Guidewire with a distal end configured to take on multiple shapes

Abstract

Medical guidewires for improved vascular navigation have a densely braided coil, spring-like coil, or multi-coil along their length. The coil has a central passage and a distal end that is curved when no external force is applied, a shaft that defines the central passage, and a central spring. The stopper mechanism has either a connecting ring between the spring and the coil, or the coil has multiple diameters. A straight core crosses the central passage of the shaft, the spring, and the main central passage of the coil, and allows the distal end to take on a curved configuration when pulled. The shaft compresses the spring and forces the distal end of the coil to rotate when moved distally while the distal end of the coil is curved. A longitudinal sleeve covers part of the coil and the joint between the shaft and the coil.

Description

Technical Field

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[0001] Field of the Invention The present invention belongs to the field of medical guidewires used for neurosurgery and cardiology.

Background Art

[0002] Background of the Invention When a neurosurgeon needs to navigate blood vessels in the brain (to reach a thrombus, an area of hemorrhagic stroke or an aneurysm), the time from when a thrombus, for example an ischemic (stroke) thrombus, is formed until its removal becomes clinically effective is limited. Regarding thrombus removal, time is extremely important in determining the optimal treatment method.

[0003] Guided by real-time imaging of blood vessels, the surgeon must navigate the guidewire endovascularly to an artery in the brain. This procedure takes time and typically is not initiated until about 3 hours after the patient notices symptoms. Therefore, for the surgeon, the time to reach the blood vessel and perform a clinically effective intervention is limited.

[0004] There are steerable guidewires and non-steerable guidewires. Steerable guidewires are typically of a larger diameter. In a steerable guidewire, there is a proximal mechanism for steering the guidewire. This mechanism includes a valve for hemostasis to prevent blood backflow. Generally, steerable guidewires have a complex structure, which requires a larger outer diameter (often 2 - 5 mm or more).

Summary of the Invention

[0005] Summary of Embodiments Many blood vessels (e.g., those containing blood clots) are difficult to reach because they may bend, loop, or branch. As a result, navigating to a desired area of ​​a vessel for clinical intervention is a laborious process for neurosurgeons. A significant amount of time is spent navigating the vessel using guidewires simply to reach the location of the problem.

[0006] In a maneuverable guidewire, a proximal mechanism exists for maneuvering the guidewire. This mechanism includes a valve for hemostasis to prevent backflow of blood. Whenever the guidewire needs to be turned or the core of the guidewire needs to be moved axially, the core must first be partially released from the valve for hemostasis. This step is repeated many times during the procedure of navigating the guidewire to the problem location in the blood vessel, and this is repetitive effort and time-consuming. The applicant has discovered a structure for a guidewire that eliminates this step in certain embodiments.

[0007] In some embodiments, the user can manipulate the shape and orientation of the distal end of the coil and guidewire without taking any steps involving touching or releasing a valve for hemostasis. For example, the core may be moved axially to straighten the distal end of the guidewire, or the core may rotate by simply rotating the core within the coil of the guidewire to change the direction of the bend (e.g., J-shape) at the distal end of the coil. The core may be tightly fitted within the coil.

[0008] In pediatric neurosurgery, where the diameter of blood vessels (especially distal capillaries) is extremely small, guidewires need to be less than 0.05 mm in diameter. The applicant has discovered that it is possible to construct an effective guidewire with an outer diameter of approximately 0.27–0.29 mm and an internal core of approximately 0.11 mm.

[0009] The applicant also determined that it is advantageous to use a guidewire with the narrowest possible diameter from the viewpoint of avoiding incidental damage to tissue originating from the guidewire insertion or the microcatheter placed on the guidewire. In some embodiments, the core of the guidewire may have a diameter of 0.11 mm, and the outer diameter of the coil is 0.27 to 0.29 mm in some embodiments.

[0010] Small-diameter guidewires typically lack the structural stability required to quickly and effectively navigate blood vessels (especially those that are difficult to navigate) and to effectively manipulate thrombi, bulges (of aneurysm origin), and bleeding within the vessels (and to quickly navigate the coil's path). However, in certain embodiments described herein, the distal end of the coil is braided into a tightly entangled blade to increase the structural strength of the guidewire coil. Due to the structural integrity of the braided coil, the core of the guidewire does not inadvertently extend through spaces in the braided coil, because a tightly entangled braided coil does not have such spaces (despite the illustration shown in Figure 14). Alternatively, the coil is a tightly wound spring, where the windings of the spring are adjacent to each other.

[0011] The applicant has found that it is possible to reduce the amount of tissue damage (of which it is volume-dependent) caused by the guidewire while still maintaining the structural stability of the guidewire. Incidental damage caused by bulkier guidewires is reduced without compromising the versatility and effectiveness typically achieved by larger diameter guidewires.

[0012] Furthermore, in certain embodiments, the applicant has configured the guidewire such that the change in shape from a curved shape to a straight shape at the distal end of the guidewire is achieved by pushing the core through a central passage within a woven coil (or spring-like coil), such that the core enters the central passage at the distal end to straighten the coil, or the core, already in the central passage at the distal end, is compressed within the central passage at the distal end of the coil.

[0013] One embodiment is a medical guidewire for improved vascular navigation, which is: It has a shaft that defines a central aisle; It extends from the distal end of the shaft, is attached to the shaft, and has a spring that defines a central passage; It has a coil, which has a main central passage and a curved distal end when no external force is applied to the coil, and the coil includes a distal tip; The coil has a stopper mechanism that restricts the proximal movement of the coil, which either (i) has a connecting ring between the spring and the coil, or (ii) has a coil having a central section of a first diameter and a distal section of a second diameter larger than the first diameter; It has a straight core that crosses the central passage of the shaft, the main central passage of the spring and coil, and this core is configured to allow the distal end to be curved when pulled from the main central passage at the distal end of the coil. When the shaft is moved distally, with its distal end in a curved configuration, it compresses the spring and forces the distal end of the coil to rotate. The longitudinal sleeve covers most of the length of the coil proximal to the spring and the joint between the shaft and the coil.

[0014] In some embodiments, the rotation of the distal end of the coil is from J-shape to J-shape.

[0015] In some embodiments, the rotation is substantially towards a symmetric shape.

[0016] In some embodiments, the rotation of the distal end is up to 360 degrees.

[0017] In some embodiments, the coil has a tightly wound straight portion and a tightly wound distal end.

[0018] In some embodiments, the guide wire further has a flat wire longitudinally positioned between the core and the coil on one side of the guide wire.

[0019] In some embodiments, the coil is a tightly braided coil.

[0020] In some embodiments, the coil is a spring-like coil.

[0021] In some embodiments, the stopper mechanism has a rigid and hollow connecting ring between the spring and the coil.

[0022] In some embodiments, the coil has a central section of a first diameter and a distal section of a second, larger diameter, and the distal tip extends into the distal section.

[0023] In some embodiments, the coil is welded to the shaft by circumferential fillet welding.

[0024] In some embodiments, the longitudinal sleeve covers the entire coil proximal to the spring.

[0025] Another embodiment is a medical guide wire for improved vascular navigation, the guide wire comprising: a braided coil defining a tightly braided distal end that curves when no external force is applied to the central passage and the coil; It has a linear core that traverses the central passage along at least a part of the braided coil, and this core has a rounded distal tip; The linear core is configured to move through the central passage of the densely braided distal end and straighten the densely braided distal end when pushed distally from the proximal end of the guide wire.

