An introducer device including an electrically active tip on a guidewire

Abstract

To provide a catheter and a guide wire using a tip end of an electroactive polymer.SOLUTION: A catheter comprises a hollow sheath 20 and a guide wire 12 extendable within the hollow sheath. The guide wire comprises a controllably bendable tip portion, a hollow tubular intermediate portion 14 connected to the tip portion, an electrical connection portion 21 connected to the hollow tubular portion, at least one first 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 where 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.SELECTED DRAWING: Figure 1

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 April 30, 2018, entitled "INTRODUCTION DEVICE INCLUDING AN ELECTROACTIVE TIP ON A GUIDEWIRE," which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to the field of intraluminal guidewires and catheters, and more particularly to the field of guidewires and catheters that utilize electroactive polymer tip ends. [Background technology]

[0003] Guidewires are used to guide an auxiliary sheath, which is fed over and along the guidewire, to a desired location within a body, e.g., a mammalian body, such as a human body. In one application, the guidewire is introduced into a body lumen, i.e., blood vessel, by making an incision in the patient's skin and the lumen wall, from which the introduced or distal end of the guidewire is guided to a desired location in the lumen or in a lumen that merges with or branches off from the lumen into which the guidewire was introduced.

[0004] One problem with guidewire introduction systems is their limited ability to steer the distal end of a guidewire around tortuous lumen shapes and into intersecting or branching lumens relative to the lumen in which the distal end of the guidewire is located. To guide the distal end of a guidewire into a branched lumen, the distal end of the guidewire must be controllably moved from alignment with the lumen in which it reached the branched location to an alignment where moving the guidewire further into the body will cause the guidewire to enter and follow the branched lumen. In some cases, the branched lumen in which the distal end of the guidewire is intended to be delivered intersects the lumen in which the distal end resides at a large angle, e.g., greater than 45 degrees, or even greater than 90 degrees.

[0005] One method of controlling the orientation of the distal end of a guidewire involves incorporating an electroactive polymer contacted by at least two electrical conductors positioned at at least two different locations on the electroactive polymer. Selectively biasing at least one of the electrical conductors allows the orientation of the electroactive polymer portion of the guidewire to be controllably changed relative to the remainder of the guidewire. When the bias is removed, the section of the guidewire having the electroactive polymer therein 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 controllably positioned by the user of the guidewire.

[0006] These guidewire systems suffer from several limitations in reliability and functionality due to their construction. The distal end of the electroactive polymer segment has an inherently limited physical range of motion, which limits the ability to position the distal end of the guidewire in a lumen that intersects the lumen through which the guidewire is currently guided at a large coupling angle. Furthermore, because the conductors used to actuate the electroactive polymer segment must be connected to at least one of an electrical bias voltage or an electrical ground to establish a bias across the electroactive polymer, the electroactive polymer portion of the guidewire is hardwired to a voltage source and ground, thereby limiting rotational actuation of the guidewire by the user.

[0007] Furthermore, the guidewires are typically very small, comprising rods or tubes with diameters of approximately 1-4 mm. The conductors that provide the bias across the electroactive polymer segment must extend along or through the guidewire, and the connections between the conductors and the surface of the electroactive polymer, or between the electrodes in contact with the surface of the electroactive polymer, are small and fragile, frequently resulting in open circuit conditions that prevent the user from remotely manipulating the distal end of the guidewire. Summary of the Invention

[0008] Provided herein are guidewire systems incorporating electroactive polymer segments, where the range of positioning of the distal tip of the guidewire relative to the body of the guidewire is operable over angles greater than 90 degrees, such as those disclosed in WO2017136729A1 and U.S. Provisional Patent Application No. 62 / 539,346, which are incorporated herein by reference. Furthermore, the guidewire systems are configured for infinite rotation from a location outside the body where the guidewire is to be introduced, such as at or adjacent the proximal end of the guidewire, while maintaining a conductive path between a voltage source, electrical ground, or both, and the wall or side of the electroactive polymer. Additionally, exemplary improved connections between electrical conductors and electroactive polymers are provided.

[0009] In one aspect, the catheter comprises a hollow sheath and a guidewire extendable through the hollow sheath, the guidewire comprising a controllably bendable distal portion, a hollow tubular intermediate portion connected to the distal 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 peripheral conductor and at a second end to a surface of the distal end, and a power supply connector, wherein the electrical connection portion is received in the power supply connector and a first terminal of the power supply connector contacts the first peripheral conductor.

[0010] In another aspect, a catheter comprises a controllably bendable 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 at a proximal end to the proximal electrical connection portion and at a distal end to a surface of the tip end of the distal portion, and a power supply connector, wherein the electrical connection portion is received in the power supply connector and a first terminal of the power supply connector contacts the proximal electrical connection portion.

[0011] So that the above-mentioned features of the present disclosure can be understood in detail, a more particular description of the present disclosure, briefly summarized above, can be provided by reference to embodiments, some of which are illustrated in the accompanying drawings. It should be noted, however, that the accompanying drawings illustrate only exemplary embodiments and are therefore not to be considered limiting of the scope thereof, as other equally effective embodiments may be recognized. [Brief explanation of the drawings]

