Guidewire device with formable polymer tip

Abstract

The present disclosure relates to a guidewire device having a shapeable tip and effective torqueing capabilities. The guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section of the core extends into the tube structure and distally beyond the tube structure. The portion of the core extending distally beyond the tube forms a shapeable tip. A polymeric covering wraps the tip. The tip is configured to reduce the tendency of elastic forces from the tube structure to disrupt a customized shape of the tip.

Description

[0001] This application is a divisional application of the invention patent application of Vascular Science Ltd. (filed on July 10, 2017, application number 201780057199.3, invention title "Guidewire Device with Formable Polymer Ends").

[0002] Cross-references to related applications

[0003] This application claims priority and benefit to U.S. Patent Application Serial No. 15 / 611,344, filed June 1, 2017, entitled “GUIDEWIRE DEVICES HAVING SHAPEABLE POLYMER TIPS,” and U.S. Provisional Patent Application Serial No. 62 / 363,760, filed July 18, 2016, entitled “GUIDEWIRE DEVICES HAVING SHAPEABLE TIPS.” All of the foregoing applications are incorporated herein by reference in their entirety. Background Technology

[0004] Guidewire devices are commonly used to guide or direct catheters or other interventional devices to target anatomical locations within a patient's body. Typically, the guidewire enters and passes through the patient's vascular system to reach the target location, which may be, for example, at or near the patient's heart or neurovascular tissue. Radiographic imaging is often used to aid in guiding the guidewire to the target location. In many cases, the guidewire remains in the appropriate position within the body during the interventional procedure, where it can be used to guide multiple catheters or other interventional devices to the target anatomical location.

[0005] Some guidewire devices are configured with curved or bent ends to allow the operator better navigation within the patient's vascular system. Using such a guidewire, the operator can apply torque to the proximal end of the guidewire or its attached proximal handle to orient the end in the desired direction. The operator can then further guide the guidewire in the desired direction within the patient's vascular system.

[0006] Adjusting the flexibility of the guidewire assembly (especially the distal segment) is also an issue. In many cases, a relatively high level of flexibility is desired to provide the guidewire with sufficient bendability to allow it to navigate at angles through the twists and turns of the vascular system pathways to reach the target area. For example, guiding the guidewire to the neurovascular system requires navigating through tortuous pathways, such as the carotid siphon and other convoluted routes.

[0007] Another issue related to guidewire devices is the ability of a given guidewire device to transmit torque from proximal to distal (i.e., the guidewire device's "torsional capacity"). As more of the guidewire enters and passes through the vascular system channel, the amount of frictional contact between the guidewire and the vascular system increases, hindering easy movement of the guidewire through the vascular system channel. A guidewire with good torsional capacity allows the torque force at the proximal end to be transmitted through the guidewire to the distal end, thereby enabling the guidewire to rotate and overcome friction.

[0008] Some guidewire devices include a micromachined hypotube positioned distally above the distal end of the guidewire core, intended to further guide the applied torsional force distally toward the end of the device. Because the torsional force is transmitted primarily through the outer section of the component's cross-section, the tube is configured to provide a path for transmitting an increased amount of torque compared to the torque transmitted by the untubed guidewire core.

[0009] While the aforementioned guidewire device offers many benefits, it also has several limitations. For example, many design features of guidewires with torque transmission tubes, while providing increased torque transmission, are detrimental to and limit the shapeability of the guidewire tip. Summary of the Invention

[0010] This disclosure relates to a wire guide device having a formable end and effective torque. In one embodiment, the wire guide device includes a core having a proximal section and a distal section. The distal section may taper to a smaller diameter than the proximal section. A tubular structure is coupled to the core such that the distal section of the core enters the tubular structure and extends distally beyond the tubular structure to form a formable end. The wire guide device also includes a coil that wraps at least a portion of the distal portion of the core. The coil is positioned such that the proximal portion of the coil is disposed between an outer surface of the core and an inner surface of the tubular structure, and that the distal portion of the coil extends distally beyond the tubular structure to wrap at least a portion of the formable end. The wire guide device also includes a polymeric covering that wraps at least a portion of the distal portion of the coil. The end is configured to reduce the tendency of elastic forces from the tubular structure to disrupt the customized shape of the end.

