Guidewire Systems
The guidewire system with a tapered distal section and coils/grooves enhances torque transmission and shape control, addressing navigation challenges in tortuous vasculature.
Patent Information
- Application Number
- JP2025532541
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-07
- Filing Date
- 2023-12-07
- Publication Date
- 2025-11-28
AI Technical Summary
Navigating medical guidewires through tortuous vasculature, such as the cerebral hemisphere, is challenging due to the need for high torque characteristics and shape control, particularly in distal anatomical locations.
A guidewire system with a tapered distal section, alternating uniform and tapered diameter segments, and coils or grooves along the core wire, combined with a polymer jacket, to enhance torque transmission and shape maintainability.
Improves vascular access and tracking control by efficiently transmitting torque and maintaining the guidewire's shape, facilitating navigation through complex anatomical structures.
Smart Images
Figure 2025538713000001_ABST
Abstract
Description
[Technical Field]
[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 386,422, entitled "Guidewire System," filed December 7, 2022, which is incorporated herein by reference in its entirety. [Background technology]
[0002] Navigating various medical devices through tortuous vasculature to distal anatomical locations can be extremely challenging under certain circumstances. For example, navigating a guidewire within the cerebral hemisphere may require high torque characteristics, shape control at the distal end, and / or the ability to maintain the original shape of the guidewire for further navigation within the vasculature.
[0003] For navigation in potentially challenging conditions, such as tortuous anatomy, it may be desirable for the guidewire to have a shapeable tip that aids in efficient introduction into the body while also providing torque characteristic advantages. Such an approach may rely on the location of each crossing profile of the guidewire and / or the stiffness of the core wire as factors that determine the quality of the guidewire's torque characteristics. Summary of the Invention [Problem to be solved by the invention]
[0004] Means to solve the problem Disclosed herein are exemplary embodiments of a guidewire system in which a distal section of a core wire is tapered from a larger outer diameter to a smaller outer diameter. In exemplary embodiments, the distal section may be comprised of both uniform diameter segments and tapered diameter segments. The uniform diameter segments and tapered diameter segments may be configured to alternate along the length of the distal section of the core wire.
[0005] In one embodiment, one or more coils may be connected to or disposed around at least a portion of the distal portion of the core wire. In one embodiment, the one or more coils may include an inner coil and an outer coil. In one embodiment, an additional extension coil may be connected to or disposed around the distal end of the core wire.
[0006] In one embodiment, the guidewire can have a variable transverse profile and stiffness over its distal portion, for example, over a distal length ranging from about 40 cm to 50 cm.
[0007] In one embodiment, a polymeric outer jacket may cover the inner coil, outer coil, and core wire.
[0008] In one embodiment, the inner and outer coils may have substantially similar threads.
[0009] In one embodiment, the outer coil may be constructed from platinum tungsten and the inner coil may be constructed from stainless steel.
[0010] In one embodiment, one or both of the inner and / or outer coils may have a pitch that increases distally.
[0011] In one embodiment, the inner coil can have pitch dimensions in the distal direction of approximately 0.005 inches, 0.008 inches, and 0.013 inches.
[0012] In one embodiment, the inner coil may have a distally long pitch of about 15 mm.
[0013] In one embodiment, the inner coil and the outer coil may be substantially the same length.
[0014] In one embodiment, soldering may be used on the distal and proximal portions of each coil to hold the coil in place relative to the core wire.
[0015] In one embodiment, a guidewire can advance a polymer jacket between the coil and the core wire, and thus the polymer jacket can be applied over the coil and the underlying core wire.
[0016] In one embodiment, the polymer jacket may maintain a blend ratio of about 15% to 20%.
[0017] In one embodiment, the polymeric jacket may be applied over the coil and core wire using a dip coating method.
[0018] In one embodiment, in addition to the inner and outer coils, an extension coil may be utilized.
[0019] In one embodiment, the length of the extension coil may be about 8% to 11% of the length of the outer coil or inner coil.
[0020] In one embodiment, the extension coil may be constructed of the same material as the outer coil.
[0021] In one embodiment, the extension coil may have a uniform pitch relative to the inner coil and / or outer coil.
[0022] In one embodiment, a polymeric jacket may also be applied over the extension coil.
[0023] In one embodiment, instead of using separate coils attached to the core wire, the core wire is cut with radial grooves that provide a similar function to an attached coil. The radial grooves may consist of 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.
[0024] In one embodiment, efficient torque transmission from the proximal to the distal end of the guidewire may improve vascular access and improve tracking control of the guidewire.
[0025] In one embodiment, the guidewire can have a variable transverse profile and stiffness over its distal portion, for example, the distal 40 cm to 50 cm.
[0026] In one embodiment, the distal end of the guidewire may be flattened.
[0027] In one embodiment, the guidewire may maintain a minimal annular region between its core wire and the inner coil secured thereto. [Brief explanation of the drawings]
[0028] The following drawings are set forth to illustrate certain aspects of the present disclosure and should not be considered exclusive or limiting. The disclosed subject matter is capable of considerable change, modification, combination, and equivalents in form and function, provided that one skilled in the art has the benefit of this disclosure. Please see the accompanying drawings.
[0029] [Figure 1] FIG. 1 shows a perspective view of a core wire of a guidewire system according to an exemplary embodiment of the present disclosure.
