Medical guidewire device with controllable features

Abstract

A 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 also include a tube (105) extending distally from the handle assembly and including a proximal portion and a distal portion, and an inner body (401); the inner body extends from the handle assembly through the tube to the distal portion of the tube, wherein the inner body is coupled to the shaft. The shaft may be configured to move longitudinally through the handle body as the actuator rotates to move the inner body longitudinally through the tube.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 408,705, filed on September 21, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0002] Aspects of the present disclosure generally relate to medical systems, devices, and related methods. More specifically, the present disclosure relates to medical systems, devices, and methods for positioning one or more medical devices within a body cavity. Background Art

[0003] Medical procedures involving navigation to internal body sites typically require medical guidewires. Guidewires are used in a variety of catheterization and other medical procedures to assist in the placement of catheters or other devices at selected sites within the human body. With or without fluoroscopy, the guidewire can be advanced through an endoscope under direct visualization conditions. Typically, the guidewire is lubricious to facilitate easy movement within small tubular body cavities. When a small force is applied to the proximal end of the wire, the lubricious low friction facilitates force transmission and fine movement. Once the guidewire is placed adjacent to the target anatomical structure, it is desirable to maintain the position of the guidewire for the safety and effectiveness of the procedure. Navigation of the guidewire typically requires movement through complex and tortuous anatomical structures. In some instances, due to limitations on the ability of the guidewire to move within the body cavity, it can be difficult for the user to position the target anatomical structure within the body cavity to initiate the procedure. Difficulties in guidewire movement can prolong the procedure and / or can increase the likelihood of complications and / or surgical failure.

[0004] The systems, devices, and methods of the present disclosure can correct some of the deficiencies described above or can address other aspects of the prior art. Summary of the Invention

[0005] Examples of the present disclosure relate to medical systems, devices, and methods, among others. Each of the examples disclosed herein can include one or more of the features described in connection with any one of the other disclosed examples.

[0006] According to one aspect, a guidewire assembly can include a handle assembly that includes: a handle body, a shaft, and an actuator, the shaft extending through the handle body. The guidewire assembly can further include a tube and an inner body; the tube extends distally from the handle assembly and includes a proximal portion and a distal portion, the inner body extends from the handle assembly through the tube to the distal portion of the tube, wherein the inner body is coupled to the shaft. As the actuator rotates to longitudinally move the inner body through the tube, the shaft can be configured to longitudinally move through the handle body.

[0007] 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, coiled, and / or include a one-hundred-eighty-degree bend 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 chuck. The actuator may be cylindrical and may longitudinally extend through the central longitudinal axis of the handle body, and the shaft may longitudinally extend through the lumen of the actuator. The handle body may include a cylindrical proximal portion, a distal portion spaced apart from the proximal portion, and a pair of frame arms that are coupled to the distal portion and the proximal portion. The distal end of the inner body may be coupled to the distal end portion of the tube. The actuator may include a circular protrusion that is received by a recess of each of the pair of frame arms. The inner body may be removably coupled to the proximal end of the shaft via a proximal chuck and a proximal cap. The actuator may include a helical recess configured to receive a helical protrusion of the shaft. When the actuator rotates about the central longitudinal axis of the handle assembly, the actuator may be configured to move the shaft proximally or distally. 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 pitch in a proximal section of the tube and a second pitch in a distal section of the tube, where the second pitch is different from the first pitch, and where the inner body includes a slot aligned with the distal section of the tube.

[0008] In other aspects, 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, a shaft, and an actuator; the handle body includes a proximal section, a distal section spaced apart from the proximal section, and a pair of frame arms that are coupled to the proximal section and the distal section; the shaft extends through the handle body and is coupled to the inner body, where the inner body longitudinally extends through the handle body; the actuator is located between the pair of frame arms. Rotation of the actuator about the central longitudinal axis of the handle assembly may be configured to move the inner body relative to the handle assembly proximally or distally.

[0009] 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 a helical protrusion of the shaft. The inner body may include a slot at the distal portion of the inner body, and the distal end of the inner body is coupled to the distal end portion of the tube. The handle assembly may further include a distal cap that is removably coupled to the distal most end of the handle body; the distal cap may be configured to couple to the tube, and the tube may be configured to receive the inner body.

[0010] In other aspects, a method of moving a guidewire assembly for positioning within a patient may include (i) moving the shaft of the guidewire assembly distally, where the shaft includes a tube and an inner body that extends longitudinally through the tube; and (ii) rotating an actuator on the handle of the guidewire assembly about a central longitudinal axis of the handle, where the inner body moves distally through the tube as the actuator rotates. As the inner body moves into the distal portion of the tube, the distal portion of the tube transitions from a bent position to at least a partially straight position.