[0011] In some embodiments, the guide wire device further includes a braided material that is coupled to and extends distally from the tubular structure. In some embodiments, the braided material is embedded within a polymeric covering.

[0012] In one embodiment, the core is formed of and / or comprises stainless steel, the tubular structure is formed of and / or comprises a superelastic material (such as nitinol, a nickel-titanium alloy), and the coil is formed of and / or comprises a non-transmissive material (such as platinum).

[0013] In some embodiments, the tubular structure includes a plurality of fenestrations defining a plurality of axially extending beams connected to a plurality of circumferentially extending rings. The tubular structure may include one or more of a single-beam cutout pattern, a double-beam cutout pattern, a triple-beam cutout pattern, or a cutout pattern with more than three beams. In some embodiments, a rotational offset is applied between successive segments to minimize a preferred bending direction along the length of the tubular structure.

[0014] Further features and advantages will be set forth in part in the description which follows, and will be apparent in part from the description, or may be learned by practice of the embodiments disclosed herein. The objects and advantages of the embodiments disclosed herein will be understood and appreciated by means of the elements and combinations particularly pointed out in the appended claims. It should be understood that the foregoing brief summary and the following detailed description are exemplary and illustrative only, and are not intended to limit the embodiments disclosed herein or as claimed. Attached Figure Description

[0015] To describe how the above and other advantages and features of the invention can be obtained, a more specific description of the invention briefly described above will be given by reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. The invention will be described and explained with additional features and details using the drawings, in which:

[0016] Figure 1A and Figure 1B An exemplary embodiment of a guidewire device is shown, which provides effective torsional capability and has a polymer-encapsulated, formable end;

[0017] Figure 2 Another embodiment of the guide wire device is shown, which has a shapeable end, wherein the braided material is embedded within a polymeric cover;

[0018] Figures 3 to 8 Various exemplary cut patterns that can be formed in the tube of a guidewire device are shown; and

[0019] Figures 9 to 11 Various distal end configurations that can be used with guidewire devices are shown. Detailed Implementation

[0020] introduce

[0021] This disclosure relates to a guidewire device that provides effective anatomical navigation performance. The ability to guide and direct a guidewire to a target anatomical location depends on balancing and optimizing the torsional capacity with the ability to maintain the shaped distal end. The guidewire device may include a shapeable distal end to allow the operator to orient the distal end toward a desired direction within the vascular system by rotating it. However, if the torsional capacity of such a guidewire device is insufficient, the operator will not be able to transmit torsional force all the way to the shaped distal end to control the orientation of the shaped distal end. This obstacle becomes increasingly problematic as the guidewire device penetrates further into the vascular system and is subjected to increased frictional resistance. Furthermore, if the guidewire device fails to properly form and maintain the shaped distal end, its ability to adjust the distal end orientation is limited, making endovascular navigation more difficult.

[0022] The embodiments described herein provide one or more features that balance and / or optimize the relationship between guidewire torsional capacity and the ability to form and maintain shaped ends. The guidewire responds to operator manipulation during guidewire deployment and provides effective navigation performance by enabling the shaped distal end to receive transmitted torsional forces.

[0023] In some embodiments, a shapeable tip allows the operator to customize the tip, such as by manually shaping it before deploying the guidewire device within the patient's vascular system. Thus, the operator is able to customize the shaping of the distal tip according to the specific conditions and / or preferences of a given application. The guidewire device is also configured to efficiently transmit torque while maintaining the shaped tip. At least some of the embodiments described herein include tips that are capable of maintaining a bent or flexed shape throughout the procedure, across multiple procedures, or even indefinitely, until subjected to a reaction reshaping force.

[0024] Guide wire device with shapeable end

[0025] Figure 1A and Figure 1B An exemplary guide wire device 100 with an effectively formable end is shown. Figure 1A A side view of the device is shown. Figure 1B A cross-sectional view of the device is shown. The guidewire assembly 100 includes a core 102. A tube 104 is coupled to the core 102 and extends distally from the attachment point with the core 102. As shown, the distal section of the core 102 extends into and is surrounded by the tube 104. In some embodiments, the core 102 includes one or more tapering sections, allowing the core 102 to be fitted within and extend into the tube 104. For example, the distal section of the core 102 may be ground to taper to a smaller diameter at the distal end. In this example, the core 102 and the tube 104 have substantially similar outer diameters at their adjacent attachment point 103 where they are attached to each other.

