Guidewire device

Abstract

A medical guidewire device and method is disclosed that employs an expandable structure or multiple discs to center a core wire to improve torque transfer control. Also disclosed is a guidewire device that includes a radiopaque coil or braid constructed of two or more different materials to improve the formability and shape retention of the device, and a guidewire device that includes an indicator to provide a visual indication of changes in the stiffness profile of the device to assist the physician during clinical use. Also disclosed is a guidewire device that includes a core wire constructed of a metal composite wire to provide more manufacturing options through various combinations of inner core and outer sheath of the metal composite wire and / or through adjusting the metal composite wire inner core fill percentage.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 636,054, filed April 18, 2024, entitled “Device and Method for Centering Core Wires on Hypotube Guidewire,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This application generally relates to medical devices and methods for manufacturing and using medical devices to treat diseases. In particular, various embodiments of guidewire devices and methods are described. Background Technology

[0004] Guidewire devices are widely used in the medical field to guide auxiliary devices to specific locations within a patient's body to perform delicate surgeries, such as guiding catheters deep into the body's vascular system. Guidewire devices often require a variable stiffness profile, typically with the most flexible portion at the distal end, while maintaining good torque transmission for trackability and delivery capabilities in complex anatomical structures.

[0005] Guidewire devices typically consist of a core wire that may have a tapered distal portion reinforced by a structure attached to a non-invasive tip. Traditionally, metal coils or braids have been used as guidewire reinforcements. With advancements in micromachining and laser cutting technologies, slotted hypotubes have also entered the field as device components.

[0006] While progress has been made in the field of guidewire devices, the need for improvement remains. There is a need to center the core wire within the hyaluronic acid tube-based guidewire device to enhance torque transmission and prevent or minimize kinking or swaying. Improved formability and shape retention of hyaluronic acid tube-based guidewires are needed to facilitate passage through tortuous and complex paths. A greater selection of materials for constructing core wires with various support or stiffness profiles is desired. Visual indications of variations in the guidewire's stiffness profile are expected to aid in the delivery of auxiliary devices. Summary of the Invention

[0007] In one aspect, embodiments of the present disclosure feature a guidewire device. Generally, embodiments of the guidewire device include a core wire extending between a proximal end portion and a distal end portion, and a tube member positioned proximate the distal end portion of the core wire. The tube member is fixed to the core wire and defines a space between the core wire and the tube member. An expandable structure is disposed in the space between the core wire and the tube member. The expandable structure is configured to interference fit onto an inner surface of the tube member and includes a proximal end having an opening and a distal end having an opening to allow the core wire to pass through the expandable structure. The openings of the proximal end and the distal end of the expandable structure are substantially aligned with a central longitudinal axis of the tube member and are configured to encircle the core wire, thereby substantially aligning the core wire with the central longitudinal axis of the tube member.

[0008] In another aspect, embodiments of the present disclosure feature a guidewire device. Generally, embodiments of the guidewire device include a core wire extending between a proximal end portion and a distal end portion, and a tube member positioned proximate the distal end portion of the core wire. The tube member is fixed to the core wire and defines a space between the core wire and the tube member. A plurality of discs are coupled to the distal end portion of the core wire. The plurality of discs are spaced apart from one another and are configured to interference fit onto an inner surface of the tube member. The plurality of discs each include an opening configured to allow the core wire to pass through and substantially align the core wire with a central longitudinal axis of the tube member.

[0009] In another aspect, embodiments of the present disclosure feature a guidewire device. Generally, embodiments of the guidewire device include a core wire extending between a proximal end portion and a distal end portion, a tube member positioned proximate the distal end portion of the core wire and coupled to the core wire, and a radiopaque marker in the tube member and coupled to the core wire, wherein the radiopaque marker includes a first material that is radiopaque and a second material that is plastically deformable.

[0010] In another aspect, embodiments of the present disclosure feature a guidewire device. Generally, embodiments of the guidewire device include a core wire and an indicator fixed to the core wire. A distal end portion of the core wire includes a first portion having a first stiffness profile and a second portion having a second stiffness profile different from the first stiffness profile. The indicator is positioned at a junction of the first portion and the second portion to provide a visual indication of a change in the stiffness profile of the core wire.

[0011] In another aspect, embodiments of the present disclosure feature a guidewire device. Generally, embodiments of the guidewire device include a core wire extending between a proximal end portion and a distal end portion. The core wire includes a drawn filled tube (DFT) wire including an inner core of a first material and an outer sheath of a second material different from the first material.

[0012] This Summary is provided to introduce a selection of aspects and embodiments of the present disclosure in a simplified form and is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter. The selection and presentation of aspects and embodiments presented in this Summary are intended to provide a summary of some features of the application and not to be used to determine the scope of the application. Other aspects and embodiments of the present disclosure are described in the detailed description.

[0013] These and various other aspects, embodiments, features and advantages of the present disclosure will be better understood with regard to the following detailed description when read in conjunction with the appended drawings. BRIEF DESCRIPTION OF DRAWINGS

[0014] FIG. 1 is a simplified illustration of an example guidewire device according to embodiments of the present disclosure.

[0015] FIG. 2 is a simplified illustration of a guidewire device shown in FIG. 1 with components separated to more clearly show the core wire, tube member, and other components.

[0016] FIG. 3 is a simplified illustration of a guidewire device shown in FIG. 1 with components separated to more clearly show the core wire, tube member, and other components.

[0017] FIG. 4 schematically illustrates the use of a stent-like structure for centering a core wire in a guidewire device according to embodiments of the present disclosure.

[0018] FIG. 5 depicts a cut-tube structure that can be used to center a core wire in a guidewire device according to embodiments of the present disclosure.

[0019] FIG. 6 depicts an expanded state of the cut-tube structure shown in FIG. 5 .

[0020] FIG. 7 shows a nail-crown structure that can be used to center a core wire in a guidewire device according to embodiments of the present disclosure.

[0021] FIG. 8 depicts an expanded state of the nail-crown structure shown in FIG. 7 .

[0022] FIG. 9 schematically illustrates the use of multiple disc structures for centering a core wire in a guidewire device according to embodiments of the present disclosure.

[0023] FIG. 10 is a simplified illustration of a guidewire device shown in FIG. 9A cross-sectional end view of the illustrated guidewire device taken along line B-B.

[0024] FIG. 11 An example disk-shaped structure that can be used to center a core wire in a guidewire device is depicted in accordance with embodiments of the present disclosure.

[0025] FIG. 12 Another disk-shaped structure that can be used to center a core wire in a guidewire device is depicted in accordance with embodiments of the present disclosure.

[0026] FIG. 13 A simplified illustration of an example guidewire device in accordance with embodiments of the present disclosure.

[0027] FIG. 14 A simplified illustration of an example core wire including a radiopaque marker coupled to a distal portion of the core wire in accordance with embodiments of the present disclosure.

[0028] FIG. 15 An example radiopaque coil is depicted in accordance with embodiments of the present disclosure.

[0029] FIG. 16 An example radiopaque coil is depicted in accordance with alternative embodiments of the present disclosure.

[0030] FIG. 17 An example radiopaque coil is depicted in accordance with alternative embodiments of the present disclosure.

[0031] FIG. 18 An example radiopaque braid is depicted in accordance with embodiments of the present disclosure.

[0032] FIG. 19 A simplified illustration of an example guidewire device in accordance with embodiments of the present disclosure.

[0033] FIG. 20 A simplified illustration of an example guidewire device is depicted in accordance with embodiments of the present disclosure. FIG. 19 A simplified illustration of the illustrated guidewire device with the tube member removed to more clearly show the core wire and other components.

[0034] FIG. 21 A simplified illustration of an example guidewire device is depicted in accordance with embodiments of the present disclosure. FIG. 19 A cross-sectional end view of the illustrated example guidewire device taken along line C-C.

