Wheel lock for thumbwheel-operated devices

Abstract

A wheel lock or clip for maintaining the position of a thumbwheel or wheel of a rotary actuated delivery device includes an arcuate or curved body having a live hinge extending therefrom connected to an arm having an engaging tooth extending therefrom, the tooth being operatively connected to a tab for actuation by a user to disengage the engaging tooth from teeth on a gear or barrel of the wheel or thumbwheel of the rotary actuated device, thereby allowing free movement of the wheel or thumbwheel.

Description

Technical Field

[0001] Embodiments of the present invention relate to stent delivery devices, specifically, one-handed thumbwheel-driven delivery handles.

Background Art

[0002] There are several medical conditions and procedures in which devices such as stents are placed within the body to form or maintain a passageway. There are a wide variety of stents used for various purposes, from expandable coronary, vascular, and biliary stents to plastic stents used to allow urine flow between the kidney and bladder.

[0003] Self-expanding stents, as well as balloon-expandable stents, can also be used to treat various problems related to the vasculature, including but not limited to May-Thurner syndrome and deep vein thrombosis.

[0004] Stents are typically delivered to the target site in a compressed state and then deployed to an expanded state to support the blood vessel and help maintain the blood vessel in an open position. A delivery system is used to implant or deploy the stent at the target site within the diseased blood vessel.

[0005] Stents are generally delivered using a catheter delivery system. A common type of delivery system for delivering self-expanding stents is called a pull-back delivery system. This type of delivery system utilizes two concentrically arranged catheters or shafts. The stent is axially carried around the distal end of the inner catheter or shaft. The stent is carried to the delivery site at the distal end of the delivery device held in a compressed delivery position by the outer shaft or catheter. When the desired placement site is reached, the outer shaft is pulled back and the stent is released to self-expand.

[0006] In another embodiment, a thumbwheel-operated delivery system can be used to deliver a stent to its desired position. These devices are often pre-energized by the stent for delivery, but unwanted operation of the delivery device, particularly a thumbwheel-operated device, impairs the ability to use the designed delivery system. Therefore, a mechanism is needed to prevent unwanted operation of operating members, such as thumbwheels, on the stent delivery system. [Overview of the project] [Problems that the invention aims to solve]

[0007] Therefore, the present invention relates to a wheel lock for a thumbwheel-operated device that eliminates one or more problems caused by the limitations and drawbacks of the related technology. [Means for solving the problem]

[0008] In accordance with the object of the present invention, as embodied and broadly described herein, a clip for reducing the motion of a wheel having a plurality of teeth on its outer circumference, wherein the plurality of teeth have grooves of a predetermined shape and size between them, the clip comprises a body; an arm connected to and extending from the body, the arm having a bent portion and an extended portion, the arm being movable toward and away from the body together with the bent portion having hinge-like properties; an engaging tooth extending from the arm and sized to be received in at least one of grooves between two of the plurality of teeth of the wheel; and a tab operably connected to the engaging tooth, such that the movement of the tab disengages the engaging tooth from the plurality of teeth of the wheel.

[0009] In another aspect of the present invention, the kit comprises a wheel-actuated device wheel, a wheel having a plurality of gear-like teeth, the gear-like teeth having grooves between them around at least a portion of the circumference of the wheel, an axle on which the wheel is movable around it, and a housing, the wheel being at least partially within the housing and having a portion of the wheel extending above the housing; and a removable wheel lock, comprising a body, an arm connected to and extending from the body, the arm having a bent portion and an extended portion, so that the arm is movable toward and away from the body together with the bent portion having hinge-like properties, an engaging tooth extending from the arm and receiving into at least one of grooves between two of the gear-like teeth of the wheel, and a tab, operably connected to the engaging tooth, so that the movement of the tab disengages the engaging tooth from the plurality of teeth of the wheel.

[0010] Additional advantages are partially described in the following description, partially obvious from the description, or can be learned through the practice of the invention. The advantages of the invention will be realized and achieved by the elements and combinations specifically indicated in the appended claims. It should be understood that both the above summary and the following embodiments for carrying out the invention are merely illustrative and descriptive and do not limit the claimed invention.

[0011] Further embodiments, features, and advantages of the rotary handle stent delivery system and method, as well as the structure and operation of various embodiments of the rotary handle stent delivery system and method, are described in detail below with reference to the accompanying drawings.

[0012] It should be understood that both the above summary and the following embodiments for carrying out the invention are merely illustrative and descriptive, and do not limit the claimed invention. [Brief explanation of the drawing]

[0013] The accompanying drawings incorporated herein and forming part of this specification illustrate a wheel lock for a thumbwheel-operated device. Along with the description, the drawings further serve to illustrate the principles of the rotary handle stent delivery system and method described herein, thereby enabling those skilled in the art to manufacture and use the rotary handle stent delivery system and method.

[0014] Refer to the attached drawings here, but they are not necessarily drawn to scale. The patent or application documents include at least one drawing made in color. Copies of this patent or patent application publication and the color drawings will be provided by the office upon request and payment of the necessary fees.

