Medical guide wire devices and methods

Abstract

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

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 636,054, filed on 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

[0002] The present application relates generally to medical devices and methods of making and using medical devices to treat disease. In particular, various embodiments of guidewire devices and methods are described. Background Art

[0003] Guidewire devices are widely used in the medical field to guide auxiliary devices to specific locations in the patient's body for delicate procedures, such as guiding a catheter deep into the body's vasculature. 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 deliverability through tortuous anatomy.

[0004] Guidewire devices typically include a core wire with a tapered distal end that may be reinforced by a structure connected to an atraumatic tip. Traditionally, metal coils or braids have been used as guidewire reinforcements. With the advancement of micromachining and laser cutting technologies, slotted hypotubes have also entered the market as device components.

[0005] While progress has been made in the field of guidewire devices, a need for improvement remains. There is a need to center the core wire within a hypotube-based guidewire device to enhance torque transfer and avoid or minimize kinking or whipping. There is a need to improve the formability and shape retention of hypotube-based guidewires to facilitate navigation through tortuous and complex pathways. It is desirable to provide more options for materials for constructing core wires with various support or stiffness profiles. It is desirable to provide a user of the guidewire with a visual indication of changes in the stiffness profile of the guidewire to aid in the delivery of an assist device. Summary of the Invention

[0006] In one aspect, an embodiment of the present disclosure is characterized in that a guide wire device is provided. Generally, an embodiment of the guide wire device includes a core wire extending between a proximal portion and a distal portion and a tubular member located near the distal portion of the core wire. The tubular member is fixed to the core wire and defines a space between the core wire and the tubular member. An expandable structure is provided in the space between the core wire and the tubular member. The expandable structure is configured to be interference fit onto the inner surface of the tubular 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 opening at the proximal end and the opening at 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 so that the core wire is substantially aligned with the central longitudinal axis of the tubular member.

[0007] In another aspect, embodiments of the present disclosure are characterized in that a guide wire device is provided. Typically, embodiments of the guide wire device include a core wire extending between a proximal portion and a distal portion and a tubular member located near the distal portion of the core wire. The tubular member is fixed to the core wire and defines a space between the core wire and the tubular member. A plurality of disks are coupled to the distal portion of the core wire. The plurality of disks are spaced apart from each other and are configured to be interference fit onto the inner surface of the tubular member. Each of the plurality of disks includes an opening configured to allow the core wire to pass through and to align the core wire substantially with the central longitudinal axis of the tubular 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 portion and a distal portion, a tubular member located near the distal portion of the core wire and coupled to the core wire, and a radiopaque marker in the tubular member and coupled to the core wire, wherein the radiopaque marker includes a first radiopaque material and a second plastically deformable material.

[0009] In another aspect, embodiments of the present disclosure are characterized by a guidewire device. Typically, embodiments of the guidewire device include a core wire and an indicator secured to the core wire. The distal 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 located at the 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.

[0010] 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 portion and a distal portion. The core wire comprises a drawn fill tube (DFT) wire comprising an inner core of a first material and an outer sheath of a second material different from the first material.

[0011] This Summary is provided to introduce selected aspects and embodiments of the present disclosure in a simplified form. It is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The selected aspects and embodiments presented are intended solely to provide the reader with an overview of certain possible forms the present invention may take and are not intended to limit the scope of the present invention. Other aspects and embodiments of the present disclosure are described in the Detailed Description section.

[0012] These and various other aspects, embodiments, features and advantages of the present disclosure will be better understood from the following detailed description when read in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a simplified illustration of an example guidewire device according to an embodiment of the present disclosure.

[0014] Figure 2 yes Figure 1 A simplified illustration of a guidewire device with the components separated to more clearly show the core wire, tubing member, and other components.

[0015] Figure 3 yes Figure 1 A cross-sectional end view of the guidewire device shown in FIG. 1 taken along line AA.

[0016] Figure 4 The use of a stent-like structure for centering a core wire in a guidewire device according to an embodiment of the present disclosure is schematically illustrated.

[0017] Figure 5 Depicted are cutting tube structures that may be used to center a core wire in a guidewire device according to embodiments of the present disclosure.

[0018] Figure 6 Describes an embodiment of the present disclosure Figure 5 The cut tube structure is shown in its expanded state.

[0019] Figure 7 A spike crown structure that may be used to center a core wire in a guidewire device according to an embodiment of the present disclosure is shown.

[0020] Figure 8 Describes an embodiment of the present disclosure Figure 7 The crown-like structure is shown in its expanded state.

[0021] Figure 9 Schematically illustrates the use of multiple disc-like structures for centering a core wire in a guidewire device according to an embodiment of the present disclosure.

[0022] Figure 10 yes Figure 9The guidewire device is shown in a cross-sectional end view taken along line BB.

[0023] Figure 11 Depicted are example disc-like structures that may be used to center a core wire in a guidewire device according to embodiments of the present disclosure.

[0024] Figure 12 Another disc-like structure that may be used to center a core wire in a guidewire device according to an embodiment of the present disclosure is depicted.

[0025] Figure 13 is a simplified illustration of an example guidewire device according to an embodiment of the present disclosure.

[0026] Figure 14 is a simplified illustration of an example corewire including a radiopaque marker coupled to a distal portion of the corewire in accordance with an embodiment of the present disclosure.

[0027] Figure 15 Depicted are example radiopaque coils according to embodiments of the present disclosure.

[0028] Figure 16 Depicted are example radiopaque coils according to alternative embodiments of the present disclosure.

[0029] Figure 17 Depicted are example radiopaque coils according to alternative embodiments of the present disclosure.

[0030] Figure 18 Depicted are example radiopaque braids according to embodiments of the present disclosure.

[0031] Figure 19 is a simplified illustration of an example guidewire device according to an embodiment of the present disclosure.

[0032] Figure 20 yes Figure 19 A simplified illustration of a guidewire device is shown with the tubing removed to more clearly show the core wire and other components.

[0033] Figure 21 yes Figure 19 A cross-sectional end view of an example guidewire device is shown taken along line CC.

[0034] Figure 22 is a simplified illustration of an example core wire according to an embodiment of the present disclosure.

[0035] Figure 23A 、 Figure 23B and Figure 23C is a simplified diagram showing a cross-sectional end view of an example core wire according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0036] Various embodiments of the guidewire devices and methods will now be described with reference to the accompanying drawings. The accompanying drawings are intended to facilitate the description of the embodiments of the present disclosure and are not necessarily drawn to scale. Certain specific details may be set forth in the accompanying drawings to provide a comprehensive understanding of the present disclosure. It will be understood by those of ordinary skill in the art that some of these specific details may not be used to practice the embodiments of the present disclosure. In other cases, structures, components, systems, materials and / or operations that are generally associated with known medical procedures may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present disclosure.

