Vascular access wire tip with crank

Abstract

A vascular access wire is disclosed, including 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 the crank center of rotation to induce or affect deflection and / or deformation of the core member proximally when the core member is sufficiently axially loaded and the crank distal surface presses against a wall of a target vessel.

Description

[Technical Field]

[0001] The present disclosure, in some embodiments thereof, relates to devices and methods for providing vascular access, and more particularly, but not exclusively, to vascular access wires and / or vascular access kits. [Background technology]

[0002] The Seidinger technique is currently the preferred approach for gaining vascular access; once the needle has penetrated the vessel and the needle tip is confirmed to be inside the vessel, a vascular access wire is inserted through the needle and moved to the desired location in the vessel, the needle is then removed, and a catheter may be placed over the vascular access wire in the designated area.

[0003] Unintentional perforation or dissection of a blood vessel is not an uncommon failure when using the Seidinger technique. When the needle tip is placed near the vessel centerline and at an acute angle to it, the vascular access wire should exit the needle tip without causing unnecessary perforation, as described. However, in many cases, the needle tip is too close to or partially penetrates the opposing vessel wall, and the operator may get blood return through the inserted needle, which seems to be a positive indicator of correct needle placement. However, when the vascular access wire is pushed through the needle and into the vessel, the tip of the vascular access wire can perforate the vessel wall and / or dissect the vessel wall layer because the vascular access wire is specifically designed for sufficient pushability to allow its advancement through the needle and vessel.

[0004] The problem of unintentional penetration (e.g., perforation and / or dissection) of the vessel wall when creating vascular access is particularly pronounced in veins, which have thin, flexible walls, whereby the operator may not sense any resistance from the needle and continue to advance the vascular access wire out of the vein through the unintentionally created penetration opening. In arteries, on the other hand, a blood return situation, preventing the advancement of the wire, is more common. In such cases, the wire tip may press directly against the vessel wall, causing dissection and / or irritation that can lead to access complications, particularly vasospasm commonly associated with vascular occlusion, even if it does not penetrate the vessel wall.

[0005] It should be noted that this Background is not intended to aid in determining the scope of the claimed subject matter, nor should it be construed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above. Discussion of any technology, document, or reference in this Background section should not be construed as an admission that the content thereof is prior art to any of the 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 vascular access wires and / or vascular access kits configured to prevent unintentional damage to the blood vessel wall when forming vascular access.

[0007] In some embodiments, a vascular access wire is provided comprising an elongate core member and a distal tip comprising a crank configured with a crank distal surface and a crank center of rotation, hi some embodiments, the crank is configured to rotate about the crank center of rotation to induce or affect deflection and / or deformation of the core member proximally when the core member is sufficiently axially loaded and the crank distal surface is pressed against a wall of a target vessel.

[0008] In some embodiments, the deflection and / or deformation comprises buckling, bending, and / or rotation.

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

[0010] In some embodiments, the core member includes or is integrated with the distal tip by a hinge configured to facilitate and / or allow articulation of the crank about the hinge to translate axial motion of the core member into rotational motion of the crank and / or to translate rotational motion of the crank into axial motion of the core member. In some embodiments, the distance of the hinge from the crank's center of rotation is less than the diameter of the blood vessel. In some embodiments, the distance of the hinge from the crank's center of rotation is about 2 mm or less, or optionally specifically about 1 mm or less. In some embodiments, the hinge is configured as a bending portion of the core member and includes a curved length along which the core member is fixedly offset laterally relative to linearly aligned portions of the core member adjacent proximally and distally to the curved length. In some embodiments, the length of the curved portion is about 0.5 mm or less.

[0011] In some embodiments, the vascular access wire is 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 the crank center of rotation, and / or when the core member is axially loaded with a second axial force greater than the predetermined compressive force, the crank is caused to rotate about the crank center of rotation, In some embodiments, the predetermined compressive force is in a range of 0.1 N to 2 N, optionally specifically in a range of 0.2 N to 0.8 N.

[0012] In some embodiments, the vascular access wire further comprises a cylindrical coil member extending longitudinally around the length of the core member. In some embodiments, the distal tip fixedly joins the distal ends of the core member and the coil member. In some embodiments, the distal tip is formed by integrally welding and / or fusing portions of the core member and the coil member. In some embodiments, the distal tip includes most or all of a heat affected zone resulting from the welding and / or fusing.

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

[0014] In some embodiments, the core member includes an elongated segment extending between a proximal expansion segment and a distal expansion segment, such that the deflection and / or deformation occurs in the elongated segment. In some embodiments, the elongated segment includes or is integrated with the distal expansion segment by a hinge configured to facilitate and / or enable articulation of the crank about the elongated segment to convert between rotational motion of the crank and linear motion of the core member. In some embodiments, the distal expansion segment is integrated with the distal tip at a distal integration portion. In some embodiments, a volume ratio between a total volume of the distal tip and a total volume of the distal expansion segment is greater than 1.3. In some embodiments, the total volume of the distal tip is less than 0.2 mm. 3 ~0.5mm 3 and / or the total volume of the distal widening segment is within the range of 0.005 mm 3 ~0.03mm 3 In some embodiments, the length ratio between the total length of the distal tip and the total length of the distal expansion segment is in the range of 1 to 2. In some embodiments, the total length of the distal tip is about 0.35 mm or less and / or the total length of the distal expansion segment is about 0.75 mm or less. In some embodiments, the elongated segment and / or the distal expansion segment are elongated and have a circular, oval, or rectangular cross-section. In some embodiments, a coiled member is configured with a larger coil pitch along the elongated segment than along the distal expansion segment.

