Stent Delivery Handle Assembly

Abstract

A stent delivery catheter assembly for delivering and implanting a self-expanding stent into a body lumen includes a handle assembly for one-handed use having mode selections for advancing, retracting, and locking the stent delivery components. Rotation of a thumb wheel simultaneously retracts a sheath proximally and pushes a pusher member distally, allowing a physician to precisely position and implant a self-expanding stent into a body lumen in a controlled manner.

Description

[Technical field]

[0001] Disclosed herein are devices and methods for delivering a stent into an internal vessel or an external structure, such as a polymer tube, used for testing or demonstration purposes. [Background technology]

[0002] Internal blood vessels, or certain non-corporeal structures, such as polymeric tubes, may become at least partially occluded. To restore patency to the vessel, a stent may be inserted into the lesion or occlusion. Stents may also be used for other functions, such as trapping embolic material, increasing fluid flow, etc.

[0003] Certain types of stents, such as self-expanding stents, are often deployed with a push-pull catheter handle. Although this design is simple, it does not aid the user in placing the stent accurately. At least one component must be moved relative to the patient, and often two components must be moved relative to the patient. Two hands are often required to place the stent.

[0004] What is needed is a stent delivery handle that allows for one-handed deployment of a self-expanding stent. It is easy to use for controlled retraction of the sheath (proximally) while pushing the stent distally. The stent delivery handle does not need to move relative to the patient (it can remain stationary). It may include a stabilizer to help maintain its position relative to the patient. The stent delivery handle is reversible to allow for retrieval of the stent before deployment is complete. Summary of the Invention

[0005] In certain embodiments, a system for delivering a self-expanding stent includes a self-expanding stent, a stent delivery catheter, and a handle. The stent has a radially contracted configuration and a radially expanded configuration. The stent has a proximal end, a distal end, and a length between the proximal and distal ends. The stent comprises a plurality of openings along its length. The stent delivery catheter comprises an elongate outer tubular member, an elongate inner tubular member, and a stent-engaging member. The outer tubular member has a proximal end and a distal end. The stent is housed within the distal end of the outer tubular member in the radially contracted configuration. The elongate inner tubular member has a proximal end and a distal end. The inner tubular member extends within the outer tubular member. The inner tubular member at least partially defines a guidewire lumen.

[0006] In one embodiment, the catheter assembly is used to deliver and implant a self-expanding stent into a body lumen. The handle has a thumbwheel and a selector tab for selecting rotation of the thumbwheel. Reverse rotation of the thumbwheel is defined by the physician pressing the thumb along an upper portion of the thumbwheel such that the upper portion of the thumbwheel moves in a direction from the proximal end of the handle toward the distal end of the handle. Similarly, forward rotation of the thumbwheel is defined by the physician pressing the thumb along an upper portion of the thumbwheel such that the upper portion of the thumbwheel moves in a direction from the distal end of the handle toward the proximal end of the handle. A selector member is pivotally mounted within the thumbwheel and attached to the selector tab. A first ratchet member and a second ratchet member are pivotally mounted within the thumbwheel such that rotation of the selector member engages and disengages the selector member. Each of the first and second ratchet members has a first end, a second end, a cam surface, and a spring wire in the form of an elongated flexible rod. A sheath wire is wound around the sheath spool, the distal end of the sheath wire being attached to the sheath. A pusher wire is wound around the pusher spool, the distal end of the pusher wire being attached to the pusher member. A self-expanding stent is disposed within the distal portion of the sheath and distal to the pusher member.

