Guide wire activation mechanism and proximal action mechanism

Abstract

The intraluminal guidewire can include an elongate shaft extending between a distal end of the elongate shaft and a proximal end of the elongate shaft. The intraluminal guidewire can include a user-actuated segment disposed proximal to the proximal end of the elongate shaft, the user-actuated segment configured to move relative to the elongate shaft. The intraluminal guidewire can include a core wire secured to the user-actuated segment and a distal portion of the hollow elongate shaft. The intraluminal guidewire can also include an inner member having a proximal end disposed at least partially within the user-actuated segment and secured relative to the user-actuated segment, and a distal end disposed at least partially within the hollow elongate shaft, the core wire passing through the inner member. In some embodiments, the intraluminal guidewire can be configured such that a distal segment of the inner member exhibits a frictional constraint during movement within the elongate shaft, the frictional constraint during movement being a frictional force between an outer surface of the inner member and an inner surface of the hollow elongate shaft.

Description

Technical Field

[0001] The present disclosure relates to intravascular and / or intraluminal medical devices, and various embodiments thereof relate to deflectable guidewires for introducing catheters and other medical devices into body cavities.

Background Art

[0002] A guidewire can be used to advance intravascular and intraluminal medical devices, such as catheters and thrombectomy devices, to a treatment site within the body. In some cases, the guidewire can pass through the body until the distal tip of the guidewire is positioned at the desired treatment site. After the guidewire is placed, an intraluminal device can be advanced over the guidewire and used to treat the medical condition at the treatment site.

[0003] To pass through a tortuous anatomical structure, a guidewire can include a steering mechanism, such as a pull wire, configured to bend or deflect the distal tip of the guidewire in a desired direction. The pull wire can be secured to a user-actuated segment, such as a handle at the proximal end of the guidewire, and the user can axially move the pull wire relative to the guidewire to control deflection and straightening of the distal tip of the guidewire. Since the user-actuated segment is configured to axially move relative to the guidewire, it may be difficult to prevent movement of the user-actuated segment during an operation involving use of the guidewire, such as when the guidewire rotates or when an intraluminal device advances over the guidewire. As a result, the distal tip of the guidewire may be inadvertently bent or straightened, causing the guidewire to deviate from the desired delivery path and making it difficult to pass the guidewire through the anatomical structure.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Thus, to avoid accidental movement of the guidewire, a locking mechanism is provided which is configured to fix the user-operated segment in place. However, the need for an intraluminal guidewire remains, which does not interfere with the deflection and straightening of the distal tip of the guidewire by the user-operated segment. Embodiments of the present disclosure provide a self-locking function for a guidewire which can be configured to firmly hold the user-operated segment and the guidewire in their respective positions until the user-operated segment is repositioned by the user.

[0005] Embodiments of the present disclosure include a hollow elongated shaft, which may include a hollow elongated shaft extending between the distal end and the proximal end of the hollow elongated shaft. According to one embodiment, the intraluminal guidewire may include a user-operated segment positioned proximal to the proximal end of the hollow elongated shaft, configured to move relative to the hollow elongated shaft. The intraluminal guidewire may include a core wire extending between the user-operated segment and the distal portion of the hollow elongated shaft. The intraluminal guidewire may also include an inner member. The inner member may be at least partially positioned within the user-operated segment and have a proximal end fixed to the user-operated segment. The inner member may further have a distal end positioned at least partially within the hollow elongated shaft and configured to move axially relative to the hollow elongated shaft, through which the core wire can pass. In some embodiments, the lumen guidewire is configured such that a locking segment of an inner member, which is positioned within a hollow, elongated shaft, exhibits frictional constraint during movement within the hollow, elongated shaft, and the frictional constraint during movement is configured to be a frictional force between the outer surface of the inner member and the inner surface of the hollow, elongated shaft.

[0006] In some embodiments, the intraluminal guidewire may include a deflectable segment located at least partially within the distal portion of a hollow, elongated shaft. The core wire may be fixed to the deflectable segment. The core wire may be configured such that movement of a user-operated segment causes deflection of the deflectable segment.

[0007] In some embodiments, the locking segment of the inner member may also include at least one bend so that when the locking segment of the inner member is inserted into the hollow elongated shaft, the at least one bend of the inner member can exert a frictional force on the inner surface of the hollow elongated shaft.

[0008] In some embodiments, the locking segment of the inner member can be sufficiently flexible so that it can be configured to partially straighten at least one bend when the locking segment of the inner member is inserted into a hollow, elongated shaft.

[0009] In some embodiments, the locking segment of the inner member may include a plurality of bends. Each of the bends may be configured to exert a frictional force on another portion of the inner surface of the hollow, elongated shaft.

[0010] In some embodiments, the intubal device may include a connecting member fixed to a user-operated segment and extending from the proximal end of the user-operated segment. The connecting member may include at least one bend, the at least one of which may be configured to exert a second frictional force on the inner surface of a second hollow elongated shaft.

