A guide wire device having a coil extending distally and a formable tip

Abstract

To provide improved guidewire devices having shapeable tips and effective torquability.SOLUTION: A guidewire device 100 includes a core 102 having a proximal section 110 and a tapered distal section 112. A tube structure 104 is coupled to the core such that the tapered distal section of the core extends into and distally beyond the tube structure. The portion of the core extending distally beyond the tube forms a shapeable tip 106. One or more coils 114 and 118 also extend distally beyond the tube. The tip is configured to reduce the tendency of resilient forces from the tube structure to disrupt a customized shape of the tip.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit and priority of U.S. Patent Application No. 15 / 611,328, filed Jun. 1, 2017, entitled “GUIDEWIRE DEVICES HAVING DISTALLY EXTENDING COILS AND SHAPEABLE TIPS,” and U.S. Provisional Patent Application No. 62 / 363,760, filed Jul. 18, 2016, entitled “GUIDEWIRE DEVICES HAVING SHAPEABLE TIPS.” All of the applications mentioned above are hereby incorporated by reference in their entirety.

Background Art

[0002]

[0002] Guidewire devices are often used to guide or direct a catheter or other interventional device to a target anatomical location within a patient's body. Typically, a guidewire is passed into and through a patient's vasculature to reach a target location, such as one that may be or may be near the patient's heart or neurovascular tissue. X - ray imaging is commonly utilized to assist in navigating the guidewire to the target location. In many cases, the guidewire is left in a fixed position within the body during the intervention, where it can be used to guide multiple catheters or other interventional devices to the target anatomical location.

[0003]

[0003] Some guide wire devices are configured with a curved or bent distal tip, which enables the surgeon to better navigate to the patient's vasculature. When using such a guide wire, the surgeon can apply torque to the proximal end of the guide wire or to a proximal handle attached thereto for the purpose of orienting the distal tip in a desired direction. The surgeon can then move the guide wire further in a desired direction within the patient's vasculature.

[0004]

[0004] It is also a matter to consider adjusting the flexibility of a guide wire device, and particularly of the distal section of a guide wire device. In many circumstances, a relatively high level of flexibility is desired to obtain sufficient bendability of the guide wire for the purpose of enabling the guide wire to be angled through the meandering bends or curves of the vasculature passageway to reach the target area. For example, to move a guide wire to a portion of the neurovasculature, it is necessary to pass the guide wire through a curved passageway such as the carotid siphon or other meandering path.

[0005]

[0005] Another matter to consider in relation to a guide wire device is the ability of a given guide wire device to transmit torque from the proximal end to the distal end (i.e., the "torquability" of the guide wire device). When the guide wire is further passed into or through the passageway of the vasculature, the amount of frictional surface contact between the guide wire and the vasculature increases, thereby impeding the easy movement of the guide wire through the passageway of the vasculature. A guide wire with good torque transmission ability enables the torqueing force at the proximal end to be transmitted through the guide wire to the distal end, so that the guide wire can rotate and overcome the frictional force.

[0006]

[0006] Some guide wire devices have a distally disposed micro-machined hypo-tube positioned over the distal end of a guide wire core to move an applied torsional force further distally toward the end of the device. Since the torsional force is primarily transmitted through the outer section of the cross-section of the member, the tube is configured to provide a path that enhances torque transmission as compared to the magnitude of torque transmitted by the guide wire core not covered by the tube.

[0007]

[0007] While such guide wire devices offer many advantages, several constraints still remain. For example, many of the design characteristics of guide wires with torque transmission tubes function to achieve enhanced torque transmission but act adversely on the formability of the guide wire tip, limiting formability.

Summary of the Invention

Means for Solving the Problems

[0008]

[0008] The present disclosure relates to a guide wire device having a formable tip and having effective torque transmission. In one embodiment, the guide wire device has a core having a proximal section and a distal section. The distal section may taper so as to have a smaller diameter than the proximal section. A tube structure is coupled to the core such that the distal section of the core passes into and through the tube structure and extends distally beyond the tube structure to form a formable tip. The guide wire device further has an inner coil that surrounds at least a portion of the distal portion of the core. The inner coil is positioned such that a proximal portion of the inner coil is disposed between an outer surface of the core and an inner surface of the tube structure and such that a distal portion of the inner coil extends distally beyond the tube structure so as to surround at least a portion of the formable tip. The guide wire device further has an outer coil coupled to the distal end of the tube structure and extending distally from the tube structure. The outer coil is positioned so as to surround at least a portion of the inner coil. The tip is configured to reduce the tendency for the customized shape of the tip to be disrupted by elastic forces from the tube structure.