[0037] The present disclosure provides guidewire devices that include unique features that can improve the performance of the device. Embodiments of the present disclosure use metal composite wires to construct the core wire, allowing for a wider range of material choices through various combinations of metal composite wire inner cores and outer sheaths and / or by adjusting the metal composite wire inner core fill percentage. A radiopaque coil or braid comprising 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. An indicator can be attached to the core wire to provide a visual indication of changes in the stiffness profile of the core wire to assist the physician during clinical use. Embodiments of the present disclosure also provide methods for centering the core wire in a hypotube-based guidewire device to improve torque transfer control and other performance.

[0038] Figures 1 to 2 An example guidewire device 100 according to an embodiment of the present disclosure is schematically shown. The guidewire device 100 is typically configured for use in conjunction with a medical device to perform procedures such as neurological, cardiac, or peripheral vascular interventions. One example application of the guidewire device 100 of the present disclosure is for guiding a catheter deep into the neurovascular system. In general, the guidewire device 100 includes an elongated core wire 110 and a tubular 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 toward the distal end to provide greater bending flexibility. The proximal portion 112 of the core wire 110 can have an increased diameter to maintain the pushability and torsional rigidity of the guidewire device 100. The tubular member 150 can be located near the distal portion 114 of the core wire 110 and fixed to the core wire 110 to provide reinforcement and enhance the performance of the guidewire device 100. The tubular member 150 may be fixed to the distal portion 114 of the core wire 110 via various means (e.g., bonding, welding, brazing, etc.) to allow the torsional force to be transmitted from the proximal portion 112 of the core wire 110 to the tubular member 150 and / or from the tubular member 150 to the distal portion 114 of the core wire 110. In the space defined between the tubular member 150 and the distal portion 114 of the core wire 110, there may be provided means such as radiopaque markers, centering devices, core wire stiffness indicators, etc. Figures 1 to 2The tubular member 150 may be a hypotube constructed of a shape memory material and may include a plurality of cutouts 152 configured to enhance the effectiveness of the guidewire device 100, such as by providing a desired balance between bending flexibility, torsional stiffness, tensile strength, and the like. The cutouts 152 may be vertical cutouts and / or spiral cutouts extending circumferentially around the central longitudinal axis of the tubular member. US Ser. No. 18 / 963,683, entitled “Guidewire and Medical Device including Laser Cut Tube,” filed on November 28, 2025, and US Ser. No. 19 / 043,429, entitled “Intravascular Medical Devices Including Laser Cut Tube,” filed on February 1, 2025, describe various embodiments of cutout tube structures that may be used as tubular members of guidewire devices. The disclosures of US Ser. No. 18 / 963,683 and No. 19 / 043,429 are hereby incorporated by reference in their entirety. Alternatively, a polymer sheath can be used as a reinforcing structure to replace the tubular member 150. For example, a rounded atraumatic tip 116 can be formed at the distal end of the guidewire device 100 to prevent damage to the blood vessel.

[0039] Core wire centering Reference Figures 3 to 12 , various embodiments of devices and methods for centering a core wire in a guidewire device are now described.

[0040] Figure 3 yes Figure 1 1 is a simplified illustration of a cross-sectional end view of a guidewire device 100 showing a core wire 110, a tubular member 150 surrounding the core wire 110, and a space 120 defined between the tubular member 150 and the core wire 110 at a distal end portion 114 of the guidewire device 100. The space 120 between the tubular member 150 and the core wire 110 at the distal end portion 114 of the guidewire device 100 can increase as the guidewire size increases, e.g., from 0.010 inches to 0.014 inches, 0.018 inches, 0.024 inches, 0.038 inches, etc.

[0041] One problem associated with conventional hypotube-based guidewire devices is misalignment of the corewire with the central longitudinal axis of the hypotube, i.e., the corewire becomes radially offset from the center, particularly at the distal portion of the guidewire device. Misalignment of the corewire may result in reduced control of torque transfer, erratic tip behavior, and other issues. These issues may be exacerbated when navigating a tortuous vessel with complex curves, where the relatively stiff corewire does not bend as well as the relatively flexible hypotube. Severe misalignment of the corewire may result in guidewire tip jitter and loss of torque control, which would negate the purported advantage of hypotube-based guidewires—fine-tuning torque control of the guidewire tip for navigating selected anatomical structures.

[0042] Traditional methods for centering the core wire use one or more coils to occupy the free space between the core wire and the hypotube. In these traditional methods, the centering coils provide no functionality beyond simply filling the space between the core wire and the hypotube. Furthermore, these traditional solutions are not easily scalable, as the centering coils must be redesigned as the space between the core wire and the hypotube increases in larger guidewire devices.

[0043] According to an embodiment of the present disclosure, an expandable structure is used to center a core wire in a tubular member of a guidewire device, or to align the core wire with the central longitudinal axis of the tubular member. Typically, the expandable structure is configured to be 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 opening and / or the distal opening of the expandable structure are substantially aligned with the central longitudinal axis of the tubular member and are sized or configured to surround the core wire so that the core wire is substantially aligned with the central longitudinal axis of the tubular member.

[0044] Reference Figure 4According to an embodiment of the present disclosure, the expandable structure 160 for centering the core wire 110 includes, for example, a plurality of stent-like structures 160 having various shapes and sizes. The stent-like structure 160 includes a contracted state and an expanded state. The stent-like structure 160 includes a proximal portion 162, a distal portion 164, and a main body portion 166. Each of the proximal portion 162 and the distal portion 164 can be tapered and have an opening that is sized or configured to allow the core wire 110 to pass through. The main body portion 166 can have a predefined, for example, cylindrical, expansion structure that can be interference fit onto the inner surface 152 of the tubular member 150 and apply an outward radial force to the tubular member 150. The openings in the tapered proximal and distal portions 162, 164 can be similar to or slightly larger than the cross-sectional dimensions of the core wire 110 and substantially aligned with one another on the central longitudinal axis 151 of the tubular member 150, allowing the core wire 110 to self-center radially within the tubular member 150. In alternative embodiments, the tapered proximal and / or distal portions 162, 164 can be secured to the core wire 110 via any suitable means, such as adhesive bonding, welding, soldering, crimping, etc.