[0026] In some embodiments, the outer diameter of the core does not exceed 0.13 mm.

[0027] In some embodiments, the outer diameter of the coil is less than 0.3 mm.

[0028] In some embodiments, the braided coil includes a densely braided straight portion.

[0029] In some embodiments, the braided distal end bends to form an arc of at least 70 degrees when no external force is applied.

[0030] In some embodiments, the braided distal end bends to form an arc of at least 90 degrees when no external force is applied.

[0031] In some embodiments, the rounded distal tip has a larger diameter than the diameter of the linear core proximal to the distal tip.

[0032] In some embodiments, the braided coil alternately has flat portions and bulging radiopaque portions.

[0033] In some embodiments, the guide wire further has a flat wire longitudinally positioned between the core and the braided coil on one side of the guide wire, and this flat wire is configured to increase the rigidity of the coil.

[0034] In some embodiments, the guidewire further has a proximal mechanism for acting on the core, which includes a valve for hemostasis, and the core is free from the valve for hemostasis, and the core is axially movable and rotatable in the distal direction without first releasing or adjusting the valve.

[0035] In some embodiments, the guide wire further has a shaft that surrounds a portion of the core.

[0036] In some embodiments, the densely woven distal end blades extend from the inner wall of the coil to the outer wall of the coil.

[0037] In some embodiments, the densely woven distal end blade extends throughout the entire length of the densely woven distal end.

[0038] A further embodiment is a medical guidewire for improved vascular navigation, which is: It has a spring-like coil, which has a central passage and a distal end that is curved when no external force is applied to the coil; The spring-like coil has a linear core that crosses the central passage in the outer region of the distal end, and this core has a rounded distal tip; Having a shaft that covers at least a portion of the core, The straight core is configured to move through the central passage at the distal end of the coil when pushed distally from the proximal end of the guidewire, thereby straightening the distal end of the coil.

[0039] In some embodiments, the diameter of the coil does not exceed 0.3 mm.

[0040] In some embodiments, the distal end is J-shaped.

[0041] In some embodiments, the coil includes densely woven straight sections.

[0042] In some embodiments, the distal end is bent in an arc of at least 70 degrees when no external force is applied.

[0043] In some embodiments, the distal end is bent in an arc of at least 90 degrees when no external force is applied.

[0044] In some embodiments, the rounded distal tip has a larger diameter than the proximal straight core relative to the distal tip.

[0045] In some embodiments, the spring-like coil has alternating flat sections and bulging, radiopaque sections.

[0046] In some embodiments, the guide wire further has a flat wire positioned longitudinally between the core and the spring-like coil on one side of the guide wire, and this flat wire is configured to increase the stiffness of the coil.

[0047] In some embodiments, the guidewire further has a proximal mechanism for acting on the core, which includes a valve for hemostasis, and the core is free from the valve for hemostasis, allowing the core to move axially and rotate distally without first releasing or adjusting the valve.

[0048] In some embodiments, the guide wire further has a shaft that surrounds a portion of the core.

[0049] Still, a further embodiment is a medical guidewire for improved vascular navigation, which guidewire is: It has a spring-like coil, which has a central passage and a tightly woven, coiled distal end that is curved when no external force is applied to the coil; It has a straight core that crosses the central passage along a curved distal end when no external force is applied, the tip of the core is welded to the tip of a spring-like coil, and the core has a distal portion containing a compressible, spaced-out winding; Having a shaft that covers at least a portion of the core, The straight core is configured to compress the spaced windings when pushed distally from the proximal end of the guidewire, thereby straightening the distal end of the coil.

[0050] In some embodiments, the coil has a rounded distal end.

[0051] In some embodiments, the guide wire further has a flat wire positioned longitudinally between the core and the coil on one side of the guide wire.

[0052] In some embodiments, the coil has densely woven straight sections.

[0053] Still, yet another embodiment is a medical guidewire for improved vascular navigation, which guidewire is: It has a woven coil, which has a central passage and a tightly woven distal end that curves when no external force is applied to the coil; It has a straight core with a wire that crosses a central passage along a curved distal end, the tip of the core is welded to the tip of a braided coil, and the core has a distal portion containing a compressible, spaced-out winding; Having a shaft that covers at least a portion of the core, The straight core is configured to compress the spaced windings when pushed distally from the proximal end of the guidewire, thereby straightening the distal end of the braided coil.

[0054] In some embodiments, the coil has a rounded distal end.

[0055] In some embodiments, the guide wire further has a flat wire positioned longitudinally between the core and the coil on one side of the guide wire.

[0056] In some embodiments, the braided coil has densely braided straight sections.

[0057] Another embodiment is a method for inserting a guidewire into a blood vessel containing a difficult-to-navigate portion, which is: The method involves inserting the guidewire described in claim 1 into a blood vessel while the distal tip of the core extends into the distal end of the guidewire, The method involves pulling or releasing the core while the guidewire is in the blood vessel to remove the coil from its distal end and create a curved shape at the distal end of the coil; and, The method involves rotating the distal end of the guidewire by pushing the shaft while the distal end of the guidewire is curved.

[0058] In some embodiments, the coil is a braided coil, and the curved distal end is a curved braided distal end.

[0059] In some embodiments, this method further involves using the rounded distal tip of the core to smoothly navigate through the curved distal end of the coil to straighten the coil.

[0060] In some embodiments, the proximal operating mechanism includes a valve for hemostasis, and this method further includes pushing the core through the distal end of the braided coil to straighten the braided coil without first having to release the valve for hemostasis.

[0061] In some embodiments, the coil includes a straight section. [Brief explanation of the drawing]

[0062] Various embodiments are described herein by reference only to the accompanying drawings.