[0011] The foregoing general description and the following detailed description are exemplary and explanatory only and do not limit 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, apparatus, article, or device that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or device. Further, the term “exemplary” is used in a sense of “an example” rather than “an ideal.” As used herein, the terms “about,” “substantially,” and “approximately” indicate a numerical range of + / -5% of the recited value. Brief Description of the Drawings

[0012] The drawings incorporated in and constituting a part of this specification illustrate various exemplary embodiments and, together with the detailed description, serve to explain the principles of the disclosure.

[0013] Figure 1 Exemplary guidewire systems are shown in accordance with aspects of the present disclosure.

[0014] Figures 2A to 2C An exemplary distal portion of a guidewire system is shown in accordance with aspects of the present disclosure.

[0015] Figure 3 Exemplary hypotubes are shown in accordance with aspects of the present disclosure.

[0016] Figure 4 Exemplary distal portions of a guidewire system are shown in accordance with aspects of the present disclosure Figure 1 are shown.

[0017] Figure 5 Exemplary distal portions of a guidewire system are shown in accordance with aspects of the present disclosure Figure 1 are shown.

[0018] Figure 6 and Figure 7 Exemplary distal portions of a guidewire system are shown in accordance with aspects of the present disclosure Figure 1Different views of an exemplary handle assembly of a guidewire system.

[0019] Figure 8 According to various aspects of the present disclosure, Figure 6 and Figure 7 A side cross-sectional view of the handle assembly.

[0020] Figure 9 According to various aspects of the present disclosure, Figure 6 and Figure 7 An exemplary internal shaft of a handle assembly.

[0021] Figure 10 According to various aspects of the present disclosure, Figure 1 A side view of multiple portions of an exemplary hypotube of a guidewire system.

[0022] Figure 11A and Figure 11B Perspective and side views of another exemplary guidewire system are shown in accordance with aspects of the present disclosure.

[0023] Figure 12A , Figure 12B and Figure 12C According to various aspects of the present disclosure, Figure 11A and Figure 11B A side view of the multiple parts of the guidewire system.

[0024] Figure 13 According to various aspects of the present disclosure, Figure 11A and Figure 11B A stereoscopic view of the distal portion of a guidewire system with various representative symbols illustrating movement of the distal portion. DETAILED DESCRIPTION

[0025] Examples of the present disclosure include systems, devices and methods to improve the effectiveness and safety of minimally invasive surgery or other medical procedures. For example, aspects of the present disclosure may relate to medical systems, devices and methods for delivering medical devices to a part of an anatomical structure in a patient's body, such as, for example, surgery to remove kidney stones or other materials from a patient's kidney or other organ. In some embodiments, the medical system of the present disclosure may include a guide wire to deliver medical tools for diagnosis or treatment of a body orifice. The medical device of the present disclosure includes a guide wire, which is used to assist the placement of a catheter or other medical device in a body lumen. In particular, the guide wire of the present disclosure can be transformed between a preformed configuration of the distal portion of the guide wire and a straight configuration of the distal portion of the guide wire.

[0026] Embodiments of the present disclosure are described herein with reference to steerable guidewires for use in minimally invasive medical procedures and / or other medical procedures. For example, it should be understood that aspects of the present invention can be readily adapted for a variety of purposes such as, but not limited to, endoscopic retrograde cholangiopancreatography (ERCP), percutaneous nephrolithotomy (PCNL), balloon and laser angioplasty, nephrostomy, electrode placement, etc. These applications can all benefit from the manipulation of a guidewire to a remote location within a patient's body.

[0027] Reference will now be made in detail to the examples of the present disclosure described above and shown in the drawings. Wherever possible, the same reference numerals will be used in all the figures to refer to the same or like parts.

[0028] The terms "proximal" and "distal" are used herein to refer to the relative positions of components of an exemplary medical device. When used herein, "proximal" refers to a position relatively closer to the operator using the medical device. In contrast, "distal" refers to a position relatively farther from the operator using the medical device. The proximal and distal directions are marked in all of the figures.

[0029] Figure 1 A perspective view of a guidewire system 100 is shown, the guidewire system 100 including a handle assembly 104, a shaft 102, and a distal portion 103. The shaft 102 may include a tube 105, and as Figure 4 shown, an inner body 401 may extend through the tube 105. The tube 105 may be coupled to the distal end of the handle assembly 104, and the distal portion 103 may include the farthest distal portion of the tube 105. The distal portion 103 may include a preformed portion of the tube 105 and may include nitinol and / or any other shape memory material having the ability to return to an initial shape after deformation.

