web 320 and the spacing between the cross-cut slots 318. Here, the slots are laser-cut into a normally continuous tube of the material containing the hypo tube 260, but may be provided by other means or mechanisms such as physical cuts or milling, or pattern etching.Assuming that the hypotube 260 is not bent or twisted as shown in Figure 24 and has a centerline 322, each pair of crosscut slots 318 extends through the wall 324 of the hypotube 260 at an angle (90 degrees) perpendicular to the centerline 322, where the depth of the cut from the center of its circumferential span forming each crosscut slot 318 defines the circumferential span of the crosscut slot 318 in the outer wall 324 of the hypotube 260, as well as the remaining circumferential span including the web 320 extending circumferentially between each end of each directly opposing pair of crosscut slots 318.

[0031] Figure 22 shows a set of such cross-cut slots 318, where the slot period in the longitudinal direction of the centerline 322 of the hypotube 260 varies in relation to the distance along the hypotube 260 from the first end 262 into which the electroactive polymer portion 270 is received by the receiving slot 312. Here, four sets of slots 318a-d extend across the hypotube 260, each having different spacings, different slot depths, or a combination of both, where the deepest cross-cut slot 318 is located in slot 318a of the first region adjacent to the first end 262 of the hypotube 260 and spaced away from the receiving slot 312, and these cross-cut slots 318 are also spaced closest to each other in the longitudinal direction of the centerline 322 of the hypotube 260. The cross-cut slots 318 of the second set of slots 318 are positioned adjacent to the slots 318a of the first set, such that the slots 318a of the first set are located between the first end 262 of the hypotube 260 and the second set of slots 318b. The cross-cut slots 318 of the second set of slots 318b are offset in the longitudinal direction of the centerline 322 of the hypotube 260 such that circumferentially adjacent cross-cut slots 318 around the hypotube 260 are not formed on opposite sides of the hypotube 260 at the same length position of the centerline 322 from its first end 262. Rather, they are linearly offset in the direction of the centerline 322 of the hypotube 260 by the same distance as the longitudinally adjacent slots 318 in the first set of slots 318a. In the third set of slots 318c, the cross-cut slots 318 again face each other in the circumferential direction and are spaced wider apart in the longitudinal direction of the centerline 322 of the hypotube 260 than the spacing between the slots 318a and 318b of the first or second set, and the slots 318b of the second set are located between the slots 318a of the first set and the slots 318c of the third set.The slots 318d of the fourth set are located further from the first end 262 than the slots 318c of the third set, and these slots include opposing pairs of cross-cut slots 318, where each pair gradually widens in the longitudinal direction of the centerline 322 of the hypotube 260 away from the second end 256 of the hypotube 260.

[0032] Furthermore, in some sets of slots, the angular distribution relative to each other varies along the length of the hypotube. For example, Figure 23 shows the angles of the side walls of two pairs of adjacent cross-cut slots 318, 318' in the length of the hypotube 260. Here, the base wall of slot 318 (solid line) extends at angle A with respect to the reference direction D1, and the base wall of slot 318' in the second set (dashed line) extends at angle B with respect to the reference direction A, where angle B is smaller than angle A. In the first, second, and third sets of slots 318a-c, each adjacent cross-cut slot 318 is cut at a different angle with respect to the reference direction, and the angular difference between one cross-cut slot 318 and its neighbor in the length of the hypotube 260 is the same within each slot group 318a-c. As a result, the orientation of the cross-cut slots 318 precesses along the length of the hypotube, and similarly, the position of the pivot formed by the web 320 precesses circumferentially along its length around the hypotube 260, thereby increasing the flexibility of the hypotube 260. In this hypotube, the angular difference between the cross-cut slots 318 and cross-cut slots 318' along the length of the hypotube is the same in the first to third sets of slots, approximately 10 to 11.25 degrees. In all cases, the direction of angular change is the same from cross-cut slot 318 to cross-cut slot. In the fourth set of slots 318d, each adjacent pair of cross-cut slots 318 is offset by approximately 90 degrees from the adjacent pair of cross-cut slots 318. Furthermore, the spacing of the crosscut slots 318 in the first set of slots 318a is 0.0013 inches, the first crosscut slot 318 in 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 0.400 mm inward from the first end 262 of the hypo tube 260, and slot 312 is approximately 0.120 mm thick.For example, Hypotube 260 is made of stainless steel and has an outer circumference of approximately 0.0140 inches and an inner diameter of approximately 0.0100 inches.