[0007] With the selector tab moved to a forward position on the handle, the selector member pivots to disengage the second ratchet member from the thumbwheel so that the thumbwheel can only rotate in a forward direction toward the proximal end of the handle, which simultaneously retracts the sheath proximally and pushes the pusher member distally to push the self-expanding stent distally and implant the self-expanding stent into the body lumen. More specifically, as the selector member pivots, the second end of the second ratchet member disengages from the inner ridge of the thumbwheel. At the same time, the second end of the first ratchet member remains in contact and engaged with the inner ridge of the thumbwheel, so that the thumbwheel can only ratchet and rotate in a forward direction. In this position, the second spring wire on the second ratchet member bends and flexes, creating a spring force on the second spring wire. When the selector tab is moved from the forward position to the locked position, the selector member pivots to allow the second end of the second ratchet member to engage the inner ridge of the thumbwheel, and at the same time, the spring force of the second spring wire is reduced so that the second spring wire generally straightens, spring biasing the second ratchet member to apply a continuous force to maintain the engagement of the second end of the second ratchet member with the inner ridge of the thumbwheel. The pusher spool, the sheath spool, and the thumbwheel always rotate in the same direction. As the thumbwheel rotates in the forward direction, the pusher spool rotates in the forward direction. The distal end of the pusher wire is attached to the pusher member, and as the pusher spool rotates in the forward direction, the pusher wire unwinds from the pusher spool and advances distally, advancing the pusher member distally, thus pushing the self-expanding stent distally. During assembly, the pusher wire is wound onto the pusher spool, and as the pusher spool rotates in a forward direction, the pusher wire is unwound. As the thumbwheel rotates in a forward direction, the sheath spool rotates in a forward direction. The distal end of the sheath wire is attached to the sheath member, and as the sheath spool rotates in the forward direction, the sheath wire is retracted proximally, pulling the sheath member proximally, thus deploying the self-expanding stent.During assembly, a portion of the sheath wire is wound on the sheath spool, and when the sheath spool is rotated in a forward direction, the sheath wire is wound onto the sheath spool. The selector member has a first cam and a second cam, and when the selector tab is moved to the forward position, the selector member pivots to cause the second cam to engage a second cam surface on the second ratchet member, which pivots to disengage from the thumbwheel. A second end of the first ratchet member engages inner ridges spaced apart along an inner peripheral surface of the thumbwheel. Engagement of the second end with the inner ridges of the thumbwheel allows the thumbwheel to rotate only in the forward direction.

[0008] To pull the self-expanding stent back into the sheath, the selector tab is moved to the reverse position, which pivots the selector member to engage the first cam with the first ratchet member, which pivots to disengage from the thumbwheel. The second end of the second ratchet member engages inner ridges spaced along the inner circumferential surface of the thumbwheel, allowing the thumbwheel to rotate only in the reverse direction. Rotation of the thumbwheel in the reverse direction rotates the sheath spool and the pusher spool in the reverse direction, which pushes the sheath wire distally to push the sheath distally on the stent and retracts the pusher member proximally to pull the self-expanding stent back into the sheath.

[0009] When the selector tab is in the locked position, the first and second cams of the selector member do not engage the first and second ratchet members, respectively, and the second end of the first and second ratchet members engage inner ridges spaced apart along the inner circumferential surface of the thumbwheel, thereby preventing rotation of the thumbwheel.