[0030] Figures 2A to 2C An example of the distal portion 103 of the guidewire system 100 is shown. Figure 2A An S-shaped curved distal portion 203 is shown, which may be preformed as an S-shaped curved tube. Figure 2B A straight distal portion 204 is shown, which may be preformed in a straight configuration. Figure 2C A curved distal portion 205 is shown, which may be bent approximately 180 degrees such that the farthest distal end 205a of the distal portion 205 generally faces proximally. Although not shown in the figures, other shapes of the distal portion 103 may be incorporated into the guidewire system, such as a helical distal portion, a serrated distal portion, a square wave distal portion, a ramped distal portion, or any other preformed configuration of the tubular body.

[0031] Figure 3Shows a portion of the tube 105 removed from the handle assembly 104. The tube 105 may include a laser cut pattern to provide flexibility at one or more portions of the tube 105, such as at the distal portion of the tube 105; and to provide the geometry or shape of the articulated section of the tube 105. As will be further discussed with respect to Figure 10 , the tube 105 may include a variable pitch laser cut pattern, which may provide variable stiffness of the tube 105 along the longitudinal length of the tube 105. The laser cut pattern in the tube 105 may include a series of recesses 440, 441( Figure 4 ) on the radially outer surface relative to the central longitudinal axis 150 along the longitudinal length of the tube 105. In some instances, the laser cut pattern may provide a means to maintain articulation in a desired plane, e.g., the laser cut pattern may prevent movement in a specific plane and may limit movement to only one particular plane.

[0032] Figure 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 Figure 4 to show the inner body 401 located within the tube 105. The inner body 401 may be cylindrical and may be biased towards a straight configuration. In some instances, the inner body 401 may be a wire (e.g., a guide wire). The inner body 401 may be located within the central lumen 410 of the tube 105 and may be 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 where the tube 105 is bent or otherwise curved in the case where the inner body 401 is not located within the tube 105 (e.g., as shown in Figure 2A and Figure 2C ) to (ii) a second position where the tube 105 is generally or substantially straight in the case where the inner body 401 is located within the lumen 410 of the tube 105. The inner body 401 may include a generally planar distal front face 443, and the distal tip 443 may be configured to be non-invasive when adjacent to tissue. The proximal end (not shown) of the inner body 401 may be coupled to a portion of the handle assembly 104, and the handle assembly 104 may control the proximal and distal movement of the inner body 401 within the tube 105.

[0033] Figure 5 Shows an exemplary portion of the guide wire system 100, the guide wire system 100 including a tube 105 having a distal portion 103 and a proximal portion 505. As Figure 5As shown, the proximal portion 505 includes a laser-cut recess pattern on the tube 105, and the laser-cut recess pattern in the tube 105 can be configured to increase the flexibility of the tube 105. The distal portion 103 has a preformed bend of approximately 180 degrees, or has a bias toward a U-shaped configuration. The farthest distal end face 103a of the distal portion 103 can face in the proximal direction. 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 ( Figure 4 ) is pushed distally through Figure 5 's tube 105, when the inner body 401 is located within the distal portion 103 along the entire length of the distal portion 103, the distal portion 103 will transition from a U-shaped configuration ( Figure 5 as shown) to a substantially or approximately straight configuration. When the inner body 401 is removed from Figure 5 's distal portion 103 (i.e., retracted proximally), the distal portion 103 will transition to the Figure 5 -shown U-shaped configuration. As will be further discussed below, a user can actuate an actuator of the handle assembly 104 to move the inner body 401 distally or proximally through the tube 105, e.g., into and out of the distal portion 103.

[0034] Figure 6 and Figure 7 show perspective views of the handle assembly 104 of Figure 1 , where the shaft 102 has been removed from or otherwise separated from the handle assembly 104. As Figure 6As shown, 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 generally cylindrical, and the proximal portion 641 of the handle body 631 may include a circular 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 that connect the proximal portion 641 to the distal portion 642 of the handle body 631. Each of the frame arms 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 protruding portions 656, 657 that extend radially outward relative to the central longitudinal axis 150. Each of the protruding portions 656, 657 may be configured to receive a circular protrusion 639 of the actuator 634. The first frame arm 636 of the pair of frame arms 636, 637 may be located on one side of the central longitudinal axis 150 opposite the second frame arm 637 of the pair of frame arms 636, 637. The distal portion 642 of the handle body 631 may extend distally beyond the most distal end of each of the frame arms 636, 637. As discussed 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.