[0012] [Figure 1] 1 is a schematic plan view of a catheter including an outer sheath, an inner guidewire, and electrical connections. [Figure 2] FIG. 2 is a schematic cross-sectional view of the catheter of FIG. 1. [Figure 3]FIG. 3 is an isometric view of a controllably bendable tip of the catheter of FIGS. 1 and 2. [Figure 4] FIG. 3 is a side view of the guidewire of FIGS. 1 and 2. [Figure 5] 5 is a partial view of the guidewire of FIG. 4 showing the interconnection of the conductive wires with the controllably bendable distal end. [Figure 6] FIG. 7 is an end view of the wire of FIG. 6 before connection to a controllably bendable tip end. [Figure 7] FIG. 10 is an enlarged isometric view of the connection between the controllably bendable distal end and the intermediate section of the guidewire. [Figure 8] FIG. 10 is an enlarged isometric view of the electrical connection portion of the guidewire. [Figure 9] FIG. 5 is a phantom isometric view of a power supply connector for powering the controllably bendable portion of the guidewire of FIG. 4. [Figure 10] 10 is a cross-sectional view of the power supply connector of FIG. 9. [Figure 11] 10 is an enlarged side view, partially in section, of an alternative configuration for connecting a power supply to a controllably bendable distal end of a guidewire. FIG. [Figure 12] FIG. 10 is an enlarged side view of an alternative electrical connection portion of a guidewire. [Figure 13] FIG. 10 is an enlarged isometric view of an alternative electrical connection portion of the guidewire with the terminal removed. [Figure 14] FIG. 10 is an enlarged isometric view of an alternative electrical connection portion of a guidewire. [Figure 15] 10A-10C are isometric views showing steps in connecting a guidewire into a guide sheath. [Figure 16] 10A-10C are isometric views showing steps in connecting a guidewire into a guide sheath. [Figure 17] FIG. 1 is an isometric view of a ready-to-use guidewire and catheter including a power supply connector. [Figure 18] 1 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] FIG. 19 is a plan view of the core or tapered core of the catheter of FIG. 18. [Figure 20] 19 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] FIG. 19 is an isometric view of the conductive leads extending from the tapered core to the electroactive polymer portion of the catheter of FIG. 18. [Figure 22] FIG. 19 is a plan view of the outer sheath of the catheter of FIG. 18. [Figure 23] FIG. 23 is a schematic diagram of the outer sheath of FIG. 22, showing the relative angles between certain adjacent slots therein. [Figure 24A] 21 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] 21 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] FIG. 19 is a plan view of the proximal ends of the outer sheath and inner guidewire of the catheter of FIG. 18, as well as the electrical connection components. [Figure 26] FIG. 20 is a plan view showing the terminal arrangement of the control box of the catheter of FIG. 18. [Figure 27] FIG. 19 is a plan view of the tapered core of the catheter of FIG. 18. [Figure 28] FIG. 28 is an isometric view showing one end of the coil adhered to the guidewire of FIG. 27. [Figure 29] FIG. 28 is an isometric view showing the second end of the coil adhered to the guidewire of FIG. 27. [Figure 30] FIG. 10 is a diagram of the distal end of the outer sheath and inner guidewire, showing the coil glued inside the outer sheath, and the electrical connection components. [Figure 31] FIG. 10 is a view of the distal end of the outer sheath and the leads extending therefrom, with electroactive polymer portions adhered within slots in the outer sheath. [Figure 32]32 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 in the outer sheath of FIG. 31 and with insulating material between the first side of the electroactive polymer portion and the outer sheath. [Figure 33] 32 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 of FIG. 31 , the lead electrically connected to a first side of the electroactive polymer portion, and the outer sheath electrically connected to a second side of the electroactive polymer portion. [Figure 34] FIG. 10 is a view of the distal end of the outer sheath with the lead electrically connected to a first side of the electroactive polymer portion and the outer sheath electrically connected to a second side of the electroactive polymer portion, the portions covered with an encapsulant. [Figure 35] 10 is a plan view, partially in section, of a further embodiment of a guidewire. FIG. [Figure 36] 36A-36C are schematic diagrams showing steps in assembling the guidewire of FIG. 35. [Figure 37] 36 is a schematic diagram showing a further step in assembling the guidewire of FIG. 35. [Figure 38] 36 is a schematic diagram showing a further step in assembling the guidewire of FIG. 35. [Figure 39] FIG. 36 is a partially assembled plan view of the guidewire of FIG. 35. [Figure 40] FIG. 10 is a plan view showing a connection portion of a portion of a guidewire before an electrical connection portion is formed on the guidewire. [Figure 41] FIG. 36 is a plan view showing a connection portion of a portion of a guidewire after assembling a first portion of the electrical connection portion to the guidewire for electrically connecting to a first conductor contacting a first side of the electroactive polymer portion of the guidewire of FIG. [Figure 42]FIG. 36 is a plan view showing a connection portion of a portion of the guidewire after assembling a second portion of the electrical connection portion to the guidewire for electrically connecting to a second conductor contacting the second side of the electroactive polymer portion of the guidewire of FIG. [Figure 43] 36 is a plan view of the guidewire connection portion of FIG. 35 after the connection detector of the electrical connection portion has been assembled to the guidewire. [Figure 44] FIG. 36 is a partial isometric view of the distal end portion of the partially assembled guidewire of FIG. 35, showing the electroactive polymer portion connected to the outer sheath of the guidewire. [Figure 45] FIG. 36 is a further partial isometric view of the distal end portion of the partially assembled guidewire of FIG. 35 showing the space between the inner wall of the sheath and the electroactive polymer portion filled, with the filling further covering the adjacent end of the outer sheath. [Figure 46] FIG. 36 is a further partial isometric view of the distal end portion of the partially assembled guidewire of FIG. 35, showing the electrical connector and the conductive adhesive covering adjacent sides of the electroactive polymer portion. [Figure 47] FIG. 36 is a further partial isometric view of the distal end portion of the guidewire of FIG. 35. [Figure 48] FIG. 10 is a schematic side view of a portion of an electroactive polymer portion showing radiopaque markers on the opposing surface. [Figure 49] FIG. 49 is a schematic side view of a portion of the electroactive polymer portion of FIG. 48 showing a radiopaque marker at the distal end. DETAILED DESCRIPTION OF THE INVENTION

[0013] To facilitate understanding, like reference numerals have been used, where possible, to refer to like elements common to multiple figures. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further recitation.

[0014] Referring initially to Figures 1 and 2, Figure 1 shows a guidewire system 10 including a guidewire 12, generally shown in Figure 2, a sheath 20 surrounding the majority of the length of the guidewire 12, and a power supply connector 21 disposed over the proximal end of the guidewire 12. The guidewire 12 is comprised of a hollow tubular shaft 14 forming its intermediate section, an electrical connection section 16 (Figures 2 and 16) forming its proximal end, and a controllably bendable section 18 forming the distal end of the guidewire 12. Here, the guidewire 12 is shown extending in a generally straight path, and the bendable section 18 in its free state, i.e., with no electrical bias applied therethrough, is shown with a curve or bend 22 therein. The bend 22 is shown in Figure 2 as a series of bends having a radius centered at point 24 and may be formed by forcing the controllably bendable section over a round or curved mandrel and conforming the controllably bendable section to the curved surface. Alternatively, the bends 22 forming the pre-bent portions of the controllably bendable portion 18 may be formed along only a short length of the controllably bendable portion 18, in other words, over only a portion of the length of that portion, such that generally straight sections of the controllably bendable portion 18 extend from one or both sides of the bend. Other bends, such as compound bends that include two or more bend angles along the length of the controllably bendable portion 18, are also contemplated.