[0015] [Figure 1A] Various embodiments of exemplary delivery handles are shown. [Figure 1B] Various embodiments of exemplary delivery handles are shown. [Figure 1C] Various embodiments of exemplary delivery handles are shown. [Figure 2] Figure 1 is an illustrative top view of a stent delivery handle. [Figure 3A] An exemplary wheel lock or locking tab, according to the principle described herein, for use with a wheel / thumbwheel actuated system or device, is shown. [Figure 3B] An exemplary side view of a wheel lock or clip for a wheel to be locked is shown. [Figure 4A] A perspective view of the wheel lock / clip in the unengaged state. [Figure 4B] This is a side view of the wheel lock / clip in the disengaged state shown in Figure 4A. [Figure 4C] This is a front view of the wheel lock / clip in the disengaged state (Figure 4A). [Figure 5A] Figure 4B shows the features of detail A. [Figure 5B] Figure 4B shows the features of Detail B. [Figure 6A]Shows a wheel lock / clip according to the principles described herein, located on an exemplary thumbwheel actuated stent delivery device. [Figure 6B] Shows a wheel lock / clip according to the principles described herein, located on an exemplary thumbwheel actuated stent delivery device. [Figure 6C] Shows a wheel lock / clip according to the principles described herein, located on an exemplary thumbwheel actuated stent delivery device. [Figure 7] A general view of a wheel lock / clip engaged with an exemplary thumbwheel actuated delivery system. [Figure 8] Another general view of a wheel lock / clip engaged with an exemplary thumbwheel actuated delivery system. [Figure 9] Shows an exploded view of the features of an exemplary delivery handle. [Figure 10] A cross-sectional view of an assembled exemplary delivery handle. [Figure 11] A cross-sectional view showing the movement of an exemplary thumbwheel and timing belt. [Figure 12A] A cross-sectional view of an exemplary delivery device showing the movement of the timing belt link and outer sheath during thumbwheel movement. [Figure 12B] A cross-sectional view of an exemplary delivery device showing the movement of the timing belt link and outer sheath during thumbwheel movement. [Figure 12C] A cross-sectional view of an exemplary delivery device showing the movement of the timing belt link and outer sheath during thumbwheel movement. [Figure 13] Shows a perspective view of an exemplary delivery device including a delivery catheter device. [Figure 14] A cross-sectional view showing details of an exemplary thumbwheel assembly. [Figure 15] Shows a portion of an exemplary thumbwheel. [Figure 16] Shows exemplary belt teeth. [Figure 17] Shows exemplary belt teeth. [Figure 18] An exemplary thumbwheel / barrel assembly with a timing belt is shown. [Figure 19] An exemplary barrel with two sets of teeth is shown. [Figure 20] An example of a modular thumbwheel assembly is shown. [Figure 21] An exemplary timing belt with timing belt teeth is shown. [Figure 22] An exemplary timing belt with timing belt teeth is shown. [Figure 23A] Figure 22 shows an example idler that can be used with the Pozidriv belt shown. [Figure 23B] Figure 22 shows an example idler that can be used with the Pozidriv belt shown. [Figure 24] An exemplary thumbwheel / barrel assembly with a timing belt is shown. [Figure 25] This shows alternative types of Pozidriv belts that may be used in delivery assemblies. [Figure 26] This shows alternative types of Pozidriv belts that may be used in delivery assemblies. [Figure 27] An example timing belt link for use with a Pozidriv belt is shown. [Figure 28] Figure 27 shows an exemplary embodiment of the first portion of the timing belt link. [Figure 29] Figure 27 shows an exemplary embodiment of the second portion of the timing belt link. [Figure 30] This is a photograph showing an exemplary Pozidriv belt code structure that may be used in wheel-actuated delivery devices. [Figure 31] This is a photograph showing an exemplary Pozidriv belt code structure that may be used in wheel-actuated delivery devices. [Figure 32] This is a photograph showing an exemplary Pozidriv belt code structure that may be used in wheel-actuated delivery devices. [Modes for carrying out the invention]

[0016] Herein, with reference to the attached figures, embodiments of wheel locks for thumbwheel-operated devices are described in detail. The various embodiments disclosed herein illustrate devices and associated methods for delivering expandable stents or other medical devices for implantation or deployment of stents or other medical devices to a target site within a diseased blood vessel. Exemplary thumbwheel-operated delivery devices are described in U.S. Patents 10,441,449 and 10,449,073, which are incorporated herein by reference as if they were fully described herein. While wheel locks for thumbwheel-operated devices are described with reference to the stent delivery devices of U.S. Patents 10,441,449 and 10,449,073, wheel locks as described herein may be used with any wheel / thumbwheel-operated device, including but not limited to stent delivery devices.

[0017] Figures 1A, 1B, and 1C illustrate various embodiments of a stent delivery handle. As shown, the handle 10 includes a housing 14 and a thumbwheel / thumbwheel assembly 18 from which a catheter 22 extends. Figure 2 is a top view of an exemplary embodiment of the delivery handle of Figure 1. In the embodiment shown in Figure 2, the delivery handle 10 has two thumbwheels 118a and 118b (e.g., a dual-disc thumbwheel assembly), as well as a thumbwheel assembly having an inner barrel 66. As shown, the handle 210 includes a housing 14 and a thumbwheel / thumbwheel assembly 218 from which a catheter 222 extends. The thumbwheel assembly may include a single unit having an inner barrel continuous with one or both of the thumbwheels, or it may be a separate part. The thumbwheel assembly may have only one thumbwheel. The thumbwheel assembly 218 in the illustrated embodiment of Figure 2 includes two thumbwheels, 118a and 118b, as well as an inner barrel 66. As can be seen in Figure 2, the inner barrel 66 includes a scalloped or toothed surface. The toothed surface may be designed or pitched to engage with a timing belt or other mechanism for transmitting the movement of the thumbwheel to drive the device, as can be seen in various embodiments herein. For example, the inner barrel may have barrel teeth having a pitch corresponding to a drive belt or screw, which causes the drive belt or screw to move when the thumbwheel is actuated, and the barrel teeth have grooves or recesses between adjacent teeth. However, the scope of the invention as described herein is not limited to a particular delivery mechanism and may be applied to any wheel-driven device having a toothed thumbwheel assembly as described herein.

[0018] Figure 3A shows an exemplary wheel lock or lock tab 311 for use with a wheel / thumbwheel actuation system or device (not shown). Figure 3B shows a side view of an exemplary wheel lock or clip 311 for a wheel 318 to be locked. As can be understood, in Figures 3A and 3B, the elements are shown separated from the wheel actuation device for illustrative purposes. The device may be used in combination with any wheel actuation device in which it is appropriate to prevent wheel movement in a variety of situations. As shown, the exemplary wheel lock 311 includes a tab 315 that, when pulled, allows at least one engaging tooth 319 of the wheel lock 311 to disengage from the wheel 318. In addition to the tab 315 and the engaging tooth 319, the wheel lock / clip 311 includes a body 323, an arm 326 with an extension portion 327, and a U-shaped or bent portion 331. The U-shaped bend 331 exhibits hinge-like behavior and may be a living hinge, but it may also be another structure that exerts an outward force on the extension 327, moving the substantially straight portion away from the body 323. The body 323 may be arc-shaped or curved to mimic the curved shape of the wheel / wheel assembly 318. The arm 326 extends from the body 323 via the bend 331. The tab 315 is connected to the arm 326, and the end of the tab 315 extends beyond the end of the body 323, allowing the user to access the tab 315 and move it in a desired direction. As shown in the figure, the tab 315 may extend from the end of the extension 327 to the opposite end of the bend 331. The engaging teeth 319 extend in one direction from a portion of the extension 327 such that user movement of the tab 315 disengages the engaging teeth 319 from a complementary set of barrel teeth on the outer circumference of the inner barrel 66 (not shown in Figure 3B) (e.g., a set of teeth spaced apart to receive the engaging teeth 319 between them). Additional teeth 335 may be provided on the inside of the arcuate clip body to provide an additional engagement position of the wheel lock / clip to the wheel / wheel assembly 318. The additional teeth 335 are complementary to the barrel teeth on the outer circumference of the inner barrel and are sized to engage with the barrel teeth.These additional teeth 335 also provide engagement at a predetermined point on the wheel to help the wheel lock / clip be released in the correct position and reduce wheel / thumbwheel movement during release. Three additional teeth 335 are shown in Figure 3A, but more or fewer additional teeth may or may not be included in the device. Figure 3A further shows the cavity between the additional teeth 335 and the inner surface of the clip body 323. Such a cavity may be omitted from the wheel lock / clip 311. Figure 4A is a perspective view of the wheel lock / clip 311 in an unengaged state.