[0033] As shown in Figures 20, 22, and 24 (in Figure 24, a portion of the first set of slots 318a is removed for clarity), the hypotube 260 includes a continuous outer surface portion 326 extending between the base of slot 312 and the nearest cross-cut slot 318. The second end 256 of the tapered core 250 is positioned longitudinally inside the hypotube 260, and a conductive lead 300 extends from there to the first side 272 of the electroactive polymer portion 270. Slot 312 includes opposing first and second sidewalls 328, 330, and the hypotube 260 is electrically connected to the first sidewall 328 by conductive adhesive 332 or other mechanism and electrically insulated from the second sidewall 330 using a layer of insulating paste or adhesive 334. Therefore, as shown in Figure 22, the hypotube does not short-circuit between the first and second side walls 328 and 330 of the receiving slot 312 at the first end 262 of the hypotube 260.

[0034] To connect the tapered core 250 and the hypo tube 260 to different power sources, such as different output terminals of a single DC power supply, the first end 254 of the tapered core 250 extends outward from the second end 264 of the hypo tube 260, and each is receivable into the opening 340 of the connection box 228. Referring to Figure 25, the first dielectric sleeve 342, the hollow connecting band 344, the second dielectric sleeve 346, and the dummy electrode 348 extend in this order consecutively from the second end 246 of the hypo tube 260. A portion of the main part 252 of the tapered core 250 extends through the first dielectric sleeve 342, the hollow connecting band 344, the second dielectric sleeve 346, and the dummy electrode 348. The tapered core 250 is electrically connected to the hollow connecting band 344 by being electrically connected inside the hollow connecting band 344, but is not electrically connected to the first and second dielectric sleeves 342, 346, or the dummy electrode 348. The connecting 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 the opening 340 of the connecting box 228, and each of which includes a portion that extends into the opening of the connecting box 228. The distance between the portions of the first and second terminals 350, 352 that extend inward into the opening 340 is at least as long as the length of the first dielectric sleeve 342, the distance between the portions of the second and third terminals 352, 354 that extend inward into the opening 340 is at least as long as the length of the second dielectric sleeve 346, and the distance between the portions of the third and fourth terminals 354, 356 that extend inward into the opening is the difference 348. The first end 254 of the tapered core 250 extends outward from the dummy electrode 348, establishing a gap between the end of the dummy electrode 348 and the base of the opening 340.

[0035] By inserting the dummy electrode 348, the second dielectric sleeve 346, the connecting band 344, the first dielectric sleeve 342, and a portion of the hypotube 260 adjacent to the end 264 of the hypotube 260 into the opening 340 with the tapered core 250 extending therein, and pushing them in until the end 254 of the tapered core 250 engages with the base of the opening 240, the first terminal 350 makes electrical contact with the outside of the hypotube 260, the second terminal 353 makes electrical contact with the hollow connecting band 344 and thus with the tapered core 250 therein, and the third and fourth terminals 354 and 356 both make electrical contact with the dummy electrode 348. By supplying current from one terminal of a power supply unit (not shown) to one of the third and fourth terminals 354, 356, and connecting the other of the third and fourth terminals 354, 356 to the other terminal of the power supply unit, the current flows through the dummy electrode 348, and it is shown that the dummy electrode, and therefore the hypo tube 250 and guide wire 260 and hollow connecting band 344 connected thereto, are appropriately positioned in the connection box 228, and that a voltage can be selectively applied to the first and second sides 272, 274 of the electroactive polymer portion via the tapered core 250 and hypo tube 260, respectively. Four wires 360-366 extend from the control and power module 220 into the connection box 228 via the electrical lead portion 222. 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, by supplying a positive voltage through the first wire 360 ​​and a negative or ground voltage through the second wire 362, the electroactive polymer portion can be bent in a first direction. Reversing these voltages reverses the direction of bending. As previously described herein, the direction and range of bending are controlled by voltages supplied to the first and second sides 272, 274 of the electroactive polymer portion 270, which are relative in both polarity (+ or -) and magnitude.The third and fourth wires 364 and 366 are connected to the third and fourth terminals 354 and 356, respectively, with their opposite ends connected to a different power supply (not shown) than those connected to the first and second wires 360 and 362, such as the opposite poles (+ and -) of a battery. When the third and fourth terminals 354 and 356 simultaneously contact the dummy electrode 348, this completes the electrical circuit, indicating that the junction box 228 is properly connected to the system, which can be indicated by the illumination of an LED or other signaling element in the circuit.

