Medical guidewire device with controllable characteristics

Abstract

The guidewire assembly (100) may include a handle assembly (104) including a handle body, a shaft (102) extending through the handle body, and an actuator (634). The guidewire assembly may further include a tube (105) extending distally from the handle assembly and including a proximal portion and a distal portion, and an inner body (401) extending from the handle assembly through the tube to the distal portion of the tube and coupled to the shaft. The shaft may be configured to move longitudinally through the handle body as the actuator is rotated to move the inner body longitudinally through the tube.

Description

[Technical Field]

[0001] Various aspects of the present disclosure relate generally to medical systems, devices, and related methods. More particularly, the present disclosure relates to medical systems, devices, and methods for positioning one or more medical devices within a body lumen. [Background technology]

[0002] Medical procedures involving navigation to a location within the body often require a medical guidewire. Guidewires are used in many catheterization and other medical procedures as an aid for placing catheters or other devices at selected locations within the human body. Guidewires can be advanced under direct endoscopic visualization, with or without fluoroscopy. Typically, guidewires are lubricated to facilitate easy movement within small, tubular body lumens. The low friction provided by the lubricant facilitates force transmission and fine movement when small forces are applied to the proximal end of the wire. Once a guidewire is positioned proximate to a target anatomy, maintaining its position is desirable for the safety and efficiency of the procedure. Guidewire navigation often requires movement through complex and tortuous anatomy. In some instances, because a guidewire has limited ability to move within a body lumen, users may have difficulty locating the target anatomy within the body lumen to begin the procedure. Difficulty in navigating a guidewire can prolong the procedure and / or increase the likelihood of complications and / or failure.

[0003] The systems, devices, and methods of the present disclosure may remedy some of the deficiencies discussed above and / or address other aspects of the art. Summary of the Invention

[0004] Examples of the present disclosure relate to, among other things, medical systems, devices, and methods. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

[0005] According to one aspect, a guidewire assembly may include a handle assembly including a handle body, a shaft extending through the handle body, and an actuator. The guidewire assembly may further include a tube extending distally from the handle assembly and including a proximal portion and a distal portion, and an inner body extending from the handle assembly through the tube to the distal portion of the tube and coupled to the shaft. The shaft may be configured to move longitudinally through the handle body as the actuator is rotated to move the inner body longitudinally through the tube.

[0006] In other aspects, the guidewire assembly may include one or more of the following features: The distal portion of the inner body may be a shape memory material; The distal portion of the inner body may be U-shaped, S-shaped, helical, spiral, and / or include a 180-degree curve in the inner body; The proximal portion of the tube may include a laser cut pattern; The tube may be coupled to the handle assembly at the distal end of the handle assembly; The tube may be removably coupled to the distal end of the handle assembly via a distal cap and a distal collet; The actuator may be cylindrical and extend longitudinally through a central longitudinal axis of the handle body, and the shaft may extend longitudinally through a lumen of the actuator; The handle body may include a cylindrical proximal portion, a distal portion spaced from the proximal portion, and a pair of frame arms coupled to the distal and proximal portions; The distal tip of the inner body may be coupled to a distal tip portion of the tube; The actuator may include a circular protrusion received by a recess in each of the pair of frame arms. The inner body may be removably coupled to the proximal end of the shaft via a proximal collet and a proximal cap. The actuator may include a helical recess configured to receive the helical protrusion of the shaft. The actuator may be configured to move the shaft proximally or distally when the actuator is rotated about a central longitudinal axis of the handle assembly. The circular protrusion may be configured to engage one or more recesses of the pair of frame arms to lock the actuator. The tube may include a laser cut pattern having a first spacing at a proximal section of the tube and a second spacing at a distal section of the tube, the second spacing being different from the first spacing, and the inner body includes a slot aligned with the distal section of the tube.

[0007] In another aspect, a guidewire assembly for positioning within a patient's body may include an inner body and a handle assembly. The handle assembly may include a handle body including a proximal section, a distal section spaced from the proximal section, and a pair of frame arms coupled to the proximal and distal sections, a shaft extending through the handle body and coupled to the inner body, the inner body extending longitudinally through the handle body, and an actuator positioned between the pair of frame arms. Rotation of the actuator about a central longitudinal axis of the handle assembly may be configured to move the inner body proximally or distally relative to the handle assembly.

[0008] In other aspects, the guidewire assembly may include one or more of the following features: the actuator may include a helical recess configured to receive the helical protrusion of the shaft; the inner body may include a slot at a distal portion of the inner body, the distal tip of the inner body being coupled to a distal tip portion of the tube; the handle assembly may further include a distal cap removably coupled to a distal-most end of the handle body; the distal cap may be configured to be coupled to the tube, the tube being configured to receive the inner body.

[0009] In other aspects, a method of moving a guidewire assembly for positioning within a patient may include (i) distally moving a shaft of the guidewire assembly, the shaft including a tube and an inner body extending longitudinally through the tube, and (ii) rotating an actuator on a handle of the guidewire assembly about a central longitudinal axis of the handle, the inner body moving distally through the tube as the actuator is rotated. A distal portion of the tube transitions from a curved position to an at least partially straight position as the inner body moves into the distal portion of the tube.

