Medical device with composite core wire

Abstract

Medical devices and methods of making medical devices are disclosed. A medical device includes a core wire (212) having a proximal shaft portion (222) and a distal shaft portion (224) coupled to the proximal shaft portion. The proximal shaft portion (222) includes a first material. The distal shaft portion (224) includes an inner shaft (234) formed of a second material and an outer shell (236) disposed along an outer surface of the inner shaft. The housing (236) is formed from the first material. A tip member (242) is disposed on a distal region of the distal shaft portion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 339,139, filed on May 6, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention relates to medical devices and methods for making medical devices. More particularly, the present invention relates to medical devices having a composite core wire. Background Art

[0003] A wide variety of in vivo medical devices have been developed for medical use, such as intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0004] The present invention provides designs, materials, manufacturing methods and use alternatives for medical devices. A medical device is disclosed. The medical device includes: a core wire having a proximal shaft portion and a distal shaft portion coupled to the proximal shaft portion; wherein the proximal shaft portion comprises a first material; wherein the distal shaft portion comprises an inner shaft formed of a second material and an outer shell disposed along an outer surface of the inner shaft, the outer shell being formed of the first material; and a terminal member disposed on a distal region of the distal shaft portion.

[0005] Alternatively or additionally to any of the above embodiments, the first material comprises stainless steel.

[0006] Alternatively or additionally to any of the above embodiments, the second material includes nickel titanium alloy.

[0007] Alternatively or additionally to any of the above embodiments, the second material includes a superelastic nickel titanium alloy.

[0008] Alternatively or additionally to any of the above embodiments, the proximal shaft portion includes a taper.

[0009] Alternatively or additionally to any of the above embodiments, the distal shaft portion includes a taper.

[0010] Alternatively or additionally to any of the above embodiments, the housing comprises a cone.

[0011] Alternatively or additionally to any of the above embodiments, the end member comprises a polymer end.

[0012] Alternatively or additionally to any of the above embodiments, the tip member comprises a coil.

[0013] Alternatively or additionally to any of the above embodiments, the inner shaft is tubular.

[0014] Alternatively or additionally to any of the above embodiments, it also includes a rod extending within the inner shaft.

[0015] Alternatively or additionally to any of the above embodiments, the rod comprises a radiopaque material.

[0016] A method for manufacturing a core wire is disclosed. The method includes: contacting a first end region of a first shaft with a second end region of a second shaft; wherein the first shaft includes a first material; wherein the second shaft includes an inner region and an outer shell disposed along the inner region, the inner region includes the second material, and the outer shell includes the first material; thermally bonding the first shaft to the second shaft; and grinding a portion of the second shaft to remove at least a portion of the outer shell.

[0017] Alternatively or additionally to any of the above embodiments, the first material comprises stainless steel.

[0018] Alternatively or additionally to any of the above embodiments, the second material includes nickel titanium alloy.

[0019] Alternatively or additionally to any of the above embodiments, the second material includes a superelastic nickel titanium alloy.

[0020] Alternatively or additionally to any of the above embodiments, the second shaft has a third end region opposite the second end region, and wherein grinding a portion of the second shaft to remove the outer shell from at least a portion of the second shaft includes grinding the second shaft at a position adjacent to the third end region.

[0021] A guidewire is disclosed. The guidewire comprises: a core wire having a proximal shaft and a distal shaft coupled to the proximal shaft; wherein the proximal shaft comprises stainless steel; wherein the proximal shaft has a first region, the first region having a first outer diameter; wherein the proximal shaft has a second region, which is disposed distally of the first region and has a second outer diameter smaller than the first outer diameter; wherein the distal shaft comprises an inner nickel-titanium alloy member and an outer stainless steel cladding; wherein the distal shaft comprises a third region attached to the second region of the proximal shaft; wherein the distal shaft comprises a fourth region disposed distally of the third region, the fourth region having no housing; and a terminal member disposed on the fourth region of the distal shaft.

[0022] Alternatively or additionally to any of the above embodiments, the second region of the proximal shaft, the third region of the distal shaft, or both include a taper.

[0023] Alternatively or additionally to any of the above embodiments, the tip member comprises a polymer guidewire tip or a spring tip.