[0015] In some embodiments, a vascular access kit is provided comprising the vascular access wire and a needle comprising a beveled opening, hi some embodiments, the hinge is disposed along the beveled opening when the distal end of the vascular access wire is juxtaposed with the distal end of the needle.

[0016] In some embodiments, a method for creating vascular access using the vascular access kit is provided. The method may include penetrating a blood vessel with the beveled opening and pressing the distal tip of the vascular access wire through the beveled opening against a wall of the blood vessel until generating rotational movement of the crank about the crank center of rotation sufficient to induce and / or affect proximal deflection and / or deformation of the core member of the crank and / or to induce or affect articulation of the crank about the hinge. In some embodiments, the method further includes advancing the vascular access wire distally in the blood vessel and allowing the core member to bend back and / or realign with the distal tip.

[0017] In some embodiments, a method of manufacturing the vascular access wire is provided. The method may include joining a distal end of the core member and a distal end of the coil member and forming a hinge. In some embodiments, the forming step includes or is caused by fixedly changing a linearly aligned length of the core member. In some embodiments, the forming step includes or is caused by fixedly deforming a portion of the core member into a curved length.

[0018] In some embodiments, the forming step includes forcing the core member along a selected pushing axis against a surface perpendicular to the pushing axis. In some embodiments, the forcing occurs while a selected unsupported length of the core member is allowed to buckle or bend laterally relative to the pushing axis and a supported length of the core member proximal to the unsupported length is prevented from buckling or bending laterally relative to the pushing axis. In some embodiments, a portion of the distal tip is prevented from moving laterally relative to the pushing axis and / or is supported in a niche surrounded by the surface.

[0019] In some embodiments, the method further includes shaping the distal tip. In some embodiments, the forming step follows the joining step and / or the molding step. In some embodiments, the joining step includes or results in the molding step. In some embodiments, the distal tip is shaped to form a crank including a spherical dome-shaped portion with a distally pointing apex. In some embodiments, the shaping step includes molding a pre-shaped tip into the distal tip. In some embodiments, the joining step includes welding and / or fusing pre-fused portions of the core member and the coil member together. In some embodiments, the pre-fused portions are configured to form a weld pool to facilitate the welding and / or fusing. In some embodiments, the distal tip is configured to maintain most or all of a heat affected zone resulting from the welding and / or fusing such that the core member adjacent the hinge is structurally and / or functionally unaffected by the welding and / or fusing.

[0020] All technical or / and scientific words, terms, and / or phrases used herein have the same or similar meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs, unless specifically defined or described otherwise herein. In case of conflict, the present patent specification, including definitions, will control.

[0021] It is understood that various configurations of the subject technology will become apparent to those skilled in the art from this disclosure, and various configurations of the subject technology have been shown and described by way of example. As will be understood, the subject technology is capable of other different configurations, and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not restrictive. [Brief explanation of the drawings]

[0022]

[0013] Several embodiments of the present disclosure are described herein, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings in detail, it is emphasized that the details shown are by way of example and for the purpose of illustrative explanation of several embodiments of the present disclosure. In this regard, the description taken in conjunction with the accompanying drawings will make apparent to those skilled in the art how several embodiments of the present disclosure may be practiced. [Figure 1A] 1A-1B schematically illustrate side cross-sectional views of an exemplary vascular access wire comprising a crank before and after subjecting the crank to a rotational movement, respectively, in accordance with some embodiments. [Figure 1B] 1A-1B schematically illustrate side cross-sectional views of an exemplary vascular access wire comprising a crank before and after subjecting the crank to a rotational movement, respectively, in accordance with some embodiments. [Figure 2A] 2A-2B show a side view and a cross-sectional side view of a front length of an exemplary vascular access wire, respectively, according to some embodiments. [Figure 2B] 2A-2B show a side view and a cross-sectional side view of a front length of an exemplary vascular access wire, respectively, according to some embodiments. [Figure 3A] FIG. 3A illustrates an exemplary intravenous access kit including an exemplary needle and the vascular access wire shown in FIG. 2A, according to some embodiments. [Figure 3B] FIG. 3B shows a cross-sectional side partial view of the intravenous kit shown in FIG. 3A in an exemplary deployment, according to some embodiments. [Figure 3C] FIG. 3C shows a schematic diagram representing a possible scenario in the implementation of a method for creating intravenous access using the kit of FIG. 3A, according to some embodiments. [Figure 4A] 4A-4C show side views of a distal portion of an exemplary vascular access wire core member, respectively, with different exemplary bend portion configurations, according to some embodiments. [Figure 4B]4A-4C show side views of a distal portion of an exemplary vascular access wire core member, respectively, with different exemplary bend portion configurations, according to some embodiments. [Figure 4C] 4A-4C show side views of a distal portion of an exemplary vascular access wire core member, respectively, with different exemplary bend portion configurations, according to some embodiments. [Figure 5A] 5A-5C show a side cross-sectional view of a distal portion of an exemplary vascular access wire before welding and shaping its distal tip, a side cross-sectional view of the distal portion after welding and shaping its distal tip, and a side view, respectively, according to some embodiments. [Figure 5B] 5A-5C show a side cross-sectional view of a distal portion of an exemplary vascular access wire before welding and shaping its distal tip, a side cross-sectional view of the distal portion after welding and shaping its distal tip, and a side view, respectively, according to some embodiments. [Figure 5C] 5A-5C show a side cross-sectional view of a distal portion of an exemplary vascular access wire before welding and shaping its distal tip, a side cross-sectional view of the distal portion after welding and shaping its distal tip, and a side view, respectively, according to some embodiments. [Figure 6] FIG. 6 illustrates a side cross-sectional view of an exemplary fastener configured to form a hinge in a core member of an exemplary vascular access wire, according to some embodiments. [Figure 7A] 7A-7C show sequential frames visualizing a distal portion of an exemplary vascular access wire during an exemplary process of forming a hinge, according to some embodiments. [Figure 7B] 7A-7C show sequential frames visualizing a distal portion of an exemplary vascular access wire during an exemplary process of forming a hinge, according to some embodiments. [Figure 7C] 7A-7C show sequential frames visualizing a distal portion of an exemplary vascular access wire during an exemplary process of forming a hinge, according to some embodiments. Detailed Description of the Invention

[0023] The following description and examples detail some exemplary implementations, embodiments, and configurations of the disclosed invention. Those skilled in the art will recognize that there are numerous variations and modifications of the invention that fall within the scope of the invention. Therefore, the description of specific exemplary embodiments should not be considered as limiting the scope of the invention.

