Vascular access guidewire tip including crank

Abstract

A vascular access guidewire is disclosed. The vascular access guidewire includes an elongate core member and a distal tip. The distal tip includes a crank configured with a crank distal surface and a crank center of rotation. The crank is configured to rotate about a crank center of rotation when the core member is sufficiently axially loaded and when the crank distal surface is pressed against the target vessel wall to trigger or affect deflection and / or deformation of the core member proximal to the crank.

Description

Technical Field

[0001] The present disclosure, in some embodiments thereof, relates to devices and methods for accessing a blood vessel, and more particularly, but not exclusively, to a vascular access guidewire and / or a vascular access kit. Background Art

[0002] The Seldinger technique is currently the preferred method of accessing a vessel, in which a needle is inserted into the vessel, and once the needle tip is confirmed to be within the vessel, a vascular access guidewire is inserted through the needle and moved to the desired location in the vessel, the needle is then removed and a catheter is placed over the vascular access guidewire in the designated area.

[0003] Accidental perforation or incision of a vessel is not an uncommon occurrence when using the Seldinger technique. If the needle tip is positioned near the centerline of the vessel and at an acute angle thereto, the vascular access guidewire should exit the needle tip without causing the aforementioned unwanted perforation. However, in many cases, although the operator may obtain blood flashback through the inserted needle, which is considered a positive indication of proper needle placement, the needle tip is too close to the opposing vessel wall and even partially penetrates the vessel wall. However, as the vascular access guidewire is pushed through the needle into the vessel, the tip of the vascular access guidewire may perforate the vessel wall and / or incise the vessel wall layers, particularly since the vascular access guidewire is designed to have sufficient pushing force to allow it to be advanced through the needle and vessel.

[0004] The problem of accidental penetration (e.g., perforation and / or incision) of the vessel wall when creating access to the vessel is particularly evident in veins, where the wall is thin and flexible, so the operator may not feel any resistance from the needle and continue to advance the vascular access guidewire out of the vein through the accidentally created penetration opening. On the other hand, in arteries, it is more common for blood to flow back and prevent the guidewire from being advanced. In this case, the guidewire tip may be pushed directly against the vessel wall, even if it does not penetrate the vessel wall, causing incision and / or irritation, which may lead to vasospasm, which is often associated with access complications, especially vessel occlusion.

[0005] It should be noted that this background is not intended to help determine the scope of the claimed subject matter, nor should it be considered to limit the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above. The discussion of any technology, document, or reference in this background section should not be interpreted as an admission that the material is prior art to any subject matter claimed herein. Summary of the invention

[0006] The present disclosure, in some embodiments thereof, relates to devices and methods for accessing a blood vessel, and more particularly, but not exclusively, to a vascular access guidewire and / or a vascular access kit configured to prevent unintended damage to the vessel wall when establishing access to the vessel.

[0007] In certain embodiments, a vascular access guidewire is provided, comprising an elongated core member and a distal end, the distal end comprising a crank, the crank being configured to have a crank distal surface and a crank rotation center. In some embodiments, the crank is configured to rotate about the crank rotation center when the core member is sufficiently axially loaded and when the crank distal surface is pressed against the wall of the target vessel to trigger or affect deflection and / or deformation of the core member proximal to the crank.

[0008] In some embodiments, deflection and / or deformation includes flexion, bending, and / or rotation.

[0009] In some embodiments, the crank distal surface is curved, and the crank rotation center coincides with or is adjacent to the center of curvature of the crank distal surface. In some embodiments, the crank radius of curvature of the crank distal surface is in the range of 0.1 mm to 0.5 mm, optionally particularly about 0.25 mm.

[0010] In some embodiments, the core member includes a hinge or is merged with the distal end by a hinge, and the hinge is configured to facilitate and / or allow the crank to be articulated around it, so as to convert the axial motion of the core member into the rotational motion of the crank and / or convert the rotational motion of the crank into the axial motion of the core member. In some embodiments, the distance between the hinge and the center of rotation of the crank is less than the diameter of the blood vessel. In some embodiments, the distance between the hinge and the center of rotation of the crank is equal to or less than about 2 millimeters, or optionally particularly equal to or less than about 1 millimeter. In some embodiments, the hinge is configured as a flexure of the core member and includes a bending length, and the core member is fixedly deviated laterally along the bending length relative to the straight alignment portion of the core member proximally and distally adjacent to the bending length. In some embodiments, the length of the flexure is about 0.5 millimeters or less.

[0011] In some embodiments, the vascular access guidewire is configured so that when the core member is axially loaded with a first axial force less than a predetermined compressive force, the crank is prevented from rotating about the crank rotation center, and / or so that when the core member is axially loaded with a second axial force greater than the predetermined compressive force, the crank is forced to rotate about the crank rotation center. In some embodiments, the predetermined compressive force is in the range of 0.1N to 2N, optionally in particular in the range of 0.2N to 0.8N.

[0012] In certain embodiments, the vascular access guide wire also includes a cylindrical coil member extending longitudinally around the length of the core member. In certain embodiments, the distal end is fixedly connected to the distal end of the core member and the distal end of the coil member. In certain embodiments, the distal end is formed by welding and / or fusing the part of the core member and the coil member together. In certain embodiments, the distal end includes most or all of the heat affected zones produced by welding and / or fusion.

[0013] In some embodiments, the distal tip comprises a spherical dome-shaped portion having an apex pointing distally.

[0014] In some embodiments, the core member includes an elongated section extending between the proximal widening section and the distal widening section so that deflection and / or deformation are prone to occur in the elongated section. In some embodiments, the elongated section includes a hinge or merges with the distal widening section through a hinge, and the hinge is configured to facilitate and / or allow the crank to be hinged around it to convert between the rotational motion of the crank and the linear motion of the core member. In some embodiments, the distal widening section merges with the distal end at the distal merging portion. In some embodiments, the volume ratio between the total volume of the distal end and the total volume of the distal widening section is greater than 1.3. In some embodiments, the total volume of the distal end is in the range of 0.2 cubic millimeters to 0.5 cubic millimeters, and / or the total volume of the distal widening section is in the range of 0.005 cubic millimeters to 0.03 cubic millimeters. In some embodiments, the length ratio between the total length of the distal end and the total length of the distal widening section is in the range of 1 to 2. In some embodiments, the total length of the distal end is about 0.35 mm or less, and / or the total length of the distal widened section is about 0.75 mm or less. In some embodiments, the elongated section and / or the distal widened section are elongated and have a circular, oval or rectangular cross-section. In some embodiments, the coiled member is configured such that the coil pitch along the elongated section is greater than the coil pitch along the distal widened section.