[0030] [Figure 2] FIG. 2 shows a side view of a core wire of a guidewire system according to an exemplary embodiment of the present disclosure.
[0031] [Figure 3] FIG. 3 shows a graph of a core wire cross profile according to an exemplary embodiment of the present disclosure.
[0032] [Figure 4] FIG. 4 illustrates the graph of FIG. 3 in tabular form showing taper values for the core wire of the guidewire system, according to an exemplary embodiment of the present disclosure.
[0033] [Figure 5] FIG. 5 shows a side view of a guidewire system according to an exemplary embodiment of the present disclosure.
[0034] [Figure 6] FIG. 6 shows a side view of the second (outer) coil of a guidewire system according to an exemplary embodiment of the present disclosure.
[0035] [Figure 7] FIG. 7 shows a side view of a first (inner) coil of a guidewire system according to an exemplary embodiment of the present disclosure.
[0036] [Figure 8] FIG. 8 shows a side view of a guidewire system having a coil disposed over a portion of the length of the core wire, according to an exemplary embodiment of the present disclosure.
[0037] [Figure 9] FIG. 9 shows a side view of a guidewire system including three coils, according to an exemplary embodiment of the present disclosure.
[0038] [Figure 10] FIG. 10 shows a side view of a third (extension coil) of a guidewire system according to an exemplary embodiment of the present disclosure.
[0039] [Figure 11] FIG. 11 shows a side view of a core wire of a guidewire system with a coiled groove cut therein, according to an exemplary embodiment of the present disclosure.
[0040] [Figure 12] FIG. 12 shows a side view of the distal tip of a core wire of a guidewire system, according to an exemplary embodiment of the present disclosure.
[0041] [Figure 13] FIG. 13 shows a side view of the distal tip of a core wire of a guidewire system, according to an exemplary embodiment of the present disclosure.
[0042] [Figure 14]FIG. 14 shows a cross-sectional view of a distal tip of a core wire of a guidewire system, according to an exemplary embodiment of the present disclosure.
[0043] [Figure 15] FIG. 15 illustrates a sweep cup pattern of opposing first and second coiled grooves according to an exemplary embodiment of the present disclosure.
[0044] [Figure 16] FIG. 16 shows a side view of a guidewire system having a radiopaque marker mounted on a portion of the distal portion of the corewire, according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0045] Specific embodiments of the present disclosure will now be described with reference to the accompanying drawings. The present disclosure may be embodied in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the accompanying drawings is not intended to limit the present disclosure. In the drawings, the same reference numerals refer to the same elements.
[0046] As used herein, the terms "about," "around," or "approximately" when referring to a value can be understood to mean within 5% of the stated value (which may be greater or less).
[0047] The guidewire system may comprise a core wire, an inner coil, an outer coil, and / or an extension coil.
[0048] The guidewire system may include an elongate body including a proximal portion and a distal portion. The elongate body may be comprised of a core wire. The proximal portion of the core wire may be comprised of a uniform diameter, and the distal portion of the core wire may be comprised of a generally tapered portion. Thus, the outer diameter of the core wire may decrease between the proximal end of the distal portion and the distal end of the 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 polished to form the tapered portion. The core wire may be comprised of a variety of materials. For example, the core wire may be comprised of nitinol.
[0049] The proximal portion of the core wire may form more than half of the length of the core wire, and may be longer than the distal portion. By way of example, the total length of the core wire may be about 2000 mm, the total length of the proximal portion of the core wire may be about 1600 mm, and the total length of the distal portion of the core wire may be about 400 mm.
[0050] The tapered section may consist solely of tapered diameter sections, each tapered diameter section having a diameter that decreases toward the distal end of the elongate body. Multiple tapered diameter sections having different tapers (e.g., rates of diameter decrease toward the distal end) may be used. Thus, a first tapered section may have a first taper and a second tapered section may have a second taper that is different (e.g., greater or lesser) than the first taper.
[0051] A third tapered section may also be provided, and this third tapered section may have a third taper degree that is different from the first and second taper degrees, or may have the first or second taper degree. Thus, when multiple tapered sections are used in the tapered section, two or more tapered sections may share substantially the same taper degree, and one or more tapered sections may have a different taper degree.
[0052] The tapered section itself may be comprised of a plurality of uniform diameter regions and a plurality of variable diameter regions (e.g., tapered diameter regions). The uniform diameter regions and tapered diameter regions may be tapered such that each tapered diameter region has at least one adjacent uniform diameter region, or such 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 section may be staggered.
[0053] The lengths of the uniform diameter regions and tapered diameter regions may vary over the length of the tapered section. For example, a first uniform diameter region may not be the same length as a second uniform diameter region, a first tapered diameter region may not be the same length as a second tapered diameter region, etc. The total length of the uniform diameter regions may be greater than the total length of the tapered diameter regions. For example, the total length of the uniform diameter regions in the distal section may be approximately 390 mm, and the total length of the tapered diameter regions may be approximately 10 mm.
[0054] The outer diameter of the core wire may vary along its length. For example, the outer diameter of the proximal portion of the core wire may be uniform along its length and be approximately 0.0135 inches, while the outer diameter of the distal portion may be "stepped down" along its length and may take steps such as approximately 0.008 inches, 0.0069 inches, 0.0055 inches, 0.0047 inches, and 0.0029 inches.
