Guidewire with elastically articulatable tip

Abstract

To provide guidewires and / or vascular access kits configured to prevent unintentional puncture of blood vessel wall when forming access into a blood vessel.SOLUTION: A guidewire 30 for vascular access has an elastically articulatable tip configured to minimize risk of blood vessel wall OBW damage during initial insertion of the guidewire 30 into the vasculature of a patient. The guidewire 30 may have a local flexible portion in a tip segment of the guidewire 30 and / or a core thereof.SELECTED DRAWING: Figure 4C

Description

Technical Field

[0001] In some embodiments thereof, the present disclosure relates to devices and methods for accessing blood vessels, and more particularly, but not limited thereto, to guidewires and / or vascular access kits.

Background Art

[0002] The Seldinger technique is currently the preferred technique for accessing blood vessels. In this technique, a needle penetrates the blood vessel, and when it is confirmed that the needle is inside the blood vessel, a guidewire is inserted through the needle, maneuvered to the desired location in the blood vessel, and then the needle is removed, and a catheter can be positioned over the guidewire in the designated area.

[0003] When using the Seldinger technique, unintentional perforation or incision of the blood vessel is not an uncommon failure. When the needle tip is positioned near the centerline of the blood vessel and at an acute angle thereto, the guidewire should exit the needle tip without causing unnecessary perforation as described. The operator may perform a blood return that is assumed to be a positive indicator of the correct placement of the inserted needle through the inserted needle. However, in many cases, the needle tip is too close to or even partially penetrates the opposite vessel wall and / or the access angle of the needle to the blood vessel is too shallow (e.g., greater than about 60°). However, since the guidewire is forced into the blood vessel through the needle, especially if the guidewire is designed to have sufficient pushability to travel through the needle into the blood vessel, the tip of the guidewire may perforate the vessel wall and / or incise the vessel wall layer.

[0004] When forming access to a blood vessel, the problem of inadvertently piercing the vessel wall (e.g., perforating and / or incising) is particularly prominent in blood vessels, where the wall is thin and flexible, such that an operator may continue to advance a guide wire outside the blood vessel through an inadvertently formed puncture without perceiving any resistance from the needle at all.

[0005] It should be noted that this background art is not intended to be an aid in determining the scope of the claimed subject matter, nor is it intended to be construed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above. None of the techniques, documents, or references in this background art section should be construed as an admission that the described subject matter is prior art to any of the claimed subject matter herein. SUMMARY OF THE INVENTION

[0006] The present disclosure, in some of its embodiments, relates to devices and methods for accessing blood vessels, and more specifically, but not limited thereto, to a guide wire and / or a blood vessel access kit configured to prevent inadvertent puncture of the blood vessel wall when forming access to the blood vessel.

[0007] In one implementation, the guide wire includes a guide wire body ending in a tip region, the tip region including a local articulation bend, a forward portion extending distally from the local articulation bend, and a rearward portion extending proximally from the local articulation bend. The articulation bend is configured to have a resistance to bending that is substantially less than the resistance to bending in the remaining portion of the guide wire body, whereby the forward portion is elastically articulable relative to the rearward portion about the articulation bend. A guide wire for transcatheter delivery of an artifact into a blood vessel is included.

[0008] In another implementation, the guide wire includes a guide wire body, which includes a proximal section of the guide wire, a distal section, and a middle section of the guide wire that extends between the proximal section and the distal section of the guide wire. The resistance to bending in the middle section of the guide wire along most or all of its length is less than the resistance to bending along most or all of the length of the proximal section of the guide wire. The distal section includes a local joint bending portion, and the local joint bending portion has a resistance to bending that is substantially less than the resistance to bending in the middle section of the guide wire, the front portion of the distal section that extends distally from the local joint bending portion, and the rear portion of the distal section that extends proximally from the local joint bending portion, thereby affecting the local elastic joint movement of the front portion of the distal section relative to the rear portion of the distal section and / or the middle section of the guide wire.

[0009] In another implementation, the guide wire includes an elongated core member that includes a distal section, where the distal section terminates at a distal end for insertion into a patient's blood vessel. The distal section has a bending resistance profile configured to transition the distal section from a substantially straight configuration to a folded configuration in response to an insertion force that presses the distal end against the blood vessel wall, where the folding occurs without the distal end substantially piercing the tissue of the blood vessel wall against which the distal end is pressed.

[0010] In another implementation, the guide wire includes a distal section that terminates at the distal end of the guide wire, where the distal section is characterized by a bending resistance profile that includes a first region characterized by a first bending resistance, a second region characterized by a second bending resistance, and a third region characterized by a third bending resistance, the second region is positioned between the first region and the third region, the second bending resistance is less than both the first bending resistance and the third bending resistance, the first region includes the distal end of the guide wire, and at least a portion of the first region, the second region, and the third region is continuous, and all of these are located within 20 mm from the distal end of the guide wire.

[0011] In another embodiment, the kit includes a guide wire according to any novel guide wire embodiment described herein, and a needle including an angled opening proximal to the distal needle tip in the distal direction. The angled opening is configured to have a configured length such that when the front portion of the tip section is pressed against the blood vessel wall, the front portion undergoes articulation movement about the articulation bending section as it projects axially from the angled opening.

[0012] In another implementation, a method of inserting a guide wire into a patient's blood vessel includes inserting an opening of a lumen into the patient's blood vessel, and inserting the distal end of the guide wire into the lumen until the distal end projects from the opening and contacts the lower blood vessel wall to form a catch point there. The method further includes (1) buckling the tip section of the guide wire extending in the proximal direction from the distal end of the guide wire, thereby releasing the distal end of the guide wire from the catch point, and (2) elastically returning the tip section of the guide wire to an unbuckled state and applying an insertion force to the proximal portion of the guide wire so as to be sufficient to direct the distal end of the guide wire in the intended operating direction inside the blood vessel.

[0013] In any embodiment of the guide wire, kit, or method described herein, any one or more of the following features may be provided in any combination.

[0014] The articulation bending section may have a length of about 3 mm or less and may be located within about 5 mm from the distal end of the guide wire body.

[0015] The articulation bending section may be configured to elastically restore the orientation before articulation movement and / or the alignment of the front portion and the rear portion when the front portion is released from being forced to undergo articulation movement with respect to the rear portion.

[0016] When the front part of the distal section is forced to undergo articular movement with respect to the rear part, the articulating portion may be configured to promote and / or cause the rear part of the distal section to elastically recoverably buckle as the guide wire body is longitudinally compressed against the blood vessel wall.

[0017] The guide wire may include an elastic core member extending along most or all of the length of the guide wire body, and the core member incorporates the articulating portion along the distal section.

[0018] The elastic core member may include a widened portion proximal to the articulating portion, and the diameter of the elastic core member substantially increases along the front part from the widened portion to the distal end of the guide wire body.

[0019] The elastic core member along the rear part may have a diameter substantially the same as that of the articulating portion.

[0020] The articulating portion may be configured to promote and cause the elastically recoverable buckling of the rear part of the distal section as the guide wire body is longitudinally compressed against the blood vessel wall when the front part of the distal section is forced to undergo articular movement with respect to the rear part.

[0021] The distal section may have an overall length of 20 mm or less.

[0022] The distal section may have an overall length of 10 mm or less.

[0023] The distal section may have an overall length of 5 mm or less.

[0024] The articulating portion may include at least one of a slit, an engaging portion, a recessed portion, a coiled section, or any combination thereof.

[0025] The guide wire may include an elastic core member extending along most or all of the length of the guide wire body.

