Guide wire system

Abstract

A guidewire system having improved torque capability and formability for access to a distal anatomical structure through a curved blood vessel. The guidewire system may include a core wire having a proximal portion and a distal portion. The distal portion may be tapered along at least a portion of its length. The distal portion may include both a plurality of uniform diameter sections and a plurality of tapered diameter sections. One or more coils may be attached to the core wire, such as an inner coil and an outer coil. A radiopaque marker may be secured to the distal tip of the core wire for visualization by an imaging device. Alternatively, one or more winding grooves may be cut into the core wire to perform the same function as the coil. The entire core wire, including any fixed coil, may be encapsulated in a polymer sheath.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 386,422, filed on December 7, 2022, entitled Guidewire System, the entire contents of which are incorporated herein by reference in their entirety. Background Art

[0003] In some cases, navigating various medical devices through tortuous vessels to distal anatomical structures can be incredibly challenging. For example, navigating a guidewire through the cerebral hemispheres may require substantial torsion capability, distal tip shape capability, and / or the ability to maintain the original shape of the guidewire to navigate further into the vasculature.

[0004] When navigating potentially difficult conditions such as tortuous anatomy, it may be desirable for a guidewire to have a shapeable tip that both facilitates efficient introduction into the body and provides torqueability advantages. This approach may rely on the location of each intersection profile and / or the stiffness of the guidewire's core wire as determining factors for the quality of the guidewire's torqueability. Summary of the Invention

[0005] Disclosed herein is an exemplary embodiment of a guidewire system comprising a core wire having a distal segment that tapers from a larger outer diameter to a smaller outer diameter. In an exemplary embodiment, the distal segment can include both a uniform diameter segment and a tapered diameter segment. The uniform diameter segment and the tapered diameter segment can be configured to alternate along the length of the distal segment of the core wire.

[0006] In an exemplary embodiment, one or more coils can be connected to or positioned around at least a portion of the distal segment of the core wire. In an exemplary embodiment, the one or more coils can include an inner coil and an outer coil. In an exemplary embodiment, an additional extension coil can be positioned around or connected to the distal tip of the core wire.

[0007] In an exemplary embodiment, the guidewire may have a variable cross-sectional profile and stiffness across the distal section, such as for a distal length of approximately 40-50 cm.

[0008] In an exemplary embodiment, a polymer outer sheath may enclose the inner coil, the outer coil, and the core wire.

[0009] In an exemplary embodiment, the inner and outer coils may have substantially similar wires.

[0010] In an exemplary embodiment, the outer coil may be composed of platinum tungsten and the inner coil may be composed of stainless steel.

[0011] In an exemplary embodiment, one or both of the inner coil and / or the outer coil may have a pitch that increases distally.

[0012] In an exemplary embodiment, the inner coil can include distally increasing pitch dimensions of approximately 0.005 inches, 0.008 inches, and 0.013 inches.

[0013] In an exemplary embodiment, the inner coil may have a distally increasing pitch that is approximately 15 mm long.

[0014] In an exemplary embodiment, the inner and outer coils may have substantially the same length.

[0015] In an exemplary embodiment, welding may be utilized at the distal and proximal sections of corresponding coils to hold them in place relative to the core wire.

[0016] In an exemplary embodiment, the guidewire may allow the polymer sheath to pass between the coil and the core wire. Thus, the polymer sheath may be applied over the coil and the underlying core wire.

[0017] In an exemplary embodiment, the polymer sheath may maintain a mix ratio of approximately 15%-20%.

[0018] In an exemplary embodiment, the polymer sheath may be applied over the coil and core wire using a dip coating method.

[0019] In an exemplary embodiment, an extension coil may be used in addition to the inner and outer coils.

[0020] In an exemplary embodiment, the length of the extension coil may be approximately 8%-11% of the length of the outer coil or the inner coil.

[0021] In an exemplary embodiment, the extension coil may be constructed of the same material as the outer coil.

[0022] In an exemplary embodiment, the extension coil may have a uniform pitch relative to the inner coil and / or the outer coil.

[0023] In exemplary embodiments, a polymer sheath may also be applied over the extension coil.

[0024] In an exemplary embodiment, instead of using discrete coils connected to the core wire, the core wire may instead include radial grooves cut into the core wire that provide a similar function as the attached coils. The radial grooves may include a first groove cut in a sweeping pattern in a clockwise direction and a second groove cut in a sweeping pattern in a counterclockwise direction.

[0025] In exemplary embodiments, vascular access may be enhanced and better guidewire tracking control may be achieved by efficiently transmitting torque from the proximal end of the guidewire to the distal tip.

[0026] In an exemplary embodiment, the guidewire may have a variable cross-sectional profile and stiffness over its distal segment (such as the distal 40 cm-50 cm segment, etc.).

[0027] In an exemplary embodiment, the distal tip of the guidewire may be flat.

[0028] In an exemplary embodiment, the guidewire may maintain a minimal annular area between its core wire and the inner coil secured thereto. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The following drawings are included to illustrate certain example aspects of the disclosure and should not be considered exhaustive or limiting. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

[0030] Referring to the accompanying drawings,

[0031] Figure 1 A perspective view of a core wire of a guidewire system according to an exemplary embodiment of the present disclosure is illustrated.

[0032] Figure 2 Illustrated is a side view of a core wire of a guidewire system according to an exemplary embodiment of the present disclosure.

[0033] Figure 3 A graph illustrating core wire intersection profiles according to an exemplary embodiment of the present disclosure is illustrated.

[0034] Figure 4 The table shows an exemplary embodiment of the present disclosure. Figure 3 The graph shows the taper values ​​of the core wire of the guidewire system in tabular form.

[0035] Figure 5 A side view of a guidewire system according to an exemplary embodiment of the present disclosure is illustrated.