[0024] A medical device is disclosed. The medical device includes: a core wire having a proximal shaft portion and a distal shaft portion coupled to the proximal shaft portion; wherein the proximal shaft portion includes a first material; wherein the proximal shaft portion has a first region, the first region having a first outer diameter; wherein the proximal shaft portion has a second region, which is disposed distally of the first region and has a second outer diameter smaller than the first outer diameter; wherein the distal shaft portion includes an inner shaft formed of the second material and an outer shell disposed along an outer surface of the inner shaft, the outer shell being formed of the first material; wherein the distal shaft portion includes a third region attached to the second region of the proximal shaft portion; wherein the distal shaft portion includes a fourth region disposed distally of the third region, the fourth region having no outer shell; and a terminal member disposed on the fourth region of the distal shaft portion.

[0025] Alternatively or additionally to any of the above embodiments, the first material comprises stainless steel.

[0026] Alternatively or additionally to any of the above embodiments, the second material includes nickel titanium alloy.

[0027] Alternatively or additionally to any of the above embodiments, the second material includes a superelastic nickel titanium alloy.

[0028] Alternatively or additionally to any of the above embodiments, the second region of the proximal shaft portion comprises a taper.

[0029] Alternatively or additionally to any of the above embodiments, the third region of the distal shaft portion comprises a taper.

[0030] Alternatively or additionally to any of the above embodiments, the end member comprises a polymer end.

[0031] Alternatively or additionally to any of the above embodiments, the tip member comprises a coil.

[0032] Alternatively or additionally to any of the above embodiments, the inner shaft is tubular.

[0033] Alternatively or additionally to any of the above embodiments, it also includes a rod extending within the inner shaft.

[0034] Alternatively or additionally to any of the above embodiments, the rod comprises a radiopaque material.

[0035] A method for manufacturing a core wire is disclosed. The method includes: contacting a first end region of a first shaft with a second end region of a second shaft; wherein the first shaft includes a first material; wherein the second shaft includes an inner region and an outer shell disposed along the inner region, the inner region includes the second material, and the outer shell includes the first material; thermally bonding the first shaft to the second shaft; and grinding a portion of the second shaft to remove the outer shell from at least a portion of the second shaft.

[0036] Alternatively or additionally to any of the above embodiments, the first material comprises stainless steel.

[0037] Alternatively or additionally to any of the above embodiments, the second material includes nickel titanium alloy.

[0038] Alternatively or additionally to any of the above embodiments, the second material includes a superelastic nickel titanium alloy.

[0039] Alternatively or additionally to any of the above embodiments, the second shaft has a third end region opposite the second end region, and wherein grinding a portion of the second shaft to remove the outer shell from at least a portion of the second shaft includes grinding the second shaft at a position adjacent to the third end region.

[0040] A guidewire is disclosed. The guidewire comprises: a core wire having a proximal shaft and a distal shaft coupled to the proximal shaft; wherein the proximal shaft comprises stainless steel; wherein the proximal shaft has a first region, the first region having a first outer diameter; wherein the proximal shaft has a second region, which is disposed distally of the first region and has a second outer diameter smaller than the first outer diameter; wherein the distal shaft comprises an inner nickel-titanium alloy member and an outer stainless steel cladding; wherein the distal shaft comprises a third region attached to the second region of the proximal shaft; wherein the distal shaft comprises a fourth region disposed distally of the third region, the fourth region having no housing; and a terminal member disposed on the fourth region of the distal shaft.

[0041] Alternatively or additionally to any of the above embodiments, the second region of the proximal shaft comprises a taper.

[0042] Alternatively or additionally to any of the above embodiments, the third region of the distal shaft comprises a taper.

[0043] Alternatively or additionally to any of the above embodiments, the tip member comprises a polymer guidewire tip or a spring tip.

[0044] A medical device is disclosed. The medical device comprises: a core wire having a proximal shaft portion and a distal shaft portion coupled to the proximal shaft portion; wherein the proximal shaft portion comprises a first material; wherein the distal shaft portion comprises an inner shaft formed of a second material and an outer shell disposed along an outer surface of the inner shaft, the outer shell being formed of a material compatible with the first material; and a terminal member disposed on a distal region of the distal shaft portion.