[0010] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the claimed features. As used herein, the terms "comprises," "comprising," "including," "having," or other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, device, article, or apparatus comprising a list of elements does not include only those elements, but may also include other elements not expressly listed or other elements inherent to such process, method, article, or apparatus. Additionally, the term "exemplary" is used herein in the sense of "example," not "ideal." As used herein, the terms "about," "substantially," and "nearly" indicate values ​​within a range of + / - 5% of the stated value.

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the present disclosure. [Brief explanation of the drawings]

[0012] [Figure 1] 1 illustrates an exemplary guidewire system according to aspects of the present disclosure. [Figure 2A] 1 illustrates an exemplary distal portion of a guidewire system according to aspects of the present disclosure. [Figure 2B] 1 illustrates an exemplary distal portion of a guidewire system according to aspects of the present disclosure. [Figure 2C] 1 illustrates an exemplary distal portion of a guidewire system according to aspects of the present disclosure. [Figure 3] 1 illustrates an exemplary hypotube according to aspects of the present disclosure. [Figure 4] 2 illustrates an exemplary distal portion of the guidewire system of FIG. 1 according to an embodiment of the present disclosure. [Figure 5] 2 illustrates an exemplary distal portion of the guidewire system of FIG. 1 according to an embodiment of the present disclosure. [Figure 6] 2A-2C illustrate different views of an exemplary handle assembly of the guidewire system of FIG. 1 according to an embodiment of the present disclosure. [Figure 7] 2A-2C illustrate different views of an exemplary handle assembly of the guidewire system of FIG. 1 according to an embodiment of the present disclosure. [Figure 8] 8 shows a cross-sectional side view of the handle assembly of FIGS. 6 and 7 according to an embodiment of the present disclosure. FIG. [Figure 9] 8 illustrates an exemplary inner shaft of the handle assembly of FIGS. 6 and 7, according to an embodiment of the present disclosure. [Figure 10] 2 shows a side view of a portion of an exemplary hypotube of the guidewire system of FIG. 1 according to an embodiment of the present disclosure. [Figure 11A] 1A-1C show perspective and side views of a portion of another exemplary guidewire system according to aspects of the present disclosure. [Figure 11B] 1A-1C show perspective and side views of a portion of another exemplary guidewire system according to aspects of the present disclosure. [Figure 12A] 11A and 11B, according to an embodiment of the present disclosure. FIG. [Figure 12B] 11A and 11B, according to an embodiment of the present disclosure. FIG. [Figure 12C] 11A and 11B, according to an embodiment of the present disclosure. FIG. [Figure 13] 11A and 11B, along with various representative notations showing movement of the distal portion, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] Examples of the present disclosure include systems, devices, and methods for improving the effectiveness and safety of minimally invasive surgery and other medical procedures. For example, aspects of the present disclosure may relate to medical systems, devices, and methods for delivering a medical device to a portion of a patient's internal anatomical structure, such as a procedure to remove kidney stones or other material from the patient's kidney or other organ. In some embodiments, a medical system of the present disclosure may include a guidewire for delivering a medical tool for diagnosis or treatment of a body orifice. A medical device of the present disclosure includes a guidewire used to assist in the placement of a catheter or other medical device within a body lumen. Specifically, a guidewire of the present disclosure may transition between a pre-shaped configuration of a distal portion of the guidewire and a straight configuration of the distal portion of the guidewire.

[0014] Embodiments of the present disclosure are described herein with reference to steerable guidewires for use in minimally invasive and / or other medical procedures. For example, it will be appreciated that aspects of the present invention may be readily adapted for purposes including, but not limited to, endoscopic retrograde cholangiopancreatography (ERCP), percutaneous nephrolithotomy (PCNL), balloon and laser angioplasty, nephrostomy, electrode placement, and the like. All of these applications can benefit from steering a guidewire to a remote site located inside a patient's body.

[0015] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The terms "proximal" and "distal" are used herein to refer to the relative locations of components of exemplary medical devices. As used herein, "proximal" refers to a location relatively closer to an operator using the medical device. In contrast, "distal" refers to a location relatively farther away from an operator using the medical device. The proximal and distal directions are labeled throughout the figures.

[0016] FIG. 1 shows a perspective view of guidewire system 100 including handle assembly 104, shaft 102, and distal portion 103. Shaft 102 may include tube 105 through which inner body 401 may extend, as shown in FIG. 4. Tube 105 may be coupled to the distal end of handle assembly 104, and distal portion 103 may comprise the distal-most portion of tube 105. Distal portion 103 may comprise a pre-formed portion of tube 105 and may include nitinol and / or any other shape memory material having the ability to restore its original shape after deformation.