[0010] All of these embodiments are intended to be within the scope of the invention disclosed herein. These and other embodiments will become readily apparent to those skilled in the art from the following detailed description taken in conjunction with the accompanying drawings, and the invention is not limited to the specific disclosed embodiments. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a perspective view of a catheter assembly for delivering a self-expanding stent. [Diagram 2] FIG. 1 is an exploded view of a catheter assembly. [Diagram 3] FIG. 1 is an exploded view of a catheter assembly. [Figure 4A] FIG. 13 is a side perspective view showing a side of the thumbwheel. [Figure 4B] FIG. 13 is a side perspective view showing a side of the thumbwheel. [Figure 5A] FIG. 2 is a side perspective view showing a side surface of the first ratchet member and the second ratchet member. [Figure 5B] FIG. 2 is a side perspective view showing a side surface of the first ratchet member and the second ratchet member. [Figure 5C] FIG. 13 is a side perspective view of an alternative embodiment of a ratchet member. [Figure 6A] FIG. 4 is a side perspective view showing a side surface of the selector member. [Figure 6B] FIG. 4 is a side perspective view showing a side surface of the selector member. [Figure 7A] FIG. 2 is a side perspective view showing a side surface of the handle base. [Figure 7B] FIG. 2 is a side perspective view showing a side surface of the handle base. [Figure 8A] FIG. 2 is a side perspective view showing a side of the pusher storage cup. [Figure 8B] FIG. 2 is a side perspective view showing a side of the pusher storage cup. [Figure 9A] FIG. 4 is a side perspective view showing a side surface of the pusher spool. [Figure 9B] FIG. 4 is a side perspective view showing a side surface of the pusher spool. [Figure 10A] FIG. 2 is a side perspective view showing a side of the sheath storage cup. [Figure 10B] FIG. 2 is a side perspective view showing a side of the sheath storage cup. [Figure 11A] FIG. 2 is a side perspective view showing a side of the sheath spool. [Figure 11B] FIG. 2 is a side perspective view showing a side of the sheath spool. [Figure 12A] FIG. 4 is a side perspective view showing a side surface of the cover plate. [Figure 12B] FIG. 4 is a side perspective view showing a side surface of the cover plate. [Figure 13A] FIG. 2 is a side perspective view showing a side surface of the handle top. [Figure 13B] FIG. 2 is a side perspective view showing a side surface of the handle top. [Figure 14] FIG. 2 is a vertical cross-sectional view showing a handle top and a pusher storage cup. [Figure 15] FIG. 4 is a vertical cross-sectional view showing a handle base and a pusher spool. [Figure 16] FIG. 11 is a longitudinal section showing the thumbwheel together with the handle base and selector member in an exploded view for clarity; [Figure 17] FIG. 4 is a vertical cross-sectional view showing the handle base and the selector member set in the forward mode. [Figure 18] FIG. 4 is a vertical cross-sectional view showing the handle base and the selector member set in the reverse mode. [Figure 19] FIG. 11 is a vertical cross-sectional view showing the handle base and the selector member set in the locked mode. [Figure 20] FIG. 1 is a cross-sectional view taken through the centerline of the thumbwheel, showing the pusher spool and the sheath spool. [Figure 21] 9C is a side perspective view showing the pusher spool and a guide path for the pusher wire of FIGS. 9A and 9B. FIG. [Figure 22] FIG. 13 is a side perspective view showing a pusher spool installed in the handle base and a guide path for the pusher wire. [Diagram 23]FIG. 11C is a side perspective view showing the sheath spool and the guide path of the sheath wire of FIGS. 11A and 11B. [Figure 24] FIG. 13 is a side perspective view showing a sheath spool installed in the handle base and a guide path for the sheath wire. [Diagram 25] FIG. 13 is a longitudinal cross-sectional view of the handle base showing the sheath spool and the guide path of the sheath wire. [Figure 26] FIG. 2 is a vertical cross-sectional view of the handle base, showing the pusher spool and the guide path of the pusher wire. [Figure 27A] 1A-1C are enlarged elevational views of a stent in expanded and compressed configurations. [Figure 27B] FIG. 2 is an enlarged longitudinal cross-sectional view showing a stent placed within a sheath. [Figure 28] FIG. 11 is a vertical cross-sectional view showing the handle base and the selector member set in the locked mode. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] In certain embodiments, a system for delivering a self-expanding stent includes a self-expanding stent, a stent delivery catheter, and a handle. Self-expanding stents are well known in the art and have a radially contracted configuration and a radially expanded configuration. The stent has a proximal end, a distal end, and a length between the proximal and distal ends. The stent includes a plurality of openings along its length.