[0036] Referring here to Figures 27 to 34, a portion of the manufacturing sequence of the introduction device 200 is shown. To prevent short circuits between the tapered core 250 and the hypo tube 260, the outer surface of the tapered core is covered with an insulating coating. For example, parylene may be deposited on the tapered core 250 by vapor deposition using an adhesion promoter to form an insulating coating 370 (Figure 27) thereon, or the tapered core 250 may be immersed in an electrically insulating epoxy to form an insulating coating thereon, or an insulating coating may be formed by other means. Then, as shown in Figures 28 and 29, the coil 280 is slid to cover a portion of the tapered portion 258 immediately adjacent to the second end 256 of the tapered core 250 and fixed therein with a non-conductive adhesive 372, such as a non-conductive acrylic adhesive, disposed between the inner diameter of the coil 260 and the outer circumference of the tapered portion 258 and on the coil 260. Next, as shown in Figure 21, the first generally flat portion 302 of the lead 300 and the outer surface of the tapered core 250 are joined at their second ends by locally removing their insulating coating 370 and welding or otherwise bonding them to each other.

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

[0038] The fixing of the electroactive polymer portion 270 to the hypotube 260 is performed here. As shown in Figure 31, a coating of adhesive 378 is provided on the base 380 of the receiving slot 312, and the fixing end of the electroactive polymer portion 270 is inserted into the receiving slot 312 and in contact with the adhesive 378, such that there is a gap between a portion of the electroactive polymer in the receiving slot 312 and the opposing first and second side walls 328, 330 of the receiving slot 312. The gap between the second side of the slot 312 and the electroactive polymer portion 270 is filled with insulating filler 382, ​​which extends over the entire first end of the hypotube 260, and the filler also covers the lead portion 306 of the lead 300, but the second generally flat portion 310 is left exposed, as shown in Figure 32. The exposed second flat portion 310 is then covered by the first conductive layer 384, physically and electrically connecting the flat portion 310 to the first side 272 of the electroactive polymer portion 270. As shown in Figure 33, the second conductive layer 386 fills the space between the first side wall 328 of the receiving slot 312 and the second side 274 of the electroactive polymer portion 270, extending outward from the hypo tube 260 along the second side 274, electrically connecting the hypo tube 260 to the second side 274 of the electroactive polymer portion. The first and second conductive layers 384, 386 are composed of, for example, a conductive paste, conductive epoxy, or another conductive adhesive material.

[0039] Next, the portion of the hypotube 260 immediately adjacent to the first end 262, the first and second conductive layers 384, 386, and the portion of the electroactive polymer portion 270 immediately adjacent thereto are covered with a thin layer of capsule material such as silicone, then covered with a coating of adhesive such as parylene, and then covered with a second capsule material such as silicone (Figure 34). Parylene is preferably vapor-coated onto the relevant portion of the introduction device, and silicone may be coated thereon by immersion coating.

[0040] Next, in order to use the introduction device, the first dielectric sleeve 342, the hollow connecting band 344, the second dielectric sleeve 346, and the dummy electrode 346 are slid to cover a portion of the tapered core 250 extending from the second end 264 of the hypo tube 260 and fixed therein with adhesive. The first dielectric sleeve 342, the second dielectric sleeve 346, and the dummy electrode 346 are fixed to the tapered core 250 using a non-conductive adhesive, and the hollow connecting band 344 and the tapered core 250 are fixed to each other with a conductive adhesive or crimp connection to ensure electrical connection between them. The control box 220 comprises a push button, toggle, or other tactile element, which the operator can move or press to selectively apply a voltage of desired polarity and magnitude to the first and second sides 272, 274 of the electroactive polymer portion, thereby achieving the effect shown with respect to the electroactive polymer portion of the bendable portion 18 in Figure 2 of this specification.