[0045] The stent-like structure 160 can be woven using two or more filaments, such as nitinol filaments or other metallic or polymer shape-memory materials. Alternatively, the stent-like structure 160 can be formed by creating multiple holes in a tubular member of the shape-memory material using a laser, a blade, or other suitable means. Shape-memory materials often exhibit temperature-induced phase transitions, resulting in the material adopting a preferred configuration or shape that can be set by heating the material above a specific 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, the transition temperature can be selected to be above room temperature but below body temperature for ease of assembly. This allows the stent-like structure 160 to expand and form an interference fit with the tubular 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, nickel titanium (NiTi) or Nitinol®, CuZnAl, FeNiAl, and other alloys. Suitable polymer 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), and the like.

[0046] According to embodiments of the present disclosure, one or more stent-like structures 160 may be used to center the core wire 110 based on the size, design, or application of the guidewire device 100 .

[0047] Figures 5 and 6 Another example expandable structure 170 is shown according to an alternative embodiment of the present disclosure. Figures 5 and 6The expandable structure 170 shown in FIG. 1 comprises a tubular body 171 of a shape memory alloy or polymer. The tubular body 171 is provided with a plurality of longitudinal slits or cuts 172 forming 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 may have a non-expanded state ( Figure 5 ) and the expansion state ( Figure 6 Cutting 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 tubular member 150 of guidewire device 100, allowing cutting tube structure 170 to interference fit onto inner surface 152 of tubular member 150 of guidewire device 100. The openings in proximal portion 174 and distal portion 175 can be similar to or slightly larger than the cross-sectional dimensions of core wire 110 and substantially aligned with one another along central longitudinal axis 151 of tubular member 150, allowing core wire 110 to radially self-center within tubular member 150. In alternative embodiments, proximal portion 174 and / or distal portion 175 can be secured to core wire 110 via any suitable means, such as bonding, welding, brazing, etc. Suitable metallic shape memory materials for tubular body structure 170 include, but are not limited to, nickel titanium (NiTi) or Nitinol®, CuZnAl, FeNiAl, and the like. Suitable polymer 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), and the like.

[0048] Figures 7 and 8 Another example expandable structure 180 is shown according to an alternative embodiment of the present disclosure. Figures 7 and 8 The illustrated expandable structure 180 comprises a spike crown-like structure 180 comprising 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 may have a non-expanded state ( Figure 7 ) and the expansion state ( Figure 8Crown structure 180 is constructed from a shape-memory alloy or polymer and is heat-set to provide a predefined expanded shape, causing the plurality of elongated elements 183 to flex outwardly away from annular band portion 182 and exert a radial force on tubular member 150, allowing crown elements 180 to interference fit onto inner surface 152 of tubular member 150 of guidewire device 100. The opening in annular band portion 182 of crown structure 180 can be similar to or slightly larger than the cross-sectional dimensions of core wire 110 and substantially aligned along the central longitudinal axis of tubular member 150, allowing core wire 110 to radially self-center within tubular member 150. In alternative embodiments, annular band portion 182 can be secured to core wire 110 via a suitable means, such as bonding, welding, brazing, or the like. Suitable metallic shape-memory materials for crown structure 180 include, but are not limited to, nickel titanium (NiTi) or Nitinol®, CuZnAl, FeNiAl, and the like. Suitable polymer shape memory materials for constructing the crown structure 180 include, but are not limited to, polytetrafluoroethylene (PTFE), polylactic acid (PLA), ethylene vinyl acetate (EVA), and the like.

[0049] Reference Figures 9 to 12 , an alternative embodiment of the present disclosure provides a method for centering the core wire by using a disc-like structure 190. A plurality of discs 190 can be coupled to the distal portion of the elongated core wire 110. The plurality of discs 190 can be spaced apart from one another and configured to be interference fit onto the inner surface 152 of the tubular member 150. Each of the plurality of discs 190 includes an opening 192 configured to allow the core wire 110 to pass therethrough and be substantially aligned with the central longitudinal axis 151 of the tubular member 150.

[0050] Each of the plurality of disks 190 may be generally circular or annular in shape having a circumferential profile adapted to be interference fit onto the inner surface 152 of the tubular member 150. Figure 11 As shown, when the disk 190 is disposed in the tubular member 150, the opening 192 in the disk 190 can be circular and centered on the central longitudinal axis 151 of the tubular member 150. Figure 11 ) can have a diameter similar to or slightly larger than the cross-sectional diameter of the core wire 110, allowing the core wire 110 to self-center radially within the tubular member 150. Alternatively, the disc 190 can be secured to the core wire 110 via any suitable means, such as bonding, welding, brazing, etc.

[0051] In an alternative embodiment, the opening 192 in the disk 190 may be a slot extending from the center to the periphery of the disk 190 ( Figure 12 By inserting the core wire 110 into the groove 192 from the periphery of the disk 190, the groove 192 in the disk 190 ( Figure 12) can simplify assembly. The limiting size of the groove 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 tubular member 150 when in use. Figure 12 )'s disk 190 may also be fixed to the core wire 110 via any suitable means, such as bonding, welding, brazing, etc.

[0052] The disk 190 may be constructed of a polymeric material. Suitable polymeric materials include, but are not limited to, polyethylene, polypropylene, polystyrene, acetal copolymers, nylon, and other suitable polymers.

[0053] The core wire centering method of the present invention uses the interference fit between the centering components 160, 170, 180, 190 and the tubular member 150, allowing the core wire 110 to be better centered than the traditional centering coil, because the traditional design must leave space between the centering coil and the tubular member and there is no direct contact or connection to the tubular member. The centering method of the present invention can be easily scaled up because the expandable structure 160, 170, 180 can be expanded to a larger outer diameter for larger diameter tubular members, while in the traditional method, for larger guide wire devices, such as guide wires equal to or greater than 0.014 inches, the centering coil needs to be redesigned as the space between the coil and the tubular member increases. In addition, the expandable structure 160, 170, 180 or the disc 190 can be directly fixed to the core wire 110, allowing the core wire 110 and the tubular member 150 to be aligned in a 1:1 ratio when the core wire 110 rotates to improve the torque control of the guide wire device 100.

[0054] Radiopaque marker on the distal tip of the core wire Reference Figures 13 to 18 Various embodiments of guidewire devices including radiopaque markers on a distal portion of a core wire are now described. The radiopaque markers include two or more different materials configured to improve formability and shape retention of the guidewire device.

[0055] Formability and shape retention are important characteristics for the performance of guidewire devices. Formability is the ability of a guidewire to be manually shaped or bent at the distal end prior to use to accommodate varying vascular anatomies. Good formability is particularly useful for navigating tortuous and complex vascular pathways, such as those in the neurological or cardiovascular systems. Shape retention is the ability of a guidewire to maintain its assigned shape. It ensures that the guidewire maintains its curve or angle, allowing for stable and predictable navigation.