[0017] 2A-2C illustrate examples of distal portion 103 of guidewire system 100. FIG. 2A illustrates an S-shaped curved distal portion 203 that may be preformed as an S-shaped curved tube. FIG. 2B illustrates a straight distal portion 204 that may be preformed into a straight configuration. FIG. 2C illustrates a curved distal portion 205 that may be curved approximately 180 degrees such that the distal-most end 205a of the distal portion 205 faces substantially proximally. Although not shown, other shapes of distal portion 103 may be incorporated into the guidewire system, such as a helical, sawtooth, square-wave, or angled distal portion, or any other preformed configuration of a tubular body.

[0018] FIG. 3 shows a portion of the tube 105 removed from the handle assembly 104. The tube 105 may include a laser cut pattern to provide flexibility in one or more portions of the tube 105, such as in a distal portion of the tube 105, and a geometry or shape of the articulating section of the tube 105. As further described in connection with FIG. 10 , the tube 105 may include a variable spacing laser cut pattern that may provide variable stiffness of the tube 105 along its longitudinal length. The laser cut pattern in the tube 105 may include a series of recesses 440, 441 ( FIG. 4 ) in the outer surface radially relative to the central longitudinal axis 150 along the longitudinal length of the tube 105. In some examples, the laser cut pattern may provide a means for maintaining articulating motion in a desired plane; for example, the laser cut pattern may prevent movement in a particular plane or may limit movement to only one particular plane.

[0019] FIG. 4 shows a perspective view of a portion of the tube 105 and the inner body 401. The tube 105 is shown as transparent in FIG. 4 to show the inner body 401 positioned within the tube 105. The inner body 401 may be cylindrical and biased toward a straight configuration. In some examples, the inner body 401 may be a wire (e.g., a guidewire). The inner body 401 may be positioned within a central lumen 410 of the tube 105 and configured to move proximally and distally through the lumen 410. The inner body 401 may have sufficient rigidity to move the tube 105 from (i) a first position in which the tube 105 is bent or otherwise curved (e.g., as shown in FIGS. 2A and 2C ) without the inner body 401 being positioned within the tube 105, to (ii) a second position in which the tube 105 is substantially or nearly straight with the inner body 401 positioned within the tube lumen 410 of the tube 105. The inner body 401 can include a substantially planar distal front surface 443, which can be configured to be atraumatic when abutting tissue. A proximal end (not shown) of the inner body 401 can be coupled to a portion of the handle assembly 104, which can control proximal and distal movement of the inner body 401 within the tube 105.

[0020] FIG. 5 illustrates an exemplary portion of a guidewire system 100 including a tube 105 having a distal portion 103 and a proximal portion 505. As shown in FIG. 5, the proximal portion 505 includes a laser cut pattern of recesses in the tube 105, which may be configured to increase the flexibility of the tube 105. The distal portion 103 has a preformed approximately 180-degree curve or bias toward a U-shaped configuration. The distal-most end face 103a of the distal portion 103 may face proximally. The distal portion 103 does not include the laser cut pattern of the proximal portion 505 of the tube 105. When the inner body 401 (FIG. 4) is pushed distally through the tube 105 of FIG. 5, the distal portion 103 will transition from a U-shaped configuration (shown in FIG. 5) to a substantially or nearly straight configuration when the inner body 401 is positioned within the distal portion 103 over the entire length of the distal portion 103. When the inner body 401 is removed from within the distal portion 103 of FIG. 5 (i.e., retracted proximally), the distal portion 103 will transition to the U-shaped configuration shown in FIG. 5. As described further herein below, a user can actuate an actuator on the handle assembly 104 to move the inner body 401 distally or proximally through the tube 105, e.g., into or out of the distal portion 103.

[0021] 6 and 7 show perspective views of the handle assembly 104 of FIG. 1 with the shaft 102 removed or otherwise decoupled from the handle assembly 104. As shown in FIG. 6, the handle assembly 104 may include a handle body 631, an actuator 634, a shaft 630, a distal cap 633, and a proximal cap 632. The handle body 631 may be substantially cylindrical, and a proximal portion 641 of the handle body 631 may include a circular radially outer surface relative to the central longitudinal axis 150 of the handle assembly 104. The handle body 631 may include a pair of frame arms 636, 637 connecting the proximal portion 641 to the distal portion 642 of the handle body 631. Each frame arm 636, 637 may extend around the actuator 634, may have a rectangular cross-section taken perpendicular to the central longitudinal axis 150, and may include a protruding portion 656, 657 extending radially outward relative to the central longitudinal axis 150. Each protruding portion 656, 657 may be configured to receive a circular protrusion 639 of the actuator 634. A first frame arm 636 of a pair of frame arms 636, 637 may be positioned on the opposite side of the central longitudinal axis 150 from a second frame arm 637 of the pair of frame arms 636, 637. A distal portion 642 of the handle body 631 may extend distally beyond the distal-most end of each frame arm 636, 637. As described in detail below, the distal cap 633 may be removably coupled to the distal portion 642 of the handle body 631, and the proximal cap 632 may be removably coupled to the proximal end 661 of the shaft 630.