[0015] In certain embodiments, a vascular access kit is provided, comprising a vascular access guidewire and a needle having a bevel opening. In certain embodiments, when the distal end of the vascular access guidewire is juxtaposed with the distal end of the needle, the hinge is positioned along the bevel opening.

[0016] In certain embodiments, a method for forming a vascular access using a vascular access kit is provided. The method may include: penetrating a blood vessel with a bevel opening; pushing the distal end of a vascular access guidewire against the blood vessel wall through the bevel opening until a rotational movement of the crank around the crank's center of rotation is generated, the rotational movement being sufficient to trigger and / or affect a deflection and / or deformation of a core member proximal to the crank, and / or sufficient to trigger or affect articulation of the crank around a hinge. In some embodiments, the method also includes advancing the vascular access guidewire distally in the blood vessel and allowing the core member to flex backward and / or realign with the distal end.

[0017] In certain embodiments, a method for producing a vascular access guidewire is provided. The method may include connecting the distal end of a core member and the distal end of a coil member, and forming a hinge. In certain embodiments, the formation includes fixedly changing the straight alignment length of the core member, or the formation is caused by fixedly changing the straight alignment length of the core member. In certain embodiments, the formation includes fixedly deforming a part of the core member into a bending length, or the formation is caused by fixedly deforming a part of the core member into a bending length.

[0018] In some embodiments, the forming includes pushing the core member along a selected push axis against a surface perpendicular to the push axis. In some embodiments, pushing is performed while allowing a selected unsupported length of the core member to flex or bend transversely to the push axis and preventing a supported length of the core member proximal to the unsupported length from flexing or bending transversely to the push axis. In some embodiments, a portion of the distal tip is prevented from moving transversely to the push axis and / or a portion of the distal tip is supported in a groove surrounded by a surface.

[0019] In some embodiments, the method also includes shaping the distal end. In some embodiments, the forming is performed after connecting and / or shaping. In some embodiments, the connection includes or causes shaping. In some embodiments, the distal end is shaped to form a crank, which includes a spherical dome-shaped portion with a vertex pointing distally. In some embodiments, shaping includes shaping the preformed end to the distal end. In some embodiments, the connection includes welding and / or fusing the pre-fused portion of the core member and the pre-fused portion of the coil member together. In some embodiments, the pre-fused portion is configured to form a weld pool to facilitate welding and / or fusion. In some embodiments, the distal end is configured to withstand most or all of the heat-affected zones produced by welding and / or fusion, so that the core member adjacent to the hinge is not affected by welding and / or fusion in structure and / or function.

[0020] All technical and / or scientific words, terms and / or phrases used herein have the same or similar meaning as commonly understood by those of ordinary skill in the art to which the present disclosure belongs, unless otherwise expressly defined or indicated herein. In the event of a conflict, the patent specification (including definitions) shall prevail.

[0021] It should be understood that those skilled in the art will clearly understand various configurations of the subject technology from this disclosure, wherein various configurations of the subject technology are shown and described by way of example. As will be appreciated, the subject technology can adopt other different configurations, and its several details can be modified in various other aspects, all of which will not depart from the scope of the subject technology. Therefore, the overview, drawings and detailed description should be regarded as illustrative in nature, rather than restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Some embodiments of the present disclosure are described herein with reference to the accompanying drawings only by way of example. With specific and detailed reference now to the accompanying drawings, it is emphasized that the details shown are by way of example and are used to illustratively describe some embodiments of the present disclosure. In this regard, the description in conjunction with the accompanying drawings makes it clear to those skilled in the art how some embodiments of the present disclosure can be practiced.

[0023] Figure 1A-1B schematically illustrates side cross-sectional views of an exemplary vascular access guidewire including a crank before and after the crank is forced to perform a rotational motion, respectively, according to some embodiments;

[0024] Figure 2A-2B A side view and a cross-sectional side view of a front length of an exemplary vascular access guidewire according to some embodiments are respectively shown;

[0025] Figure 3A An exemplary intravenous access kit is shown according to some embodiments, including an exemplary needle and Figure 2A The vascular access guidewire shown in ;

[0026] Figure 3B According to some embodiments Figure 3A A cross-sectional partial side view of an IV set in an exemplary deployment is shown in;

[0027] Figure 3C Schematically illustrates a method for expressing the use of Figure 3A A view of possible scenarios in the performance of a method of forming intravenous access in a kit;

[0028] Figures 4A-4C 10 and 11 respectively illustrate side views of distal portions of exemplary vascular access guidewire core members having different exemplary flexure configurations according to some embodiments;

[0029] Figures 5A-5C A side cross-sectional view, a side cross-sectional view, and a side view, respectively, of a distal portion of an exemplary vascular access guidewire according to some embodiments, before welding and forming its distal tip, a side cross-sectional view, and a side view of the distal portion after welding and forming the distal tip;

[0030] Figure 6 illustrates a side cross-sectional view of an exemplary fixation device configured to form a hinge in a core member of an exemplary vascular access guidewire, according to some embodiments; and

[0031] Figures 7A-7C Shown are sequential frames visualizing a distal portion of an exemplary vascular access guidewire during an exemplary process of forming a hinge, in accordance with some embodiments. DETAILED DESCRIPTION

[0032] The following description and examples describe in detail some exemplary implementations, embodiments and arrangements of the disclosed invention. Those skilled in the art will recognize that the present invention has many variations and modifications, which are all included within its scope. Therefore, the description of a certain exemplary embodiment should not be considered as limiting the scope of the present invention.

[0033] The present disclosure, in some embodiments thereof, relates to devices and methods for accessing a blood vessel, and more particularly, but not exclusively, to vascular access guidewires and / or vascular access kits that are configured to prevent accidental injury (e.g., puncture) to a vessel wall when forming a path into a vessel. The term "vascular access wire" (or "guidewire") refers to any thin member that is configured to facilitate delivery of an article along a selected path in a body vessel to a target location, such as by delivering a sheath, cannula, catheter, or any other device through the vascular access guidewire into a cavity or vessel. In some embodiments, the term vascular access guidewire includes a vascular access guidewire used in the process of forming a vascular access, for example, optionally prior to inserting another vascular access guidewire that is intended to guide the article along a path to a deeper portion of the patient's vascular system.