[0055] The distal end of the core wire may be flattened to form a paddle. The length of the paddle at the distal end of the core wire may vary. For example, the length of the paddle may be approximately 5 mm to 11 mm. The paddle can serve a variety of functions. For example, the paddle can accommodate both the inner and outer coils. The paddle can maintain a minimal annular area between the inner coil and the core wire. The paddle allows the polymer jacket to fit between the coil and the core wire.
[0056] 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 onto the core wire, and the outer coil can be attached directly onto the inner coil, with the inner coil nested within the outer coil.
[0057] The inner coil can be constructed from a variety of materials, including stainless steel. The total length of the inner coil can be approximately 250-350 mm. The coil pitch of the inner coil increases distally. For example, the proximal portion of the inner coil has a coil gap of approximately 0.0005 inches, while the midsection of the inner coil has a coil gap of approximately 0.00175 inches. The distal portion of the inner coil, e.g., the distal 15 mm length, can have coil pitches of approximately 0.0013 inches, 0.008 inches, and 0.005 inches toward the distal end of the inner coil. This configuration improves the formability of the distal end of the guidewire.
[0058] The outer coil can be constructed of various materials, including platinum-tungsten. Therefore, the material of the inner coil does not have to be the same as that of the inner coil. However, in some circumstances, the inner and outer coils may be constructed of the same material. The overall length of the outer coil may be the same as or different from that of the inner coil. For example, the overall length of the outer coil is approximately 250-350 mm. The inner coil may be slightly longer than the outer coil.
[0059] The inner and outer coils can both have substantially the same filamentary outer diameter, such as about 0.00125 inches. The coil pitch of the outer coil can be uniform along its entire length, for example, about 0.00175 inches. The coil gap of the outer coil can be uniform along its entire length, for example, about 0.0005 inches.
[0060] The inner and outer coils may be wound in opposite directions relative to one another, i.e., the inner coil may be wound in a first direction and the outer coil may be wound in a second direction, the first direction being opposite the second direction. In other words, the inner and outer coils may intersect at multiple locations along their respective lengths to form a crossing pattern along the length of the core wire to which they are secured.
[0061] To maintain the positional relationship of the outer coil and inner coil relative to each other and the core wire, the core wire, inner coil, and outer coil can be covered with a polymer jacket. Various polymers known in the art can be used. The polymer jacket can maintain a blend ratio of approximately 15% to 20%. The polymer jacket can be applied in various ways, for example, by dip coating. By covering and coating the core wire, inner coil, and outer coil with such a polymer jacket, the coils and core wire can be kept intact.
[0062] A third extension coil may also be used. The extension coil may be secured to the distal end of the core wire. The extension coil may at least partially overlap the inner and / or outer coil, or may be axially disposed relative to the inner and / or outer coil such that the proximal end of the extension coil abuts or is secured to the distal end of the inner and / or outer coil. The extension coil may be placed over the inner and / or outer coil.
[0063] The extension coil can be made of various materials. For example, the extension coil can be made of platinum-tungsten. Thus, the extension coil can be made of the same material as the outer coil. The length of the extension coil can be shorter than the inner coil and / or outer coil. For example, the length of the extension coil can be approximately 20 mm to 30 mm. Further, for example, the length of the extension coil can be approximately 6% to 12% of the length of the inner coil and / or outer coil.
[0064] The extension coil can have a uniform pitch throughout its length. However, in some circumstances, the pitch of the extension coil may vary throughout its length. The winding direction of the extension coil may vary. The extension coil may be wound in the same direction as the inner coil, in which case the extension coil is wound in the opposite direction from the outer coil. Conversely, the extension coil may be wound in the same direction as the outer coil, in which case the extension coil is wound in the opposite direction from the inner coil.
[0065] The extension coils can be secured to the distal end of the core wire so that they surround the distal end. Because the distal end of the core wire has a smaller diameter than the extension coils, an annular region can be defined between the extension coils and the distal end of the core wire. This annular region is useful for introducing a polymer jacket between each coil and the core wire to which it is secured, allowing the polymer jacket to penetrate into the coils. The extension coils can be soldered to the distal end of the core wire or secured using various methods known in the art.
[0066] The guidewire system may include an elongate body having one or more grooves therein to perform a function similar to the coils described above. The elongate body may include a core wire. The core wire may have a length and profile substantially similar to the core wires described above, or may have different dimensions than the core wires described above.
[0067] The core wire can have a proximal section and a distal section. The proximal section can have a uniform diameter, and the distal section can have a tapered diameter that decreases linearly or nonlinearly over its length. For example, starting at the distal end of the proximal section, the outer diameter of the core wire can taper from 0.035 inches, 0.021 inches, 0.018 inches, and 0.014 inches at the distal tip. The distal tip can be tapered and / or flattened to accommodate a radiopaque coil, as described below.
[0068] The proximal section can make up the majority of the length of the core wire, and the distal section can make up a smaller portion of the length of the core wire. Thus, the proximal section can be longer than the distal section. For example, the distal section can make up approximately 5% to 20% of the total length of the core wire.
[0069] The core wire can be constructed from a variety of materials, such as nitinol. The total length of the distal portion of the core wire can be approximately 300 mm to 400 mm. The distal tip of the distal portion of the core wire can be 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 be approximately 20 to 30 mm.
[0070] One or more grooves can 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 the distal tip. However, the one or more grooves may 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.