[0022] The distal cap 633 may be cylindrical and may include a conical distal portion 663. The distal cap 633 may taper from a first circumference about the central longitudinal axis 150 to a second circumference about the central longitudinal axis 150 that is smaller than the first circumference (i.e., from the proximal portion to the distal portion). A central lumen 655 may extend longitudinally through a center (i.e., the radial center) of the distal cap 633, and the central lumen 655 may be configured to receive a portion of the inner body 401. Threads 671 (shown in FIG. 8 ) may be positioned within the central lumen 655, and the threads 671 may be configured to removably couple the distal cap 633 to the handle body 631 (i.e., to the distal portion 642). The distal cap 633 may include a series of protrusions 638 that protrude radially outward from the conical distal portion 663 relative to the central longitudinal axis 150. Each protrusion 638 may be substantially oval and extend longitudinally in the proximal-distal direction across the conical distal portion 663. The series of protrusions 638 may facilitate gripping the distal cap 633, for example, when coupling and / or uncoupling the distal cap 633 to the handle body 631.

[0023] The proximal cap 632 may be cylindrical and may include a rounded proximal end 681. A central lumen 755 of the proximal cap 632 may extend longitudinally through the proximal cap 632 and may be aligned with the central longitudinal axis 150. The central lumen 755 may be configured to receive a portion of the inner body 401. In some examples, the inner body 401 may extend completely through the proximal cap 632, and a proximal-most portion of the inner body 301 may be positioned outside the proximal cap 632 and the shaft 630. The proximal cap 632 may include a longitudinal recess 738 extending longitudinally on its outer surface radially relative to the central longitudinal axis 150 of the proximal cap 632. The recess 738 may facilitate gripping the proximal cap 632, for example, when coupling and / or uncoupling the proximal cap 632 to the handle body 631. Threads 672 (FIG. 8) may be positioned within the proximal cap 632 and may be configured to removably couple the proximal cap 632 to the shaft 630, which may have corresponding threads for coupling the proximal cap 632 to the shaft 630.

[0024] The actuator 634 may be cylindrical and may include a longitudinal ridge 657 extending longitudinally from the proximal end to the distal end of the actuator 634. The longitudinal ridge 657 may facilitate a user's gripping of the actuator 634, for example, to rotate the actuator 634 clockwise or counterclockwise. A circular protrusion 639 may extend circumferentially around the actuator 634 and may include a longitudinal ridge 732 configured to facilitate gripping the circular protrusion 639 for clockwise or counterclockwise rotation about the axis 150. The circular protrusion 639 may be aligned with and adjacent to the protrusions 656, 657 of each frame arm 636, 637. The actuator 634 may be a knob, a roller actuator, or any other actuator. The actuator 634 can be configured to rotate relative to the handle body 631 about the central longitudinal axis 150, for example, both clockwise and counterclockwise.

[0025] Referring to the side cross-sectional view of handle assembly 104 shown in FIG. 8 , actuator 634 includes a lumen 879 extending longitudinally through actuator 634. The radially inwardly facing surface 879 forming lumen 879 may be cylindrical and may include one or more helical recesses 871 extending circumferentially along an inner periphery about central longitudinal axis 150. Helical recesses 871 of actuator 634 may be configured to receive one or more protrusions 861 of shaft 630 ( FIG. 9 ). As shown in FIG. 8 , lumen 879 is configured to receive shaft 630.

[0026] A proximal collet 815 may be positioned at the proximal-most end of the shaft 630. Note that the proximal collet 815 is shown in cross section here in FIG. 8 . The proximal collet 815 may be cylindrical and may include a conical-shaped proximal-most end portion. The proximal collet 815 may be configured to receive a portion of the inner body 401, and the proximal collet 815 may be configured to retract radially inward and couple to the inner body 401 when the proximal cap 632 is coupled to the shaft 630. The proximal collet 815 may serve to securely couple the inner body 401 to the proximal portion of the shaft 630 such that proximal and distal movement of the shaft 630 moves the inner body 401 proximally or distally, respectively. The proximal collet 815 may be received within a recessed portion of the shaft 630 at its proximal-most end, and the proximal collet 815 may be longitudinally aligned with the central longitudinal lumen 809 of the shaft 630. In some examples, the proximal collet 815 may include a longitudinal lumen extending therethrough configured to receive a proximal portion of the inner body 401, and the longitudinal lumen of the proximal collet 815 may extend the entire length of the proximal collet 815 from its proximal-most end to its distal-most end.