[0015] As shown in FIG. 3, in one embodiment, the controllably bendable portion 18 is comprised of an electroactive polymer portion 34 sandwiched between electrodes 36, 38 formed directly on or adhered to opposite sides of the electroactive polymer portion 34.

[0016] By forming the controllably bendable portion 18 to include a deviation from the linear path of its free state, such as by imparting a bend or curve to the controllably bendable portion 18 in its free or unenergized state, a tangent 32 to the end of the distal end 30 of the controllably bendable portion 18 can be oriented at an angle θ of from about 0 to about 90 degrees from a tangent 33 to the controllably bendable portion 18 at the connection with the hollow tubular shaft 14 shown in Figure 1. It is contemplated herein that the tangent 32 to the end of the distal end 30 of the controllably bendable portion 18 can be oriented at an angle greater than 90 degrees from a tangent to the connection between the controllably bendable portion 18 and the hollow tubular shaft 14, or to an additional intermediate member therebetween. For example, if the end of tip 30 of the controllably bendable segment is, in its free state, oriented at 45 degrees from the orientation of the end of hollow tubular shaft 14, and the end of tip 30 of controllably bendable segment 18 can be bent through an angle of + / - 45 degrees by electrically actuating the electrically actuatable polymer, then the end of tip 30 can be oriented under operator control from 0 to 90 degrees relative to the connection of controllably bendable segment 18 and hollow tubular shaft 14, i.e., angle θ ranges from about 0 to 90 degrees. If, under the same pre-bending conditions, controllably bendable segment 18 can be controllably actuated at + / - 60 degrees, angle θ can be controllably established from -15 to +105 degrees. By selecting the pre-bent bend angle and bendability of the controllably bendable portion, the operator or user of guidewire system 10 can controllably select the desired orientation of the end of tip 30 relative to hollow tubular shaft 14, enabling the end of tip 30 of guidewire 12 to be positioned to establish its placement in tortuous luminal tissue, including within branched lumens.

[0017] In one embodiment herein, the controllably bendable portion 18 is configured to have a strip-shaped electroactive polymer base with opposing conductors on opposite sides of the strip. For example, as shown in FIG. 3 , the strip 40 of electroactive polymer portion 34 includes opposing major surfaces 44, 46 and opposing minor surfaces 48, with each minor surface 48 extending between the two major surfaces 44, 46. While the major surfaces 44, 46 are shown as having rectangular profiles, other profiles in plan view are contemplated, such as triangular, truncated triangular, or other polygonal shapes, or shapes with curved sides. Each major surface 46, 48 is provided with a carbon layer 42 bonded to and pressed against the electroactive polymer portion 34 by pressing, and a metal electrode 50 overlying the carbon layer 42. By forming one carbon layer 42 on one major surface 44 or 46 to be thicker than the carbon layer on the other major surface 44 or 46, the inherent stress differential in the carbon layers 42 causes the controllably bendable portion 18 to inherently form a continuous curvature along its length, as shown in Figures 1 and 2. The relative thicknesses of the carbon layers 42 define the total angular difference (angle θ) between a tangent 32 to the distal end 54 of the controllably bendable portion 18 and a tangent 33 to the proximal end 56 of the controllably bendable portion 18. By maintaining a constant thickness for each of the different carbon layers 42 along its length from the proximal end 56 to the distal end 54 or tip end 30 of the controllably bendable portion 18, a continuous curvature will inherently form about point 24 as a result of the constant internal stress differential in the two carbon layers 42 along its length from the proximal end 56 to the distal end 54 of the controllably bendable portion 18. Each metal electrode 50 is disposed on the carbon layer 42 to provide a highly conductive path for distributing electricity across the length and width of each major 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 approximately the same thickness.The carbon layer 42 may include 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 NiTi-based alloy, that is formed into the controllably bendable portion 18 by sputtering, vapor deposition, or other deposition or bonding methods. In this embodiment, a thin layer of NiTi alloy, formed, for example, by co-sputtering nickel and titanium targets in a processing chamber, is deposited on the major surfaces 44, 46 of the controllably bendable portion 18. One or more desired bends, such as a continuous curve or a sharp kink-type bend, are then imparted 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 FIG. 3 , allowing it to be inserted into a delivery sheath or other sheath and, while the controllably bendable portion 18 is still in the sheath 20, heated again to a temperature at which the internal phase changes back to the austenite phase. Shape memory material may also be deposited on the 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, and the controllably bendable portion is pushed outward from the distal end of the sheath, in the absence of a bias or potential applied across the electroactive polymer, the controllably bendable portion will return to its bent shape before it cooled and unbent 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 changed.

[0020] 4 and 5, exemplary connections for connecting the + and - terminals of a power source, such as a capacitor or battery, to opposing electrodes 50 are shown. As shown in FIG. 1, guidewire system 10 herein includes guidewire 12, a sheath 20 surrounding a majority of the length of guidewire 12, and a power supply connector 21 positioned at the proximal end of the guidewire system. Guidewire 12 is generally configured to include a first tubular portion 60, a controllably bendable portion 18, and a flexible member 62 disposed between and interconnecting a distal end 64 of first tubular portion 60 and a proximal end 66 of controllably bendable portion 18, as shown in FIG. 4. Flexible member 62 herein is configured as a coil spring having turns 68 spaced at approximately equal pitch along its length between tubular first portion 60 and controllably bendable portion 18. The flexible member 62 provides flexible support that enables the guidewire assembly 10 to follow the tortuous anatomy of a body lumen as it is guided inside the lumen. Furthermore, to connect the opposing electrodes 50 to a power source, a first wire 70 (FIG. 5) is connected to and extends between one electrode 50 and a first terminal 72 located on the outer surface of the generally tubular portion 60, and a second wire 71 (FIG. 5) is connected to and extends between 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.

[0021] 5 and 6, each of the wires 70, 71 includes an outer insulating coating 86 and an inner conductive core 88 that terminates in a generally flat, trapezoidal portion 90 that forms a terminal. One end of each of the wires 70, 71 is connected to one of the electrodes 50 on the controllably bendable portion by a conductive adhesive 92 (e.g., gold paste), thereby providing an electrical connection between the wires 70, 71 and the terminal 90. As shown in FIGS. 7 and 8, once the terminals 90 are attached to the electrodes 50 on either side 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 threaded through the flexible member 62 and connected to one of the terminals 80, 82 that are received in the power supply connector 21, such as by attaching each of the conductive cores 88 of the wires 70, 72 to the respective terminals 80, 82 using a conductive adhesive. This may be accomplished by drilling holes through the terminals 80, 82 and threading the conductive cores 88 through the holes from within the tubular packaging of the terminals 80, 82, or by other mechanisms. The terminals 80, 82 are circumferentially surrounded by the tubular portion 60 and are spaced apart from one another along the length L of the tubular portion 60. As shown in FIG. 4, the proximal end of the controllably bendable portion 18 is adhered to the distal end of the flexible member 62 with an adhesive 94 (e.g., polyimide or UV curable), which also covers the conductive adhesive 92.