[0026] The core member may have a reduced diameter from a first core member diameter proximal to the narrow portion to a second core member diameter distal to the narrow portion and smaller than the first core member diameter.

[0027] The core member may include a widened portion proximal to the joint flexion portion, and the widened portion enlarges the diameter of the core member from a third core member diameter proximal to the widened portion to a fourth core member diameter distal to the widened portion and larger than the third core member diameter.

[0028] The third core member diameter may be equal to or smaller than the second core member diameter, and / or the fourth core member diameter may be substantially equal to the first core member diameter.

[0029] The core member may be at least partially embedded in a matrix of a flexible material between the narrow portion and the widened portion of the core member, whereby the overall diameter of the guide wire body along most or all of the length of the intermediate section of the guide wire is substantially equal to the first core member diameter.

[0030] The core member may be at least partially covered by a cylindrical coiled member between the narrow portion and the widened portion of the core member, whereby the overall diameter of the guide wire body along most or all of the length of the intermediate section of the guide wire is substantially equal to the first core member diameter.

[0031] The coiled member may be formed of a spring and / or an elastic metal alloy, and the coiled member is fixed to the core member at or near the narrow portion and / or at or near the widened portion.

[0032] The core member may incorporate a joint flexion portion along the tip section.

[0033] The joint flexion portion may have a length of 5 mm or less along the guide wire body.

[0034] The joint bending portion may have a length of 3 mm or less along the guide wire body.

[0035] The joint bending portion may have a length of 1 mm or less along the guide wire body.

[0036] The core member may be formed of a selectively heat-treated shape memory alloy.

[0037] The heat treatment may be configured to raise the temperature of the portion of the desired length to about 500 °C or less over a period of about 1 minute or less.

[0038] Optionally, the heat treatment may be performed before fixing the distal end of the coiled member to the core member distal to the joint bending portion by welding, riveting, brazing or soldering.

[0039] When the angle formed between the front portion and the rear portion of the tip section is reduced, the resistance to bending in the joint bending portion may increase.

[0040] The minimum allowable joint angle between the front portion and the rear portion may be between 150° and 90°.

[0041] The minimum allowable joint angle may be between 135° and 95°.

[0042] When the front portion and the rear portion of the tip section are aligned, the resistance to bending in the joint bending portion may be less than the resistance to the tip section piercing the blood vessel wall.

[0043] When the front portion and the rear portion of the tip section form the minimum allowable joint angle therebetween, the resistance to bending in the joint bending portion may be greater than the resistance to buckling of the rear portion of the tip section.

[0044] The total length of the joint bending portion may be 0.5 mm or less.

[0045] The diameter of the joint flexion portion may be substantially equal to the diameter of the rear portion and / or the intermediate section of the guide wire.

[0046] The center of the joint flexion portion may be within 5 mm from the distal end of the guide wire body.

[0047] The center of the joint flexion portion may be within 1 mm from the distal end of the guide wire body.

[0048] By folding, a part of the tip section containing the distal end may be transitioned from a state facing the intended operation direction of the guide wire to a state facing away from the intended operation direction of the guide wire.

[0049] By folding, the distal end of the guide wire may be released from the retention point on the blood vessel wall.

[0050] The bending resistance may be elastic, whereby the folding is elastically recoverable and returns the tip portion to a substantially straight configuration.

[0051] The joint flexion portion may be configured to elastically restore the orientation before joint movement and / or the alignment of the front portion and the rear portion when the front portion is released from being forcibly joint-moved relative to the rear portion.

[0052] The joint flexion portion may be configured to promote and / or cause the rear portion of the tip section to elastically recoverably buckle as the guide wire body is longitudinally compressed against the blood vessel wall when the front portion of the tip section is forcibly joint-moved relative to the rear portion.

[0053] The center of the second region may be located less than 10 mm from the distal end.

[0054] The center of the second region may be located less than 5 mm from the distal end.

[0055] The second region may extend along the guide wire to a length of less than 5 mm.

[0056] The second region may extend along the guide wire to a length of less than 3 mm.

[0057] The beveled opening may have a length equal to or at most 2 mm greater than the front portion.

[0058] The beveled opening may have a length equal to or at most 2 mm less than the front portion.

[0059] The applied insertion force may be insufficient for the distal end of the guide wire to significantly penetrate the tissue of the blood vessel wall at the retention point.

[0060] The applied insertion force may be sufficient for the tip section to bend at the first position before buckling at a second position proximal to the first position.

[0061] Technical and / or scientific words, terms, and / or phrases used in this specification shall have the same or a similar meaning as commonly understood by those skilled in the technical field to which this disclosure pertains, unless explicitly defined or described in this specification. In case of conflict, this patent specification, including the definitions, shall prevail.

[0062] It will be understood that various configurations of the subject technology will be apparent to those skilled in the art from this disclosure in which various configurations of the subject technology are shown and described by way of example. As will be recognized, the subject technology can take other different configurations and some of its details can be changed in various other respects without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description should be regarded in their essence as illustrative and not restrictive.

Brief Description of the Drawings

[0063] Some embodiments of the present disclosure are described herein by way of example with reference to the accompanying drawings. Referring specifically to the drawings in detail, it is emphasized that the illustrated details are by way of example and for the purpose of illustrative explanation of some embodiments of the present disclosure. In this regard, how some embodiments of the present disclosure can be practiced will be apparent to those skilled in the art from the detailed description presented with the accompanying drawings.

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[0064] The following description and examples illustrate in detail some exemplary implementations, embodiments, and configurations of the disclosed invention. Those skilled in the art will recognize that numerous variations and modifications of the invention exist that are within the scope of the invention. Accordingly, the description of specific embodiments should not be construed as limiting the scope of the invention.

[0065] The present disclosure, in some of its embodiments, relates to devices and methods for accessing blood vessels, and more particularly, but not limited thereto, to guidewires and / or vascular access kits configured to prevent unintentional puncture of the blood vessel wall when forming access to a blood vessel. The term "guidewire" (or "guide wire") refers to any thin member configured to facilitate the selection and advancement of an artifact along a blood vessel in the body for passing the artifact to a desired location within the body, such as by passing a sheath, cannula, catheter, or any other device on the guidewire through the lumen or into the blood vessel. In some embodiments, the term "guidewire" includes, for example, optionally, a vascular access wire used in the process of forming vascular access before inserting another guidewire defined to send an artifact deep into the patient's vascular structure.

[0066] Figure 1A schematically shows a prior art guide wire (10) having an elongated guide wire body (11), which includes a proximal section (12) adjacent to a distal section (13), as is the case with a typical commercially available guide wire. As is known in the art, in order to facilitate pushing the guide wire through a bend or the like into a patient's vascular structure, the proximal section (12) and the structural member forming its outer diameter may be narrower at some point along its length (or gradually along its entire length). The distal section (13) may be covered with a coiled member, or an elastic paint or elastic matrix. This design concept was developed to improve the flexibility and maneuverability of the distal section of the guide wire when inserted into the blood vessel while preventing its buckling, but the problems related to accessing the blood vessel with the initial guide wire were not solved.

[0067] As shown in FIGS. 1B - 1C, which illustrate a part of the conventional Seldinger method, first, a needle (20) is inserted into a blood vessel BV until its needle tip (21) is positioned in the vicinity of the opposite blood vessel wall OBW. Thereafter, the distal section (13) of the guide wire (10) is inserted into the blood vessel BV through the needle (20). In related publications, the distal section (13) is considered to be relatively flexible, but the initial protruding length (15) of the distal section (13), which exits from the beveled opening (22) near the tip (21) of the needle (20), is too short to bend at a joint, which is because, as shown in FIG. 1C, its resistance to bending is greater than the resistance of the blood vessel wall OBW to being pierced by the distal end (16) of the guide wire (10).