[0056] Plastically deformable materials, such as stainless steel and nickel-cobalt alloys (e.g., MP35N), have been used in the construction of core wires due to their formability and shape retention. Plastically deformable materials can undergo deformation without breaking when subjected to stress exceeding their elastic limit. This ability, or plasticity, allows the material to change shape and maintain its new form after the applied force is removed. Shape-memory hypotubes, on the other hand, have been used as components in guidewire devices to improve performance. For example, some conventional guidewire devices include a shape-memory slotted hypotube located at the distal tip of the core wire to improve the device's torque control. A radiopaque coil of pure metal, such as platinum (Pt), is often positioned within the hypotube to visualize the position of the core wire's distal tip. While a hypotube at the distal tip of a guidewire can improve the device's torque capability, its shape-memory properties force it to return to its original or predefined configuration after deformation when exposed to body temperature. Therefore, due to its tendency to return to its original or predefined configuration, the shape-memory hypotube can negatively impact the formability and shape retention of the guidewire device.

[0057] According to embodiments of the present disclosure, radiopaque markers composed of two or more different materials are used to help maintain or improve the formability and shape retention of a guidewire device. Figure 13 As shown, an example guidewire device 200 of the present 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 within the tubular member 250 and coupled to the core wire 210. The radiopaque marker 260 comprises a first radiopaque material and a second plastically deformable material. While the first radiopaque material provides radiopacity, the plastically deformable second material helps maintain the shape imparted to the distal portion of the guidewire device 200. In an embodiment, the tubular member 250 is constructed of a shape memory material and includes a plurality of cutouts 252 extending circumferentially around a central longitudinal axis of the tubular member. The radiopaque marker 260 of the present 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.

[0058] According to an embodiment of the present disclosure, the radiopaque first material of the radiopaque marker can be any suitable radiopaque material visible via fluoroscopy, including but not limited to tungsten, platinum, iridium, gold, tantalum or any alloy thereof, such as platinum-iridium alloy, platinum-tungsten alloy, etc.

[0059] According to an embodiment of the present disclosure, the plastically deformable second material of the radiopaque marker can be a metal, a metal alloy, a 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.

[0060] Reference Figure 14 According to an embodiment of the present disclosure, the radiopaque marker 260 can be in the form of a coil wrapped around a portion of the core wire distal portion 214. The radiopaque coil 260 can be secured to the core wire 210 via bonding, welding, soldering, crimping, or any other suitable means. The pitch of the radiopaque coil 260 can be constant or varying. For example, the radiopaque coil 260 can have a varying winding pitch that increases toward the distal end to increase the flexibility of the guidewire tip and / or reduce the stiffness caused by the plastically deformable material used in the radiopaque coil 260.

[0061] Reference Figures 15 and 16 According to an embodiment of the present disclosure, the radiopaque marker coil 260 can be formed of a metal composite wire 261 including an inner core 262 and an outer sheath 264. For example, the metal composite wire 261 can be a drawn-filled tubing (DFT) wire including 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, etc.). In some embodiments, the metal composite wire 261 can be a round wire or have a circular or substantially circular cross-section, such as Figure 15 In some embodiments, the metal composite wire 261 may be a ribbon or flat wire, or have a non-circular cross-section, such as Figure 16 The rectangular shape shown, or other shapes having a core cross-sectional area including a wider dimension and a narrower dimension. Using a ribbon or flat metal composite wire 261 ( Figure 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.

[0062] Reference Figure 17According to an embodiment of the present disclosure, the radiopaque marker coil 260 can be formed from a double-stranded wire 265, comprising a first wire 266 and a second wire 268 parallel to the first wire 266. The first wire 266 of the double-stranded wire 265 can comprise a radiopaque material, such as tungsten, platinum, iridium, gold, tantalum, or any alloy thereof. The second wire 268 of the double-stranded wire 265 can comprise 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 wound together around a portion of the core wire distal portion 214, allowing the first wire 266 of the radiopaque material and the second wire 268 of the plastically deformable material to alternate within the radiopaque marker coil 260 without crossing each other.

[0063] Reference Figure 18 According to an embodiment 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 than a radiopaque coil because there is friction between each intersection of the braid. The radiopaque braid 260a can be thicker than a radiopaque coil and can be more useful in guidewire devices of larger sizes (such as 0.024 or 0.35 inches). The radiopaque braid 260a can be secured to the core wire distal portion 214 via crimping, bonding, welding, soldering, or any other suitable means.

[0064] The radiopaque braid 260a can be composed of 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, etc., as described above in conjunction with the radiopaque coil.

[0065] According to an embodiment 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, etc.

[0066] Back to Figure 13According to an embodiment of the present disclosure, the guidewire device 200 may include a radiopaque tip 216 coupled to the distal end of the core wire 210 and / or the tubular member 250. The radiopaque tip 216 may be a radiopaque metal ball, such as a platinum or gold ball, secured to the core wire tip via bonding, brazing, welding, or other suitable means. Alternatively, the radiopaque tip 216 may be formed at the distal end of the core wire 210 and / or the tubular member 250 using a radiopaque solder or epoxy. Although a radiopaque coil 260 or braid 260a comprising a plastically deformable material may reduce the radiopacity of the marker coil or braid, using gold solder, gold epoxy, platinum ball, or other radiopaque material in the tip 216 will enable a physician to easily identify a black dot representing the radiopaque tip of the guidewire device 200.

[0067] 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 shape memory hypotube-based guidewire devices, use pure metal coils, such as platinum and tantalum coils, on the distal end of the core wire for radiopacity, and have the problem of difficulty in forming the guidewire tip or maintaining its imparted shape during use. The radiopaque marker of the present disclosure can be constructed of a metal composite wire including an outer sheath of a plastically deformable material, or of a double strand of wire including a plastically deformable material, or in the form of a braid in which at least one of the wires of the braid is made includes 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 non-invasive tip of the guidewire can be constructed of a radiopaque material to account for the lighter color resulting from the use of the plastically deformable material. Alternatively, or in addition, ribbon or flat metal composite wire may be used to increase the radiopacity of the marker coil.

[0068] Core support ramp-up indicator (RAMP-UP INDICATOR) Reference Figures 19 to 21 , embodiments of guidewire devices including indicators for indicating changes in the support or stiffness profile of a core wire are now described.

[0069] Manufacturers often offer guidewires with various support or stiffness profiles, such as soft, standard, and support profiles. These different support or stiffness profiles provide physicians with options when it comes to assisting with product access and delivery. For example, a guidewire with a softer profile may be preferred when accessing more distal anatomical structures, while a stiffer guidewire may be considered for delivery of heavier devices, such as balloons.

