Operable medical device, handle for medical device, and method for operating a medical device

Abstract

A handle for a medical device includes a handle body and a knob rotatable relative to the handle body. A first gear is associated with the knob. A slide assembly is housed within the handle body or the knob. The slide assembly includes a first lead screw. A second gear is associated with the slide assembly. A third gear is housed within the handle body or the knob and coupled between the first and second gears. Rotation of the knob drives rotation of the first gear, which drives rotation of the third gear, which drives rotation of the second gear, which drives rotation of the lead screw.

Description

[Technical Field]

[0001] This document relates to medical devices, and more particularly to steerable medical devices such as steerable sheaths, catheters, and introducers. [Background technology]

[0002] There remains a need in the art for improved steerable medical devices. Summary of the Invention

[0003] The following summary is intended to introduce the reader to various aspects of the detailed description, but is not intended to define or define any of the invention. A manipulable medical device is disclosed. According to some embodiments, the manipulable medical device includes a handle having a handle body and a knob rotatable relative to the handle body. A first gear is associated with the knob. A slide assembly is housed within the handle. The slide assembly includes a first lead screw. A second gear is associated with the slide assembly. A third gear is housed within the handle and coupled between the first gear and the second gear. Rotation of the knob drives rotation of the first gear, which drives rotation of the third gear, which drives rotation of the second gear, which drives rotation of the lead screw. An elongated tool extends from the handle, and at least one control wire is coupled between the slide assembly and the tool. Rotation of the lead screw causes tension in the control wire, which causes deflection of the tool.

[0004] In some examples, the first gear is an internal gear of the rotatable knob, the second gear is a sun gear fixed relative to the lead screw, and the third gear is a planetary gear coupled between the internal gear and the sun gear. The medical device can optionally further include an additional planetary gear coupled between the internal gear and the sun gear. The planetary gear can optionally be fixed in position relative to the internal gear and the sun gear.

[0005] In some examples, the slide assembly further includes a slider coupled to the lead screw and the control wire, wherein rotation of the lead screw can cause translation of the slider relative to the lead screw, and translation of the slider can cause tension in the control wire.

[0006] In some examples, the first gear is a first bevel gear mounted to the knob, the second gear is a second bevel gear mounted to the slide assembly, and the third gear is a third bevel gear coupled between the first and second bevel gears. The first bevel gear can optionally be fixed relative to the knob. The first bevel gear, the second bevel gear, the third bevel gear, and the lead screw can optionally be translatable relative to the knob and the handle body.

[0007] In some instances, rotation of the lead screw causes translation of the lead screw, and translation of the lead screw causes tension in the control wire. In some instances, the tool is a sheath, a catheter, or an introducer.

[0008] A handle for a medical device is also disclosed. According to some embodiments, the handle for a medical device includes a handle body and a knob rotatable relative to the handle body. A first gear is associated with the knob. A slide assembly is housed within the handle body or the knob, the slide assembly including a first lead screw. A second gear is associated with the slide assembly. A third gear is housed within the handle body or the knob and coupled between the first gear and the second gear. Rotation of the knob drives rotation of the first gear, which drives rotation of the third gear, which drives rotation of the second gear, which drives rotation of the lead screw.

[0009] In some examples, the first gear is an internal gear of the rotatable knob, the second gear is a sun gear fixed relative to the lead screw, and the third gear is a planetary gear coupled between the internal gear and the sun gear. The handle can optionally further include an additional planetary gear coupled between the internal gear and the sun gear. The planetary gear can optionally be fixed in position relative to the internal gear and the sun gear.

[0010] In some examples, the slide assembly further includes a slider coupled to the lead screw, wherein rotation of the lead screw can cause translation of the slider relative to the lead screw. In some examples, the first gear is a first bevel gear mounted to the knob, the second gear is a second bevel gear fixed to the slide assembly, and the third gear is a third bevel gear coupled between the first and second bevel gears. The first bevel gear can optionally be fixed to the knob. The first bevel gear, the second bevel gear, the third bevel gear, and the lead screw can optionally be translatable relative to the knob and the handle body.