[0041] Referring here to Figures 35 to 49, a further configuration of the guidewire device is shown, which uses a control and power module 218, a core configured as a tapered core 250 extending within a hypo tube 260, an electroactive polymer portion 270, and other components of the device illustrated and described with respect to Figures 18 to 24 herein, where the power supply and the electrical connection to the opposite first and second sides 272, 274 of the electroactive polymer portion are provided via dedicated conductors surrounded by insulators, so that the tapered core 250 and the hypo tube 260 do not need to be electrically insulated from each other.

[0042] As shown in Figure 35, a portion of the hypotube 260 adjacent to the first end 262 of the hypotube 260 is shown in cross-section to reveal the internal details. A first conductor 400 having a conductive core and surrounding insulator, and a second conductor 402 having a conductive core and surrounding insulator, extend into the hypotube 206, where the conductive portion of the first conductor 400 is electrically connected to the first side 272 of the electroactive polymer portion 270, and the conductive portion of the second conductor 274 is connected to the second side 274 of the electroactive polymer portion 270. Here, the conductive portion of the conductor is made of a base metal such as stainless steel and covered with a thin layer of gold, but a cover of other conductive material such as silver, copper, cobalt, rhenium, or ruthenium may be used as the conductor.

[0043] The first and second conductors 400 and 402 are electrically connected to the first and second sides 272 and 274, respectively, of the electroactive polymer portion 270 with conductive adhesive. Each conductor extends outward from its connection to the electroactive polymer portion through the hypotube 260 and from the second end 264 of the hypotube 260, where the conductor is connected to the conductor of the electrical connection portion 404, which is receivable in the connection box 228 of the control and power module 218 as previously described herein.

[0044] By using conductors 400 and 402 as current-carrying paths for applying a desired voltage to the first and second sides 272 and 274 of the electroactive polymer portion 270, the assembly of a catheter or guidewire consisting of a tapered core 250, hypotube 260, electroactive polymer portion 270, conductors 400 and 402, and connecting portions can be made relatively easy. To assemble the catheter or guidewire, a fish 410 (Figure 36) having the same diameter as the main portion 252 of the tapered core 240 is extended through the hypotube 260 such that its end 412 extends outward from the first end of the hypotube 260. The conductors 400 and 402 are placed on the diametrically opposed side of the tapered core adjacent to the first end 254 of the tapered core, and the heat-shrinkable tube is extended over them such that the first end 254 of the tapered core 250 extends inside the first open end 416 of the heat-shrinkable tube 414, and the end 412 of the fish 410 extends inside the second open end 418. Then, as shown in Figure 37, the heat-shrinkable tube 414 is heated and it shrinks radially, physically fixing the conductors 400 and 402, the fish 410, and the first end 254 of the tapered core to each other. Prior to this operation, the conductive portions of the conductors 400 and 402 extending between the heat-shrinkable tube 414 and the tapered core may be processed to flatten them, forming flat regions similar to the flat portion 302 of the conductive lead 300, or terminals (not shown) may be connected to each. These operations may be performed when the conductor is drawn through the hypo tube 260 and exposed outward from its second end 264.

[0045] Next, the end 412 of the fish 410 is pulled in from the first end 262 to the second end of the hypo tube, as shown in Figure 38, until the heat-shrinkable tube 410 is positioned outside the second end 264 of the hypo tube 260. Then, an adhesive such as acrylic adhesive is injected into the first and second ends 262, 264 on both sides of the hypo tube 260 to form a first adhesive band 420 that extends around the outside of the tapered core 250 and conductors 400, 402, and around its interior just inside from the second end 264 of the hypo tube 260, and a second adhesive band 422 that extends around the outside of the tapered core 250 and conductors 400, 402, and around its interior just inside from the first end 262 of the hypo tube 260. The conductors 400, 402 extend along the side walls of the receiving slot 312 through the first adhesive band 420.