[0011] In some embodiments, the outer diameter of the user-operated segment is smaller than or substantially equal to the outer diameter of the hollow, elongated shaft.

[0012] In some embodiments, the intraluminal device may include an external handle that is fixed to a user-operated segment. The external handle may be configured to receive the proximal end of a hollow, elongated shaft internally.

[0013] In some embodiments, at least a portion of the core wire can extend into the outer handle and be fixed to the outer handle.

[0014] Other configurations and advantages of the disclosed embodiments are partially described below, and some will be apparent from the description, or may be known by the practice of the disclosed embodiments. The configurations and advantages of the disclosed embodiments will be realized and achieved by the elements and combinations specifically indicated in the appended claims.

[0015] It should be understood that the above general description and the following detailed description are examples and illustrative only and do not limit the embodiments claimed and disclosed.

[0016] The accompanying drawings incorporated herein and constituting part of this specification illustrate the disclosed embodiments and, together with the description, are useful in illustrating the disclosed embodiments. [Brief explanation of the drawing]

[0017] [Figure 1A] This is a diagram illustrating a guide wire of a first configuration consistent with various embodiments of the present disclosure. [Figure 1B] Figure 1A shows a guide wire in a second configuration consistent with various embodiments of the present disclosure. [Figure 1C] Figure 1A shows a guide wire in a third configuration consistent with various embodiments of this disclosure. [Figure 2] This is a diagram of another exemplary guidewire consistent with various embodiments of the present disclosure. [Figure 3] Further exemplary guidewire diagrams consistent with various embodiments of this disclosure. [Figure 4A] A diagram of an exemplary inner member of a guide wire that conforms to various embodiments of the present disclosure. [Figure 4B] A diagram of an exemplary guide wire including the inner member of FIG. 4A that conforms to various embodiments of the present disclosure. [Figure 5] A diagram of yet another exemplary guide wire that conforms to various embodiments of the present disclosure. [Figure 6A] Shows another exemplary guide wire that conforms to various embodiments of the present disclosure. [Figure 6B] Shows another exemplary guide wire that conforms to various embodiments of the present disclosure. [Figure 7] A diagram of an exemplary guide wire having an outer member that conforms to various embodiments of the present disclosure. [Figure 8] A diagram of another exemplary guide wire having an outer member that conforms to various embodiments of the present disclosure. [Figure 9A] Shows an exemplary method of inserting an inner member into an outer shaft that conforms to various embodiments of the present disclosure. <000008​​​​​​​​​​​​​​​​​​Figure 10A shows the rotation of a guide wire having a torque device, consistent with various embodiments of this disclosure. [Figure 11] This shows the advancement of a microcatheter on an exemplary guidewire, consistent with various embodiments of the present disclosure. [Modes for carrying out the invention]

[0018] The annotations appearing in the drawings are for illustrative purposes only and do not limit the claimed invention.

[0019] Exemplary embodiments are described with reference to the accompanying drawings. In drawings not necessarily drawn to a consistent scale, the leftmost digit of the reference numeral identifies the drawing in which the reference numeral first appears. Where convenient, the same reference numeral is used throughout the drawings to refer to the same or similar parts. While examples and configurations of the disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Furthermore, the words “comprising,” “containing,” “including,” and other similar forms are intended to be equivalent in meaning and to be open-ended in that one or more items following any one of these words does not mean that one or more items are a complete list of such one or more items, or that the list is limited to only one or more items. It should also be noted that, when used herein and in the accompanying claims, the singular “a,” “an,” and “the” include multiple references unless the context clearly indicates otherwise.

[0020] Embodiments of the present disclosure relate, broadly speaking, to medical guidewires and methods for transporting medical devices into a body cavity using guidewires. More specifically, embodiments of the present disclosure relate to guidewires having a user-operated segment configured to control the bending and / or deflection of the distal end of the guidewire. Exemplary guidewires may include a self-locking function configured to fix the user-operated segment to prevent movement relative to the guidewire, for example, to hold the distal end of the guidewire in a desired configuration while transporting a medical device along the guidewire into a body cavity.

[0021] As shown in Figures 1A to 1C, a guidewire 100 consistent with the present disclosure may include a hollow outer shaft 120 extending along the longitudinal axis A between the distal end 102 and the proximal end 104 of the guidewire. In this disclosure, the term “proximal” refers to the end of the device (e.g., guidewire 100) closer to the operator of the device during use, and the term “distal” refers to the end of the device further away from the operator of the device during use. The outer shaft 120 may be made of a biocompatible material such as stainless steel, nitinol, PEEK, urethane, and / or polycarbonate. The guidewire 100 may have any suitable length, for example, about 100 centimeters to about 350 centimeters, so that the guidewire is sufficient to extend from at least a location outside the patient’s body to a desired location inside the body.