[0036] Figure 6 Illustrated is a side view of a second (outer) coil of a guidewire system according to an exemplary embodiment of the present disclosure.

[0037] Figure 7 Illustrated is a side view of a first (inner) coil of a guidewire system according to an exemplary embodiment of the present disclosure.

[0038] Figure 8A side view of a guidewire system is illustrated according to an exemplary embodiment of the present disclosure, wherein a coil is positioned over a portion of the length of the core wire.

[0039] Figure 9 Illustrated is a side view of a guidewire system including three coils according to an exemplary embodiment of the present disclosure.

[0040] Figure 10 Illustrated is a side view of a third (extension coil) of a guidewire system according to an exemplary embodiment of the present disclosure.

[0041] Figure 11 Illustrated is a side view of a core wire of a guidewire system in which a winding groove has been cut, according to an exemplary embodiment of the present disclosure.

[0042] Figure 12 Illustrated is a side view of the distal tip of a core wire of a guidewire system according to an exemplary embodiment of the present disclosure.

[0043] Figure 13 Illustrated is a side view of the distal tip of a core wire of a guidewire system according to an exemplary embodiment of the present disclosure.

[0044] Figure 14 Illustrated is a cross-sectional view of the distal tip of a core wire of a guidewire system according to an exemplary embodiment of the present disclosure.

[0045] Figure 15 Illustrated are sweep cut patterns for opposing first and second wrapping grooves according to exemplary embodiments of the present disclosure.

[0046] Figure 16 Illustrated is a side view of a guidewire system having a radiopaque marker affixed to a portion of a distal portion of a corewire according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION

[0047] Specific embodiments of the present disclosure will now be described with reference to the accompanying drawings. However, the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present disclosure will be thorough and complete and fully convey the scope of the present disclosure to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present disclosure. In the drawings, the same reference numerals refer to the same elements.

[0048] For the purposes of this specification, use of the terms "about," "approximately," or "substantially" when referring to a value may be understood to mean within 5% (larger or smaller) of the stated value, inclusive.

[0049] The guidewire system may include a core wire, an inner coil, an outer coil, and / or an extension coil.

[0050] The guidewire system may include an elongated body comprising a proximal portion and a distal portion. The elongated body may include a core wire. The proximal portion of the core wire may include a uniform diameter, and the distal portion of the core wire may include an overall tapered portion. Thus, the outer diameter of the core wire may decrease between the proximal end of its distal portion and the distal end of its distal portion. The taper rate may vary over the length of the distal portion (e.g., the taper may not be uniform). The core wire may be grounded to form the tapered portion. The core wire may be made of various materials. For example, the core wire may be made of nitinol.

[0051] The proximal portion of the core wire can be formed to be greater than half the length of the core wire, such that the length of the proximal portion is greater than the length of the distal portion. By way of example, the total length of the core wire can be approximately 2000 mm, the total length of the proximal portion of the core wire can be approximately 1600 mm, and the total length of the distal portion of the core wire can be approximately 400 mm.

[0052] The tapered portion may comprise only tapered diameter segments. The diameter of each tapered diameter segment may decrease toward the distal end of the elongated body. Multiple tapered diameter segments having varying degrees of tapering (e.g., the rate of decrease in diameter toward the distal end) may be used. Thus, a first tapered segment may comprise a first taper, and a second tapered segment may comprise a second taper that is different from (e.g., larger or smaller than) the first taper.

[0053] A third tapered section may also be included, which may have a third taper different from the first and second tapers, or may have the first or second tapers. Thus, where multiple tapered sections are used in the tapered portion, two or more of the tapered sections may share substantially the same taper, and one or more of the tapered sections may have different tapers.

[0054] The tapered portion itself can include multiple uniform diameter regions and multiple variable (e.g., tapered) diameter regions. The uniform diameter regions and tapered diameter regions can be tapered so that each tapered diameter region has at least one adjacent uniform diameter region, or so that each uniform diameter region has at least one adjacent tapered diameter region. Thus, the tapered diameter regions and uniform diameter regions of the tapered portion can be staggered.

[0055] The length of each of the respective uniform diameter regions and tapered diameter regions can vary across the length of the tapered portion, such that, for example, the first uniform diameter region has a different length than the second uniform diameter region, the first tapered diameter region has a different length than the second tapered diameter region, and so on. The combined length of the uniform diameter regions can be greater than the combined length of the tapered diameter regions. By way of example, the combined length of the uniform diameter regions can be approximately 390 mm, and the combined length of the tapered diameter regions of the distal portion can be approximately 10 mm.

[0056] The outer diameter of the core wire can vary throughout its length. For example, the outer diameter of the proximal portion of the core wire (which can be uniform throughout its length) can be approximately 0.0135 inches. The outer diameter of the distal portion of the core wire (which can "step down" throughout its length) can include step-down values ​​of approximately 0.008 inches, 0.0069 inches, 0.0055 inches, 0.0047 inches, and 0.0029 inches.

[0057] The distal tip of the core wire can be flattened to form a paddle. The length of the paddle at the distal end of the core wire can vary. For example, the paddle can be approximately 5 mm to 11 mm in length. The paddle can perform multiple functions. For example, the paddle can accommodate both the inner and outer coils. The paddle can maintain a minimum annular area between itself and the inner coil. The paddle can also allow the polymer sheath to enter between the coil and the core wire.

[0058] One or more coils can be attached to the core wire. For example, an inner coil and an outer coil can be attached to the core wire. The inner coil can be attached directly over the core wire, and the outer coil can be attached directly over the inner coil, so that the inner coil is nested within the outer coil.