[0009]

[0009] In one embodiment, the core is formed of and / or includes stainless steel, the tube structure is formed of and / or includes a superelastic material such as nitinol, the inner coil is formed of and / or includes an x-ray opaque material such as platinum, and the outer coil is formed of and / or includes stainless steel.

[0010]

[0010] In some embodiments, the tube structure has a plurality of windows that define a plurality of axially extending beams that couple a plurality of circumferentially extending rings. The tube structure can have one or more notch patterns of a one-beam notch pattern, a two-beam notch pattern, a three-beam notch pattern, or a notch pattern of four or more beams. In some embodiments, a rotational offset is applied between successive segments to minimize the range of favorable bending directions over the length of the tube structure.

[0011]

[0011] Additional features and advantages are set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the embodiments disclosed herein. The objectives and advantages of the embodiments disclosed herein are realized and attained by means of the elements and combinations particularly pointed out in the appended claims. The above summary and the following detailed description are both exemplary and explanatory only and are not restrictive of the embodiments disclosed or claimed herein.

[0012]

[0012] For the purpose of explaining how the advantages and features listed above of the present invention and other advantages and features can be obtained, a more specific description of the present invention outlined above is provided with reference to specific embodiments shown in the accompanying drawings. Understanding that these drawings merely depict typical embodiments of the present invention and are not to be considered limiting of its scope, the present invention will be described more specifically and in detail using the accompanying drawings.

Brief Description of the Drawings

[0013]

Figure 1

[0013] FIG. is a diagram showing an exemplary embodiment of a guide wire device that provides effective torque transmission and has a formable tip.

Figure 2

[0014] FIG. 1 is a cross-sectional view of the guide wire device of FIG. 1.

Figure 3

[0015] A diagram showing various exemplary notch patterns that can be formed within the tube of a guide wire device.

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

[0016] A diagram showing various configurations of distal tips that can be utilized with a guide wire device.

Figure 10

Figure 11

DETAILED DESCRIPTION OF THE INVENTION

[0014] Introduction section

[0017] The present disclosure relates to guidewire devices that provide effective anatomical navigation capability. The ability to steer and navigate a guidewire to a target anatomical location depends on optimizing the tradeoff between torque transmission and the ability to maintain a shaped tip while maintaining a balance between the two. A guidewire device may have a shapeable tip to allow the operator to rotate the distal tip to orient the tip in a desired direction within the vasculature. However, if the torque transmission of such a guidewire device is insufficient, the operator will not be able to consistently transmit torsional forces to the shaped distal tip to control the orientation of the shaped distal tip. This obstacle becomes more problematic as the guidewire device is advanced further into the vasculature and encounters greater frictional resistance. Additionally, if the guidewire device is unable to properly form and maintain a shaped tip, this will limit the ability of the guidewire device to adjust tip orientation, making navigation within the vasculature more difficult.

[0015]

[0018] The embodiments described herein provide one or more features that maintain a balance and / or optimize the relationship between the torqueability of the guidewire and its ability to form and maintain a shaped tip. It is responsive to operator manipulation during deployment and provides effective navigation capabilities by allowing the shaped distal tip to absorb transmitted torsional forces.