[0026] The tube 104 is coupled to the core 102 in a manner that allows torsional forces to be transmitted from the core 102 to the tube 104 and thereby further distally through the tube 104 (e.g., using adhesives, soldering, and / or welding). Medical-grade adhesives / polymers may be used to connect the tube 104 to the core 102 at one or more points (e.g., including attachment point 103).

[0027] As explained in more detail below, tube 104 is microfabricated to include multiple slits. The slits are arranged to form a slit pattern that advantageously provides effective formability near the distal end of the guidewire assembly 100 while maintaining good torsional capacity. For clarity, in Figures 1A to 2 The cut pattern is not shown, but will be referenced. Figures 3 to 8 Describe it.

[0028] In some embodiments, the proximal segment 110 of the guidewire device 100 extends proximally to a length sufficient to provide a guidewire for delivery to the target anatomical region. The proximal segment 110 typically has a length ranging from about 50 cm to 300 cm (about 19.69 inches to 118.11 inches). The proximal segment 110 may have a diameter of about 0.36 mm (about 0.014 inches), or a diameter ranging from about 0.20 mm to 3.175 mm (about 0.008 inches to 0.125 inches). The distal segment 112 of the core 102 may taper to a diameter of about 0.051 mm (about 0.002 inches), or a diameter ranging from about 0.025 mm to 1.27 mm (about 0.001 inches to 0.050 inches). In some embodiments, the length of the tube 104 ranges from about 3 cm to 100 cm (about 1.18 inches to 39.37 inches). The tube 104 may be formed of and / or comprise a hyperelastic material (such as nitinol). Alternatively, the tube 104 may be formed of and / or comprise a linear elastic material (e.g., having at least about 6% recoverable strain). The length of the portion of the device extending distally beyond the tube 104 (referred to as the end 106) may be measured to be about 0.5 cm to 5 cm, or about 1 cm to 3 cm.

[0029] In some embodiments, the distal segment 112 of the core 102 tapers to a circular cross-section. In other embodiments, the distal segment 112 of the core 102 has a flat or rectangular cross-section. The distal segment 112 may also have another cross-sectional shape, such as another polygonal shape, an oval shape, an irregular shape, or a combination of different cross-sectional shapes at different regions along its length.

[0030] Typically, the user shapes the distal end of the guidewire assembly 100 by manually bending, twisting, or otherwise shaping approximately 1 cm to 3 cm into a desired form. The illustrated guidewire assembly 100 includes a distal end 106 that extends distally beyond the tube 104. The end 106 is configured to be formable, allowing the operator to manually bend, twist, or otherwise shape it into a desired form. In some embodiments, the end 106 includes one or more formable components formed of stainless steel, platinum, and / or other formable materials. In a preferred embodiment, the end 106 includes one or more components formed of a material exhibiting work-hardening properties, such that the end provides a higher modulus of elasticity in the formed section during forming (i.e., plastic deformation) than before forming.

[0031] Coil 114 is partially located within tube 104, on at least a portion of the distal segment 112 of core 102. Coil 114 extends distally beyond tube 104 to form a portion of end 106. Coil 114 is preferably formed of one or more radiopaque materials, such as platinum group metals, gold, silver, palladium, iridium, osmium, tantalum, tungsten, bismuth, dysprosium, gadolinium, etc. Alternatively or additionally, coil 114 may be at least partially formed of stainless steel or other materials that effectively retain their shape after being bent or otherwise handled by a user.

[0032] In the illustrated embodiment, coil 114 is located at or near the distal end of the device and extends proximally toward attachment point 103. In the illustrated device, a significant portion of the length of coil 114 extends distally beyond tube 104. In other embodiments, coil 114 may extend further proximally. Coil 114 may extend 1 cm, 2 cm, 4 cm, 6 cm, 8 cm, 10 cm, 12 cm, 15 cm, 20 cm, 25 cm, 30 cm, or 35 cm from the distal end, or may extend a distance defined by any two of the aforementioned values.