[0063] [Figure 1A] Figure 1A is a schematic diagram of a guidewire containing a coil in the form of a spring before an external force is applied, according to one embodiment. [Figure 1B] Figure 1B is a schematic diagram of a guidewire including a coil in the form of a spring after an external force has been applied to the coil, according to one embodiment. [Figure 1C] Figure 1C is a schematic diagram of a guidewire containing a coil in the form of a spring before an external force is applied, according to one embodiment. [Figure 1D] Figure 1D is a schematic diagram of a guidewire containing coils of different shapes, which represent the spring configuration after an external force is applied to the coil, according to one embodiment. [Figure 2A] Figure 2A is a cross-sectional view of a substantially circular wire in a spring-like coil according to one embodiment. [Figure 2B] Figure 2B is a cross-sectional view of a substantially rectangular wire in a spring-like coil according to one embodiment. [Figure 2C] Figure 2C is a cross-sectional view of a substantially rectangular wire in a spring-like coil having a radiopaque section, according to one embodiment. [Figure 3] Figure 3 is a schematic cross-sectional view of a braided or spring-like coil of guide wires, which includes a flat wire inserted into the central passage of the coil to reinforce the guide wires, according to one embodiment. [Figure 4] Figure 4 is a cross-sectional view of a portion of the guide wire showing a braided coil in a closed configuration according to one embodiment. [Figure 5] Figure 5 is a cross-sectional view of a portion of the guide wire showing a braided coil in an open configuration according to one embodiment. [Figure 6] Figure 6 is a partial cross-sectional view of a guidewire showing a coil as a spring in an open configuration according to one embodiment. [Figure 7] Figure 7 is a partial cross-sectional view of a guidewire using a hybrid coil having alternatingly arranged flat sections and circular radiopaque sections in an open coil configuration according to one embodiment. [Figure 8] Figure 8 is a schematic diagram of a heat-treated coil (which may be a braided coil or a spring-like coil) according to one embodiment. [Figure 9] Figure 9 is a schematic diagram of a heat-treated guidewire core having an open spring-like or zigzag section, according to one embodiment. [Figure 10] Figure 10 is a schematic diagram of a portion of the guide wire before an external force is applied to it, in a closed configuration according to one embodiment, where the core of Figure 9 inside the passage is defined by the coil of Figure 8, the tip of the core is laser-welded to the tip of the coil. [Figure 11] Figure 11 is a schematic diagram of a portion of the guidewire shown in Figure 10, after the coil has been pressed to tighten its open spring-like portion and thereby straighten the distal end of the guidewire, according to one embodiment. [Figure 12] Figure 12 is a schematic and partial cross-sectional view of a guidewire, including a shaft and a valve for hemostasis, and including different embodiments of the core, according to one embodiment. [Figure 13] Figure 13 is a schematic diagram of a coil having three different wires of different diameters, according to one embodiment. [Figure 14] Figure 14 is a schematic diagram of a blade to show a densely woven coil of guide wires according to one embodiment. [Figure 15A] Figure 15A is a schematic side view of a guidewire according to one embodiment, after a tensile force has been applied to the core but before a compressive force has been applied to the shaft. [Figure 15B]Figure 15B is a schematic side view of the guidewire before a tensile force is applied to the core, similar to Figure 15A, according to one embodiment. [Figure 15C] Figure 15C is a schematic diagram of the shaft shown in Figure 15A, according to one embodiment, in which the shaft walls are indicated by dashed lines. [Figure 15D1] Figure 15D1 is a schematic diagram of another embodiment of the guidewire, which has a spring 60 and an alternative stopping mechanism to the guidewire stopping mechanism of Figures 15A-15B, and is shown after a tensile force has been applied to the core. [Figure 15D2] Figure 15D2 is a schematic diagram of a guidewire similar to Figure 15D1 before a tensile force is applied to the core, according to one embodiment. [Figure 15E1] Figure 15E1 is a schematic diagram of another embodiment of a guide wire, similar to Figure 15D1 but with an overlapping mounting configuration, according to one embodiment. [Figure 15E2] Figure 15E2 is a schematic diagram similar to Figure 15E1, following one embodiment, before a tensile force is applied to the core. [Figure 15F1] Figure 15F1 is a schematic diagram of a guide wire of the type shown in Figures 1A and 1B (without spring 60) having a sleeve 51C shown after a tensile force has been applied to the core, according to one embodiment. [Figure 15F2] Figure 15F2 is a schematic diagram of a guidewire similar to Figure 15F1, according to one embodiment, before a tensile force is applied to the core. [Figure 15G1] Figure 15G1 is a schematic diagram of the guide wire shown after a tensile force has been applied to the core, and is similar to Figure 15F1 except for the overlapping mounting configuration according to one embodiment. [Figure 15G2] Figure 15G2 is a schematic diagram similar to Figure 15G1, following one embodiment, before a tensile force is applied to the core. [Figure 16A] Figure 16A is a schematic diagram of the progression of a guidewire when penetrating a thrombus, according to one embodiment. [Figure 16B] Figure 16B is a schematic diagram of a prior art guidewire used when approaching a thrombus. [Figure 17] Figure 17 is a flowchart showing a method according to one embodiment. [Modes for carrying out the invention]

[0064] Detailed description of the embodiment The following detailed description represents the best currently conceivable mode of carrying out the present invention. This description should not be construed as limiting, but is provided solely for the purpose of illustrating the general principles of the present invention, and the scope of the invention is best defined by the appended claims.

[0065] Certain embodiments generally provide guidewires for navigating blood vessels that are difficult to navigate.

[0066] This guidewire is used to navigate difficult-to-navigate vessels (e.g., looping, bending, or branching vessels) to reach thrombi, aneurysms, or hemorrhagic strokes in preparation for clinical intervention. Typically, it takes a considerable amount of time for a neurosurgeon to navigate a vessel with a guidewire. However, the outcome of a clinical intervention largely depends on the time it takes for the neurosurgeon to perform the intervention. Therefore, minimizing the time before a neurosurgeon can begin a procedure to remove a thrombus, repair an aneurysm, or perform another clinical intervention is crucial. The earlier the vessel location is reached, the sooner the guidewire can be positioned. The arduous process of navigating through winding vessels wastes valuable time in the laborious process of reaching the desired vessel location.

[0067] In some embodiments, a medical guidewire for improved vascular navigation has a braided coil or a spring-like coil that defines a central passage and has a tightly braided straight section (or a spring-like coil including a straight section) and a tightly braided distal end (or the distal end of a spring-like coil) that is curved when no external force is applied to the coil. For example, a straight core having a wire occupies (tightly in some embodiments) the central passage at least along the straight section of the braided coil, and the coil rotates when the user rotates the core, and the core has a rounded distal end. In embodiments where the core extends into the distal end of the coil even before an external force is applied, the distal end of the core is welded to the distal end of the coil. In such cases, the coil may have a closed configuration.

[0068] As used herein, the phrase “densely woven” refers to the tightly interwoven blades of the coil 20A, which, due to the density and hardness of the blades, withstand any attempt to penetrate the densely woven coil 20 by the core 40 or the tip portions 42, 42A. In one embodiment, the densely woven coil 20A has no openings or has openings smaller than 0.05 mm.

[0069] When an external force is applied to the guidewire (for example, when the core is pushed from the proximal to the distal end of the guidewire, either manually or robotically), the core is configured to move through the central passage of the densely woven distal end to straighten the densely woven distal end. In versions where the core is already at the distal end of the coil, the open spring-like windings of the core at the distal end are compressed, and this straightens the distal end of the coil and the distal end of the guidewire. The distal end of the core can be considered as the portion of the core located at the distal end of the central passage within the distal end of the coil.

[0070] In another embodiment, the core extends into the curved distal end of the coil before any external force is applied to the guidewire. The core includes a compressible zigzag section having spaced-out or zigzag windings. When an axial external force is applied to the core in the distal direction, the spaced-out windings are compressed, and this causes the distal end of the coil to straighten.

[0071] In some embodiments, the entire procedure involving guide wires is guided by a robot.

[0072] In this specification, the term "about" refers to ±5% unless otherwise specified. For example, "about X millimeters" means 0.95X to 1.05X millimeters.

[0073] The principle and operation of a guidewire having a distal end configured to take on multiple shapes can be better understood by referring to the drawings and accompanying descriptions.

[0074] As shown in Figures 1-16B, a medical guidewire 10 for improved vascular navigation may have a coil 20. The coil 20 may take one of several forms, including a braided coil 20A and a spring-like coil 20B (or a multi-coil 20C as shown in Figure 13). The various embodiments described below can be implemented using a braided coil 20A or a spring-like coil 20B (or a multi-coil). The term “multi-coil” refers to a coil 20 having wires of different diameters, as shown in Figure 13 (where three wires of different diameters are shown).