[0071] The one or more grooves may include one or more coiled grooves. The one or more coiled grooves may be continuous or discontinuous. The one or more coiled grooves may include a first coiled groove and a second coiled groove. The coiled grooves may be formed by sweep cuts into the core wire body. The first coiled groove may be wound in a first direction and the second coiled groove may be wound in a second direction, the first direction being opposite to the second direction. For example, the first coiled groove may be cut in a clockwise direction and the second coiled groove may be cut in a counterclockwise direction. The first and second coiled grooves may overlap at regular intervals or intersect to form an X-shaped pattern when intersecting.
[0072] The one or more grooves may be non-coiled or may take any non-coiled shape. For example, the one or more grooves may consist of multiple individual circular 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 located along or on the distal end.
[0073] A radiopaque marker can be secured to the distal end of the core wire. The radiopaque marker can be, for example, a coiled wire and / or a marker band. The radiopaque marker can be made of various radiopaque materials, such as platinum-tungsten. For example, the radiopaque marker can be made of platinum-tungsten wire coiled around the distal end of the core wire.
[0074] The distal end of the core wire may be provided with a cap or a blunt, rounded, or curved protrusion to prevent the distal end of the core wire from terminating in a sharp point or sharp point that could penetrate tissue. The distal end itself may be rounded or blunt, without the need for a separate cap.
[0075] The embodiments shown in the drawings and described herein can be designed to enhance torque transmission, formability, and resilience (i.e., ability to maintain original shape). These embodiments have formable tips for introduction into the human body and can provide torque transmission advantages when traversing tortuous anatomy. The transverse profile and variable stiffness profile can contribute to the torque transmission of the guidewire system.
[0076] In some embodiments, a pair of counter-wound coils may be used to apply torque in multiple directions. The distal end of the guidewire system may be pre-shaped by the surgeon to fit various anatomical structures. The guidewire system may also be provided with a forming mandrel to assist in shaping the distal end into a desired shape or curvature.
[0077] Specific embodiments are described in further detail below, but it should be understood that any feature of each embodiment can be combined in any combination, and therefore the present disclosure is not limited to only these embodiments, but also encompasses broader combinations thereof.
[0078] The figures show an example embodiment of a guidewire system suitable for traversing tortuous blood vessels to reach a distant target site, for example, the guidewire system is suitable for traversing the cerebral hemispheres.
[0079] 1 and 2 illustrate exemplary embodiments of core wire 110 of guidewire system 100 in perspective and side views, respectively. As shown in FIG. 1, core wire 110 can include a proximal section 111 including a proximal end 110A and a distal section 112 including a distal end 110B. Proximal section 111 of core wire 110 can have a uniform outer diameter. In some exemplary embodiments, distal section 112 of core wire 110 can have a generally tapered outer diameter including tapered diameter segment 113. In some exemplary embodiments, distal section 112 of core wire 110 can also include one or more uniform diameter segments 114.
[0080] The respective lengths of the proximal and distal portions 111, 112 of the core wire 110 may vary depending on the embodiment. Generally, the proximal portion 111 may comprise at least about half of the total length of the core wire 110. In some embodiments, the proximal portion 111 may comprise at least about 75% of the total length of the core wire 110. In still other embodiments, the proximal portion 111 may comprise at least about 85% of the total length of the core wire 110. Thus, the distal portion 112 of the core wire 110 may comprise about 15% to 50% of the total length of the core wire 110 in some embodiments. However, it should be noted that in certain embodiments, the distal portion 112 may comprise less than about 15% or more than about 50% of the total length of the core wire 110.
[0081] Specific dimensions are discussed herein as non-limiting examples. However, it should be understood that these dimensions are for illustrative purposes only. Therefore, the scope of the present invention should not be construed as being limited to the specific dimensions disclosed herein.
[0082] As an example, the total length of core wire 110, and therefore the total length of guidewire system 100, may be approximately 2000 mm. In some embodiments, the length of core wire 110 may be approximately 1500 mm to 2500 mm. In some embodiments, approximately 60% to 80% (e.g., 70%) of the total length of core wire 110 may be composed of a coated wire, such as a PTFE-coated wire. The remaining length of core wire 110, i.e., approximately 20% to 40% (e.g., 30%) of the length of core wire 110, may be composed of a nitinol core wire.
[0083] In the embodiment shown in FIGS. 1-2, the proximal portion 111 of core wire 110 may be defined as approximately 80% of its total length. However, in some embodiments, the proximal portion 111 may be greater than or less than 80% of the total length of core wire 110. Similarly, the distal portion 112 of core wire 110 may be defined as approximately 20% of its total length. However, in some embodiments, the distal portion 112 may be greater than or less than 20% of the total length of core wire 110. For example, in the embodiment shown in FIGS. 1-2, the proximal portion 111 may be approximately 1600 mm and the distal portion 112 may be approximately 400 mm.
[0084] 1-2, in some embodiments, distal section 112 may comprise a polished core wire, such as polished nitinol, that decreases in outer diameter (i.e., tapers) toward distal end 110B. The use of a polished core wire 110 in distal section 112 improves both torque transmission and formability, improving the navigability of core wire 110 and guidewire system 100 as a whole.