[0027] A distal collet 816 may be positioned within the distal portion 642 of the handle body 631. The distal collet 816 may be substantially cylindrical and may include a conical distal-most end 816a. The distal collet 816 may be configured to receive the inner body 401 within an internal channel 865 of the distal collet 816. The internal channel 865 may be configured to allow the inner body 401 to move proximally or distally (i.e., longitudinally) therethrough and to restrict lateral or radial movement of the inner body 401. The internal channel 865 may extend longitudinally through the distal collet 816 and may be longitudinally aligned with the central longitudinal axis 150. The distal collet 816 may be received by the handle body 631 within a channel 878 of the distal portion 642. The distal collet 816 and the distal cap 633 are configured to couple the tube 105 to the distal end of the handle assembly 104. The tube 105 may be clamped between the distal collet 816 and the distal cap 633, and the lumen 410 of the tube 105 may be longitudinally aligned with the central longitudinal axis 150 when the tube 105 is coupled to the distal collet 816 and the distal cap 633. The distal cap 633 may include a conical interior shape configured to correspond to the conical distal-most end 816a of the distal collet 816, which may help secure the proximal end of the tube 105 when clamped between the distal collet 816 and the distal cap 633.

[0028] As shown in FIG. 8 , the helical recess 871 of the actuator 634 receives the helical protrusion 861 of the shaft 630. The distal portion of the shaft 630 is not shown in cross section to illustrate the helical protrusion 861 received within the helical recess 871. The helical protrusion 861 may be located on the distal portion of the shaft 630. The shaft 630 may be configured to move proximally or distally relative to the actuator 634 and the handle body 631. The shaft 630 may be cylindrical, may be located within the handle body 631, and may extend proximally from a proximal end of the handle body 631. The shaft 630 may include a lumen 809 extending longitudinally through the shaft 630, which may be configured to receive the inner body 401. The lumen 809 may extend the entire length of the shaft 630, from an opening at the proximal-most end of the shaft 630 to an opening at the distal-most end of the shaft 630. Lumen 809 may be aligned with lumen 865 of distal collet 816, and lumen 809 may also be aligned with lumen 889 of proximal collet 632. When inner body 401 is coupled to the proximal end of shaft 630 via proximal collet 815 and proximal cap 632, inner body 401 may move proximally or distally as shaft 630 moves proximally or distally, respectively.

[0029] FIG. 9 shows a perspective view of the shaft 630 removed from the handle assembly 104. Note that the proximal and distal directions in FIG. 9 are opposite to those in FIG. 8 (as indicated by the proximal (P) and distal (D) arrows in each view). The shaft 630 may include a proximal end portion 998 and a distal end portion 999. Threads 910 configured to receive the proximal cap 632 may be positioned on the proximal end portion 998 of the shaft 630. A series of protruding portions 911, 912, 913, 914 may be longitudinally spaced from one another along the length of the shaft 630, and a series of recessed portions 915, 916, 917 may be positioned between pairs of the protruding portions 911, 912, 913, 914. The distal-most projecting portion 914 may be cylindrical and may include one or more helical projections 861 extending across a radially outer surface 995 of the projecting portion 914 relative to the central longitudinal axis 950 of the shaft 630. The distal-most projecting portion 914 may extend to the distal-most end of the shaft 630. The helical projection 861 may extend from the distal-most end of the shaft 630 (i.e., the distal-most end of the distal-most projecting portion 914) to a proximal portion of the projecting portion 914. In some embodiments, the distal-most projecting portion 914 may extend proximally beyond the distal end of the helical projection 861. One or more projections 918, 919 may extend radially outward from the projecting portion 912 relative to the longitudinal axis 950. The projection 919 is not shown and may be positioned laterally opposite the projecting portion 912. Each of the protrusions 918, 919 may support the shaft 630 and facilitate positioning the shaft 630 within the central channel 896 of the handle body 631. For example, the protrusions 918, 919 may position the shaft 630 within a central portion of the channel 896 and prevent lateral movement or movement across the longitudinal axis 150. In some examples, the protrusions 918, 919 may be rubber that provides friction between the shaft 630 and a surface of the channel 896 of the handle body 631 that faces radially inward relative to the axis 150.If the protrusions 918, 919 are rubber or another material configured to provide a frictional engagement with the inner surface of the handle body 631, the actuator 634 may be released and the frictional engagement between the protrusions 918, 919 and the inner surface of the handle body 631 may prevent the shaft 630 from rotating about the axis 150, which may allow the user to release the actuator 634 and maintain the current position of the distal portion 103. Any number of protrusions 911, 912, 913, 914 and recessed portions 915, 916, 917 may be included on the shaft 630.

[0030] FIG. 10 shows a side view of an exemplary tube 105 of guidewire system 100 having a proximal end 1010 and a distal end 1004. In FIG. 10, a portion of tube 105 has been removed for illustrative purposes. Tube 105 may include a laser cut pattern having a proximal section 1006 and a distal section 1005. Proximal section 1006 may have a larger spacing than distal section 1005. The larger spacing in proximal section 1006 may facilitate pushability of tube 105, while the smaller spacing in distal section 1005 may increase flexibility of distal section 1005. Tube 105 may also include a proximal portion 1007, for example, that is completely devoid of a laser cut pattern.