[0022] The outer shaft 120 may include a deflectable segment 122 at its distal end. The deflectable segment 122 may be configured to be more flexible than the outer shaft 120, and the deflectable segment 122 may bend or deflect laterally in one or more directions while the outer shaft 120 remains straight along the longitudinal axis A. In some embodiments, the deflectable segment 122 may include a helical-wound wire made of an elastic material such as stainless steel, nickel alloy, nickel-titanium alloy (e.g., Nitinol), platinum, tantalum, or titanium. The helical coil of the deflectable segment 122 may extend parallel to the longitudinal axis A and may be connected to the outer shaft 120 by soldering, welding, adhesive, one or more mechanical fasteners, or other suitable means. In some alternative embodiments, the deflectable segment 122 may constitute an extension or portion of the outer shaft 120, which is manufactured or treated to be more flexible than the outer shaft 120. For example, the deflectable segment 122 may include a series of notches or grooves along one side, allowing the deflectable segment 122 to bend or deflect in the direction facing the side of the segment 122 having the notches or grooves. In some embodiments, the outer diameter of the deflectable segment 122 may be substantially equal to the outer diameter of the outer shaft 120. Alternatively, the outer diameter of the deflectable segment 122 may be larger or smaller than the outer diameter of the outer shaft. In some embodiments, the deflectable segment 122 may include a rounded, obtuse distal tip.

[0023] In some embodiments, the deflectable segment 122 can have an axial length of about 0.5 cm to about 10.0 cm. For example, the deflectable segment 122 can have an axial length of about 1.0 cm to about 5.0 cm. In various embodiments, without limitation, the deflectable segment 122 can have an axial length of 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, 4.5 cm, 5.0 cm, 5.5 cm, 6.0 cm, 6.5 cm, 7.0 cm, 7.5 cm, 8.0 cm, 8.5 cm, 9.0 cm, 9.5 cm, 10.0 cm, or at least one of these ranges.

[0024] The guidewire 100 may include a user-operated segment 130 at its proximal end 104. The user-operated segment 130 may include a member configured as a handle, which may be movable relative to the outer shaft 120. In some embodiments, at least a portion of the user-operated segment 130 may be hollow and may have an outer diameter substantially equal to the outer diameter of the outer shaft 120. The guidewire 100 may include a core wire 110, which may be connected to a deflectable segment 122 and extend through the lumen of the outer shaft 120 to its proximal end, and may be connected to the user-operated segment 130.

[0025] The connection between the user-operated segment 130 and the core wire 110 allows axial movement of the user-operated segment 130 to cause corresponding axial movement of the core wire 110 relative to the outer shaft 120. In some embodiments (indicated by dotted arrows 134a and 134b in Figures 1B and 1C), axial movement of the user-operated segment 130 relative to the outer shaft 120 can cause deflection and / or straightening of the deflectable segment 122 relative to the rest of the outer shaft 120. In the examples shown in Figures 1A–1C, the deflectable segment 130 can be configured to remain substantially straight (Figure 1A) when there is no axial force applied from the core wire 110. In some embodiments, proximal movement of the user-operated segment 130 (represented by arrow 134b in Figure 1C) can pull the core wire 110 proximal, causing the deflectable segment 122 to deflect or curve in a first direction away from the longitudinal axis A (Figure 1C). Additionally or alternatively, distal movement of the user-operated segment 130 (represented by arrow 134a in Figure 1B) can push the core wire 110 distal, causing the deflectable segment 122 to deflect or curve in a second direction away from the longitudinal axis A, opposite to the first direction (Figure 1B). The curvature of the deflectable segment 122 away from the longitudinal axis A can be provided, at least in part, by the flexibility of the deflectable segment 122.

[0026] In an alternative embodiment, the deflectable segment 122 can be configured to remain deflected or curved (for example, the configuration shown in Figure 1B or Figure 1C) in the absence of axial force applied from the core wire 110. Axial movement of the user-operated segment 130 (and therefore the core wire 110) can straighten the deflectable segment 122.

[0027] The core wire 110 can be made of one or more materials having sufficient strength to push and pull the deflectable segment 122 to control the curvature of the deflectable segment, while still being flexible enough to bend and curve within the deflectable segment. For example, the core wire 110 can be made of a stainless steel alloy, a nickel-titanium alloy, or a polymer. The core wire 110 can be connected to the deflectable segment 122 and the user-operated segment 130 by soldering, welding, adhesive, one or more mechanical fasteners, or other suitable means. In some embodiments, the core wire 110 can be connected to the distal tip of the deflectable segment 122. Additionally or alternatively, the core wire 110 can be connected to another portion of the deflectable segment 122.

[0028] In some embodiments, part or all of the guidewire 100 may include an outer coating such as PTFE, ePTFE, FEP, polyester, or polyurethane to enhance the biocompatibility of the guidewire 100 and to smooth the outer surface of the guidewire. For example, the outer shaft 120, the deflectable segment 122, and optionally the user-operated segment 130 may be treated in this manner with an outer coating. Additionally or alternatively, the core wire 110 may be coated with a material such as PTFE, ePTFE, FEP, polyester, or polyurethane to enhance the ability of the core wire 110 to slide within the outer shaft 120.