[0068] Figures 2A-2C schematically show some views of an exemplary guide wire (30) configured to deliver an artifact into a blood vessel transvaginally. As shown in Figure 2A, the guide wire (30) includes a guide wire body (31) having a guide wire distal portion and / or its core member, which includes an intermediate section (35) and a tip section (40). The guide wire intermediate section (35) is part of the distal section of the prior art guide wire described above, which may have greater flexibility and / or elasticity compared to the guide wire proximal section.

[0069] The distal section (40) has an overall length that is at least as long as the initial protrusion length (38) of a guidewire (30) defined to exit through an access needle (e.g., the needle (20) shown in FIG. 1B) for accessing a blood vessel (as shown in FIG. 3B). Optionally, the distal section (40) has a length that is two to three times the initial protrusion length (38). Optionally, the distal section (40) has an overall length of about 20 mm or less, optionally about 10 mm or less, optionally about 5 mm or less, and optionally an overall length between about 1 mm and about 4 mm. FIG. 2B is an enlarged schematic view of a portion of the distal section (40). The distal section (40) is characterized by a bending resistance profile such that different portions of the distal section have different bending resistances. The bending resistance profile is configured to facilitate and / or cause a relative elastic articulation movement between a forward portion (42) (which extends proximally from the articulation bending portion (41)) and a rearward portion (43) (which extends distally from the articulation bending portion (41)) that are in the vicinity of the distal section (40) with such longitudinal compression, and may include an articulation bending portion (e.g., a point, region, length, or extent) (41). The center of the articulation bending portion (41) may advantageously be within about 5 mm, and optionally specifically within about 1 mm, from the distal end (37) of the guidewire. The articulation movement may be in the form of bending, articulation bending, or pivoting, for example, about or within the articulation bending portion (41) in one direction, a plurality of specific directions, or any direction. The articulation bending portion (41) optionally includes at least one of a slit, an engagement portion, a recess, a coiled section, or any combination thereof. Alternatively, the articulation bending portion (41) may be made different from or in addition to other portions of the distal section (40) by heat treatment and / or chemical treatment, etc., and optionally may be made in a suitable state without affecting the articulation bending portion (41) by a change in dimension (e.g., diameter). The elastic articulation movement means that when the articulation bending force ceases or drops below a specific threshold value, the adjacent portions (42) and (43) and / or the articulation bending portion (41) return to their original positions, and relative positioning is achieved without stress or with little stress.Optionally, the front portion (42) and the rear portion (43) of the tip region (40) are normally aligned with each other, which means that, after elastic joint movement is performed and the joint flexion (joint movement) force is interrupted, due to the internal stress created by the restoring elastic joint movement of the joint flexion portion (41), the joint flexion portion (41) and / or the front portion (42) and the rear portion (43) tend to elastically restore towards where the front portion (42) and the rear portion (43) are relatively aligned.

[0070] In some embodiments, the region of the tip section that includes the joint flexion portion (41) (which may also be referred to as the second region) has less resistance to flexion than the front portion (42) and the rear portion (43) of the tip section (40) (which may also be referred to as the first region and the third region, respectively), such that, by applying a flexion force or moment thereto, the front portion (42) optionally remains substantially non-joint-flexed or even performs a joint movement (e.g., rotation) relative to the rear portion (43) that remains straight relative to the rest of the guide wire body (31). When no stress is applied, the front portion (42) and the rear portion (43) of the tip region (40) optionally normally align with each other or form a nominal positioning angle α nom therebetween, which is optionally greater than 135°, specifically greater than 150° optionally, and specifically about 180° optionally (i.e., the front portion (42) and the rear portion (43) are normally straight with respect to each other). When the front portion (42) and the rear portion (43) deviate from the nominal relative positioning or the relative positioning without stress applied, optionally the resistance to flexion in the joint flexion portion (41) increases. In some embodiments, the guide wire (30) is configured to have a minimum allowable joint angle α max between the front portion (42) and the rear portion (43) when a maximum allowable force F min is applied, which is optionally greater than 90°, between about 150° and about 90° optionally, and specifically between about 135° and about 95° specifically.

[0071] In some embodiments, the (minimum) resistance to flexion in the articulation portion (41) is less than the minimum axial force sufficient to pierce the tip section (40) into the vessel wall when the portions (42) and (43) near the tip section (40) are aligned (e.g., as shown in FIG. 3B), pressing the distal end of the guide wire (30) against the vessel wall (the inner wall structure of the vein), and the resistance gradually increases with the degree of articulation movement. This feature may be considered advantageous in helping to prevent unintentional perforation of the host vessel wall, such as during insertion of the guide wire (30) into the vessel.

[0072] Optionally further, as the articulation angle approaches the minimum allowable articulation angle α min the resistance to flexion increases and becomes greater than the resistance to buckling of the non-articulation portion, which is the remaining portion of the tip region (40) including the rear portion (43). This feature further helps to prevent or reduce damage (e.g., incision) to the vessel wall proximal to the access needle by pushing the guide wire (30) further into the vessel, directing the tip region (40) forward away from the vessel wall and the access needle through the patient's vascular structure and, in some cases, in a direction opposite to the intended operating direction of the guide wire, and optionally helps even after inadvertently piercing the vessel wall beforehand.

[0073] In some embodiments, the guidewire (30) is provided in a kit that includes at least one other vascular access member, such as the needle (120) shown in FIG. 3A. The kit may also include a sheath and / or a dilator. The needle (120) includes an angled opening (122) proximal to the distal needle tip (121) in the distal direction. The needle (120) and the guidewire (30) are configured such that the angled opening (122) has the same length as the front portion (42) of the tip section (40), whereby when the guidewire body is pressed against the vessel wall, the front portion (42) is configured to articulate about the articulation bend (41) as it axially protrudes relative to the distal needle tip (121). In some embodiments, the angled opening (122) has a length equal to or at most 2 mm greater than the front portion (42). Alternatively, the angled opening (122) may have a length equal to or at most 2 mm less than the front portion (42).

[0074] Next, referring to FIGS. 3A-3E, FIGS. 3A-3E schematically show some diagrams representing scenarios that may be considered in the implementation of a method for feeding the guidewire (30), which are optionally part of an exemplary vascular access method. In some embodiments, this vascular access method can be applied using different types of access needles, such as the needle (20). However, in some examples, it may be further advantageous to apply this exemplary technique using the needle (120) in order to maximize the results of the above method and / or to further reduce or prevent the possibility of inadvertently piercing the vessel wall.

[0075] First, the needle (120) is inserted into the blood vessel BV generally in the intended guide wire operation direction until the needle tip (121) is positioned in the vicinity of the opposite blood vessel wall OBW (Figure 3A). Thereafter, the guide wire (30) is inserted into the needle (120), whereby the tip section (40) projects beyond the needle tip (121) through the beveled opening (122) (Figure 3B), and in some cases, a small indentation or compression is caused in the opposite blood vessel wall OBW to create an anchoring point where the tip of the guide wire is inhibited from further moving in the intended operation direction. The indentation or compression may have a size corresponding to the pressing force applied thereto, as well as tissue elasticity and resistance to compression. At this stage, the articulation bending section (41) already projects at least partially forward (distally) from the beveled opening (122) of the needle.