[0035] FIG. 22 A simplified illustration of an example core wire in accordance with embodiments of the present disclosure.

[0036] FIG. 23A A simplified illustration of an example core wire is depicted in accordance with embodiments of the present disclosure. FIG. 23B A simplified illustration of an example core wire is depicted in accordance with embodiments of the present disclosure. FIG. 23C A simplified illustration of an example core wire is depicted in accordance with embodiments of the present disclosure. DETAILED DESCRIPTION

[0037] Various embodiments of guidewire devices and methods will now be described with reference to the drawings. The drawings are intended to facilitate the description of the embodiments of the present disclosure and are not necessarily drawn to scale. Certain specific details of the disclosure can be set forth in the drawings, which are intended to provide a thorough understanding of the overall description of the present disclosure. Those of ordinary skill in the art will appreciate that some of the specific details of the disclosure can not be used to practice the embodiments of the present disclosure. In other instances, well-known structures, components, systems, materials, and / or operations have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present disclosure.

[0038] The present disclosure provides guidewire devices that include unique features that can improve the performance of the devices. Embodiments of the present disclosure use metal composite wire to construct the core wire, allowing more material selection through various combinations of inner core and outer sheath within the metal composite wire and / or through adjustment of the core fill percentage within the metal composite wire. Radiopaque coils or braids that include two or more different materials can be coupled to the distal end of the core wire to improve the formability and shape retention of the guidewire device. Indicators can be attached to the core wire to provide a visual indication of the change in the stiffness profile of the core wire to assist the physician during clinical use. Embodiments of the present disclosure also provide methods of centering the core wire in a hypotube-based guidewire device to improve torque transfer control and other performance.

[0039] FIGS. 1-2 An example guidewire device 100 according to embodiments of the present disclosure is schematically illustrated. The guidewire device 100 is generally configured for use in conjunction with a medical device to perform a procedure such as a neurological, cardiac, or peripheral vascular intervention. One example application of the guidewire device 100 of the present disclosure is for guiding a catheter deep into a neurovascular system. In general, the guidewire device 100 includes an elongate core wire 110 and a tube member 150 coupled to the core wire 110. The core wire 110 extends between a proximal portion 112 and a distal portion 114 and has a length suitable for a particular application. The distal portion 114 of the core wire 110 can taper distally to provide greater bending flexibility. The proximal portion 112 of the core wire 110 can have an increased diameter to maintain pushability and torsional stiffness of the guidewire device 100. The tube member 150 can be located near the distal portion 114 of the core wire 110 and secured to the core wire 110 to provide reinforcement and improve the performance of the guidewire device 100. The tube member 150 can be secured to the distal portion 114 of the core wire 110 via various means (e.g., adhesion, welding, brazing, etc.) to allow the transfer of torsional forces from the proximal portion 112 of the core wire 110 to the tube member 150 and / or from the tube member 150 to the distal portion 114 of the core wire 110. In the space defined between the tube member 150 and the distal portion 114 of the core wire 110, various features such as radiopaque markers, centering devices, core wire stiffness indicators, etc. can be provided. FIGS. 1-2Various components of the guidewire device 100 (not shown) perform various functions, as will be described in greater detail below. The tube member 150 can be a hypotube constructed of a shape memory material and can include a plurality of cuts 152 configured to improve the effectiveness of the guidewire device 100, for example, to provide a desired balance between bending flexibility, torsional stiffness, tensile strength, and the like. The plurality of cuts 152 can be vertical cuts and / or helical cuts extending circumferentially around a central longitudinal axis of the tube member. U.S. Ser. No. 18 / 963,683, filed November 28, 2025, entitled “Guidewire and Medical Device including Laser Cut Tube,” and U.S. Ser. No. 19 / 043,429, filed February 1, 2025, entitled “Intravascular Medical Devices Including Laser Cut Tube,” describe various embodiments of cut tube structures and can be used as the tube member of the guidewire device. The disclosures of U.S. Ser. Nos. 18 / 963,683 and 19 / 043,429 are hereby incorporated by reference in their entireties. Alternatively, a polymeric sheath can be used as a reinforcing structure in place of the tube member 150. The atraumatic tip 116, which can be, for example, circular, can be formed at the distal end of the guidewire device 100 to prevent damage to the blood vessel.

[0040] Core wire centering

[0041] Referring to FIGS. 3-12 Various embodiments of devices and methods for centering a core wire in a guidewire device are now described.

[0042] FIG. 3 Is FIG. 1 A simplified illustration of a cross-sectional end view of the guidewire device 100 showing the core wire 110, the tube member 150 surrounding the core wire 110, and a space 120 defined between the tube member 150 and the core wire 110 at the distal end portion 114 of the guidewire device 100. At the distal end portion 114 of the guidewire device 100, the space 120 between the tube member 150 and the core wire 110 can increase as the guidewire size increases, for example, from 0.010 inches to 0.014 inches, 0.018 inches, 0.024 inches, and 0.038 inches, and the like.

[0043] One issue associated with traditional hypotube-based guidewire devices is that the core wire is not aligned with the central longitudinal axis of the hypotube, i.e., the core wire is radially offset from the center, particularly in the distal portion of the guidewire device. Misalignment of the core wire can result in reduced torque transfer control, erratic tip behavior, and other issues. These issues can be exacerbated when the guidewire is navigating through tortuous vessels having complex curves, where the relatively stiffer core wire does not bend as much as the relatively softer hypotube. Severe misalignment of the core wire can result in guidewire tip oscillation and loss of torque control, which would negate the purported advantage of a hypotube-based guidewire - fine-tuned torque control of the guidewire tip for navigating through selected anatomical structures.

[0044] Traditional methods of centering the core wire use one or more coils to occupy the free space between the core wire and the hypotube. In traditional methods, the centering coil does not provide functionality other than simply filling the space between the core wire and the hypotube. Moreover, traditional solutions are not easily scalable as the space between the core wire and the hypotube becomes larger in large guidewire devices, requiring redesign of the centering coil.

[0045] According to embodiments of the present disclosure, an expandable structure is used to center the core wire in the tubular member of the guidewire device, or to align the core wire with the central longitudinal axis of the tubular member. Generally, the expandable structure is configured to interference fit onto the inner surface of the tubular member. The expandable structure includes a proximal end having an opening and / or a distal end having an opening to allow the core wire to pass through the expandable structure. The proximal end opening and / or the distal end opening of the expandable structure is substantially aligned with the central longitudinal axis of the tubular member and is sized or configured to surround the core wire, thereby substantially aligning the core wire with the central longitudinal axis of the tubular member.

[0046] Reference will now be made to FIG. 4According to embodiments of the present disclosure, the expandable structure 160 for centering the core wire 110 includes, for example, a stent-like structure 160 having a plurality of struts of various shapes and sizes. The stent-like structure 160 includes a collapsed state and an expanded state. The stent-like structure 160 includes a proximal end portion 162, a distal end portion 164, and a body portion 166. Each of the proximal end portion 162 and the distal end portion 164 can be tapered and have an opening sized or configured to allow the core wire 110 to pass through. The body portion 166 can have a predefined, for example, cylindrical, expanded configuration that can be interference fit onto the inner surface 152 of the tube member 150 and exert an outward radial force on the tube member 150. The openings in the tapered proximal end portion 162 and the distal end portion 164 can be similar to or slightly larger than the cross-sectional dimension of the core wire 110 and substantially aligned with each other on the central longitudinal axis 151 of the tube member 150, allowing the core wire 110 to self-center radially within the tube member 150. In alternative embodiments, the tapered proximal end portion 162 and / or the distal end portion 164 can be fixed to the core wire 110 via any suitable means, such as adhesion, welding, brazing, crimping, etc.