[0035] The distal cap 633 may be cylindrical and may include a tapered distal portion 663. The distal cap 633 may taper from a first circumference around the central longitudinal axis 150 to a second circumference around the central longitudinal axis 150 (i.e., from the proximal portion to the distal portion), the second circumference being less than the first circumference. A central lumen 655 may extend longitudinally through the 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 ( Figure 8 as shown) may be located 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 tapered distal portion 663 relative to the central longitudinal axis 150. Each of the protrusions 638 may be generally oval-shaped and may extend longitudinally in the proximal-distal direction across the tapered distal portion 663. These protrusions 638 may facilitate gripping of the distal cap 633, for example, when coupling the distal cap 633 to the handle body 631 and / or separating the distal cap 633 from the handle body 631.

[0036] The proximal cap 632 may be cylindrical in shape and may include a circular proximal end 681. The 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 instances, the inner body 401 may extend completely through the proximal cap 632, and the most proximal portion of the inner body 301 may be located outside of the proximal cap 632 and the shaft 630. The proximal cap 632 may include a longitudinal recess 738 that extends longitudinally on the radially outer surface of the proximal cap 632 relative to the central longitudinal axis 150. The recess 738 may facilitate gripping of the proximal cap 632, for example, when coupling the proximal cap 631 to the handle body 631 and / or separating it from the handle body 631. Threads 672( Figure 8 ) may be located within the proximal cap 632 and may be configured to removably couple the proximal cap 632 to the shaft 630; and the shaft 630 may have corresponding threads to couple the proximal cap 632 to the shaft 630.

[0037] The actuator 634 may be cylindrical and may include longitudinal ridges 657 that extend longitudinally from the proximal end to the distal end of the actuator 634. The longitudinal ridges 657 may facilitate gripping of the actuator 634 by the user, for example, to rotate the actuator 634 clockwise or counterclockwise. A circular protrusion 639 may extend circumferentially around the actuator 634, and the circular protrusion 639 may include longitudinal ridges 732 that are configured to facilitate gripping the circular protrusion 639 for rotation clockwise or counterclockwise about the axis 150. The circular protrusion 639 may be aligned with and adjacent to the protrusions 656, 657 of each of the frame arms 636, 637. The actuator 634 may be a knob, a roller actuator, or any other actuator. The actuator 634 may be configured to rotate about the central longitudinal axis 150 relative to the handle body 631, for example, clockwise and counterclockwise.

[0038] Referring Figure 8 to the side cross-sectional view of the handle assembly 104 shown, the actuator 634 includes a lumen 879 that extends longitudinally through the actuator 634. The radially inward surface 879 that forms the lumen 879 may be cylindrical and may include one or more helical recesses 871 that extend circumferentially along the inner circumferential surface around the central longitudinal axis 150. The helical recesses 871 of the actuator 634 may be configured to receive one or more protrusions 861( Figure 9 ) of the shaft 630. As Figure 8 shown, the lumen 879 is configured to receive the shaft 630.

[0039] The proximal chuck 815 may be located at the most proximal end of the shaft 630. Note that the proximal chuck 815 is shown inFigure 8 In a cross-sectional view. The proximal chuck 815 may be cylindrical and may include a tapered proximal-most end portion. The proximal chuck 815 may be configured to receive a portion of the inner body 401, and the proximal chuck 815 may be configured to radially retract inwardly and couple to the inner body 401 when the proximal cap 632 is coupled to the shaft 630. The proximal chuck 815 may assist in fixedly coupling the inner body 401 to the proximal portion of the shaft 630 such that proximal and distal movement of the shaft 630 causes the inner body 401 to move proximally or distally, respectively. The proximal chuck 815 may be received within a recessed portion of the shaft 630 at the proximal-most end of the shaft 630, and the proximal chuck 815 may be longitudinally aligned with the central longitudinal lumen 809 of the shaft 630. In some instances, the proximal chuck 815 may include a longitudinal lumen extending through the proximal chuck 815, the proximal chuck 815 being configured to receive the proximal portion of the inner body 401; and the longitudinal lumen of the proximal chuck 815 may extend the entire length of the proximal chuck 815, from the proximal-most end to the distal-most end of the proximal chuck 815.

[0040] The distal chuck 816 may be located within the distal portion 642 of the handle body 631. The distal chuck 816 may be generally cylindrical and may include a tapered distal-most end 816a. The distal chuck 816 may be configured to receive the inner body 401 within an inner passage 865 of the distal chuck 816. The inner passage 865 may be configured to allow the inner body 401 to move proximally or distally (i.e., longitudinally) through the inner passage 865 and to restrict lateral or radial movement of the inner body 401. The inner passage 865 may extend longitudinally through the distal chuck 816 and may be longitudinally aligned with the central longitudinal axis 150. The distal chuck 816 may be received by the handle body 631 within a passage 878 of the distal portion 642. The distal chuck 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 chuck 816 and the distal cap 633; and when the tube 105 is coupled to the distal chuck 816 and the distal cap 633, the lumen 410 of the tube 105 may be longitudinally aligned with the central longitudinal axis 150. The distal cap 633 may include a tapered inner shape that is configured to correspond to the tapered distal-most end 816a of the distal chuck 816, which may assist in securing the proximal end of the tube 105 when the tube 105 is clamped between the distal chuck 816 and the distal cap 633.