[0013] In one embodiment, as shown in Figures 1-27B, a catheter assembly 10 is used to deliver and implant a self-expanding stent 11 into a body lumen. A handle assembly 12 has a handle top 14, a handle base 16, a handle proximal end 18, and a handle distal end 20. The handle base 16 and the handle top 14 are connected to one another and house several components therebetween. A thumbwheel 22 is attached to the handle base 16 and a selector member 24 is pivotally mounted on a pivot pin 25 inside the thumbwheel 22. The thumbwheel has a splined hub 23 that extends through a hole 17 in the handle base 16, allowing the thumbwheel 22 to rotate on the splined hub 23. A selector tab 26 is attached to the selector member 24 for use in selecting a direction of rotation of the thumbwheel 22. A first ratchet member 28 and a second ratchet member 30 are pivotally mounted to the handle base via pivot pins 27, 29, respectively, and are disposed within the thumbwheel 22 such that the selector member 24 can be rotated into or out of engagement with either the first ratchet member 28 or the second ratchet member 30. The first ratchet member 28 (FIG. 5A) has a first end 58, a second end 57, a first cam surface 53, and a first spring wire 65. The second ratchet member 30 (FIG. 5B) has a first end 64, a second end 59, a second cam surface 55, and a second spring wire 66. In one embodiment, the first ratchet member 28 and the second ratchet member 30 are formed as a unitary molded structure of plastic or metal. An alternative ratchet member 63 (FIG. 5C) has a first end 67, a second end 68, a wire rod 69, and a cam surface 71. The wire rod 69 is inserted into and attached to the ratchet member 63 during assembly. The wire rod 69 functions as a spring wire, as described further herein. The sheath spool 32 has a sheath wire 34 wound on the outer surface 31A of the sheath spool, with a distal end 36 of the sheath wire 34 attached to the sheath 38. The proximal end of the sheath wire 34 is threaded into and fixedly attached to the wire channel 31B of the sheath spool.The sheath spool 32 has a splined recess 35 that meshingly engages the splined hub 23 when the sheath spool is placed adjacent to the thumbwheel 22. The pusher spool 40 has a pusher wire 42 wound about the outer surface 39A of the pusher spool and a distal end 44 of the pusher wire 42 attached to a pusher member 46. A proximal end of the pusher wire 42 is threaded into and fixedly attached to the wire channel 39B of the pusher spool. The pusher spool 40 has a splined recess 43 that meshingly engages the splined hub 23 when the pusher spool is placed adjacent to the thumbwheel 22.

[0014] As shown most clearly in FIGS. 17-27B, the self-expanding stent 11 is placed within the distal portion 48 of the sheath 38 and disposed distally of the pusher member 46. The self-expanding stent is tightly compressed within the sheath 38, and the microprojections 47 on the distal end of the pusher member 46 extend through the openings in the interwoven wire of the self-expanding stent 11. With the selector tab 26 moved to a forward position 51 on the handle assembly 12 (FIG. 17), the selector member 24 pivots into contact with the second ratchet member 30, which in turn pivots out of engagement with the thumbwheel 22 so that the thumbwheel can only rotate in the forward direction, which simultaneously retracts the sheath 38 proximally and pushes the pusher member 46 distally to push the self-expanding stent 11 distally out of the sheath 38, thereby implanting the self-expanding stent 11 into the body lumen. The forward rotation of the thumbwheel is best seen in FIG. 17, where the physician rotates the thumbwheel by pulling the top of the thumbwheel in the direction of the arrow toward the handle proximal end 18. Thus, by rotating the thumbwheel 22 in the forward direction, the self-expanding stent 11 is deployed within the body lumen. The pusher spool 40 and the sheath spool 32 rotate in the same direction as the thumbwheel. As the thumbwheel 22 rotates in the forward direction, the pusher spool 40 rotates in the forward direction, causing the pusher wire to unwind from the pusher spool and advance distally toward the self-expanding stent. The distal end 44 of the pusher wire 42 is attached to the pusher member 46, so that as the pusher spool 40 rotates in the forward direction, the pusher wire 42 unwinds from the pusher spool 40 and advances distally, advancing the pusher member 46 distally, thus pushing the self-expanding stent 11 distally out of the sheath 38. As thumbwheel 22 rotates in a forward direction, sheath spool 32 rotates in a forward direction, winding the sheath wire onto sheath spool 32 and pulling sheath 38 proximally away from the self-expanding stent.The distal end 36 of the sheath wire 34 is attached to the proximal end 49 of the sheath 38, so that as the sheath spool 32 rotates in a forward direction, the sheath wire 34 is retracted proximally pulling the sheath 38 proximally, thus deploying the self-expanding stent 11. As the self-expanding stent 11 exits the sheath 38, the openings in the woven wire strands simply expand away from the microprotrusions 47 of the pusher member 46 and the stent continues to expand radially outward until it is implanted within the body lumen.