[0029] Figure 2 shows the proximal end of another exemplary guidewire 200. The guidewire 200 may include an inner member 240 that can be located at least partially within the outer shaft 120 and the user actuated segment 130, with the core wire 110 extending through the inner member 240. The inner member 240 may be connected to the user actuated segment 130 or the outer shaft 120 to guide and support the axial movement of the user actuated segment 130 relative to the outer shaft 120.

[0030] Figure 3 shows the proximal end of another exemplary guide wire 300. The guide wire 300 may include an inner member 340 located at least partially within the outer shaft 320 and the user actuated segment 130. In some embodiments, the inner member 340 may be connected to the user actuated segment 130 by soldering, welding, adhesive, one or more mechanical fasteners, or other suitable means. The inner member 340 may be configured to move axially relative to the outer shaft 320. In some embodiments, a portion of the inner member 340 (e.g., portion 346) may be configured to exhibit intended friction with the outer shaft 320. This is shown in Figure 3 by generally using dashed lines to indicate the outer portion 346 of the inner member 340. The friction between the inner member 340 and the outer shaft 320 may form a self-locking function, allowing the inner member 340 to move axially relative to the outer shaft 320 when the user applies sufficient axial force to the user actuated member 130 to overcome the friction. However, if no axial force is applied by the user, friction can hold the inner member 340 and the outer shaft 320 in their relative axial positions until the user applies an axial force to the user actuating member 130.

[0031] In accordance with embodiments of the present disclosure, the intended friction can be designed and implemented in many ways. In some embodiments, the intended friction can be implemented by using interference tolerances between the inner member and the outer shaft. For example, the inner member 340 may have an outer diameter 340a of about 0.2 mm to about 3.0 mm, while the outer shaft 320 may have an inner diameter 320b configured to have an interference fit tolerance with respect to the outer diameter 340a such that friction is formed between the outer diameter of the inner member 340 and the inner diameter of the outer shaft 320.

[0032] In some alternative embodiments, the inner member is configured to contact the lumen of the outer shaft by molding or other means, thus creating friction between them. For example, when the inner member is located outside the outer shaft 420, as shown in Figure 4A, the inner member 440 may exhibit a geometric shape having one or more designed bends 442. In some embodiments, the inner member 440 may be configured to take a meandering configuration, and the inner member may include one or more designed bends 442 separated by substantially straight sections. The inner member 440 may include one bend, two bends, three bends, four bends, five bends, six bends, or any other suitable number of bends. In other embodiments, the inner member 440 may include different bend patterns, such as a zigzag pattern, a sinusoidal pattern, or a helical coil pattern. In some embodiments, the inner member 440 may include different bend patterns, such as a combination of meandering and sinusoidal portions.

[0033] The inner member 440 can be made of any suitable flexible material known to those skilled in the art. Suitable flexible materials may include, but are not limited to, polymers, metals, metal alloys, and combinations thereof. In some embodiments, for example, the inner member 440 may be made of a superelastic metal such as Nitinol. As a result, when the inner member is straightened inside the outer shaft 420, the inner member 440 acts as a load spring, ensuring continuous and constant friction between the inner member 440 and the outer shaft 420 at a designated pressure / friction point 442. For example, the guide wire 400 shown in Figure 4B may include an inner member 440 configured to be straight enough to be positioned inside the outer shaft 420. However, the spring-like configuration of the inner member 440 allows the inner member to bend within the outer shaft 420 until the bend portion 442 contacts the inner surface of the outer shaft. This can generate friction between the inner member 440 and the outer shaft 420 at least at the location of the bend portion 442. When the user applies sufficient axial force to the user-operated segment 130 to overcome this friction, the inner member 440 can move axially relative to the outer shaft 420, allowing the deflectable segment (not shown in Figure 4B) to bend or straighten. In the absence of user-applied force, the intended friction can hold the inner member 440 and the outer shaft 420 in their respective axial positions. Advantageously, this friction can prevent accidental movement or detachment of the inner member and the outer shaft, allowing the deflectable segment to remain in its intended bent or straight configuration. For example, during the operation or rotation of the guidewire 400, or while a medical device is being fed along the guidewire 400, the inner member 440 and the outer shaft 420 can be held together by friction, preventing the deflectable segment from inadvertently bending or straightening. As shown in Figures 4A and 4B, the core wire 110 can be sufficiently flexible to bend within the curvature of the inner member 440.

[0034] In alternative embodiments, the inner member can be connected to the outer shaft by soldering, welding, adhesive, one or more mechanical fasteners, or other suitable means. In such embodiments, the inner member can be configured to move axially with respect to the user actuating segment, and the exemplary mechanism described above creates the intended friction between the inner member and the user actuating segment.