[0085] The rate and degree of taper of the distal section 112 may vary depending on the embodiment. In the embodiment shown in FIG. 2, the distal section 112 may include both a plurality of tapered diameter segments 113 and a plurality of uniform diameter segments 114. In some embodiments, the tapered diameter segments 113 may alternate with the uniform diameter segments 114, such that each tapered diameter segment 113 is adjacent to a uniform diameter segment 114, and each uniform diameter segment 114 is adjacent to a tapered diameter segment 113. In other words, the tapered diameter segments 113 and the uniform diameter segments 114 may alternate along at least a portion of the length of the distal section 112 of the core wire 110.
[0086] 2 , the lengths of the tapered diameter segment 113 and uniform diameter segment 114, respectively, may vary over the length of the distal section 112 of the core wire 110. For example, in some embodiments, the uniform diameter segment 114 may be configured in lengths of 105 mm, 40 mm, 205 mm, and 40 mm, with the remaining length of the distal section 112 being configured with the tapered diameter segment 113. Thus, in some embodiments, the uniform diameter segment 114 may comprise approximately 80%-90% of the length of the distal section 112 of the core wire 110, with the remaining 10%-20% of the length of the distal section 112 being configured with the tapered diameter segment 113. However, in some embodiments, up to approximately 100% of the length of the distal section 112 may be configured solely with the tapered diameter segment 113, excluding the uniform diameter segment 114.
[0087] As shown in FIGS. 1-2, the distal end 115 of the core wire 110 may include a flattened portion, such as a paddle 116. The length of the paddle 116 is approximately 5 mm to 11 mm in one embodiment, but may be less than 5 mm or greater than 11 mm in certain embodiments. The paddle 116 can serve several functions. For example, the paddle 116 can accommodate both the inner and outer coils (described below with respect to FIGS. 5-10). In some embodiments, the paddle 116 can maintain a minimal annular region between the inner coil and the core wire. In some embodiments, the paddle 116 can allow the polymer jacket to tuck between the coil and the core wire. Thus, in some embodiments, the flattened paddle 116 can improve vascular access by efficiently transmitting torque from the proximal to distal end of the guidewire and can further facilitate better control during guidewire tracking.
[0088] 3 is a graph illustrating an exemplary embodiment of a transverse profile of core wire 110, showing how the outer diameter of distal portion 112 of core wire 110 tapers toward distal end 110B. Note that the x-axis of the graph shown in FIG. 3 represents distance from the tip (i.e., distance from distal end 110B). As can be seen, the outer diameter of distal portion 112 of core wire 110 tapers in a gradual manner, with a uniform diameter segment 114 spanning the majority of the length of distal portion 112 of core wire 110.
[0089] 4 shows the graph of FIG. 3 in tabular form, with "position" calculated as distance (in mm) from distal end 110B of core wire 110. As can be seen, the outer diameter of distal section 112 of core wire 110 tapers from an initial outer diameter of about 0.0135 inches to a final outer diameter of about 0.0029 inches. Thus, the outer diameter of distal section 112 may decrease by about 75% to 85% from the initial outer diameter to the final outer diameter at distal end 110B.
[0090] It should be noted that the values shown and described in Figures 3-4 are for illustrative purposes only and are not intended to limit the scope of the present invention. It is anticipated that different dimensions may be used for different applications and medical procedures.
[0091] Figure 5 shows a side view of guidewire system 100. In some embodiments, one or more coils 120, 125 may be secured on core wire 110, including distal tip 115. One or more coils 120, 125 may at least partially surround core wire 110. In the embodiment shown in Figure 5, a first coil 120 and a second coil 125 are secured on core wire 110, with first coil 120 comprising an inner coil and second coil 125 comprising an outer coil 125 disposed on first coil 120.
[0092] Also, various types of coils 120, 125 can be used. In one embodiment, the first coil 120 can be constructed of a different material than the second coil 125. For example, the first coil 120 can be constructed of stainless steel and the second coil 125 can be constructed of platinum-tungsten.
[0093] FIG. 6 illustrates a side view of the second (outer) coil 125 of the guidewire system 100 according to one embodiment. FIG. 7 illustrates a side view of the first (inner) coil 120 of the guidewire system 100 according to one embodiment. In some embodiments, the lengths of the first coil 120 and the second coil 125 may be substantially the same. For example, the lengths of the first coil 120 and the second coil 125 may be approximately 250-350 mm. However, in some embodiments, the lengths of the first coil 120 and the second coil 125 may be slightly different. In one embodiment, the length of the first coil 120 (inner) may be approximately 280 mm, and the length of the second coil 125 (outer) may be approximately 175 mm. Similarly, the first coil 120 and the second coil 125 may have substantially the same thread dimensions, such as a thread outer diameter of 0.00125 inches.
[0094] 6, the second coil 125 can have a uniform pitch along its entire length. For example, the length of the second coil 125 can have a uniform pitch of about 0.00150 inches to 0.00200 inches, or about 0.00175 inches.
[0095] 7, in some embodiments, the first coil 120 may have an increasing pitch along its distal portion, such as between 100 mm and 150 mm of the distal length. Over the majority of the proximal length of the first coil 120, the coil pitch may be between about 0.00150 and 0.00200 inches (about 0.00175 inches), with a proximal coil gap of between about 0.0001 and 0.0010 inches (about 0.0005 inches). The remaining distal length of the first coil 120 may have a gradually increasing pitch, including pitches of about 0.005 inches, 0.008 inches, and 0.013 inches.