[0011] In some instances, rotation of the lead screw causes translation of the lead screw. Also disclosed are methods for operating a medical device. According to some embodiments, the method for operating a medical device includes the steps of: a. rotating a knob on a handle; b. transmitting the rotation of the knob to a lead screw of a slide assembly via at least one gear housed within the handle to cause rotation of the lead screw; c. causing tension in a control wire via the rotation of the lead screw; and d. causing deflection of a tool via the tension in the control wire.

[0012] In some examples, step a. includes rotating an internal gear of the knob. In some examples, step b. includes rotating planetary gears engaged with the internal gear, and rotating a sun gear engaged with the planetary gears and fixed relative to the lead screw.

[0013] In some examples, step c. includes translating the slider along the lead screw to induce tension in the control wire. In some examples, step a. includes rotating a first bevel gear mounted relative to the knob.

[0014] In some examples, step b. includes rotating a third bevel gear engaged with the first bevel gear, and rotating a second bevel gear engaged with the third bevel gear and mounted to the lead screw.

[0015] In some examples, step c. includes translating the slider along the lead screw to induce tension in the control wire. In some examples, step c. includes translating the lead screw to induce tension in the control wire.

[0016] The accompanying figures are intended to illustrate examples of the articles, methods, and apparatus of the present disclosure and are not intended to be limiting. [Brief explanation of the drawings]

[0017] [Figure 1] 1 is a perspective view of an exemplary medical device. [Figure 2] 2 is a cutaway plan view of the handle of the medical device of FIG. 1 showing the interior of the handle. [Figure 3] 3 is a cross-sectional view taken along line 3-3 of FIG. 2. [Figure 4] FIG. 10 is a cutaway plan view of the handle of another medical device showing the interior of the handle. [Figure 5] 5 is a cross-sectional view taken along line 5-5 of FIG. 4. [Figure 6] FIG. 10 is a cutaway plan view of the handle of another medical device showing the interior of the handle. [Figure 7] FIG. 10 is a cutaway plan view of the handle of another medical device showing the interior of the handle. [Figure 8] FIG. 10 is a cutaway plan view of the handle of another medical device showing the interior of the handle. DETAILED DESCRIPTION OF THE INVENTION

[0018] Various devices, processes, or configurations are described below to provide example embodiments of the claimed subject matter. The examples described below do not limit any claims, and any claim may be directed to a process, device, or configuration different from that described below. The claims are not limited to devices, processes, or configurations having all of the features of any one device, process, or configuration described below, or to features common to several or all of the devices, processes, or configurations described below. It is possible that the devices, processes, or configurations described below are not embodiments of any proprietary rights granted by the issuance of this patent application. Any subject matter described below that is not proprietary to the issuance of this patent application may be the subject of a separate protective document, e.g., a continuing patent application, and the applicant, inventor, or owner does not intend to waive, discharge, or make available to the public any such subject matter by its disclosure in this document.

[0019] Generally disclosed herein is a steerable medical device including a handle and a tool, such as a sheath, catheter, or introducer. The handle can allow a user to steer or manipulate the tool in a desired direction. More specifically, the handle can include a knob rotatably coupled to a body of the handle. In operation, rotation of the knob in a first direction can allow a user to steer or deflect the tool in a first direction, while rotation of the knob in a second direction can allow a user to steer or deflect the tool in a second direction. Rotation of the knob can be translated into deflection of the tool via a slide assembly, which can be within the handle, and one or more control wires connected between the slide assembly and the tool. The slide assembly can include a lead screw (also referred to as a bolt). Rotation of the knob can cause rotation of the lead screw. Rotation of the lead screw can cause linear translation of the lead screw or can cause linear translation of a slider along the lead screw. This translation causes tension in the control wire, whether it be the lead screw itself or the slider, resulting in deflection of the tool. For simplicity, details of the slider and control wire are not disclosed herein. However, related sliders and control wires are disclosed, for example, in U.S. Pat. No. 10,661,057 (Davies et al.), which is incorporated herein by reference in its entirety. Additionally, steerable medical devices including sliders and control wires are sold by Baylis Medical Company, Inc. (Montreal, Canada) under the brand name SureFlex® Steerable Guiding Sheath.