[0022] 9 and 10, there is shown a representative example of the connection between the power supply connector 21 and the controllably bendable portion 18 of the guidewire 12. Here, the power supply connector 21 includes an outer, generally precisely annular housing 100 and an insert 96 received therein, the insert 96 being comprised of a tapered entrance bore 102 that leads to a conduit 104 having a slotted opening 108 along its length, and a cantilevered portion 98 extending therefrom and spaced above the slotted opening 108. The maximum outer diameter of the tapered entrance bore 102 is slightly larger than the inner diameter of the housing 100, and the sidewall 110 of the cantilevered 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 the housing 100. The side of cantilevered portion 98 facing slot opening 108 is provided with first and second spaced-apart, electrically insulated terminals 112 and 114. Conduit 104 is sized to accommodate the proximal end of guidewire 12 and to allow housing 100 and guidewire 12 to rotate relative to one another. The power supply is connected via cable 106 to a DC power source, such as the output of a user-controllable, variable-output AC-DC converter connected to an AC power source. Cable 106 includes two wires 116, 118 extending therethrough, each of which is connected to one of terminals 112, 114 to selectively bias electrodes 50 of controllably bendable portion 18.

[0023] The proximal end of the guidewire 12 is inserted into the housing 100 through the 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 conductive material, such as copper, and each includes a convex portion that overlies the slotted opening 108. The first and second connection terminals 112, 114 are spaced apart by a distance 124 such that the centers of their convex portions are spaced apart the same distance as 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 of the housing 100 without breaking the electrical circuit between the power source and the electrode 50 of the electroactive polymer portion 34 of the controllably bendable section 18. Similarly, because the terminals extend circumferentially around the guidewire 12, rotational orientation of the guidewire 12 does not affect the electrical circuit through the housing 100. Guidewire 12 may be secured to housing 100, such as by crimping onto conduit 104, or an adhesive may be applied between proximal portion 120 of conduit 104 and guidewire 12. Alternatively, guidewire 12 need not be secured to housing 100, and guidewire 12 may rotate therein without interfering with contact between connection terminals 112, 114 and terminals 80, 82.

[0024] 11 and 12, an exemplary alternative configuration for electrical connection of the controllably bendable portion 18 to the electrodes 50 is shown. Here, a wire 71 extends from and through a second terminal 82 on the intermediate portion 14 of the guidewire 12, extends through the intermediate portions 14, 16 of the guidewire 12 (see FIG. 2), and is connected to one of the electrodes 50 on the controllably bendable portion 18 in the same manner as shown in FIGS. 7 and 8. In contrast, the wire 70 is shortened compared to its length in FIGS. 7 and 8 and is connected only between a first terminal 80 at the distal end of the electrical connection portion 16 and the other electrode 50 on the controllably bendable portion 18. Here, both intermediate portions 14, 16 are constructed of an electrically conductive material, such as stainless steel, which is biocompatible with other electrically 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 in a dogleg shape to bias the inner portions of the intermediate sections 14, 16 to allow sliding electrical contact therebetween.

[0025] 13 and 14, exemplary connections attaching wires 70, 72 to terminals 80, 82 are shown, the exemplary connections being the same for each but spaced apart along the length of guidewire 12. Here, the proximal end of tubular shaft 14 of guidewire 12 includes an electrical insulating adapter 130 including a reduced diameter portion 134 extending partially therein and a larger diameter portion 132, with an annular rim 140 formed between the reduced diameter portion 134, 132, spaced apart from the end of guidewire 12. Wire 72, including insulation thereon, extends between the outer wall of reduced diameter portion 134 and enters gap 138 formed between an annular end wall 136 of guidewire 12 and annular rim 140. A portion of the insulation on the portion of wire 72 extending into gap 138 is stripped or removed to expose its conductive core. Terminal 82 is configured as a cylindrical conductor and is positioned in gap 138. The annular end wall 136 includes an insulating coating thereon, and a separate insulating washer is disposed between the annular end wall of the conductive guidewire and the conductive terminal 80. As shown in FIG. 14 , the larger diameter portion 132 is pushed or pressed toward the guidewire 12 to secure the terminal and contact the conductive core of the wire 72 along its inner periphery to complete the connection between the wire 70 and the terminal. While this exemplary connection has been described in terms of a single terminal, it is possible to provide a hollow adapter 130 having a bore extending through its larger and smaller diameter portions, pull the second wire 72 therethrough, and insert a second smaller diameter portion of the second adapter, with the second terminal thereon, inside the bore to electrically connect the second terminal 82 to the conductive core of the second wire 72.

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

[0027] 18, in this embodiment of the introducer device, further configuration of the guidewire and electroactive polymer based introducer device 200 includes a control and power module 218 including a power and control box 220 and an electrical lead portion 222 having a flexible tubular protective cover 234 thereon and 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 formed as a hypotube 260 having a second end 264 receivable within the connection box 228 and a first end 262 distal thereto, the hypotube 260 selectively extending from the connection box 228 (see FIG. 20). As shown in FIGS. 20 and 21, the hypotube 260 includes therein a core formed from a tapered core 250 and an electroactive polymer portion 270 extending from the first end 262 thereof. In this configuration of introducer device 200, coil 280 is positioned over a portion of tapered core 250 at a location within hypotube 260. Connection between electroactive polymer portion 270 and the power source of control and power module 218 is made via conductive tapered core 250 and hypotube 260, each of which is connected to a separate conductor within electrical lead portion 222, with coil 280 providing flexible support that, together with a suitable insulating coating, electrically isolates hypotube 260 and tapered core 250 from each other in the region immediately adjacent electroactive polymer portion 270 where significant bending of hypotube 260 and guidewire 250 may be expected to occur. For example, tapered core 250 is electrically connected to a first side 272 of electroactive polymer portion 270, and an opposite second side 274 of electroactive polymer portion 270 is electrically connected to hypotube 260. To facilitate introduction, the hypotube 260 may include a polymer sheath extending thereover from the first end 262 to the second end 264 thereof.