[0019] As described above, the wheel lock / clip 318 itself functions as a living hinge, which is taut when applied to the inner barrel and slack when disengaged from the inner barrel. Figure 3A shows the wheel lock / clip 318 in a slackened state. Figure 3B shows the wheel lock / clip 318 taut when applied to the wheel / wheel assembly 318.

[0020] Figure 3B is a side view of the wheel assembly 318 with the wheel lock or clip 311 in the engaged position. As Figure 3B is a side view, the inner barrel 66 is not visible in the drawing. In a compressed state (e.g., a taut state), the force is applied toward the axis of the wheel 318 by a hinge formed by the arm 326 (bent portion 331 and extended portion 327) and the engaging teeth 319, which is compressed toward the axis. Thus, the wheel lock / clip 311 maintains tension and therefore holds the wheel / thumbwheel in place by the contact portion or near the contact portion between the end portion 339 of the arched body and the housing 14 of the delivery device 10.

[0021] Figure 4A is a perspective view of the wheel lock / clip 311 in the disengaged state. Figure 4B is a side view of the wheel lock / clip 311 of Figure 4A in the disengaged state. Figure 4C is a front view of the wheel lock / clip 311 of Figure 4A in the disengaged state. As shown in the figures, the body 323 has an arc (its profile is substantially curved) to conform to the wheel to which it is applied. For example, the arc of the body 323 may have a radial center point 343 that coincides with the wheel to which it is applied, but is not required. Furthermore, when applied to a wheel, the body 323 may be deformed to change its shape while tension is applied. Alternatively, the body 323 in the relaxed state may not have an arc that conforms to the wheel, but may have an arc that substantially conforms to the wheel when applied to a wheel.

[0022] The body 323 may exhibit spring-like behavior such that the arcs of the arm 326 and the body 323 combine to create a spring that imparts or biases energy when mounted on the wheel. Thus, the clip grips the wheel (via the engaging teeth 319) in a manner similar to a retractable spring clamp. When the operator removes the piece by pulling the tab 315, the spring is temporarily further tensioned by winding the spring at the U-shaped (bent portion 331) location and releasing the engaging teeth 319 from the mating gear teeth (not shown) in the thumbwheel 318.

[0023] As shown in Figure 4B, the body 323 has an upper surface 347 and a lower surface 351. The lower surface 351 should have an arc that conforms to the wheel to which the wheel lock is applied. The upper surface does not need to have an arc-shaped profile, but such an arc-shaped profile is shown in the figure. The tab 315 is shown to have a curved or arc-shaped profile, but the tab 315 may be in any configuration that allows the user to grip the tab to pull it away from the wheel with enough force to overcome the force supplied by the hinge formed by the bent portion 331 and the extended portion 327 to disengage the engaging teeth 319. The tab 315 may be flat or straight, may include a thumb or finger recess, may be textured or have any other configuration or shape to assist the user in gripping the tab 315. Details A of Figure 4B are shown in Figure 5A, and details B of Figure 4B are shown in Figure 5B.

[0024] Figure 5A illustrates additional teeth 335. As discussed above, three additional teeth 335 are shown for illustrative purposes. More or fewer additional teeth 335 may be provided within the scope of this disclosure. As shown in Figure 5A, the teeth have a triangular cross-section, and two struts 355 form a 45-degree angle, forming apex on the side of the tooth facing the wheel (not shown) to be locked. As illustrated, each of the three illustrated additional teeth has the same angle to properly engage with the teeth on the inner barrel 66 (see Figure 2). The apex of the teeth lies on arcs that share a common radial center point 343 with each other and with the wheel to engage with the wheel (not shown) to which the wheel lock / clip is applied. Although shown to include two struts, each additional tooth may be solid or hollow, and is not limited thereto, still within the spirit and scope of this disclosure. Although examples herein illustrate that additional teeth have a triangular cross-section, the shape of additional teeth is not limited thereto, as long as the teeth are shaped to engage with a complementary structure on the wheel to which they are applied.

[0025] Referring to Figure 4B, the brace arm 321 may be adjacent to the lower surface 351 of the body and may be connected to the hinge 331. As can be seen in Figure 4B, the additional teeth 335 may be separated from the body 323 by a bridge structure 371. The bridge structure 371 may include a bridge strut 375 adjacent to the lower surface 351 of the body 323. The bridge strut 375 may be spaced apart from the lower surface 351 of the body 323, extend from the body 323, and be connected to it by a lateral strut 379. The bridge structure 371 itself may form a hinge that is compressible toward the body 323. The lateral strut 379 may be a living hinge, which, when a force is applied to the additional teeth 335, makes the bridge compressible toward the body 323. In one embodiment, the lateral strut 379 may be connected to the bridge 375 such that the point where the lateral strut 379 connects to the bridge is a hinge or a living hinge. The additional teeth 335 may be attached to or simply adjacent to the bridge structure 371 such that a force applied to the additional teeth 335 causes deformation of a living hinge formed from the bridge structure 371. Furthermore, the additional teeth may extend from the body 323 via an additional tooth arm 383, which itself may be deformable / compressible toward the body 323 such that a force applied to the additional teeth 335 causes deformation of a living hinge formed from the additional tooth arm 383. The additional teeth 335 may further connect to the body via a second additional tooth strut 385, which may be adjacent to or the same as at least one of the lateral struts 379. The bridge structure 371 may further include a body strut 391 adjacent to the body 323 such that the lateral strut 379 connects the body strut 391 to the bridge 375.