[0070] The guidewire device includes a core wire that usually runs through the length of the device. The core wire serves as a central structural support for providing a stiffness profile for pushability, torque transmission and flexibility in order to guide the guidewire device to the vascular access. In order to achieve the desired stiffness or support profile, the shape or profile of the core wire can be changed along the length, for example, by grinding. Grinding away more material will result in a softer core wire or a part of a softer core wire, and vice versa. There are usually significant points in the polished 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 affects the performance of the device. It is desirable to provide a clear visual indication of changes in the support profile showing, for example, an increase in stiffness. Understanding where the support profile rises during use can help doctors properly position the guidewire during the delivery of auxiliary products.

[0071] Reference Figures 19 to 21 , an example guidewire device 300 according to an embodiment of the present disclosure includes an elongated core wire 310 having different support or stiffness profiles and an indicator 360 secured to the core wire 310 to provide a visual indication of the change in stiffness profile of the core wire 310. The guidewire device 300 may also include a tubular sleeve 350 or polymer sheath proximate to or located over a distal portion of the core wire 310 to provide reinforcement. As shown, the example tubular sleeve or tube member 350 may include a plurality of cutouts or grooves 352 configured to enhance the effectiveness of the guidewire device. Although Figures 19 to 21 Although not shown, the guidewire device 300 may also include other components, such as components for radially centering the core wire in the tubular member and / or distal radiopaque markers as described in conjunction with other embodiments of the present disclosure, or other components known in the art.

[0072] Reference Figure 20 , the elongated core wire 310 can extend between a proximal portion 312 and a distal portion 314, for example, throughout the length of the guidewire device 300. The elongated core wire 310 can be made of a single continuous piece of material, such as stainless steel, cobalt-chromium alloy, nickel-titanium alloy, platinum alloy, titanium alloy, or DFT composite, as will be described in more detail below. The core wire 310 can also be made of two or more sections of different materials connected, for example, via welding, brazing, bonding, or mechanical locking.

[0073] Reference Figure 20 , the core wire 310 has a varying profile or geometry along the length of the core wire 310. Typically, the distal portion 314 of the core wire 310 has a reduced profile to optimize the flexibility of the guide wire device 300 at the distal end for enhanced maneuverability. The proximal portion 312 of the core wire 310 can have an expanded profile to maintain the pushability and torsional stiffness of the guide wire 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 a reduced profile to an increased profile.

[0074] 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 geometric shape with a constant cross-sectional dimension. For example, the first portion 314a of the distal portion 314 can be flat or rounded with a constant cross-sectional dimension, such as a constant rectangle, circle, oval, etc. The second portion 314b of the distal portion 314 can be tapered with a varying cross-sectional dimension, such as a diameter or area that increases in a proximal direction.

[0075] Similarly, 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, such as a diameter or area that decreases in the distal direction.

[0076] Reference Figure 20 , the tapered portion 314b of the distal portion 314 of the core wire 310 and / or the tapered portion 312a of the proximal portion 312 can have a taper angle ranging from 0.01 degrees to 0.06 degrees relative to the longitudinal axis of the core wire. The value of the taper angle indicates the severity of the change in the stiffness profile of the core wire 310. A smaller taper angle indicates a gradual or progressive change in the stiffness profile, while a larger taper angle indicates a sharp increase 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.

[0077] According to an embodiment of the present disclosure, an indicator 360 is disposed in the distal portion 314 near the tapered portion 314b, for example, at the 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 a change in the stiffness profile of the core wire 310.

[0078] Indicator 360 can be a radiopaque indicator visible via fluoroscopy or computed tomography (CT). Alternatively, or in addition, indicator 360 can be other indicators visible via other imaging modalities, such as ultrasound, magnetic resonance imaging (MRI), etc. Suitable materials for 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 alloy, platinum-tungsten alloy, etc. Radiopaque indicator 360 can be in the form of a marker band or coil, or any other suitable form.

[0079] The indicator 360 can be secured to the core wire 310 by various means, such as crimping and / or laser welding. Alternatively, or in addition, the indicator 360 can be secured to the tubular member 350 using glue and / or solder that can be sunk into the cutouts or grooves 352 in the tubular member 350. A combination of 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 tubular member 350 does not cause the indicator 360 to move before the indicator 360 is secured to the tubular member 350 using glue, solder, laser welding, etc.

[0080] The indicator 360 according to an embodiment of the present disclosure provides a physician with a visual indication of the rise of the support profile of the guidewire device 300 during clinical use. Knowing where the support profile rises during use can help the physician properly position the guidewire device 300 during the delivery of the auxiliary product. Another benefit is that the indicator 360 can help center the core wire 310 within the slotted tubular member 350. The radial centering of the core wire 310 within the tubular member 350 helps provide more uniform torque transmission. Another benefit is that the indicator 360 can help prevent the slotted tubular member 350 from stretching, which would otherwise adversely affect the pushability of the guidewire device 300 during use. The indicator 360 can be fixed to both the tubular member 350 and the core wire 310, providing friction between the tubular member 350 and the core wire 310, and thereby preventing the tubular member 350 from stretching.

[0081] Metal composite core wire Reference Figure 22 23 , embodiments of core wires for use with guidewires and other medical devices are now described.

[0082] A guidewire assembly includes a core wire that typically runs the length of the guidewire. The core wire material is typically selected to balance requirements for torque response, tip formability, tip softness, and a support or stiffness profile. One problem in the art is that the selection of core wire materials is limited and an intermediate material selection is not possible. While stainless steel, cobalt-chromium alloys, and nitinol have been used to construct core wires, each material has advantages and disadvantages. For example, a core wire constructed from nitinol can provide an ultra-soft tip, but the support profile and torque response are less than ideal. A core wire constructed from cobalt-chromium alloy can provide a good support profile and torque response, but poor tip formability. In order to achieve the desired set of properties for a guidewire assembly, the design must be compensated with other components, such as an outer sheath or tubular sleeve.

[0083] Another issue in the art that is particularly relevant to small guidewire devices (e.g., 0.010 inches or smaller) is radiopacity. Conventional corewire materials are radiopaque. Therefore, conventional guidewire designs must include radiopaque markers of dense materials (such as platinum) to provide adequate visibility under fluoroscopy. If a polymer sheath 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 sheath is not included in the design, the only source of radiopacity will be the radiopaque coil on the tip of the corewire. With smaller guidewire devices, space for the radiopaque coil is limited, and increasing its size will generally reduce other benefits.

[0084] In accordance with embodiments of the present disclosure, a metal composite wire is used to construct the core wire, which overcomes these and other problems associated with conventional guidewires.