[0034] Figure 1A-1B The side cross-sectional view of the exemplary vascular access guide wire 10 including the crank 11 before and after forcing the crank to rotate is schematically shown respectively. As used herein, the term "crank" refers to a part of a mechanism, member or vascular access guide wire that is configured to and / or can rotate when pushed against a surface. When extending from an axial member or being connected to an axial member by a sufficiently flexible portion or joint (e.g., a hinge), the linear motion of the axial member can be converted into the rotational motion of the crank and / or the rotational motion of the crank can be converted into the linear motion of the axial member.

[0035] The vascular access guidewire 10 includes an elongated core member 12, a cylindrical coil member 13, and the coil member 13 extends longitudinally around the length of the core member 12. The distal end 14 extends distally from the core member 12 and can be regarded as the distal portion of the core member 12 or connected, combined or merged to the distal portion of the core member. The distal end 14 includes a crank 11, which is configured with a crank distal surface 15 and a crank rotation center 16. The crank distal surface 15 can be curved, as shown in the figure, and the crank rotation center 16 can coincide with or be adjacent to the center of curvature of the crank distal surface 15. The crank 11 is configured to rotate around the crank rotation center 16 when the core member 12 is axially loaded (e.g., by pushing against the resistance surface) and when the crank distal surface 15 is pressed against the wall W of the target blood vessel BV, enough to trigger or affect the deflection and / or deformation (e.g., flexion, bending and / or rotation) of the core member 12 proximal to the crank 11. In some embodiments, crank distal surface 15 has a crank radius of curvature in the range of 0.1 mm to 0.5 mm, optionally and particularly about 0.25 mm.

[0036] The core member 12 includes a hinge 17, or is combined with the distal end 14 by a hinge 17, and the hinge 17 is configured to facilitate and / or allow the crank 11 to be hinged around it to convert the linear motion of the core member into the rotational motion of the crank and / or convert the rotational motion of the crank into the linear motion of the core member. The distance between the hinge 17 and the crank rotation center 16 is less than the diameter of the blood vessel BV, thereby allowing the core member 12 to deflect or deform due to the rotation of the crank 11. In some embodiments, the distance between the hinge 17 and the crank rotation center 16 is equal to or less than about 5 mm or less than about 2 mm, or can be optionally equal to or less than about 1 mm to form a passage in a relatively small blood vessel (e.g., a small peripheral vein). The hinge 17 can be configured as a flexure of the core member 12, and in some such embodiments, it can include a bending length, and the core member 12 is fixedly deviated laterally along the bending length relative to the straight alignment portion of the proximal and distal adjacent bending lengths. In some such embodiments, the length of the flexure is about 0.5 mm or less.

[0037] The vascular access guidewire 10 is configured such that when the core member 12 is axially loaded with a first axial force less than a predetermined compressive force, the crank 11 is prevented from rotating about the crank rotation center 16, and / or such that when the core member 12 is axially loaded with a second axial force greater than the predetermined compressive force, the crank 11 is forced to rotate about the crank rotation center 16. For example, this can be achieved, for example, by considering mechanical, static and dynamic design aspects, such as resistance to bending of the core member 12, resistance to rotation of the hinge 17, the moment of inertia and / or radius of curvature of the hinge 17, and / or the distance between the hinge 17 and the crank rotation center 16. In some such embodiments, the predetermined compressive force is optionally taken in the range of 10 gr to 200 gr, and is optionally particularly taken in the range of 20 gr to 80 gr. In some embodiments, the predetermined compressive force can be predetermined (e.g., preset) according to the mechanical and physiological characteristics of the blood vessel BV, and the predetermined compressive force can be limited, for example, to prevent damage or penetration of the vessel wall W.

[0038] In some embodiments, the distal end 14 is fixedly connected to the distal end of the core member 12 and the distal end of the coil member 13. The distal end 14 is optionally formed by welding and / or fusing together a portion of the core member 12 and a portion of the coil member 13. In some such embodiments, the distal end 14 includes most or all of the heat-affected zone produced by welding and / or fusing. The distal end 14 may include a spherical dome-shaped portion with a distal vertex that can be formed using a selected forming process, or formed as a direct result of the welding and / or fusing technology or instrument used.

[0039] The core member 12 may include an elongated section 18 extending between a proximal widening section 19 and a distal widening section 20, such that any deflection and / or deformation is likely to occur in the elongated section 18. The elongated section 18 may include a hinge 17, or may be merged with the distal widening section 20 by a hinge 17. The volume ratio between the total volume of the distal tip 14 and the total volume of the distal widening section 20 is optionally greater than 1, optionally greater than 1.3, or optionally greater than 1.5. The total volume of the distal tip 14 is optionally in the range of 0.1 cubic millimeters to 1 cubic millimeter, optionally in particular in the range of 0.2 cubic millimeters to 0.5 cubic millimeters. The total volume of the distal widening section 20 is optionally in the range of 0.001 cubic millimeters to 0.1 cubic millimeters, optionally in particular in the range of 0.005 cubic millimeters to 0.03 cubic millimeters. The length ratio between the total length of the distal tip 14 and the total length of the distal widening section 20 is optionally in the range of 0.5 to 5, optionally in particular in the range of 1 to 2. The total length of the distal tip 14 is optionally about 1 mm or less, optionally about 0.5 mm or less, or optionally in particular about 0.35 mm or less. The total length of the distal widening section 20 is optionally about 1 mm or less, or optionally in particular about 0.75 mm or less. The elongated section 18, the proximal widening section 19 and / or the distal widening section 20 are optionally elongated and have a circular, oval or rectangular cross-section. The coiled member 13 is optionally configured such that the coil pitch along the elongated section 18 is greater than the coil pitch along other portions of the core member 12 (e.g., in particular along the distal widening section 20).