[0059] The inner coil can be made of various materials including stainless steel. The total length of the inner coil can include approximately 250mm-350mm. The coil pitch of the inner coil can increase distally. By way of example, there can be a coil gap of approximately 0.0005 inches for the proximal portion of the inner coil, followed by a coil gap of approximately 0.00175 inches at the inner portion of the inner coil. The distal portion of the inner coil (such as the distal 15mm length of the inner coil) can include a coil pitch of approximately 0.0013 inches, 0.008 inches, and 0.005 inches towards the distal tip of the inner coil. Such a configuration can improve the formability of the distal tip of the guidewire.

[0060] The outer coil can be made of a variety of materials, including platinum tungsten. Therefore, the inner coil can be made of a different material than the inner coil. However, in some cases, the inner and outer coils can be made of the same material. The total length of the outer coil can be the same as or different from the total length of the inner coil. By way of example, the total length of the outer coil can be approximately 250 mm to 350 mm. The length of the inner coil can be slightly longer than the length of the outer coil.

[0061] Both the inner and outer coils may comprise substantially the same wire outer diameter, such as approximately 0.00125 inches, etc. The coil pitch of the outer coil may be uniform throughout its length, such as approximately 0.00175 inches, etc. The coil gap of the outer coil may be uniform throughout its length, such as approximately 0.0005 inches, etc.

[0062] The inner and outer coils can have opposite orientations relative to each other. Thus, the inner coil can be wound in a first direction, and the outer coil can be wound in a second direction, where the first direction is opposite to the second direction. In other words, the inner and outer coils can cross each other at multiple locations along their respective lengths to form a cross pattern across the length of the core wire to which they are attached.

[0063] To maintain the positioning of the outer and inner coils relative to each other and the core wire, the entire core wire, inner coil, and outer coil can be encapsulated in a polymer sheath. Various polymers known in the art can be used. The polymer sheath can maintain a blend ratio of approximately 15%-20%. The polymer sheath can be applied in various ways. For example, the polymer sheath can be applied by dip coating. Using such a polymer sheath to cover and encapsulate the core wire, inner coil, and outer coil can help maintain the integrity of the coils and core wire.

[0064] A third extension coil may also be utilized. The extension coil may be attached to the distal tip of the core wire. The extension coil may at least partially overlap the inner and / or outer coils, or may be axially positioned relative to the inner and / or outer coils such that the proximal end of the extension coil abuts or rests against the distal ends of the inner and / or outer coils. The extension coil may rest on top of the inner and / or outer coils.

[0065] The extension coil can be constructed from a variety of materials. For example, the extension coil can be constructed from platinum tungsten. Thus, the extension coil can be constructed from the same material as the outer coil. The extension coil can be shorter in length than the inner and / or outer coils. For example, the extension coil can be between approximately 20 mm and 30 mm in length. As another example, the extension coil can be between approximately 6% and 12% of the length of the inner and / or outer coils.

[0066] The extension coil can have a uniform pitch throughout its length. However, in some cases, the pitch of the extension coil can vary throughout its length. The winding direction of the extension coil can vary. The extension coil can be wound in the same direction as the inner coil, in which case the extension coil can be wound in the opposite direction to the outer coil. Conversely, the extension coil can be wound in the same direction as the outer coil, in which case the extension will be wound in the opposite direction to the inner coil.

[0067] The extension coil can be attached to surround the distal tip of the core wire. Because the distal tip of the core wire has a smaller diameter than the extension coil, an annular region can exist between the extension coil and the distal tip of the core wire. This annular region can be used to introduce a polymer sheath between the respective coils and the core wire to which they are attached, such that the polymer sheath penetrates the coil. The extension coil can be welded to the distal tip of the core wire or otherwise secured to the distal tip of the core wire using various methods known in the art.

[0068] The guidewire system can include an elongated body with one or more grooves cut into it to perform a function similar to the coil described above. The elongated body can include a core wire. The core wire can have a length and profile substantially similar to the core wire discussed above, or the core wire can have a different size than previously discussed.

[0069] The core wire can have a proximal portion and a distal portion. The proximal portion can include a uniform diameter, and the distal portion can include a tapered diameter that decreases linearly or nonlinearly over its length. For example, starting from the distal end of the proximal portion, the outer diameter of the core wire can taper from 0.035 inches to 0.021 inches to 0.018 inches to 0.014 inches at its distal tip. The distal tip can be tapered and / or flat to accommodate a radiopaque coil, as discussed below.

[0070] The proximal portion may comprise the majority of the length of the core wire, and the distal portion may comprise a minority of the length of the core wire. Thus, the proximal portion may be longer than the distal portion. For example, the distal portion may comprise approximately 5%-20% of the total length of the core wire.

[0071] The core wire can be made of various materials such as nitinol. The total length of the distal portion of the core wire can include approximately 300 mm to 400 mm. The distal tip of the distal portion of the core wire can include approximately 5% to 15% of the total length of the distal portion. For example, the distal tip of the distal portion of the core wire can include approximately 20 mm to 30 mm.

[0072] One or more grooves may be cut into the distal portion of the core wire. The one or more grooves may extend the entire length of the distal portion of the core wire, including its distal tip. However, the one or more grooves may alternatively extend only a portion of the entire length of the distal portion of the core wire. For example, the one or more grooves may terminate at or before the beginning of the distal tip of the distal portion of the core wire.

[0073] The one or more grooves may include one or more winding grooves. The one or more winding grooves may be continuous and / or discontinuous. The one or more winding grooves may include a first winding groove and a second winding groove. The winding grooves may be formed by sweep cutting into the body of the core wire. The first winding groove may be wound along a first direction, and the second winding groove may be wound along a second direction, wherein the first direction is opposite to the second direction. For example, the first winding groove may be cut in a clockwise direction, and the second winding groove may be cut in a counterclockwise direction. The first winding groove and the second winding groove may overlap or intersect at specific intervals to form an X pattern when intersecting.