[0033] In some embodiments, the distal section of coil 114 extending beyond tube 104 may be formed of a different material than the proximal section of coil 114. For example, the distal section of coil 114 may be formed of stainless steel and / or other materials that preferably provide effective formability, while the proximal section of coil 114 may be formed of platinum or other materials that preferably provide effective radiopaqueness. In some embodiments, coil 114 is formed as a single integral piece. In other embodiments, coil 114 comprises a plurality of separate sections positioned adjacent to each other and / or interlocked by interwoven coils. Alternatively or additionally, these separate sections may be brazed, adhered, or otherwise fastened together to form a complete coil 114.

[0034] Although the illustrated embodiment shows the space between the outer surface of coil 114 and the inner surface of tube 104, it should be understood that this is schematically shown for ease of visualization. In some embodiments, coil 114 is sized to fill a large proportion of the space between core 102 and tube 104. For example, coil 114 may be sized to be close to both the outer surface of core 102 and the inner surface of tube 104. Some embodiments may include space between core 102 and tube 104 for at least a portion of the guide wire device 100, where tube 104 and core 102 extend together.

[0035] The portion of coil 114 disposed within tube 104 can advantageously be used to fill the space between core 102 and tube 104 so that the curvature of the distal segment 112 of core 102 aligns with the curvature of tube 104. For example, when curvature is formed in tube 104, a tightly packed segment of coil 114 serves as a filler between tube 104 and distal segment 112 to impart the same curvature to distal segment 112. Conversely, in a guide wire arrangement omitting such filler, the core may not follow the same curvature as the tube, but may extend until it abuts against the inner surface of the tube, after which it is forced to bend.

[0036] As shown, the distal end 106 extends further distally than the tube 104. This configuration advantageously allows the distal end 106 to be shaped into a desired position relative to the tube 104 and the remainder of the guidewire 100 and to maintain that position for a sufficiently long period. Compared to guidewire devices that rely on the formability of the tube or on formable components arranged more fully within the tube, the distal end 106 is able to maintain the shaped configuration without being subject to reaction forces exerted by the tube 104 itself.

[0037] Additionally, as described more fully below, tube 104 may include a slit pattern that maintains effective torsional capacity while also providing sufficient flexibility in the distal region of tube 104 to avoid disrupting the customized shape of end 106. In a preferred embodiment, the formable distal section of the core has stiffness capable of withstanding the anticipated bending forces from the tube acting on the formed distal section of the core. In some embodiments, the formable distal section of the core is formed from a material or combination of materials that provides an elastic modulus that is about 1.5 to 4 times or about 2 to 3 times greater than that of the material used to form the tube.

[0038] In contrast to the illustrated embodiment, guidewire devices that rely on tube forming to provide the desired distal end shape will be unable to maintain the formed configuration or will only be able to maintain it for a relatively short period of time. Because the tube structure is typically formed from nitinol or other hyperelastic materials, this degradation effect on the formed end occurs at least partially. These tubes will be biased towards their original (e.g., straight) orientation when bent or formed, and will exert restoring forces on any formable internal components, resulting in deformation of the end and loss of the customized shape.

[0039] Typically, guidewires that terminate distally in a tubular structure or otherwise substantially rely on bending of the tubular structure to shape the end will have a shaped end before deployment. However, during use of the guidewire, the shaped end will be lost or degraded as the hyperelastic tubing bends toward its original shape, contrary to the desired end shape. In contrast, the embodiments described herein provide the ability to shape the end without subjecting adjacent components of the guidewire assembly to deformation-restoring forces.

[0040] The illustrated guidewire device 100 also includes an external polymeric cover 118 formed of a medical-grade polymeric material. The polymeric cover 118 is bonded to and wraps around the distally extending sections of the coil 114 and the core 102. The polymeric cover 118 advantageously provides a non-invasive cover with high relative flexibility. This high relative flexibility allows the tip 106 to be custom-shaped without being subjected to reactive elastic or hyperelastic restoring forces. As shown, the polymeric material forming the polymeric cover 118 can also extend over the distal end of the core 102 to form a non-invasive terminal 120.

[0041] In some embodiments, the polymeric covering 118 is doped with a radiopaque substance, such as barium, bismuth, tungsten, etc. For example, in embodiments where the coil 114 is formed of a relatively low radiopaque material (e.g., stainless steel), the polymeric covering 118 may be configured such that the end 106 provides sufficient radiopaqueness.