[0047] The stent-like structure 160 can be woven using two or more filaments, such as Nitinol filaments or other metallic or polymeric shape memory materials. Alternatively, the stent-like structure 160 can be formed by creating a plurality of holes in a tube member of shape memory material using a laser, a blade, or other suitable means. Shape memory materials tend to have temperature-induced phase transitions, causing the material to have a preferred configuration or shape that can be set by heating the material above a particular transition temperature. The stent-like structure 160 “remembers” the shape set during the heat treatment and tends to assume that shape when the structure is placed above the transition temperature. According to embodiments of the present disclosure, to facilitate assembly, the transition temperature can be selected to be above room temperature but below body temperature. This allows the stent-like structure 160 to expand and form an interference fit with the tube member 150 only after it is introduced into the body. Suitable metallic shape memory materials for constructing the stent-like structure 160 include, but are not limited to, alloys of nickel titanium (NiTi) or Nitinol®, CuZnAl, FeNiAl, etc. Suitable polymeric shape memory materials for constructing the stent-like structure 160 include, but are not limited to, polytetrafluoroethylene (PTFE), polylactic acid (PLA), ethylene-vinyl acetate (EVA), etc.

[0048] According to embodiments of the present disclosure, one or more stent-like structures 160 can be used to center the core wire 110 based on the size, design, or application of the guidewire device 100.

[0049] FIGS. 5-6 Another example expandable structure 170 according to alternative embodiments of the present disclosure is shown. FIGS. 5-6The expandable structure 170 shown in the middle includes a tubular body 171 of shape memory alloy or polymer. The tubular body 171 is provided with a plurality of longitudinal slits or cuts 172 that form a plurality of strands 173 extending between a proximal portion 174 and a distal portion 175 of the tubular body 171. The cut tube structure 170 can have a non-expanded state ( FIG. 5 ) and an expanded state ( FIG. 6 ). The cut tube structure 170 can be heat set to provide a predefined expanded shape, for example, at body temperature, causing the plurality of strands 173 to bend outward and exert a radial force on the tube member 150 of the guidewire device 100, allowing the cut tube structure 170 to be interference fit onto the inner surface 152 of the tube member 150 of the guidewire device 100. The openings in the proximal portion 174 and the distal portion 175 can be similar to or slightly larger than the cross-sectional dimension of the core wire 110 and are substantially aligned with each other on the central longitudinal axis 151 of the tube member 150, allowing the core wire 110 to self-center radially within the tube member 150. In alternative embodiments, the proximal portion 174 and / or the distal portion 175 can be fixed to the core wire 110 via any suitable means, such as adhesion, welding, brazing, etc. Suitable metallic shape memory materials for the tubular body structure 170 include, but are not limited to, nickel-titanium (NiTi) or Nitinol®, CuZnAl, FeNiAl, etc. alloys. Suitable polymeric shape memory materials for constructing the tubular body structure 170 include, but are not limited to, polytetrafluoroethylene (PTFE), polylactic acid (PLA), ethylene-vinyl acetate (EVA), etc.

[0050] FIGS. 7-8 Another example expandable structure 180 according to alternative embodiments of the present disclosure is shown. FIGS. 7-8 The expandable structure 180 shown includes a spike crown-like structure 180 that includes an annular band portion 182 and a plurality of elongated elements 183 extending from the annular band portion 182. The spike crown-like structure 180 can have a non-expanded state ( FIG. 7 ) and an expanded state ( FIG. 8). The crown structure 180 is composed of a shape memory alloy or polymer and heat set to provide a predefined expanded shape, causing the plurality of elongate elements 183 to bend outward away from the annular band portion 182 and exert a radial force against the tube member 150, allowing the crown structure 180 to be interference fit onto the inner surface 152 of the tube member 150 of the guidewire device 100. The opening in the annular band portion 182 of the crown structure 180 can be similar to or slightly larger than the cross-sectional dimension of the core wire 110 and substantially aligned on the central longitudinal axis of the tube member 150, allowing the core wire 110 to be radially self-centered within the tube member 150. In alternative embodiments, the annular band portion 182 can be fixed to the core wire 110 via suitable means, such as adhesion, welding, brazing, etc. Suitable metallic shape memory materials for the crown structure 180 include, but are not limited to, nickel-titanium (NiTi) or Nitinol®, CuZnAl, FeNiAl, etc. alloys. Suitable polymeric shape memory materials for constructing the crown structure 180 include, but are not limited to, polytetrafluoroethylene (PTFE), polylactic acid (PLA), ethylene-vinyl acetate (EVA), etc.

[0051] Referring to FIGS. 9-12 alternative embodiments of the present disclosure provide a method of centering the core wire by using disc structures 190. A plurality of discs 190 can be coupled to the distal end portion of the elongate core wire 110. The plurality of discs 190 can be spaced apart from each other and configured to be interference fit onto the inner surface 152 of the tube member 150. Each disc 190 of the plurality of discs 190 includes an opening 192 configured to allow the core wire 110 to pass through and be substantially aligned with the central longitudinal axis 151 of the tube member 150.

[0052] Each disc 190 of the plurality of discs 190 can generally be circular or annular in shape with a circumferential profile suitable for interference fit onto the inner surface 152 of the tube member 150. As shown in FIG. 11 the opening 192 in the disc 190 can be circular and centered on the central longitudinal axis 151 of the tube member 150 when the disc 190 is disposed in the tube member 150. The circular opening 192 in the disc 190 FIG. 11 may be similar to or slightly larger than the cross-sectional diameter of the core wire 110, allowing the core wire 110 to be radially self-centered within the tube member 150. Alternatively, the disc 190 can be fixed to the core wire 110 via any suitable means, such as adhesion, welding, brazing, etc.

[0053] In alternative embodiments, the opening 192 in the disc 190 can be a slot 194 FIG. 12 extending from the center of the disc 190 to the periphery of the disc 190. By inserting the core wire 110 into the slot 192 in the disc 190 from the periphery of the disc 190, the slot 192 in the disc 190 FIG. 12) can be simplified. The confining dimension of the slot 192 can be similar to or slightly larger than the cross-sectional diameter of the core wire 110 to allow the core wire 110 to be substantially centered within the tube member 150 when in use. The disk 190 with the slot 192 FIG. 12 ) can also be secured to the core wire 110 via any suitable means, such as adhesion, welding, brazing, etc.

[0054] The disk 190 can be composed of a polymeric material. Suitable polymeric materials include, but are not limited to, polyethylene, polypropylene, polyphenyl, acetal copolymer, nylon, and other suitable polymers.

[0055] The core wire centering method of the present disclosure uses an interference fit between the centering components 160, 170, 180, 190 and the tube member 150, allowing the core wire 110 to be better centered than traditional centering coils because traditional designs must leave space between the centering coil and the tube member and have no direct contact or connection to the tube member. The centering method of the present disclosure can be easily scaled up because for larger diameter tube members, the expandable structures 160, 170, 180 can expand to a larger outer diameter, whereas in traditional methods, for larger guidewire devices, such as guidewires equal to or larger than 0.014 inches, as the space between the coil and the tube member increases, the centering coil needs to be redesigned. Additionally, the expandable structures 160, 170, 180 or the disk 190 can be directly secured to the core wire 110, allowing the core wire 110 and the tube member 150 to align 1 to 1 as the core wire 110 is rotated to improve torque control of the guidewire device 100.

[0056] Radiopaque markers on core wire distal tip

[0057] Referring to FIGS. 13-18 Various embodiments of a guidewire device including radiopaque markers on a distal portion of the core wire are now described. The radiopaque markers include two or more different materials configured to improve the formability and shape retention of the guidewire device.

[0058] Formability and shape retention are important characteristics of the performance of a guidewire device. Formability is the ability of a guidewire to be manually shaped or bent in the distal portion before use to accommodate different vascular anatomies. Having good formability is particularly useful for a guidewire to navigate through tortuous and complex vascular pathways, such as the nervous or cardiovascular systems. Shape retention is the ability of a guidewire to maintain the shape it has been imparted with. It ensures that the guidewire maintains the shape curve or angle, allowing for stable and predictable navigation.