[0024] The present disclosure, in some embodiments thereof, relates to devices and methods for creating vascular access, and more particularly, but not exclusively, to vascular access wires and / or vascular access kits configured to prevent unintentional damage (e.g., puncture) to the vessel wall when creating vascular access. The term "vascular access wire" (or "guide wire") refers to any thin member configured to facilitate a selected pathway in a body vessel, such as by passing a sheath, cannula, catheter, or any other device over the vascular access wire into a cavity or vessel, and to pass an artifact along it to a target location. In some embodiments, the term vascular access wire optionally includes a vascular access wire used in the process of creating vascular access, for example, prior to the insertion of another vascular access wire defined for routing the artifact deeper into the patient's vasculature.

[0025] 1A-1B schematically illustrate side cross-sectional views of an exemplary vascular access wire 10 including a crank 11 before and after applying a rotational motion to the crank, respectively. As used herein, the term "crank" refers to a feature, member, or portion of a vascular access wire configured and / or capable of rotating when pressed against a surface. When extending from or connected to a shaft member via a sufficiently flexible portion or joint (e.g., a hinge), linear motion of the shaft member can be translated into rotational motion of the crank, and / or rotational motion of the crank can be translated into linear motion of the shaft member.

[0026] Vascular access wire 10 comprises an elongate core member 12 and a cylindrical coil member 13 extending longitudinally around the length of core member 12. Distal tip 14 extends distally from core member 12 and may be considered a distal portion thereof or may be coupled, joined, or integral thereto. Distal tip 14 includes a crank 11 comprised of a crank distal surface 15 and a crank center of rotation 16. Crank distal surface 15 may be curved as shown, and crank center of rotation 16 may be coincident with or adjacent to the center of curvature of crank distal surface 15. Crank 11 is configured to rotate about crank center of rotation 16 sufficiently to induce or affect deflection and / or deformation (e.g., buckling, bending, and / or rotation) of core member 12 proximally of crank 11 when core member 12 is loaded axially (e.g., by pressing against a resistance surface) and when crank distal surface 15 presses against wall W of target vessel BV. 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 particularly about 0.25 mm.

[0027] The core member 12 includes or is integrated with the distal tip 14 by a hinge 17 configured to facilitate and / or enable articulation of the crank 11 about the hinge 17 to convert linear motion of the core member into rotational motion of the crank and / or to convert rotational motion of the crank into linear motion of the core member. The distance of the hinge 17 from the crank center of rotation 16 is less than the diameter of the blood vessel BV to allow deflection or deformation of the core member 12 resulting from rotation of the crank 11. In some embodiments, the distance of the hinge 17 from the crank center of rotation 16 may be about 5 mm or less, or less than about 2 mm, or optionally, about 1 mm or less to form access in substantially small vessels, such as small peripheral veins. The hinge 17 may be configured as a bending portion of the core member 12, and in some such embodiments, the core member 12 may include a curved length along which the core member 12 is fixedly offset laterally relative to its linearly aligned portion proximally and distally adjacent the curved length. In some such embodiments, the length of the bent portion is about 0.5 mm or less.

[0028] The vascular access wire 10 is configured so that the crank 11 does not rotate about the crank center of rotation 16 when the core member 12 is axially loaded with a first axial force less than the predetermined compressive force, and / or so that the crank 11 is rotated about the crank center of rotation 16 when the core member 12 is axially loaded with a second axial force greater than the predetermined compressive force. This can be achieved by considering mechanical, static, and dynamic design aspects such as, for example, the resistance to bending of the core member 12, the 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 center of rotation 16. In some such embodiments, the predetermined compressive force is optionally achieved within a range of 10 gr to 200 gr, and optionally particularly within a 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, e.g., to prevent damage or be limited to penetrate the vessel wall W.

[0029] In some embodiments, distal tip 14 fixedly joins the distal ends of core member 12 and coil member 13. Distal tip 14 is optionally formed by welding and / or fusing portions of core member 12 and coil member 13 together. In some such embodiments, distal tip 14 includes most or all of the heat affected zone resulting from welding and / or fusing. Distal tip 14 may include a spherical dome-shaped portion with a distally pointing apex, which may be so formed using a selected forming process or as a direct result of the welding and / or fusing technique or instrumentation used.

[0030] Core member 12 may include an elongated segment 18 extending between a proximal widening segment 19 and a distal widening segment 20, such that any deflection and / or deformation occurs in elongated segment 18. Elongated segment 18 may include or be integral with distal widening segment 20 via hinge 17. The volume ratio between the total volume of distal tip 14 and the total volume of distal widening segment 20 is optionally greater than 1, optionally greater than 1.3, or optionally greater than 1.5. The total volume of distal tip 14 is optionally less than 0.1 mm 3 ~1mm 3 Within the range of 0.2 mm, optionally 3 ~0.5mm 3 The total volume of the distal widening segment 20 is optionally within the range of 0.001 mm 3 ~0.1mm 3 Within the range of 0.005 mm, optionally 3 ~0.03mm 3The length ratio between the total length of the distal tip 14 and the total length of the distal expansion segment 20 is optionally within a range of 0.5 to 5, optionally particularly within a 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 particularly about 0.35 mm or less. The total length of the distal expansion segment 20 is optionally about 1 mm or less, or optionally particularly about 0.75 mm or less. The elongated segment 18, the proximal expansion segment 19, and / or the distal expansion segment 20 are optionally elongated and have a circular, oval, or rectangular cross-section. The coil member 13 is optionally configured to have a larger coil pitch along the elongated segment 18 than along other portions of the core member 12, particularly along the distal expansion segment 20.