[0026] Figure 5B illustrates the engaging tooth 319 in relation to the tab 315 in this embodiment. The engaging tooth can be formed from two struts 359 and has a triangular cross-section. Although shown to include two struts, the engaging tooth is not so limited and can be solid or hollow, still within the spirit and scope of the disclosure. Although shown to be slightly offset along the arm 327 from the lower end 363 of the tab 315, this is only one relationship of the engaging tooth 319 to the tab 315. For example, the end 367 of the strut 359 of the engaging tooth 319 can be aligned with or close to the lower end 363 of the tab 315. The end 367 is intended, but not required, to be curved or otherwise shaped to abut at least a portion of the opposing vertices of teeth (not shown) on the inner barrel 66. Furthermore, the arm 327 may have an arc such that when the wheel lock / clip 311 engages with the wheel to which it is applied, the arc of the arm 327 shares a common radial center point 343 with the wheel. Similarly, when it engages with the wheel to which it is applied, the vertices of the engaging teeth lie on arcs that share a common radial center point 343 with each other so that the wheel lock / clip 311 engages with the wheel (not shown) to which it is applied.

[0027] Figures 6A, 6B, and 6C show a wheel lock / clip 311 according to the principle described herein positioned on an exemplary thumbwheel-operated stent delivery device. As shown, the wheel lock / clip 311 is mounted on a thumb-operated wheel (not shown) having a tab 315 on the rear side of the thumbwheel. Thus, although not shown, the engaging teeth engage with teeth on an inner barrel 66 (not shown) toward the rear side of the thumbwheel. Looking closely at Figure 6A, the bent portion 331 can be seen in the space between the lower surface 351 of the body 323 and the thumb contact surface 399 of the thumbwheel 318 (in this case, 318A). Looking at Figure 6B, the strut 355, which forms one side of the leading edge of the additional teeth and one side of the trailing edge of the additional teeth, can be seen in the space between the lower surface 351 of the body 323 and the thumb contact surface 399 of the thumbwheel 318 (in this case, 318B). Figures 7 and 8 are schematic diagrams illustrating how the wheel lock / clip 311 interacts with / engages with the thumbwheel-operated delivery system of U.S. Patent No. 10,449,073. Once installed, the wheel lock / clip 311 prevents wheel movement by contacting a portion of the housing 14 of the wheel-operated device 10.

[0028] The wheel lock / clip can be applied to the wheel of the delivery device, but the additional teeth 335 abut against the respective grooves between the barrel teeth, using those teeth as pivot points to then engage the engaging teeth 319 with the corresponding grooves between the barrel teeth. As shown, the tab 315 faces the back of the delivery handle, but such orientation is not mandatory. To disengage, the user pulls the tab 315, which disengages the engaging teeth 319 from the corresponding grooves, and the additional teeth are the pivot point and the final point of disengagement from the inner barrel of the wheel lock / clip 311.

[0029] The wheel lock / clip 311 can be fabricated from any deformable material that can provide suitable higher flexural modulus and tensile properties. For example, but not limited to, nylon suitable for healthcare applications, such as Dupont Zytel® PA66, can be used to form the wheel lock / clip. Dupont Zytel® PA66 is generally resistant to EtO sterilization or gamma radiation. Nylon offers creep resistance and higher durability than several other options such as acetal copolymers and ABS, although such materials may be used instead of nylon in this design. For example, medical-grade polycarbonate / ABS blends, including materials such as Covestro Bayblend®, may also be used.

[0030] Although described in relation to applications to internal barrel structures, the wheel locks / clips described herein can be applied to any wheel having a toothed surface.

[0031] Figure 9 shows an exploded view of an exemplary delivery handle feature to which a wheel lock / clip 311 can be applied to minimize rotation of the thumbwheel for shipping. The exemplary device shown in Figure 9 includes two-part housings 114a and 114b, each of which two parts 114a and 114b can be snap-fitted together for assembly. The thumbwheel 18 may comprise two wheels 118a and 118b, a shaft 58, and a bearing 62. The wheels 118a and 118b may include teeth on their inner barrels 66. Wheel 118b has only one inner barrel as shown in Figure 9, but wheel 118a may also include an inner barrel with teeth. The teeth on the inner barrels 66 are sized to correspond to teeth on the timing belt 70. A timing belt link 74 connects the outer sheath 34 to the timing belt 70. The housing may include a bushing 78, which may be a separate component or may be integrated with the housing 14. The bushings may be formed from PEEK or other suitable material. The exemplary handle in Figure 9 further includes at least one idler pulley 82 for tensioning and guiding the timing belt. Also shown in Figure 9 is an idler pulley shaft 86 corresponding to the idler pulley 82 of the device in Figure 9. The exemplary delivery handle in Figure 9 further includes a tensioner assembly 90, which includes a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm shaft 106, and a tensioner pulley shaft 112. In the devices described herein, the timing belt has teeth on one side of the belt (outer diameter or periphery), and its inner diameter (inner surface) is smooth, substantially smooth, or flat. The smooth or flat surface of the timing belt 70 contacts the idler pulley 82 and the tensioner pulley 102.

[0032] In the exemplary device shown in Figure 9, the outer support shaft 38 is fixed to the handle housing 14, and both the inner core 42 and the outer sheath 34 are placed within the inner diameter of the outer shaft 38. The inner core 42, together with a metal (e.g., stainless steel) shaft 30, is coupled to the handle body 14 or, at its proximal end, to a female luer 116 that is clamped to the handle body 14. In one aspect of the present invention, the metal shaft 30 may be coupled to the outer diameter of the inner core 42 to provide support / rigidity at the proximal end of the inner core 42 that is not supported within the handle body 10. Support of the metal shaft 30 on the inner core 42 mitigates potential deformation / buckling of the proximal unsupported inner core 42 during stent deployment. When the outer sheath 34 is pulled back to release / deploy the stent, the inner core 42 is compressed, and therefore the unsupported proximal end of the inner core may deform. The bonded metal shaft 30 provides support and columnar strength to the unsupported proximal inner core 42. The metal shaft 30 can be sized to slide across the outer diameter of the inner core 42 and through the inner diameter of the outer sheath 34. Since the metal shaft 30 does not affect the inner diameter of the inner core 42, a guide wire (not shown) can still pass through the entire assembly. Non-metallic materials can be used for the support shaft, and the invention described herein is not limited to metal for use in the support shaft 30.