[0076] Figure 3C shows the guide wire (30) after being further pushed into the blood vessel BV. As both (longitudinal compression in the tip section (40) and resistance to compression in the opposite blood vessel wall OBW) increase, the moment acting on the articulation bending section (41) finally exceeds the initial resistance to bending, whereby the front section (42) makes an articulation movement with respect to the rear section (43) as shown.

[0077] When the longitudinal compression of the guide wire body (31) against the blood vessel wall exceeds a specific threshold value (optionally a predetermined threshold value or within a predetermined range), the joint angle becomes the nominal positioning angle α nom and the minimum allowable joint angle α minWhen in between, the tip section (40) is configured to buckle in a buckled shape (proximally) on the articulating bend section (41) with respect to the rest of the guide wire body (31) (FIG. 3D). As described previously, the buckling is set to occur before the created compressive force becomes sufficient to pierce the blood vessel wall OBW. The tip section (40) is optionally configured to buckle in a selected or predetermined direction, whereby the apex (44) of the tip section (40) in the buckled shape faces forward within the blood vessel BV so as to be away from the guide wire body (31) and the blood vessel wall OBW.

[0078] Furthermore, when the rear portion (42) is substantially horizontal with respect to the blood vessel wall OBW and is pressed against it along most or all of its side length, the pressure applied to the blood vessel wall OBW through it is reduced. Therefore, the articulating front portion (42) effectively functions as a stopper against further lateral advancement towards the opposite blood vessel wall OBW, thereby affecting the forward advancement of the portion proximal to the apex (44) of the guide wire body (31). With the further forward advancement of the guide wire (30) into the blood vessel BV, the tip section (40) can optionally bounce forward (as shown, for example, in FIG. 3E) and resume a more straight shape with respect to the blood vessel contour.

[0079] Figures 4A - 4E schematically show several figures representing other scenarios that may be considered in the implementation of a method for feeding the guide wire (30) using an exemplary vascular access method. This series of scenarios relates to possible results and / or conceivable advantages in the use of the guide wire (30) after inadvertently piercing the blood vessel wall after insertion, which causes an initial piercing of the blood vessel wall by the guide wire as the guide wire exits the access needle. For example, such an event may be more likely when using an off-the-shelf needle such as the needle (20) as opposed to using a dedicated kit including the guide wire (30) and the needle (120).

[0080] As shown, the needle (20) is inserted into the blood vessel BV until the needle tip (21) inadvertently pierces the opposite blood vessel wall OBW and stops in front of the inner blood vessel wall layer IWL. Thereafter, the guide wire (30) is inserted into the needle (20), whereby the distal section (40) projects beyond the needle tip (21) through the articulating bend (22) until it reaches the inner wall layer IWL and the articulating bend section (41) is positioned adjacent to the bevel opening (22) (Figure 4B). At such a stage, the articulating bend section (41) can freely articulate the front section (42), and the resistance to further advancement of the distal section (40) of the needle increases, causing the front section (42) to articulate with respect to all other members including the rear section (43), the remaining portion of the guide wire (30), and the needle (20), as shown in Figure 4C.

[0081] When the joint angle is between the nominal positioning angle α nom and the minimum allowable joint angle α min the distal section (40) is configured to buckle (in the proximal direction) in a buckled shape on the articulating bend section with respect to the remaining portion of the guide wire body (31) (Figure 4D). The distal section of the guide wire (40) is configured to buckle before reaching an axial force sufficient to further pierce the opposite blood vessel wall OBW through the inner wall layer IWL. The distal section (40) is optionally configured to buckle in a selected or predefined direction, whereby the apex (44) of the distal section (40) in the buckled shape faces forward within the blood vessel BV so as to be away from the guide wire body (31) and the blood vessel wall OBW.

[0082] Furthermore, when the rear portion (42) is substantially horizontal with respect to the inner wall layer IWL and is pressed against it along most or all of the length of its side surface, the pressure applied through it to the inner wall layer IWL decreases. Therefore, the articulating front portion (42) functions effectively as a stopper against further lateral progression towards the opposite vessel wall OBW, thereby affecting the forward progression of the portion proximal to the apex (44) of the guide wire body (31). With further forward progression of the guide wire (30) into the blood vessel BV, the tip section (40) can optionally bounce forward (as shown, for example, in Figure 4E) and resume a more straight shape with respect to the vessel contour.

[0083] Referring to FIGS. 5A-5I, FIGS. 5A-5I show cross-sectional side views of some exemplary variations of the guide wire (30). FIG. 4A shows a variation (50) of the guide wire (30) with a portion of the intermediate section (35) and the entire distal section (40). The variation (50) of the guide wire includes an elastic core member (51) that extends along most or all of the length of the guide wire, which is optionally formed of a metal alloy such as a Ni-Ti alloy. The core member (51) narrows in width at the second transition point (36), whereby it is narrower along most or all of the length of the distal section (40) of the guide wire than along most or all of the length of the intermediate section (35) of the guide wire. Also, the portion of the core member (51) that extends along the distal section (40) is eccentric with respect to the remaining portion of the core member (51) that extends along the intermediate section (35), and optionally also with respect to the proximal section (32) of the guide wire. The core member (51) is at least partially embedded in a matrix (52) of a flexible material along the distal section (40), having a minimal resistance to buckling, whereby the entire cross-section of the distal section (40) is concentric with the remaining length of the core member (51) along the intermediate section (35) of the guide wire. The narrow portion of the wire reduces the moment of inertia, thereby resulting in a reduction of the buckling force with longitudinal compression. The eccentricity with respect to the center-to-center distance, and the eccentricity with respect to the diameter of the wire, form an asymmetric structure, thus being able to change the movement from buckling to bending due to a reduction of the buckling force with longitudinal compression and / or the generation of a moment. Covering with a flexible matrix enables large bending forces at a small radius while maintaining the general diameter of the wire.

[0084] Figure 5B shows a modified example (55) of the distal portion of a modified example (50) of a guide wire, where the distal portion is narrower in width at two longitudinally spaced points (56) and (57), whereby the distal portion (58) of the distal portion (40) is more flexible than the proximal portion (59) of the distal portion and has less resistance to buckling, while the proximal portion (59) is more flexible than the guide wire intermediate portion (35) and has less resistance to buckling. Figure 4C shows a modified example (60) of the distal portion of a modified example (50) of a guide wire, where the core member (51) has at least one articulation flexion portion (61) in the form of a short recess along the distal portion (40), which is configured to facilitate or cause relative elastic articulation movement of the portions (62) and (63) adjacent to the articulation flexion portion (61) in the vicinity of the distal portion (40).

[0085] Figure 5D shows a modified example (65) of the distal portion of a modified example (50) of a guide wire, where the core member (51) has a distal end (66) spaced apart from the distal end (37) of the guide wire, whereby the most distal portion (67) of the distal portion (40) extending between the distal end (66) of the core member and the distal end (37) of the guide wire is occupied only by the matrix (52). The matrix (52) is substantially more flexible or malleable than the core member (51) embedded in the matrix (52), so that the most distal portion (67) is functionally configured as an articulation flexion portion (41) and promotes elastic articulation movement of the remaining portion of the distal portion (40) about the distal end (66) of the core member.

[0086] FIG. 5E shows a modification (70) of the distal portion of a modification (50) of a guide wire, where the narrow portion of the core member (51) extends straight and eccentrically along the first side surface (71) of the distal portion (40) from the intermediate portion (35) of the guide wire, curves towards the second side surface (73) of the distal portion (40) at the curved portion (72), the second side surface (73) is optionally on the opposite side of the first side surface (71), and the narrow portion of the core member (51) extends further straight and eccentrically along the second side surface (73) of the distal portion (40) towards the distal end (37) of the guide wire and ends. In this configuration, the curved portion (72) is functionally configured as a joint flexion portion (41) and / or the portion of the distal portion (40) distal to the curved portion (72) may be functionally configured as a joint movement portion (42) relative to the remaining portion of the distal portion (40).