[0031] FIG. 1A illustrates a scenario in which vascular access wire 10 penetrates its distal portion into blood vessel BV before reaching wall W via crank 11. FIG. 1B illustrates a second scenario in which wire 10 is pressed against vessel wall W and crank 11 pushes against it. As shown, after initial contact and sufficient axial force is applied to wire 10, crank 11 rotates to one side (counterclockwise in this example) about center of rotation 16, thereby inducing or affecting bending or flexing of core member 12 about hinge 17. Such rotational movement of crank 11 and bending of hinge 17 can cause deflection and / or deformation of elongated segment 18 proximal to and / or adjacent to hinge 17 as wire 10 continues to be pushed distally toward vessel wall W. In some embodiments, the bending 17 and / or deformation of the elongate segments 18 is elastic and fully or substantially recoverable, such that the core member 12 can be substantially aligned when stress is no longer applied thereto.

[0032] 2A-2B show a side view of vascular access wire 101 and a cross-sectional side view of a front length thereof, respectively. Vascular access wire 101 is optionally similar or identical, at least in part, to vascular access wire 10, as an exemplary configuration thereof. Vascular access wire 101 includes an elastic core member 103, optionally made from an elastic or superelastic material (e.g., formed of a Ni—Ti alloy), which extends along most or the entire length of the vascular access wire. Vascular access wire 101 further includes a coil member 104 that covers core member 103 along a portion of its length. The core member 103 includes three main continuous segments distinguishable by functional, structural, and / or dimensional characteristics: (1) a vascular access wire proximal segment 105 extending distally from the proximal end 106 of the vascular access wire 101 to a first narrowing 107 of the core member 103, (2) a vascular access wire intermediate segment 108 extending distally from the first narrowing 107 to a proximal widening segment 109 of the core member 103, and (3) a vascular access wire tip segment 110 extending distally from the proximal widening segment 109 to a distal end 111 of the vascular access wire 101.

[0033] Similar to other vascular access wires configured to create intravenous access, such as for inserting a sheath or line, the overall length of vascular access wire 101 may be, for example, on the order of 500 mm, optionally about 450 mm. Vascular access wire proximal segment 105 may be about 80% or more of the overall length of vascular access wire 101, optionally about 375 mm, and is shown with a substantially constant diameter (optionally about 0.45 mm) and / or with core member 103 not covered by coil member 104 along most or all of its length. Vascular access wire intermediate segment 108 may be on the order of about 10% or 15% of the overall length of vascular access wire 101, for example, optionally about 45 mm. Vascular access wire intermediate segment 108 is optionally formed with a slender, elongated, frustum-like shape that narrows continuously and / or stepwise (proximally to distally) along most or all of its length from first stenosis 107 to proximal widening segment 109. First stenosis 107 may optionally be on the order of 1%, 2%, or 5% of the overall length of vascular access wire 101, and proximal widening segment 109 is optionally steeper than first stenosis 107 and / or the tapered length of vascular access wire intermediate segment 108, optionally dropping or tapering in diameter by about 10% or more along a length of about 0.5 mm. Optionally, a short proximal widening 112 is formed between first stenosis 107 and vascular access wire intermediate segment 108, for example, due to bonding of coil member 104 to core member 103.

[0034] The vascular access wire tip segment 110 is significantly shorter than the other segments, being about 2% or less (optionally on the order of 1%) of the overall length of the vascular access wire 101, optionally less than 10 mm, and optionally about 5 mm or less. The vascular access wire tip segment 110 includes an elongated segment 113 and a distal widened segment 119 that is integrated with a local (distal) widened portion 114 of the core member 103. The elongated segment 113 at the vascular access wire tip is integrated with the vascular access wire intermediate segment 108 that has a proximal widened segment 109 and is the thinnest portion of the core member 103, having a constant and / or average diameter along its length, e.g., about 6 mm or less or about 3 mm or less, optionally on the order of 30% or less of the maximum diameter of the vascular access wire 101, optionally less than 0.15 mm, and optionally about 0.1 mm. The widened portion 114 is steep, optionally increasing in diameter by more than two times (e.g., greater than about 0.1 mm to 0.25 mm) along its minimum length, such as by about 0.5 mm or 0.25 mm. Unlike the first narrowing 107 and the proximal widened segment 109, which are formed at an acute angle, the widened portion 114 is optionally formed at an obtuse angle. The vascular access wire tip segment 110 includes a distal tip 115 with a dome-shaped crank 116. The distal tip 115 includes a proximal portion having a diameter of about 0.25 mm or more and a length of about 1.5 mm or less. The crank 116 optionally has a radius and length of about 0.23 mm. The crank 116 is configured to rotate about its center of rotation when the core member 103 is axially loaded and the distal surface of the crank is pressed against the wall of the target vessel sufficient to induce or affect a proximal deflection and / or deformation of the core member 103.