[0015] In one embodiment shown in FIG. 27B, the pusher member 46 has a plurality of protrusions 47 configured to engage and hold the self-expanding stent 11. The self-expanding stent 11 has a plurality of apertures (FIG. 27A) that receive the protrusions 47 without damaging the self-expanding stent 11. The wire of the self-expanding stent 11 shown in FIG. 27B is not actually stretched as shown, but rather the plurality of apertures in the stent fit over the protrusions 47. Thus, FIG. 27 only illustrates the stent wire engaging the protrusions 47. When the self-expanding stent 11 is fully pushed distally out of the sheath 38, the stent self-expands and releases from the protrusions 47 to expand into contact with the body lumen.

[0016] 1-27B, and in particular FIG. 17, the selector member 24 has a first cam 54 and a second cam 56, and when the selector tab 26 is moved to the forward position 51 (FIG. 17), the selector member 24 pivots such that the second cam 56 engages the second ratchet member 30, which pivots to disengage from the thumbwheel 22. As the selector member 24 pivots, the second cam 56 slides along the curved second cam surface 55, which pivots the second ratchet member 30 to disengage the second end 59 from the inner ridge 60 of the thumbwheel 22. As can be seen in FIG. 17, the second cam 56 presses against and slides along the second cam surface 55, bending the second spring wire 66, which imparts a spring force to the bent second spring wire 66. When the selector tab is moved to the locked position (FIG. 19), the second spring wire 66 straightens, applying a spring force to the second ratchet member 28, forcing the second end 59 into engagement with the inner ridge 60 of the thumbwheel 22, where it maintains the spring force until the selector tab 26 is again moved to the forward position 51. With further reference to FIG. 17, the first ratchet member 28 remains engaged with the thumbwheel 22, and as the thumbwheel 22 rotates in the forward direction, the second end 57 of the first ratchet member 28 engages and ratchets along the inner ridge 60 of the thumbwheel. The first spring wire 65 straightens, applying a spring force to the first ratchet member 28, forcing the second end 57 into engagement with the inner ridge 60. As the thumbwheel 22 is rotated in the forward direction 51 to deploy the stent, the second end 57 of the first ratchet member 28 ratches and slides over each of the inner ridges 60 of the thumbwheel 22, providing tactile feedback to the physician. In an alternative embodiment, the thumbwheel 22 does not have inner ridges 60 along its inner circumferential surface 62. The inner circumferential surface 62 can be smooth (not shown), and a self-locking ratchet member (not shown) can engage and disengage the inner circumferential surface 62 to rotate the thumbwheel 22 in the forward or reverse direction, or to lock the thumbwheel 22.

[0017] To pull the self-expanding stent back into the sheath 38, the selector tab 26 is moved to the reverse position 50 (FIG. 18), which causes the selector member 24 to pivot so that the first cam 54 engages the first ratchet member 28 and the first ratchet member 28 pivots to disengage from the thumbwheel 22. Because the second end 57 of the first ratchet member 28 disengages from the inner ridge 60 of the thumbwheel 22, the thumbwheel 22 can only rotate in the reverse direction.