[0041] As Figure 8As shown, 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 the cross-sectional view to show the helical protrusion 861 received within the helical recess 871. The helical protrusion 861 may be located at 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 and may be located within the handle body 631 and may extend proximally from the proximal end of the handle body 631. The shaft 630 may include a lumen 809 that extends longitudinally through the shaft 630, and the lumen 809 may be configured to receive the inner body 401. The lumen 809 may extend the entire length of the shaft 630, from an opening in the most proximal end of the shaft 630 to an opening in the most distal end of the shaft 630. The lumen 809 may be aligned with the lumen 865 of the distal chuck 816, and the lumen 809 may also be aligned with the lumen 889 of the proximal chuck 632. When the inner body 401 is coupled to the proximal end of the shaft 630 via the proximal chuck 815 and the proximal cap 632, the inner body 401 may move proximally or distally as the shaft 630 moves proximally or distally, respectively.

[0042] Figure 9 A perspective view of the shaft 630 removed from the handle assembly 104 is shown. Note that Figure 9 the proximal and distal directions in Figure 8Relative (as indicated by the proximal (P) and distal (D) arrows in each figure). 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 located at the proximal end portion 998 of the shaft 630. A series of protrusions 911, 912, 913, 914 may be longitudinally spaced from each other along the length of the shaft 630, and a series of recesses 915, 916, 917 may be located between pairs of the protrusions 911, 912, 913, 914. The farthest distal protrusion 914 may be cylindrical and may include one or more helical protrusions 861 that extend across the radially outer surface 995 of the protrusion 914 relative to the central longitudinal axis 950 of the shaft 630. The farthest distal protrusion 914 may extend to the farthest distal end of the shaft 630. The helical protrusions 861 may extend from the farthest distal end of the shaft 630 (i.e., the farthest distal end of the farthest distal protrusion 914) to the proximal portion of the protrusion 914. In some aspects, the farthest distal protrusion 914 may extend proximally from the distal end of the helical protrusion 861. One or more protrusions 918, 919 may extend radially outward from the protrusion 912 relative to the longitudinal axis 950. The protrusion 919 is not shown in the figure and may be located on the laterally opposite side of the protrusion 912. Each of the protrusions 918, 919 may support the shaft 630 and may 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 the central portion of the channel 896 and may prevent lateral movement or movement transverse to the longitudinal axis 150. In some instances, the protrusions 918, 919 may be rubber to provide a frictional force between the shaft 630 and the radially inwardly facing surface (relative to the axis 150) of the channel 896 of the handle body 631. When the protrusions 918, 919 are rubber or another material configured to provide 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 recesses 915, 916, 917 may be included in the shaft 630.

[0043] Figure 10 A side view of an exemplary tube 105 of a guide wire system 100 having a proximal end 1010 and a distal end 1004 is shown. For illustrative purposes, multiple portions of the tube 105 have been removed from Figure 10Removed. The tube 105 may include a laser cut pattern having a proximal section 1006 and a distal section 1005. The proximal section 1006 may have a larger pitch compared to the distal section 1005. The proximal section 1006 with the larger pitch may facilitate the pushability of the tube 105, and the smaller pitch of the distal section 1005 may increase the flexibility of the distal section 1005. The tube 105 may also include, for example, a proximal portion 1007 without any laser cut pattern.

[0044] During use, the guidewire assembly 100 (specifically, the shaft 102) may be introduced into a patient's body cavity, orifice, or incision. Then, the user may move the shaft 102 into the body cavity, for example, using the handle assembly 104 to navigate to move the distal portion 103 of the shaft 102. The user may manipulate the shaft 102 such that the distal portion 103 of the shaft 102 is adjacent to a target tissue, object, site, etc., such as, for example, 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 to move the shaft 630 proximally or distally relative to the handle body 631. For example, the user may rotate the actuator 634 counterclockwise to distally advance the inner body 401, which may move the shaft 102 distally. By moving the shaft 630 distally, the inner body 401 will be distally advanced through the tube 105 and into the distal portion 103 to at least partially straighten the distal portion 103. The user may rotate the actuator 637 clockwise, for example, 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 out of the distal portion 103 of the tube 105, the distal portion 103 will transition from at least a partially straight configuration to a preformed configuration, such as Figures 2A to 2C one of the preformed configurations shown. By allowing the user to transition the distal portion 103 between a straight and a preformed configuration, the user may more easily navigate through tortuous body cavities since the distal portion 103 of the tube 105 may be converted between a variety of different shapes. The user may also push the shaft 102 distally or pull the shaft 102 proximally to assist in repositioning the shaft 102 within the patient.