[0040] Figure 1A A situation is shown in which the vascular access guidewire 10 has penetrated into the blood vessel BV with its distal portion and before reaching the wall W with the crank 11 . Figure 1B A second situation is shown, in which the guidewire 10 is pushed against the vessel wall W as the crank 11 presses against the vessel wall W. As shown, after initial contact and applying sufficient axial force to the guidewire 10, the crank 11 has rotated to one side (counterclockwise in this example) around the center of rotation 16, thereby triggering or affecting the bending or flexing of the core member 12 around the hinge 17. As the guidewire 10 is continuously pushed distally toward the vessel wall W, this rotational movement of the crank 11 and the flexing of the hinge 17 can cause the deflection and / or deformation of the elongated segment 18 proximal to the hinge 17 and / or adjacent to the hinge 17. In some embodiments, the flexure of 17 and / or the deformation of the elongated segment 18 are elastic and fully or substantially recoverable, so that once stress is no longer applied thereto, the core member 12 can be substantially in a straight line.

[0041] Figure 2A-2BA side view of a vascular access guide wire 101 and a cross-sectional side view of its front length are shown respectively. The vascular access guide wire 101 is optionally at least partially similar or identical to the vascular access guide wire 10, optionally as its exemplary configuration. The vascular access guide wire 101 includes an elastic core member 103, which is optionally made of elastic or superelastic material (e.g., made of Ni-Ti alloy), which extends along most or all of the length of the vascular access guide wire. The vascular access guide wire 101 also includes a coil member 104 covering the core member 103 along its partial length. The core member 103 includes three major continuous segments that can be distinguished by functional, structural and / or dimensional characteristics: (1) a vascular access guidewire proximal segment 105 that extends distally from a proximal end 106 of the vascular access guidewire 101 to a first narrowed segment 107 of the core member 103, (2) a vascular access guidewire middle segment 108 that extends distally from the first narrowed segment 107 to a proximal widened segment 109 of the core member 103, and (3) a vascular access guidewire terminal segment 110 that extends distally from the proximal widened segment 109 to a distal end 111 of the vascular access guidewire 101.

[0042] Similar to other access vascular access guidewires configured for forming an intravenous access (e.g., for inserting a sheath or a line), for example, the total length of the vascular access guidewire 101 can be on the order of 500 mm, optionally about 450 mm. The vascular access guidewire proximal segment 105 can be about 80% or more of the total length of the vascular access guidewire 101, optionally about 375 mm, and is shown to have a substantially constant diameter (optionally about 0.45 mm) and / or the core member 103 is not covered by the coil member 104 along most or all of its length. The vascular access guidewire intermediate segment 108 can be on the order of 10% or 15% of the total length of the vascular access guidewire 101, for example, optionally about 45 mm. The vascular access guidewire intermediate segment 108 can be optionally formed in a shape similar to an elongated frustum, which continuously and / or gradually narrows (in the proximal to distal direction) along most or all of its length from the first narrowing segment 107 to the proximal widening segment 109. The first narrowed section 107 may optionally be on the order of 1%, 2%, or 5% of the total length of the vascular access guidewire 101, and the proximal widened section 109 may optionally be steeper than the sloped length of the first narrowed section 107 and / or the vascular access guidewire intermediate section 108, optionally dropping or sloped by about 10% or more along a length of about 0.5 mm in diameter. Optionally, a short proximal widened section 112 is formed between the first narrowed section 107 and the vascular access guidewire intermediate section 108, for example due to the bonding of the coil member 104 to the core member 103 thereon.

[0043] The vascular access guidewire terminal segment 110 is much shorter than the other segments and is about 2% or less (optionally on the order of 1%) of the total length of the vascular access guidewire 101, optionally less than 10 mm, optionally about 5 mm or less. The vascular access guidewire terminal segment 110 includes an elongated segment 113 and a distal widened segment 119, which merge with a local (distal) widened segment 114 of the core member 103. The vascular access guidewire terminal elongated segment 113 merges with the proximal widened segment 109 to the vascular access guidewire intermediate segment 108, and it is optionally the thinnest portion of the core member 103, having a constant and / or average diameter, which is on the order of 30% or less of the maximum diameter of the vascular access guidewire 101, optionally less than 0.15 mm, for example, optionally about 0.1 mm, along a length of about 6 mm or less or about 3 mm or less. The widening section 114 is steep and optionally increases in diameter by more than two times (e.g., from about 0.1 mm to more than 0.25 mm) along a minimum length (e.g., on the order of about 0.5 mm or 0.25 mm). Unlike the first narrowing section 107 and the proximal widening section 109, which are formed at acute angles, the widening section 114 is optionally formed at an obtuse angle. The vascular access guidewire terminal segment 110 includes a distal end 115, which includes a dome-shaped crank 116. The distal end 115 includes a proximal portion having a diameter of about 0.25 mm or greater and a length of about 1.5 mm or less. The radius and length of the crank 116 are optionally about 0.23 mm. Crank 116 is configured to rotate about its center of rotation when core member 103 is axially loaded and a distal surface of the crank is pressed against a wall of a target vessel, sufficient to trigger or affect deflection and / or deformation of core member 103 proximal to the crank.

[0044] The vascular access guidewire terminal elongated segment 113 includes a hinge 120, which is configured to facilitate and / or allow the crank 116 to be articulated around the hinge to convert the axial movement of the core member 103 into the rotational movement of the crank 116 and / or convert the rotational movement of the crank 116 into the axial movement of the core member 103. The hinge 120 is optionally formed by the flexure of the core member 103 along the elongated segment 113 or adjacent to it. The hinge 120 can be mechanically and / or thermally treated, such as in a subtractive process, to produce a localized smaller resistance to buckling, flexing and / or bending and / or affect a geometric misalignment of the pivot point or region sufficient to cause such tilting or articulation. In some embodiments, the hinge 120 has elastic properties, which are configured to affect the self-alignment of the distal widening segment 119 with the vascular access guidewire terminal elongated segment 113 when the torque on it stops. The hinge 120 is optionally about 1 mm or less in length, optionally about 0.5 mm or less, and is optionally 5 mm or less from the distal end 111 of the vascular access guidewire and / or optionally 1 mm or less from the distal widened section 119 .