[0042] In some embodiments, the polymer used to form the polymeric cover 118 is bonded to one or more internal portions of the tube 104. For example, a certain amount of polymeric material may be positioned within the tube 104 to help fill the space between the core 102 and the tube 104. In some embodiments, the polymer may be used as a substitute for some or all of the filling provided by the coil 114, such that the coil may be omitted or adjusted relative to the outer diameter, coil wire size, coil spacing, and / or length.

[0043] Medical-grade polymer materials may be formed from and / or include one or more medical-grade adhesives. In some embodiments, for example, the polymer material may be an acrylate-based adhesive that can be cured by applying ultraviolet and / or visible light. The polymer material may also include one or more elastomeric fillers, adhesion promoters, leveling agents, and / or curing accelerators.

[0044] Figure 2 An alternative embodiment of the guide wire device 200 is shown, which has a polymer-covered braided section 218 forming part of a formable end 206. The guide wire device 200 can be constructed in a similar manner to the guide wire device 100 of FIG. 1, and similar reference numerals indicate similar features / components. Thus, the guide wire device 200 includes a core 202 having a proximal section 210 and a distal section 212. The distal section 212 extends into a tube 204 and extends distally beyond the tube to form the formable end 206. The tube 204 can be adhered to the core 202 at an adhesion point 203. A coil 214 formed of a radiopaque and / or formable material encloses at least a portion of the core 202, which extends distally beyond the tube 204 and can extend proximally to partially reside within the tube 204.

[0045] In this embodiment, the distal end 206 includes a polymer-covered braid 218. The braid 218 at least surrounds the distal extension of the coil 214 and can serve as an embedded structure for the polymer material. The braid 218 advantageously provides the ability to transmit some torque from the tube 204 to the distal end 206 while still providing effective flexibility, allowing the end 206 to remain in the shaped configuration. The braid 218 may be formed of a suitable metal mesh material and / or may include said suitable metal mesh material, such as stainless steel mesh. The polymer material in which the braid 218 is embedded may include a radiopaque filler, such as barium sulfate and / or any other radiopaque material described herein.

[0046] Cut pattern

[0047] Figures 3 to 8 Exemplary embodiments of tube cut patterns that can be used in one or more guidewire device embodiments described herein are shown. For example, they can be based on... Figures 3 to 8 One or more constructions shown are used to cut Figure 1 and Figure 2 The tube 104 in the embodiment shown.

[0048] This article names the cut patterns based on the number of axial extension beams set between each pair of adjacent circumferential extension rings. Figure 3 and Figure 4 The cutout pattern of the "single beam" is shown. Figure 5 and Figure 6 The cutout pattern of the "double beam" is shown. Figure 7 The diagram shows a "three-beam" cutout pattern. Other embodiments may include more than three beams between each pair of adjacent rings (e.g., a four-beam cutout pattern, a five-beam cutout pattern, etc.).

[0049] Figure 3 The tube structure 304 shown includes a single beam 332 disposed between each pair of adjacent rings 334. The pairs of adjacent beams can alternate 180 degrees, as shown. Additionally or alternatively, sections may include beams positioned on one side along the length of the tube, such as those provided by… Figure 4 The tube 404, beam 432, and ring 434 are shown.

[0050] Figure 5 The tubular structure 504 shown includes a pair of circumferentially opposed beams 532 disposed between each pair of adjacent rings 534. The corresponding beams 532 in each pair can be symmetrically spaced circumferentially (i.e., approximately 180 degrees), as... Figure 5 As shown. Alternatively, the corresponding beam can be circumferentially asymmetric, such as that formed by... Figure 6 The tube 604 is shown as beam 632 and ring 634. Figure 7 The tubular structure 704 shown includes beams 732 arranged in a triad of three between each pair of adjacent rings 734. As shown, the corresponding beams in each triad can be symmetrically spaced circumferentially (i.e., approximately 120 degrees), or can be positioned according to some asymmetrical layout.

[0051] Generally, the more beams left between each pair of adjacent loops, the greater the stiffness of the tube. Therefore, the cut pattern can be selected to provide the desired flexible profile along the length of the tube. The cut spacing, width, and / or depth can also be varied to provide the desired flexibility characteristics. For example, a tube configuration may include a proximal section with relatively low flexibility and relatively high torsional capacity, rapidly progressing to a distal section with relatively high flexibility and relatively low torsional capacity. Advantageously, the flexibility provided by such a cut pattern can prevent or minimize the shape deformation of the internal structure of the guidewire (e.g., the core) caused by the tube, allowing for better formation and maintenance of a customized shape at the tip.