[0045] A medical device is disclosed. The medical device comprises: a core wire having a proximal shaft portion and a distal shaft portion coupled to the proximal shaft portion; wherein the proximal shaft portion comprises a first material; wherein the distal shaft portion comprises an inner shaft formed of a second material and an outer shell disposed along an outer surface of the inner shaft, the outer shell being formed of a material that is weldable and compatible with the first material; and a terminal member disposed on a distal region of the distal shaft portion.

[0046] A medical device is disclosed. The medical device includes: a core wire having a proximal shaft portion and a distal shaft portion coupled to the proximal shaft portion; wherein the proximal shaft portion includes a first material; wherein the distal shaft portion includes an inner shaft formed of a second material and an outer shell disposed along an outer surface of the inner shaft, the outer shell being formed of a material that is thermally bondable and compatible with the first material; and a terminal member disposed on a distal region of the distal shaft portion.

[0047] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0049] Figure 1 is a partial cross-sectional side view of an example medical device;

[0050] Figure 2 is a partial cross-sectional side view of an example medical device;

[0051] Figures 3 to 5 Example core wires and / or example processes for making the core wires are shown;

[0052] Figure 6 is a partial cross-sectional side view of an example medical device;

[0053] Figures 7 and 8 Example core wires and / or example processes for making the core wires are shown;

[0054] Fig. 9 is a partial cross-sectional side view of an example medical device.

[0055] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0056] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0057] All numerical values ​​are assumed herein to be modified by the term "about", whether or not expressly indicated. The term "about" generally refers to a range of numbers that one skilled in the art considers equivalent to the referenced value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0058] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0059] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0060] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more specific features, structures and / or characteristics. However, such a description does not necessarily mean that all embodiments include the specific features, structures and / or characteristics. Additionally, when specific features, structures and / or characteristics are described in conjunction with one embodiment, it should be understood that such features, structures and / or characteristics may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

[0061] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0062] There are many known guidewires that can be used for various interventions. For example, Figure 1An example guidewire 10 is schematically depicted. In this example, the guidewire 10 includes a core wire 12 having a tapered region 14 and a distal region 16. The guidewire 10 may include a distal tip 18. In this example, the distal tip 18 is a polymer or "poly" tip that includes a polymer end member 20 disposed on the distal region 16. Similarly, Figure 2 Another example guidewire 110 is schematically depicted. In this example, the guidewire 110 includes a core wire 112 having a tapered region 114 and a distal region 116. The guidewire 110 may include a distal tip 118. In this example, the distal tip 118 is a "spring tip" that includes a coil or spring 120 disposed on the distal region 116. A tip 122 (e.g., a solder ball tip) may be coupled to the coil 120.

[0063] In some cases, the core wire 12, 112 may need to include structural features and / or materials that provide desired properties to the guide wire 10, 110. For example, the more proximal portion of the guide wire 10, 110 may need to be harder, and the more distal portion of the guide wire 10, 110 may need to be more flexible. One way to achieve this overall goal may include using a tapered or reduced diameter area of ​​the core wire 12, 112, which can increase the flexibility near the tapered / reduced diameter area. In some of these cases and in other cases, different materials may need to be used for different parts of the core wire 12, 112. A core wire and / or a guide wire using a core wire (e.g., a composite core wire) comprising a section or portion formed by a material is disclosed herein.

[0064] Figures 3 to 5 Portions of a core, example methods of forming a core, and / or a core are shown. In this example, the core is considered to be a composite core formed from multiple materials and / or sections bonded together. For example, Figure 3 A proximal shaft 222 and a distal shaft 224 are shown. The proximal shaft 222 may include a first region 226, a second region 230, and an end or end region 232. Figure 3 , reference numeral 228 indicates an example location along the proximal shaft 222 where the first region 226 transitions to the second region 230. In some cases, reference numeral 228 can correspond to a location where the proximal shaft 222 will be processed or ground (e.g., as discussed herein). Figure 3 Also shown in FIG. 2 is a distal shaft 224. The distal shaft can include an inner shaft 234 and an outer shell or cladding 236. The distal shaft 224 can include an end or end region 237.