[0045] The coil member 104 is optionally cylindrical, has a constant outer diameter along most or all of its length, and is configured to maintain a constant maximum outer diameter of the vascular access guidewire (e.g., about 0.45 mm) around the narrowed portion of the core member 103 (including around the vascular access guidewire intermediate segment 108 and the vascular access guidewire terminal segment 110). The coil member 104 is connected to the proximal portion of the vascular access guidewire intermediate segment 108 near the first narrowed segment 107 at its proximal portion 117, thereby optionally forming a proximal widening segment 112 (shown embedded in the adhesive layer, which is an exemplary connection feature), and is connected to the distal end 115 of the distal widening segment 119 at its distal portion 118. In some embodiments, the coiled member 104 is configured with a first coil pitch CP1 along the vascular access guidewire terminal elongated section 113 (optionally, particularly at the hinge 120), which is greater than its second coil pitch CP2, which is arranged along the vascular access guidewire intermediate section 108 and the distal widening section 119 (and optionally also on the portion of the vascular access guidewire terminal elongated section 113 other than the hinge 120). In other embodiments, the coil member 104 is configured to have a first (larger) coil pitch CP1 along other portions thereof, such as along the vascular access guidewire intermediate section 108 and / or the distal widening section 119, or along most or all of its length. In some embodiments, the second coil pitch CP2 is substantially equal to the diameter of the coil wire (the wire forming the coil; for example, it can be about 0.08 mm or less), so that every two adjacent coil windings are in contact or close to contact, thereby resisting or preventing axial contraction and / or bending. The first coil pitch CP1 is optionally larger than the coil wire diameter (eg, larger than 0.09 mm) to allow axial contraction and / or bending, and is configured to facilitate tilting of the distal widened section 119 relative to the vascular access guidewire terminal elongated section 113 .

[0046] The vascular access guidewire 101 is formed by first producing a core member 103 and a coil member 104 separately, and then connecting them according to demand. The core member 103 is first formed by subtracting material from a pre-processed wire (i.e., having a substantially constant diameter), such as by grinding (e.g., using a spindle grinding, wherein the wire is concentrically aligned with the spindle of the machine and ground while maintaining a cylindrical symmetrical shape), to achieve the selected shape of the core member 103, including along the first narrowing segment 107, the vascular access guidewire middle segment 108, the second narrowing segment 114, the vascular access guidewire terminal elongated segment 113, the widening segment 114 and each of the distal widening segments 119. Then, a portion with a selected length and position on the vascular access guidewire terminal elongated segment 113 can be processed to form a hinge 120. This can include fixedly changing the straight alignment length of the vascular access guidewire terminal elongated segment 113, thereby forming a flexure. Additional chemical or thermal treatment may be required. Fixedly changing the straight alignment length to form the hinge 120 may include fixedly deforming it into a curved length along which the core member 103 is fixedly laterally deviated relative to its straight alignment portion proximally and distally adjacent to the curved length. Alternatively or additionally, the process may include forming at least one transverse groove or slit from the straight alignment length by subtractive manufacturing, such as by using a laser source or by grinding away from the main axis (eccentric) (e.g., the ground wire is parallel and transverse to the main axis). After forming the flexure, the coiled member 104 is sleeved on the core member 103 and positioned so that the vascular access guide wire terminal elongated segment 113 is surrounded by the length of the coiled member 104 configured to have a first coiling pitch CP1. In some embodiments, the proximal portion 117 of the coiled member 104 may be connected to the core member 103 by an adhesive, and its distal portion 118 may be welded or soldered to the distal end 115 of the distal widening segment 119. During or after connection of the coiled member distal portion 118 , the dome-shaped crank 116 of the distal widened section 119 may be connected (eg, welded or soldered) or formed (eg, ground or forged) from the end of the core member 103 .

[0047] Figure 3A An exemplary vascular access kit 100 is shown, which includes a vascular access guidewire 101 and an exemplary needle 102 . Figure 3BA cross-sectional side view is shown showing a distal portion of a vascular access guidewire 101 placed in an exemplary needle 102. Kit 100 can be a complete or partial Seldinger or other vascular access or puncture kit, and can include other instruments, such as syringes, catheter sheaths, and / or dilators, and it can be equipped with one or more types or sizes of vascular access guidewires 101 and / or needles 102. Needle 102 is optionally at least partially similar or identical to needle 20 or needle 60, optionally as an exemplary configuration thereof. Needle 102 includes a hollow tube 121, which is sized to allow vascular access guidewire 101 to pass through it unimpeded. The needle hollow tube 121 has a needle tip 122 at its distal end, which is configured to facilitate initial penetration of the skin layer and the vessel wall of a living subject, and has a bevel opening 123, which terminates at the needle tip 122. The length of bevel opening 123 (measured parallel to the centerline of needle hollow tube 121) is greater than the length of distal widened section 119, and optionally also greater than the additional length of vascular access guidewire 101, such that in some embodiments, when the distal ends / tips of vascular access guidewire 101 and needle 102 are juxtaposed and aligned, some, most, or all of the length of vascular access guidewire terminal elongated section 113 (including the total length of hinge 120) extends along bevel opening 123, as shown in FIG. Figure 3B As shown. Thus, when the vascular access guidewire 101 is pushed through the needle 102 and rests on a common surface of the two (i.e., the two are in contact with or adjacent thereto), such as against a vessel wall, the needle 102 does not restrict the hinge 120 and allows for local bending and / or flexing to affect the inclination of the distal widened section 119 relative to the vascular access guidewire terminal elongated section 113. In some embodiments, the bevel opening 123 is at least twice as long as the distal widened section 119, and is optionally at least 2 mm, optionally at least 4 mm, optionally at least 6 mm long, or higher, or lower, or any intermediate value.

[0048] like Figure 3C As shown, needle 102 penetrates blood vessel BV so that bevel opening 123 is completely located within the lumen of the blood vessel. In common practice, practitioners attempt to penetrate the vein at as small an angle as possible, or rotate the needle to a small angle immediately after initial penetration in order to reduce the potential hazard of the needle tip and / or vascular access guidewire accidentally penetrating the second (lower) blood vessel wall. However, by introducing kit 100, in which vascular access guidewire 101 with an articulated distal end is not constrained by the bevel opening of needle 102, practitioners can penetrate the blood vessel at a smaller acute angle (e.g., between 60° and 90°).