[0035] Figure 5 shows another exemplary guide wire 500. In some embodiments, the outer diameter 530a of the user-operated segment 530 can be substantially equal to the outer diameter 520a of the outer shaft 520. Alternatively, the outer diameter 530a of the user-operated segment 530 can be smaller than the outer diameter 520a of the outer shaft 520. At least one of the user-operated segment 530 and the outer shaft 520 can have an outer diameter in the range of 0.25 mm to 3.0 mm. For example, in some embodiments, at least one of the user-operated segment 530 and the outer shaft 520 can have an outer diameter in the range of 0.36 mm to 0.42 mm. In various embodiments, without limitation, at least one of the user-operated segment 530 and the outer shaft 520 may be 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm, 0.30mm, 0.31mm, 0.32mm, 0.33mm, 0.34mm, 0.35mm, 0.36mm, 0.37mm, 0.38mm, 0.39mm, 0.40mm, 0.41mm, 0.42mm, 0.43mm, 0.44mm, 0.45mm, 0.46mm, 0.47mm, 0.48mm, 0.49mm, 0 It may have an outer diameter of 0.50mm, 0.55mm, 0.60mm, 0.65mm, 0.70mm, 0.75mm, 0.80mm, 0.85mm, 0.90mm, 0.95mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, or at least one of these ranges.

[0036] In some embodiments, the outer diameter of the deflectable segment can be substantially equal to the outer diameter 520a of the outer shaft 520. In some alternative embodiments, the outer diameter of the deflectable segment can be larger or smaller than the outer diameter 520a of the outer shaft 520. Parts of the outer shaft 520 and the user-operated segment 530 can be hollow to accommodate an inner member 540. Thus, the inner member 540 can have an outer diameter 540a smaller than the inner diameters of the outer shaft 520 and the user-operated segment 530. The inner member 540 can have an outer diameter 540a between 0.15 mm and 3.0 mm. In some embodiments, the inner member 540 can have an outer diameter 540a in the range of 0.16 mm to 0.22 mm; for example, the inner member 540 can have an outer diameter 540a of 0.19 mm. In various embodiments, without limitation, the inner member 540 may be 0.15mm, 0.16mm, 0.17mm, 0.18mm, 0.19mm, 0.20mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm, 0.30mm, 0.31mm, 0.32mm, 0.33mm, 0.34mm, 0.35mm, 0.36mm, 0.37mm, 0.38mm, 0.39mm, 0.40mm, 0.41mm, 0.42mm, 0.43mm, 0.44mm, 0.45mm, 0.46mm, 0. It may have an outer diameter of 540a which is 47mm, 0.48mm, 0.49mm, 0.50mm, 0.55mm, 0.60mm, 0.65mm, 0.70mm, 0.75mm, 0.80mm, 0.85mm, 0.90mm, 0.95mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, or at least one of these ranges.

[0037] In some embodiments, the outer diameters of the user-operated segment 530 and the outer shaft 520 can allow the guidewire 500 to be loaded from the rear into various other compatible devices. That is, the outer diameters of the user-operated segment 530 and the outer shaft 520 can allow a medical device (e.g., a catheter) to be loaded onto the user-operated segment 530 from its proximal end 504 and advance toward its distal end 502 beyond the user-operated segment 530 and the outer shaft 520.

[0038] Figures 6A and 6B show another exemplary guidewire 600 having a connecting member 645 added to or extending from the proximal end of the user-operated segment 630. In some embodiments, the connecting member 645 may be formed integrally with the inner member 640 such that the connecting member constitutes an extension of the inner member 640. In some alternative embodiments, the connecting member 645 may be connected to the inner member 640 by, for example, soldering, welding, adhesive, one or more mechanical fasteners, or other suitable means. In some embodiments, the connecting member 645 may be connected directly to the user-operated segment 630. Alternatively, the connecting member 645 may be fixed to the user-operated segment 630 by a connection between the user-operated segment 630 and the inner member 640. In some embodiments, the connecting member 645 may have an outer diameter substantially equal to or smaller than the outer diameter of the user-operated segment 630.

[0039] The connecting member 645 can be configured to allow an extension wire, docket wire, shaft, or any other auxiliary device (e.g., device 650) to be connected to the guidewire 600. For example, as shown in Figure 6B, the auxiliary device 650 can be loaded onto the connecting member 645 from its proximal end 604 and advanced distally until the auxiliary device 650 is securely attached to the connecting member 645. In some embodiments consistent with the present disclosure, the connecting member 645 (e.g., having an extension wire or docket wire connected thereto) can be configured to extend proximal beyond the proximal end of a catheter positioned on the guidewire 600. Such an extension allows a user (e.g., a physician) to manipulate and reposition the catheter without losing access to the proximal end of the guidewire and without inadvertently removing the distal end of the guidewire from its surgical position in the body.