[0065] The proximal shaft 222 can be formed of a first material or otherwise include a first material. The first material can include one or more of the materials disclosed herein, such as stainless steel. For a variety of reasons, including, for example, providing the desired level of rigidity and / or pushability, stainless steel may be required. The inner shaft 234 of the distal shaft 224 may include a second material. The second material may include one or more of the materials disclosed herein, such as nickel-titanium alloy. For a variety of reasons, including, for example, providing the desired level of flexibility and / or elasticity, nickel-titanium alloy may be required. In some cases, nickel-titanium alloy may be a shape memory and / or superelastic nickel-titanium alloy. In other cases, nickel-titanium alloy may be a linear elastic nickel-titanium alloy. The housing 236 may include a material compatible with the first material, a material compatible with the first material weldable, a material compatible with the first material heat-bonded, a first material (e.g., stainless steel), and / or one or more of the materials disclosed herein.

[0066] The relative sizes of the components of the distal shaft 224 can vary. It should be noted that the sizes are not necessarily shown to scale in the figures and should be considered as examples only. For example, the inner shaft 234 can occupy most of the volume of the distal shaft 224, while the outer shell 236 may contribute less to the volume of the distal shaft 224 than the inner shaft 234. In other cases, the outer shell 236 can occupy most of the volume of the distal shaft 224. One way to quantify the relative contribution / size is to look at the cross-section of the distal shaft 224 and determine the relative area of ​​the inner shaft 234 and / or the outer shell 236 relative to the total cross-sectional area of ​​the distal shaft 224. In some cases, the distal shaft 224 can have a cross-sectional area, and the inner shaft 234 can occupy about 25% or more of the total cross-sectional area of ​​the distal shaft 224, or about 40% or more of the total cross-sectional area of ​​the distal shaft 224, or about 60% or more of the total cross-sectional area of ​​the distal shaft 224, or about 75% or more of the total cross-sectional area of ​​the distal shaft 224. These are just examples. Other sizes can be envisioned.

[0067] In examples where the proximal shaft 222 comprises stainless steel and the distal shaft 224 (e.g., the inner shaft 234 of the distal shaft 224) comprises nickel-titanium alloy, it may be challenging to thermally bond the proximal shaft 222 to the distal shaft 224. Including the outer shell 236 may help improve thermal bonding compatibility between the proximal shaft 222 and the distal shaft 224. For example, when the outer shell 236 is formed of the same material as the proximal shaft 222 (or a material that has good thermal bonding compatibility with the material used for the proximal shaft 222), it may be easier to form a resilient and reliable thermal bond between the proximal shaft 222 and the distal shaft 224. While not wishing to be bound by theory, it is believed that thermal bonding between the outer shell 236 and the proximal shaft 222 can help strengthen the bond between the proximal shaft 222 and the distal shaft 224, even if the inner shaft 234 has a lower thermal bonding compatibility with the proximal shaft 222.

[0068] like Figure 4 As shown, the proximal shaft 222 can be in contact with the distal shaft 224. This can include forming a thermal bond (e.g., welding) in which the end 232 of the proximal shaft 222 is bonded to the end 237 of the distal shaft 224. Figure 4 , the bonding / joining of the ends 232 , 237 is marked by a joint 238 .

[0069] In some cases, the proximal shaft 222 and / or the distal shaft 224 may be ground or otherwise processed to form the core wire 212, such as Figure 5 As shown. In this example, the second region 230 of the proximal shaft 222 is ground to form / include one or more tapers and / or tapered regions. By doing so, the second region 230 (e.g., at least a portion of the second region 230) ultimately has a reduced outer diameter relative to the first portion of the proximal shaft 222. The distal shaft 224 can also be ground. In this example, grinding can form a taper in the distal shaft 224. This can include removing a portion of the outer shell 236 and / or forming a taper in the outer shell 236. Grinding / tapering can continue until the outer shell 236 is tapered / removed to a point where the inner shaft 234 is exposed, thereby forming or defining the terminal region 240 of the distal shaft 224. In some cases, the inner shaft 234 is also partially ground. In other cases, the inner shaft 234 remains unground. In this example, along the terminal region 240, only the inner shaft 234 of the distal shaft 224 is retained.

[0070] After grinding, the size of the core wire 212 can vary. For example, in some cases, the diameter of the first region 226 can be about 0.010 to 0.040 inches or less, 0.010 to 0.035 inches or less, or about 0.012 to 0.018 inches or less, or about 0.017 inches or less. The second region 230 can taper to an outer diameter of about 0.006 to 0.014 inches, or about 0.008 to 0.012 inches, or about 0.009 to 0.010 inches. The outer diameter of the end region 240 can be about 0.004 to 0.010 inches, or about 0.005 to 0.007 inches, or about 0.006 inches. These are just examples.