[0074] The one or more grooves may be non-coiled or take any other non-coiled shape. As an example, the one or more grooves may include a plurality of individual circular groove shapes or annular grooves formed along all or a portion of the core wire (including all or a portion of the distal portion of the core wire). The one or more grooves may be positioned along or on the distal tip.

[0075] A radiopaque marker can be attached to the distal tip of the core wire. The radiopaque marker can include, for example, a coiled wire and / or a marker band. The radiopaque marker can be constructed from various radiopaque materials, such as platinum tungsten. For example, the radiopaque marker can include a platinum tungsten wire coiled around the distal tip of the core wire.

[0076] The distal tip of the core wire may include a cap or other blunt, rounded or curved protrusion that prevents the distal tip of the core wire from terminating at a point or sharp end that could potentially penetrate tissue. The distal tip itself may be rounded or blunted without the need for a separate cap.

[0077] The exemplary embodiments shown in the drawings and described herein can be designed to improve torsional capacity, formability and elasticity (i.e., the ability to maintain its initial shape). Exemplary embodiments can have a formable tip for being introduced into the human body and providing the advantage of torsional capacity during navigation through tortuous anatomical structures. Cross profiles and variable stiffness profiles can contribute to the torsional capacity of the guidewire system.

[0078] Exemplary embodiments may utilize a pair of oppositely wound coils that provide torque in more than one direction. The distal tip of the guidewire system may be pre-shaped by the operator to fit different anatomies. A shaping mandrel may be provided with the guidewire system to help shape the distal tip into a desired shape or curvature.

[0079] Specific exemplary embodiments are further described below. However, it should be understood that any features from any embodiment can be mixed and matched with each other in any combination. Therefore, the present disclosure should not be limited to these embodiments, but any broader combination thereof.

[0080] These figures illustrate exemplary embodiments of a guidewire system suitable for navigating through tortuous blood vessels to reach a distant target location.For example, the guidewire system may be suitable for navigating through the cerebral hemispheres.

[0081] Figure 1 and Figure 2 An exemplary embodiment of the core wire 110 of the guidewire system 100 is illustrated in perspective and side views, respectively. Figure 1 As shown, core wire 110 may include a proximal portion 111 and a distal portion 112, wherein proximal portion 111 includes its proximal end 110A and distal portion 112 includes its distal end 110B. Proximal portion 111 of core wire 110 may include a uniform outer diameter. In some exemplary embodiments, distal portion 112 of core wire 110 may include an overall tapered outer diameter, including tapered diameter segments 113. In some exemplary embodiments, distal portion 112 of core wire 110 may also include one or more uniform diameter segments 114.

[0082] In different embodiments, the respective lengths of the proximal portion 111 and the distal portion 112 of the core wire 110 can vary. Typically, the proximal portion 111 can comprise at least about half of the entire length of the core wire 110. In some embodiments, the proximal portion 111 can comprise at least about 75% of the entire length of the core wire 110. In still other embodiments, the proximal portion 111 can comprise at least about 85% of the entire length of the core wire 110. Thus, in some embodiments, the distal portion 112 of the core wire 110 can comprise between about 15% and 50% of the entire length of the core wire 110. However, it should be understood that in certain embodiments, the distal portion 112 can comprise less than about 15% or more than about 50% of the entire length of the core wire 110.

[0083] By way of non-limiting example, certain dimensions are discussed herein. However, it should be understood that these dimensions are for illustrative purposes only. Therefore, the scope of the present invention should not be interpreted as being limited to any specific dimensions disclosed herein.

[0084] In an exemplary embodiment, the entire length of the core wire 110, and therefore the entire guidewire system 100, can comprise approximately 2000 mm. In some embodiments, the length of the core wire 110 can be between approximately 1500 mm and 2500 mm. In some embodiments, of the entire length of the core wire 110, approximately 60%-80% (e.g., 70%) of the length of the core wire 110 can comprise a coated wire, such as a PTFE-coated wire or the like. The remaining length of the core wire 110 (approximately 20%-40% (e.g., 30%) of the length of the core wire 110 can comprise a nitinol core wire.

[0085] In e.g. Figure 1-Figure 2 In the exemplary embodiment shown in , the proximal portion 111 of the core wire 110 can be defined as approximately 80% of its total length. However, in some embodiments, the proximal portion 111 can include more or less than 80% of the total length of the core wire 110. Similarly, the distal portion 112 of the core wire 110 can be defined as approximately 20% of its total length. However, in some embodiments, the distal portion 112 can include more or less than 20% of the total length of the core wire 110. For example, in Figure 1-Figure 2 In the illustrated embodiment, the proximal portion 111 may comprise approximately 1600 mm, and the distal portion 112 may comprise approximately 400 mm.

[0086] like Figure 1-Figure 2 As further shown in FIG, in some embodiments, the distal portion 112 can include a grounded core wire, such as grounded nitinol, or the like, whose outer diameter decreases (i.e., tapers) toward its distal end 110B. Using a grounded core wire 110 at the distal portion 112 can aid in torquability and formability, which improves navigation of the core wire 110 and the entire guidewire system 100.

[0087] The ratio and degree of the tapered distal portion 112 may vary in different embodiments. Figure 2 In the illustrated embodiment, the distal portion 112 can include both a plurality of tapered diameter sections 113 and a plurality of uniform diameter sections 114. In some embodiments, the tapered diameter sections 113 can be staggered with the uniform diameter sections 114 such that each tapered diameter section 113 is adjacent to a uniform diameter section 114, and vice versa. In other words, the tapered diameter sections 113 and the uniform diameter sections 114 can alternate along at least a portion of the length of the distal portion 112 of the core wire 110.