[0045] In some instances, the user may position the distal portion 103 of the tube 105 at a target tissue, object, site, etc. within the patient; and then, remove the inner body 401 from the guidewire assembly 100 by unscrewing the proximal cap 632 from the shaft 630 and pulling the inner body 401 proximally out of the tube 105 and the handle assembly 104. Once the inner body 401 is removed from the guidewire assembly 100, the user may then separate the handle assembly 104 from the tube 105 by unscrewing the distal cap 633 and pulling the tube 105 out of the distal cap 633. Once the inner body 401 and the handle assembly 104 are removed, the user may apply a contrast fluid (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 anatomical structure. In some instances, after removal of the inner body 443, the user may apply the contrast fluid through the proximal chuck 815 and through the lumen 809 of the shaft 630 within the handle 104, thereby avoiding separating the handle 104 from the tube 105. The contrast agent may assist the user in visualizing the target anatomical structure using one or more medical imaging devices. The user may then reattach the tube 105 to the handle assembly 104, for example, using the distal cap 633 and the distal chuck 816. Once the tube 105 is reattached to the handle assembly 104, the user may insert the inner body 401 through the shaft 630 and the tube 105 into the proximal chuck 815, and may fixedly attach the proximal end of the inner body 401 to the proximal end of the shaft 630 by tightening the proximal cap 632. Because the shaft 105 may be removed from the handle assembly 104, the user may use different shafts 105 (as well as different tubes 105 and preformed distal portions 103, 203, 204, 205) with the same handle assembly 104.

[0046] In some instances, the actuator 634 may be configured to lock and hold the inner body in place such that the user may release the actuator 634, and the actuator 634 may maintain its position (e.g., thereby helping to prevent the inner body from moving proximally or distally) without further rotation about the central longitudinal axis 150. For example, the circular protrusion 639 of the actuator 634 may be rubber or coated with rubber, and the circular protrusion 639 may engage (i.e., frictionally engage) the recesses 656, 657 of 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 frictional force between the circular protrusion 639 and the recesses 656, 657, and may provide a ratchet mechanism to help fix the actuator 634 in different positions. In some instances, the actuator 634 and / or the circular protrusion 639 may be coated with any other material that provides frictional engagement between the actuator 634 and the recesses 656, 657 of the frame arms 636, 637.

[0047] Figures 11A to 13 shows the distal portion of various components of an alternative guidewire system 1100. The alternative guidewire system 1100 can include any of the structures and properties of the guidewire system 100, and can include a handle assembly 104 and a shaft 1102, which is coupled to the handle assembly 104 in the same manner as described above with respect to the guidewire assembly 100. As Figure 11A shown, the shaft 1102 can include an inner body 1101 and a tube 1105. The inner body 1101 can be located within the channel of the tube 1105 and can be configured to move proximally and distally through the tube 1105. For illustrative purposes, the shaft 1102 is shown in Figure 11A partially disassembled, where the inner body 1101 extends distally out of the tube 1105.

[0048] The inner body 1101 can be cylindrical and can include any of the features of the inner body 401. The inner body 1101 can include a distal portion 1150 and a recessed portion 1110. The distal portion 1150 includes a distal end 1103, and the recessed portion 1110 forms a slot 1111 that faces radially outwardly toward the side of the inner body 1101. The proximal portion 1112 of the inner body 1101 can extend from the distal portion 1150 to the handle assembly of the guidewire assembly 1100. The distal end 1103 can be cylindrical and can be configured to abut and / or couple to the distal end portion of the tube 1105. The slot 1111 can be an eccentric cutout of the inner body 1101, where a central longitudinal axis 1160 extends longitudinally through the slot 1111. The recessed portion 1110 can be spaced apart from the central longitudinal axis 1160. In some instances, the recessed portion 1110 can include a flat surface that faces the central longitudinal axis 1160 and radially outwardly toward the side of the inner body 1101. The recessed portion 1110 can include a series of cuts and / or recesses (not shown) that are configured to increase the flexibility of the recessed portion 1110. In some instances, the proximal portion 1112 can be cylindrical; and in other instances, the proximal portion 1112 can be rectangular (not shown). Because the slot 1111 is an eccentric cutout of the inner body 1101, the slot 1111 can be configured to bend in a first direction when the inner body 1101 is pushed distally relative to the tube 1105 and the distal end 1103 is coupled to the tube 1105, and configured to bend in a second direction (opposite to the first direction) when the inner body 1101 is pulled proximally relative to the tube 1105 and the distal end 1103 is coupled to the tube 1105. In some instances, the first direction is the direction extending from the axis 1160 toward the recessed portion 1110, and the second direction is the direction extending from the axis 1160 away from the recessed portion 1110. Figure 11BA side view of the distal portion 1150 of the inner body 1101 is shown, the inner body 1101 including a distal end 1103, a recessed portion 1110, a proximal portion 1112, and a slot 1111. Figure 11B The manner in which a central longitudinal axis 1160 extends through the slot 1111 is shown. In some examples, the inner body 1101 may be made partially or entirely of nitinol and / or any other shape memory material having the ability to return to an initial shape after deformation.