[0075] In some embodiments, the entire guidewire 10 is made of nitinol, but this is not a requirement. Other materials capable of performing the required function may be used in any of the elements. When used throughout this application, the “proximal” end of the guidewire 10 is the end where the shaft 50 and the valve 70 for hemostasis are located. The “distal” end of the guidewire 10 is the end having the end of the coil 20 that changes shape when subjected to external force. For example, in Figure 1A, the distal end 24 of the coil 20 is already curved. This is achieved through heat treatment. In certain embodiments, the distal end 24 is more curved (than shown in Figure 1A) and has a J-shape. The embodiments described herein are not limited to the exact curvature or amount of curvature shown in Figures 1A and 1B or 1C or 1D or other drawings. Figures 1A and 1B and 1C and 1D or other drawings merely show the arcuate distal end 24 of the coil 20 of the guidewire 10. Furthermore, although Figures 1A, 1B, 1C, and 1D appear to depict the coil 20 as a spring-like coil, the guide wire 10 in these figures may utilize the braided coil 20A shown in Figure 14 and schematically shown in Figures 4 and 5.

[0076] Figures 2A, 2B, and 2C show cross-sectional views of examples of coils 20 of different shapes (circular, rectangular (flat), or rectangular (flat) with rounded, bulging sections). The shapes shown in Figures 2A-2C are the cross-sectional shapes of the wires 23 of the coil 20 (e.g., individual wires). Thus, these cross-sectional shapes are applicable to both braided coils 20A and spring-like coils 20B.

[0077] As can be seen in Figures 1A and 1B, the coil 20 defines a central passage 30 located radially inward of the coil 20. In the versions of the coil 20 shown in Figures 1A and 1B, the coil 20 generally includes a straight section 22 and a distal end 24. In contrast, in the versions of the coil 20 shown in Figures 1C and 1D, the coil is curved as a whole when no external force is applied to it.

[0078] As can be seen in Figures 1A and 1B, the distal end 24 may take on multiple shapes or configurations. As shown in Figure 1A, when no external force is applied, the distal end 24 may be curved. This may be achieved by heat treatment of the coil 20 (for example, using nitinol or other material from which the coil 20 is made). As shown in Figure 1B, after external forces are applied to the core of the guidewire 10 in the axial and distal directions, the distal end 24 may be straight.

[0079] In the case of a braided coil 20, the braided coil 20A may have at least a densely braided distal end 24A (Figure 14), and may also have a densely braided straight section 22A (Figures 4 and 5) and a densely braided distal end 24A (Figure 14). In some embodiments, the straight section 22A is braided throughout its length. As shown in Figure 14, in some embodiments, the braided coil 20A is further braided throughout its entire thickness (from the outer wall to the inner wall) (in some embodiments, along the blades of the densely braided straight section and the blades of the densely braided distal end). The braided distal end 24A in the photograph in Figure 14 does not happen to have a curvature greater than 60 degrees, but this should not be interpreted as representing the typical degree of curvature of a braided distal end 24A. The curvature is usually greater than that shown in Figure 14 and may be 70 degrees, 80 degrees, 90 degrees, 100 degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees, 160 degrees, 170 degrees, 180 degrees, or even greater.

[0080] When no external force is applied to the guidewire 10, the densely braided tip portion 24A may be arc-shaped or curved. In some embodiments, when no external force is applied to the guidewire 10, the braided distal end 24A may be bent in an arc of at least 70 degrees or, in another version, in an arc of at least 90 degrees. In some embodiments, the braided distal end 24A may be curved to form an arc of 70, 80, 90, 100, 110, or 120 degrees (or 130, 140, 150, 160, 170, 180, 190, 200, or 210 degrees), or curved to form any number of arcs between 70 and 210 degrees, or curved to form an arc in any range between 70 and 210 degrees, such as 70 to 90, 70 to 100, 90 to 120, 70 to 150, 70 to 180, 90 to 180 degrees, or any other range.

[0081] As seen in Figures 1A, 1B, 4, 5, 6, and 7, the guidewire 10 may also have a linear core 40. The core 40 may be made of wire. The core 40 may traverse the central passage 30 along at least the linear portion of the coil 20. In some embodiments, the core 40 tightly occupies at least the linear portion of the coil 20 (e.g., by friction fit) and is sufficiently tightly attached (e.g., by friction fit) to the inner wall 21 of the core 20, or otherwise attached to the coil 20 so that when the user rotates the core 20 (e.g., along a plane perpendicular to the longitudinal axis of the core 40), the coil 20 rotates immediately. This provides the advantage that, in some embodiments, the surgeon only needs to manipulate one component of the guidewire (i.e., the core 20) to achieve both the action of straightening (or not straightening to restore the curvature of the distal end 24 of the coil 20) and the action of rotating the distal end of the guidewire 10 (i.e., the distal end 24 of the coil 20).

[0082] The core 40 may have a distal portion 41. The distal portion 41 of the core 40 is the part of the core 40 that occupies the central passage 30 of the coil 20 at the distal end 24 of the coil 20. In some embodiments, this occurs when an external force (e.g., an axial force in the distal direction) is applied to the core 40, as shown, for example, in Figure 1B. In other embodiments, as shown, for example, in Figure 10, this configuration (the distal portion 41 of the core 40 traversing or occupying the central passage 30 at the distal end 24 of the coil 20) exists even before an external force is applied to the core 40, and substantially exists both before and after the application of the external force (i.e., this configuration is always valid).

[0083] As can be seen in Figures 1A, 1B, 9, 10, and 11, the distal portion 41 of the core 40 may include a distal tip portion 42. In some embodiments (see, for example, Figures 1A and 1B), the distal tip portion 42 of the core 40 is a rounded distal tip portion 42A, which reduces friction to facilitate the ability of the distal portion 41 of the core 40 to move to penetrate the central passage 30 at the distal end 24 of the coil 20, in embodiments where the core 40 does not extend into the central passage 30 at the distal end 24 of the coil 20 until an axial force (in the distal direction) is applied to the core 40. As the guidewire 10 straightens, the rounded distal tip portion 42A reduces friction between the core 40 and the distal end 24 of the coil 20 as the distal portion 41 of the core 40 moves distally to traverse the distal portion of the central passage 30 at the distal end 24 of the coil 20.

[0084] The linear core 40 may be configured to move through the central passage 30 of the coil 20 (including passing through the central passage of the distal end 24 of the coil 20) when pushed distally from the proximal end of the guidewire 10, thereby straightening the distal end 24 of the coil 20 and, in doing so, the distal end 15 of the guidewire 10.

[0085] If the coil 20 is a braided coil 20A, when the linear core 40 moves through the central passage 30 of the densely braided coil 20A, the densely braided distal end 24A of the braided coil 20A is straightened, and the guide wire 10 is straightened. Figure 14 shows the braided configuration of the coil 40 which appears to have space, but it should be noted that in reality the braided coil 20A is woven so densely that, in at least certain embodiments, there is no space in the wall of the braided coil 20A of the guide wire 10.