[0035] The elongated segment 113 of the vascular access wire tip includes a hinge 120 configured to facilitate and / or enable articulation of the crank 116 about it to translate axial motion of the core member 103 into rotational motion of the crank 116 and / or translate rotational motion of the crank 116 into axial motion of the core member 103. The hinge 120 is optionally formed from a bent portion of the core member 103 along or adjacent to the elongated segment 113. The hinge 120 may be mechanically and / or heat treated, such as in a material subtraction process, to create locally less resistance to buckling, bending, and / or bending and / or to affect a geometric misalignment sufficient to create a pivot point or area for such tilting or articulation. In some embodiments, the hinge 120 has elastic properties configured to affect self-alignment of the distal widened segment 119 with the elongated segment 113 of the vascular access wire tip upon cessation of a moment thereon. 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 wire and / or optionally 1 mm or less from the distal widening segment 119.

[0036] Coil member 104 is optionally cylindrical with a constant outer diameter along most or all of its length and is configured to maintain a constant vascular access wire maximum outer diameter (e.g., about 0.45 mm) around the stenotic portion of core member 103, including around vascular access wire intermediate segment 108 and vascular access wire tip segment 110. Coil member 104 is connected by its proximal portion 117 to a proximal portion of vascular access wire intermediate segment 108 proximal to first stenosis 107, optionally thereby forming proximal widening 112 (shown embedded in an adhesive layer, which is an exemplary connection mechanism), and is connected by its distal portion 118 to distal tip 115 of distal widening segment 119. In some embodiments, coil member 104 is configured with a first coil pitch CP1 along vascular access wire tip elongated segment 113 (optionally, particularly covering hinge 120) that is larger than its second coil pitch CP2 provided along vascular access wire intermediate segment 108 and distal extension segment 119 (optionally, also covering portions of vascular access wire tip elongated segment 113 other than hinge 120). In other embodiments, coil member 104 is configured with a first (larger) coil pitch CP1 along other portions, or along most or all of its length, such as along vascular access wire intermediate segment 108 and / or distal extension segment 119. In some embodiments, second coil pitch CP2 is substantially equal to the diameter of the coil wire (the wire forming the coil, which may be, for example, about 0.08 mm or less), such that every two adjacent coil windings touch or nearly touch, thereby resisting or preventing axial contraction and / or bending. The first coil pitch CP1 is optionally configured to be larger than the diameter of the coil wire (e.g., greater than 0.09 mm), thereby enabling axial contraction and / or bending and facilitating inclination of the distal widened segment 119 relative to the elongated segment 113 at the tip of the vascular access wire.

[0037] The vascular access wire 101 is formed by first separately fabricating the core member 103 and the coil member 104 and then connecting them as described above. The core member 103 is first formed by subtracting material from a pre-machined wire (i.e., having a substantially constant diameter), such as by grinding (e.g., using spindle axis grinding to align the wire concentrically with the spindle axis of the machine and grind while maintaining a cylindrically symmetrical shape) to arrive at a selected shape for the core member 103, including along each of the first constriction 107, the vascular access wire intermediate segment 108, the second constriction 114, the vascular access wire tip elongated segment 113, the widened portion 114, and the distal widened segment 119. A portion of the vascular access wire tip elongated segment 113 having a selected length and location can then be processed to form the hinge 120. This may include fixedly changing the linearly aligned length of the vascular access wire tip elongated segment 113, thereby forming a bent portion. Additional chemical or heat treatment may be required. Fixedly modifying the linearly aligned length to form hinge 120 may include fixedly transforming it into a curved length along which core member 103 is fixedly offset laterally relative to its linearly aligned portions proximally and distally adjacent to the curved length. Alternatively, or in addition, this process may include forming at least one lateral recess or slit from the linearly aligned length by subtractive manufacturing, such as using a laser source or by off-axis (eccentric) grinding (e.g., the ground wire is fixed parallel and transverse to the spindle axis). After forming the bend, coil member 104 is sleeved over core member 103 and positioned such that elongated segment 113 of the vascular access wire tip is surrounded by the length of coil member 104 configured with the first coiled pitch CP1. In some embodiments, the proximal portion 117 of the coil member 104 may be connected to the core member 103 by adhesive, and its distal portion 118 may be welded or soldered to the distal tip 115 of the distal widening segment 119.During or after connection of the distal portion 118 of the coil member, the dome-shaped crank 116 of the distal widening segment 119 can be connected (e.g., welded or soldered) or formed (e.g., milled or forged) from the tip of the core member 103.

[0038] FIG. 3A shows an exemplary vascular access kit 100 including a vascular access wire 101 and an exemplary needle 102. FIG. 3B is a cross-sectional side view showing a distal portion of the vascular access wire 101 positioned on the exemplary needle 102. The kit 100 may be a full or partial seedinger or other vascular access or puncture kit, may include other instruments such as a syringe, introducer sheath, and / or dilator, and may be equipped with one or more types or sizes of vascular access wire 101 and / or needle 102. The needle 102, as its exemplary configuration, is optionally at least partially similar to or identical to needle 20 or needle 60. The needle 102 includes a hollow tube 121 sized to accommodate the unimpeded passage of the vascular access wire 101 therethrough. The needle hollow tube 121 terminates in a needle tip 122 configured to facilitate initial penetration through a skin layer and a blood vessel wall of a living subject, and a beveled opening 123 terminating at the needle tip 122. The length of bevel opening 123 taken parallel to the centerline of needle hollow tube 121 is longer than the length of distal widened segment 119, and optionally, an additional length of vascular access wire 101, so that in some embodiments, when the distal ends / tips of vascular access wire 101 and needle 102 are apposed, some, most, or the entire length of elongated segment 113 of the vascular access wire tip, including the entire length of hinge 120, extends along bevel opening 123, as shown in FIG. 3B . In this manner, when vascular access wire 101 is pushed through needle 102 against a surface common to both (i.e., both in contact with or adjacent to), such as against a blood vessel wall, needle 102 does not constrain hinge 120, allowing local bending and / or flexing to affect the inclination of distal widened segment 119 relative to elongated segment 113 of the vascular access wire tip. In some embodiments, the length of the bevel opening 123 is at least twice that of the distal widening segment 119, optionally at least 2 mm, optionally at least 4 mm, or optionally at least 6 mm in length, or more, or less, or any intermediate value.