[0028] 19, tapered core 250 is shown with a portion removed along its length. Tapered core 250 includes a main portion 252 extending from a first end 254 thereof and a tapered portion 258 extending from a second end 256 thereof toward first end 254. Here, approximately 15% of the length of tapered core 250 is formed from tapered portion 258 extending continuously from main portion 252 at junction "J," where the minimum outer diameter d of tapered portion 258 occurring at second end 256 thereof is approximately about 30% of the outer diameter D of main portion 258 along its length. For example, if the overall length "L" of tapered core 250 is, say, 200 cm (i.e., 2 meters), tapered section 258 will extend a length "l" of 30 cm distal from junction box 228 at its second end 256 to junction J of tapered core 250. Furthermore, if the diameter D of main portion 252 is, say, 0.20 mm, tapered section 258 will taper in a continuous or linear manner over length "l" from main portion 252 at junction J to its distal second end 256, such that the outer diameter "d" at the distal end 256 of the guidewire will be approximately 0.064 mm. Although the taper of tapered portion 258 has been described herein as occurring as a linear decrease in diameter over the length of tapered portion 258, a non-linear decrease in diameter along the length "1" from main portion 252 to distal end 256 is also contemplated. The tapering of tapered portion 258 of tapered core 250 adjacent its distal end 256 reduces the stiffness of tapered core 250 thereat and also creates a clearance space between tapered portion 258 and the inner diameter of hypotube 260 to receive conductive coil 280 therebetween.

[0029] 20, a hypotube 260 is shown in cross section, showing a tapered core 250 extending within and along the inner periphery of the hypotube 260, and a coil 280 extending around a portion of the tapered core 250's tapered section 258 adjacent the distal end 256, also within the inner periphery of the hypotube 260. The hypotube 260 and tapered core 250 each provide separate current paths to support selective application or maintenance of a voltage signal or current to thin electrodes, such as gold or silver layers, on opposite first and second sides 272, 274 of an electroactive polymer portion 270. Here, a conductive lead 300 (FIG. 21) extends from the outer peripheral surface of the tapered section 258 and connects to the first side 272 of the electroactive polymer portion 270. 21 , the conductive lead 300 includes a first generally flat first portion 302, a dogleg portion 304 extending therefrom away from the distal second end 256 of the tapered portion 258 of the tapered core 250, a lead portion 306 extending from the dogleg portion 304, and a second generally flat portion 310. The flat first portion 302 is in electrical contact with the tapered portion 258 of the guidewire 250, such as by being spot welded thereto, and the second flat portion 310 is connected to the first side 272 of the electroactive polymer member 270, such as by bonding them together with a first conductive layer 384.

[0030] Here, the hypotube 260 is a thin-walled conductive sleeve, such as a biocompatible stainless steel tube, as shown in FIG. 22, having a second tube end 264 receivable in the junction box 228 and a first tube end 262 configured with a receiving slot 312 having a slot height or width slightly greater than the thickness 316 of the electroactive polymer portion 270 (FIG. 20). By configuring the width 314 of the receiving slot 312 to be slightly greater than the thickness 316 of the electroactive polymer portion 270, the first side 272 of the electroactive polymer portion 270 can be spaced from, and thus electrically isolated from, the inner wall of the receiving slot 312. The hypotube 260 further includes a plurality of cross-cut slots 318 (see FIGS. 22 and 23) cut inwardly from opposing peripheral sides thereof, leaving pairs of opposing circumferentially extending webs 320 between some pairs of slots. The cross-cut slots 318 are formed in only a portion of the hypotube 260 adjacent its second end 256, spaced slightly from the base of the receiving slot 312, and extend along the length of the hypotube 260 a distance slightly greater than the length of the tapered portion 258 of the tapered core 250 disposed therein after assembly, with the cross-cut slots 318 gradually increasing in both the circumferential span of the web 320 and the spacing between the cross-cut slots 318. Here, the slots are laser cut into the normally continuous tube of material comprising the hypotube 260, but may be provided in other ways, such as by physical scoring or milling, or pattern etching, or by other mechanisms.Considering the hypotube 260 in an unbent or untwisted state as shown in FIG. 24 and having a centerline 322, each pair of crosscut slots 318 extends through the wall 324 of the hypotube 260 at a perpendicular (90 degree) angle 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 pair of directly opposed crosscut slots 318.

[0031] 22 illustrates a set of such cross-cut slots 318, where the slot period along the length of the centerline 322 of the hypotube 260 varies in relation to the distance along the hypotube 260 from the first end 262 where the electroactive polymer portion 270 is received in the receiving slot 312. Here, four sets of slots 318a-d, each having a different spacing, different slot depth, or a combination of both, extend across the hypotube 260, with the deepest cross-cut slot 318 being in the first region 318a adjacent the first end 262 of the hypotube 260 and spaced from the receiving slot 312, and these cross-cut slots 318 also being closely spaced along the length of the centerline 322 of the hypotube 260. The crosscut slots 318 of the second set of slots 318 are disposed adjacent to the first set of slots 318a such that the first set of slots 318a is between the first end 262 of the hypotube 260 and the second set of slots 318b. The crosscut slots 318 of the second set of slots 318b are offset longitudinally along the centerline 322 of the hypotube 260 such that circumferentially adjacent crosscut slots 318 about the hypotube 260 are not formed on opposite circumferential sides of the hypotube 260 at the same centerline 322 length from the first end 262 of the hypotube 260. Rather, they are linearly offset in the direction of the centerline 322 of the hypotube 260 by the same distance as adjacent slots 318 along the centerline 322 of the hypotube 260 in the first set of slots 318a. In the third set of slots 318c, the cross-cut slots 318 are again circumferentially opposed to one another and are spaced farther apart along the length of the centerline 322 of the hypotube 260 than the spacing of the slots 318a, b in the first or second sets, with the second set of slots 318b being disposed between the first set of slots 318a and the third set of slots 318c.The fourth set of slots 318d is disposed across the hypotube farther from the first end 262 than the third set of slots 318c, and includes opposing pairs of cross-cut slots 318, each pair being spaced apart gradually along the length of the centerline 322 of the hypotube 260 in a direction away from the second end 256 of the hypotube 260.