[0087] FIG. 5F shows a modification (75) of the distal portion of a modification (50) of a guide wire, where the narrow portion of the core member (51) extends concentrically and straight from the intermediate portion (35) of the guide wire and continues to gradually narrow along at least a portion of the length of the distal portion (40). The core member (51) expands at the distal end (37) of the guide wire and optionally expands to the outer diameter of the intermediate portion (35) of the guide wire and forms a rounded tip of the guide wire (30). The core member (51) has a joint flexion portion (76) in the distal portion (40), which optionally has the form of a slit or indentation and is configured to facilitate or cause relative elastic joint movement of the portions (77) and (78) in the vicinity of the distal portion (40) adjacent to the joint flexion portion (76).

[0088] Figure 5G shows a modification (80) of a tip section modification (75), where the core member (51) is substantially thinner than the diameter of the core member along the guide wire intermediate section (35), but is thicker along the most distal portion (77) than along a portion (78) near the proximal direction of the tip section (40). The difference in thickness affects the wire's resistance to bending, thus preventing the tip section (75) from bending before section (78) (as shown in Figure 3D, section (42) remains straight, in contrast to the bent section (43)). Figure 4H shows a different modification (81) of the tip section (75), where the articulation bending portion (76) is structurally and / or functionally configured as a coil or spring. The coiled region defines the articulation bending portion and the bending mechanism, where the coiled region is compressed and deflected due to the force created within the spring.

[0089] Figure 5I shows a modification (82) of the guide wire (30), where the core member (51) along the tip section (40) is substantially narrower than along the guide wire intermediate section (35) and is spirally wound from the side of the tip section (40) at the second transition point (36) to the opposite side of the tip section (40) at the distal end (37) of the guide wire. The core member (51) is at least partially embedded in the matrix (52) along the tip section (40), with minimal resistance to buckling, such that the entire cross-section of the tip section (40) has the same outer diameter as the remaining length of the core member (51) along the guide wire intermediate section (35). The spiral structure of the tip section (40) significantly reduces its resistance to bending compared to a straight design.

[0090] Figures 6A-6B show a perspective view and a side cross-sectional view, respectively, of another exemplary variation (85) of the guide wire (30). In this variation, the guide wire (30) includes an elastic core member (86) that extends along most or all of the length of the guide wire, which is optionally formed of a metal alloy such as a Ni-Ti alloy. The core member (86) narrows in width at a first transition point (34), such that it is narrower along most or all of the length of the intermediate section (35) of the guide wire than along most or all of the length of the proximal section (32) of the guide wire. The core member (86) further narrows in width at a second transition point (36), such that it is narrower along most or all of the length of the distal section (40) of the guide wire than along most or all of the length of the intermediate section (35) of the guide wire.

[0091] The core member (86) is covered along the distal section (40) and the intermediate section (35) of the guide wire by a cover element (87) having a maximum or average diameter that is the same as or similar to the maximum or average diameter of the proximal section (35) of the guide wire, such that the guide wire (30) typically has a substantially constant diameter along at least most of its length. The cover element (87) includes a coiled member that forms a coiled structure extending along most or all of its length. The coiled structure allows for a better bending radius than a single wire of the same diameter while maintaining good flexibility characteristics and similar pushability. The cover element (87) has a local fixed deformation (88) of the coiled structure configured to perform a fixed unwind or correction of the coiled structure. Thus, the fixed deformation (88) is functionally configured as a joint flexion portion (41) to facilitate the relative elastic articulation movement of portions (42) and (43) in the vicinity of the distal section (40) separated from the fixed deformation (88).

[0092] Figures 7A-7B schematically show cross-sectional side views of a guide wire (100) including a coiled member. The guide wire (100) is, optionally, a variant of the guide wire (30) and, for example, has a structure, function, and / or implementation form that is essentially the same and / or at least partially the same as that described with reference to exemplary scenarios such as those described with reference to FIGS. 3A-3E and / or FIGS. 4A-4E when implementing the above method. The guide wire (100) includes a guide wire body (101), and the guide wire body (101) includes a guide wire proximal segment (102), a distal segment (103), and a guide wire intermediate segment (104) that extends between and interconnects or is adjacent to the guide wire proximal segment (102) and the distal segment (103). The resistance to bending in the guide wire intermediate segment along most or all of the length of the guide wire intermediate segment is less than the resistance to bending along most or all of the length of the guide wire proximal segment (102).

[0093] The distal section (103) includes a local joint flexion section (105), and the local joint flexion section (105) has a resistance to flexion that is substantially less than the resistance to flexion in the guide wire intermediate section (104), as well as in the front section (106) (extending distally from the joint flexion section (105)) and the rear section (107) (extending proximally from the joint flexion section (105)) near the distal section (103), thereby affecting the local elastic joint movement of the front section (106) with respect to the rear section (107) and / or the guide wire intermediate section (104). The joint flexion section (105) is configured to promote and cause elastic buckling of the rear section (107) as the guide wire body (101) sufficiently longitudinally compresses the blood vessel wall when the front section (106) has already undergone joint movement and is inclined with respect to the rear section (107). The distal section (103) is very short in length compared to the proximal section (102) and the intermediate section (104) of the guide wire body (101) in order to substantially retain all the required characteristics such as pushability along the entire guide wire body (101) and increased lateral flexibility along the guide wire intermediate section (104). However, the distal section (103) must be long enough to facilitate both the joint movement of the front section (106) and the buckling of the rear section (107) within the blood vessel being treated. In some embodiments, the distal section (103) has an overall length of about 20 mm or less, optionally specifically about 10 mm or less, or optionally specifically about 5 mm or less. The overall length of the joint flexion section (105) is optionally about 3 mm or less, optionally about 1 mm or less, or optionally about 0.5 mm or less, and is (e.g., its center is) within about 5 mm, optionally specifically within about 1 mm, from the distal end of the guide wire body. The joint flexion section optionally has a diameter that is substantially equal to the diameter of the rear section (107) and / or the guide wire intermediate section (104).

[0094] In some embodiments, the articulating flexion portion (105) is configured to have a variable resistance to flexion, and optionally, as the joint angle β formed between the front portion (106) and the rear portion (107) decreases, from a first angle β1 when straight (as shown in FIG. 7A) to a second angle β2 when fully articulated (as shown in FIG. 7B), etc., the variable resistance increases. In some embodiments, when the front portion (106) and the rear portion (107) are aligned, the resistance to flexion in the articulating flexion portion (105) is less than the resistance to penetration of the vessel wall by the tip section (103), such that the front portion (106) is more likely to move in an articulation about the articulating flexion portion (105) rather than inadvertently penetrate or continue to penetrate through the vessel wall, and when articulated (i.e., when the joint angle is substantially less than β1 and closer to β2), the front portion (106) functions as a stopper and is configured to resist further penetration. The second angle β2 is optionally the minimum allowable joint angle β, optionally between 150° and 90°, and optionally specifically between 135° and 95°. The tip section (103) is configured to create internal stresses that can cause or increase the likelihood of buckling of the rear portion (107) by a force applied in reverse from the vessel wall contacting the distal end of the guidewire body (101) when the joint angle β is between the first angle β1 and the second angle β2. In some such embodiments, when the front portion (106) and the rear portion (107) form a joint angle β such as a minimum allowable joint angle (second) angle β2 that is greater than the first angle β1, the resistance to flexion in the articulating flexion portion (105) is greater than the resistance to buckling in the rear portion (107) of the tip section (103).