[0040] As shown in Figures 6A and 6B, the connecting member 645 can also incorporate a design with intended friction for a firm connection with the auxiliary device 650, similar to the exemplary inner member described above. For example, as shown in Figure 6A, the connecting member 645 may exhibit a geometric shape with one or more designed bends 646 when the connecting member is located outside the auxiliary device 650. In some embodiments, the connecting member 645 may be configured to take a meandering configuration so that the connecting member can include one or more designed bends 646 separated substantially by straight sections. The connecting member 645 can include one bend, two bends, three bends, four bends, five bends, six bends, or any other suitable number of bends. In other embodiments, the connecting member 645 can include different bend patterns, such as a zigzag pattern, a sinusoidal pattern, or a helical coil pattern. In some embodiments, the connecting member 645 can include different bend patterns, for example, a combination of meandering and sinusoidal portions.

[0041] The connecting member 645 can be made of any suitable flexible material known to those skilled in the art. Suitable flexible materials may include, but are not limited to, polymers, metals, metal alloys, and combinations thereof. In some embodiments, for example, the connecting member 645 may be made of a superelastic metal such as nitinol. As a result, the connecting member 645 can be configured to be straight enough to be positioned within the auxiliary device 650. However, due to the spring-like configuration of the connecting member 645, it can bend within the auxiliary device 650 until the bent portion 646 contacts the inner surface of the auxiliary device 650. This can cause friction between the connecting member 645 and the auxiliary device 650, at least at the location of the bent portion 646. If the user applies sufficient axial force to the auxiliary device 650, this friction can be overcome, and the auxiliary device 650 can advance distally over the connecting member 645. However, in the absence of user-applied force, friction can hold the connecting member 645 and the auxiliary device 650 in their respective axial positions.

[0042] In some embodiments, including the embodiment shown in Figure 6B, the inner member 640 and the connecting member 645 can be configured to frictionally engage the outer shaft 620 and the auxiliary device 650, respectively, according to the exemplary configuration described above. Advantageously, this configuration allows the deflectable segment 622 to be maintained in a desired straight or bent configuration by the fixed relative position of the user-operated segment 630 and the outer shaft, while the auxiliary device 650 remains fixed to the guide wire 600. Additionally, or alternatively, the user can adjust the curvature of the deflectable segment 622 by moving the user-operated segment 630 axially, which can cause corresponding axial movement of the inner member 640, the connecting member 645, and the auxiliary device 650. This allows the auxiliary device to remain fixed to the guide wire 600 even while the user-operated segment 630 is used to bend or straighten the deflectable segment 622.

[0043] Figure 7 shows an exemplary guide wire 700 including a user-operated segment 730 on which an outer member 760 is located. In some embodiments, the user-operated segment 730 can be fully receptacled within the outer member 760. Alternatively, a portion of the user-operated segment 730 can extend from the outer member 760. The outer member 760 can also accommodate at least a portion of the outer shaft 720 internally. In some embodiments, the user-operated segment 730 and the outer member 760 can be fixed together (not shown) so that the outer member 760 can move axially relative to the outer shaft 720 to control the curvature of the deflectable segment. The outer member 760 can be configured as a handle to provide improved support and ease of use. The outer member 760 can be permanently or removablely fixed to the user-operated segment 730.

[0044] Figure 8 shows an exemplary guide wire 800 including an outer member 860 which can be configured as a proximal end friction handle section. A user actuated segment 830 may be located within the outer member 860 and can be fixed to an inner member 840. The inner member 840 may extend from the distal end of the outer member 860. In some embodiments, the outer member 860 may have an outer diameter 860a substantially equal to the outer diameter 820a of the outer shaft 820. Alternatively, the outer diameter 860a of the outer member 860 may be larger than the outer diameter 820a of the outer shaft 820.

[0045] The outer member 860 can have an outer diameter 860a of approximately 0.3 mm to approximately 3.0 mm. In some embodiments, the outer member 860 can have an outer diameter 860a in the range of 0.36 mm to 0.42 mm. In various embodiments, without limitation, the outer member 860 may be 0.30mm, 0.31mm, 0.32mm, 0.33mm, 0.34mm, 0.35mm, 0.36mm, 0.37mm, 0.38mm, 0.39mm, 0.40mm, 0.41mm, 0.42mm, 0.43mm, 0.44mm, 0.45mm, 0.46mm, 0.47mm, 0.48mm, 0.49mm, 0.50mm, 0.51mm, 0.52mm, 0.53mm, 0.54mm, 0.55mm, 0.56mm, 0.57mm, 0.58mm It can have an outer diameter of 860a which is m, 0.59 mm, 0.60 mm, 0.65 mm, 0.70 mm, 0.75 mm, 0.80 mm, 0.85 mm, 0.90 mm, 0.95 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, or at least one of these ranges.