[0032] Additionally, the angular distribution of some of the sets of slots relative to one another varies along the length of the hypotube. For example, FIG. 23 illustrates the angles of the sidewalls of two pairs of crosscut slots 318, 318′ immediately adjacent to one another along the length of the hypotube 260. Here, the base walls (solid lines) of the slots 318 extend at an angle A relative to the reference direction D1, while the base walls (dashed lines) of the second set of slots 318′ extend at an angle B relative to the reference direction A, where angle B is less than angle A. In the first, second, and third sets of slots 318a-c, each adjacent crosscut slot 318 is cut at a different angle relative to the reference direction, and the angular difference between one crosscut slot 318 and the next crosscut slot 318 along the length of the hypotube 260 is the same within each slot group 318a-c. This causes the orientation of the crosscut slots 318 to precess along the length of the hypotube, which in turn causes the location of the pivot formed by the web 320 to precess circumferentially around the hypotube 260 along its length, increasing the flexibility of the hypotube 260. In this hypotube, the angular difference between crosscut slots 318 and crosscut slots 318' along the hypotube length in the first through third sets of slots is the same, approximately 10 to 11.25 degrees. In each case, the direction of the angular change is the same from crosscut slot 318 to crosscut slot 318. In the fourth set of slots 318d, each pair of adjacent crosscut slots 318 is offset approximately 90 degrees from the adjacent pair of crosscut slots 318. Additionally, the spacing between the crosscut slots 318 of the first set of slots 318a is 0.0013 inches, the first crosscut slot 318 of the first set of slots 318a is spaced 0.200 mm from the base of the slot 312 along the length of the tube, the slots 312 extend 0.400 mm inward from the first end 262 of the hypotube 260, and the slots 312 are approximately 0.120 mm thick.For example, the hypotube 260 is constructed from 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 (with a portion of the first set of slots 318a removed for clarity in Figure 24), the hypotube 260 includes a continuous outer surface portion 326 extending between the base of the slots 312 and the nearest crosscut slot 318. The second end 256 of the tapered core 250 is disposed along its length inside the hypotube 260, with the conductive leads 300 extending therefrom to the first side 272 of the electroactive polymer portion 270. The slot 312 includes opposing first and second sidewalls 328, 330, and the hypotube 260 is electrically connected to the first sidewall 328 by a conductive adhesive 332 or other mechanism and electrically insulated from the second sidewall 330 using a layer of insulating paste or adhesive 334. 22, the hypotube does not create a short circuit between the first and second side walls 328, 330 of the receiving slot 312 at the first end 262 of the hypotube 260.

[0034] To connect the tapered core 250 and the hypotube 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 hypotube 260, and each is receivable within an opening 340 in the connection box 228. Referring to FIG. 25 , a first dielectric sleeve 342, a hollow connecting band 344, a second dielectric sleeve 346, and a dummy electrode 348 extend sequentially, in that order, from the second end 246 of the hypotube 260. A portion of the main portion 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 connection band 344 by being electrically connected to the interior of the hollow connection band 344, but is not electrically connected to any of the first and second dielectric sleeves 342, 346 or the dummy electrode 348. The connection 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 one another along the opening 340 of the connection box 228, and each of which includes a portion that extends into the opening of the connection box 228. The distance between the portions of the first and second terminals 350, 352 that extend inside the opening 340 is at least as great as the length of the first dielectric sleeve 342, the distance between the portions of the second and third terminals 352, 354 that extend inside the opening 340 is at least as great 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 inside the opening is difference 348. The first end 254 of the tapered core 250 extends outward from a dummy electrode 348 and establishes a spacing 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 the end 264 of the hypotube 260, with the tapered core 250 extending therethrough, into the opening 340 and pushing them in until the end 254 of the tapered core 250 engages 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 therefore the tapered core 250 therein, and the third and fourth terminals 354, 356 both make electrical contact with the dummy electrode 348. By applying a current from one terminal of a power supply (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, current flows through the dummy electrode 348, indicating that the dummy electrode, and thus its connected hypotube 250, guidewire 260, and hollow connection band 344, are properly positioned within the connection box 228 so 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 hypotube 260, respectively. Four wires 360-366 extend from the control and power module 220 through the electrical lead portion 222 and into the connection 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 applied through the first wire 360 ​​and a negative or ground voltage can be applied through the second wire 362 to bend the electroactive polymer portion in a first direction. Reversing these voltages reverses the direction of bending. As previously described herein, the relative voltages, both in polarity (+ or −) and magnitude, applied to the first and second sides 272, 274 of the electroactive polymer portion 270 control the direction and extent of that bending.The third and fourth wires 364, 366 are connected to the third and fourth terminals 354, 356, respectively, and their opposite ends are connected to opposite poles (+, -) of a power supply (not shown) different from that connected to the first and second wires 360, 362, e.g., a battery, when the third and fourth terminals 354, 356 simultaneously contact the dummy electrode 348, thereby completing an electrical circuit and indicating that the connection box 228 is properly connected to the system, which may be indicated by the illumination of an LED or other signaling element in the circuit.

[0036] 27-34, a portion of the manufacturing sequence for introducer device 200 is shown. To prevent shorting between tapered core 250 and hypotube 260, the outer surface of the tapered core is covered with an insulating coating. For example, parylene may be deposited on tapered core 250 by vapor deposition using an adhesion promoter to form insulating coating 370 (FIG. 27), or tapered core 250 may be dipped in electrically insulating epoxy to form the insulating coating thereon, or the insulating coating may be formed using other methods. Next, as shown in FIGS. 28 and 29, coil 280 is slid over a portion of tapered section 258 immediately adjacent second end 256 of tapered core 250 and secured thereto with a non-conductive adhesive 372, such as a non-conductive acrylic adhesive, disposed between the inner diameter of coil 260 and the outer periphery of tapered section 258 and on coil 260. As shown in FIG. 21, the first generally flat portion 302 of the lead 300 and the outer surface of the tapered core 250 are then joined at their second ends by locally removing their insulating coatings 370 and welding or otherwise adhering them together.

[0037] The first end 254 of the tapered core 250, with the lead 300 and coil 280 attached, is then fed into the first end 262 of the hypotube 260 until the first end 254 of the tapered core 250 extends outward from the second end 264 of the hypotube 260, and the lead portion 306 extending from the dogleg portion 306 and the lead second generally flat portion 310 extend outward from the first end 262 of the hypotube 260. As shown in FIG. 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 hypotube 260 at least adjacent the first end 262 of the hypotube 260. This secures the tapered core 250 and the hypotube 260 in place.