[0086] In some embodiments, as shown in Figure 3, a flat wire 29 is positioned longitudinally between the core 40 (within the passage 30) and the inner wall 21 of the coil 20 (for example, within the passage 30 of the braided coil 20A). The flat wire 29 is configured to increase the stiffness of the coil 20.

[0087] In any embodiment, as shown in Figures 4, 5, 6, and 7, whether the coil 20 is a braided coil or a spring-like coil, the coil 20 may be open or closed at its distal end. For example, Figure 4 is a partial cross-sectional view of the guidewire 10 showing a braided coil 20A in a closed configuration, while Figure 5 shows a braided coil in an open configuration. Figure 6 is a partial cross-sectional view of the guidewire 10, showing the coil 20 as a spring-like coil 20B in an open configuration, but it could also be the closed configuration shown in Figure 4. Figure 7 is a partial cross-sectional view of the guidewire 10 using a hybrid coil having alternating flat sections and circular radiopaque sections in an open configuration of the coil 20, which is also applicable to the closed configuration of the coil shown in Figure 4. All dimensions in Figures 4-7 are for illustrative purposes only.

[0088] In some embodiments, as can be seen in Figure 6, the outer diameter of the core 40 does not exceed 0.13 mm. In some embodiments, the outer diameter of the core 40 is 0.11 mm, or 0.10 to 0.12 mm, or less than 0.13 mm, or less than 0.12 mm, or less than 0.11 mm.

[0089] In some embodiments, the core 40 has a rounded distal tip 42A, as shown in Figures 1A and 1B. In some embodiments, the outer diameter of the coil is less than 0.3 mm. In certain embodiments, the outer diameter of the coil is 0.27 to 0.29 mm. For example, in Figure 4, in a particular embodiment where the coil 20 is a braided coil, the outer diameter of the coil is shown to be 0.27 mm, but this is just one example of a non-limiting dimension. In Figure 6, the outer diameter of the coil spring is shown to be 0.29 mm in some embodiments, but this is just an example.

[0090] As shown in Figure 7, in some embodiments (whether the coil 20 is a braided coil, a spring, or a multi-coil), the coil 20 has alternating sections consisting of flat sections 26 and bulging radiopaque sections 27. The radiopaque sections 27 may be made of an alloy that allows for clear visibility of the coil 20 in X-ray and other imaging techniques.

[0091] As can be seen in Figures 1A, 1B, 10, 11, and 12, at least a portion of the core 40 is located within the shaft 50. In any embodiment described herein, a proximal mechanism for acting the core is shown, which includes, for example, a valve 70 for hemostasis using a Y-connector (Figure 12). As a result of the structure of the guidewire 10, in which the core is located within the shaft and is not directly connected to the valve 70 for hemostasis, the core is free from the valve for hemostasis, and the core is able to move axially and rotate distally without first releasing or adjusting the valve.

[0092] In the case of a coil 20 which is a spring-like coil 20 that defines the central passage 30, the spring-like coil 20 may be tightly woven, particularly in the straight portion of the coil 20. When no external force is applied to the coil 20, the distal end 24 may be curved. A straight core 40 may traverse the central passage 30 along the straight portion of the spring-like coil 20 (and, in some embodiments, occupy it tightly, like a friction fit). The core 40 may have a rounded distal tip 42. The shaft 50 may cover at least a portion of the core 40. The straight core 40 is configured to move through the central passage 30 at the distal end when pushed distally from the proximal portion 11 of the guidewire, thereby straightening the distal end 24 of the coil 20.

[0093] For guidewires 10 in which coil 20 is a braided coil 20A, all versions and variations of the components described herein are also applicable to embodiments of guidewires 10 utilizing a spring-like coil 20 (except for the inclusion of a blade), and similarly, for guidewires 10 in which coil 20 is a spring-like coil 20B, all variations of the components described herein are also applicable to embodiments of guidewires 10 utilizing a braided coil 20A (except for the inclusion of a spring).

[0094] Optionally, as shown in Figure 1A (and this option is also possible for any other embodiment), a radiopaque sleeve 51A may be present around the shaft 50. The sleeve 51A is approximately 50 microns or larger. Alternatively, as shown in Figure 1B (and this option is also possible for any other embodiment), the shaft 50 may have a hydrophilic coating 51B (e.g., including fluoride) or a hydrophobic coating to reduce friction.

[0095] As shown in Figures 8, 9, 10, and 11, another embodiment of the guidewire 10 for improved vascular navigation has a spring-like coil 20 which defines a central passage 30 and has a coiled straight section (in some embodiments, a tightly woven straight section) and a curved distal end when no external force is applied to the coil. The guidewire 10 may also include a straight core 40 (which may be a wire) which traverses and occupies the central passage 30 along the straight section and curved distal end of the spring-like coil, even before any external force is applied. The tip 42 of the core 40 may be firmly attached (for example, by welding) to the tip 28 of the spring-like coil 20.

[0096] As can be seen in Figure 9, in this embodiment, the core 40 has a distal portion 41 containing compressible spaced windings 44 (for example, appearing as a zigzag shape as in Figures 9 and 10). Figure 10 shows the distal portion 41 of the core 40 and the distal end of the shaft 50. As can be seen in Figure 10, the shaft 50 may cover at least a portion of the core 40. As shown in Figure 10, a straight core 40 may be configured to compress the spaced windings 44 of the core 40 when pushed distally from the proximal end of the guidewire. This tightening of the windings 44 increases the resistance of the tightened windings 44 to bending in the distal portion 41 of the core 40. This has the effect of straightening the distal portion 41 of the core and, by means of straightening the distal end 24 of the coil 20 to reach the configuration shown in Figure 11.

[0097] The embodiments shown in Figures 9-11 are also applicable to the braided coil 20 (and any version thereof), the spring-like coil (Figure 8) (and any version thereof), and the multi-coil coil 20 shown in Figure 13.

[0098] In some versions of this embodiment, the coil 20 has a rounded distal end (whether the coil 20 is a spring coil, a braided coil, or a multi-coil), and in some versions, the guidewire 10 further has a flat wire, typically on one side of the guidewire 10, that is longitudinally located within the central passage 30 of the coil 20 between the core 40 and the coil 20.

[0099] As shown in Figures 15A and 15B, another embodiment is a medical guidewire 10 for improved vascular navigation, having a shaft 50 (Figure 15C) defining a central passage 55, a spring 60 (defining a central passage 65) extending from the distal end 52 of the shaft 50 and attached to the outer wall of the shaft, and a coil 20 (spring-like or braided coil) defining a main central passage 30. The coil 20 (spring-like or braided coil) may have a straight section and a curved distal end 24 (or 24A) when no external force is applied to the coil 20 (or 20A). When the coil 20 has a spring-like coil 20, the spring 60 may be called a central spring 60 to distinguish it from the coil 20.

[0100] The guide wire 10 may have a stopper mechanism that restricts the proximal movement of the coil 20 (or 20A). The stopper mechanism may (i) have a connecting ring between the spring and the coil, and (ii) the coil may have multiple diameters.