[0088] Continue to refer Figure 2 , the lengths of the respective tapered diameter sections 113 and uniform diameter sections 114 can vary across the length of the distal portion 112 of the corewire 110. For example, in some embodiments, the uniform diameter section 114 can be comprised of lengths of 105 mm, 40 mm, 205 mm, and 40 mm, with the remaining length of the distal portion 112 comprising the tapered diameter section 113. Thus, in some embodiments, the uniform diameter section 114 can comprise approximately 80%-90% of the length of the distal portion 112 of the corewire 110, and the remaining 10%-20% of the length of the distal portion 112 can comprise the tapered diameter section 113. However, in some embodiments, up to approximately 100% of the length of the distal portion 112 can comprise only the tapered diameter section 113, without any uniform diameter section 114.

[0089] like Figure 1-Figure 2As shown in FIG, the distal tip 115 of the core wire 110 may include a flat portion, such as a paddle 116. In an exemplary embodiment, the length of the paddle 116 may be between about 5 mm and 11 mm, although in some embodiments, its length may be less than 5 mm or greater than 11 mm. The paddle 116 may perform multiple functions. For example, the paddle 116 may accommodate the inner and outer coils (see below). Figure 5-10 Discussion). In some embodiments, the paddle 116 can maintain a minimum annular area between itself and the inner coil. In some embodiments, the paddle 116 can allow the polymer sheath to enter between the coil and the core wire. Thus, in some embodiments, the flat paddle 116 can enhance vascular access by effectively transmitting torque from the proximal end of the guidewire to the distal tip, and can further promote better control during guidewire tracking.

[0090] Figure 3 Graph illustrating an exemplary embodiment of a cross-profile of a core wire 110 illustrating how the outer diameter of the distal portion 112 of the core wire 110 may taper toward its distal end 110B. Note that Figure 3 The x-axis of the graph shown in lists the distance from the tip (ie, the distance from the distal end 110B). As can be seen, the outer diameter of the distal portion 112 of the core wire 110 can be gradually tapered, with the uniform diameter section 114 comprising most of the length of the distal portion 112 of the core wire 110.

[0091] Figure 4 The table shows Figure 3 , where "position" is calculated as the distance (in mm) from the distal end 110B of the core wire 110. It can be seen that the outer diameter of the distal portion 112 of the core wire 110 can taper downward from an initial outer diameter of approximately 0.0135 inches to a final outer diameter of approximately 0.0029 inches. Thus, the outer diameter of the distal portion 112 can decrease by approximately 75%-85% from its initial outer diameter to its final outer diameter at its distal end 110B.

[0092] It should be understood that Figure 3-Figure 4 The values ​​shown and described in the are for exemplary purposes only, and therefore they should not be construed as limiting the range. It is contemplated that different dimensions may be utilized to accommodate different applications or medical procedures.

[0093] Figure 5 A side view of the guidewire system 100 is shown. In some embodiments, one or more coils 120, 125 can be attached to a core wire 110 including a distal tip 115. The one or more coils 120, 125 can at least partially surround the core wire 110. Figure 5In the illustrated embodiment, a first coil 120 and a second coil 125 may be attached to the core wire 110 , wherein the first coil 120 comprises an inner coil and the second coil 125 comprises an outer coil 125 positioned on the first coil 120 .

[0094] Different types of coils 120, 125 may be used. In an exemplary embodiment, the first coil 120 may be constructed of a different material than the second coil 125. For example, the first coil 120 may be constructed of stainless steel and the second coil 125 may be constructed of platinum tungsten.

[0095] Figure 6 Illustrated is a side view of the second (outer) coil 125 of the guidewire system 100 according to an exemplary embodiment. Figure 7 A side view of the first (inner) coil 120 of the guidewire system 100 according to an example embodiment is illustrated. In some exemplary embodiments, the lengths of the first coil 120 and the second coil 125 can be substantially similar. For example, each of the first coil 120 and the second coil 125 can include a length of approximately 250mm-350mm. However, in some embodiments, the lengths of the first coil 120 and the second coil 125 can be slightly different. In an exemplary embodiment, the length of the first (inner) coil 120 can be approximately 280mm and the length of the second (outer) coil 125 can be approximately 175mm. Similarly, the first coil 120 and the second coil 125 can include substantially the same wire size, such as a wire outer diameter of 0.00125 inches, etc.

[0096] refer to Figure 6 , the second coil 125 can include a uniform pitch along its entire length. For example, the length of the second coil 125 can include a uniform pitch of approximately 0.00150 inches-0.00200 inches or approximately 0.00175 inches.

[0097] refer to Figure 7 In some embodiments, the first coil 120 can have increasing pitch along its distal portion, such as between 100 mm and 150 mm of its distal length. For the majority of the proximal length of the first coil 120, the coil pitch can be between about 0.00150 and 0.00200 inches or about 0.00175 inches, with a proximal coil gap between about 0.0001 inches and 0.0010 inches or about 0.0005 inches. The remaining distal length of the first coil 120 can have gradually increasing pitch, including pitches of about 0.005 inches, 0.008 inches, and 0.013 inches.

[0098] like Figure 5As shown, the coils 120, 125 may be located over and attached to the entire length of the core wire 110 or only over and attached to a portion of the length of the core wire 110. Figure 5 In the exemplary embodiment shown, it can be seen that both coils 120 , 125 are attached to the length of core wire 110 .

[0099] Figure 8 A side view of the guidewire system 100 is shown with the coils 120, 125 positioned over a portion of the length of the core wire 110. Figure 8 In the exemplary embodiment shown, it can be seen that the distal tip 115 of the core wire 110 remains exposed and, therefore, is not covered by either of the coils 120 , 125 .