[0059] Deformable materials, such as stainless steel and nickel-cobalt alloys (e.g., MP35N), have been used to construct wire cores due to their formability and shape retention. Deformable materials can deform without breaking when subjected to stresses exceeding their elastic limits. This ability, or plasticity, allows the material to change shape and retain the new form after the applied force is removed. Shape memory thiocarbamates, on the other hand, have been used as components in wire guidewire devices to improve performance. For example, some conventional wire guidewire devices include shape memory slotted thiocarbamates located at the distal tip of the wire to improve torque control. Transmissive coils of pure metals (such as platinum (Pt)) are often placed within the thiocarbamate for visualization of the distal tip's position. While a thiocarbamate at the distal tip of the wire can improve the device's torque capability, its shape memory nature will force it to revert to its initial or predefined configuration after deformation upon exposure to body temperature. Therefore, due to the tendency of shape memory thiocarbamates to revert to their initial or predefined configuration, they can adversely affect the formability and shape retention of the wire guidewire device.

[0060] According to embodiments of this disclosure, radiopaque markers made of two or more different materials are used to help maintain or improve the formability and shape retention of the guidewire device. For example... FIG. 13 As shown, the example guidewire device 200 of this disclosure includes an elongated core wire 210 extending between a proximal portion 212 and a distal portion 214, a tubular member 250 coupled to the distal portion 214 of the core wire 210, and a radiopaque marker 260 in the tubular member 250 and coupled to the core wire 210. The radiopaque marker 260 includes a first radiopaque material and a second malleable material. While the first radiopaque material provides radiopaque linearity, the malleable second material helps maintain the shape of the distal portion of the guidewire device 200. In an embodiment, the tubular member 250 is made of a shape memory material and includes a plurality of slits 252 extending circumferentially around the central longitudinal axis of the tubular member. The radiopaque marker 260 of this disclosure can provide resistance to the tendency of the shape memory tubular member 250 to return to its initial or predefined configuration, thereby improving the formability and retention of the guidewire device 200.

[0061] According to embodiments of this disclosure, the first radiopaque material of the radiopaque marker can be any suitable radiopaque material visible by fluorescence, including but not limited to tungsten, platinum, iridium, gold, tantalum or any alloy thereof, such as platinum-iridium alloy, platinum-tungsten alloy, etc.

[0062] According to embodiments of this disclosure, the second material for the plastic deformation of the non-transparent marker can be a metal, metal alloy, or metal composite, including but not limited to stainless steel, nickel-cobalt (e.g., MP35N), nickel-titanium alloy (e.g., nitinol), cobalt-chromium alloy, platinum alloy, titanium alloy, etc.

[0063] Referring to FIG. 14 , according to embodiments of the present disclosure, the radiopaque marker 260 can be in the form of a coil that wraps a portion of the core wire distal portion 214. The radiopaque coil 260 can be secured to the core wire 210 via adhesion, welding, soldering, crimping, or any other suitable means. The pitch of the radiopaque coil 260 can be constant or varied. For example, the radiopaque coil 260 can have a varied winding pitch that increases toward the distal end to increase the flexibility of the guidewire tip, and / or to decrease the stiffness caused by the plastically deformable material used in the radiopaque coil 260.

[0064] Referring to FIGS. 15-16 , according to embodiments of the present disclosure, the radiopaque marker coil 260 can be formed from a metal composite wire 261 that includes an inner core 262 and an outer sheath 264. For example, the metal composite wire 261 can be a drawn-filled tubing (DFT) wire that includes an inner core 262 of a radiopaque material, such as tungsten, platinum, iridium, gold, tantalum, or any alloy thereof, and an outer sheath 264 of a plastically deformable material, such as stainless steel, nickel-cobalt alloy, nickel-titanium alloy, cobalt-chromium alloy, platinum alloy, titanium alloy, or the like. In some embodiments, the metal composite wire 261 can be a round wire or have a circular or substantially circular cross-section, as shown in FIG. 15 In some embodiments, the metal composite wire 261 can be a ribbon or flat wire, or have a non-circular cross-section, such as a rectangular shape, as shown in FIG. 16 Using a ribbon or flat metal composite wire 261 FIG. 16 , the radiopaque marker coil 260 can be formed such that the wider dimension of the inner core 262 is in the radial direction when secured to the distal portion 214 of the core wire 210. This arrangement or design will allow more radiopaque material to block radiation during fluoroscopy, thereby increasing the radiopacity of the marker coil 260.

[0065] Referring to FIG. 17According to embodiments of the present disclosure, the radiopaque marker coil 260 can be formed from a double strand wire 265 including a first wire 266 and a second wire 268 parallel to the first wire 266. The first wire 266 of the double strand wire 265 can include a radiopaque material, such as tungsten, platinum, iridium, gold, tantalum, or any alloy thereof. The second wire 268 of the double strand wire 265 can include a plastically deformable material, such as stainless steel, nickel-cobalt alloy, nickel-titanium alloy, cobalt-chromium alloy, platinum alloy, titanium alloy, or the like. The first wire 266 of the radiopaque material and the second wire 268 of the plastically deformable material can be co-wound around a portion of the core wire distal end portion 214, allowing the first wire 266 of the radiopaque material and the second wire 268 of the plastically deformable material to alternate but not cross each other in the radiopaque marker coil 260.

[0066] Referring to FIG. 18 According to embodiments of the present disclosure, the radiopaque marker 260 can be in the form of a braid. The radiopaque braid 260a will provide greater shape retention capability than the radiopaque coil, as there is friction between each crossing point of the braid. The radiopaque braid 260a can be thicker than the radiopaque coil and can be more useful in larger size (such as 0.024 or 0.035 inch) guidewire devices. The radiopaque braid 260a can be secured to the core wire distal end portion 214 via crimping, adhesion, welding, brazing, or any other suitable means.

[0067] The radiopaque braid 260a can be constructed from two or more metal composite wires, such as DFT wires. Each of the two or more DFT wires can include an inner core of a radiopaque material, such as tungsten, platinum, iridium, gold, tantalum, or any alloy thereof, and an outer sheath of a plastically deformable material, such as stainless steel, nickel-cobalt alloy, nickel-titanium alloy, cobalt-chromium alloy, platinum alloy, titanium alloy, or the like, as described above in connection with the radiopaque coil.

[0068] According to embodiments of the present disclosure, the radiopaque braid 260a can be formed from two or more different wires. The two or more different wires can include a first wire of a radiopaque material, such as tungsten, platinum, iridium, gold, tantalum, or any alloy thereof, and a second wire of a plastically deformable material, such as stainless steel, nickel-cobalt alloy, nickel-titanium alloy, cobalt-chromium alloy, platinum alloy, titanium alloy, or the like.

[0069] Referring back to FIG. 13According to embodiments of the present disclosure, the guidewire device 200 can include a radiopaque tip 216 coupled to the core wire 210 and / or the distal end of the tube member 250. The radiopaque tip 216 can be a radiopaque metal ball, such as a platinum or gold ball, affixed to the core wire tip via adhesion, brazing, welding, or other suitable means. Alternatively, a radiopaque solder or epoxy can be used to form the radiopaque tip 216 at the distal end of the core wire 210 and / or the tube member 250. While the use of a radiopaque coil 260 or braid 260a comprising a plastically deformable material can reduce the radiopacity of the marker coil or braid, the use of a gold solder, gold epoxy, platinum ball, or other radiopaque material in the tip 216 will enable the physician to readily identify the radiopaque tip representative of the guidewire device 200.