[0071] The core wire 212 can be used to form the guide wire 210, such as Figure 6 The guidewire 210 may include a tip or tip member 242 disposed along the tip region 240. In this example, the tip member 242 includes a polymer tip 244. Thus, the tip member 242 may be similar to Figure 1 The polymer or "poly" end of the exemplary guidewire 10 shown in FIG. In other examples, the end member 242 can be changed to be similar to Figure 2210 is a schematic diagram of a spring end of a guide wire 110 shown in FIG. Other ends can be envisioned, including a hybrid end (e.g., a structure including both a polymer end and a spring end). In addition, the guide wire 210 can also include other structures that can be used for the guide wire, such as a forming band, a marking band, a marking coil, etc. Similarly, the core wire 212 can be used for a variety of medical devices / structures, including guide wires, catheters, guide wires, introducers, trocars, dilators, etc. The guide wire 210 can be used for peripheral intervention, coronary intervention, delivery of implants (such as stents, artificial valves, etc.), etc.

[0072] Figures 7 and 8 A portion of another core wire, an example method of forming another example core wire, and / or another example core wire are shown. Figure 7 As shown, the proximal shaft 322 may include a first region 326, a second region 330, and an end or end region. Figure 7 , reference numeral 328 indicates an example location along the proximal shaft 322 where the first region 326 transitions to the second region 330. In some cases, reference numeral 328 can correspond to a location where the proximal shaft 322 will be processed or ground (e.g., as discussed herein). Figure 7 Also shown is a distal shaft 324. The distal shaft may include an inner shaft 334 and an outer shell or cladding 336. A rod 346 may extend through the inner shaft 334. The distal shaft 324 may include an end or end region. Figure 7 As shown, the proximal shaft 222 can be in contact with the distal shaft 324. This can include attaching the end of the proximal shaft 322 to the end of the distal shaft 324. Figure 7 , the junction of the ends is marked by connector 338.

[0073] Like the proximal shaft 222, the proximal shaft 222 can be formed of a first material or otherwise include a first material. The first material can include one or more of the materials disclosed herein, such as stainless steel. For a variety of reasons, including, for example, to provide the desired level of stiffness and / or pushability, stainless steel may be required. The inner shaft 334 of the distal shaft 324 may include a second material. The second material may include one or more of the materials disclosed herein, such as nickel titanium alloy. For a variety of reasons, including, for example, to provide the desired level of flexibility and / or elasticity, nickel titanium alloy may be required. In some cases, the nickel titanium alloy may be a shape memory and / or superelastic nickel titanium alloy. In other cases, the nickel titanium alloy may be a linear elastic nickel titanium alloy. The housing 336 may include a material compatible with the first material, a material compatible with the first material weldable, a material compatible with the first material heat bondable, a first material (e.g., stainless steel) and / or one or more of the materials disclosed herein. In some cases, the rod 346 may include a radiopaque material (e.g., bismuth, tantalum, tungsten and / or tungsten alloy, gold, platinum, palladium, iridium alloy, combinations thereof, other materials such as disclosed herein, etc.). In some of these cases and in other cases, the rod 346 can include stainless steel and / or a linear elastic nickel titanium alloy. When the inner shaft 334 includes a superelastic and / or shape memory superelastic alloy, the use of a stainless steel and / or linear elastic nickel titanium alloy rod 346 can help provide some formability to the guidewire 310 (e.g., to provide formability to the end region 340).

[0074] In some cases, the proximal shaft 322 and / or the distal shaft 324 may be ground or otherwise processed to form the core wire 312, such as Figure 8 As shown. In this example, the second region 330 of the proximal shaft 322 is ground to form / include a taper. By doing so, the second region 330 ultimately has a reduced outer diameter relative to the first portion of the proximal shaft 322. The distal shaft 324 may also be ground. The grinding / tapering may continue until the outer shell 336 is tapered / removed to a point where the inner shaft 334 is exposed, thereby forming or defining the terminal region 340 of the distal shaft 324. Along the terminal region 340, only the inner shaft 334 and the rod 346 are retained. In some cases, the inner shaft 334 is also partially ground. In other cases, the inner shaft 334 remains unground.