[0095] The elastic core member (108) extends along most or the entire length of the guide wire body (101) and is optionally, but not necessarily, made of, for example, a single material or extrusion. The core member (108) is optionally formed of a shape memory alloy and / or a superplastic alloy such as a Ni-Ti alloy and incorporates an articulating bend portion (105) along the distal section (103). The core member (108) may include at least one narrow portion (109) at or near a first transition point (111) adjacent to the guide wire proximal section (102) and the guide wire intermediate section (104). The narrow portion (109) may be relatively steep (e.g., tapering with a diameter reduction of one or more steps as an example). In some embodiments, distally from the narrow portion, the core member (108) tapers continuously and gradually along the length of the guide wire intermediate section (104) in the shape of a frustum of a cone (as shown). The narrow portion (109) reduces the diameter of the core member (108) from a first core member diameter D1 proximal to the narrow portion (109) to a second core member diameter D2 distal to the narrow portion (109) that is smaller than the first core member diameter D1. The first core member diameter D1 is optionally substantially equal to the overall outer diameter of the guide wire body (101), optionally within the range of 0.2 mm to 1.2 mm, or optionally within the range of 0.3 mm to 0.6 mm, or optionally about 0.45 mm. The first core member diameter D1 may be substantially constant along most or the entire length of the guide wire proximal section (102) including the first transition point (111). The second core member diameter D2 may be at least about 0.1 mm smaller than the first core member diameter D1 and is located within a few millimeters, optionally within about 1 mm, distal to the first transition point (111).

[0096] The distal section (103) is adjacent to the guide wire intermediate section (104) at the second transition point (114) and may continue in a substantially conical shape without a narrow section up to and including the articulating bend section (105) as shown, however, the core member (108) may include a second narrow section at or near the second transition point (114). The core member (108) may also include a widened section proximal to the articulating bend section (105), whereby the core member (108) has a diameter that increases from a third core member diameter D3 proximal to the widened section (110) to a fourth core member diameter D4 (greater than the third core member diameter D3) distal to the widened section (110). The third core member diameter D3 is optionally substantially smaller than the second core member diameter D2, for example, about 50% or less of the second core member diameter D2, optionally about one third of the second core member diameter D2. The widened section (110) may be relatively steep (e.g., the diameter increases in one or more stepped fashion as shown) or may gradually slope along the forward section (106). The fourth core member diameter D4 may be substantially equal to or smaller than the first core member diameter D1, optionally the maximum diameter of the distal section (103), optionally specifically the maximum diameter of the distal section (103) of its forward section (106).

[0097] The core member (108) is at least partially covered by a cylindrical coil-like member which extends between the narrow portion (109) and the widened portion (110) (optionally, from near the narrow portion (109) to near the widened portion (110)). The coil-like member (112) has a substantially constant outer diameter and is substantially equal to the first core member diameter D1 and / or the fourth core member diameter D4, whereby the overall diameter of the guide wire body (101) is substantially constant and / or equal to the first core member diameter D1, including along most or all of the length of the guide wire intermediate section (104). The coil-like member (112) is optionally formed of a spring and / or an elastic metal alloy such as, for example, stainless steel or tungsten plated with gold, and its respective ends are fixed to the core member (108) at or near the narrow portion (109) and / or at or near the widened portion (110).

[0098] Figures 8A - 8D schematically show several views representing scenarios that may be considered in implementing a method for forming the distal section (103) of the guide wire (100). The first optional scenario may include thinning a length portion (115) of the core member (108) by grinding or the like (the non-thinned state is shown in Figure 8A), whereby the diameter shrinks thinner along this length from the first core member diameter D1 and optionally tapers to have a third core member diameter D3 near the proximal direction of the widened portion (110) (as shown in Figure 8B). The thinned length portion (115) is optionally equal to the length of the distal section (103) that is distally of the articulation bending portion (105) and optionally specifically equal to the length of its rear portion (107). By thinning the length portion (115) of the core member (108), its resistance to bending and / or buckling along this length is reduced.

[0099] FIG. 8B also shows a second scenario, where the joint flexion portion (105) is brought into an appropriate state by local heat treatment focused on the intended length (116) of the core member (108), which is optionally about 5 mm or less, optionally specifically about 3 mm or less, or optionally specifically about 1 mm or less. The heat treatment may include the use of laser heating, induction heating, and / or Joule (e.g., direct current) heating. Exemplary laser heating may be continuous or applied as a plurality of laser pulses projected from a laser source (117), and may be precisely directed at the intended length (116) on or near one side of the core member (108). Optionally, the heat treatment is configured to raise the temperature of a portion of the core member (108) along the intended length (116) to a selected maximum temperature, such as about 500° C. or less, over a selected period, optionally over a period of about 1 minute or less, optionally over a net total of several seconds. The heat treatment is configured to increase the flexibility of the treatment area forming the joint flexion portion (105), thereby increasing its resistance to flexion and optionally also its yield strength.

[0100] Following the formation of the joint flexion portion (105), the coiled member (112) is disposed on the core member (108) along the lengths of the intermediate section (104) and the distal section (103) (as shown in FIG. 8C), and can then be fixed thereto. The distal end of the coiled member (112) is fixed to the core member (108) in the distal direction of the joint flexion portion (105), and optionally, is fixed by adhesion, welding, riveting, brazing or soldering. Optionally, (as shown in FIG. 8D), the distal end of the tip member (118) may be fixed to the free end (119) of the core member (108). The tip member (118) may have a maximum outer diameter equal to or larger than the outer diameter of the coiled member (112) to prevent its release, and the maximum outer diameter is optionally equal to the first core member diameter D1 and / or the fourth core member diameter D4. The proximal end of the coiled member (112) may be fixed to the core member (108) by means of a bond using an adhesive, etc., and optionally, may be fixed in the vicinity of the narrow section (109). In some embodiments, the tip member (118) is welded to the core member (108) and / or the coiled member (112) using the same laser source (117) previously applied in the heat treatment to form the joint flexion portion (105). The laser source (117) is connected to a CAD system programmed to shift the laser source (117) from a first position relative to the core member (108) to a second position relative to the core member (108), and from a first set of laser operating parameters required for the heat treatment process of the desired length to a second set of laser operating parameters required for the welding process of the tip member (118).

Example

[0101] Example 1 The metal core of the guide wire was heat-treated by a laser applied at a spot size of approximately 1 mm in diameter, with the center approximately 3 mm away from the distal end of the guide wire. The wire was rotated under the laser and the tip portion was heat-treated to form a section with higher flexibility.

[0102] Subsequently, the guide wire was tested by animal experiments on August 30, 2020. The guide wire was inserted into the blood vessel of the test sheep at an angle exceeding 60 degrees from the horizontal. The insertion procedure of the guide wire was observed under fluoroscopy during insertion.

[0103] The results are shown in FIGS. 9A to 9D. FIG. 9A shows the guide wire first inserted into the blood vessel through the needle. In FIG. 9B, a steep insertion force is applied onto the blood vessel wall, forming a depression there. FIG. 9C shows that when the buckling of the guide wire described above is released without puncturing the lower blood vessel wall, the tip of the guide wire elastically restores. FIG. 9D shows the guide wire deployed in the blood vessel and ready to proceed into the blood vessel structure.