[0016]

[0019] In some embodiments, the formable tip allows the operator to custom shape the tip, such as by manually shaping the tip immediately prior to deploying the guidewire device within the patient's vasculature. Thus, the operator can customize the shaping of the distal tip according to preferences and / or conditions, and particularly according to a given application. Further, the guidewire device is configured to effectively transmit torque while maintaining the formed tip. At least some of the embodiments described herein have a tip that can maintain a bent or curved shape throughout the procedure or throughout multiple procedures, i.e., permanently until it is subjected to reshaping forces that act in the opposite direction. Guidewire device having a formable tip

[0020] Figures 1 and 2 show an exemplary guidewire device 100 having an effective formable tip. FIG. 1 shows a side view of the device and FIG. 2 shows a cross-sectional view of the device. The guidewire device 100 has a core 102. A tube 104 is coupled to the core 102 and extends distally from the point of attachment to the core 102. As shown, the distal section of the core 102 extends into the tube 104 and is surrounded by the tube 104. In some embodiments, the core 102 has one or more tapered sections such that the core 102 can be fitted into and extend into the tube 104. For example, the distal section of the core 102 can be ground to be progressively tapered and have a smaller diameter at the distal end. In this example, the core 102 and the tube 104 have substantially the same outer diameter at the attachment point 103, and the core 102 and the tube 104 are attached adjacent to each other at the attachment point 103.

[0017]

[0021] The tube 104 is coupled to the core 102 (e.g., using adhesion, soldering, and / or welding) in a manner that allows torsional force to be transmitted from the core 102 to the tube 104 and thereby further transmitted distally by the tube 104. A medical grade adhesive can be used to couple the tube 104 to the core wire 102 at one or more points (e.g., including the attachment point 103). A medical grade adhesive / polymer can also be used to form a non-traumatic covering 120 even at the distal end of the device.

[0018]

[0022] As will be described in more detail later, the tube 104 is microfabricated to have a plurality of notches. The notches are configured to form a notch pattern that advantageously provides effective formability near the distal tip of the guide wire device 100 while also maintaining good torque transmission. For clarity, the notch pattern is not shown in FIGS. 1 and 2. Examples of notch patterns that can be utilized within the tube 104 are shown in FIGS. 3 - 8.

[0019]

[0023] In some embodiments, the proximal section 110 of the guide wire device 100 extends proximally by only the length necessary to provide a sufficient guide wire length to reach a target anatomical region (not shown). The proximal section 110 typically has a length in the range of about 50 to 300 cm (about 19.69 to 118.11 inches). The proximal section 110 can have a diameter of about 0.36 mm (about 0.014 inches), or can have a diameter within the range of about 0.20 to 3.175 mm (about 0.008 to 0.125 inches). The distal section 112 of the core 102 can taper to a diameter of about 0.051 mm (about 0.002 inches), or to a diameter within the range of about 0.025 to 1.27 mm (about 0.001 to 0.050 inches). In some embodiments In a form, the tube 104 has a length in the range of about 3 to 100 cm (about 1.18 to 39.37 inches). The tube 104 can be formed from a superelastic material such as Nitinol and / or can include a superelastic material such as Nitinol. Alternatively, the tube 104 can be formed from a linearly elastic material and / or can include a linearly elastic material (e.g., having at least about 6% recoverable strain). The portion of the device (referred to as the distal tip 106) that extends distally beyond the tube 104 can measure a length of about 0.5 to 5 cm, or a length of about 1 to 3 cm.

[0020]

[0024] In some embodiments, the distal section 112 of the core 102 tapers so as to have a circular cross-section. In some embodiments, the distal section 112 of the core 102 has a flat or rectangular cross-section. The distal section 112 may have another cross-sectional shape, such as another polygonal shape, an oval shape, an irregular shape, or a combination of different cross-sectional shapes in different regions along its length direction.

[0021]

[0025] Typically, the user manually bends, twists, or otherwise manipulates the (about) 1 cm to 3 cm distal portion of the guidewire device 100 into a desired shape to form the distal end of the guidewire device 100. The illustrated guidewire device 100 has a distal tip 106 that extends distally beyond the tube 104. The tip 106 is configured to be formable to allow the surgeon to manually bend, twist, or otherwise manipulate the tip 106 into a desired shape. In some embodiments, the tip 106 has one or more formable components formed from stainless steel, platinum, and / or other formable materials. In a preferred embodiment, the tip 106 has one or more components formed from a material that exhibits work hardening, such that when formed (i.e., plastically deformed), the tip provides a higher modulus of elasticity at the formed section than before forming.