[0101] A rigid, hollow connecting ring 99 may be present between the spring and the coil. The connecting ring 99 may function as a stopper mechanism because its inner diameter (i.e., hollow portion) may be smaller than the diameter of the distal end 42A of the core 40. The guidewire 10 may also include a central passage of the shaft 50, a spring and a connecting ring 99, and a straight core 40 that crosses at least the proximal portion of the main central passage 30 of the coil 20 (whether it is a spring-like coil or a braided coil). As shown in Figure 15B, the guidewire 10 is positioned at a desired location in the blood vessel in a configuration in which the core 20 crosses the main central passage 30 at the distal end 24 of the coil 20, and the distal end 24 of the coil is straight. The core 40 is configured to allow the distal end 24 of the coil 20 (spring-like coil or braided coil) to take on its "natural" curved configuration when pulled from the main central passage 30 of the coil 20. Subsequently, using the shaft 50, which may be a proximal shaft (such as a tube) as shown in Figures 15A and 15B, the shaft 50 can be moved axially in the distal direction (when the distal end 24 of the coil 20 is configured to be curved as shown in Figure 15A), thereby compressing the spring 60 and exerting a force on the distal end 24 of the coil 20 (a spring-like coil or a braided coil), thereby forcing the distal end 24 of the coil 20 (which may be a braided distal end 24A) to rotate. In some embodiments, this rotation is at least 90 degrees, or at least 180 degrees, or at least 270 degrees, or approximately 360 degrees, around an axis A of rotation parallel to the length of the guidewire 10. This provides the important advantage that the inserted guidewire 10 can be bent at its distal ends 24, 24A, and that its distal ends may rotate at any angle as needed.

[0102] The rotation of the distal end 24 of the coil 20 (20A, 20B) may be from one shape of the distal end 24 to a symmetrical or substantially symmetrical shape of the distal end 24. For example, the rotation of the distal end 24 of the coil 20 may be from a first J shape to a second J shape which is approximately 180 degrees rotationally from the first J shape.

[0103] As in other embodiments, all versions are possible, including one or more of the following versions. For example, the coil 20 (20A or 20B) may have a rounded distal end. The coil 20 (spring coil or braided coil) may have a tightly wound straight section and a tightly wound distal end 24. The guidewire may also include, for example, a flat wire 29 (Figure 3) longitudinally positioned between the core 40 and the coil 20 on one side of the guidewire. Furthermore, this embodiment (shown in Figures 15A and 15B) is applicable to the coil 20 which is a braided coil 20A, the coil 20 which is a spring coil 20, and a multi-coil (Figure 13). All versions of the braided coil, spring coil and multi-coil (including all described variations relating to the tightness of the coil) are included in this description.

[0104] Figures 15D1 and 15D2 show a guidewire 10 that is generally similar to that shown in Figure 15B, and it includes a (central) spring 60. However, instead of using a connecting ring 99 (see Figure 15B) to restrict the proximal (posterior) movement of the distal tip 42A of the core 40, a different (stopper) mechanism is employed to restrict the proximal movement of the distal tip 42A. As seen in Figures 15D1 and 15D2, the coil 20 is constructed from multiple sections 201, 202 (e.g., a first section 201 and a second section 202), each section having a different diameter. The first section (e.g., the distal section 201 of the coil 20) has a larger diameter than the second section (e.g., the central section 202 of the coil 20). Furthermore, the diameter of the distal tip 42A exceeds the inner diameter of the central section 202 of the coil 20 (or braided coil 20A), thereby restricting the proximal (posterior) movement of the core 40. The distal tips 42,42A of the coil may extend into a distal section 201 having a second (larger) diameter.

[0105] In any embodiment, including but not limited to those shown in Figures 15A to 15G2, the distal tip 42A of the core 40 may be spherical and have a wider diameter than the portion of the core 40 immediately distal thereto, forming a spherical head. In some embodiments, this serves multiple functions. One is to restrict the proximal or posterior movement of the core 40. A second function is to prevent the core 40 from penetrating the coils 20 (20A, 20B) (although this objective may be achieved by using tightly woven coils 20A). The spherical head 42A also acts as a plunger by facilitating interference fit with the coils 20 and facilitating deformation of the working elements (i.e., the distal ends 24, 24A of the coils 20, 20A) to produce rotation. As can be seen in Figures 15D1 and 15D2, the coil 20 may be connected to the shaft 50 by a butt joint (e.g., butt welding) at point W where the proximal end of the coil 20 (whether it is 20A or 20B) begins at the distal end of the shaft 50 (e.g., by welding). Alternatively, as can be seen in Figures 15E1 and 15E2, the coil 20 (whether it is 20A or 20B) may be attached to the shaft 50 using an overlap connection (in region WR), such as a circumferential overlap weld (e.g., by welding). It is called an "overlap" because it overlaps with the shaft 50.

[0106] The guide wire 10 in Figures 15D1, 15D2, 15E1, and 15E2 may also have a sleeve 51C to add structural stability. In some embodiments, the guide wire 10 is held within the sleeve 51C. The sleeve 51C is designed to prevent the spring 6 from stretching and to ensure a connection between the spring 60 and the shaft / tube 50. The sleeve 51C may be long enough to cover the joint between the spring 60 and the shaft 50 at the proximal end, and in some embodiments, it may also be long enough to cover most of the length of the coil 20 proximal to the spring 60. However, in one non-limiting embodiment, the sleeve 51C leaves the spring 60 free and does not cover it.

[0107] When the guidewire 10 is located deep within the human brain, many winding blood vessels are present. Due to the constant turns in the blood vessels, there is a risk that the spring 60 will stretch. If this occurs, the formation of the curved distal ends 24,24A (e.g., J-shaped) of the coils 20 (20A,20B) in response to the axial movement of the core 40 may be significantly hindered.

[0108] Based on experiments, the applicant found that if the guidewire 10 is placed on a flat surface such as a table and is perfectly straight along its entire length, axial movement of the core 40 (in this case, pulling in the proximal direction) allows the distal ends 24,24A of the coil 20 to take on their "natural" curved configuration (e.g., a "J" shape in one non-limiting example). In embodiments of the guidewire 10 including a spring 60, it is more difficult for the distal ends 24,24A to take on their curved configuration in response to pulling the core 40 when the elongated portion of the spring 60 is started to bend, for example to navigate turns in blood vessels in the brain. The applicant found that adding a sleeve 51C to the guidewire 10 eliminates this difficulty and allows the guidewire 10 to function perfectly, even when the elongated portion of the spring 60 is bent, as it does when navigating through windings in blood vessels of the brain.

[0109] In other implementations, the sleeve 51C covers the guidewire 10 from the entire distal end 24,24A of the core 20 to the entire proximal end of the guidewire 10. In some embodiments, the sleeve 51C allows a portion of the proximal end of the shaft 50 or core 40 to protrude from the sleeve 51C (so that it can be held by the user).

[0110] Figures 15F1 and 15F2 depict the guide wire 10 of the embodiment of Figures 1A and 1B (without the spring 60) having a sleeve 51C, and this utilizes a butt joint (such as butt welding) similar to the mounting method in Figures 15D1 and 15D2. Figures 15G1 and 15G2 depict the guide wire 10 of Figures 1A and 1B having a sleeve 51C, and this utilizes an overlap joint (for example, overlap butt welding).