[0046] Next, the portion of the tapered core 250 extending outward from the second end 264 of the hypo tube 260 is covered with an insulating tube, which is heated to a temperature higher than its solidus temperature and reflowed so that it can adhere to the outer surface of the tapered core 250, allowing a conductor to be placed on it. Then, the insulating cover on the conductors 400 and 402 is removed at their ends 406 and 408 to form the electrical connection portion 404 (Figure 40). Next, the first thin-walled tubular insulator 424 is slid to cover the exposed portion of the tapered core 250, and a conductive paste such as gold paste is placed inside the first thin-walled conductor 426. When the first thin-walled conductor 426 is slid to cover the exposed portion of the tapered core 250 and comes into contact with 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. Next, the second thin-walled tubular insulator 428 is slid to cover the exposed portion of the tapered core 250 and comes into contact with the first thin-walled conductor 426. A conductive paste, such as gold paste, is placed inside the second thin-walled conductor 430. When the second thin-walled conductor 430 is slid to cover the exposed portion of the tapered core 250 and comes into contact with 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. Next, the third thin-walled tubular insulator 432 is slid to cover the exposed portion of the tapered core 250, and a thin-walled detection connector 434, which performs the same function as the dummy electrode 348, is slid to cover the exposed portion of the tapered core 250 and comes into contact with the third thin-walled tubular insulator 432, where it is bonded with adhesive. This completes the assembly of the electrical connection portion 404. The connection portion 404 is configured to be receptacle to and work in conjunction with the connection box 228 described earlier in this specification.When properly inserted into the opening of the connection 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 of the connection box 228, each of which includes a portion extending into the opening of the connection box 228. Thus, the voltage applied to the first terminal 350 is applied to the first side 272 of the electroactive polymer portion 270, and the voltage applied to the second terminal 352 is applied to the second side 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] The electroactive polymer portion 270 is fixed within the receiving slot 312 by inserting one end of it into the receiving slot 312 (where the first and second side walls 328, 330 of the receiving slot 314, as well as the base, are covered with an adhesive such as acrylic adhesive) and contacting the adhesive, which, upon curing, forms a fixing layer 440. When the end of the electroactive polymer portion 270 is inserted into the receiving slot 312, its flat terminal ends 436, 438 (Figure 44) are positioned above the opposite first and second sides 272, 274 of the electroactive polymer portion 270. Next, the empty area between portions of the first and second sides 727, 274 of the electroactive polymer portion 270 and the inner wall of the hypotube 260 (Figure 44) is filled with adhesive to form plugs 446, 448 (Figure 45). The plugs may be formed from, for example, an acrylic adhesive that, upon curing, forms plugs 446, 448. Next, the flat terminal portions 436, 438 are electrically connected to the first and second sides 272, 274 of the electroactive polymer portion, respectively, with conductive slags 456, 452. The conductive slag may include, for example, a cured conductive epoxy, such as a gold-filled epoxy (Figure 46). Then, the exposed portion of the first end 262 of the hypo tube 260, and the slags 456, 452, as well as the adjacent portions of the first and second sides 272, 274 of the electroactive polymer portion 270, are respectively covered with layers 454, 456 of a capsule material composed of, for example, a silicone adhesive. Next, as shown in Figure 48, radiopaque marker plates 460, 462 are attached to the opposite first and second sides 272, 274 of the electroactive polymer portion 270. For example, marker plates 460 and 462 are made of a platinum-iridium alloy and are positioned slightly inward from the leading edge 464 of the electroactive polymer portion 270, on the opposite first and second sides 272 and 274. Each marker plate 460 and 462 is positioned less than 1 millimeter from the leading edge of the electroactive polymer portion 270, and each is less than 1 mm in length. For example, the length is 0.5 millimeters.Alternatively, the leading edge 464 of the electroactive polymer portion 272 may be coated with a radiopaque layer 466, for example, a platinum-iridium alloy or a layer of gold, in addition to or instead of the marker plates 462, 464. Subsequently, adjacent portions of the electroactive polymer portion 272, capsule material 454, 456, and hypotube 260 are immersed in a silicone dispersion and coated therewith, and then the hypotube 260, and the immersion-coated electroactive polymer and capsule material 452, 454 extending therefrom, are vapor-coated with, for example, a parylene coating. The adjacent portions of the gas-phase coated electroactive polymer portion 272, capsule materials 454, 456, and hypotube 460 are immersed in a silicone dispersion and coated thereafter. The hypotube 260, as well as the immersion-coated electroactive polymer and capsule materials 452, 454, are then coated again with, for example, a gas-phase coating of parylene, and the parylene coating is then covered with a hydrophilic coating to complete the assembly of the catheter or guidewire portion of this system.