[0096] As shown in Figure 5, the coils 120, 125 may be positioned and secured along the entire length of the core wire 110, or may be positioned and secured along only a portion of the length of the core wire 110. In the exemplary embodiment shown in Figure 5, it can be seen that both coils 120, 125 are secured along the length of the core wire 110.
[0097] 8 shows a side view of guidewire system 100 in which coils 120, 125 are disposed over a portion of the length of core wire 110. In the exemplary embodiment shown in FIG. 8, it can be seen that distal end 115 of core wire 110 remains exposed and is therefore not covered by either of coils 120, 125.
[0098] The winding directions of the first coil 120 and the second coil 125 may vary depending on the embodiment. In the illustrated embodiment, the first coil 120 is wound in a first direction and the second coil 125 is wound in a second direction, which is opposite to the second direction. For example, the first coil 120 may be wound counterclockwise and the second coil 125 may be wound clockwise, or vice versa. Thus, the first coil 120 and the second coil 125 may intersect at multiple points along the length of the core wire 110.
[0099] The method of securing coils 120, 125 to core wire 110 may vary depending on the embodiment. In one embodiment, the proximal and distal portions of each of coils 120, 125 may be soldered to core wire 110 and then coated with a polymer jacket as described herein.
[0100] FIG. 9 shows a side view of a guidewire system 100 including three coils. In the embodiment shown in FIG. 9, in addition to the first coil 120 and the second coil 125, a third coil 130 may be secured to the distal end 115 of the core wire 110. The third coil 130 may function as an extension coil axially positioned 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. Generally, the length of the third coil 130 is substantially shorter than the lengths of 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 approximately 20 mm to 30 mm.
[0101] FIG. 10 shows a side view of an exemplary embodiment of the third (extension) coil 130. In some embodiments, the third coil 130 may be constructed of the same material as the second coil 125, e.g., platinum-tungsten. However, in some embodiments, the third coil 130 may be the same material as the first coil 120, or may be a different material from the first and second coils 120, 125. The third coil 130 may have the same pitch as the first coil 120 and / or the second coil 120, 125, or may have a different pitch from the first coil 120 and / or the second coil 120, 125. The third coil 130 may have a uniform pitch throughout its length, as shown in FIG. 10, or may have a variable pitch.
[0102] As previously mentioned, at least a portion of the core wire 110, including one or more coils 120, 125, 130, may be coated within a polymer jacket. The polymer jacket may, for example, help hold the core wire 110 and the coils 120, 125, 130 together. The method of applying the polymer jacket may vary depending on the embodiment. In one embodiment, the polymer jacket may be applied by dip coating and / or the use of shrink tubing. The small diameter of the distal end 115 of the core wire 110 facilitates the threading of the polymer jacket between the coils 120, 125, 130. A variety of materials may be used for the polymer jacket, including, but not limited to, polyurethane.
[0103] 11-15 illustrate an exemplary embodiment of guidewire system 100 in which core wire 150 has one or more grooves 155A, 155B cut into it, which may function to enhance torque transmission and formability, similar to the individual coils 120, 125, 130 of the previous exemplary embodiments. Thus, the exemplary embodiment illustrated in FIGS. 11-15 illustrates core wire 110 in which the coils cut into core wire 110 are integral rather than separate.
[0104] One or more of the grooves 155A, 155B may be comprised of coiled or non-coiled grooves. In one embodiment, one or more of the grooves 155A, 155B may be comprised of non-coiled shapes, such as independent circular or ring-shaped grooves that are spatially separated along all or part of the length of the core wire 110. One or more of the grooves 155A, 155B may be continuous or discontinuous.
[0105] Figure 11 shows a side view of one embodiment of core wire 150 of guidewire system 100, with coiled grooves 155A, 155B cut into core wire 150. As shown in Figure 11, core wire 150 can include a proximal portion 151 and a distal portion 152 including a distal tip 153. Proximal portion 151 can make up the majority of the overall length of core wire 150.
[0106] In one embodiment, the length of the proximal portion 151 of the core wire 150 may be defined as approximately 80% of its total length. However, in some embodiments, the length of the proximal portion 151 may be greater 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 may be defined as approximately 20% of its total length. However, in some embodiments, the length of the distal portion 152 may be greater than or less than 20% of the total length of the core wire 150.
[0107] By way of example, the length of distal portion 152 of core wire 150 can be approximately 340 mm to 400 mm. Distal tip 153 of distal portion 152 of core wire 150 can account for approximately 5% to 10% of the total length of distal portion 152. In one embodiment, the length of distal tip 153 can be approximately 20 mm to 30 mm of the total length of distal portion 152.
[0108] As shown in the figures, the distal section 152 of the core wire 150 may be tapered to a smaller diameter distally. For example, the outer diameter of the distal section 152 of the core wire 150 may be reduced from about 0.035 inches to about 0.014 inches. To prevent the distal tip 153 from penetrating tissue and terminating at a tip that could cause injury or complications, a cap 154 may be attached to the distal tip 153 of the core wire 150, as shown in FIGS. 12-13. Alternatively, the distal tip 153 itself may be blunt without a separate cap 154.
[0109] 12-14 show views (side and cross-sectional views) of distal end 153 of core wire 150 of guidewire system 100, with one or more coil grooves 155A, 155B cut into core wire 150. In one embodiment, one or more coil grooves 155A, 155B are cut into at least a portion of distal section 152 of core wire 150. In the embodiment shown in FIGS. 12-13, coil grooves 155A, 155B do not extend all the way to distal end 153 of distal section 152, although in some embodiments, coil grooves 155A, 155B may extend all the way to distal end 153.