[0049] Figures 4A-4CA side view of a distal portion of an exemplary configuration of core member 103 is shown, respectively (without forming distal tip 115 and / or forming crank 116, or before distal tip 115 is formed and / or forming crank 116), differing in the exemplary configuration of hinge 120. In some embodiments, the exemplary configurations described herein are intended to cause (influence) localized buckling and / or bending of the distal elongated segment 113 of the vascular access guidewire along or near hinge 120 when core member 103 is subjected to axial compression, such as when pushed with a force equal to or less than the force typically used to push the access guidewire through an access needle. An exemplary normal push force and / or axial compression force on the vascular access guidewire sufficient to cause such buckling, bending and / or tilting in the vascular access guidewire 101 is optionally less than 2N (Newtons), optionally about 1N or less, optionally about 0.75N or less, optionally about 0.5N or less, optionally about 0.2N or less, optionally about 0.1N or less. This will also allow or create a tilting of the distal widened section 119 relative to the vascular access guidewire terminal elongated section 113 when the distal widened section 119 is fully within the beveled opening 123 of the needle 102. This configuration is intended to avoid common accidents associated with known access vascular access guidewires and kits where the needle restricts and prevents such buckling, bending and / or tilting when the vascular access guidewire is pushed with a normal force, thereby increasing the likelihood of damaging the vessel wall, such as through accidental puncture and / or incision.

[0050] Figure 4A A vascular access guidewire 101 is shown having a first configuration of a hinge 120, wherein the hinge 120 includes a curved length 125 along which the core member 103 is fixedly laterally offset relative to straight aligned portions 126 and 127 of the core member 103 proximally and distally adjacent to the curved length 125. In this configuration, the core member 103 is offset in the transverse axis (relative to the long axis) along the curved length 120. Thus, when the core member 103 is subjected to axial compression, the local resistance to buckling and / or bending caused by the hinge 120 along the curved length 125 is less than the local resistance to buckling and / or bending caused along the straight aligned portions 126 and 127. Figure 4B Shown with Figure 4A The hinge 120 is configured similar to the previous configuration of , wherein the length of the core member 103 distal to the bend length 125 is fixedly inclined at an inclination angle IA relative to the length of the core member 103 proximal to the bend length 125. The inclination angle IA is optionally less than about 20°, optionally less than about 10°, optionally less than about 5°, or has any intermediate value. Figure 4CA vascular access guidewire 101 is shown having a second configuration of a hinge 120, wherein the hinge 120 forms a coil along a curved length 125. In this configuration, the core member 103 deviates in several axes along the curved length 120 and can be axially compressed under an axial load. Thus, when the core member 103 is subjected to axial compression, the hinge 120 is configured to have less resistance to buckling and / or bending along the curved length 125 than in any direction along the straight aligned portions 126 and 127.

[0051] Figures 5A-5C A side cross-sectional view of the distal portion of the vascular access guidewire 101 with the preformed tip 115' prior to welding and forming the distal tip 115 is shown, respectively. Figure 5A ), a side cross-sectional view of the distal portion after welding and forming the distal tip 115 ( Figure 5B ) and side view ( Figure 5C ). As shown, the coil member 104 is sleeved on the core member 103, and the distal end 128 of the core member 103 is placed juxtaposed with the distal end 129 of the coil member 104. Then, the distal ends 128 and 129 are connected together as a single component to form the distal end 115, for example, by welding, soldering and / or fusing (e.g., welding) the pre-fused portion of the core member 103 and the pre-fused portion of the coil member 104 together. Welding and / or fusing includes forming the distal end 115 by melting the preformed end 115' and cooling or cooling it into a new shape, or then forming the distal end 115 by melting the preformed end 115' and cooling or cooling it into a new shape, the new shape including a crank 116 with a spherical dome-shaped portion, the spherical dome-shaped portion having a vertex pointing to the distal side. In some embodiments, the pre-fused portion is configured to form a weld pool to facilitate welding and / or fusion, and the preformed end 115' and / or the distal end 115 are configured to withstand most or all of the heat affected zone generated by the welding and / or fusion, so that the core member 103 adjacent to the hinge 120 (before or after its formation) is structurally and / or functionally unaffected by the welding and / or fusion.

[0052] Figure 6A side cross-sectional view of an exemplary fixture 200 is shown, which is configured to form a hinge (as a flexure) in a vascular access guidewire, such as a hinge 120 in a core member 103. The fixture 200 includes a rigid body 201, an anvil 202, and a base 203. The rigid body 201 and the anvil 202 are fixedly connected to the base 203 at a fixed interval therebetween, and the base 203 can be fixedly connected in place. The rigid body 201 has an elongated channel extending from its rear side to its front side. A rigid channel 204 (e.g., in the form of a straight sleeve or a pipe) is fixedly retained in the channel of the rigid body 201 and along the channel so that a front channel portion 205 is exposed from the front side of the rigid body 201. The rigid channel 204 is cylindrical, sized to accommodate a guidewire passing therethrough, such as a vascular access guidewire 101, and includes a central axis coinciding with a push axis PA, along which the guidewire can be pushed through the rigid channel 204. The anvil 203 has a surface 206 perpendicular to the push axis PA. The surface 206 surrounds a groove 207 located just in front of the front channel portion 205, and the central axis of the groove 207 also coincides with the push axis PA. For example, the unsupported distance 208 between the innermost cavity of the groove 207 and the end of the front channel portion 205 is selected based on the preferred position of the hinge 120 relative to the distal end 115. In some such embodiments, the unsupported distance 208 is about 5 mm or less, or optionally about 3 mm or less, or optionally about 2 mm or less.

[0053] In order to Figure 5C The vascular access guidewire 101 shown having hinge 120 formed therein can be placed in the rigid channel 204 with the distal tip 115 pointing toward the surface 206 and the groove 207, and then gently pushed until the distal tip 115 contacts the groove 207 and a portion of the distal tip 115 is supported (e.g., nested) in the groove 207, thereby preventing it from moving transversely to the push axis PA. Thus, an unsupported length of the core member 103 equal to the unsupported distance 208 extends between the channel portion 205 and the groove 207 and can be freely flexed or bent transversely to the push axis PA, while a supported length of the core member 103 proximal to the unsupported length remains in the rigid channel 204 and is prevented from flexing or bending transversely to the push axis PA. Figures 7A-7C Successive frames are shown visualizing a distal portion of an exemplary vascular access guidewire, such as guidewire 101 , during an exemplary process of forming a hinge, such as hinge 120 , using a fixation device, such as fixation device 200 . Fig. 7AAn initial arrangement is shown in which the unsupported length 210 extends through the channel portion 205 and is supported distally in the groove 207. The guidewire 101 is then pushed against the surface 206 (along the push axis PA) sufficiently firmly that it produces a bend and / or flexion of the unsupported length 210 ( Figure 7B ), and optionally, an additional length of the guidewire 101 then exits the channel portion 205 until the distal tip 115 is forced out of the groove 207 ( Figure 7C ). In some embodiments, the unsupported length 210 includes the distal end 115 and a portion of the elongated segment 113, such that bending and / or flexion occurs proximally adjacent to the distal end 115 along the unsupported length. In some embodiments, the characteristics of the core member 103, the selected magnitude of the unsupported distance 208, and / or the applied force used to push the guidewire 101 to cause bending and / or flexion cause the straight aligned lengths of the core member 103 to be fixedly alternating and / or a portion of the core member 103 to be fixedly deformed (e.g., by plastic deformation) to a bent length.