[0018] When the selector tab 26 is in the locked position 52 (FIG. 19), the first cam 54 and the second cam 56 of the selector member 24 do not engage the first ratchet member 28 and the second ratchet member 30, respectively, so that the second end 57 of the first ratchet member 28 and the second end 59 of the second ratchet member 30 engage the inner ridge 60, respectively, thereby preventing rotation of the thumbwheel 22. In the locked position 52, the first spring wire 65 on the first ratchet member 28 and the second spring wire 66 on the second ratchet member 30, respectively, are substantially straight, providing a spring force that urges the second ends 57 and 59 into engagement with the inner ridge 60, thereby preventing rotation of the thumbwheel 22.

[0019] The sheath spool 32 is closely seated in a sheath spool storage cup 70 (FIGS. 10A / 10B) to maintain the sheath wire 34 on the sheath spool 32. The sheath storage cup 70 has an optional flange 75 that helps keep the sheath wire 34 wound around the outer surface 31A of the sheath spool. The pusher spool 40 is closely seated in a pusher spool storage cup 72 (FIGS. 8A / 8B) to maintain the pusher wire 42 on the pusher spool 40. The pusher spool storage cup 72 has an optional flange 73 that helps keep the pusher wire 42 wound around the outer surface 39A of the pusher spool. A retainer plate 74 is attached to the sheath storage cup 70 and helps retain the sheath spool 32 within the storage cup. Additionally, sheath spool 32 and pusher spool 40 each have optional flanges (not shown) that help maintain sheath wire 34 and pusher wire 42 on their respective spools as the wires are wound and unwound.

[0020] 28, the selector member 24 is in the locked position 52 and the first cam 54 and second cam 56 of the selector member 24 are not engaged with the first ratchet member 28 and second ratchet member 30, respectively, so that the second end 57 of the first ratchet member 28 and the second end 59 of the second ratchet member 30 engage the inner ridge 60, respectively, thereby preventing rotation of the thumbwheel 22. In this embodiment, a coil spring 100 is attached to a first hook 102 on the end of the first ratchet member 28 and a second hook 104 on the end of the second ratchet member 30. The coil spring 100 is always under tension and the tension can change in response to pivoting of the selector member 24. In the locked position 52, the coil spring 100 provides tension, drawing the first hook 102 and the second hook 104 toward one another while simultaneously engaging both the first end 57 and the second end 59 with the inner ridge 60 of the thumbwheel 22. When the selector tab 26 is moved to the forward position 51 (similar to the position shown in FIG. 17 ), the selector member 24 pivots to engage the second cam 56 with the second cam surface 55, which in turn pivots the second ratchet member 30 to disengage the second end 59 from the inner ridge 60 of the thumbwheel 22. The thumbwheel 22 is free to rotate in the forward direction while simultaneously retracting the sheath 38 proximally and pushing the pusher member 46 distally, thereby pushing the self-expanding stent 11 distally from the sheath 38. As the second ratchet member 30 pivots, the distance between the first hook 102 and the second hook 104 increases, stretching the coil spring 100 attached to the second hook 104. As the coil spring 100 stretches, the tension on the coil spring 100 also increases, which increases the contact force exerted by the second end 57 as it contacts the inner ridge 60 of the thumbwheel 22. This provides a positive tactile sensation when the physician rotates the thumbwheel in a forward direction to deploy the self-expanding stent 11.

[0021] 28, when the selector tab 26 is moved to the reverse position 50 (similar to the position shown in FIG. 18), the selector member 24 pivots and the first cam 54 engages the first cam surface 53, which causes the first ratchet member 28 to pivot and disengage the second end 57 from the inner ridge 60 of the thumbwheel 22. As the thumbwheel 22 rotates in the reverse direction, the sheath 38 is moved distally and the pusher member 46 is moved proximally, retracting the self-expanding stent 11 into the sheath 38. The coil spring 100 again expands and exerts an increased force on the second end 59 in contact with the inner ridge 60.