[0052] A section of a tube having a double-beam cutout pattern with substantially circumferentially equidistant beams (e.g.) Figure 5 (As shown) typically has a relatively high torque transmission capacity and relatively low flexibility, while sections of the tube with asymmetric spacer beams (such as...) Figure 6 The torque transmission and flexibility (as shown) are typically found in symmetrically spaced beam patterns versus single-beam patterns (such as...). Figure 3(As shown). The smaller the circumferential symmetry of the corresponding pair of beams, the closer the resulting beams will be in the circumferential direction, and therefore the more similar the asymmetric double-beam cut pattern will be to the single-beam cut pattern. Therefore, this asymmetric double-beam pattern can be used as a transition between symmetrical double-beam patterns and single-beam patterns.

[0053] The notch pattern can form "segments" of repeating structural units along the length of the tube. In a typical single-beam embodiment, a single segment can be defined as a first beam 332 disposed between two adjacent rings 334 (a proximal ring and a distal ring) and a second opposing beam 332 extending from the distal ring and rotated approximately 180 degrees relative to the first beam 332. Similarly, in a typical double-beam embodiment, a single segment can be defined as a first pair of beams 532 disposed between two adjacent rings 534 (a proximal ring and a distal ring) and a second pair of beams 532 extending from the distal ring and rotated approximately 90 degrees relative to the first pair of beams. Similarly, in a typical triple-beam embodiment, a single segment can be defined as a first triple beam 732 disposed between two adjacent rings 734 (a proximal ring and a distal ring) and a second triple beam 732 extending from the distal ring and rotated approximately 60 degrees relative to the first triple beam.

[0054] Figure 8 A tube 804 with multiple beams 832 and rings 834 is shown. The cut pattern shown includes a rotational offset applied at each consecutive segment of the tube 804 to minimize a preferred bending direction in the tube. When used herein, "rotational offset" is an angular rotation between two adjacent segments. Thus, a rotational offset can be applied from one segment to the next, or even individual cuts within a segment can be offset from each other.

[0055] As shown in the figure, the cuts can be arranged to form a substantially consistent rotational offset from one segment to the next. The cut pattern shown illustrates a rotational offset of approximately 5 degrees from one segment to the next. When multiple consecutive segments with this angular offset are formed, the pattern of the beam formed along a sufficient length of tube 804 winds around the axis of tube 804 in a continuously rotating helical pattern. The angular offset can be approximately 5 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 80 degrees, or 85 degrees. In some embodiments, the angular offset is applied at each consecutive segment. In other embodiments, multiple consecutive segments are arranged adjacent to each other without offset, and then the angular offset is applied.

[0056] The example shown illustrates a double-beam cutout pattern with a series of rotational offsets. However, it should be understood that the same principle can be applied to other cutout patterns, such as single-beam cutout patterns in each pair of adjacent rings, three-beam cutout patterns, or cutout patterns with more than three beams. In a preferred embodiment, each successive cutout or group of cutouts (e.g., every second cutout, every third cutout, every fourth cutout, etc.) along the length of a given segment is rotationally offset by approximately 1 degree, 2 degrees, 3 degrees, 5 degrees, or 10 degrees, or in a single-beam pattern by approximately 1 degree, 2 degrees, 3 degrees, 5 degrees, or 10 degrees from 180 degrees, in a double-beam pattern by approximately 1 degree, 2 degrees, 3 degrees, 5 degrees, or 10 degrees from 90 degrees, in a three-beam pattern by approximately 1 degree, 2 degrees, 3 degrees, 5 degrees, or 10 degrees from 60 degrees, and so on for patterns with a greater number of beams. These rotational offset values ​​advantageously demonstrate a good ability to eliminate kinking deviations.

[0057] Can be combined Figures 3 to 8 The individual components and features of the cutout patterns shown are used to form different tube constructions. For example, some tubes can be constructed with double-beam cutout sections that transition to single-beam cutout sections.