[0054] Each of the following terms written in singular grammatical form: "a", "an", and "the", as used herein, means "at least one" or "one or more". The use of the phrase "one or more" herein does not change the original meaning of "a", "an", or "the". Therefore, the terms "a", "an", and "the" used herein may also refer to and cover the plural number of the entity or object, unless otherwise clearly defined or stated herein, or unless the context clearly dictates otherwise. For example, the phrases "a unit", "a device", "a component", "a mechanism", "a part", "an element", and "a step or procedure" as used herein may also refer to and cover multiple units, multiple devices, multiple components, multiple mechanisms, multiple parts, multiple elements, and multiple steps or procedures, respectively.

[0055] Each of the following terms: "comprises", "having", "including" and their linguistic / grammatical variations, derivatives or / and inflections, as used herein, means "including, but not limited to", and should be deemed to specify stated components, features, properties, parameters, integers or steps, and does not preclude the addition of one or more additional components, features, properties, parameters, integers, steps or groups thereof. Each of these terms is deemed equivalent in meaning to the phrase "consisting essentially of".

[0056] The term "method" as used herein refers to steps, procedures, ways, means and / or techniques for completing a given task, including but not limited to those steps, procedures, ways, means and / or techniques that are known to practitioners in the relevant field of the disclosed content or that are readily developed from known steps, procedures, ways, means and / or techniques.

[0057] Throughout the present disclosure, the numerical value of a parameter, feature, characteristic, object or size can be stated or described in a numerical range format. This numerical range format used herein illustrates the implementation of some exemplary embodiments of the present disclosure, and will not strictly limit the scope of exemplary embodiments of the present disclosure. Therefore, the numerical range stated or described also refers to and encompasses all possible subranges and each single numerical value (wherein numerical value can be expressed as an integral, integer or fraction) within the numerical range of the statement or description. For example, the numerical range "from 1 to 6" stated or described also refers to and encompasses all possible subranges within the numerical range of the statement or description of "from 1 to 6", such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc., and each single numerical value, such as "1", "1.3", "2", "2.8", "3", "3.5", "4", "4.6", "5", "5.2" and "6". Regardless of the numerical width, scope or size of the numerical range stated or described, this applies.

[0058] In addition, for the purpose of stating or describing a numerical range, the phrase "in the range between about a first value and about a second value" is considered equivalent to the phrase "in the range from about a first value to about a second value" and has the same meaning, and therefore, these two equivalent phrases can be used interchangeably. For example, for the purpose of stating or describing a numerical range of room temperature, the phrase "room temperature refers to a temperature in the range between about 20°C and about 25°C" is considered equivalent to the phrase "room temperature refers to a temperature in the range from about 20°C to about 25°C" and has the same meaning.

[0059] As used herein, the term "about" refers to ± 10% of the stated numerical value.

[0060] It is fully understood that certain aspects, features, and characteristics of the disclosure that are illustratively described and presented in the context or form of multiple separate embodiments for clarity may also be illustratively described and presented in the context or form of a single embodiment in any suitable combination or subcombination. Conversely, various aspects, features, and characteristics of the disclosure that are illustratively described and presented in the context or form of a single embodiment in combination or subcombination may also be illustratively described and presented in the context or form of multiple separate embodiments.

[0061] Although the present disclosure has been illustratively described and presented through specific exemplary embodiments and examples thereof, it is apparent that many alternatives, modifications and / or variations thereof will be apparent to those skilled in the art. Therefore, it is intended that all such alternatives, modifications and / or variations fall within the spirit of the broad scope of the appended claims and be included within the broad scope of the appended claims.

[0062] All publications, patents and / or patent applications cited or mentioned in this disclosure are incorporated by reference in their entirety into this specification to the same extent as if each individual publication, patent and / or patent application were expressly and individually indicated to be incorporated by reference into this specification. In addition, the citation or identification of any reference in this specification should not be interpreted or understood as an admission that such reference represents or corresponds to the prior art of the present disclosure. To the extent that section headings are used, they should not be interpreted as necessarily limiting.

[0063] When describing absolute values ​​of features or characteristics of things or actions described herein, the terms "substantial," "substantially," "essentially," "about," and / or other terms or phrases of degree may be used without specifically listing numerical ranges. When applied to features or characteristics of things or actions described herein, these terms refer to ranges of features or characteristics that are consistent with providing the desired function associated with the feature or characteristic.

[0064] It will be readily apparent to those skilled in the art that various modifications may be made to the implementations described in this disclosure, and that the general principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the implementations shown herein, but rather should be given the widest scope consistent with the claims, principles, and novel features disclosed herein. The term "exemplary" is used herein specifically to mean "as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as superior or better than other implementations.

[0065] Certain features described in this specification in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately in multiple implementations or in any suitable subcombination. Furthermore, although features may be described above as functioning in certain combinations and even initially claimed in that manner, in some cases one or more features may be deleted from the claimed combinations, and the claimed combinations may be directed to subcombinations or variations of subcombinations.

[0066] The methods disclosed herein include one or more steps or actions for implementing the methods. The method steps and / or actions may be interchangeable with each other without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

Claims

1. A vascular access guidewire, comprising: an elongated core member; as well as a distal tip including a crank configured with a crank distal surface and a crank rotation center; Wherein, the crank is configured to rotate about the crank rotation center to trigger or affect deflection and / or deformation of the core member proximal to the crank when the core member is sufficiently axially loaded and when the distal surface of the crank is pressed against the wall of the target vessel.

2. The vascular access guidewire of claim 1, wherein the deflection and / or deformation comprises flexion, bending and / or rotation.

3. The vascular access guidewire of claim 1, wherein the crank distal surface is curved, and the crank rotation center coincides with or is adjacent to the center of curvature of the crank distal surface.