[0022]

[0026] The inner coil 114 is partially positioned within the tube 104 in at least a portion of the distal section 112 of the core 102. The inner coil 114 extends distally beyond the tube 104 and forms a portion of the distal tip 106. The inner coil 114 is preferably formed from one or more radiopaque materials such as platinum group, gold, silver, palladium, iridium, osmium, tantalum, tungsten, bismuth, dysprosium, and gadolinium. Additionally or alternatively, the coil 114 may be at least partially formed from stainless steel or from other materials that can effectively maintain their formed state after being bent or otherwise manipulated by the user.

[0023]

[0027] In the illustrated embodiment, the inner coil 114 is disposed at or near the distal end of the device and extends proximally a certain distance toward the attachment point 103. In the illustrated device, most of the length of the inner coil 114 extends distally beyond the tube 104. In other embodiments, the inner coil 114 may extend further proximally. The inner coil 114 may extend from the distal end by 1, 2, 4, 6, 8, 10, 12, 15, 20, 25, 30, or 35 cm, or may extend a distance within a range defined by any two of the above values.

[0024]

[0028] In some embodiments, the section of the inner coil 114 that extends distally beyond the tube 104 may be formed of a different material than the more proximal section of the inner coil 114. For example, the distal section of the inner coil 114 may be formed from stainless steel and / or other materials primarily selected to provide effective formability, whereas the proximal section of the inner coil 114 may be formed from platinum or other materials primarily selected to provide effective radiopacity. In some embodiments , the inner coil 114 is formed as a single integral piece. In other embodiments, the inner coil 114 has a plurality of separate sections that are positioned adjacent to each other and / or interlocked via twisted coils. Additionally or alternatively, such separate segments can be soldered, adhered, or otherwise fixed to each other to form the complete inner coil 114.

[0025]

[0029] The embodiment shown depicts the space between the outer surface of the inner coil 114 and the inner surface of the tube 104, but it should be understood that this is done schematically for ease of visualization. In some embodiments, the inner coil 114 is sized to occupy a higher percentage of the space between the core 102 and the tube 104 and fill the interior. For example, the inner coil 114 can be sized to abut both the outer surface of the core 102 and the inner surface of the tube 104. Some embodiments can have a space between the core 102 and the tube 104 at least in part of this section of the guidewire device 100 where the tube 104 and the core 102 have the same spread.

[0026]

[0030] The portion of the inner coil 114 disposed within the tube 104 can advantageously function to fill the space between the core 102 and the tube 104, thereby aligning the curved portion of the distal section 112 of the core 102 with the curved portion of the tube 104. For example, when a curved portion is formed within the tube 104, the densely packed segments of the inner coil 114 function as a filler between the tube 104 and the distal section 112, giving the distal section 112 the same curved portion. In contrast, the core of a guidewire device without such a filler may not follow the same curvature as the tube, while the tube can extend until it abuts the inner surface of the tube before being forced to curve.

[0027]

[0031] As shown, the distal end portion 106 extends further distally rather than the tube 104. The configuration shown advantageously allows shaping the distal end portion 106 to a desired position relative to the remainder of the tube 104 and the guide wire 100, and holding the distal end portion 106 in the shaped position for a sufficient length of time. In contrast to guide wire devices that rely on the formability of the tube or on a formable component that is more fully disposed within the tube, the distal end portion 106 shown is capable of maintaining the shaped configuration without receiving a restoring force that would act to invalidate it from the tube 104 itself.

[0028]

[0032] In addition, as will be more fully described later, the tube 104 can have a notch pattern that provides effective torque transmission while also providing sufficient flexibility in the distal region of the tube 104, thereby avoiding disruption of the custom shape of the distal end portion 106. In a preferred embodiment, the formable distal section of the core has a stiffness capable of withstanding the expected bending forces from the tube acting on the distal section of the core after shaping. In some embodiments, the formable distal section of the core is formed from a material or combination of materials that provides a modulus of elasticity about 1.5 to 4 times, or about 2 to 3 times, the modulus of elasticity of the material used to form the tube.