[0039] As shown in FIG. 3C , the needle 102 is penetrated into the blood vessel BV so that the bevel opening 123 is entirely within the vessel lumen. In typical practice, practitioners attempt to penetrate the vein at as shallow an angle as possible, or to rotate the needle to a shallow angle immediately after initial penetration, to reduce the potential harm of unintentional penetration of the second (lower) vessel wall by the needle tip and / or vascular access wire. However, by incorporating a kit 100 having a tip articulatable vascular access wire 101 that is not constrained by the bevel opening of the needle 102, the practitioner may penetrate the blood vessel at a less acute angle, such as between 60° and 90°.

[0040] 4A-4C each show a side view of a distal portion of an exemplary configuration of core member 103 (without or prior to shaping of distal tip 115 and / or formation of crank 116), distinguished from an exemplary configuration of hinge 120. In some embodiments, the exemplary configurations described herein are intended to cause (affect) localized buckling and / or bending of elongated segment 113 of the vascular access wire tip along or proximate hinge 120 when core member 103 is subjected to axial compression, such as when pushed with a force equal to or less than that typically used to push an access wire through an access needle. Exemplary typical pushing and / or axial compression forces on the vascular access wire sufficient to cause such buckling, bending, and / or tilting in the vascular access wire 101 are optionally less than 2 Newtons (N), optionally about 1 N or less, optionally about 0.75 N or less, optionally about 0.5 N or less, optionally about 0.2 N or less, and optionally about 0.1 N or less. This allows for or creates tilting of the distal widened segment 119 relative to the elongated segment 113 of the vascular access wire tip, even when the distal widened segment 119 is fully within the bevel opening 123 of the needle 102. In such a configuration, the objective is to avoid common failures associated with known vascular access wires and kits, whereby when the vascular access wire is pushed with normal force, such buckling, bending, and / or tilting is constrained and prevented by the needle, thereby increasing the likelihood of damaging the vessel wall by unintentional puncture and / or dissection, etc.

[0041] FIG. 4A shows a vascular access wire 101 having a first configuration of hinge 120, where hinge 120 includes a curved length 125 along which core member 103 is fixedly offset laterally relative to linearly aligned portions 126 and 127 of core member 103 adjacent proximally and distally to curved length 125. In this configuration, core member 103 is offset laterally (relative to the longitudinal axis) along curved length 120. Thus, hinge 120 induces locally less resistance to buckling and / or bending along curved length 125 than along linearly aligned portions 126 and 127 when core member 103 is subjected to axial compression. FIG. 4B shows a configuration of hinge 120 similar to the previous configuration of FIG. 4A, where the length of core member 103 distal to curved length 125 is fixedly tilted at tilt angle IA relative to the length of core member 103 proximal to curved length 125. The inclination angle IA is optionally less than about 20°, optionally less than about 10°, optionally less than about 5°, or any intermediate value. Figure 4C shows vascular access wire 101 with a second configuration of hinge 120, where hinge 120 forms a coil along curved length 125. In this configuration, core member 103 is biased in several axes along curved length 120 and can compress axially under an axial load. Thus, hinge 120 is configured such that when core member 103 is subjected to axial compression, the resistance to buckling and / or bending along curved length 125 is less than the resistance along linearly aligned portions 126 and 127 in any direction.

[0042] 5A-5C show a cross-sectional side view (FIG. 5A) of a distal portion of vascular access wire 101 having a pre-shaped tip 115' prior to welding and shaping distal tip 115, and a cross-sectional side view (FIG. 5B) and a side view (FIG. 5C), respectively, of the distal portion after welding and shaping distal tip 115. As shown, coil member 104 is sleeved over core member 103, and distal end 128 of core member 103 is juxtaposed with distal end 129 of coil member 104. Distal ends 128 and 129 are then joined together as a single piece to form distal tip 115, for example, by welding, soldering, and / or fusing (e.g., fusion welding) the pre-fused portions of core member 103 and coil member 104 together. The welding and / or fusing includes or follows shaping the distal tip 115 by melting the pre-shaped tip 115' and allowing it to cool or cool into a new shape including a crank 116 having a spherical dome-shaped portion with a distally pointing apex. In some embodiments, the pre-fused portion is configured to form a weld pool to facilitate the welding and / or fusing, and the pre-shaped tip 115' and / or distal tip 115 are configured to maintain most or all of the heat-affected zone resulting from the welding and / or fusing. Thus, the core member 103 adjacent the hinge 120 (before or after it is formed) is structurally and / or functionally unaffected by the welding and / or fusing.

[0043] 6 shows a side cross-sectional view of an exemplary anchor 200 configured to form a hinge (as a bend) in a vascular access wire, for example, hinge 120 in core member 103. The anchor 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 with a fixation space therebetween, and the base 203 can be fixedly connected in place. The rigid body 201 has an elongated passageway extending from its rear to its front side. A rigid channel 204 (e.g., in the form of a straight cannula or pipe) is fixedly held within and along the passageway of the rigid body 201 such that a forward channel portion 205 emerges from the forward side of the rigid body 201. The rigid channel 204 is cylindrical and sized to accommodate a wire, such as the vascular access wire 101, therethrough and includes a central axis that coincides with the pushing axis PA, along which the wire can be pushed through the rigid channel 204. The anvil 203 has a surface 206 that is perpendicular to the pushing axis PA. The surface 206 surrounds a niche 207 located just anterior to the front channel portion 205, the central axis of which also coincides with the pushing axis PA. An unsupported distance 208 between the innermost cavity of the niche 207 and the tip of the front channel portion 205 is selected according to, for example, the preferred location of the hinge 120 relative to the distal tip 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.