[0070] Advantageously, embodiments of the present disclosure include a plastically deformable material in the radiopaque marker to improve the formability and shape retention of the guidewire device. Conventional guidewire devices, particularly those based on shape memory hypotube, use pure metal coils, such as platinum and tantalum coils, on the distal end of the core wire for radiopacity, and there is a problem in that it is difficult to shape the guidewire tip or retain the shape imparted thereto while in use. The radiopaque marker of the present disclosure can be constructed from a metal composite wire comprising a plastically deformable material in the outer sheath, or from a double-stranded wire comprising a plastically deformable material in the wire, or in the form of a braid in which at least one wire in which the braid is manufactured comprises a plastically deformable material. The radiopaque marker of the present disclosure includes a plastically deformable material that significantly improves the formability and shape retention of the guidewire device. The pitch of the marker coil can vary throughout its length to account for the stiffness of the plastically deformable material. The guidewire atraumatic tip can be constructed from a radiopaque material to account for the lighter color due to the use of the plastically deformable material. Alternatively, or in addition, a ribbon or flat metal composite wire can be used to improve the radiopacity of the marker coil.

[0071] Core wire support ramp-up indicator

[0072] Reference FIGS. 19-21 Embodiments of a guidewire device including an indicator for indicating a change in the support or stiffness profile of the core wire will now be described.

[0073] Guidewires having various support or stiffness profiles are commonly provided by manufacturers, such as soft, standard, and support profiles, among others. Different support or stiffness profiles provide the physician with a choice when it comes to the assisted product access and delivery. For example, a guidewire having a softer profile can be preferred when accessing more distal anatomy, while a stiffer guidewire can be considered for the delivery of a heavier device, such as a balloon.

[0074] A guidewire device includes a core wire that generally runs through the length of the device. The core wire serves as a central structural support in order to provide a stiffness profile for the guidewire device to be pushable, torque transmitting, and flexible. In order to achieve a desired stiffness or support profile, the shape or profile of the core wire can vary along the length, for example, by grinding. Grinding away more material results in a softer core wire or a softer portion of the core wire, and vice versa. There are typically significant points in the ground profile where the stiffness rises more sharply than at other locations, and this increase in stiffness can be felt on the assembled guidewire and directly impacts the performance of the device. It is desirable to provide a clear visual indication showing the variation in the support profile, for example, the rise in stiffness. Knowing where the support profile rises during use can help the physician to properly position the guidewire during delivery of the secondary product.

[0075] Referring to FIGS. 19-21 An example guidewire device 300 according to embodiments of the present disclosure includes an elongate core wire 310 having a varying support or stiffness profile and an indicator 360 secured to the core wire 310 to provide a visual indication of the variation in the stiffness profile of the core wire 310. The guidewire device 300 can also include a tubular sleeve 350 or polymeric sheath proximate to or over a distal portion of the core wire 310 to provide reinforcement. As shown, the example tubular sleeve or tube member 350 can include a plurality of cuts or slots 352 configured to improve the effectiveness of the guidewire device. While the example guidewire device 300 is shown as having a single tubular sleeve 350, it is contemplated that the guidewire device 300 can include two or more tubular sleeves 350, for example, to provide a more gradual transition from the distal portion of the core wire 310 to the proximal portion of the core wire 310. FIGS. 19-21 While not shown in FIG. 1, the guidewire device 300 can also include other components, for example, components for radially centering the core wire in the tube member and / or distal radiopaque markers as described in connection with other embodiments of the present disclosure, or other components known in the art.

[0076] Referring to FIG. 20 The elongate core wire 310 can extend between a proximal portion 312 and a distal portion 314, for example, through the length of the guidewire device 300. The elongate core wire 310 can be constructed of a single continuous piece of material, for example, stainless steel, cobalt-chrome alloy, nickel-titanium alloy, platinum alloy, titanium alloy, or DFT composite, as will be described in greater detail below. The core wire 310 can also be constructed of two or more segments of different materials connected, for example, via welding, brazing, adhesion, or mechanical locking.

[0077] Referring to FIG. 20 The core wire 310 has a varying profile or geometry along the length of the core wire 310. Generally, the distal portion 314 of the core wire 310 has a reduced profile to optimize the flexibility of the guidewire device 300 at the distal end for enhanced maneuverability. The proximal portion 312 of the core wire 310 can have an enlarged profile to maintain the pushability and torsional stiffness of the guidewire device 300. The core wire 310 can include one or more tapered portions in the distal portion 314 and the proximal portion 312 to facilitate a gradual transition from the reduced profile to the enlarged profile.

[0078] For example, the distal portion 314 of the core wire 310 can include a distal or first portion 314a and a proximal or second portion 314b. The first portion 314a of the distal portion 314 can have a profile or geometry with a constant cross-sectional dimension. For example, the first portion 314a of the distal portion 314 can be flat or circular with a constant cross-sectional dimension, e.g., constant rectangular, circular, oval, etc. The second portion 314b of the distal portion 314 can be tapered with a varying cross-sectional dimension, e.g., a diameter or area that increases in the proximal direction.

[0079] Likewise, the proximal portion 312 of the core wire 310 can include a distal or first portion 312a and a proximal or second portion 312b. The second portion 312b of the proximal portion 312 can have a profile or geometry with a constant cross-sectional dimension. For example, the second portion 312b of the proximal portion 312 can be cylindrical with a constant diameter. The first portion 312a of the proximal portion 312 can be tapered with a varying cross-sectional dimension, e.g., a diameter or area that decreases in the distal direction.

[0080] Referring to FIG. 20 The tapered portion 314b of the distal portion 314 and / or the tapered portion 312a of the proximal portion 312 of the core wire 310 can have a taper angle ranging from 0.01 degrees to 0.06 degrees with respect to the longitudinal axis of the core wire. The value of the taper angle represents the degree of abruptness of the change in the stiffness profile of the core wire 310. A smaller taper angle represents a gradual or progressive change in the stiffness profile, while a larger taper angle represents a sharp rise in the stiffness profile. For example, the tapered portion 314b at the distal portion 314 of the core wire 310 can have a taper angle ranging from 0.02 degrees to 0.05 degrees.

[0081] According to embodiments of the present disclosure, the indicator 360 is disposed in the distal portion 314 near the tapered portion 314b, e.g., at a junction 314c between the constant first portion 314a and the tapered second portion 314b. The indicator 360 is configured to provide a visual indication of the change in the stiffness profile of the core wire 310.

[0082] The indicator 360 can be a radiopaque indicator that is visible via fluoroscopy or computed tomography (CT). Alternatively, or in addition, the indicator 360 can be other indicators that are visible via other imaging modalities, such as ultrasound, magnetic resonance imaging (MRI), etc. Suitable materials for the radiopaque indicator 360 include heavy metals or metal alloys, including but not limited to tungsten, platinum, iridium, gold, tantalum, or any alloys thereof, such as platinum-iridium alloys, platinum-tungsten alloys, etc. The radiopaque indicator 360 can be in the form of a marker band or coil, or any other suitable form.

[0083] The indicator 360 can be secured to the core wire 310 in various ways, such as crimping and / or laser welding. Alternatively, or in addition, the indicator 360 can be secured to the tube member 350 by using glue and / or solder that can sink into a cutout or slot 352 in the tube member 350. A combination of various securing methods can also be used. For example, laser welding, crimping, glue, or solder can be used to lightly secure the indicator 360 to the core wire 310 so that further assembly with the tube member 350 does not move the indicator 360 before securing the indicator 360 to the tube member 350 with glue, solder, laser welding, etc.

[0084] The indicator 360 according to embodiments of the present disclosure provides a visual indication to the physician of where the support profile of the guidewire device 300 rises during clinical use. Knowing where the support profile rises during use can help the physician to properly position the guidewire device 300 during delivery of the secondary product. Another benefit is that the indicator 360 can help to center the core wire 310 within the slotted tube member 350. Radial centering of the core wire 310 within the tube member 350 helps to provide more uniform torque transmission. Another benefit is that the indicator 360 can help to prevent the slotted tube member 350 from stretching, which otherwise can adversely affect pushability of the guidewire device 300 during use. The indicator 360 can be secured to both the tube member 350 and the core wire 310, providing friction between the tube member 350 and the core wire 310 and thereby preventing the tube member 350 from stretching.