[0031] During use, the guidewire assembly 100, and specifically the shaft 102, may be introduced into a body cavity, opening, or incision in a patient. A user may then navigate, for example, using the handle assembly 104, and move the distal portion 103 of the shaft 102 to move the shaft 102 into the body lumen. The user may manipulate the shaft 102 so that the distal portion 103 of the shaft 102 is proximate a target tissue, object, site, or the like, such as a kidney stone. To move the distal portion 103, the user may rotate the actuator 634 about the central longitudinal axis 150 of the handle assembly 104. As the actuator 634 rotates about the axis 150, the helical recess 871 of the actuator 634 engages the helical protrusion 861 of the shaft 630, moving the shaft 630 proximally or distally relative to the handle body 631. For example, a user can rotate the actuator 634 counterclockwise to advance the inner body 401 distally, thereby moving the shaft 102 distally. Moving the shaft 630 distally advances the inner body 401 distally through the tube 105 and into the distal portion 103, causing the distal portion 103 to at least partially straighten. A user can rotate the actuator 637, for example, clockwise, to move the shaft 630 proximally through the handle body 631 and pull the inner body 401 proximally through the tube 105. As the inner body 401 moves proximally from the distal portion 103 of the tube 105, the distal portion 103 will transition from an at least partially straight configuration to a pre-shaped configuration, such as one of the pre-shaped configurations shown in FIGS. 2A-2C . By allowing the user to transition the distal portion 103 between a straight and a pre-formed configuration, the distal portion 103 of the tube 105 can transition between multiple different shapes, allowing the user to more easily navigate through tortuous body lumens. The user can also push the shaft 102 distally or pull the shaft 102 proximally to facilitate repositioning the shaft 102 within the patient's body.

[0032] In some examples, a user may position the distal portion 103 of the tube 105 at a target tissue, object, site, etc. within a patient and then remove the inner body 401 from the guidewire assembly 100 by unscrewing the proximal cap 632 from the shaft 630 and withdrawing the inner body 401 proximally from the tube 105 and handle assembly 104. Once the inner body 401 is removed from the guidewire assembly 100, the user can uncouple the handle assembly 104 from the tube 105 by unscrewing the distal cap 633 and withdrawing the tube 105 distally from the distal cap 633. Once the inner body 401 and handle assembly 104 are removed, the user can apply a contrast liquid, such as a contrast agent or other dye or liquid colorant (e.g., an iodine-based contrast agent or any other contrast agent known in the art), to the proximal end of the tube 105 to apply the contrast agent to the target anatomy. In some examples, after removing the inner body 443, a user can apply contrast fluid through the proximal collet 815 and through the lumen 809 of the shaft 630 within the handle 104, avoiding separating the handle 104 from the tube 105. The contrast fluid can help the user visualize the target anatomy using one or more medical imaging devices. The user can then recouple the tube 105 to the handle assembly 104, for example, using the distal cap 633 and distal collet 816. Once the tube 105 is recoupled to the handle assembly 104, the user can securely couple the proximal end of the inner body 401 to the proximal end of the shaft 630 by inserting the inner body 401 through the shaft 630 and tube 105 and into the proximal collet 815, and tightening the proximal cap 632. The shaft 105 is removable from the handle assembly 104 so that a user can use different shafts 105 (as well as different tubes 105 and pre-shaped distal portions 103 , 203 , 204 , 205 ) with the same handle assembly 104 .

[0033] In some examples, the actuator 634 may be configured to lock and hold the inner body in place (e.g., to help prevent the inner body from moving proximally or distally) so that a user can release the actuator 634 and the actuator 634 can maintain its position without further rotation about the central longitudinal axis 150. For example, the circular protrusion 639 of the actuator 634 may be made of rubber or coated with rubber, and the circular protrusion 639 may engage (i.e., frictionally engage) with the recesses 656, 657 in the frame arms 636, 637 to help prevent rotation of the actuator 634 when the user releases the actuator 634. The longitudinal ridges 732 of the circular protrusion 639 may increase the engagement and friction between the circular protrusion 639 and the recesses 656, 657 and may provide a ratchet mechanism that helps secure the actuator 634 in a variety of different positions. In some examples, the actuator 634 and / or the circular protrusion 639 may be coated with any other material that provides a frictional engagement between the actuator 634 and the recesses 656, 657 of the frame arms 636, 637.

[0034] 11A-13 show the distal portion of various components of an alternative guidewire system 1100. The alternative guidewire system 1100 may include any of the structures and characteristics of guidewire system 100 and may include a handle assembly 104 and a shaft 1102 coupled to the handle assembly 104 in the same manner as described above in connection with guidewire assembly 100. As shown in FIG. 11A , the shaft 1102 may include an inner body 1101 and a tube 1105. The inner body 1101 may be positioned within a channel of the tube 1105 and may be configured to move proximally and distally through the tube 1105. The shaft 1102 is shown partially exploded in FIG. 11A for illustrative purposes, with the inner body 1101 extending distally from the tube 1105.