[0111] As shown in Figures 15F1 and 15F2, and not shown in Figures 15D1, 15D2, 15E1 and 15E2, the cover of the sleeve 51C may extend to the origin of the distal ends 24,24A of the core 20 (whether it is 20A or 20B), or alternatively, the sleeve 51C may extend to the most distal end of the guidewire 10 (including the distal ends 24,24A). This depends largely on the material from which the sleeve 51C is made. This ensures the flexibility of the distal ends 24,24A (if the material from which the sleeve 51C is made is not flexible or is not sufficiently flexible).

[0112] All versions of the braided coil, spring coil, and multi-coil described with reference to other embodiments are also applicable to the versions of the guide wire 10 shown in Figures 15A to 15G2 (including, but not limited to, the dimensions).

[0113] Figure 16B shows the progression of the guidewire 10 as it penetrates a thrombus 85 in a patient's blood vessel. From Figure 16B, it can be seen that the distal end of the guidewire 10, which first contacts the thrombus 85, is now in a straight configuration, so only a diameter of approximately 0.2-0.3 mm encounters the side surface of the thrombus 85. This makes penetration of the thrombus 85 even easier. Compare this with Figure 16A of the prior art. Furthermore, in certain embodiments, only a single short motion needs to be taken by the neurosurgeon to straighten the guidewire. In some embodiments, simply pressing the proximal button 14A, which controls the axial extrusion motion of the core 40, straightens the distal end 24 of the coil 20, and thus the distal end of the guidewire 10. In such embodiments, there is no need to release the valve 70 for hemostasis, no need to rotate the core or coil to position the core for the straightening motion, and no need to perform more than one simple short motion. This difference makes sense when considering the arduous, time-constrained, and frequently repetitive task of a neurosurgeon: navigating the winding pathways of the brain's capillaries (or arteries) before implementing clinical interventions.

[0114] As shown in the flowchart of Figure 17, one embodiment is a method 100 for inserting a guidewire into a blood vessel containing a difficult-to-navigate portion. Method 100 may include a step 110 for inserting a guidewire 10 into a blood vessel, the guidewire 10 having a coil 20 (whether 20A or 20B) that defines a central passage. The coil 20 (20A, 20B) has a curved distal end and may also include a straight section. The guidewire 10 may also include a straight core 40 that traverses the central passage 30 at least to a curved distal end 24 (and not included in some embodiments). The core 40 may have a rounded distal tip 42. The guidewire 10 may include any of the above structural versions. For example, the guidewire 10 may have a shaft 50 that defines the central passage and a spring 60 that extends from the distal end of the shaft, is attached to the shaft, and defines the central passage, as shown in any version of Figures 15A to 15G2.

[0115] Method step 110 may include pushing the core 40 across the central passage and moving it into the distal ends of coils 20A and 20B to straighten the coils.

[0116] Method 100 may also include step 120, while the guidewire is in the blood vessel, pulling the core through the distal end of the coil to create a curved shape at the distal end of the coil. The coil may be a braided coil 20A, a spring coil 20B, or a multi-coil.

[0117] In some versions of step 120, this step further includes pushing the entire guidewire 10 forward into the thrombus 85 so that the distal end of the guidewire 10 faces the side of the thrombus 85 (Figure 16B). This is a much more effective way for the guidewire 10 to penetrate the thrombus 85 than certain prior art guidewires that have a curved distal end. When these prior art guidewires approach the thrombus 85, as shown in Figure 16A, the broad surface of the distal end of the guidewire inevitably faces the side of the thrombus, making it much more difficult to penetrate the thrombus 85.

[0118] Method 100 may also include step 130 of pulling the core 40 while the guidewire 10 is in the blood vessel to move the core 40 away from the distal end 24 of the coil 20, thereby restoring the curved shape of the tip of the coil 20. This can be done, for example, by releasing the extrusion motion by pulling or pressing a button (e.g., a proximal button 14A) that releases the extrusion motion while the guidewire is in the blood vessel. The movement of the core 40 away from the distal end 24 of the coil 20 has the effect of restoring the curved shape (e.g., J-shape) of the distal end 24,24A of the coil 20.

[0119] Method 100 may include step 130 of pushing the shaft 50 to rotate the distal end 24A along an axis A running along the length of the guidewire 10 (by about 360 degrees of rotation, or at least 90 degrees, or at least 180 degrees, or at least 270 degrees in other versions). This occurs while the guidewire is in the blood vessel. This allows the physician to navigate to any location in the complex blood vessels of the brain where both bending and rotating the distal end of the guidewire 10 is required. In some versions of Method 100, further steps are to push the core 40 again through the distal end 24 of the coil 20 while the guidewire 10 is in the blood vessel, straightening the coil 20, and pushing the entire guidewire 10 forward into the thrombus 85 so that the distal end of the guidewire faces the side of the thrombus 85 (Figure 16B).

[0120] In some versions of Method 100, the coil is a braided coil, and the curved distal end is a curved braided distal end.

[0121] In some versions of Method 100, Method 100 includes the step of straightening the coil 20 by smoothly navigating through the curved distal end 24 of the coil 20 using the rounded distal tip 42A of the core.

[0122] In some versions of Method 100, the proximal acting mechanism includes a valve 70 for hemostasis, and this method further includes pushing the core through the distal end of the braided coil to straighten the braided coil without first having to release the valve 70 for hemostasis.

[0123] In some embodiments, the outer diameter of the coil 20 (whether it is 20A or 20B) is 0.27 to 0.29 mm.

[0124] In one implementation, the mechanism for manipulating the core is located at the proximal end 14 of the guidewire 10, which is part of the proximal portion 11 of the guidewire 10.

[0125] In any embodiment, the core and coil may be made of Nitinol (a metal alloy of nickel and titanium). In one non-limiting implementation, the thicker portions of the core are the proximal and central portions, while the outer diameter of the core tapers downward towards the distal end. In one embodiment, the core has a width of 0.11 millimeters in diameter.

[0126] Although the present invention has been described with reference to a limited number of embodiments, it will be understood that many variations, modifications, and other applications of the present invention may be made. Accordingly, the claimed inventions described in the following claims are not limited to the embodiments described herein.

Claims

1. A medical guidewire for improved vascular navigation, wherein the guidewire is: It has a shaft that defines a central aisle; Extending from the distal end of the shaft and attached to the shaft, and having a spring that defines a central passage; Having a coil, the coil having a main central passage and a curved distal end when no external force is applied to the coil, and the coil including a distal tip; The device has a stopper mechanism that restricts the proximal movement of the coil, the mechanism having either (i) a connecting ring between the spring and the coil, or (ii) the coil having a central section of a first diameter and a distal section of a second diameter greater than the first diameter; The shaft has a central passage, the spring and the coil have a linear core that crosses the main central passage, and the core is configured such that the distal end of the coil is curved when pulled from the main central passage at the distal end, When the shaft is moved distally while its distal end is in the curved configuration, it compresses the spring and forces the distal end of the coil to rotate. The longitudinal sleeve covers most of the length of the coil proximal to the spring and the joint between the shaft and the coil. The aforementioned guide wire.

2. The guide wire according to claim 1, wherein the rotation of the distal end of the coil is from J-shape to J-shape.

3. The guide wire according to claim 1, wherein the rotation is substantially symmetrical.

4. The guide wire according to claim 1, wherein the rotation of the distal end is up to 360 degrees.

5. The guide wire according to claim 1, wherein the coil has a tightly wound straight section and a tightly wound distal end.