[0029]

[0033] In contrast to the embodiment shown, guide wire devices that rely on shaping the tube to provide the desired distal tip shape cannot hold the shaped configuration, i.e., can only hold the shaped configuration for a relatively short time. This degradation effect of the shaped tip occurs at least in part because the tube structure is typically formed from nitinol or other superelastic materials. Such tubes, when bent or shaped, are biased towards their original (straight) position, thereby imparting a restoring force to any formable internal components and thereby deforming and losing the customized shape of the tip.

[0030]

[0034] For example, a guide wire that terminates at a location with a tube structure distally or that substantially depends on bending a tube structure to form a tip often has a formed tip prior to deployment. However, the formed tip is lost or degraded during use of the guide wire because the superelastic tube bends back towards its original shape opposite to the desired tip shape. In contrast, the embodiments described herein provide a tip that can be formed without receiving a restoring force that deforms adjacent components of the guide wire device.

[0031]

[0035] In the illustrated guide wire device 100, an outer coil 118 overlays a section of an inner coil 114 that extends distally. The inner coil 114 and the outer coil 118 may use similar coil characteristics or may use dissimilar coil characteristics (diameter of the coil wire, pitch, etc.). Typically, the outer coil 118 is formed from a coil wire with a larger diameter compared to the wire diameter of the inner coil 114. The outer coil 118 may be formed from stainless steel or other suitable materials that can provide suitable formability. Notch pattern

[0036] Figures 3 through 8 show exemplary embodiments of tube notch patterns that may be utilized in one or more embodiments of the guide wire devices described herein. For example, the tube 104 of the embodiments shown in FIGS. 1 and 2 can be cut according to one or more of the configurations shown in FIGS. 3 through 8.

[0032]

[0037] The notch pattern is referred to herein according to the number of axially extending beams disposed between each pair of adjacent circumferentially extending rings. FIGS. 3 and 4 show a "one-beam" notch pattern, FIGS. 5 and 6 show a "two-beam" notch pattern, and FIG. 7 shows a "three-beam" notch pattern. Other embodiments may have four or more beams between each pair of adjacent rings (e.g., a four-beam notch pattern, a five-beam notch pattern, etc.).

[0033]

[0038] The tube structure 304 shown in FIG. 3 has a single beam 332 disposed between each pair of adjacent rings 334. Pairs of adjacent beams may alternate at 180 degrees as shown. Additionally or alternatively, a section may have beams positioned on one side along a certain length of the tube, as shown by the beams 432 and rings 434 of the tube 404 in FIG. 4.

[0034]

[0039] The tube structure 504 shown in FIG. 5 has a pair of circumferentially opposing beams 532 disposed between each pair of adjacent rings 534. Corresponding beams 532 within each pair may be symmetrically spaced circumferentially (i.e., by about 180 degrees) as shown in FIG. 5. Alternatively, as shown by the beams 632 and rings 634 of the tube 604 in FIG. 6, the corresponding beams may be asymmetric in the circumferential direction. The tube structure 704 shown in FIG. 7 has a triplet of beams 732 disposed between each pair of adjacent rings 734. Corresponding beams within each triplet may be symmetrically spaced circumferentially (i.e., by about 120 degrees) as shown, or may be positioned according to some asymmetric configuration.

[0035]

[0040] Generally, as the number of beams left between each pair of adjacent rings increases, the stiffness of the tube increases relatively. Thus, the notch pattern may be selected to provide a desired flexibility profile along the length of the tube. The spacing, width, and / or depth of the notches may also vary to provide the desired flexibility characteristics. For example, one tube configuration has a relatively low flexibility and a relatively high torque transmissibility at the proximal It can have a proximal section that transitions abruptly into a distal section having relatively high flexibility and relatively low torque transmissibility. Advantageously, the flexibility provided by such a notch pattern can minimize or prevent the tube from deforming the shape of the internal structure (e.g., the core) of the guide wire, such that the customized shape of the distal tip can be better formed and maintained.

[0036]

[0041] A section of a tube having a two-beam notch pattern with beams spaced substantially equidistantly circumferentially (similar to FIG. 5) typically has a relatively high ability to transmit torque and relatively low flexibility, whereas a section of a tube having asymmetrically spaced beams (similar to FIG. 6) typically has torque transmissibility and flexibility that are between those of a symmetrically spaced beam pattern and those of a one-beam pattern. As the circumferential symmetry of the positioning of corresponding pairs of beams decreases, the resulting beams are closer together circumferentially and thus the asymmetric two-beam notch becomes more similar to a one-beam notch pattern. Thus, such an asymmetric two-beam pattern can be used as a transition between a symmetric two-beam pattern and a one-beam pattern.