[0044] 5C , the wire 101 can be positioned within a rigid channel 204 having a surface 206 and a distal tip 115 facing toward a niche 207. The distal tip 115 can then be gradually pushed until it contacts the niche 207 and a portion of the distal tip 115 is supported (e.g., nested) within the niche 207, thereby preventing the distal tip from moving laterally relative to the pushing 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 niche 207 and is free to buckle or bend laterally relative to the pushing axis PA, while a supported length of the core member 103 proximal to the unsupported length is held within the rigid channel 204 and prevented from buckling or bending laterally relative to the pushing axis PA. 7A-7C show sequential frames visualizing a distal portion of an exemplary vascular access wire, such as wire 101, during an exemplary process of forming a hinge, such as hinge 120, using a fixture, such as fixture 200. FIG. 7A shows an initial setup in which unsupported length 210 extends through channel portion 205 and is supported distally within niche 207. Wire 101 is then pushed (along pushing axis PA) toward surface 206 sufficiently to cause bending and / or buckling of unsupported length 210 ( FIG. 7B ), and optionally, additional length of wire 101 then exits channel portion 205 until distal tip 115 is pushed out of niche 207 ( FIG. 7C ). Unsupported length 210 includes distal tip 115 and a portion of elongated segment 113 such that bending and / or buckling occurs proximally adjacent to and along distal tip 115. In some embodiments, the properties of the core member 103, the selected magnitude of the unsupported distance 208, and / or the force applied to push the wire 101, resulting in bending and / or buckling, cause a fixed alternation of linearly aligned lengths of the core member 103 and / or a fixed deformation (e.g., by plastic deformation) of portions of the core member 103 into curved lengths.

[0045] Each of the following terms is written in singular grammatical form. As used herein, "a," "an," and "the" mean "at least one" or "one or more." The use of the phrase "one or more" herein does not change this intended meaning of "a," "an," or "the." Thus, as used herein, the terms "a," "an," and "the" can also refer to and include a plurality of stated entities or objects, unless otherwise specifically defined or stated herein or unless the context clearly dictates otherwise. For example, as used herein, the terms "unit," "device," "assembly," "mechanism," "component," "element," and "step or procedure" can also refer to and include a plurality of units, devices, assemblies, mechanisms, components, elements, and steps or procedures, respectively.

[0046] Each of the following terms, "includes," "including," "has," "having," "comprises," and "comprising," and their linguistic / grammatical variations, derivatives, and / or conjugates, as used herein, means "including, but not limited to" and should be interpreted as specifying the stated components, features, and characteristics. No parameter, integer, or step precludes the addition of one or more additional components, features, characteristics, parameters, integers, steps, or groups thereof. Each of these terms is considered equivalent in meaning to the phrase "consisting essentially of."

[0047] The term "method," as used herein, refers to steps, procedures, modes, means, or / and techniques for accomplishing a given task, including, but not limited to, steps, procedures, modes, means, or / and techniques that are known or readily developed from known steps, procedures, modes, means, or / and techniques by a practitioner in the art relevant to the disclosed disclosure.

[0048] Throughout this disclosure, numerical values of parameters, features, characteristics, objects, or dimensions may be described or stated in terms of a numerical range format. When used herein, such numerical range formats illustrate implementations of some exemplary embodiments of the present disclosure and do not inflexibly limit the scope of the exemplary embodiments of the present disclosure. Thus, a stated or described numerical range also refers to and encompasses all possible subranges and individual numerical values (wherein numerical values may be expressed as integers, whole numbers, or fractions) within that stated or described numerical range. For example, a stated or described numerical range of "1 to 6" also refers to and encompasses all possible subranges, such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," "3 to 6," and individual numerical values, such as "1," "1.3," "2," "2.8," "3," "3.5," "4," "4.6," "5," "5.2," and "6," within the stated numerical range of "1 to 6." This applies regardless of the numerical width, range, or magnitude of the stated or described numerical range.

[0049] Furthermore, for the purpose of describing or describing a numerical range, the phrase "in a range of between about a first numerical value and about a second numerical value" is considered equivalent and to have the same meaning as the phrase "in a range of from about a first numerical value to about a second numerical value," and thus these two equivalent phrases can be used interchangeably. For example, for the purpose of describing or describing a numerical range of room temperature, the phrase "room temperature," referring to a temperature in the range of about 20° C. to about 25° C., is considered equivalent and to have the same meaning as the phrase "room temperature," referring to a temperature in the range of about 20° C. to about 25° C.

[0050] As used herein, the term "about" refers to ±10% of the stated numerical value.

[0051] It should be fully understood that certain aspects, characteristics, and features of the present disclosure that are, for clarity, illustratively described and presented in the context or form of multiple separate embodiments, may also be illustratively described and presented in any suitable combination or subcombination in the context or form of a single embodiment. Conversely, various aspects, characteristics, and features of the present disclosure that are illustratively described and presented in combination or subcombination in the context or form of a single embodiment may also be illustratively described and presented in the context or form of multiple separate embodiments.

[0052] While the present disclosure has been illustratively described and presented by way of specific and exemplary embodiments and examples thereof, it is evident that many alternatives, modifications, and / or variations thereof will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and / or variations that fall within the spirit and broad scope of the appended claims.

[0053] All publications, patents, and / or patent applications cited or referenced in this disclosure are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, and / or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference herein should not be construed or understood as an admission that such reference represents or corresponds to prior art to the present disclosure. To the extent section headings are used, they should not be construed as necessarily limiting.