[0085] Metal composite core wire

[0086] Reference to FIG. 22 Referring now to FIG. 23, embodiments of a core wire for guidewires and other medical devices are now described.

[0087] Guidewire devices include a core wire that generally runs through the length of the guidewire. Core wire materials are generally selected to balance the needs of torque response, tip formability, tip softness, support or stiffness profile, and the like. One problem in the art is that there are limited core wire materials to choose from and no middle ground. While stainless steel, cobalt-chrome, and nitinol have been used to construct core wires, each material has its advantages and disadvantages. For example, a core wire constructed of nitinol can provide an ultra-soft tip, but the support profile and torque response are less than ideal. A core wire constructed of cobalt-chrome can provide a good support profile and torque response, but the tip formability is poor. To achieve the desired set of performance for a guidewire device, the design must be compensated for with other components, such as an outer sheath or tubular sleeve.

[0088] Another issue in the art particularly relevant to small guidewire devices (e.g., 0.010 inch or smaller) is radiopacity. Traditional core wire materials are radiopaque. Therefore, the design of traditional guidewires must include a radiopaque marker of a dense material (such as platinum) to provide proper visibility under fluoroscopy. If a polymer jacket is used as a guidewire component, a radiopaque material (such as tungsten or barium sulfate) can be loaded onto the polymer to increase radiopacity. However, if a polymer jacket is not in the design, the only source of radiopacity will be a radiopaque coil on the tip of the core wire. For smaller guidewire devices, there is limited space for a radiopaque coil, and increasing its size will typically reduce other benefits.

[0089] According to embodiments of the present disclosure, the core wire is constructed using a metal composite wire, which overcomes these and other issues associated with traditional guidewires.

[0090] FIG. 22 An example guidewire device including a core wire according to embodiments of the present disclosure is schematically illustrated. FIG. 23A 、 FIG. 23B and FIG. 23C is a simplified illustration showing a cross-sectional end view of an example core wire. As FIG. 22 and FIGS. 23A-23C illustrate, the example guidewire device 400 includes an elongate core wire 410 extending between a proximal end portion 412 and a distal end portion 414. The core wire 410 can be formed of a metal composite wire including an inner core 416 and an outer sheath 418 both extending along the length of the core wire 410. The inner core 416 of the metal composite wire 410 includes a first material. The outer sheath 418 of the metal composite wire 410 includes a second material different from the first material of the inner core 416. Although not illustrated in Figs. 4A and 4B, the guidewire device 400 can also include a polymer jacket or tubular or coil sleeve disposed on the distal end portion 414 of the core wire 410, a component for centering the core wire 410 in the tube sleeve, and / or a distal end radiopaque marker as described in connection with other embodiments of the present disclosure, or other components known in the art. FIG. 22 FIGS. 23A-23C illustrate, the guidewire device 400 includes an elongate core wire 410 extending between a proximal end portion 412 and a distal end portion 414. The core wire 410 can be formed of a metal composite wire including an inner core 416 and an outer sheath 418 both extending along the length of the core wire 410. The inner core 416 of the metal composite wire 410 includes a first material. The outer sheath 418 of the metal composite wire 410 includes a second material different from the first material of the inner core 416. Although not illustrated in Figs. 4A and 4B, the guidewire device 400 can also include a polymer jacket or tubular or coil sleeve disposed on the distal end portion 414 of the core wire 410, a component for centering the core wire 410 in the tube sleeve, and / or a distal end radiopaque marker as described in connection with other embodiments of the present disclosure, or other components known in the art.

[0091] ​According to embodiments of the present disclosure, the first material of the metal composite inner core 416 comprises a radiopaque material. One advantage of using a radiopaque material as the metal composite inner core 416 is that it allows the core wire 410 itself to be visible via fluoroscopy. This is particularly beneficial for small diameter guide wires (e.g., 0.010 inch or less) that use a tubular sleeve that provides limited space for a radiopaque coil as reinforcement. For larger guide wires that have a radiopaque coil disposed at the distal tip, a metal composite core wire that includes an elongated radiopaque inner core 416 can also improve the overall radiopacity of the guide wire device. Suitable radiopaque materials that can be used as the metal composite inner core 416 include, but are not limited to, gold, silver, platinum, tantalum, tungsten, and any alloys thereof.

[0092] In some embodiments, the metal composite inner core 416 comprises a radiopaque material, such as Nitinol, to take advantage of the softness of, for example, Nitinol. Alternatively, the metal composite inner core comprises a cobalt-chrome alloy, a platinum alloy, a titanium alloy, or a stainless steel.

[0093] According to embodiments of the present disclosure, the second material of the metal composite outer sheath 418 comprises a different material than the first material of the inner core 416 to provide other desired properties, such as strength, flexibility, elasticity, etc. Suitable materials for the metal composite outer sheath 418 include, but are not limited to, a cobalt-chrome alloy, a nickel-titanium alloy, a platinum alloy, or a titanium alloy, a stainless steel, etc. A stainless steel can provide relatively balanced properties for the core wire in terms of torque response, support profile, tip formability, and tip softness. A cobalt-chrome alloy can provide better properties in terms of torque response and support profile, although tip formability and tip softness are less ideal. A nickel-titanium alloy (Nitinol) can provide excellent tip softness, but tip formability, torque response, and support profile are less ideal.

[0094] Table 1 provides example materials that can be used for the outer sheath of a metal composite wire to construct the core wire 410 of the present disclosure, comparing their advantages or disadvantages.

[0095] Table 1

[0096]

[0097] According to embodiments of the present disclosure, therefore, the materials of both the inner core 416 and the outer sheath 418 of the metal composite guidewire 410 can be varied to provide various performance advantages. In traditional guidewire manufacturing, there is generally no middle ground in selecting a core wire material. The metal composite guidewire 410 of the present disclosure provides a middle ground. For example, as shown in Table 1, using a metal composite guidewire 410 with a cobalt-chrome outer sheath 418 and a platinum inner core 416 filling will allow for greater formability due to the increased ductility of platinum, and will improve tip softness due to the fact that platinum is softer than cobalt-chrome. While there can be tradeoffs associated with the tip support profile, the support profile of the cobalt-chrome / platinum composite guidewire 410 is not worse than stainless steel.

[0098] According to embodiments, the metal composite guidewire 410 of the present disclosure includes an inner core 416 of a radiopaque material selected from the group consisting of gold, silver, platinum, tantalum, tungsten, and any alloys thereof.

[0099] According to embodiments, the metal composite guidewire 410 of the present disclosure includes an outer sheath 418 of a material selected from the group consisting of cobalt-chrome alloys, nickel-titanium alloys, platinum alloys, titanium alloys, and stainless steel.

[0100] According to embodiments, the metal composite guidewire 410 of the present disclosure includes an inner core 416 of a radiopaque material selected from the group consisting of gold, silver, platinum, tantalum, tungsten, and any alloys thereof, and an outer sheath 418 of a material selected from the group consisting of cobalt-chrome alloys, nickel-titanium alloys, platinum alloys, titanium alloys, and stainless steel.

[0101] According to particular embodiments, the metal composite guidewire 410 of the present disclosure includes an inner core 416 of platinum and an outer sheath 418 of cobalt-chrome alloy.

[0102] According to particular embodiments, the metal composite guidewire 410 of the present disclosure includes a drawn filled tube (DFT) wire including an inner core 416 and an outer sheath 418.

[0103] Referring to FIGS. 23A-23C According to embodiments of the present disclosure, the fill percentage of the metal composite guidewire 410 can also be adjusted to prioritize the benefits of one material over the other. As used herein, the phrase "fill percentage" refers to the proportion of the cross-sectional area of the metal composite wire that is occupied by the inner core 416 material (filling material) relative to the total cross-sectional area of the metal composite guidewire 410. According to embodiments of the present disclosure, the metal composite guidewire 410 includes a fill percentage of the inner core 416 material in the range of about 10% to 45% along the length of the guidewire 410.