[0037]

[0042] The notch pattern can form a "segment" of a repeating structural unit along the length direction of the tube. In a typical one-beam embodiment, one segment can be defined by a first beam 332 disposed between two adjacent rings 334 (one proximal ring and one distal ring), and a beam 332 on the opposite side of the distal ring that is offset from the first beam 332 by approximately 180 degrees in the rotational direction. Similarly, in a typical two-beam embodiment, one segment can be defined by a first pair of beams 532 disposed between two adjacent rings 534 (one proximal ring and one distal ring), and a second pair of beams 532 extending from the distal ring that is offset from the first pair of beams by approximately 90 degrees in the rotational direction. Similarly, in a typical three-beam embodiment, one segment can be defined by a first triplet of beams 732 disposed between two adjacent rings 734 (one proximal ring and one distal ring), and a second triplet of beams 732 extending from the distal ring that is offset from the first triplet by approximately 60 degrees in the rotational direction.

[0038]

[0043] FIG. 8 shows a tube 804 having a plurality of beams 832 and rings 834. The notch pattern shown has a rotational offset in the direction applied to each successive segment of the tube 804 to minimize the range of suitable bending directions within the tube. As used herein, "rotational offset" is the angular rotation between two adjacent segments. Thus, even if the individual notches within a segment may also be offset from each other, the rotational offset is applied from one segment to the next.

[0039]

[0044] As shown, the notch may be configured to form a substantially constant rotational offset in a rotational direction from one segment to the next. The shown notch pattern indicates a rotational offset of about 5 degrees in a rotational direction from one segment to the next. When a plurality of consecutive segments having such an angular offset are formed, the resulting pattern of the beam along a sufficient length of the tube 804 wraps around the axis of the tube 804 as a continuously rotating helical pattern. The angular offset may be about 5, 15, 30, 45, 60, 75, 80, or 85 degrees. In some embodiments, the angular offset is applied to each consecutive segment. In other embodiments, a plurality of consecutive segments are arranged adjacent to each other such that they have no offset prior to the application of the angular offset. are arranged.

[0040]

[0045] The illustrated embodiment shows a two-beam notch pattern having a series of rotational offsets. However, it will be understood that the same principle may be applied to other notch patterns, such as a one-beam notch pattern, a three-beam notch pattern, or a notch pattern having four or more beams for each pair of adjacent rings. In a preferred embodiment, each consecutive notch or set of notches (e.g., every other, every third, etc.) along the length direction of a given section is offset in the rotational direction by about 1, 2, 3, 5, or 10 degrees, or offset from 180 degrees of a one-beam pattern by about 1, 2, 3, 5, or 10 degrees, or offset from 90 degrees of a two-beam pattern by about 1, 2, 3, 5, or 10 degrees, or offset from 60 degrees of a three-beam pattern by about 1, 2, 3, 5, or 10 degrees, or similarly offset in a pattern having a greater number of beams. These rotational offset values have the convenient property shown for eliminating a flexing bias.

[0041]

[0046] The distinct components and features of the notch patterns shown in FIGS. 3 through 8 can be combined to form another tube configuration. For example, some tubes can be configured to have sections of a two-beam notch that transition into sections of a one-beam notch. Deformable configurations of the distal end

[0047] FIGS. 9 through 11 show embodiments of various distal tip configurations that can be utilized with one or more of the embodiments described herein. FIG. 9 shows a tip configuration of continuous diameter. Here, coil 918 surrounding tapered core 902 has a substantially continuous diameter. FIG. 10 shows a stepped tip configuration, where outer coil 1018 positioned over core 1002 has a substantially continuous diameter. Inner coil 1014 of smaller diameter is positioned to extend further distally than outer coil 1018 so as to provide a stepped changing diameter at the tip. FIG. 11 shows a tapered tip configuration, where coil 1118 tapers to conform to at least a portion of the tapered portion of core 1102. The tip embodiments shown in FIGS. 9 through 11 can be combined with any of the embodiments of the guidewire devices described herein. For example, a desired tip configuration can be selected to provide desired formability characteristics and / or flexibility characteristics for a given guidewire application.