[0104] As used herein, each of the following terms "a", "an", and "the" written in the singular grammatical form means "at least one", or "one or more". In this specification, the use of the phrase "one or more" does not change this intended meaning of "a", "an", or "the". Thus, as used herein, the terms "a", "an", and "the" refer to and can also include the described plural entities or objects, unless otherwise clearly defined or described in this specification, or unless the context clearly indicates otherwise. Also, for example, as used herein, the phrases "unit", "device", "assembly", "mechanism", "component", "element", and "step or procedure" each refer to and can also include a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and a plurality of steps or procedures.

[0105] As used herein, each of the following terms "includes", "including", "has", "having", "comprises", and "comprising", and their respective linguistic / grammatical variations, derivatives, or / and conjugations, shall mean "including but not limited to", and shall be construed as identifying the recited components, functions, features, parameters, integers, or steps, and shall not preclude the addition of one or more further components, functions, features, parameters, integers, steps, or groups thereof. Each of these terms is considered to be equivalent in meaning to the phrase "consisting essentially of".

[0106] As used herein, the term "method" refers to a process, procedure, mode, means, or / and technique for accomplishing a given task, including but not limited to processes, procedures, modes, means, or / and techniques that are known or readily developed by a person of ordinary skill in the art in the relevant field of the present disclosure being disclosed.

[0107] Throughout this disclosure, numerical values of parameters, functions, features, objects, or dimensions may be described or recited in the form of numerical ranges. As used herein, such a form of numerical range is illustrative of implementations of some exemplary embodiments of the disclosure and does not rigidly limit the scope of the exemplary embodiments of the disclosure. Accordingly, the described or recited numerical range also refers to and encompasses all possible partial ranges and individual numerical values (the numerical values may be represented as integers or decimals in their entirety) within the described or recited numerical range. For example, the described or recited numerical range "1 to 6" refers to and encompasses all possible partial ranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc., and individual numerical values within the described or recited numerical range "1 to 6" such as "1", "1.3", "2", "2.8", "3", "3.5", "4", "4.6", "5", "5.2", and "6", etc. This applies regardless of the numerical width, range, or magnitude of the described or recited numerical range.

[0108] Furthermore, for describing or reciting a numerical range, the phrase "in the range near the first numerical value and the second numerical value" is considered equivalent to and means the same as the phrase "in the range from near the first numerical value to near the second numerical value", and thus, two phrases with equivalent meanings may be used interchangeably. For example, for describing or reciting the 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 and means the same as the phrase "room temperature refers to a temperature in the range from about 20°C to about 25°C".

[0109] As used herein, the term "about" refers to ±10% of the recited numerical value.

[0110] Certain aspects, features, and functions of the present disclosure are illustratively described and presented in the context or format of a plurality of distinct embodiments for clarity, and may also be illustratively described and presented in any suitable combination or partial combination in the context or format of a single embodiment. Conversely, the various aspects, features, and functions of the present disclosure that are illustratively described and presented in combination or partial combination in the context or format of a single embodiment may also be illustratively described and presented in the context or format of a plurality of distinct embodiments.

[0111] The present disclosure has been illustratively described and presented by certain exemplary embodiments and examples thereof, but it is clear that many changes, modifications, or / and variations will be apparent to those skilled in the art. Accordingly, all such changes, modifications, or / and variations are intended to fall within the broad scope of the spirit of the appended claims and be thereby encompassed.

[0112] All publications, patents, or / and patent applications cited or referenced in the present disclosure are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or / and patent application was specifically and individually indicated to be incorporated herein by reference. Further, any citation or identification of a reference herein shall not be construed or understood as an admission that such reference represents prior art to the present disclosure or corresponds thereto. To the extent that column headings are used, they shall not necessarily be construed as limiting.

[0113] When the absolute value of a feature or characteristic of an object or operation described herein is described, terms such as "substantially", "essentially", "substantially", "approximately", and / or other terms or phrases of degree are used without specifically reciting a numerical range. When applied to a feature or characteristic of an object or operation described herein, these terms refer to a range of features or characteristics that are consistent with bringing about the desired function associated with that feature or characteristic.

[0114] 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 can be applied to other implementations without departing from the spirit or scope of the disclosure. Accordingly, the disclosure is not intended to be limited to the implementations shown herein, and the broadest scope consistent with the claims, principles, and novel features disclosed herein should be permitted. The word "exemplary" is used 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.

[0115] Also, the specific features described herein in the context of separate implementations can be implemented in combination in a single implementation. Conversely, the various features described in the context of a single implementation can be implemented separately in multiple implementations or in any suitable partial combination. Further, although features are described above as operating in a particular combination and even initially claimed as such, one or more features from the claimed combination may in some cases be deleted from the combination, and the claimed combination may be a partial combination or a variation of a partial combination.

[0116] The methods disclosed herein include one or more steps or acts for achieving the described methods. The steps and / or acts of the method can be interchanged with each other without departing from the scope of the claims. In other words, unless a specific order of steps or acts is specified, the order and / or use of specific steps and / or acts can be changed without departing from the scope of the claims.

Claims

**Claim 1** A guide wire, comprising a guide wire body ending in a distal section, the distal section including a local joint flexion portion, a front portion extending distally from the joint flexion portion, and a rear portion extending proximally from the joint flexion portion, wherein the joint flexion portion is configured to have a resistance to flexion that is substantially less than the resistance to flexion in the remaining portion of the guide wire body, whereby the front portion is elastically joint-movable relative to the rear portion about the joint flexion portion. **Claim 2** The guide wire according to claim 1, wherein the joint flexion portion has a length of about 3 mm or less and is located within about 5 mm from the distal end of the guide wire body. **Claim 3** The guide wire according to claim 1, wherein the joint flexion portion is configured to elastically restore the orientation before joint movement and / or the alignment of the front portion and the rear portion when the front portion is released from being forced to perform joint movement relative to the rear portion. **Claim 4** The guide wire according to claim 1, wherein the joint flexion portion is configured to facilitate and / or cause the rear portion of the distal section to elastically restore and buckle when the guide wire body is longitudinally compressed against the blood vessel wall when the front portion of the distal section is forced to perform joint movement relative to the rear portion. **Claim 5** The guide wire according to claim 1, further comprising an elastic core member extending along most or the entire length of the guide wire body, the core member incorporating the joint flexion portion along the distal section. **Claim 6** The guide wire according to claim 5, wherein the elastic core member includes a widened portion proximal to the joint flexion portion, and the diameter of the elastic core member substantially increases along the front portion from the widened portion to the distal end of the guide wire body. **Claim 7** The guide wire according to claim 5, wherein the diameter of the elastic core member along the rear portion is substantially the same as that of the joint flexion portion. **Claim 8** A guide wire for transcatheter delivery of an artifact into a blood vessel, the guide wire comprising ​ A guide wire body, the guide wire body including a guide wire body including a guide wire proximal section, a distal section, and a guide wire intermediate section extending between the guide wire proximal section and the distal section, The resistance to bending in the guide wire intermediate section along most or all of the length of the guide wire intermediate section is less than the resistance to bending along most or all of the length of the guide wire proximal section, The distal section includes a local joint bending portion, and the local joint bending portion has a resistance to bending that is substantially less than the resistance to bending in the guide wire intermediate section, the front portion of the distal section extending distally from the local joint bending portion, and the rear portion of the distal section extending proximally from the local joint bending portion, whereby the local elastic joint movement of the front portion of the distal section with respect to the rear portion of the distal section and / or the guide wire intermediate section is affected. A guide wire.