[0054] When describing absolute values of features or characteristics of objects or acts described herein, the terms "substantial," "substantially," "essentially," "approximately," and / or other terms or phrases may be used without specifically reciting a numerical range. When applied to features or characteristics of objects or acts described herein, these terms refer to a range of the feature or characteristic consistent with providing a desired functionality associated with that feature or characteristic.

[0055] Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, the present disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the claims, principles, and novel features disclosed herein. The word "exemplary" is used exclusively herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" should not necessarily be construed as preferred or advantageous over other implementations.

[0056] Some features described herein 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 in multiple implementations separately or in any suitable subcombination. Furthermore, while features may be described above as working in a particular combination and may initially be claimed as such, one or more features from a claimed combination may, in some cases, be deleted from that combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination.

[0057] The methods disclosed herein include one or more steps or actions for achieving the described method. The steps and / or actions of the methods may be interchanged with one another 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. 1. A vascular access wire, comprising: an elongated core member; a distal tip comprising a crank configured with a crank distal surface and a crank center of rotation; A vascular access wire, wherein the crank is configured to rotate about the crank center of rotation to induce or affect deflection and / or deformation of the core member proximally when the core member is sufficiently axially loaded and when the crank distal surface is pressed against the wall of the target vessel.

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

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

4. The vascular access wire of claim 3 , wherein the crank distal surface has a crank radius of curvature in the range of 0.1 mm to 0.5 mm, optionally specifically about 0.25 mm.

5. 2. The vascular access wire of claim 1, wherein the core member includes or is integrated with the distal tip by a hinge configured to facilitate and / or allow articulation of the crank about the hinge to translate axial movement of the core member into rotational movement of the crank and / or translate rotational movement of the crank into axial movement of the core member.

6. The vascular access wire of claim 5 , wherein the distance of the hinge from the crank center of rotation is less than a diameter of the blood vessel.

7. The vascular access wire of claim 6 , wherein the distance of the hinge from the crank center of rotation is about 2 mm or less, or optionally specifically about 1 mm or less.

8. 6. The vascular access wire of claim 5, wherein the hinge is configured as a bent portion of the core member and includes a curved length along which the core member is fixedly offset laterally relative to linearly aligned portions of the core member adjacent proximally and distally to the curved length.

9. The vascular access wire of claim 8 , wherein the bent portion has a length of about 0.5 mm or less.

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

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

12. The vascular access wire of claim 1 , further comprising a cylindrical coil member extending longitudinally around the length of the core member, the distal tip fixedly joining a distal end of the core member and the coil member.

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

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

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

16. The vascular access wire of claim 1 , wherein the core member includes an elongated segment extending between a proximal expansion segment and a distal expansion segment, such that the deflection and / or deformation occurs in the elongated segment.

17. 17. The vascular access wire of claim 16, wherein the elongated segment includes or is integrated with the distal widened segment by a hinge configured to facilitate and / or enable articulation of the crank about the hinge to convert between rotational motion of the crank and linear motion of the core member.

18. The vascular access wire of claim 16 , wherein the distal widened segment merges with the distal tip at a distal integration portion.

19. The vascular access wire of claim 16 , wherein a volume ratio between a total volume of the distal tip and a total volume of the distal widened segment is greater than 1.

3.

20. The total volume of the distal tip is 0.2 mm ３ ~0.5mm ３ and / or the total volume of the distal widening segment is within the range of 0.005 mm ３ ~0.03mm ３ The vascular access wire of claim 16 , wherein the wire length is in the range of

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

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

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

24. The vascular access wire of claim 16 , wherein the coiled member is configured with a greater coil pitch along the elongated segment than along the distal flared segment.

25. 1. A vascular access kit, comprising: The vascular access wire according to claim 5 ; a needle having a beveled opening; The vascular access kit, wherein the hinge is positioned along the bevel opening when the distal end of the vascular access wire is juxtaposed with the distal end of the needle.

26. 26. A method of creating vascular access using the vascular access kit of claim 25, comprising: penetrating a blood vessel with the beveled opening; and pressing the distal tip of the vascular access wire against the wall of the blood vessel through the bevel opening until generating rotational movement of the crank about the crank center of rotation sufficient to induce and / or affect deflection and / or deformation of the core member proximally of the crank and / or to induce or affect articulation of the crank about the hinge.

27. advancing the vascular access wire distally in the blood vessel; allowing the core member to bend backward and / or realign with the distal tip; 27. The method of claim 26, further comprising:

28. 13. The method of manufacturing a vascular access wire of claim 12, comprising joining a distal end of the core member and a distal end of the coil member and forming a hinge.

29. 30. The method of claim 28, wherein the forming step includes or is caused by fixedly varying the linearly aligned length of the core member.

30. 30. The method of claim 28, wherein the forming step includes or is caused by rigidly deforming a portion of the core member into a curved length.

31. 30. The method of claim 28, wherein the forming step includes forcing the core member along a selected axis of force against a surface perpendicular to the axis of force.

32. 32. The method of claim 31 , wherein the forcing is performed while a selected unsupported length of the core member is allowed to buckle or bend laterally relative to the pushing axis and a supported length of the core member proximal to the unsupported length is prevented from buckling or bending laterally relative to the pushing axis.

33. 32. The method of claim 31, wherein a portion of the distal tip is prevented from moving laterally relative to the pushing axis and / or is supported in a niche surrounded by the surface.

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

35. 35. The method of claim 34, wherein the forming step follows the bonding step and / or the molding step.

36. 35. The method of claim 34, wherein the joining step includes or results in the molding step.

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

38. 35. The method of claim 34, wherein the shaping step includes shaping a pre-shaped tip into the distal tip.

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

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

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

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