[0075] The core wire 312 can be used to form the guide wire 310, such as Fig. 9 The guidewire 310 may include a tip or tip member 342 disposed along the tip region 340. In this example, the tip member 342 includes a polymer tip 344. Thus, the tip member 342 may be similar to Figure 1 The polymer or "poly" end of the exemplary guidewire 10 shown in FIG. In other examples, the end member 342 can be changed to be similar to Figure 2 310 is a schematic diagram of a spring end of a guide wire 110 shown in FIG. Other ends can be envisioned, including a hybrid end (e.g., a structure including both a polymer end and a spring end). In addition, guide wire 310 can also include other structures that can be used for guide wires, such as a forming band, a marking band, a marking coil, etc. Similarly, core wire 312 can be used for a variety of medical devices / structures, including guide wires, catheters, guide wires, introducers, trocars, dilators, etc. Guide wire 310 can be used for peripheral intervention, coronary intervention, delivery of implants (such as stents, artificial valves, etc.), etc.

[0076] The materials that can be used for the various components of the guidewires 10, 110, 210, 310 can include those commonly associated with medical devices. For simplicity, the following discussion refers to the guidewire 10 and other components of the guidewire 10. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other similar tubular members and / or components of the tubular members or devices disclosed herein.

[0077] The guidewire 10 may be made of a metal, a metal alloy, a polymer (some examples of which are disclosed below), a metal-polymer composite, a ceramic, a combination thereof, or the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., commercially available from DuPont), ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., commercially available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers, such as those commercially available from DuPont ), polyamide (for example, commercially available from Bayer or commercially available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name commercially available), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as commercially available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0078] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel titanium alloys, such as linear elastic and / or superelastic Nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0079] In at least some embodiments, part or all of the guidewire 10 may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be capable of producing a relatively bright image on a fluoroscopic screen or with another imaging technique during a medical procedure. This relatively bright image helps the user of the guidewire 10 determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the guidewire 10 to achieve the same result.

[0080] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the guidewire 10. For example, the guidewire 10 or portions thereof may be made of a material that does not substantially distort the image and create a substantial amount of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may create artifacts in the MRI image. The guidewire 10 or portions thereof may also be made of a material that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol, etc.

[0081] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. A medical device comprising: a core wire having a proximal shaft portion and a distal shaft portion coupled to the proximal shaft portion; wherein the proximal shaft portion comprises a first material; wherein the distal shaft portion comprises an inner shaft formed of a second material and an outer shell disposed along an outer surface of the inner shaft, the outer shell being formed of the first material; and A tip member is disposed at a distal region of the distal shaft portion.

2. The medical device according to claim 1, wherein: The first material includes stainless steel.

3. The medical device according to any one of claims 1 to 2, wherein: The second material includes nickel-titanium alloy.

4. The medical device according to any one of claims 1 to 3, wherein: The second material includes a superelastic nickel-titanium alloy.

5. The medical device according to any one of claims 1 to 4, wherein: The proximal shaft portion includes a taper.

6. The medical device according to any one of claims 1 to 5, wherein: The distal shaft portion includes a taper.

7. The medical device according to any one of claims 1 to 6, wherein: The housing includes a cone.

8. The medical device according to any one of claims 1 to 7, wherein: The end member includes a polymer end.

9. The medical device according to any one of claims 1 to 8, wherein: The end member includes a coil.

10. The medical device according to any one of claims 1 to 9, wherein: The inner shaft is tubular.

11. The medical device of claim 10, further comprising a rod extending within the inner shaft.

12. The medical device according to claim 11, wherein: The rod comprises a radiopaque material.

13. A method for manufacturing a core wire, the method comprising: contacting a first end region of the first shaft with a second end region of the second shaft; wherein the first shaft comprises a first material; wherein the second shaft comprises an inner region and a shell disposed along the inner region, the inner region comprises a second material, and the shell comprises a first material; thermally bonding the first shaft to the second shaft; and A portion of the second shaft is ground to remove at least a portion of the housing.

14. The method according to claim 13, wherein: The first material includes stainless steel.

15. The method according to any one of claims 13 to 14, wherein: The second material includes nickel-titanium alloy.

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