9. When the front portion of the distal section is forcibly joint-moved with respect to the rear portion, the joint bending portion promotes and causes the rear portion of the distal section to elastically recover and buckle as the guide wire body is longitudinally compressed against the blood vessel wall. The guide wire according to claim 8, which is configured to

10. The distal section has an overall length of 20 mm or less. The guide wire according to claim 8.

11. The distal section has an overall length of 10 mm or less. The guide wire according to claim 8.

12. The distal section has an overall length of 5 mm or less. The guide wire according to claim 8.

13. The joint bending portion includes at least one of a slit, an engaging portion, a recess, a coiled section, or any combination thereof. The guide wire according to claim 8.

14. The guide wire includes an elastic core member extending along most or all of the length of the guide wire body. The guide wire according to claim 8.

15. The core member has a diameter that decreases from a first core member diameter proximal to the narrow portion to a second core member diameter distal to the narrow portion and smaller than the first core member diameter. The guide wire according to claim 14.

16. The core member includes a widened portion proximal to the joint flexion portion, and the widened portion expands the diameter of the core member from a third core member diameter proximal to the widened portion to a fourth core member diameter distal to the widened portion and larger than the third core member diameter. The guide wire according to claim 15.

17. The third core member diameter is equal to or smaller than the second core member diameter, and / or the fourth core member diameter is substantially equal to the first core member diameter. The guide wire according to claim 16.

18. The core member is at least partially embedded in a matrix of a flexible material between the narrow portion and the widened portion of the core member, whereby the overall diameter of the guide wire body along most or all of the length of the intermediate section of the guide wire is substantially equal to the first core member diameter. The guide wire according to claim 17.

19. The core member is at least partially covered by a cylindrical coiled member between the narrow portion and the widened portion of the core member, whereby the overall diameter of the guide wire body along most or all of the length of the intermediate section of the guide wire is substantially equal to the first core member diameter. The guide wire according to claim 17.

20. The coiled member is formed of a spring and / or an elastic metal alloy, and the coiled member is fixed to the core member at or near the narrow portion and / or at or near the widened portion. The guide wire according to claim 19.

21. The core member incorporates the joint flexion portion along the tip section. The guide wire according to claim 14.

22. The joint flexion portion has a length of 5 mm or less along the guide wire body. The guide wire according to claim 8.

23. The joint flexion portion has a length of 3 mm or less along the guide wire body. The guide wire according to claim 8.

24. The joint flexion portion is 1 mm or less. The guide wire according to claim 8.

25. The core member is formed of a shape memory alloy selectively heat-treated. The guide wire according to claim 12.

26. The guide wire according to claim 25, wherein the heat treatment is configured to raise the temperature of a portion of a desired length to 500 ° C or less over a period of about 1 minute or less.

27. The guide wire according to claim 25, wherein the heat treatment is optionally performed prior to fixing the distal end of the coiled member to the core member distal to the joint flexion portion by welding, riveting, brazing or soldering.

28. The guide wire according to claim 8, wherein when the angle formed between the front portion and the rear portion of the tip section is reduced, the resistance to flexion in the joint flexion portion increases.

29. The guide wire according to claim 28, wherein the minimum allowable joint angle between the front portion and the rear portion is between 150 ° and 90 °.

30. The guide wire according to claim 29, wherein the minimum allowable joint angle is between 135 ° and 95 °.

31. The guide wire according to claim 8, wherein when the front portion and the rear portion of the tip section are aligned, the resistance to flexion in the joint flexion portion is less than the resistance to penetration of the blood vessel wall by the tip section.

32. The guide wire according to claim 8, wherein when the front portion and the rear portion of the tip section form a minimum allowable joint angle therebetween, the resistance to flexion in the joint flexion portion is greater than the resistance to buckling of the rear portion of the tip section.

33. The guide wire according to claim 8, wherein the total length of the joint flexion portion is 0.5 mm or less.

34. The guide wire according to claim 8, wherein the diameter of the joint flexion portion is substantially equal to the diameter of the rear portion and / or the intermediate section of the guide wire.

35. The guide wire according to claim 8, wherein the center of the joint flexion portion is within 5 mm from the distal end of the guide wire body.

36. The guide wire according to claim 8, wherein the center of the joint flexion portion is within 1 mm from the distal end of the guide wire body.

37. A kit, the kit comprising: The guide wire according to claim 8; A needle including an angled opening adjacent to the distal direction at the distal needle tip. The beveled opening is configured to have a configured length such that when the front portion of the tip section is pressed against the blood vessel wall, as the front portion protrudes axially from the beveled opening, the front portion moves in a joint motion about the joint bending section. Kit.

38. The beveled opening has a length equal to or at most 2 mm greater than the front portion, the kit according to claim 37.

39. The beveled opening has a length equal to or at most 2 mm smaller than the front portion, the kit according to claim 37.

40. A guide wire, the guide wire includes an elongated core member including a tip section, the tip section ending at a distal end for insertion into a patient's blood vessel, The tip section has a bending resistance profile configured to transition the tip section from a substantially straight configuration to a folded configuration in response to an insertion force pressing the distal end against the blood vessel wall, and the folding occurs without the distal end substantially piercing the tissue of the blood vessel wall against which the distal end is pressed. Guide wire.

41. By the folding, a part of the tip section containing the distal end can be transitioned from a state facing the intended operation direction of the guide wire to a state facing away from the intended operation direction of the guide wire, the guide wire according to claim 40.

42. By the folding, the distal end of the guide wire can be released from the retention point at the blood vessel wall, the guide wire according to claim 40.

43. The bending resistance is elastic, whereby the folding is elastically recoverable and returns the tip portion to the substantially straight configuration, the guide wire according to claim 40.

44. A guide wire, the guide wire includes a tip section ending at the distal end of the guide wire, wherein the tip section is characterized by a bending resistance profile, the bending resistance profile including a first region characterized by a first bending resistance, a second region characterized by a second bending resistance, and a third region characterized by a third bending resistance, the second region being positioned between the first region and the third region, The second bending resistance is smaller than both the first bending resistance and the third bending resistance. The first region includes the distal end of the guide wire, At least a part of the first region, the second region, and the third region are continuous, and all of these are located within 20 mm from the distal end of the guide wire, the guide wire.

45. The guide wire according to claim 44, wherein the center of the second region is located less than 10 mm from the distal end.

46. The guide wire according to claim 44, wherein the center of the second region is located less than 5 mm from the distal end.

47. The guide wire according to claim 44, wherein the second region extends along the guide wire for a length of less than 5 mm.

48. The guide wire according to claim 44, wherein the second region extends along the guide wire for a length of less than 3 mm.

49. A method of inserting a guide wire into a patient's blood vessel, the method comprising: Inserting an opening of the lumen into the patient's blood vessel; Inserting the distal end of the guide wire into the lumen until the distal end of the guide wire protrudes from the opening and contacts the lower blood vessel wall to form an anchoring point there; (1) Buckling the distal section of the guide wire extending in the proximal direction from the distal end of the guide wire, thereby releasing the distal end of the guide wire from the anchoring point, and (2) elastically returning the distal section of the guide wire to an unbuckled state and applying an insertion force to the proximal portion of the guide wire so as to direct the distal end of the guide wire in the intended operating direction inside the blood vessel.

50. The method according to claim 49, wherein the applied insertion force is insufficient for the distal end of the guide wire to significantly pierce the tissue of the blood vessel wall at the anchoring point.

51. The method according to claim 49, wherein the applied insertion force is sufficient for the distal section to bend at the first position before buckling at a second position proximal to the first position.

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