[0104] According to embodiments of the present disclosure, the fill percentage of the metal composite core wire 410 can vary along the length of the core wire 410. For example, the metal composite core wire 410 can include a first fill percentage at a proximal portion 412 of the core wire 410 and a second fill percentage at a distal portion 414 of the core wire 410 that is different (e.g., greater) than the first fill percentage. This would allow the material properties of the inner core 416 to dominate more at the distal portion 414 of the core wire 410 and the material properties of the outer sheath 418 to dominate more at the proximal portion 412 of the core wire 420. For example, the metal composite core wire 410 of the present disclosure can include a platinum inner core 416 and a cobalt-chromium alloy outer sheath 418. As shown in FIG. 4, a greater fill percentage of the platinum inner core 416 at the distal portion 414 of the metal composite core wire 410 would favor improved softness, formability, and radiopacity of the core wire 410. Alternatively, or in addition, as shown in FIG. 5, a smaller fill percentage of the platinum inner core 416 at the proximal portion 412 of the metal composite core wire 410 would focus more on the support profile and torque response of the core wire 410. FIG. 23A FIG. 23C

[0105] According to embodiments of the present disclosure, the metal composite core wire 410 can include a constant fill percentage at a portion of the metal composite core wire 410. Alternatively, or in addition, the metal composite core wire 410 can include a varying or continuously varying fill percentage at a portion of the metal composite core wire 410. For example, in the proximal portion 412 of the core wire 410, the metal composite core wire 410 can have a generally constant small fill percentage of the inner core 416 material. In the distal portion 414 of the core wire 410, which can include one or more constant portions and one or more tapered portions, the fill percentage of the metal composite core wire can vary. For example, the distal portion 414 of the metal composite core wire 410 can include a distal first portion 414a having a constant diameter or cross-section and a proximal tapered or second portion 414b having a varying diameter or cross-section. The fill percentage of the metal composite core wire 410 at the constant first portion 414a can be constant, while the fill percentage of the metal composite core wire 410 at the tapered second portion 414b can continuously vary, e.g., decrease in the proximal direction.

[0106] According to embodiments of the present disclosure, the original metal composite wire 410 can be ground to remove a portion of the outer sheath 418 material to achieve a desired fill percentage of the metal composite core wire 410. For example, as shown in FIG. 4, more outer sheath 418 material can be ground at the distal portion 414 of the core wire 410 to achieve a greater fill percentage, while as shown in FIG. 5, less outer sheath 418 material can be ground at the proximal portion 412 of the core wire 410 to achieve a smaller fill percentage. FIG. 23A FIG. 23C ​​​As shown, a smaller fill percentage can be achieved by grinding less of the outer sheath 418 material at the proximal portion 412 of the core wire 410. Alternatively, or additionally, different fill percentages can be achieved by gradually grinding the metal composite wire 410 to form a tapered segment.

[0107] According to embodiments of the present disclosure, the metal composite core wire 410 may have an outer diameter ranging from 0.0007 inches to 0.125 inches at its proximal portion 412. In some embodiments, the metal composite core wire has an outer diameter ranging from 0.007 inches to 0.035 inches at its proximal portion 412.

[0108] Various embodiments of the guidewire device and method have been described with reference to the accompanying drawings. It should be noted that the aspects described in connection with a particular embodiment are not necessarily limited to that embodiment and can be practiced in any other embodiment. For example, in connection with... FIGS. 1-12 The described embodiments of the centering core wire can be incorporated into the combination. FIGS. 13-18 The embodiments described, which are non-transparent coils or braids, or vice versa, can be incorporated into the design. FIGS. 19-21 The described core wire support indicator embodiments are either as described or the reverse, and can be incorporated into the combination. FIG. 22 as well as FIGS. 23A-23C The embodiments described are either the metal composite core wires or vice versa. Similarly, in combination with FIGS. 13-18 The described embodiments of non-transparent coils or braids, combined with FIGS. 19-21 The described embodiments of the core wire support indicator and their combination FIG. 22 as well as FIGS. 23A-23C The embodiments of the metal composite core wires described herein may each be incorporated into any other embodiment or aspect of this disclosure.

[0109] The accompanying drawings are intended to illustrate embodiments but are not intended to be exhaustive or to limit the scope of this disclosure. Alternative structures, components, and materials will readily be considered feasible without departing from the principles of the invention. Furthermore, while some embodiments of this disclosure are described in conjunction with guidewire devices, this is not intended to be limiting. For example, the core wire described herein can be used as a component of other interventional devices.

[0110] Unless otherwise defined, all technical and scientific terms used herein have the meaning commonly understood by one of ordinary skill in the art. As used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural references unless the context clearly dictates otherwise. The term "or" means "and / or" unless the context clearly dictates otherwise. The term "proximal" and its grammatical equivalents mean the location, direction, or orientation toward the side of the user or physician. The term "distal" and its grammatical equivalents mean the location, direction, or orientation away from the side of the user or physician. Designations such as "rearward," "forward," and the like do not imply that the referenced component is limited to a particular direction. It will be understood that such designations refer to the orientation of the referenced component as shown in the figures; the systems and devices of the present disclosure can be used in any orientation that is suitable for the user. The terms "first" or "second" and the like can be used to distinguish one element from another during the description of various similar elements. It should be noted that the use of the terms "first" and "second" as used herein encompasses reference to two or more than two. Further, the use of the terms "first" or "second" should not be interpreted in any particular order, unless the context clearly dictates otherwise. In alternative embodiments, the order of execution of the method steps can be changed. One or more of the method steps can be skipped, and one or more optional steps can be included. All numerical values are provided for illustration and assume modification by the term "about" whether or not explicitly stated. The term "about" generally refers to a range of numbers that a person of skill in the art would consider equivalent to the referenced value, e.g., having the same function or result. The term "about" can include numbers rounded to the nearest significant figure. Expressions of ranges of numerical values by endpoints include all numbers within that range.

[0111] Those of skill in the art will understand that various other modifications can be made. All such and other variations and modifications are contemplated as being within the scope of the present disclosure.

Claims

1. A wire guide device, the wire guide device comprising: A core wire extending between a proximal portion and a distal portion; A tubular component located near the distal portion of the core wire, the tubular component being fixed to the core wire and defining a space between the core wire and the tubular component; as well as An expandable structure is disposed in the space between the core wire and the tubular member. The expandable structure is configured to be interference-fitted to the inner surface of the tubular member and includes a proximal end with an opening and a distal end with an opening to allow the core wire to pass through the expandable structure. The openings at the proximal end and the distal end of the expandable structure are substantially aligned with the central longitudinal axis of the tubular member and are configured to surround the core wire, thereby making the core wire substantially aligned with the central longitudinal axis of the tubular member.

2. The guide wire device according to claim 1, wherein, The expandable structure includes a support structure.

3. The guide wire device according to claim 2, wherein, The scaffold-like structure comprises a woven fabric made of shape memory filaments.

4. The guide wire device according to claim 2, wherein, The proximal and / or distal ends of the support structure are securely fastened to the core wire.

5. The guide wire device according to claim 1, wherein, The expandable structure includes a cut tube structure comprising a tubular body made of shape memory material and provided with a plurality of longitudinal slits to form multiple strands extending between a proximal and distal portion of the tubular body, wherein the cut tube structure is heat-set to provide an expanded shape in which the multiple strands bend outward and apply radial force to the tube member, thereby allowing the cut tube structure to be interference-fitted to the inner surface of the tube member of the guidewire device.

6. The guide wire device according to claim 5, wherein, The tubular body is made of nickel-titanium alloy.

7. The guide wire device according to claim 5, wherein, The proximal and distal portions of the tubular body are securely fastened to the core wire.