4. A vascular access guidewire according to claim 3, wherein the crank distal surface has a crank curvature radius in the range of 0.1 mm to 0.5 mm, optionally in particular about 0.25 mm.

5. The vascular access guidewire according to claim 1, wherein: The core member includes or is merged with the distal tip by a hinge configured to facilitate and / or allow the crank to articulate about the hinge to convert axial movement of the core member into rotational movement of the crank and / or convert rotational movement of the crank into axial movement of the core member.

6. The vascular access guidewire of claim 5, wherein the distance between the hinge and the center of rotation of the crank is less than the diameter of the blood vessel.

7. The vascular access guidewire of claim 6, wherein the distance between the hinge and the center of rotation of the crank is equal to or less than about 2 mm, or optionally, in particular, equal to or less than about 1 mm.

8. A vascular access guidewire according to claim 5, wherein the hinge is configured as a flexure portion of the core member and includes a bend length along which the core member is fixedly laterally offset relative to straight aligned portions of the core member proximally and distally adjacent the bend length.

9. The vascular access guidewire of claim 8, wherein the length of the flexure is approximately 0.5 mm or less.

10. The vascular access guidewire of claim 1 , configured such that when the core member is axially loaded with a first axial force less than a predetermined compressive force, the crank is prevented from rotating about a crank rotation center, and / or such that when the core member is axially loaded with a second axial force greater than the predetermined compressive force, the crank is forced to rotate about the crank rotation center.

11. The vascular access guidewire according to claim 10, wherein the predetermined compressive force is in the range of 0.1N to 2N, optionally in particular in the range of 0.2N to 0.8N.

12. The vascular access guidewire of claim 1, further comprising: a cylindrical coil member extending longitudinally about the length of the core member; The distal tip fixedly connects the distal end of the core member and the distal end of the coil member.

13. The vascular access guidewire of claim 12, wherein the distal tip is formed by welding and / or fusing together portions of the core member and portions of the coil member.

14. The vascular access guidewire of claim 13, wherein the distal tip includes most or all of a heat affected zone resulting from welding and / or fusion.

15. The vascular access guidewire of claim 1, wherein the distal tip comprises a spherical dome-shaped portion having an apex pointing distally.

16. The vascular access guidewire of claim 1, wherein the core member includes an elongated section extending between a proximal widened section and a distal widened section such that deflection and / or deformation tends to occur in the elongated section.

17. A vascular access guidewire according to claim 16, wherein the slender section includes a hinge or merges with the distal widened section through a hinge, and the hinge is configured to facilitate and / or allow the crank to articulate about the hinge to convert between rotational movement of the crank and linear movement of the core member.

18. The vascular access guidewire of claim 16, wherein the distal widened section merges with the distal tip at a distal merging portion.

19. The vascular access guidewire of claim 16, wherein a volume ratio of a total volume of the distal tip to a total volume of the distal widened section is greater than 1.

3.

20. The vascular access guidewire of claim 16, wherein the total volume of the distal tip is in the range of 0.2 cubic millimeters to 0.5 cubic millimeters, and / or the total volume of the distal widened section is in the range of 0.005 cubic millimeters to 0.03 cubic millimeters.

21. The vascular access guidewire of claim 16, wherein a length ratio between a total length of the distal tip and a total length of the distal widened section is in a range of 1 to 2.

22. The vascular access guidewire of claim 16, wherein the total length of the distal tip is approximately 0.35 mm or less, and / or the total length of the distal widened section is approximately 0.75 mm or less.

23. The vascular access guidewire of claim 16, wherein the elongated segment and / or the distal widened segment is elongated and has a circular, oval, or rectangular cross-section.

24. The vascular access guidewire of claim 16, wherein the coiled member is configured such that a coil pitch along the elongated section is greater than a coil pitch along the distal widened section.

25. A vascular access kit comprising: The vascular access guidewire according to claim 5; as well as A needle including a bevel opening; Therein, when the distal end of the vascular access guidewire is juxtaposed with the distal end of the needle, the hinge is positioned along the bevel opening.

26. A method of forming a vascular access using the vascular access kit of claim 25, the method comprising: Use the bevel opening to puncture the blood vessel; The distal tip of the vascular access guidewire is pushed through the beveled opening against the wall of the vessel until rotational movement of the crank about the crank's center of rotation is produced, which rotational movement is sufficient to trigger and / or affect deflection and / or deformation of the core member proximal to the crank and / or is sufficient to trigger or affect articulation of the crank about the hinge.

27. The method according to claim 26, further comprising: Advance the vascular access guidewire distally within the vessel; as well as The core member is allowed to flex rearwardly and / or realign with the distal tip.

28. A method of producing the vascular access guidewire according to claim 12, the method comprising: connecting the distal end of the core member to the distal end of the coil member; and A hinge is formed.

29. The method of claim 28, wherein said forming comprises or is caused by fixedly varying the straight aligned length of the core members.

30. The method of claim 28, wherein the shaping comprises or results from fixedly deforming a portion of the core member to a curved length.

31. The method of claim 28, wherein the forming comprises pushing the core member along a selected push axis against a surface perpendicular to the push axis.

32. The method of claim 31, wherein pushing is performed while allowing a selected unsupported length of the core member to flex or bend transversely to the pushing axis and preventing a supported length of the core member proximal to the unsupported length from flexing or bending transversely to the pushing axis.

33. The method of claim 31 , wherein a portion of the distal tip is prevented from moving transversely to the push axis and / or supported in a recess enclosed by the surface.

34. The method of claim 28, further comprising shaping the distal tip.

35. The method of claim 34, wherein said forming is subsequent to said connecting and / or said shaping.

36. The method of claim 34, wherein said connecting comprises said shaping or causes said shaping.

37. The method of claim 34, wherein the distal tip is shaped to form a crank comprising a spherical dome-shaped portion having an apex pointing distally.

38. The method of claim 34, wherein the shaping comprises shaping the preformed tip into a distal tip.

39. The method of claim 38, wherein the connecting comprises welding and / or fusing together the pre-fused portion of the core member and the pre-fused portion of the coil member.

40. The method of claim 39, wherein the pre-fused portion is configured to form a weld pool to facilitate welding and / or fusion.

41. The method of claim 39, wherein the distal tip is configured to withstand most or all of the heat affected zone resulting from welding and / or fusion such that the core member adjacent the hinge is structurally and / or functionally unaffected by the welding and / or fusion.

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