[0100] In different embodiments, the winding directions of the first coil 120 and the second coil 125 can vary. In an exemplary embodiment as shown in the figure, the first coil 120 can be wound in a first direction and the second coil 125 can be wound in a second direction, the first direction being opposite to the second direction. By way of example, the first coil 120 can be wound in a counterclockwise direction and the second coil 125 can be wound in a clockwise direction, or vice versa. Thus, the first coil 120 and the second coil 125 can cross each other at multiple points along the length of the core wire 110.

[0101] In different embodiments, the manner in which the coils 120, 125 are attached to the core wire 110 may vary. In an exemplary embodiment, the corresponding proximal and distal segments of each of the coils 120, 125 may be welded to the core wire 110 and then encapsulated in a polymer sheath as described herein.

[0102] Figure 9 A side view of a guidewire system 100 comprising three coils is shown. Figure 9 In the exemplary embodiment shown, a third coil 130 may be attached to the distal tip 115 of the core wire 110 in addition to the first coil 120 and the second coil 125. The third coil 130 may serve as an extension coil axially relative to the first coil 120 and the second coil 125. In some embodiments, the third coil 130 may at least partially overlap both the first coil 120 and the second coil 125. Typically, the third coil 130 will be substantially shorter in length than the first coil 120 and the second coil 125. For example, the length of the third coil 130 may be approximately 10% of the length of the first coil 120 and / or the second coil 125. As a more specific example, the length of the third coil 130 may be between approximately 20 mm and 30 mm.

[0103] Figure 10A side view of an exemplary embodiment of the third (extended) coil 130 is illustrated. In some embodiments, the third coil 130 can be constructed of the same material as the second coil 125 (such as platinum tungsten, etc.). However, in some embodiments, the third coil 130 can be the same material as the first coil 120, or can be a different material than the first coil 120 and the second coil 125. The third coil 130 can have the same pitch as the first coil 120 and / or the second coil 125, or can have a different pitch than the first coil 120 and / or the second coil 125. The third coil 130 can include a plurality of coils extending across its length (such as a plurality of coils extending across its length). Figure 10 shown, etc.) or may have a variable pitch.

[0104] As previously discussed, at least a portion of the core wire 110 (including one or more coils 120, 125, 130) can be encapsulated in a polymer sheath that helps, for example, hold the core wire 110 and coils 120, 125, 130 together. The manner in which the polymer sheath is applied can vary in different embodiments. In an exemplary embodiment, the polymer sheath can be applied by dip coating and / or the use of shrink tubing. The reduced diameter of the distal tip 115 of the core wire 110 can help the polymer sheath penetrate between the coils 120, 125, 130. Various materials can be used for the polymer sheath, including but not limited to polyurethane.

[0105] Figure 11-Figure 15 An exemplary embodiment of a guidewire system 100 is illustrated in which one or more grooves 155A, 155B may be cut into the core wire 150 to perform the same function of improving torsional capability and formability as the individual coils 120, 125, 130 of the previously discussed exemplary embodiments. Figure 11-Figure 15 The exemplary embodiment shown in illustrates a core wire 110 having an integrated coil cut into the core wire 110 rather than a discrete coil.

[0106] The one or more grooves 155A, 155B may comprise winding or non-winding grooves. In an exemplary embodiment, the one or more grooves 155A, 155B may comprise non-winding shapes, such as separate circular or annular grooves that are spaced apart along all or a portion of the length of the core wire 110. The one or more grooves 155A, 155B may be continuous and / or discontinuous.

[0107] Figure 11 A side view of an exemplary embodiment of the core wire 150 of the guide wire system 100 is shown in which winding grooves 155A, 155B have been cut. Figure 11As shown, core wire 150 can include a proximal portion 151 and a distal portion 152 including a distal tip 153. Proximal portion 151 can comprise a majority of the total length of core wire 150.

[0108] In an exemplary embodiment, the length of the proximal portion 151 of the core wire 150 can be defined as approximately 80% of its total length. However, in some embodiments, the length of the proximal portion 151 can comprise more than or less than 80% of the total length of the core wire 150. Similarly, the length of the distal portion 152 of the core wire 150 can be defined as approximately 20% of its total length. However, in some embodiments, the length of the distal portion 152 can comprise more than or less than 20% of the total length of the core wire 150.

[0109] By way of example, the length of the distal portion 152 of the core wire 150 can be comprised between approximately 340 mm and 400 mm. The distal tip 153 of the distal portion 152 of the core wire 150 can comprise approximately 5% to 10% of the total length of the distal portion 152. In an exemplary embodiment, the length of the distal tip 153 can comprise between approximately 20 mm and 30 mm of the total length of the distal portion 152.

[0110] As shown in the figures, the distal portion 152 of the core wire 150 can be tapered so as to reduce in diameter distally. By way of example, the outer diameter of the distal portion 152 of the core wire 150 can be reduced from about 0.035 inches to about 0.014 inches. To prevent the distal tip 153 from terminating at a point where it could penetrate tissue and thereby cause injury or complications, a cap 154 ​​can be attached to the distal tip 153 of the core wire 150, such as Figures 12 to 13 Alternatively, the distal tip 153 itself may be blunted without the need for a separate cap 154 ​​.

[0111] Figure 12-14 The diagram illustrates views (side view and cross-sectional view) of the distal tip 153 of the core wire 150 of the guidewire system 100, wherein one or more winding grooves 155A, 155B may be cut into the core wire 150. In an exemplary embodiment, the one or more winding grooves 155A, 155B may be cut into at least a portion of the distal portion 152 of the core wire 150. Figure 12-13 In the exemplary embodiment shown, the winding grooves 155A, 155B may not extend into the distal tip 153 of the distal portion 152 ; however, in some embodiments, the winding grooves 155A, 155B may extend into the distal tip 153 .