[0046] Additionally, or alternatively, the outer shaft 820 may have an outer diameter 820a of approximately 0.25 mm to approximately 0.6 mm. In some embodiments, the outer shaft 820 may have an outer diameter 820a in the range of 0.38 mm to 0.42 mm, for example, the outer shaft 820 may have an outer diameter 820a of 0.40 mm. In various embodiments, without limitation, the outer shaft 820 may have an outer diameter of 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, 0.30 mm, 0.31 mm, 0.32 mm, 0.33 mm, 0.34 mm, 0.35 mm, 0.36 mm, 0.37 mm, 0.38 mm, 0.39 mm, 0.40 mm, 0.41 mm, 0.42 mm, 0.43 It may have an outer diameter of 820a which is 0.44 mm, 0.45 mm, 0.46 mm, 0.47 mm, 0.48 mm, 0.49 mm, 0.50 mm, 0.51 mm, 0.52 mm, 0.53 mm, 0.54 mm, 0.55 mm, 0.56 mm, 0.57 mm, 0.58 mm, 0.59 mm, 0.60 mm, or at least one of these ranges.

[0047] As shown in Figure 8, the proximal end of the outer shaft 820 may have a reduced outer diameter 865a, allowing the proximal end of the outer shaft to be at least partially received within the outer member 860. This configuration can provide a smooth outer surface at the intersection 865 between the outer shaft 820 and the outer member 860, and can also improve the stability of the guide wire 800 while the outer member 860 is being operated. In some embodiments, the outer diameter 820a of the outer shaft 820 may be reduced to an outer diameter 865a at the intersection 865. The reduced outer diameter 865a of the outer shaft 820 can be in the range of 0.20 mm to 0.56 mm, for example, the outer shaft 820 may have a reduced outer diameter 865a of 0.31 mm at the intersection 865. In various embodiments, without limitation, the outer shaft 820 has a cross section 865 with a length of 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, 0.30 mm, 0.31 mm, 0.32 mm, 0.33 mm, 0.34 mm, 0.35 mm, 0.36 mm, 0.37 mm, 0.38 mm It may have a reduced outer diameter 865a of 0.39 mm, 0.40 mm, 0.41 mm, 0.42 mm, 0.43 mm, 0.44 mm, 0.45 mm, 0.46 mm, 0.47 mm, 0.48 mm, 0.49 mm, 0.50 mm, 0.51 mm, 0.52 mm, 0.53 mm, 0.54 mm, 0.55 mm, 0.56 mm, or at least one of these ranges.

[0048] In some embodiments, the outer shaft 820 may have an inner diameter 820b in the range of 0.10 mm to 0.40 mm, for example, the outer shaft 820 may have an inner diameter 820b of 0.20 mm. In various embodiments, without limitation, the outer shaft 820 may have an inner diameter 820b which is 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, 0.30 mm, 0.31 mm, 0.32 mm, 0.33 mm, 0.34 mm, 0.35 mm, 0.36 mm, 0.37 mm, 0.38 mm, 0.39 mm, 0.40 mm, or at least one of these ranges.

[0049] During use, the outer member 860 can be moved axially relative to the outer shaft 820 to control the curvature of the deflectable segment (not shown). Proximal movement of the outer member 860 can cause a reduction in the length of the intersection 865 between the outer shaft 820 and the outer member 860. In some embodiments, the intersection 865 may include a stopper or detent configured to prevent the proximal movement of the outer member 860 beyond a certain position. The outer member 860 can also be moved distally relative to the outer shaft 820, thus increasing the length of the intersection 865. In some embodiments, the outer member 860 can be moved distally until its distal end abuts against the larger diameter portion of the outer shaft 820 (for example, the configuration shown in Figure 8).

[0050] Figures 9A to 9D illustrate exemplary methods for inserting the distal end 944 of the inner member 940 by the outer shaft 920. As shown in Figure 9A, the inner member 940 may have a curved or bent configuration when positioned outside the outer shaft 920. For example, the inner member 940 may include several bends 942, giving the inner member a zigzag or meandering configuration. The bends 942 of the inner member 940 may be partially straightened when the inner member is inserted into the outer shaft 920 (Figures 9B and 9C), thus achieving friction fitting between them. In some embodiments, the inner member 940 may be inserted distally until all of the bends 942 are positioned within the outer shaft 920 (Figure 9D).

[0051] Figures 10A and 10B show the relative motion of the user-operated segment 1020 and optionally the outer member 1060 with respect to the outer shaft 1020 to affect the deflection and / or straightening of the deflectable segment 1022. The frictional fitting between the inner member 1040 and the outer shaft 1020 allows the deflectable segment 1022 to be held in a desired deflected or straight configuration while the guide wire 1000 is being manipulated. For example, Figures 10C and 10D show the deflectable segment 1022 held in a desired deflected configuration while the torquer 1070 is inserted into and removed from the guide wire 1000. The torquer 1070 can be fixed to the guide wire 1000 at any point to rotate the guide wire. For example, Figure 10C shows the torquer 1070 being fixed to the outer member 1060 and the rotation of the torquer to result in the rotation of the guide wire 1000. Figure 10D also shows the fixing of the torquer 1070 to the outer shaft 1020 and the rotation of the torquer to bring about the rotation of the guide wire 1000. In both configurations, the frictional fitting between the inner member 1040 and the outer shaft 1020 allows the deflectable segment 1022 to be held in the desired curved or straightened configuration while the guide wire 1000 is rotated by the torquer 1070.