[0020] The maneuverable medical devices disclosed herein are configured to avoid, minimize, or reduce undesired relaxation in tool deflection and avoid, minimize, or reduce slop in tool operation. More specifically, in the maneuverable medical devices disclosed herein, a gear train is provided between the knob and the slide assembly. The gear train can enable the lead screw to have a relatively small thread pitch, thereby reducing slop. Furthermore, the gear train can enable the lead screw to rotate faster than the knob, which can compensate for the reduced linear displacement per knob rotation resulting from the small thread pitch. Furthermore, the gear train can provide mechanical resistance to unwinding without increasing friction throughout the system.

[0021] Referring now to FIG. 1 , an exemplary steerable medical device 100 is shown. The steerable medical device 100 generally includes a handle 102 and an elongated tool 104 extending from the handle 102. The tool 104 can be, for example, but not limited to, a sheath, a catheter, or an introducer. The handle 102 includes a handle body 106 and a knob 108 rotatable relative to the handle body 106. The knob 108 can be rotated to manipulate the tool 104. Rotating the knob 108 in a first direction (e.g., clockwise) can deflect the tool 104 to the first direction (i.e., the configuration shown in dotted lines in FIG. 1 ), and rotating the knob 108 in a second direction (e.g., counterclockwise) can deflect the tool 104 to the second direction (i.e., back to the configuration shown in solid lines in FIG. 1 ). The tool 104 is shown only in FIG. 1 and is omitted from FIGS. 2-7 for simplicity.

[0022] Referring to FIG. 2 , in which the handle body 106 and knob 108 are cut away to show the interior of the handle 102, a slide assembly 110 is housed within the handle 102. As will be described in further detail below, the knob 108 is coupled to the slide assembly 110, such that rotation of the knob 108 drives movement of the slide assembly 110. More specifically, in the illustrated example, the slide assembly 110 includes a lead screw 112 and a slider 114 coupled to the lead screw. The slider 114 is received on the lead screw 112 and is translatable along the lead screw 112. Rotation of the knob 108 is transmitted to the lead screw 112, causing rotation of the lead screw 112. Rotation of the lead screw 112 causes translation of the slider 114 along the lead screw 112. A control wire 116 is further coupled between the slider 114 of the slide assembly 110 and the tool 104 (shown in FIG. 1 ). Movement of the slide assembly 110, i.e., translation of the slider 114 caused by rotation of the lead screw 112, causes tension in the control wire 116, which in turn causes deflection of the tool 104. As mentioned above, details of the slider 114 and control wire 116, and the connections between the slider 114, control wire 116, and tool 104, are disclosed in U.S. Pat. No. 10,661,057 (Davies et al.), and will not be repeated here.

[0023] 2 and further with reference to FIG. 3, to drive the movement of the slide assembly 110 via rotation of the knob 108, the handle 102 includes a gear train: a first gear 118 associated with the knob 108, a second gear 120 associated with the slide assembly 110, and a third gear 122 coupled between the first gear 118 and the second gear 120. Rotation of the knob 108 drives rotation of the first gear 118, which in turn drives rotation of the third gear 122, which in turn drives rotation of the second gear 120, which in turn drives rotation of the lead screw 112.

[0024] As used herein, the term "associated" can mean attached, fastened, fixed, adhered, connected, integrated, part of, movable therewith, and / or incorporated therein. Accordingly, a reference to "the handle 102 includes a first gear 118 associated with the knob 108" can mean, for example, that the first gear 118 is incorporated into the knob 108 (as described below with reference to FIGS. 2 and 3) or that the first gear 118 is a separate piece attached to the knob 108 (as described below with reference to FIGS. 6 and 7).