8. The guide wire device according to claim 1, wherein, The expandable structure includes a pin crown structure comprising an annular band portion and a plurality of elongated elements extending from the annular band portion, wherein the pin crown structure is made of a shape memory material and is heat-set to provide an expanded shape, in which the plurality of elongated elements bend outward away from the annular band portion and apply a radial force to the tubular member, thereby allowing the pin crown structure to interfere with the inner surface of the tubular member of the guidewire device.

9. The guide wire device according to claim 8, wherein, The nail-shaped structure is made of nickel-titanium alloy.

10. The guide wire device according to claim 8, wherein, The annular band portion of the crown-shaped structure is securely fastened to the core wire.

11. The guide wire device according to claim 1, wherein, The proximal portion of the core wire has an outer diameter equal to or greater than 0.014 inches.

12. The guide wire device according to claim 1, wherein, The proximal portion of the core wire has an outer diameter ranging from 0.014 inches to 0.038 inches.

13. The guide wire device according to claim 1, wherein, The tubular component includes a plurality of cuts extending circumferentially around the central longitudinal axis of the tubular component.

14. The guide wire device according to claim 1, wherein, The guide wire device includes a radiopaque marker that is in the tube member and coupled to the core wire, wherein the radiopaque marker comprises a first radiopaque material and a second malleable material.

15. The guide wire device according to claim 14, wherein, The radiopaque marker is in the form of a coil wound around the distal portion of the core wire.

16. The guide wire device according to claim 15, wherein, The coil is formed of a metal composite wire, which includes an inner core of a first material that is non-transmissive and an outer sheath of a second material that is malleable.

17. The guide wire device according to claim 16, wherein, The metal composite wire has a non-circular core cross-section, the non-circular shape comprising a wider dimension and a narrower dimension, wherein the metal composite wire is wound around the distal portion of the core wire such that the wider dimension of the non-circular shape in the radial direction improves the radiopaque linearity of the radiopaque marker.

18. The guide wire device according to claim 16, wherein, The coil includes a variable pitch that increases in the distal direction to improve the flexibility of the distal portion of the core wire.

19. The guide wire device according to claim 16, wherein, The second material for the plastically deformable outer sheath of the metal composite wire includes a nickel-cobalt alloy or stainless steel.

20. The guide wire device according to claim 15, wherein, The coil comprises a double-stranded wire, the double-stranded wire comprising a first wire and a second wire parallel to the first wire, the first wire of the double-stranded wire comprising a first material that is non-transparent, and the second wire of the double-stranded wire comprising a second material that is malleable.

21. The guide wire device according to claim 20, wherein, The second material that can be plastically deformed includes a nickel-cobalt alloy or stainless steel.

22. The guide wire device according to claim 20, wherein, The twin strands are wound around the distal portion of the core wire with a varying pitch that increases in the distal direction to improve the flexibility of the distal portion of the core wire.

23. The guide wire device according to claim 14, wherein, The radiopaque marker is in the form of a woven fabric.

24. The guide wire device according to claim 23, wherein, The braid is composed of two or more metal composite threads, each of which includes an inner core of a first material that is non-transparent and an outer sheath of a second material that is malleable.

25. The guide wire device according to claim 23, wherein, The woven fabric is composed of two or more threads, including a first thread of the first material that is non-transparent and a second thread of the second material that is malleable.

26. The guide wire device according to claim 23, wherein, The core wire has an outer diameter equal to or greater than 0.024 inches at its proximal portion.

27. The wire guide device according to claim 14, further comprising a circular tip coupled to the distal end of the core wire, wherein, The circular tip is made of a non-transparent material.

28. The guide wire device according to claim 14, wherein, The tubular component is made of shape memory alloy and includes a plurality of circumferentially extending slits around the central longitudinal axis of the tubular component.

29. The guide wire device according to claim 1, wherein, The distal portion includes a first portion having a first stiffness profile and a second portion having a second stiffness profile different from the first stiffness profile; The guide wire device includes an indicator fixed to the core wire, wherein the indicator is located at the junction of the first portion and the second portion to provide a visual indication of changes in the stiffness profile of the core wire.

30. The guide wire device according to claim 29, wherein, The first portion has a substantially constant cross-sectional dimension.

31. The guide wire device according to claim 30, wherein, The second part is a cone with a cross-sectional dimension that increases in the proximal direction.

32. The guide wire device according to claim 31, wherein, The second part has a taper angle equal to or greater than 0.02 degrees.

33. The guide wire device according to claim 29, wherein, The indicator includes an indicator that does not transmit light.

34. The guide wire device according to claim 33, wherein, The non-transmissive indicator is in the form of a marking strip or a coil.

35. The wire guide device of claim 29, further comprising a tube member located near the distal portion of the core wire, the tube member comprising a plurality of circumferentially extending around the central longitudinal axis of the tube member.

36. The guide wire device according to claim 35, wherein, The indicator is also fixed to the pipe member.

37. The guide wire device according to claim 1, wherein, The core wire includes a metal composite wire, which includes an inner core of a first material and an outer sheath of a second material different from the first material.

38. The guide wire device according to claim 37, wherein, The first material of the inner core includes a non-transparent material.

39. The guide wire device according to claim 38, wherein, The first material of the inner core includes gold, silver, platinum, tantalum, tungsten, or alloys thereof.

40. The guide wire device according to claim 38, wherein, The second material of the outer sheath includes cobalt-chromium alloy, nickel-titanium alloy, platinum alloy, titanium alloy, or stainless steel.

41. The guide wire device according to claim 40, wherein, The metal composite wire, along its length from the core wire, comprises a filling percentage of the first material of the inner core ranging from approximately 10% to approximately 45%.

42. The guide wire device according to claim 37, wherein, The first material of the inner core includes cobalt-chromium alloy, nickel-titanium alloy, platinum alloy, titanium alloy, or stainless steel.

43. The guide wire device according to claim 42, wherein, The second material of the outer sheath includes cobalt-chromium alloy, nickel-titanium alloy, platinum alloy, titanium alloy, or stainless steel.

44. The guide wire device according to claim 43, wherein, The metal composite wire comprises a filling percentage of the first material in the core ranging from approximately 10% to approximately 45%.

45. The guide wire device according to claim 37, wherein, The metal composite wire comprises a filling percentage of the first material in the core ranging from approximately 10% to approximately 45%.

46. ​​The guide wire device according to claim 45, wherein, The fill percentage includes a first fill percentage in the distal portion of the core wire and a second fill percentage in the proximal portion of the core wire, wherein the second fill percentage is less than the first fill percentage.

47. The guidewire device according to claim 37, wherein, The distal portion of the core wire further includes a first portion and a second portion, wherein the first portion includes a constant fill percentage of the first material of the inner core, and the second portion includes a varying fill percentage of the first material of the inner core that decreases in the proximal direction.

48. The guide wire device according to claim 47, wherein, The first material of the inner core comprises a radiopaque material selected from the group consisting of gold, silver, platinum, tantalum, tungsten and their alloys, and the second material of the outer sheath comprises a material selected from the group consisting of cobalt-chromium alloys, nickel-titanium alloys, platinum alloys, titanium alloys and stainless steel.

49. The guide wire device according to claim 37, wherein, The first material of the inner core comprises platinum, the second material of the outer sheath comprises a cobalt-chromium alloy, and the metal composite wire comprises a fill percentage of the inner core ranging from about 10% to about 45% along the length of the core wire.

50. The wire guide device of claim 37, further comprising a tube member located near the distal portion of the core wire, the tube member comprising a plurality of circumferentially extending around the central longitudinal axis of the tube member.

51. The guide wire device according to claim 37, wherein, The metal composite wire has an outer diameter ranging from 0.007 inches to 0.035 inches at the proximal portion of the core wire.

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