[0035] The inner body 1101 may be cylindrical and may include any of the features of the inner body 401. The inner body 1101 may include a distal portion 1150 including a distal tip 1103 and a recessed portion 1110 forming a slot 1111 facing radially outward toward a side of the inner body 1101. The proximal portion 1112 of the inner body 1101 may extend from the distal portion 1150 to the handle assembly of the guidewire assembly 1100. The distal tip 1103 may be cylindrical and configured to abut and / or couple to a distal end portion of the tube 1105. The slot 1111 may be an eccentric cutout in the inner body 1101 and have a central longitudinal axis 1160 extending longitudinally therethrough. The recessed portion 1110 may be spaced apart from the central longitudinal axis 1160. In some examples, the recessed portion 1110 may include a flat surface facing the central longitudinal axis 1160 and facing radially outward toward a side of the inner body 1101. The recessed portion 1110 may include a series of notches and / or recesses (not shown) configured to increase the flexibility of the recessed portion 1110. In some examples, the proximal portion 1112 may be cylindrical, and in other examples, the proximal portion 1112 may be rectangular (not shown). Because the slot 1111 is an eccentric notch in the inner body 1101, the slot 1111 may be configured to bend in a first direction when the inner body 1101 is pushed distally relative to the tube 1105 and the distal tip 1103 is coupled to the tube 1105, and to bend in a second direction (opposite the first direction) when the inner body 1101 is pulled proximally relative to the tube 1105 and the distal tip 1103 is coupled to the tube 1105. In some examples, the first direction extends from the axis 1160 toward the recessed portion 1110, and the second direction extends from the axis 1160 away from the recessed portion 1110. Figure 11B shows a side view of the distal portion 1150 of the inner body 1101, including the distal tip 1103, the recessed portion 1110, the proximal portion 1112, and the slot 1111. Figure 11B shows how the central longitudinal axis 1160 extends through the slot 1111.In some examples, the inner body 1101 may be made partially or entirely from nitinol and / or any other shape memory material that has the ability to restore its original shape after deformation.

[0036] 12A shows a side view of the distal portion of tube 1105. Tube 1105 may include a distal tip portion 1250, a flexible section 1251, and a relatively rigid section 1252. Flexible section 1251 may extend longitudinally between and connect distal tip portion 1250 and rigid section 1252. Tube 1105 may include a laser cut pattern, and the laser cut pattern on rigid section 1252 may have greater spacing than the laser cut pattern on flexible section 1251. For example, slots or openings in the laser cut pattern may be spaced further apart longitudinally in rigid section 1252 compared to flexible section 1251. Distal tip portion 1250 may not include a laser cut pattern. It is understood that rigid section 1252 is flexible but less flexible than flexible section 1251.

[0037] 12B shows a side view of the distal portion 1150 of the inner body 1101. The slot 1111 of the inner body 1101 can be configured to align with the flexible section 1251, the distal tip 1103 can be configured to align with the distal tip portion 1250, and the proximal portion 1112 can be configured to align with the rigid portion 1252. As shown, the slot 1111 can be shorter than the flexible portion 1251.

[0038] 12C shows the shaft 1102 in a fully assembled state, with the inner body 1101 coupled to the tube 1105. The distal tip 1103 of the inner body 1101 can be coupled to the distal tip portion 1250 of the tube 1105. The recessed portion 1110 and the proximal portion 1112 can be configured to move within the tube 1105 when fully assembled. The distal tip 1103 can be laser welded to the distal tip portion 1250. In some examples, the recessed portion 1110 can extend through the flexible section 1251, and the proximal portion 1112 can extend through the rigid portion 1252.

[0039] When a user actuates the handle assembly of guidewire assembly 1100, inner body 1101 can move proximally or distally through tube 1105 to a distal portion of tube 1105, e.g., distal tip 1250, flexible section 1251, and / or rigid section 1252. Because distal tip 1103 is coupled to distal tip section 1250, relative movement occurs between (i) recessed portion 1110 and proximal portion 1112, and (ii) flexible section 1251 and rigid section 1252 of tube 1105. FIG. 13 shows a perspective view of the distal portion of guidewire assembly 1100, including various directional arrows to indicate the movement capabilities of shaft 1102. A user can move the shaft 1102 proximally 1305 or distally 1306, rotate the shaft 1102 clockwise 1303 or counterclockwise 1304 about the central longitudinal axis 1350, and bend the distal portion of the shaft upward 1301 or downward 1302. Although shown in FIG. 13 as upward 1301 and downward 1302, the bidirectional bending capability of the shaft 1102 can be in any first direction 1301 and any second direction 1302 opposite the first direction 1301. Representative dotted lines 1360 and 1361 illustrate an example position of the shaft 1105 in a downward bend position 1360 and an example position of the shaft 1105 in an upward bend position 1361.