[0110] Figures 12-14 illustrate that a radiopaque marker 160, such as a coiled wire composed at least in part of a radiopaque material, can be positioned along all or part of the length of the distal portion 153. Figures 12-13 illustrate an embodiment in which the radiopaque marker 160 can be wrapped more tightly around at least a portion of the distal portion 153. Figure 14 illustrates an embodiment in which the radiopaque marker 160 can be wrapped more loosely around at least a portion of the distal portion 153.
[0111] In one embodiment, the first coil groove 155A may be cut into the core wire 150 in a first direction and the second coil groove 155B may be cut into the core wire 150 in a second direction, where the first direction is opposite to the second direction. For example, the first coil groove 155A may be cut in a clockwise direction and the second coil groove 155B may be cut in a counterclockwise direction, or vice versa. In this manner, the first coil groove 155A and the second coil groove 155B intersect at a particular point to form an X-shaped pattern.
[0112] 15 illustrates an exemplary embodiment of a sweep cut pattern of opposing first and second coil grooves 155A, 155B. The method of forming the coil grooves 155A, 155B in the core wire 150 may vary depending on the embodiment. For example, the coil grooves 155A, 155B may be formed by making opposing sweep cuts in the body of the core wire 150 to form the grooves. The transverse profile of the core wire can be achieved by varying the depth of the sweep cuts across the distal portion 152 of the core wire 150 to meet desired guidewire performance requirements.
[0113] FIG. 16 shows a side view of a guidewire system having a radiopaque marker 160 attached to a portion of the distal portion of core wire 150. In embodiments such as those shown in FIGS. 11-14 and 16, a separate radiopaque marker 160 may be secured to at least a portion of the distal portion 152 of core wire 150. It will be appreciated that in the embodiment shown in FIGS. 11-14 and 16, radiopaque marker 160 may comprise a wire wrapped around distal tip 153 of core wire 150. However, in other embodiments, radiopaque marker 160 may comprise a marker band or the like. Radiopaque marker 160 may be comprised of various radiopaque materials, such as, but not limited to, platinum-tungsten.
[0114] In use, the improved formability and torqueability of the various embodiments of guidewire system 100 shown and / or described herein facilitates navigation through tortuous vasculature and into distal anatomy. The tip of the corewire may be pre-shaped by the physician prior to use to conform to the planned path to the target site. In some embodiments, guidewire system 100 may be provided with a separate mandrel to facilitate pre-shaping the tip of the corewire prior to use.
[0115] [Provisions]
[0116] Exemplary embodiments are described in the following numbered clauses.
[0117] Clause 1. An elongate body including a proximal portion having a uniform diameter and a distal portion having a tapered diameter; a first coil means cut into the distal portion of the elongate body for providing torqueability and / or formability; a second coil means for providing torqueability and / or formability cut into the distal portion of the elongate body, A guidewire system, wherein the first coil means is oriented in a first direction and the second coil means is oriented in a second direction, the first direction being opposite the second direction.
[0118] Clause 2. The guidewire system of clause 1, wherein said first coil means comprises a first groove cut into said core wire and said second coil means comprises a second groove cut into said core wire.
[0119] Clause 3. The guidewire system of clause 1, wherein said first coil means comprises a first coiled wire and said second coil means comprises a second coiled wire.
[0120] Clause 4. The guidewire system of clause 3, wherein the first coiled wire is an outer coil and the second coiled wire is an inner coil.
[0121] Clause 5. The guidewire system of clause 3 or 4, wherein the first coiled wire is constructed from stainless steel and the second coiled wire is constructed from platinum-tungsten.
[0122] Clause 6. The guidewire system of any preceding clause, further comprising a radiopaque marker secured to the distal tip of the distal portion of the elongate body.
[0123] Clause 7. The guidewire system of clause 7, wherein the radiopaque marker comprises a coiled wire.
[0124] Clause 8. The guidewire system of clause 7, wherein the radiopaque marker comprises a marker band.
[0125] Clause 9. The guidewire system of any preceding clause, further comprising a polymeric jacket covering said elongate body, said first coil means and said second coil means.
[0126] Clause 10. A guidewire system according to any preceding clause, wherein the length of said first coil means is substantially similar to the length of said second coil means.
[0127] Clause 11. A guidewire system according to any preceding clause, wherein the first direction is clockwise and the second direction is counterclockwise.
[0128] Clause 12. The guidewire system of any preceding clause, wherein the elongate body comprises a core wire.
[0129] Clause 13. The guidewire system of any preceding clause, wherein the elongate body is constructed of nitinol.
[0130] Clause 14. The guidewire system of any preceding clause, wherein the distal section is comprised of a plurality of uniform diameter segments and a plurality of tapered diameter segments.
[0131] Clause 15. The guidewire system of any preceding clause, wherein the uniform diameter segments and the tapered diameter segments are staggered.
[0132] Clause 16. The guidewire system of any preceding clause, wherein each of the plurality of tapered diameter segments is adjacent to one of the plurality of uniform diameter segments.
[0133] Clause 17. A guidewire system according to any preceding clause, wherein the thread dimension of said first coil means is substantially the same as the thread dimension of said second coil means.