[0112] Figure 12-14 It is illustrated that a radiopaque marker 160 , such as a coiled wire composed at least in part of a radiopaque material, or the like, may be positioned along all or a portion of the length of the distal portion 153 . Figure 12-13 An exemplary embodiment is illustrated in which the radiopaque marker 160 may be wrapped more tightly around at least a portion of the distal portion 153 . Figure 14 An exemplary embodiment is illustrated in which the radiopaque marker 160 may be more loosely wrapped around at least a portion of the distal portion 153 .

[0113] In an exemplary embodiment, the first winding groove 155A can be cut into the core wire 150 in a first direction and the second winding groove 155B can be cut into the core wire 150 in a second direction, wherein the first direction is opposite to the second direction. By way of example, the first winding groove 155A can be cut in a clockwise direction and the second winding groove 155B can be cut in a counterclockwise direction, or vice versa. Thus, the first winding groove 155A and the second winding groove 155B can intersect at certain points to form an X pattern.

[0114] Figure 15 Illustrated is an exemplary embodiment of a sweep cut pattern of a relative first winding groove 155A and a second winding groove 155B. The manner in which winding grooves 155A, 155B are formed in core wire 150 can vary in different embodiments. By way of example, winding grooves 155A, 155B can be formed by performing relative sweep cuts in the body of core wire 150 to form grooves therein. A core wire cross profile can be achieved by forming a sweep cut of variable depth on the distal portion 152 of core wire 150 to provide desired guidewire performance requirements.

[0115] Figure 16 A side view of a guidewire system is shown having a radiopaque marker 160 affixed to a portion of the distal portion of a core wire 150. Figure 11-14 as well as Figure 16 In the exemplary embodiment shown, a separate radiopaque marker 160 may be attached to at least a portion of the distal portion 152 of the core wire 150. Figure 11-14 and Figure 16 In the embodiment shown in FIG, it can be seen that the radiopaque marker 160 can include a wire wrapped around the distal tip 153 of the core wire 150. However, in other embodiments, the radiopaque marker 160 can include a marker band, etc. The radiopaque marker 160 can be constructed of various radiopaque materials, such as, but not limited to, platinum tungsten, etc.

[0116] In use, the improved formability and torsion of the different example embodiments of the guidewire system 100 shown and / or described herein can easily navigate to distal anatomical structures through tortuous blood vessels. The tip of the core wire can be pre-shaped by the physician before use to fit the path planned to the target location. In certain embodiments, a separate mandrel can be provided in the guidewire system 100 to easily pre-shape the tip of the core wire before use.

[0117] Terms:

[0118] Exemplary embodiments are set forth in the following numbered clauses:

[0119] Item 1. A guidewire system comprising: an elongated body comprising a proximal portion and a distal portion, wherein the proximal portion comprises a uniform diameter and wherein the distal portion comprises a tapered diameter; a first coil device for imparting torsional capability and / or formability to a distal portion cut into the elongated body; a second coil device for imparting torsional capability and / or formability to a distal portion cut into the elongated body; and wherein the first coil device is oriented in a first direction, wherein the second coil device is oriented in a second direction, and wherein the first direction is opposite to the second direction.

[0120] Clause 2. The guidewire system of Clause 1 , wherein the first coil device comprises a first groove cut into the core wire, and wherein the second coil device comprises a second groove cut into the core wire.

[0121] Clause 3. The guidewire system of Clause 1, wherein the first coil device comprises a first wound wire, and wherein the second coil device comprises a second wound wire.

[0122] Clause 4. The guidewire system of Clause 3, wherein the first wound wire is an outer coil, and wherein the second wound wire is an inner coil.

[0123] Clause 5. The guidewire system of Clause 3 or 4, wherein the first coiled wire comprises stainless steel, and wherein the second coiled wire comprises platinum tungsten.

[0124] Clause 6. The guidewire system of any preceding clause, further comprising a radiopaque marker attached to the distal tip of the distal portion of the elongated body.

[0125] Clause 7. The guidewire system of Clause 7, wherein the radiopaque marker comprises a coiled wire.

[0126] Clause 8. The guidewire system of Clause 7, wherein the radiopaque marker comprises a marker band.

[0127] Clause 9. The guidewire system of any preceding clause, further comprising a polymer sheath encapsulating the elongated body, the first coil device, and the second coil device.

[0128] Clause 10. The guidewire system of any preceding clause, wherein a length of the first coil device and a length of the second coil device are substantially similar.

[0129] Clause 11. The guidewire system of any of the preceding clauses, wherein the first direction is clockwise, and wherein the second direction is counterclockwise.

[0130] Clause 12. The guidewire system of any preceding clause, wherein the elongate body comprises a core wire.

[0131] Clause 13. The guidewire system of any of the preceding clauses, wherein the elongated body comprises nitinol.

[0132] Clause 14. The guidewire system of any preceding clause, wherein the distal portion comprises a plurality of uniform diameter sections and a plurality of tapered diameter sections.

[0133] Clause 15. The guidewire system of any preceding clause, wherein the uniform diameter sections and tapered diameter sections are interleaved.

[0134] Clause 16. The guidewire system of any preceding clause, wherein each of the plurality of tapered diameter sections is adjacent to one of the plurality of uniform diameter sections.

[0135] Clause 17. The guidewire system of any preceding clause, wherein the wire size of the first coil device is substantially similar to the wire size of the second coil device.

[0136] Clause 18. The guidewire system of any preceding clause, wherein a length of the first coil device and a length of the second coil device are substantially similar.

[0137] Clause 19. The guidewire system of any preceding clause, wherein the pitch of the first coil device is uniform.

[0138] Clause 20. The guidewire system of any preceding clause, wherein the pitch of the second coil device is variable.