[0049] Figure 12A A side view of the distal portion of the tube 1105 is shown. The tube 1105 may include a distal end portion 1250, a flexible section 1251, and a relatively rigid section 1252. The flexible section 1251 may extend longitudinally between and connect the distal end portion 1250 and the rigid section 1252. The tube 1105 may include a laser cut pattern, and the laser cut pattern on the rigid section 1252 may have a greater pitch than the laser cut pattern on the flexible section 1251. For example, the slots or openings of the laser cut pattern may be longitudinally spaced farther apart in the rigid section 1252 than in the flexible section 1251. The distal end portion 1250 may not include a laser cut pattern. It should be understood that the rigid section 1252 is flexible but less flexible than the flexible section 1252.

[0050] Figure 12B A side view of the distal portion 1150 of the inner body 1101 is shown. The slot 1111 of the inner body 1101 may be configured to align with the flexible section 1251, the distal end 1103 may be configured to align with the distal end portion 1250, and the proximal portion 1112 may be configured to align with the rigid portion 1252. As shown, the slot 1111 is shorter than the flexible section 1251.

[0051] Figure 12C The shaft 1102 is shown in a fully assembled state, where the inner body 1101 is coupled to the tube 1105. The distal end 1103 of the inner body 1101 may be coupled to the distal end portion 1250 of the tube 1105. The recessed portion 1110 and the proximal portion 1112 may be configured to move within the tube 1105 when in the fully assembled state. The distal end 1103 may be laser welded to the distal end portion 1250. In some examples, the recessed portion 1110 may extend through the flexible section 1251, and the proximal portion 1112 may extend through the rigid portion 1252.

[0052] When a user actuates the handle assembly of the guide wire assembly 1100, the inner body 1101 can move proximally or distally through the tube 1105 to the distal portion of the tube 1105, such as the distal tip 1250, the flexible section 1251, and / or the rigid section 1252. Since the distal tip 1103 is coupled to the distal tip portion 1250, relative movement occurs between (i) the recessed portion 1110 and the proximal portion 1112 and (ii) the flexible portion 1251 and the rigid portion 1252 of the tube 1105. Figure 13 A perspective view of the distal portion of the guide wire assembly 1100 is shown, and the guide wire assembly 1100 includes various directional arrows to illustrate the movement capabilities of the shaft 1102. A user can move the shaft 1102 proximally 1305 or distally 1306, can rotate the shaft 1102 clockwise 1303 or counterclockwise 1304 about the central longitudinal axis 1350, and can bend the distal portion of the shaft upward 1301 or downward 1302. Although shown as upward 1301 and downward 1302 in Figure 13 , the bi-directional bending ability of the shaft 1102 can be any first direction 1301 and any second direction 1302 opposite the first direction 1301. Representative dashed lines 1360 and 1361 illustrate an example position of the shaft 1105 in the downward bent position 1360 and an example position of the shaft 1105 in the upward bent position 1361.

[0053] The slot 1111 in the inner body 1101 allows the body 1101 at the recessed portion 1110 to be more flexible than the proximal portion 1112 of the inner body 1101. This flexibility difference along the longitudinal length of the inner body 1101 allows the inner body 1101 to bend the tube 1105 in the Figure 13 manner shown. When the user pushes the inner body 1101 distally relative to the shaft 1105 (via the handle assembly), the inner body 1101 proximal to the tip 1103 can move through the tube 1105, the recessed portion 1110 (and in some instances, the distal portion of the proximal portion 1112) can bend in a first direction, and the distal tip 1103 can be prevented from moving distally relative to the tube 1105 because the distal tip 1103 is coupled to the distal portion 1250. Since the recessed portion 1110 is bent when the inner body 1101 moves distally, the inner body bends the tube 1105 upward 1301 or downward 1302. Since the slot 1111 is an eccentric cutout in the inner body 1101, the recessed portion 1110 can bend in a direction opposite to when the inner body 1101 moves distally when the user moves the inner body proximally relative to the shaft 1105. By providing the slot 1111, the inner body 1101 will continuously bend upward 1301 and downward 1302 (compared to other directions) when the inner body 1101 moves distally and proximally within the tube 1105.