[0033] The outer sheath 34 is connected to or coupled to a timing belt link 74 to deliver the stent by retracting the outer sheath 34 by the movement of a thumbwheel, the thumbwheel then engages with the teeth of the timing belt 70 via the teeth on the inner barrel 66 and the teeth on the inner barrel 66. A metal shaft 30 connected to or coupled to an inner core 42 / female luer 116 is a guide rail through which the outer sheath 34 and the timing belt link 74 move proximal during deployment.

[0034] Figure 10 is a cross-sectional view of an assembled exemplary delivery handle. The exemplary device shown in Figure 10 shows one part 114b of a two-part housing, and each of the two parts can be snap-fitted together for assembly. The two parts can be joined together using other assembly methods such as welding, binding, gluing, or other methods. It is assumed that each side of the two-part housing is symmetrical and complementary, but such a configuration is not required. The parts of the thumbwheel assembly 18 can be formed by molding, such as injection molding. The housing 14 may be a single piece.

[0035] Figure 10 illustrates one wheel of a thumbwheel assembly 18, which may include two wheels 118a and 118b, a shaft 58, and a bearing 62. The bearing may include a ball bearing with inner and outer grooved bearing races. The bearing serves to reduce rotational friction between the thumbwheel and the shaft and may be removed if the frictional force is acceptable. Instead of the bearing 62, an acetal bush or other method of friction reduction may be used.

[0036] Wheels 118a and 118b may include teeth on their inner barrels 66. Although only one inner barrel is shown on wheel 118b in Figure 10, wheel 118a may also include an inner barrel having teeth. The teeth on the inner barrels 66 are sized to correspond to the timing belt 70. The inner barrels may be formed by molding, such as injection molding, and the teeth may be formed as part of the molding or other method such that the teeth are integral with the inner barrels 66. In another embodiment, the teeth are separable from the inner barrels 66.

[0037] As shown, the timing belt link 74 connects the outer sheath 34 to the timing belt 70. The exemplary handle in Figure 10 further includes at least one idler pulley 82 for guiding tension on the timing belt 74. Also in Figure 10 is an idler pulley shaft 86 corresponding to the idler pulley 82 of the device in Figure 10. The exemplary delivery handle in Figure 10 further includes a tensioner assembly 90, which includes a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm shaft 106, and a tensioner pulley shaft 112. In the exemplary device in Figure 10, the outer support shaft 38 is fixed to the handle housing 14, and both the inner core 42 and the outer sheath 34 are contained within the inner diameter of the outer shaft 38. The inner core 42, together with the metal (e.g., stainless steel) shaft 30, is coupled to the handle body 14, or at its proximal end, to a female lure 116 that is clamped to the handle body 14.

[0038] Figure 11 further illustrates the movement of the thumbwheel 18, timing belt 70, and timing belt link 74 for stent deployment. As shown in Figure 11, the outer sheath 34 is translated proximal over the guide tube / inner core 42 by the timing belt 70 by rotating the thumbwheel in the direction of the arrow. The timing belt 70 is driven by the operator via a dual thumbwheel assembly 18 which may include integrally molded gear teeth, the pitch and shape of which correspond to the teeth of the timing belt 70 for synchronizing / engaging the timing belt and causing the movement of the timing belt, and the timing belt link is coupled to the outer sheath 34, causing its movement and exposing (deploying) the stent housed therein. The diameter of the inner barrel 66, the number of teeth on the timing belt 70, and the pitch / frequency of the teeth on the timing belt 70 can be adjusted / modified, respectively, to allow for variable mechanical advantages and a variable translation ratio during stent deployment. In addition, variable-speed delivery can also be achieved by operating the thumbwheel assembly 18 at a desired speed.

[0039] In the device shown in Figure 11, proximal rotation (in the direction of the arrow) of the outer thumbwheel 18 portion of the handle moves the upper part of the timing belt portion adjacent to the inner thumbwheel portion of the handle distally (in the direction of the arrow). The timing belt 70 extends around the idler pulley 82 such that a portion of the timing belt 70 adjacent to the timing belt link 74 moves proximal (in the direction of the arrow), engaging with the timing belt link 74 and moving the timing belt link 74 proximal, thereby moving the outer sheath 34 coupled to it proximal, and thereby exposing the stent for deployment. The movement can be reversed for resheathing the catheter after stent deployment.

[0040] Figures 12A, 12B, and 12C are cross-sectional views of an exemplary delivery device showing the movement of the timing belt link 74 and the outer sheath 34 when the thumbwheel 18 moves counterclockwise in the context of Figures 12A, 12B, and 12C. The direction of thumbwheel rotation described herein is explained in the context of the provided cross-sections, but it should be understood that the external portion of the thumbwheel on the handle 14 is assumed to rotate backward (in the proximal direction). It is also intended that the configuration of the timing belt 70 may be adjusted to correct the direction of thumbwheel rotation corresponding to the proximal movement (reverse movement) of the outer sheath 34 (for example, it may loop over the thumbwheel).

[0041] As shown in Figure 12A, in the introduction position, the timing belt link is at the distal end of the handle housing. When the thumbwheel 18 is actuated in a predetermined direction, for example counterclockwise in the cross-sectional configuration shown, the timing belt link / shuttle 74 moves proximal. Since the timing belt link / shuttle 74 is coupled to the outer sheath 34, the outer sheath moves proximal with the timing belt link / shuttle to expose a stent or other medical device mounted on the inner core 42 (not shown). Figure 12B shows the positioning of the timing belt link / shuttle in a partially deployed position (for example, when a stent is partially deployed (not shown)). As shown in Figure 12C, when the thumbwheel 18 rotates further within the timing belt link / shuttle 74, it moves further proximal so that the stent or medical device can be fully deployed from the side of the inner core 42. In the device described herein, the thumbwheel 18 is actuated so that the upper (external) part of the thumbwheel rotates proximal, allowing the timing belt link / shuttle 74 to pass proximal. It should be understood that the configuration / path of the timing belt 70 may be configured such that distal rotation of the upper (external) portion of the thumbwheel 18 causes the timing belt link / shuttle 74 to pass proximally, retracting the outer sheath 34 from the inner core 42, thereby enabling the deployment of a medical device (not shown).