[0134] Clause 18. A guidewire system according to any preceding clause, wherein the length of the first coil means is substantially the same as the length of the second coil means.
[0135] Clause 19. A guidewire system according to any preceding clause, wherein the pitch of the first coil means is uniform.
[0136] Clause 20. A guidewire system according to any preceding clause, wherein the pitch of the second coil means is variable.
[0137] Clause 21. A guidewire system according to any preceding clause, wherein the pitch of the second coil means increases towards its distal end.
[0138] Clause 22. The guidewire system of any preceding clause, wherein the distal end of the elongate body is flattened.
[0139] Clause 23. The guidewire system of any preceding clause, wherein the distal end of the elongate body comprises a paddle.
[0140] Clause 24. The guidewire system of any preceding clause, including a mandrel for pre-shaping the distal end of the elongate body.
[0141] Clause 25. The guidewire system of any preceding clause, further comprising a cap secured to the distal end of the elongate body.
[0142] Clause 26. A guidewire system according to any preceding clause, wherein the first coiled means is constructed of stainless steel.
[0143] Clause 27. A guidewire system according to any preceding clause, wherein the second coiled means is constructed of platinum tungsten.
[0144] Clause 28. A guidewire having an elongate body including a proximal portion having a uniform diameter and a distal portion comprised solely of a plurality of tapered diameter segments.
[0145] Clause 29. The guidewire of Clause 28, wherein each of the plurality of tapered diameter segments decreases in diameter toward the distal end of the elongate body.
[0146] While the present disclosure has been described with respect to particular embodiments and applications, those skilled in the art may, in light of the present disclosure, devise further embodiments and modifications without departing from the spirit or scope of the claims. It is therefore to be understood that the drawings and descriptions herein are presented by way of example to facilitate understanding of the invention and should not be construed as limiting the scope of the invention.
Claims
1. an elongate body including a proximal portion having a uniform diameter and a distal portion having a tapered diameter; a first groove cut into the distal portion of the elongate body.
2. The guidewire of claim 1 , wherein the distal section comprises no more than one-third of the length of the elongate body.
3. The guidewire of claim 1 , wherein the first groove comprises a clockwise sweep cut pattern.
4. The guidewire of claim 1 further comprising a second groove cut into the distal portion of the elongate body.
5. The guidewire of claim 4 , wherein the first groove and the second groove overlap.
6. The guidewire of claim 4 , wherein the first groove is cut in a first direction and the second groove is cut in a second direction, the first direction being opposite the second direction.
7. The guidewire of claim 4 , wherein the first groove is configured with a clockwise sweep cut pattern and the second groove is configured with a counterclockwise sweep cut pattern.
8. The guidewire of claim 1 , wherein the distal end of the elongate 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 elongate body.
10. The guidewire of claim 1 , wherein the first groove comprises a first coiled groove.
11. A guidewire having an elongate body including a proximal portion having a uniform diameter and a distal portion made up of a plurality of tapered diameter segments.
12. The guidewire of claim 11 , wherein the distal section is further comprised of a plurality of uniform diameter segments.
13. The guidewire of claim 12 , wherein each of the plurality of tapered diameter segments is adjacent to one of the plurality of uniform diameter segments.
14. The guidewire of claim 11 , wherein the proximal section comprises at least half the length of the elongate body.
15. 12. The guidewire of claim 11, further comprising a first coiled wire and a second coiled wire, each of the first and second coiled wires disposed over at least a portion of the elongate body.
16. 16. The guidewire of claim 15, wherein the first coiled wire comprises an inner coiled wire and the second coiled wire comprises an outer coiled wire.
17. The guidewire of claim 15 further comprising a third coiled wire disposed on the distal end of the elongate body.
18. 16. The guidewire of claim 15, further comprising a polymeric jacket covering the elongate body, the first coiled wire, and the second coiled wire.
19. 16. The guidewire of claim 15, wherein the first coiled wire is wound in a first direction and the second coiled wire is wound in a second direction, the first direction being opposite the second direction.
20. an elongate body including a proximal portion having a uniform diameter and a distal portion configured with a plurality of tapered diameter regions and a plurality of uniform diameter regions; an inner coil secured to at least partially surround the distal portion of the elongate body; an outer coil disposed over the inner coil and secured to at least partially surround the distal portion of the elongate body, A guidewire, wherein the inner coil is wound in a first direction and the outer coil is wound in a second direction, the first direction being opposite to the second direction.
21. an elongate body including a proximal portion having a uniform diameter and a distal portion configured with a plurality of tapered diameter regions and a plurality of uniform diameter regions; an inner coil secured to at least partially surround the distal portion of the elongate body; an outer coil disposed over the inner coil and secured to at least partially surround the distal portion of the elongate body; a radiopaque extension coil attached to a distal tip of the distal section of the elongate body, A guidewire, wherein the inner coil is wound in a first direction and the outer coil is wound in a second direction, the first direction being opposite to the second direction.
22. an elongate body including a proximal portion having a uniform diameter and a distal portion configured with a plurality of tapered diameter regions and a plurality of uniform diameter regions; an inner coil secured to at least partially surround the distal portion of the elongate body; an outer coil disposed over the inner coil and secured to at least partially surround the distal portion of the elongate body; a polymer jacket covering the elongate body, the inner coil, and the outer coil, A guidewire, wherein the inner coil is wound in a first direction and the outer coil is wound in a second direction, the first direction being opposite to the second direction.