[0042]

[0048] As used herein, the expressions “about,” “approximately,” and “substantially” represent an amount or condition that is close to the recited amount or condition and that still performs the desired function or still achieves the desired result. For example, the expressions “about,” “approximately,” and “substantially” can mean an amount or condition that deviates from the recited amount or condition by less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01%.

[0043]

[0049] Elements described in connection with any embodiment described and / or illustrated herein may be combinable with and used in conjunction with elements described in connection with any other embodiment described and / or illustrated herein. For example, any element described in connection with a tube section of any of FIGS. 3-8 and / or any element described in connection with a tip configuration of any of FIGS. 9-11 may be combined with and used with the guidewire device of FIGS. 1 and 2. In any of the above combinations, the distal tip of the core wire may be circular, flat, or another shape.

[0044]

[0050] The present invention may be embodied in other forms without departing from the spirit or essential characteristics thereof. The embodiments described are to be considered in all respects only as illustrative and not restrictive. Accordingly, the scope of the present invention is indicated by the appended claims rather than by the foregoing description. All modifications within the meaning and range of equivalents of the claims are embraced within the scope of the present invention. The present invention may be embodied in other forms without departing from the spirit or essential characteristics thereof. The embodiments described are to be considered in all respects only as illustrative and not restrictive. Accordingly, the scope of the present invention is indicated by the appended claims rather than by the foregoing description. All modifications within the meaning and range of equivalents of the claims are embraced within the scope of the present invention.

Claims

1. A guide wire device having a formable tip, wherein the guide wire device comprises a core having a proximal section and a distal section, the distal section having a smaller diameter than the proximal section, a nitinol tube structure coupled to the core, such that the distal section of the core passes into and through the tube structure and extends distally beyond the tube structure to form a formable tip, a coil surrounding at least a portion of the formable tip and the coil has (i) an outer coil formed from stainless steel and coupled to the distal end of the nitinol tube structure and extending distally from the tube structure, and (ii) an inner coil disposed at least partially within the tube structure, the outer coil surrounding at least a portion of the inner coil extending distally beyond the tube structure, the inner coil is at least partially formed from a material capable of effectively maintaining its shape after being bent by a user, and the portion of the inner coil extending distally beyond the tube structure is longer along the longitudinal direction of the tube structure than the portion of the inner coil within the tube structure, the inner coil is at least partially positioned between the outer surface of the core and the inner surface of the tube structure, the inner coil is sized and shaped to fill the space between the core and the tube structure, such that when the tube structure is curved, the curved portion of the tube structure is aligned with the corresponding curved portion of the core, the inner coil is sized to abut against both the outer surface of the core and the inner surface of the tube structure, a guide wire device.

2. The guide wire device according to claim 1, wherein the distal section of the core tapers from the proximal section of the core.

3. The guide wire device according to claim 1, wherein the formable tip extends distally beyond the tube structure at a distance of from 0.5 cm to 5 cm, or from 1 cm to 3 cm.

4. The guide wire device according to claim 1, wherein the inner coil is formed from a radiopaque material.

5. The guide wire device according to claim 4, wherein the inner coil is formed of platinum. **Claim 6** The guide wire device according to claim 1, wherein the core is formed of stainless steel. **Claim 7** The guide wire device according to claim 1, wherein the tube structure has a plurality of windows defining a plurality of axially extending beams that couple a plurality of circumferentially extending rings. **Claim 8** The guide wire device according to claim 7, wherein the plurality of windows are configured to be one or more notch patterns of a one-beam notch pattern, a two-beam notch pattern, or a three-beam notch pattern. **Claim 9** The guide wire device according to claim 7, wherein the window defines a notch pattern having a rotational offset in a rotational direction that rotates each successive segment along the length direction of the tube structure circumferentially from the previous segment. **Claim 10** The guide wire device according to claim 1, wherein the diameter of the wire of the outer coil is larger than the diameter of the wire of the inner coil.

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