[0042] Figure 13 shows a perspective view of an exemplary delivery device including a catheter device. As shown in Figure 13, the timing belt 70 extends around an idler pulley 82 and a tensioner pulley 102 of a tensioner 90. The tensioner pulley 102 is coupled to a torsion spring 94 via a tensioner arm 98. Tension is maintained on the timing belt by the torsion spring 94 on the tensioner arm axis 106, which causes the tensioner pulley 102 to contact the timing belt 70 via the tensioner arm 98. An example of the idler pulley 82 is shown in Figures 23A and 23B.

[0043] Figure 14 is a cross-sectional view showing details of an exemplary thumbwheel assembly 18 and timing belt link 74. As shown in Figure 14, one part 118b of the two-part thumbwheel 18 has an outer surface 122 which may be textured for ease of use. The thumbwheel portion 118b may also include an inner surface or rim 126. The inner barrel 66 extends from the thumbwheel portion 118b and has a plurality of barrel teeth 130 thereon. The barrel teeth 130 on the inner barrel 66 are sized to correspond to a timing belt (not shown). Although not shown, the barrel teeth 130 may have a standard periodicity (pitch) or may have a variable periodicity (pitch) so that the operation of the thumbwheel assembly may cause movement of the timing belt (not shown), and thus cause translation of the outer sheath 34 at a first speed when the first periodic barrel teeth engage with the timing belt (not shown), and at a second speed when the second periodic barrel teeth engage with the timing belt (not shown). Such variable speed can be provided by having different spacing / periodicity / pitch of teeth on a timing belt instead of, or in addition to, different spacing / periodicity / pitch of barrel teeth 130 on the inner barrel 66. Figure 14 further illustrates the thumbwheel bearing 62 and the thumbwheel shaft 58.

[0044] A safety lock function (not shown) may be incorporated into the handle design to reduce unintentional operation of the handle during transport and storage. The safety lock function may be a removable / discardable or toggle function that engages teeth on the inner barrel to lock it in place and prevent rotation. The safety lock function may also be a function that engages the timing belt link to prevent its movement.

[0045] Figure 15 shows a portion of an exemplary thumbwheel. The thumbwheel may include at least two wheel portions 120a and 120b, as shown in Figure 3. As shown in Figure 15, one of the wheel portions 120a may be a body 222 including a portion of the thumbwheel 218a (e.g., an outer circumference extending through the housing so that the user can rotate the thumbwheel to operate the device) and a portion of the barrel 266a (e.g., a portion that engages with a timing belt (not shown) to move the timing belt). The wheel portion 120a may be integral (e.g., they may be formed in a single molding process) so that the thumbwheel portion 218a extending through the housing and the barrel portion 266a may be integral. The other wheel (not shown) may also include both a portion of the thumbwheel and a portion of the barrel for operation so that the two “wheels” can fit together to form a thumbwheel and barrel assembly. In other words, the other wheel may be a mirror image of the wheel described above. In some configurations, the two "wheels" may be identical, and consequently, only one mold may be used. Also, the thumbwheel assembly may be formed as a single unit containing both the barrel and thumbwheel portions.

[0046] As shown in the exemplary device of Figure 15, the exemplary wheel portion barrel portion 266a includes grooves 232 that are substantially equally spaced to engage with the pitch of a corresponding timing belt (not shown). The timing belt includes a plurality of teeth that are substantially equally spaced along the surface of the belt to engage with the grooves 232 on the corresponding barrel 266. Figure 16 shows exemplary belt teeth. The belt shown in Figure 16 is illustrative only because it shows only two teeth, but the belt is designed to have enough teeth along the belt to fully deploy the stent.

[0047] Other exemplary belt teeth are shown in Figure 17. As shown in Figure 17, the exemplary belt teeth 471 may have a tapered shape with a flat top, for example, a trapezoidal cross-section, to enable engagement with the barrel teeth 230 or groove 232. Although a trapezoidal cross-section is shown, the teeth may have any cross-section that is sufficient to engage with the barrel teeth, and are not limited thereto, to enable the movement of the belt to be actuated by the rotation of the barrel. Other possible shapes, but are not limited thereto, include circular, cylindrical, rhombic, square, triangular, or any variation thereof.

[0048] In some embodiments, the timing belt may be looped over the barrel of the thumbwheel to provide a more complete engagement of the timing belt with the barrel. In this device, a longer timing belt is used so that approximately 360 degrees of engagement between the belt and the barrel can be achieved. Figure 18 shows a prototype thumbwheel / barrel assembly 522 with a timing belt 570, the barrel width being sized to allow the timing belt 570 to be looped around the barrel 566 for at least one full turn. For example, the cylindrical surface of the toothed barrel 566 may be sized to twice the width of the timing belt 570 in order to accommodate the timing belt 570 looped over the barrel 566 twice. Thus, the enlarged barrel 566 may have the two parts of the thumbwheels 518a and 518b further spaced apart than when the timing belt engages with the barrel 566 only on a small portion of the circumference of the barrel 566. In one embodiment, the outer cylindrical edge of the thumbwheel may be modified so that several portions of the outer edge of each part of the thumbwheel "overhang" the barrel in order to allow for a larger surface area for user engagement.

[0049] In another embodiment, the barrel may be substantially cylindrical, and as a result, one end of the barrel has a pair of teeth and / or grooves, and the other end of the barrel has a pair of teeth and / or grooves. The barrel may further include a core region between the ends having teeth and / or grooves. Such a teethed barrel may be a single piece or two parts mounted together. The ends of a substantially cylindrical barrel are spaced far enough apart to accommodate the central portion of the belt between them. A timing belt for use with a barrel described in this way may have, for example, a plurality of projections on the opposite side of the belt extending perpendicular to the pitch axis of the belt. The projections are designed to engage with corresponding teeth and / or grooves on the barrel to transmit torque from the barrel to the belt coupled to the outer sheath as described above, causing the stent to deploy. The barrel may further include grooves therein for accommodating a portion of the belt, so that the barrel itself does not have to be substantially cylindrical.

[0050] A barrel assembly can be formed by arranging two discs having appropriately spaced teeth on their circumferential edges, separated by a sufficient distance to allow each tooth of the disc to engage with the teeth of the timing belt. A cylindrical core may extend between each of the discs. The cylindrical core and the “discs” may be a single piece that is substantially cylindrical in practice, so that one end of the cylinder has a set of teeth and / or grooves, and the other end of the cylinder has a set of teeth and / or grooves with a core region between them. The teeth and / or grooves at both ends may be substantially aligned.