[0025] 2 and 3, in the illustrated example, the first gear 118 is the internal gear of the knob 108. The second gear 120 is a sun gear fixed to the lead screw 112. The third gear 122 is a planetary gear attached to the handle body 106 and coupled between the internal gear (i.e., first gear 118) and the sun gear (i.e., second gear 120). Rotation of the knob 108 causes rotation of the internal gear (i.e., first gear 118), which in turn causes rotation of the planetary gear (i.e., third gear 122), which in turn causes rotation of the sun gear (i.e., second gear 120), which in turn causes rotation of the sun gear (i.e., second gear 120).

[0026] In the illustrated example, the planetary gears (i.e., third gear 122) are fixed in position relative to the internal gear (i.e., first gear 118) and the sun gear (i.e., second gear 120). That is, the planetary gears do not orbit the sun gear. In an alternative example, the planetary gears can orbit the sun gear.

[0027] In the example shown in FIGS. 2 and 3, the handle 102 includes one planetary gear. In alternative examples, the handle can include additional planetary gears. One such example is shown in FIGS. 4 and 5. In FIGS. 4 and 5, features similar to those in FIGS. 1-3 are identified by similar reference numerals incremented by 300. Furthermore, for brevity, only certain features of FIGS. 4 and 5 will be described. In the illustrated example, the handle 402 includes a first gear 418 in the form of an internal gear of the knob 408, a second gear 420 in the form of a sun gear fixed to the lead screw 412, and third and fourth gears 422 and 424 in the form of planetary gears coupled between the first and second gears 418 and 420.

[0028] In the example of FIGS. 1-3 , the rotatable knob 108 is a relatively small portion of the handle 102 and is located at the top of the handle 120, while the handle body 106 is a relatively larger portion of the handle 102 and is located at the bottom of the handle 102. An alternative example is shown in FIG. 6 . In FIG. 6 , features that are similar to those in FIGS. 1-3 are identified by similar reference numbers incremented by 500. Furthermore, for brevity, only certain features of FIG. 6 will be described. In the example of FIG. 6 , the rotatable knob 608 is a relatively large portion of the handle 602 that is located at the bottom of the handle 602, and the handle body 606 is a relatively small portion that is located at the top of the handle 602. In this example, a first gear 618, a second gear 620, and a third gear 622 are housed within the knob 608.

[0029] Referring now to Figure 7, another example of a handle 702 is shown. In Figure 7, features that are similar to those in Figures 1-3 are identified by like reference numerals incremented by 600. Furthermore, for the sake of brevity, only certain features of Figure 7 will be described. In the handle 702, the first gear 718 is a first bevel gear fixed to and rotatable with the knob 708, the second gear 720 is a second bevel gear mounted to the slide assembly 710 to drive the movement of the slide assembly 710 (as described further below), and the third gear 722 is a third bevel gear mounted to the handle body 706 and rotatable relative to the handle body 706. The third gear 722 is coupled between the first gear 718 and the second gear 720, such that rotation of the knob 708 relative to the handle body 706 drives rotation of the first gear 718 relative to the handle body 706, rotation of the first gear drives rotation of the third gear 722 relative to the handle body 706, and rotation of the third gear 722 drives rotation of the second gear 720 relative to the handle body 706.

[0030] 7 , in the illustrated example, the slide assembly 710 includes a plate 726 rotatable with the second gear 720 and a set of four primary lead screws 728 (only two of which are visible) rotatably mounted relative to and rotatable with the plate 726. The slider 714 includes a secondary lead screw 730 and a slider body 732 secured to the secondary lead screw 730. The secondary lead screw 730 is disposed between and engaged with the primary lead screws 728. Rotation of the plate causes orbiting 726 of the primary lead screw 726 around the secondary lead screw 730, thereby causing translation of the secondary lead screw 730 and the slider body 732. Translation of the slider body 732 causes tension in the control wire 716 and deflection of a tool (not shown).