6. Furthermore, the guide wire according to claim 1, wherein one side of the guide wire has a flat wire positioned longitudinally between the core and the coil.

7. The guide wire according to claim 1, wherein the coil is a densely woven coil.

8. The guide wire according to claim 1, wherein the coil is a spring-shaped coil.

9. The guide wire according to claim 1, wherein the stopper mechanism has a rigid, hollow connecting ring between the spring and the coil.

10. The guidewire according to claim 1, wherein the coil has the central section having the first diameter and the distal section having a second, larger diameter, and the distal tip extends into the distal section.

11. The guide wire according to claim 1, wherein the coil is welded to the shaft by overlapping welding in the circumferential direction.

12. The guide wire according to claim 1, wherein the longitudinal sleeve covers the entire coil proximal to the spring.

13. A medical guidewire for improved vascular navigation, wherein the guidewire is: Having a braided coil, the coil has a central passage and a tightly braided distal end that curves when no external force is applied to the coil; The braided coil has a straight core that crosses the central passage along at least a portion of it, the core having a rounded distal end; The aforementioned straight core is configured to move through the central passage of the densely woven distal end when pushed distally from the proximal end of the guidewire, thereby straightening the densely woven distal end. The aforementioned guide wire.

14. The guide wire according to claim 13, wherein the outer diameter of the core does not exceed 0.13 mm.

15. The guide wire according to claim 13, wherein the outer diameter of the coil is less than 0.3 mm.

16. The guide wire according to claim 13, wherein the braided coil includes a densely braided straight section.

17. The guide wire according to claim 13, wherein the braided distal end is bent in an arc of at least 70 degrees when no external force is applied.

18. The guide wire according to claim 13, wherein the braided distal end is bent in an arc of at least 90 degrees when no external force is applied.

19. The guidewire according to claim 13, wherein the rounded distal tip has a larger diameter than the diameter of the linear core proximal to the distal tip.

20. The guide wire according to claim 13, wherein the braided coil alternates between flat portions and bulging radiopaque portions.

21. Furthermore, the guide wire according to claim 13, wherein one side of the guide wire has a flat wire positioned longitudinally between the core and the braided coil, and the flat wire is configured to increase the rigidity of the coil.

22. Furthermore, the guidewire according to claim 13, having a proximal mechanism for acting on the core, the mechanism including a valve for hemostasis, the core being free from the valve for hemostasis, and the core being able to move axially and rotate distally without first releasing or adjusting the valve.

23. Furthermore, the guide wire according to claim 13, having a shaft that surrounds a part of the core.

24. The guide wire according to claim 13, wherein the densely braided distal end blade extends from the inner wall of the coil to the outer wall of the coil.

25. The guide wire according to claim 13, wherein the densely braided distal end blade extends through the entire length of the densely braided distal end.

26. A medical guidewire for improved vascular navigation, wherein the guidewire is: It has a spring-like coil, the coil having a central passage and a distal end that is curved when no external force is applied to the coil; The spring-like coil has a linear core in the outer region of its distal end that crosses the central passage, and the core has a rounded distal tip; Having a shaft that covers at least a portion of the core, The aforementioned straight core is configured to move through the central passage at the distal end of the coil when pushed distally from the proximal end of the guide wire, thereby straightening the distal end of the coil. The aforementioned guide wire.

27. The guide wire according to claim 26, wherein the diameter of the coil does not exceed 0.3 mm.

28. The guide wire according to claim 26, wherein the distal end is J-shaped.

29. The guide wire according to claim 26, wherein the coil includes a densely woven straight section.

30. The guide wire according to claim 26, wherein the distal end is bent in an arc of at least 70 degrees when no external force is applied.

31. The guide wire according to claim 27, wherein the distal end is bent in an arc of at least 90 degrees when no external force is applied.

32. The guidewire according to claim 28, wherein the rounded distal tip has a diameter greater than the diameter of the linear core proximal to the distal tip.

33. The guide wire according to claim 28, wherein the spring-shaped coil alternately has flat portions and bulging radiopaque portions.

34. Furthermore, the guide wire according to claim 28, wherein one side of the guide wire has a flat wire positioned longitudinally between the core and the spring-like coil, and the flat wire is configured to increase the rigidity of the coil.

35. Furthermore, the guidewire according to claim 28, having a proximal mechanism for acting on the core, the mechanism including a valve for hemostasis, the core being free from the valve for hemostasis, and the core being able to move axially and rotate distally without first releasing or adjusting the valve.

36. Furthermore, the guide wire according to claim 28, having a shaft that surrounds a part of the core.

37. A medical guidewire for improved vascular navigation, this guidewire is: It has a spring-like coil, the coil having a central passage and a tightly woven, coiled distal end that is curved when no external force is applied to the coil; When no external force is applied, it has a straight core that crosses the central passage along the curved distal end, the tip of the core is welded to the tip of the spring-like coil, and the core has a distal portion containing a compressible, spaced-out winding; Having a shaft that covers at least a portion of the core, The aforementioned straight core is configured to compress the spaced windings when pushed distally from the proximal end of the guide wire, thereby straightening the distal end of the coil. The aforementioned guide wire.

38. The guidewire according to claim 37, wherein the coil has a rounded distal tip.

39. Furthermore, the guide wire according to claim 37, wherein one side of the guide wire has a flat wire positioned longitudinally between the core and the coil.

40. The guide wire according to claim 37, wherein the coil has a densely woven straight section.

41. A medical guidewire for improved vascular navigation, the guidewire being: Having a woven coil, the coil has a central passage and a tightly woven distal end that is curved when no external force is applied to the coil; It has a straight core having a wire that crosses the central passage along the curved distal end, the tip of the core is welded to the tip of the braided coil, and the core has a distal portion containing a compressible, spaced-out winding; Having a shaft that covers at least a portion of the core, The aforementioned straight core is configured to compress the spaced windings when pushed distally from the proximal end of the guide wire, thereby straightening the distal end of the braided coil. The aforementioned guide wire.

42. The guidewire according to claim 41, wherein the coil has a rounded distal tip.

43. Furthermore, the guide wire according to claim 41, wherein one side of the guide wire has a flat wire positioned longitudinally between the core and the coil.

44. The guide wire according to claim 41, wherein the braided coil has a densely braided straight section.

45. A method for inserting a guidewire into a blood vessel containing a difficult-to-navigate portion, the method being: The procedure involves inserting the guidewire according to claim 1 into the blood vessel while the distal tip of the core extends into the distal end of the guidewire, The method includes pulling or releasing the core while the guidewire is in the blood vessel to remove the coil from the distal end of the coil and to create the curved shape of the distal end of the coil; and, The method involves rotating the distal end of the guide wire by pushing the shaft while the distal end of the guide wire has the curved shape described above. The aforementioned method.

46. The method according to claim 45, wherein the coil is a braided coil, and the curved distal end is a curved braided distal end.

47. The method according to claim 45, further comprising using the rounded distal tip of the core to smoothly navigate through the curved distal end of the coil to straighten the coil.

48. The method according to claim 45, wherein the proximal operating mechanism includes a valve for hemostasis, and the method further comprises pushing the core through the distal end of the braided coil to straighten the braided coil without first releasing the valve for hemostasis.

49. The method according to claim 45, wherein the coil includes a straight section.

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