[0051] Figure 19 shows an exemplary barrel 666 having two sets of teeth 681 with grooves between them. Between the two sets of teeth 681 arranged around the circumference of a circular cross-section is a surface 668 that separates the sets of teeth 681 from each other. As shown, the surface is smooth, but not limited to that. Furthermore, although a surface is shown, a surface is not mandatory. The teeth may be separated by simply separating two discs having teeth and / or grooves that are spaced a suitable distance apart on the periphery, and perhaps both discs are mounted on a common shaft (not shown). As discussed in detail above, the barrel assembly 666 may be integral or integral with a thumbwheel (not shown in Figure 19). As illustrated in Figure 20, the thumbwheel assembly with the barrel 666 may be modular such that the first lateral portion of the barrel 666a and the first lateral portion of the thumbwheel 618a are integral and can be mated together with another integral piece comprising the second lateral portion of the barrel 666b and the second lateral portion of the thumbwheel 618b. The lateral component thumbwheel assembly may also include surfaces 668a and 668b that, when mounted together, form surfaces that allow for spacing between sets of teeth that are separated from each other.

[0052] Figure 21 shows an exemplary timing belt with teeth. A timing belt intended for use with a barrel as described herein has, for example, multiple projections on the opposite side of the belt that extend perpendicular to the belt's pitch axis. The belt shown in Figure 21 is illustrative only, as it shows only three sets of teeth, but the belt is designed to have enough teeth along the belt to fully deploy the stent.

[0053] An exemplary belt tooth is shown in Figure 22. As shown in Figure 22, the exemplary belt tooth may have a cylindrical shape with a flat top, for example, a trapezoidal cross-section, to enable engagement with the barrel teeth. Although a trapezoidal cross-section is shown, the teeth may have any cross-section that is sufficient to engage with the barrel teeth, and are not limited thereto, to enable the movement of the belt to be actuated by the rotation of the barrel. Other possible shapes, but are not limited thereto, include rounded, trapezoidal, cylindrical, rhombic, square, triangular, or any variation thereof.

[0054] Figure 23A shows an idler pulley 1182 that can be used with the positive drive belt shown in Figure 22. Figure 23B shows a cross-section of the idler pulley illustrated in Figure 24A with the positive drive belt.

[0055] Figure 24 shows an exemplary thumbwheel / barrel assembly 922 having a cylindrical core 968 and a thumbwheel portion 918, with a timing belt 970 having projections 971 on two edges of the timing belt 970, such as a single core positive drive belt. The cylindrical core 968 can be seen between two sets of teeth / grooves 981.

[0056] Figures 25 and 26 illustrate alternative types of the Pozidriv belt 1171 that may be used in an exemplary delivery device. The illustrated Pozidriv belt 1170 is "twin-core" such that there are recesses or openings 1177 between each "crossbar" or tooth 1171 of the belt. The thumbwheel assemblies and pulleys described herein may be adapted to engage with the openings between the teeth of the belt to perform the movements described herein without affecting the overall function of the delivery device.

[0057] Referring again to Figures 3A and 3B, the spacing and shape of the engaging teeth 319 and the additional teeth 335 can be appropriately sized for the type of drive belt used without departing from the spit and scope of this disclosure.

[0058] Figure 27 shows an exemplary timing belt link 1074 for use with a Pozidriv belt 1070 in an exemplary delivery handle. As shown, the exemplary timing belt link 1074 comprises two parts 1074a and 1074b that can be snapped together. Each part can be injection molded or formed by any suitable process. The first part 1074a fits over the timing belt teeth 1071 of the timing belt 1070, snaps around the outer sheath 1034, and captures a cylindrical feature 1035 that is fixed to or integrated with the outer sheath 1034. The cylindrical feature 1035 can be integrated with the outer sheath 1034, or otherwise fixed to the outer sheath 1034, so that the outer sheath 1034 can move with the movement of the cylindrical feature 1035. The second section 1074b snaps onto the outer sheath 1034 from below to create a support system around the first section 1074a in order to provide rigidity. The second section 1074b provides the strength necessary to withstand the deployment force. The intent of this design is to allow rotation of the outer sheath 1034 relative to the belt 1070. According to one aspect of this design, there is clearance between the timing belt link sections 1074a and 1074b, the outer sheath 1034, and the cylindrical feature 1035 that allows the outer sheath 1034 to rotate freely without significant interference from the timing belt link 1074, but allows linear movement of the timing belt link 1074 to cause movement of the outer sheath 1034 for deployment of a stent (not shown). Such movement is caused by the “confinement” of the cylindrical feature 1035 by the timing belt link 1074. Therefore, the system can maintain its function when the distal end of the catheter is fixed and the proximal end (handle) is rotated a full 360° around the catheter's axis (not shown).

[0059] Figure 28 shows an example of the first portion 1074a of the timing belt link 1074a of Figure 27. The first portion 1074a includes an upper body portion 1076, extension arms 1084 extending in a common direction from the upper body portion 1076, and engagement grooves 1096 complementary to the teeth 1071 of the timing belt 1070. As shown, each extension arm 1084 extends from a corner 1077 of the upper body portion 1076, but the design is not limited thereto. The distal end 1085 of the extension arm 1084 may be curved to engage around a cylindrical outer sheath 1034, for example, to provide rough interference or a snap fit. In the illustrated device, there are four extension arms 1084, each extension arm 1084 extending from a corner 1077 of the upper body portion 1076. The upper body portion 1076 has a long dimension 1087 and a short dimension 1088, the long dimension 1087 being parallel to the axial direction of the outer sheath 1034 when engaged with the outer sheath 1034, and the short dimension 1088 being substantially perpendicular to the axial direction of the outer sheath 1034 when engaged with the outer sheath 1034. In the illustrated exemplary device, the engagement groove 1096 is formed along the long dimension 1087 such that there are at least two grooves 1096 between the long dimension 1087 of the upper body portion 1076 and the extension arm 1085 above it. The illustrated groove 1096 is U-shaped, and when there are two such grooves 1096, there is a projection 1089 from the upper body 1076 at a position between the corners 1077 of the upper body 1076 along the long dimension 1087 of the upper body 1076 that forms the two grooves 1096. Although two grooves 1096 are shown, more grooves can be formed by more projections from the upper body so that two or more linearly adjacent belt teeth can engage. There may also be projections extending from both long edges / dimensions of the upper body so that grooves on both sides of a Pozidriv belt can engage. In the device currently shown, the longitudinal section of the upper body 1076 may be U-shaped to fit over the outer sheath 1034.