[0031] Referring now to FIG. 8, another example of a handle 802 is shown. In FIG. 8, features that are similar to those in FIGS. 1-3 are identified by like reference numerals incremented by 700. Furthermore, for brevity, only certain features of FIG. 8 will be described. In this example, a slide assembly 810 includes a lead screw 812 that is itself translatable relative to the handle body 806 (i.e., no separate slider is provided) to induce tension in a control wire 816. That is, the slide assembly 810 includes a lead screw 812, and the inner surface of the handle body 806 is threaded and threadingly engaged with the lead screw 812. Rotation of the lead screw 812 relative to the handle body 806 induces translation of the lead screw 812 along the handle body, and translation of the lead screw 812 induces tension in the control wire 816. In this example, the control wire is mounted against a bearing 823 fixed to the lead screw 812 to prevent twisting of the wire during translation. In an alternative example, the control wires may be routed along the lead screw rotation axis to avoid or prevent tangling.

[0032] Still referring to Figure 8, in the illustrated example, the gears are configured similarly to the example of Figure 7. That is, handle 802 includes a first gear 818 in the form of a first bevel gear secured to and rotatable with knob 808, a second gear 820 in the form of a second bevel gear mounted to and driving the rotation of lead screw 812, and a third gear 822 in the form of a third bevel gear coupled between first gear 818 and second gear 820. However, in the example of Figure 8, first gear 818, second gear 820, and third gear 822 are translatable together with lead screw 812 relative to handle body 806 and knob 808.

[0033] In an alternative example, lead screw 812 of FIG. 8 may be replaced by a set of lead screws (similar to those of FIG. 7). While the above description provides one or more example processes or devices or configurations, it will be understood that other processes or devices or configurations may be within the scope of the appended claims.

[0034] To the extent that any amendment, characterization, or other statement heretofore made (in this patent application or patent, or any related patent application or patent, including any parent, sibling, or progeny patent) with respect to any technology or prior art or otherwise may be construed as a disclaimer of any subject matter supported by the present disclosure of this application, applicants hereby vacate and withdraw such disclaimer. Applicants also respectfully submit that any prior art heretofore considered in any related patent application or patent, including any parent, sibling, or progeny patent, may need to be re-referenced.

Claims

1. a handle having a handle body and a knob rotatable relative to the handle body; a first bevel gear attached to the knob; a slide assembly housed within the handle, the slide assembly including a lead screw; a second bevel gear mounted to the slide assembly; a third bevel gear housed within the handle body and coupled between the first bevel gear and the second bevel gear, wherein rotation of the knob drives rotation of the first bevel gear, which in turn drives rotation of the third bevel gear, which in turn drives rotation of the second bevel gear, which in turn drives rotation and translation of the lead screw; an elongated tool extending from the handle; An operable medical device comprising: at least one control wire coupled between the slide assembly and the elongated tool, whereby rotation of the lead screw causes tension in the control wire, and the tension in the control wire causes deflection of the elongated tool.

2. The steerable medical device of claim 1 , wherein the first bevel gear is fixed relative to the knob.

3. The steerable medical device of claim 1 , wherein the first bevel gear, the second bevel gear, the third bevel gear, and the lead screw are translatable relative to the knob and the handle body.

4. The steerable medical device of claim 3 , wherein rotation of the lead screw causes translation of the lead screw.

5. The steerable medical device of claim 1 , wherein the tool is a sheath, a catheter, or an introducer.

6. The steerable medical device of claim 1 , wherein the handle body is larger than the knob.

7. The steerable medical device of claim 1 , wherein the first bevel gear, the second bevel gear, and the third bevel gear are positioned within the handle body.

8. The steerable medical device of claim 3 or 4, wherein the interior surface of the handle body is threaded and threadably engaged with the lead screw.

9. 9. The operable medical device of claim 3, wherein the at least one control wire is mounted in a bearing fixed to the lead screw to prevent twisting of the at least one control wire during translation of the lead screw.

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