[0022] In any of the embodiments disclosed herein, the sheath spool 32 and the pusher spool 40 can have equal or different diameters. For example, as shown in FIGS. 21-24, the pusher spool 40 has a first pusher spool diameter 41 that is larger than the first sheath spool diameter 33 of the sheath spool 32. In one embodiment, the first sheath spool diameter remains constant for a family of stents of different sizes, but the first pusher spool diameter 41 varies with the diameter of the stent, i.e., the larger the diameter of the stent, the larger the first pusher spool diameter 41. For example, a self-expanding stent 11 having a larger diameter is matched with a larger first pusher spool diameter 41, and thus the pusher spool 40 can provide a larger displacement of the pusher wire 42 and thus push a larger diameter stent distally out of the sheath 38 over the pusher member 46. In one embodiment, first sheath spool diameter 33 is 0.79 inches (20.0 mm) and first pusher spool diameter 41 is 1.26 inches (32.0 mm). In another embodiment, first sheath spool diameter 33 is within the range of 0.39 inches (10.0 mm) to 1.89 inches (48.0 mm) and first pusher spool diameter 41 is within the range of 0.39 inches (10.0 mm) to 1.89 inches (48.0 mm). These sheath and pusher spool diameters allow stents of various lengths and diameters to be delivered and implanted.

[0023] In one embodiment, the self-expanding stent 11 has an implanted inner stent diameter 80 in the range of 0.12 inches (3.0 mm) to 0.39 inches (10.0 mm) and an implanted stent length 82 in the range of 1.18 inches (30.0 mm) to 7.87 inches (200.0 mm). These dimensions represent the implanted diameter 80 and the stent length 82. A self-expanding stent 11 having an implanted length 82 of 3.94 inches (100.00 mm) and an implanted diameter 80 of 0.28 inches (7.0 mm) may have a compressed length 86 of 7.87 inches (200.0 mm) to 11.81 inches (300.0 mm) when placed within the sheath 38, and a compressed diameter 84 in the range of 0.060 inches (1.5 mm) to 0.24 inches (6.0 mm). As the self-expanding stent 11 expands from its compressed configuration within the sheath 38, it shortens in length as disclosed above. Similarly, as the self-expanding stent 11 is pushed out of the sheath 38, it expands from its compressed configuration to its implantation diameter as disclosed above. This has the effect of deploying a constant stent length for every constant angular rotation of the thumbwheel 22.

[0024] 1-27B, and particularly FIGS. 27A / 27B, the ratio of the length of the self-expanding stent 11 in a compressed configuration having a compressed length 86 to the expanded implanted length 82 is in the range of 1.5:1 to 4:1. By way of example, a self-expanding stent 11 having a compressed length 86 of 11.81 inches (300 mm) and an implanted length 82 of 3.94 inches (100 mm) has a ratio of 3:1. In this example, for a self-expanding stent 11 having a length of 3.94 inches (100 mm), simultaneously, the sheath 38 is retracted proximally 3.94 inches (100 mm) and the pusher member 46 is advanced distally 7.87 inches (200 mm) to push the self-expanding stent 11 distally out of the proximally moving sheath 38. Thus, the combined 3.94 inches (100 mm) of proximal movement of the sheath 38 and 7.87 inches (200 mm) of distal movement of the pusher member 46 results in a total stent movement of 11.81 inches (300 mm), a 3:1 ratio compared to the implantation length 32 of 3.94 inches (100 mm). Since the self-expanding stent 11 immediately self-expands and contacts the vessel wall upon exiting the sheath 38, it is critical that the pusher member 46 simultaneously moves distally to push the self-expanding stent 11 out of the sheath 38, which moves proximally. This procedure ensures that the self-expanding stent 11 is implanted in the exact portion of the vessel selected by the physician.