[0058] End variant example

[0059] Figures 9 to 11 Examples of various distal end configurations that can be used with one or more embodiments described herein are shown. Figure 9 The continuous diameter end construction is shown. The coil 918, surrounding the tapering core 902, has a substantially continuous diameter. Figure 10 A stepped end configuration is shown, wherein an outer coil 1018 positioned above core 1002 has a substantially continuous diameter. An inner coil 1014 with a smaller diameter is positioned to extend further distally than the outer coil 1018 to provide a stepped variation in the end diameter. Figure 11 A tapered end configuration is shown, in which coil 1118 tapers to match at least a portion of the tapered portion of core 1102. Figures 9 to 11 The end-cap embodiments shown can be combined with any of the guidewire device embodiments described herein. For example, a desired end configuration can be selected to provide the desired shapeability and / or flexibility for a given guidewire application.

[0060] As used herein, the terms “approximately,” “about,” and “substantially” mean a quantity or condition that is close to the stated quantity or condition and still performs the desired function or achieves the desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to a quantity or condition that deviates from the stated quantity or condition by less than 10%, or less than 5%, or less than 1%, or less than 0.1%, or less than 0.01%.

[0061] Elements described with respect to any embodiment depicted and / or described herein may be combined with elements described with respect to any other embodiment depicted and / or described herein. For example, regarding Figures 3 to 8 Any element and / or information described in any of the pipe sections in the document. Figures 9 to 11 Any element described by the end construction of any one of them can be combined and with Figure 1A , Figure 1B and Figure 2 It is used in conjunction with a guide wire assembly. In any of the aforementioned combinations, the distal end of the core wire can be round, flat, or other shapes.

[0062] The invention may be implemented in other forms without departing from the concept or essential characteristics thereof. The described embodiments should be considered in all respects as illustrative rather than restrictive. Therefore, the scope of the invention is indicated by the appended claims rather than the foregoing description. All variations falling within the meaning and equivalents of the claims are included within their scope.

Claims

1. A guidewire device having a shapeable tip, the guidewire device comprising: a core having a proximal section and a distal section, the distal section having a smaller diameter than the proximal section; a tube structure coupled to the core such that the distal section of the core enters the tube structure and extends distally beyond the tube structure to form a shapeable tip, wherein the tube structure comprises a plurality of windows defining a plurality of axially extending beams coupled with a plurality of circumferentially extending rings; a coil partially disposed within the tube structure and partially extending distally beyond the tube structure, the coil being sized and shaped to pack a space between the core and the tube structure such that when the tube structure is bent, a curvature of the tube structure coincides with a curvature of a coinciding portion of the core; a braided material coupled to a distal end of the tube structure and extending distally from the tube structure; and a polymeric covering embedded with the braided material, the polymeric covering bonded to and wrapping a portion of the core extending distally beyond the tube structure and forming at least a portion of the shapeable tip, the shapeable tip configured to be shaped into a shaped configuration relative to the tube structure and configured to retain the shaped configuration without a reactive force applied by the tube structure. The distal section of the core tapers from the proximal section of the core.

2. The guidewire device of claim 1, wherein, The shapeable tip extends distally beyond the tube structure a distance of 0.5 cm to 5 cm.

3. The guidewire device of claim 1, wherein, The shapeable tip extends distally beyond the tube structure a distance of 1 cm to 3 cm.

4. The guidewire device of claim 1, wherein, The portion of the coil extending distally beyond the tube structure is wrapped by the polymeric covering.

5. The guidewire device of claim 1, wherein, The portion of the coil disposed within the tube structure wraps the core and is positioned between an outer surface of the core and an inner surface of the tube structure.

6. The guidewire device of claim 1, wherein, The coil is formed of a radiopaque material.

7. The guidewire device of claim 1, wherein, The tube structure is formed of nitinol.

8. The guidewire device of claim 1, wherein, The core is formed of stainless steel.

9. The guidewire device of claim 1, wherein, The polymeric covering comprises a radiopaque material.

10. The guidewire device of claim 1, wherein, The plurality of windows are arranged in one or more of a single-beam cut pattern, a double-beam cut pattern, or a triple-beam cut pattern.

11. The guidewire device of claim 1, wherein, The windows define a cut pattern having a rotational offset such that each successive segment along a length of the tube structure is rotated circumferentially from a previous segment.

12. The guidewire device of claim 1, wherein, The windows define a cut pattern having cuts having an increasing depth toward a distal end of the tube structure and / or having a decreasing spacing between successive cuts toward the distal end of the tube structure.

13. The guidewire device of claim 1, wherein, ​

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