[0060] Although not shown, the positioning of the extension arms is not limited to the corners of the upper body. In other words, the position from which they extend from the outer body can vary as long as it is sufficient for the extension arms to fit around the grooves that engage with the outer sheath and the timing belt. For example, the extension arms may extend from the midpoint of the length dimension of the upper body, while the projections may extend from the corners 1077 or end regions of the upper body. Additional projections may extend from the upper body to allow additional timing belt teeth to be engaged by the upper body. The timing belt link 1074 may include only the first part, but may further include a second part to provide additional strength to the assembly, for example, to withstand unfolding forces.

[0061] As shown in Figure 29, an exemplary second portion 1074b of the timing belt link 1074a in Figure 27 may include a lower body portion 1075 having two U-shaped end pieces 1079 having a substantially circular central cutout 1080 sized to accommodate the circumference of the outer sheath 1034. Each end 1083 of the “U” is separated by a distance smaller than the outer diameter of the outer sheath 134 so that the outer sheath 134 can be pushed into the substantially circular central cutout 1080 of the “U”-shaped end 1079. The U-shaped ends 1079 are connected by two upper side rails 1089 extending between the upper parts 1079 of each “U” to connect the two end pieces 1079.

[0062] Therefore, the outer sheath 1034 may be coupled to the drive belt 1070 by a first portion 1074a of a timing link 1074, which extends above the upper part of the outer sheath 1034, with an extension arm end 1085 extending below the lower part of the outer sheath 1034. A second portion 1074b of the timing belt link 1074 is located above the extension arm 1084 of the first portion and snaps into place around the outer sheath 1034 by inserting the outer sheath 1034 into a substantially circular central cutout 1080 of the U-shaped end 1079 of the second portion 1074b. The outer sheath 1034 may further include a cylindrical body 1035 sized to be between the extension arms 1085 of the upper body 1076 when the upper body 1076 is on the outer sheath 1034. For example, the cylindrical body 1035 may be permanently fixed to the outer sheath 1034 and thus engaged by the timing belt link 1074, holding the timing belt link 1074 in the appropriate position relative to the outer sheath 1034.

[0063] Figures 30, 31, and 32 show exemplary Pozidriv belt code structures that may be used in exemplary delivery devices.

[0064] Those skilled in the art will see that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Accordingly, the present invention is intended to encompass modifications and variations of the invention, as long as they remain within the scope of the appended claims and their equivalents.

[0065] While various embodiments of the present invention have been described above, it should be understood that these are presented only as examples and not as limitations. Those skilled in the art will see that various forms and details can be modified within the spirit and scope of the invention without departing from it. Therefore, the breadth and scope of the invention should not be limited by any of the exemplary embodiments described above, but should be defined solely in accordance with the following claims and their equivalents.

Claims

1. A clip for reducing the motion of a wheel having multiple teeth on its outer circumference, wherein the multiple teeth have grooves of a predetermined shape and size between them, and the clip is The main unit and An arm having a bent portion and an extended portion, wherein the arm is connected to the main body at the bent portion, extends from the main body, and the arm is movable toward and toward the main body together with the bent portion having hinge-like characteristics, Extending from the extended portion of the arm, the engaging teeth are sized to be received in at least one of the grooves between two of the plurality of teeth of the wheel, A tab is operably connected to the engaging teeth via the end of the extended portion of the arm opposite to the bent portion, so that the movement of the tab disengages the engaging teeth from the plurality of teeth of the wheel. clip.

2. The clip according to claim 1, further comprising at least additional teeth operably connected to the main body, wherein the additional teeth are sized to be received in a corresponding groove of the grooves between each of the plurality of teeth.

3. The clip according to claim 2, wherein at least two of the additional teeth are spaced apart from the engaging teeth along the body.

4. The clip according to claim 2, further comprising a bridge extending from and adjacent to the main body, wherein the additional teeth extend from a portion of the bridge.

5. The clip according to claim 4, wherein the bridge comprises a living hinge.

6. The clip according to claim 1, wherein the bent portion is a living hinge.

7. The clip according to claim 1, wherein the bent portion and the extended portion are a single, integrated structure.

8. The clip according to claim 1, wherein the main body, the arm, the engaging teeth, and the tab form a single, integrated structure.

9. The clip according to claim 1, wherein the body is substantially curved.

10. The clip according to claim 1, wherein the clip is formed as a single, integrated structure.

11. It's a kit, A wheel-actuated device, A wheel having multiple gear-like teeth, wherein the gear-like teeth have grooves between them around at least a portion of the circumference of the wheel. The wheel has an axis around which it can move, and A wheel-actuated device comprising a housing, wherein the wheel is at least partially located within the housing and has a portion of the wheel extending above the housing, A removable wheel lock, Main unit, An arm having a bent portion and an extended portion, wherein the arm is connected to the main body at the bent portion and extends from the main body, and the arm is movable toward and toward the main body together with the bent portion having hinge-like characteristics, An engaging tooth extending from the extended portion of the arm and receiving into at least one of the grooves between two of the gear-like teeth of the wheel, and A kit comprising a removable wheel lock, the tab being operably connected to the engaging teeth via the end of the extended portion of the arm opposite to the bent portion, such that the movement of the tab disengages the engaging teeth from the plurality of teeth of the wheel.

12. The kit according to claim 11, wherein the removable wheel lock further comprises at least additional teeth operably connected to the body, the additional teeth being sized to receive into a corresponding groove in the groove between each of the plurality of gear-like teeth of the wheel.

13. The kit according to claim 12, wherein the at least two additional teeth are spaced apart from the engaging teeth along the body.

14. The kit according to claim 12, wherein the removable wheel lock further comprises a bridge extending from and adjacent to the body, and the additional teeth extending from a portion of the bridge.

15. The kit according to claim 14, wherein the bridge of the removable wheel lock further comprises a living hinge.

16. The kit according to claim 11, wherein the bent portion of the arm of the wheel lock is a living hinge.

17. The kit according to claim 11, wherein the bent portion and the extended portion of the removable wheel lock are a single, integrated structure.

18. The kit according to claim 11, wherein the body, arm, engaging teeth, and tab of the removable wheel lock are a single, integrated structure.

19. The kit according to claim 11, wherein the body of the removable wheel lock is substantially curved.

20. The wheel lock is a single, integrated structure, according to claim 1.

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