[0085] Figure 22 An example guidewire device including a core wire according to an embodiment of the present disclosure is schematically illustrated. Figure 23A 、 Figure 23B and Figure 23C is a simplified diagram showing a cross-sectional end view of an example core wire. Figure 22 and Figures 23A to 23C As shown, the example guidewire device 400 includes an elongated core wire 410 extending between a proximal portion 412 and a distal portion 414. The core wire 410 can be formed from a metal composite wire including an inner core 416 and an outer sheath 418, both of which extend 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 that is different from the first material of the inner core 416. Although Figure 22 and Figures 23A to 23C Not shown, the guidewire device 400 may further include a polymer sheath or tubular or coiled sleeve disposed over the distal portion 414 of the core wire 410, components for centering the core wire 410 within the tubular sleeve, and / or distal radiopaque markers as described in conjunction with other embodiments of the present disclosure, or other components known in the art.

[0086] According to an embodiment 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 guidewires (e.g., 0.010 inches or less) that are reinforced using a tubular sleeve that provides limited space for a radiopaque coil. For larger guidewires that have a radiopaque coil disposed at the distal tip, a metal composite core wire comprising an elongated radiopaque inner core 416 can also improve the overall radiopacity of the guidewire 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.

[0087] In some embodiments, the metal composite inner core 416 comprises a radiopaque material such as Nitinol to take advantage of the softness of Nitinol, for example. Alternatively, the metal composite inner core comprises a cobalt-chromium alloy, a platinum alloy, a titanium alloy, or stainless steel.

[0088] According to an embodiment of the present disclosure, the second material of the metal composite outer sheath 418 comprises a material different from 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, cobalt-chromium alloys, nickel-titanium alloys, platinum alloys or titanium alloys, stainless steel, etc. Stainless steel can provide relatively balanced performance for the core wire in terms of torque response, support profile, tip formability, and tip softness. Cobalt-chromium alloys can provide better performance in terms of torque response and support profile, although the tip formability and tip softness are less than ideal. Nickel-titanium alloys (Nitinol) can provide excellent tip softness, but the tip formability, torque response, and support profile are less than ideal.

[0089] Table 1 provides example materials that may 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.

[0090] Table 1

[0091] Thus, according to embodiments of the present disclosure, the materials of both the inner core 416 and outer sheath 418 of the metal composite core wire 410 can be varied to provide various performance advantages. In conventional guidewire manufacturing, there is typically no middle ground when it comes to selecting a core wire material. The metal composite core wire 410 of the present disclosure provides an intermediate. For example, as shown in Table 1, using a metal composite core wire 410 with a cobalt-chromium outer sheath 418 and a platinum inner core 416 filler allows for greater formability due to the increased ductility of platinum and improves tip softness due to platinum being softer than cobalt-chromium. While there may be trade-offs associated with the tip support profile, the support profile of the cobalt-chromium / platinum composite core wire 410 is no worse than that of stainless steel.

[0092] According to an embodiment, the metallic composite core wire 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.

[0093] According to an embodiment, the metal composite core wire 410 of the present disclosure includes an outer sheath 418 of a material selected from the group consisting of cobalt-chromium alloys, nickel-titanium alloys, platinum alloys, titanium alloys, and stainless steel.

[0094] According to an embodiment, the metal composite core wire 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 alloys thereof, and an outer sheath 418 of a material selected from the group consisting of cobalt-chromium alloys, nickel-titanium alloys, platinum alloys, titanium alloys, and stainless steel.

[0095] According to certain embodiments, the metallic composite core wire 410 of the present disclosure includes an inner core 416 of platinum and an outer sheath 418 of a cobalt-chromium alloy.

[0096] According to certain embodiments, the metal composite core wire 410 of the present disclosure comprises a drawn fill tube (DFT) wire including an inner core 416 and an outer sheath 418 .

[0097] Reference Figures 23A to 23C According to embodiments of the present disclosure, the fill percentage of the metal composite core wire 410 can also be adjusted to prioritize the benefits of one material over another. As used herein, the phrase "fill percentage" refers to the proportion of the cross-sectional area of the metal composite wire occupied by the inner core 416 material (the filler material) relative to the total cross-sectional area of the metal composite wire 410. According to embodiments of the present disclosure, the metal composite core wire 410 includes a fill percentage of the inner core 416 material within a range of approximately 10% to 45% along the length of the core wire 410.

[0098] 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 from (e.g., greater than) the first fill percentage. This will allow the material properties of the inner core 416 to be more dominant at the distal portion 414 of the core wire 410 and the material properties of the outer sheath 418 to be more dominant at the proximal portion 412 of the core wire 420. For example, the metal composite core wire 410 of the present disclosure can include an inner core 416 of platinum and an outer sheath 418 of a cobalt-chromium alloy. As Figure 23A As shown, a greater fill percentage of the platinum inner core 416 at the distal end portion 414 of the metal composite core wire 410 will be beneficial in improving the softness, formability and radiopacity of the core wire 410. Alternatively, or in addition, as Figure 23C As shown, a smaller fill percentage of the platinum inner core 416 at the proximal portion 412 of the metal composite core wire 410 will provide more focus on the support profile and torque response of the core wire 410 .

[0099] According to embodiments of the present disclosure, the metal composite core wire 410 may include a constant fill percentage throughout a portion of the metal composite core wire 410. Alternatively, or in addition, the metal composite core wire 410 may include a varying or continuously varying fill percentage throughout a portion of the metal composite core wire 410. For example, in a proximal portion 412 of the core wire 410, the metal composite core wire 410 may have a substantially constant, small fill percentage of the inner core 416 material. In a distal portion 414 of the core wire 410, which may include one or more constant portions and one or more tapered portions, the fill percentage of the metal composite core wire may vary. For example, the distal portion 414 of the metal composite core wire 410 may 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 in the constant first portion 414a may be constant, while the fill percentage of the metal composite core wire 410 in the tapered second portion 414b may continuously vary, e.g., decrease in a proximal direction.

[0100] According to embodiments of the present disclosure, the raw metal composite wire 410 may 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, Figure 23A As shown, a greater fill percentage can be achieved by grinding more of the outer sheath 418 material at the distal portion 414 of the core wire 410, as shown in FIG. Figure 23C As shown, a smaller fill percentage can be achieved by grinding less outer sheath 418 material at the proximal portion 412 of the core wire 410. Alternatively, or in addition, different fill percentages can be achieved by gradually grinding the metal composite wire 410 to form a tapered section.

[0101] According to embodiments of the present disclosure, the metal composite core wire 410 of the present disclosure may have an outer diameter at the proximal portion 412 ranging from 0.0007 inches to 0.125 inches. In some embodiments, the metal composite core wire has an outer diameter at the proximal portion 412 ranging from 0.007 inches to 0.035 inches.