[0139] Clause 21. The guidewire system of any preceding clause, wherein a pitch of the second coil device increases towards a distal end thereof.

[0140] Clause 22. The guidewire system of any preceding clause, wherein the distal tip of the elongate body is flattened.

[0141] Clause 23. The guidewire system of any preceding clause, wherein the distal tip of the elongate body comprises a paddle.

[0142] Clause 24. The guidewire system of any preceding clause, further comprising a mandrel for pre-forming the distal tip of the elongate body.

[0143] Clause 25. The guidewire system of any preceding clause, further comprising a cap attached to the distal tip of the elongated body.

[0144] Clause 26. The guidewire system of any preceding clause, wherein the first winding means comprises stainless steel.

[0145] Clause 27. The guidewire system of any preceding clause, wherein the second winding means comprises platinum tungsten.

[0146] Clause 28. A guidewire comprising: an elongated body including a proximal portion and a distal portion, wherein the proximal portion comprises a uniform diameter, and wherein the distal portion comprises only a plurality of tapered diameter sections.

[0147] Clause 29. The guidewire of Clause 28, wherein the diameter of each of the plurality of tapered diameter sections decreases toward the distal end of the elongated body.

[0148] Although the present disclosure has been described in terms of specific embodiments and applications, it is contemplated that those skilled in the art, in light of the present teachings, may generate additional embodiments and modifications without departing from the spirit or scope of the invention. Therefore, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding and should not be construed as limiting the scope thereof.

Claims

1. A guide wire comprising: an elongated body comprising a proximal portion and a distal portion; wherein said proximal portion comprises a uniform diameter; wherein the distal portion comprises a tapered diameter; and A first groove is cut into the distal portion of the elongated body.

2. The guidewire according to claim 1, wherein The distal portion comprises no more than one-third of the length of the elongated body.

3. The guidewire according to claim 1, wherein The first groove includes a clockwise sweep cut pattern.

4. The guidewire of claim 1 further comprising a second groove cut into the distal portion of the elongated body.

5. The guide wire according to claim 4, wherein The first groove and the second groove overlap. The guide wire according to claim 4 , wherein: The first groove is cut in a first direction, wherein the second groove is cut in a second direction, and wherein the first direction is opposite to the second direction.

7. The guide wire according to claim 4, wherein The first groove comprises a clockwise swept cut pattern, and wherein the second groove comprises a counterclockwise swept cut pattern.

8. The guidewire according to claim 1, wherein The distal end of the elongated body includes a flattened distal tip.

9. The guidewire of claim 1 further comprising a wire wrapped around at least a portion of the distal portion of the elongated body.

10. The guidewire according to claim 1, wherein The first groove comprises a first winding groove.

11. A guide wire comprising: an elongated body comprising a proximal portion and a distal portion; wherein said proximal portion comprises a uniform diameter; Wherein, the distal portion includes a plurality of tapered diameter sections.

12. The guidewire according to claim 11, wherein The distal portion also includes a plurality of uniform diameter sections.

13. The guidewire according to claim 12, wherein Each of the plurality of tapered diameter sections is adjacent to a uniform diameter section of the plurality of uniform diameter sections.

14. The guidewire according to claim 11, wherein The proximal portion includes a length between at least half of the elongated body.

15. The guidewire of claim 11, further comprising a first winding wire and a second winding wire, the first winding wire and the second winding wire respectively positioned on at least a portion of the elongated body.

16. The guidewire according to claim 15, wherein The first winding wire comprises an inner winding wire, and wherein the second winding wire comprises an outer winding wire.

17. The guidewire of claim 15, further comprising a third coiled wire positioned above the distal tip of the elongated body.

18. The guidewire of claim 15, further comprising a polymer sheath encapsulating the elongated body, the first coiled wire, and the second coiled wire.

19. The guidewire according to claim 15, wherein The first winding filament is wound in a first direction, wherein the second winding filament is wound in a second direction, and wherein the first direction is opposite to the second direction.

20. A guidewire comprising: an elongated body comprising a proximal portion and a distal portion; wherein said proximal portion comprises a uniform diameter; wherein the distal portion comprises a plurality of tapered diameter regions and a plurality of uniform diameter regions; an inner coil attached to the distal portion at least partially surrounding the elongated body; and an outer coil attached to the distal portion at least partially surrounding the elongated body, wherein the outer coil is positioned above the inner coil; and wherein the inner coil is wound in a first direction, wherein the outer coil is wound in a second direction, and wherein the first direction is opposite to the second direction.

21. A guidewire comprising: an elongated body comprising a proximal portion and a distal portion; wherein said proximal portion comprises a uniform diameter; wherein the distal portion comprises a plurality of tapered diameter regions and a plurality of uniform diameter regions; an inner coil attached to the distal portion at least partially surrounding the elongated body; an outer coil attached to the distal portion at least partially surrounding the elongated body, wherein the outer coil is positioned above the inner coil; wherein the inner coil is wound in a first direction, wherein the outer coil is wound in a second direction, and wherein the first direction is opposite to the second direction; and A radiopaque extension coil is attached to the distal tip of the distal portion of the elongated body.

22. A guide wire comprising: an elongated body comprising a proximal portion and a distal portion; wherein said proximal portion comprises a uniform diameter; wherein the distal portion comprises a plurality of tapered diameter regions and a plurality of uniform diameter regions; an inner coil attached to the distal portion at least partially surrounding the elongated body; an outer coil attached to the distal portion at least partially surrounding the elongated body, wherein the outer coil is positioned above the inner coil; wherein the inner coil is wound in a first direction, wherein the outer coil is wound in a second direction, and wherein the first direction is opposite to the second direction; and A polymer sheath encapsulates the elongated body, the inner coil, and the outer coil.

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