[0038] Securement of the electroactive polymer portion 270 to the hypotube 260 is now performed. As shown in FIG. 31 , a coating of adhesive 378 is disposed on 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 within the receiving slot 312 and the opposing first and second sidewalls 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 an insulating filler 382, ​​where the filler 382 extends across the first end of the hypotube 260, and the filler also covers the lead portion 306 of the lead 300, while leaving the second generally planar portion 310 exposed, as shown in FIG. 32 . The exposed second flat portion 310 is then covered by a first conductive layer 384, physically and electrically connecting the flat portion 310 and the first side 272 of the electroactive polymer portion 270. As shown in FIG. 33 , a second conductive layer 386 is filled between the first sidewall 328 of the receiving slot 312 and the second side 274 of the electroactive polymer portion 270 and extends outward from the hypotube 260 along the second side 274 to electrically connect the hypotube 260 and 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, a conductive epoxy, or another conductive adhesive material.

[0039] Next, the hypotube 260 immediately adjacent the first end 262 of the hypotube 260, 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 encapsulant such as silicone, followed by a coating of adhesive such as parylene, followed by a second encapsulant such as silicone (FIG. 34). The parylene is preferably vapor-coated onto the relevant portion of the delivery device, and the silicone may be coated therein by dip coating.

[0040] To use the introducer, the first dielectric sleeve 342, hollow connecting band 344, second dielectric sleeve 346, and dummy electrode 346 are then slid over the portion of the tapered core 250 extending from the second end 264 of the hypotube 260 and adhesively secured thereto. The first dielectric sleeve 342, second dielectric sleeve 346, and dummy electrode 346 are secured to the tapered core 250 using a non-conductive adhesive, and the hollow connecting band 344 and tapered core 250 are secured to each other with a conductive adhesive or a crimp connection to ensure an electrical connection therebetween. The control box 220 may comprise a push button, toggle, or other tactile element that an operator may move or press to selectively apply voltage of a desired polarity and magnitude to the first and second sides 272, 274 of the electroactive polymer portion to achieve the effect shown with respect to the electroactive polymer portion of the bendable portion 18 in FIG. 2 herein.

[0041] 35-49, a further configuration of a guidewire device is shown that utilizes a control and power module 218, a core configured as a tapered core 250 extending within a hypotube 260, an electroactive polymer portion 270, and other components of the device as shown and described with respect to FIGS. 18-24 herein, wherein electrical connection between the power source and the opposing first and second sides 272, 274 of the electroactive polymer portion is provided via dedicated conductors surrounded by insulation, and therefore the tapered core 250 and the hypotube 260 do not need to be electrically isolated from each other.

[0042] As shown in FIG. 35 , in which a portion of the hypotube 260 adjacent the first end 262 thereof is shown in cross section to reveal internal details, a first conductor 400 having a conductive core and surrounding insulation and a second conductor 402 having a conductive core and surrounding insulation extend within the hypotube 206, with the conductive portion of the first conductor 400 electrically connected to the first side 272 of the electroactive polymer portion 270 and the conductive portion of the second conductor 274 connected to the second side 274 of the electroactive polymer portion 270. Here, the conductive portions of the conductors are constructed from a base metal, such as stainless steel, and are covered with a thin layer of gold, although other conductive material covers, such as silver, copper, cobalt, or rhenium, or ruthenium, may also be used as conductors.

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

[0044] The use of the conductors 400, 402 as electrical current paths for applying a desired voltage to the first and second sides 272, 274 of the electroactive polymer portion 270 allows for a relatively simple assembly of a catheter or guidewire comprised of the tapered core 250, hypotube 260, electroactive polymer portion 270, conductors 400, 402, and connecting portions. To assemble the catheter or guidewire, a fish 410 (FIG. 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, 402 are placed on diametrically opposite sides of the tapered core adjacent the first end 254 of the tapered core, and a heat-shrinkable tube 414 is extended thereover so 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 of the heat-shrinkable tube 414. The heat-shrinkable tube 414 is then heated to radially shrink it, physically securing the conductors 400, 402, the fish 410, and the first end 254 of the tapered core together, as shown in FIG. 37 . Prior to this operation, the conductive portions of the conductors 400, 402 extending between the heat-shrinkable tube 414 and the tapered core may be flattened to form flat areas similar to the flat portion 302 of the conductive lead 300, or terminals (not shown) may be connected to each. Such action may be performed when the conductor is pulled through the hypotube 260 and exposed outwardly from its second end 264 .

[0045] The end 412 of the fish 410 is then retracted from the first end 262 to the second end 264 of the hypotube 260, as shown in FIG. 38 , until the heat-shrinkable tubing 410 is positioned outside the second end 264 of the hypotube 260. An adhesive, such as an acrylic adhesive, is then injected into both the first and second ends 262, 264 of the hypotube 260 to form a first adhesive band 420 extending around the exterior of the tapered core 250 and conductors 400, 402 and the interior of the hypotube 260 just inboard from the second end 264, and a second adhesive band 422 extending around the exterior of the tapered core 250 and conductors 400, 402 and the interior of the hypotube 260 just inboard from the first end 262. The conductors 400, 402 extend through the first adhesive band 420 and along the sidewalls of the receiving slot 312.

[0046] The portion of tapered core 250 extending outward from second end 264 of hypotube 260 is then covered with an insulating tube, which is heated above its solidus temperature to reflow and adhere to the outer surface of tapered core 250, allowing a conductor to be disposed thereon. The insulating coverings on conductors 400, 402 are then removed at their ends 406, 408, forming electrical connection 404 (FIG. 40). Next, a first thin-walled tubular insulator 424 is slid over the exposed portion of tapered core 250, and a conductive paste, such as gold paste, is placed inside first thin-walled conductor 426, such that the exposed conductive portion of first conductor 400 is connected to first thin-walled conductor 426 via the paste when first thin-walled conductor 426 is slid over the exposed portion of tapered core 250 and abuts first thin-walled tubular insulator 424. A second thin-walled tubular insulator 428 is then slid over the exposed portion of tapered core 250 and abuts against first thin-walled conductor 426, and a conductive paste, such as gold paste, is disposed inside second thin-walled conductor 430. When second thin-walled conductor 430 is slid over the exposed portion of tapered core 250 and abuts second thin-walled tubular insulator 428, the exposed conductive portion of second conductor 402 is connected to second thin-walled conductor 430 via the paste. A third thin-walled tubular insulator 432 is then slid over the exposed portion of tapered core 250, and a thin-walled detection connector 434, which performs the same function as dummy electrode 348, is slid over the exposed portion of tapered core 250 and abuts third thin-walled tubular insulator 432 and is adhered thereto with an adhesive. This completes the assembly of electrical connection portion 404. The connection portion 404 is configured to be receivable and cooperate in conjunction with the connection box 228 described earlier in this specification.When properly inserted into the opening in 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 and fourth terminals 354 and 356, each of which are spaced apart along the opening 340 in the connection box 228 and each of which includes a portion that extends into the opening in the connection box 228. Thus, a voltage applied to the first terminal 350 is applied to the first side 272 of the electroactive polymer portion 270, a voltage applied to the second terminal 352 is applied to the second side of the electroactive polymer portion 270, and a connection detection circuit is completed when the thin-walled detection connector 434 contacts the third and fourth terminals 354 and 356.