[0054] The disclosed guide wire assemblies 100, 1100 and their various parts shown in the figures and discussed above facilitate the positioning of other medical devices during a medical procedure. By facilitating the movement of shafts 102, 1102 through a patient's anatomy and maintaining the guide wire in the area of the target anatomy, while also providing a catheter for applying contrast to the target anatomy, the guide wire assemblies 100, 1100 and their various parts can contribute to an effective and efficient procedure. The design of the handle assembly 104 can facilitate the movement of shafts 102, 1102 through a patient's anatomy, which can reduce procedure time and can limit procedural errors and / or patient complications.

[0055] It is contemplated that the guide wires, systems, and methods discussed herein can be applicable to any endoscopic and / or minimally invasive procedure. For example, the systems, devices, and methods discussed above can be used during the following procedures: percutaneous nephrolithotomy / lithotripsy (PCNL), endoscopic retrograde cholangiopancreatography (ERCP), balloon and laser angioplasty, nephrostomy, electrode placement, etc. The systems, devices, and methods discussed above can also be used to remove ureteral stones, gallstones, bile duct stones, polyps, stent placement, gastroenterostomy, choledochoduodenostomy, and so on during a procedure.

[0056] While the principles of the present disclosure are described herein with reference to exemplary examples of specific applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art and those touched by the teachings provided herein will recognize that additional modifications, applications, embodiments, and alternatives of equivalents fall within the scope of the features described herein. Therefore, the claimed features should not be considered limited by the foregoing detailed description.

Claims

1. A guide wire assembly, comprising: A handle assembly, the handle assembly comprising: A handle body; A shaft, the shaft extending through the handle body; and An actuator; A tube, the tube extending distally from the handle assembly and including a proximal portion and a distal portion; and An inner body, the inner body extending from the handle assembly through the tube to the distal portion of the tube, wherein the inner body is coupled to the shaft; Wherein the shaft is configured to longitudinally move through the handle body as the actuator rotates to longitudinally move the inner body through the tube.

2. The guide wire assembly according to claim 1, wherein the distal portion of the inner body is a shape memory material.

3. The guide wire assembly according to any one of the preceding claims, wherein the distal portion of the inner body is U-shaped, S-shaped, helical, coiled, and / or includes a one-hundred-and-eighty-degree bend in the inner body.

4. The guide wire assembly according to any one of the preceding claims, wherein the proximal portion of the tube includes a laser cut pattern.

5. The guide wire assembly according to any one of the preceding claims, wherein the tube is coupled to the handle assembly at the distal end of the handle assembly.

6. The guide wire assembly according to claim 5, wherein the tube is removably coupled to the distal end of the handle assembly via a distal cap and a distal chuck.

7. The guide wire assembly according to any one of the preceding claims, wherein the actuator is cylindrical and longitudinally extends through the central longitudinal axis of the handle body, and wherein the shaft longitudinally extends through the lumen of the actuator.

8. The guide wire assembly according to claim 7, wherein the handle body includes a cylindrical proximal portion, a distal portion spaced apart from the proximal portion, and a pair of frame arms that are coupled to the distal portion and the proximal portion.

9. The guide wire assembly according to any one of the preceding claims, wherein the distal end of the inner body is coupled to the distal end portion of the tube.

10. The guide wire assembly according to claim 8, wherein the actuator includes a circular protrusion that is received by a recess of each of the pair of frame arms.

11. The guide wire assembly according to any one of the preceding claims, wherein the inner body is removably coupled to the proximal end of the shaft via a proximal chuck and a proximal cap.

12. The guide wire assembly according to any one of the preceding claims, wherein the actuator includes a helical recess configured to receive a helical protrusion of the shaft.

13. The guide wire assembly according to claim 12, wherein when the actuator rotates about the central longitudinal axis of the handle assembly, the actuator is configured to move the shaft proximally or distally.

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

15. The guide wire assembly according to any one of the preceding claims, wherein the tube comprises a laser cut pattern having a first pitch in a proximal section of the tube and a second pitch in a distal section of the tube, wherein the second pitch is different from the first pitch, and wherein the inner body comprises a slot aligned with the distal section of the tube.

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