[0102] Various embodiments of guidewire devices and methods have been described with reference to the accompanying drawings. It should be noted that aspects described in conjunction with a particular embodiment are not necessarily limited to that embodiment and can be practiced in any other embodiment. Figures 1 to 12 The described embodiments of the centering core may be incorporated into a combination Figures 13 to 18The embodiments of the radiopaque coil or braid described herein, or vice versa, may be incorporated into a combination Figures 19 to 21 The embodiment of the core wire support indicator described or vice versa and can be incorporated into the combination Figure 22 as well as Figures 23A to 23C In the embodiment of the metal composite core described above or vice versa. Figures 13 to 18 Embodiments of the radiopaque coil or braid described, in combination Figures 19 to 21 The embodiment of the core wire support indicator described and the combination Figure 22 as well as Figures 23A to 23C The described embodiments of the metal composite core wire may each be incorporated into any other embodiment or aspect of the present disclosure described herein.

[0103] The accompanying drawings are intended to illustrate embodiments, but are not intended to be exhaustive or to limit the scope of the present disclosure. Without departing from the principles of the present invention, alternative structures, components, and materials will readily be considered feasible. In addition, although some embodiments of the present disclosure are described in conjunction with guidewire devices, this is not intended to be restrictive. For example, the core wire described herein can be used as a component of other interventional devices.

[0104] Unless expressly defined otherwise, all technical and scientific terms used herein have the meanings 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 reference unless the context clearly dictates otherwise. The term "or" refers to a non-exclusive "or" unless the context clearly dictates otherwise. The term "proximal" and its grammatical equivalents refer to a position, direction, or orientation toward the side of a user or physician. The term "distal" and its grammatical equivalents refer to a position, direction, or orientation away from the side of a user or physician. Designations such as "rearward" and "forward" are not intended to limit the referenced components to a particular orientation. It will be understood that such designations refer to the orientation of the referenced components as shown in the figures; the systems and devices of the present disclosure can be used in any orientation suitable for the user. The terms "first" or "second," etc., may be used to distinguish one element from another when describing various similar elements. It should be noted that the terms "first" and "second" as used herein include reference to two or more elements. Furthermore, unless the context clearly dictates otherwise, the use of the terms "first" or "second" should not be construed in any particular order. In alternative embodiments, the order in which the method steps are performed can be changed. One or more method steps can be skipped entirely, and one or more optional steps can be included. All numerical values are provided for illustration and are assumed to be modified by the term "approximately", whether or not explicitly stated. The term "approximately" generally refers to a range of numbers that one skilled in the art would consider equivalent to the cited value, e.g., to have the same function or result. The term "approximately" can include numbers rounded to the nearest significant figure. Representations of numerical ranges by endpoints include all numbers within that range.

[0105] It will be understood by those skilled in the art that various other modifications may be made. All of these and other changes and modifications are contemplated by the inventors and are within the scope of the invention.

Claims

1. A guide wire device, comprising: a core wire extending between the proximal portion and the distal portion; a tube member located near the distal end portion of the core wire, the tube member being fixed to the core wire and defining a space between the core wire and the tube member; as well as An expandable structure is disposed in a space between the core wire and the tubular member, the expandable structure being configured to be interference fit onto an inner surface of the tubular member and comprising a proximal end having an opening and a distal end having an opening to allow the core wire to pass through the expandable structure, wherein the opening at the proximal end and the opening at the distal end of the expandable structure are substantially aligned with a central longitudinal axis of the tubular member and are configured to surround the core wire so that the core wire is substantially aligned with the central longitudinal axis of the tubular member.

2. The guide wire device according to claim 1, wherein The expandable structure comprises a stent-like structure.

3. The guide wire device according to claim 2, wherein: The stent-like structure includes a braid of shape memory filaments.

4. The guide wire device according to claim 2, wherein: The proximal end and / or the distal end of the stent-like structure is fixedly fastened to the core wire.

5. The guide wire device according to claim 1, wherein: The expandable structure includes a cutting tube structure, which includes a tubular body composed of a shape memory material and is provided with a plurality of longitudinal slits to form a plurality of strands extending between a proximal portion and a distal portion of the tubular body, wherein the cutting tube structure is heat set to provide an expanded shape, in which the plurality of strands bend outward and apply radial forces to the tubular member, thereby allowing the cutting tube structure to be interference fit onto the inner surface of the tubular member of the guidewire device. 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 end portions of the tubular body are fixedly secured to the core wire.

8. The guide wire device according to claim 1, wherein: The expandable structure comprises a crown structure comprising an annular band portion and a plurality of elongated elements extending from the annular band portion, wherein the crown structure is constructed of a shape memory material and is heat set to provide an expanded shape in which the plurality of elongated elements bend outwardly away from the annular band portion and exert a radial force on the tubular member, thereby allowing the crown structure to interference fit onto the inner surface of the tubular member of the guidewire device.

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

10. The guide wire device according to claim 8, wherein: The annular band portion of the crown is fixedly secured 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 between 0.014 inches and 0.038 inches.

13. The guide wire device according to claim 1, wherein: The tubular member includes a plurality of cutouts extending circumferentially about the central longitudinal axis of the tubular member.

14. A guide wire device, comprising: a core wire extending between the proximal portion and the distal portion; a tube member located near a distal end portion of the core wire, the tube member being fixed to the core wire and defining a space between the core wire and the tube member; as well as a plurality of disks coupled to the distal portion of the core wire, the plurality of disks being spaced apart from one another and configured to interference fit onto the inner surface of the tubular member, wherein each of the plurality of disks includes an opening configured to permit passage of the core wire and to substantially align the core wire with a central longitudinal axis of the tubular member.

15. The guide wire device according to claim 14, wherein: The plurality of disks are constructed of a polymer material.

16. The guide wire device according to claim 14, wherein: The opening of one or more of the plurality of disks is circular.

17. The guide wire device according to claim 14, wherein: The opening of one or more of the plurality of disks is a slot extending from a center to a periphery of the one or more of the plurality of disks.

18. The guide wire device according to claim 14, wherein: The tubular member includes a plurality of cutouts extending circumferentially about a central longitudinal axis of the tubular member.

19. The guide wire device according to claim 18, wherein: The plurality of discs are fixedly secured to the core wire.

20. The guidewire device according to claim 19, wherein The plurality of discs are further fixedly secured to the tubular member.

21. The guidewire device according to claim 14, wherein: The proximal portion of the core wire has an outer diameter equal to or greater than 0.014 inches.