[0047] The electroactive polymer segment 270 is secured within the receiving slot 312 by inserting one end thereof into the receiving slot 312 (where the first and second sidewalls 328, 330 and base of the receiving slot 314 are coated with an adhesive, such as an acrylic adhesive) and contacting the adhesive, which forms an adhesive layer 440 upon hardening. When the end of the electroactive polymer segment 270 is inserted into the receiving slot 312, its flat terminal ends 436, 438 ( FIG. 44 ) are positioned on the opposing first and second sides 272, 274 of the electroactive polymer segment 270. Next, the open area ( FIG. 44 ) between portions of the first and second sides 272, 274 of the electroactive polymer segment 270 and the inner wall of the hypotube 260 is filled with adhesive to form plugs 446, 448 ( FIG. 45 ). The plugs may be formed, for example, from an acrylic adhesive that forms the plugs 446, 448 upon hardening. The flat terminal portions 436, 438 are then electrically connected to the first and second sides 272, 274, respectively, of the electroactive polymer portion by conductive slugs 456, 452. The conductive slugs may comprise, for example, a cured conductive epoxy, such as a gold-filled epoxy (FIG. 46). The exposed portions of the first end 262 of the hypotube 260 and the slugs 456, 452, as well as adjacent portions of the first and second sides 272, 274 of the electroactive polymer portion 270, are then covered with layers of encapsulant 454, 456, respectively, comprised of, for example, a silicone adhesive. Radiopaque marker plates 460, 462 are then attached to the opposing first and second sides 272, 274 of the electroactive polymer portion 270, as shown in FIG. 48. For example, the marker plates 460, 462 are constructed from an alloy of platinum and iridium and are disposed on opposite first and second sides 272, 274 slightly inward from the distal end 464 of the electroactive polymer portion 270. Each marker plate 460, 462 is disposed less than 1 millimeter from the distal end of the electroactive polymer portion 270 and each has a length of less than 1 mm, for example, 0.5 millimeters.Alternatively, 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 layer of gold, in addition to or instead of the marker plates 462, 464. The electroactive polymer portion 272, the encapsulant 454, 456, and adjacent portions of the hypotube 260 are then dipped into and coated with a silicone dispersion, and then the hypotube 260 and the dip-coated electroactive polymer and encapsulant 452, 454 extending therefrom are vapor-phase coated with a coating of, for example, parylene. The vapor-coated electroactive polymer portion 272, encapsulant 454, 456, and adjacent portions of the hypotube 460 are dipped into and coated with a silicone dispersion, the hypotube 260 and dip-coated electroactive polymer and encapsulant 452, 454 are again coated with a vapor coating of, for example, parylene, and the parylene coating is then covered with a hydrophilic coating to complete assembly of the catheter or guidewire portion of the system.

Claims

1. a controllably bendable distal portion having at least a first surface and a second surface opposite the first surface; a proximal electrical connection portion comprising at least a first peripheral conductor and a second peripheral conductor, the first peripheral conductor and the second peripheral conductor being spaced apart from each other in an axial direction of the proximal electrical connection portion and each having a peripheral conductive surface extending in the axial direction; 1. A power supply connector comprising a first connection terminal including a first convex portion and a second connection terminal including a second convex portion, the power supply connector further comprising a tapered inlet bore at a distal side of the power supply connector leading to a conduit having a slotted opening, the proximal electrical connection portion being received in the conduit of the power supply connector through the tapered inlet bore, the power supply connector further comprising a cantilevered portion at an outer side of the conduit facing the slotted opening and extending into the interior of the power supply connector, the diameter of the tapered inlet bore being such that the diameter of the distal side of the power supply connector is greater than the diameter of the conduit of the power supply connector. a power supply connector having a diameter tapered from the proximal side toward the cantilevered portion, the first convex portion and the second convex portion being electrically insulated from each other and provided on the cantilevered portion at the same distance apart as the first peripheral conductor and the second peripheral conductor are spaced apart from each other in the axial direction of the proximal electrical connection portion, the first convex portion electrically connecting to the first peripheral conductor of the proximal electrical connection portion through the slot opening, and the second convex portion electrically connecting to the second peripheral conductor of the proximal electrical connection portion through the slot opening; a first intermediate conductor extending from an electrical connection to the first peripheral conductor to electrically connect to the first side of the controllably bendable distal portion; and a second intermediate conductor extending from an electrical connection to the second peripheral conductor to electrically connect to the second side of the controllably bendable distal portion. A guide wire comprising:

2. the first intermediate conductor is a first conductive wire connected at a proximal end to the first surrounding conductor and connected at a distal end to the first surface of the controllably bendable distal portion; the second intermediate conductor is a second conductive wire connected at a proximal end to the second surrounding conductor and connected at a distal end to the second surface of the controllably bendable distal portion; The guidewire of claim 1 .

3. The guidewire of claim 1 , wherein the tip end of the distal portion of the guidewire is pre-bent.

4. the controllably bendable distal portion an electroactive polymer core having opposed first and second surfaces; a first carbon layer formed on the first surface and a second carbon layer formed on the second surface; The guidewire of claim 1 , comprising:

5. The guidewire of claim 4 , wherein the first carbon layer and the second carbon layer have different thicknesses.

6. The guidewire of 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 guidewire of claim 1 , wherein the first intermediate conductor is a hollow tubular conductor and the second intermediate conductor is a core conductor extending through the hollow tubular conductor.

8. The guidewire of claim 7 , wherein the hollow tubular conductor includes a patterned laser cut on an outer surface of the hollow tubular conductor.

9. The guidewire of claim 7 , wherein the core conductor comprises a coil tube surrounding at least a portion of the distal end of the core conductor.

10. The guidewire of claim 7 , wherein the core conductor comprises a tapered portion at a distal end of the core conductor.

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