Claims

1. Hollow sheath and, A guide wire that can extend through the hollow sheath, wherein the guide wire is A distal portion that can be bent in a controllable manner. A hollow, tubular intermediate portion connected to the distal portion, The proximal electrical connection portion connected to the hollow tubular portion, At least one core extending through the hollow tubular portion, connected to the proximal electrical connection portion at its proximal end, and connected to the surface of the tip end of the distal portion at its distal end, A power supply connector, wherein the electrical connection portion is received by the power supply connector, and the first terminal of the power supply connector contacts the proximal electrical connection portion. A guide wire equipped with A catheter equipped with [a specific feature / equipment].

2. Each of these extends through the hollow tubular portion and is connected to a first conductive wire at its proximal end to a first peripheral connector and at its distal end to a surface of the tip end other than the surface to which the core is connected. Each of these extends through the hollow tubular portion and is connected to a second periphery connector at its proximal end and to the surface of the tip end other than the surface to which the core and the first wire are connected at its distal end, A power supply connector wherein the electrical connection portion is received by the power supply connector, and the first terminal of the power supply connector contacts the first surrounding conductor and the second surrounding connector. The catheter according to claim 1, further comprising:

3. The catheter according to claim 1, wherein the tip end of the guide wire is bent in advance.

4. The distal portion that can be controlled to bend is An electroactive polymer core having opposite first and second surfaces, The first carbon layer formed on the first surface and the second carbon layer formed on the second surface The catheter according to claim 1, comprising:

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

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

7. The catheter according to claim 1, wherein the hollow tubular intermediate portion acts as a first conductor and the core acts as a second conductor.

8. The catheter according to claim 1, wherein the hollow tubular intermediate portion further includes a patterned laser cut surrounding its outer surface.

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

10. The catheter according to claim 1, wherein the core further comprises a tapered portion at its distal end.

11. The catheter according to claim 1, wherein the proximal electrical connection portion further comprises a first peripheral conductor and a second peripheral conductor.

12. A distal portion that can be bent in a controllable manner, A hollow, tubular intermediate portion connected to the distal portion, A proximal electrical connection portion connected to the aforementioned hollow tubular portion, A core extending through the aforementioned hollow tubular portion, connected at its proximal end to the proximal electrical connection portion, and connected at its distal end to the surface of the tip end of the distal portion, A power supply connector wherein the electrical connection portion is received by the power supply connector, and the first terminal of the power supply connector contacts the proximal electrical connection portion. A guide wire equipped with a guide wire.

13. The guide wire according to claim 12, wherein the hollow tubular intermediate portion acts as a first conductor and the core acts as a second conductor.

14. The guidewire according to claim 12, wherein the hollow tubular intermediate portion further includes a patterned laser cut surrounding its outer surface.

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

16. The guide wire according to claim 12, wherein the core further comprises a tapered portion at its distal end.

17. The guide wire according to claim 12, wherein the proximal electrical connection portion further comprises a first peripheral conductor and a second peripheral conductor.

18. Each of these extends through the hollow tubular portion and is connected to a first conductive wire at its proximal end to a first peripheral connector and at its distal end to a surface of the tip end other than the surface to which the core is connected. Each of these extends through the hollow tubular portion and is connected to a second periphery connector at its proximal end and to the surface of the tip end other than the surface to which the core and the first wire are connected at its distal end, A power supply connector wherein the electrical connection portion is received by the power supply connector, and the first terminal of the power supply connector contacts the first peripheral conductor and the second peripheral connector. The guide wire according to claim 17, further comprising:

19. The guide wire according to claim 12, wherein the tip end of the guide wire is bent in advance.

20. The distal portion that can be controlled to bend is An electroactive polymer core having opposite first and second surfaces, The first carbon layer formed on the first surface and the second carbon layer formed on the second surface The guide wire according to claim 12, comprising:

21. The guide wire according to claim 20, wherein the thicknesses of the first carbon layer and the second carbon layer are different.

22. The first metal layer on the first carbon layer and the second metal layer on the second carbon layer The guide wire according to claim 20, further comprising:

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