22. The guidewire device according to claim 14, wherein: The proximal portion of the core wire has an outer diameter ranging between 0.014 inches and 0.038 inches.

23. A guide wire device, comprising: a core wire extending between the proximal portion and the distal portion; a tubular member positioned adjacent a distal end portion of the core wire and coupled to the core wire; as well as A radiopaque marker is within the tubular member and coupled to the core wire, wherein the radiopaque marker comprises a first radiopaque material and a second plastically deformable material.

24. The guidewire device according to claim 23, wherein: The radiopaque marker is in the form of a coil wrapped around the distal portion of the core wire.

25. The guidewire device according to claim 24, wherein The coil is formed from a metallic composite wire including an inner core of the radiopaque first material and an outer sheath of the plastically deformable second material.

26. The guidewire device according to claim 25, wherein The metal composite wire has a cross-section of an inner core having a non-circular shape, the non-circular shape including a wider dimension and a narrower dimension, and wherein the metal composite wire is wrapped around a distal portion of the core wire such that the wider dimension of the non-circular shape is in a radial direction to increase the radiopacity of the radiopaque marker.

27. The guidewire device according to claim 25, wherein The coil includes a varying pitch that increases in a distal direction to increase the flexibility of the distal portion of the core wire.

28. The guidewire device according to claim 25, wherein The second plastically deformable material of the outer sheath of the metal composite wire includes nickel-cobalt alloy or stainless steel.

29. The guidewire device according to claim 24, wherein The coil includes a double wire including a first wire and a second wire parallel to the first wire, the first wire of the double wire including a first radiopaque material, and the second wire of the double wire including a second plastically deformable material.

30. The guidewire device according to claim 29, wherein The second plastically deformable material includes nickel-cobalt alloy or stainless steel.

31. The guidewire device according to claim 29, wherein The double wire is wound around the distal end portion of the core wire at a varying pitch that increases in a distal direction to improve the flexibility of the distal end portion of the core wire.

32. The guidewire device according to claim 23, wherein The radiopaque marker is in the form of a braid.

33. The guidewire device according to claim 32, wherein: The braid is comprised of two or more metallic composite wires, each of the two or more metallic composite wires including an inner core of the radiopaque first material and an outer sheath of the plastically deformable second material.

34. The guidewire device according to claim 32, wherein: The braid is comprised of two or more strands including first strands of the radiopaque first material and second strands of the plastically deformable second material.

35. The guidewire device of claim 32, wherein: The core wire has an outer diameter equal to or greater than 0.024 inches at a proximal end portion of the core wire.

36. The guidewire device of claim 23, further comprising a rounded tip coupled to the distal end of the core wire, wherein The rounded tip comprises a radiopaque material.

37. The guidewire device according to claim 23, wherein: The tubular member is constructed of a shape memory alloy and includes a plurality of cutouts extending circumferentially about a central longitudinal axis of the tubular member.

38. A guide wire device, comprising: a core wire extending between a proximal portion and a distal portion, the distal portion including a first portion having a first stiffness profile and a second portion having a second stiffness profile different from the first stiffness profile; as well as An indicator is secured to the core wire, wherein the indicator is located 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.

39. The guidewire device according to claim 38, wherein The first portion has a substantially constant cross-sectional dimension.

40. The guidewire device according to claim 39, wherein The second portion is tapered with a cross-sectional dimension increasing in a proximal direction.

41. The guidewire device according to claim 40, wherein The second portion has a taper angle equal to or greater than 0.02 degrees.

42. The guidewire device of claim 38, wherein: The indicator comprises a radiopaque indicator.

43. The guidewire device according to claim 42, wherein The radiopaque indicator is in the form of a marker band or coil.

44. The guidewire device of claim 38, further comprising a tubular member positioned adjacent a distal portion of the core wire, the tubular member comprising a plurality of cutouts extending circumferentially about a central longitudinal axis of the tubular member.

45. The guidewire device of claim 44, wherein: The indicator is also secured to the tube member.

46. A guidewire device comprising a core wire extending between a proximal portion and a distal portion, wherein The core wire comprises a metal composite wire including an inner core of a first material and an outer sheath of a second material different from the first material.

47. The guidewire device according to claim 46, wherein The first material of the inner core comprises a radiopaque material.

48. The guidewire device of claim 47, wherein: The first material of the inner core includes gold, silver, platinum, tantalum, tungsten or alloys thereof.

49. The guidewire device of claim 47, wherein: The second material of the outer sheath includes cobalt-chromium alloy, nickel-titanium alloy, platinum alloy, titanium alloy or stainless steel.

50. The guidewire device according to claim 49, wherein The metal composite wire includes a fill percentage of the first material of the inner core ranging from approximately 10% to 45% along the length of the core wire.

51. The guidewire device of claim 46, wherein: The first material of the inner core includes cobalt-chromium alloy, nickel-titanium alloy, platinum alloy, titanium alloy or stainless steel.

52. The guidewire device according to claim 51, wherein The second material of the outer sheath includes cobalt-chromium alloy, nickel-titanium alloy, platinum alloy, titanium alloy or stainless steel.

53. The guidewire device according to claim 52, wherein: The metal composite wire includes a fill percentage of the first material of the core ranging from approximately 10% to 45%.

54. The guidewire device of claim 46, wherein: The metal composite wire includes a fill percentage of the first material of the core ranging from approximately 10% to 45%.

55. The guidewire device of claim 54, wherein: The fill percentage includes a first fill percentage in a distal portion of the core wire and a second fill percentage in a proximal portion of the core wire, the second fill percentage being less than the first fill percentage.

56. The guidewire device of claim 46, wherein: The distal portion of the core wire further comprises a first portion and a second portion, and the first portion comprises a constant fill percentage of the first material of the inner core, and the second portion comprises a varying fill percentage of the first material of the inner core that decreases in a proximal direction.

57. The guidewire device of claim 56, wherein: The first material of the inner core comprises a radiopaque material selected from the group consisting of gold, silver, platinum, tantalum, tungsten, and alloys thereof, 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.

58. The guidewire device of claim 46, wherein: The first material of the inner core includes platinum, the second material of the outer sheath includes cobalt-chromium alloy, and the metallic composite wire includes a fill percentage of the inner core ranging from approximately 10% to 45% along the length of the core wire.

59. The guidewire device of claim 46, further comprising a tubular member positioned adjacent a distal portion of the core wire, the tubular member comprising a plurality of cutouts extending circumferentially about a central longitudinal axis of the tubular member.

60. The guidewire device of claim 46, wherein: The metal composite wire has an outer diameter at a proximal portion of the core wire ranging from 0.007 inches to 0.035 inches.

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