[0052] Figure 11 shows an exemplary guidewire 1100 on which a microcatheter 1180 is positioned. In Figure 11, the portion of the guidewire 1100 located within the microcatheter 1180 is shown as a dashed line. In some embodiments, the outer diameter of the user-operated segment 1130 can be substantially equal to or smaller than the outer diameter of the outer shaft 1120. As a result, a device such as the microcatheter 1180 can be advanced into the body by passing over the guidewire 1100, which includes the user-operated segment 1130, while the friction fitting holds the user-operated segment 1130 and thus keeps the deflectable segment 1122 stationary. In some embodiments, a catheter exchange operation can be performed on the guidewire 1100 while the friction fitting keeps the guidewire component stationary. In a catheter exchange operation, a first microcatheter can be removed from the guidewire 1100 and a second microcatheter can be inserted onto the guidewire 1100. Because frictional fitting remains during the replacement operation, the deflectable segment 1122 maintains the desired deflection configuration, and the distal end of the guide wire 1100 does not displace during replacement.

[0053] While exemplary embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, variations, omissions, combinations (e.g., aspects across diverse embodiments), applications, or modifications based on this disclosure. Elements within the claims should be interpreted broadly in accordance with the language used in the claims and not limited to the examples described herein or during the examination of this application, and such examples should be interpreted as non-limiting. Furthermore, the steps of the disclosed methods can be modified in any way, including by rearranging the steps or by inserting or deleting steps. Thus, the specification and examples are intended to be considered only as examples, and the true scope and spirit are indicated by the entire scope of the following claims and their equivalents.

Claims

1. In intraluminal guidewires, A hollow, elongated shaft, the hollow, elongated shaft extending between its distal end and proximal end, A user-operated segment positioned near the proximal end of the hollow, elongated shaft, the user-operated segment configured to move relative to the hollow, elongated shaft, A core wire extending between the user-operated segment and the distal portion of the hollow, elongated shaft, An inner member, A proximal end is located at least partially within the user-operated segment and fixed to the user-operated segment, An inner member having a distal end that is at least partially disposed within the hollow elongated shaft and configured to move axially with respect to the hollow elongated shaft, such that the core wire passes through the inner member, and An outer handle fixed to the user-operated segment and configured to receive the proximal end of the hollow, elongated shaft inside. Equipped with, The locking segment of the inner member, configured to be positioned within the hollow, elongated shaft, is configured to provide frictional restraint when it moves within the hollow, elongated shaft, and the frictional restraint during movement is the frictional force between the outer surface of the inner member and the inner surface of the hollow, elongated shaft. The locking segment of the inner member is provided with at least one bent portion, and when the locking segment of the inner member is inserted into the hollow elongated shaft, the at least one bent portion of the inner member is configured to exert a frictional force on the inner surface of the hollow elongated shaft. The outer diameter of the inner member at at least one of the bent portions is smaller than the inner diameter of the hollow, elongated shaft. The hollow, elongated shaft comprises a deflectable segment that encloses the distal end of the hollow, elongated shaft, At least a portion of the core wire extends into the outer handle and is fixed to the outer handle. The core wire is an intraluminal guide wire fixed to the deflectable segment.

2. The intraluminal guide wire according to claim 1, wherein the connection between the user-operated segment and the core wire causes axial movement of the user-operated segment to cause corresponding axial movement of the core wire relative to the hollow elongated shaft, thereby causing deflection and / or straightening of the distal end of the deflectable segment relative to the rest of the hollow elongated shaft.

3. The intraluminal guidewire according to claim 1, wherein the locking segment of the inner member has sufficient flexibility to ensure that at least one bent portion is at least partially straightened when the locking segment of the inner member is inserted into the hollow elongated shaft.

4. The intraluminal guide wire according to claim 1, wherein the locking segment of the inner member includes a plurality of bends, and each of the plurality of bends is configured to exert a frictional force on another portion of the inner surface of the hollow elongated shaft.

5. The intraluminal guide wire according to claim 1, further comprising a connecting member fixed to the user-operated segment and extending from the proximal end of the user-operated segment.

6. The intraluminal guidewire according to claim 1, wherein the outer diameter of the user-operated segment is smaller than or substantially the same as the outer diameter of the hollow, elongated shaft.

7. The intraluminal guide wire according to claim 1, wherein the locking segments of the inner member are arranged in a helical, zigzag, or sinusoidal pattern.

8. The intraluminal guide wire according to claim 1, wherein the inner member is made of a superelastic material.

9. The intraluminal guide wire according to claim 1, wherein the movement of the user-operated segment causes deflection in the deflectable segment.

10. The intraluminal guide wire according to claim 5, wherein the connecting member is connected to or integrally formed with the inner member.

11. The intraluminal guide wire according to claim 5, wherein the connecting member comprises at least one bent portion, and the at least one bent portion of the connecting member is configured to exert a second frictional force on the inner surface of a second hollow elongated shaft.

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