[0040] The slots 1111 in the inner body 1101 allow the body 1101 to be more flexible at the recessed portion 1110 than at the proximal portion 1112 of the inner body 1101. This difference in flexibility along the longitudinal length of the inner body 1101 allows the inner body 1101 to bend the tube 1105 in the manner shown in FIG. 13. When a user (via the handle assembly) pushes the inner body 1101 distally relative to the shaft 1105, the inner body 1101 proximal to the tip 1103 moves through the tube 1105, the recessed portion 1110 (and, in some examples, the distal portion of the proximal portion 1112) may bend in a first direction, and because the distal tip 1103 is coupled to the distal portion 1250, the distal tip 1103 may be prevented from moving distally relative to the tube 1105. As the inner body 1101 is moved distally, the recessed portion 1110 bends, causing the inner body to bend the tube 1105 upward 1301 or downward 1302. The slot 1111 is an eccentric notch in the inner body 1101 so that when a user moves the inner body proximally relative to the shaft 1105, the recessed portion 1110 can bend in the opposite direction than when the inner body 1101 is moved distally. By providing the slot 1111, the inner body 1101 will bend consistently upward 1301 and downward 1302 (compared to other directions) as the inner body 1101 is moved distally and proximally within the tube 1105.

[0041] The guidewire assemblies 100, 1100 of the present disclosure, and portions thereof shown in the figures and described above, facilitate the positioning of other medical devices during medical procedures. The guidewire assemblies 100, 1100, and portions thereof, can help facilitate movement of the shaft 102, 1102 through the patient's anatomy and maintain the positioning of the guidewire in the target anatomy region, thereby enabling efficient and effective procedures, while also providing a conduit for applying contrast media to the target anatomy. The design of the handle assembly 104 can facilitate movement of the shaft 102, 1102 through the patient's anatomy, which can shorten procedure time and limit procedural errors and / or patient complications.

[0042] It is contemplated that the guidewires, systems, and methods described herein may be applicable to any endoscopic and / or minimally invasive procedure. For example, the above-described systems, devices, and methods may be used during percutaneous nephrolithotomy / nephrolithotomy (PCNL), endoscopic retrograde cholangiopancreatography (ERCP), balloon and laser angioplasty, nephrostomy, electrode placement, etc. The above-described systems, devices, and methods may also be used in procedures such as ureteral stones, gallstones, bile duct stones, polyp removal, stent placement, gastrointestinal anastomosis, hepaticoduodenostomy, etc.

[0043] While the principles of the present disclosure have been described herein with reference to illustrative examples of particular applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize additional modifications, applications, embodiments, and equivalent substitutions that are all within the scope of the features described herein. Accordingly, the features set forth in the claims should not be deemed limited by the foregoing description.

Claims

1. 1. A handle assembly comprising: The handle body and a shaft extending through the handle body; a handle assembly including an actuator; a tube extending distally from the handle assembly and including a proximal portion and a distal portion; an inner body coupled to the shaft, the inner body extending from the handle assembly through the tube to the distal portion of the tube; the shaft is configured to move longitudinally through the handle body as the actuator is rotated to move the inner body longitudinally through the tube; Guidewire assembly.

2. The guidewire assembly of claim 1 , wherein the distal portion of the inner body is a shape memory material.

3. The guidewire assembly of claim 1 or 2, wherein the distal portion of the inner body is U-shaped, S-shaped, helical, spiral, and / or includes a 180-degree curve in the inner body.

4. The guidewire assembly of any one of claims 1 to 3, wherein the proximal portion of the tube includes a laser cut pattern.

5. The guidewire assembly according to any one of claims 1 to 4, wherein the tube is coupled to the handle assembly at a distal end thereof.

6. The guidewire assembly of claim 5 , wherein the tube is removably coupled to the distal end of the handle assembly via a distal cap and a distal collet.

7. 7. The guidewire assembly of claim 1, wherein the actuator is cylindrical and extends longitudinally through a central longitudinal axis of the handle body, and the shaft extends longitudinally through a lumen of the actuator.

8. 8. The guidewire assembly of claim 7, wherein the handle body includes a cylindrical proximal portion, a distal portion spaced from the proximal portion, and a pair of frame arms coupled to the distal portion and the proximal portion.

9. The guidewire assembly of any preceding claim, wherein a distal tip of the inner body is coupled to a distal tip portion of the tube.

10. The guidewire assembly of claim 8 , wherein the actuator includes a circular protrusion received by a recess in each of the pair of frame arms.

11. The guidewire assembly of any one of claims 1 to 10, wherein the inner body is removably coupled to the proximal end of the shaft via a proximal collet and a proximal cap.

12. The guidewire assembly of any preceding claim, wherein the actuator includes a helical recess configured to receive a helical protrusion of the shaft.

13. The guidewire assembly of claim 12 , wherein the actuator is configured to move the shaft proximally or distally when the actuator is rotated about a central longitudinal axis of the handle assembly.

14. The guidewire assembly of claim 10 , wherein the circular protrusion is configured to engage one or more recesses in the pair of frame arms to lock the actuator.

15. 15. The guidewire assembly of claim 1, wherein the tube includes laser cut patterns having a first spacing at a proximal section of the tube and a second spacing at a distal section of the tube, the second spacing being different from the first spacing, and the inner body includes a slot aligned with the distal section of the tube.

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