[0025] In one embodiment, as shown in Figures 24-27B, the stabilizer 90 has a stabilizer lumen 92 for slidingly receiving the sheath 38. The stabilizer 90 is fixedly attached to the distal end 20 of the handle. The stabilizer lumen 92 is sized to slidingly receive the sheath 38 such that the sheath 38 can slide easily within the stabilizer lumen 92 without twisting and is supported through some movement of the sheath 38, up to about 3.94 inches (100 mm). The stabilizer 90 provides support for the sheath 38 and the stabilizer lumen 92 provides a tunnel or lumen for the guidewire lumen 78, the sheath wire 34, and the pusher wire 42 such that the wires are not exposed to the body lumen or the guide catheter (not shown) or introducer (not shown). Depending on the length of the self-expanding stent 11 being implanted, the stabilizer 90 can be the same length as the sheath 38, or can be significantly longer, up to 130 cm. For example, if a 3.94 inch (100 mm) long self-expanding stent 11 is to be placed within the sheath 38, then the sheath 38 must be at least 3.94 inches (100 mm) long, and the stabilizer 90 can be at least this length, up to a maximum of 130 cm.

[0026] How to use The method of use includes a system for delivering a self-expanding stent to a body lumen, such as a peripheral artery, and implanting a self-expanding stent in an artery. The catheter assembly operates in three different modes: a forward position 51 (FIG. 17) for deploying a stent, a reverse position 50 (FIG. 18) for retrieving a stent, and a locked position 52 (FIG. 19) in which the thumbwheel 22 cannot rotate.

[0027] 1-27B, and in particular FIG. 17, the catheter assembly 10 is used to deliver and implant a self-expanding stent 11 into a body lumen. With the selector tab 26 moved to a forward position 51 on the handle assembly 12, the selector member 24 pivots into contact with the second ratchet member 30, which in turn pivots out of engagement with the thumbwheel 22 so that the thumbwheel can only rotate in a forward direction, which simultaneously retracts the sheath 38 proximally and pushes the pusher member 46 proximally to push the self-expanding stent 11 distally out of the sheath 38, thereby implanting the self-expanding stent 11 into the body lumen. Thus, when the physician uses his or her thumb to rotate thumbwheel 22 in a forward direction (the top of the thumbwheel rotates from the distal end of the handle toward the proximal end of the handle), pusher spool 40 rotates in a forward direction, pushing pusher wire 42 distally and pushing stent 11 distally out of sheath 38. At the same time, sheath spool 32 rotates in a forward direction, causing sheath wire 39 to pull sheath 38 proximally. As thumbwheel 22 rotates in a forward direction, pusher spool 40 rotates in a forward direction, causing pusher wire 42 to unwind from pusher spool 40 and advance distally toward the self-expanding stent. The distal end 44 of the pusher wire 42 is attached to the pusher member 46 such that as the pusher spool 40 rotates in a forward direction, the pusher wire 42 advances distally to advance the pusher member 46 distally, thus pushing the self-expanding stent 11 distally from the sheath 38. As the thumbwheel 22 rotates in a forward direction, the sheath spool 32 rotates in a forward direction, causing the sheath wire to wind onto the sheath spool 32 and pull the sheath 38 proximally away from the self-expanding stent. The distal end 36 of the sheath wire 34 is attached to the proximal end 49 of the sheath 38 such that as the sheath spool 32 rotates in a forward direction, the sheath wire 34 is retracted proximally to pull the sheath 38 proximally, thus deploying the self-expanding stent 11.As the self-expanding stent 11 exits the sheath 38, the openings in the woven wire strands expand radially away from the microprotrusions 47 of the pusher member 46 and the stent continues to expand radially outward until it is implanted within the body lumen.

[0028] 1-27B and the method of use as shown in FIG. 17, the selector member 24 is used to determine whether to rotate the thumbwheel in a forward direction to deploy the stent, rotate the thumbwheel in a reverse direction to retract the stent into the sheath, or lock the thumbwheel from rotating. The selector member 24 has a first cam 54 and a second cam 56, and when the selector tab 26 is moved to the forward position 51 (FIG. 17), the selector member 24 pivots so that the second cam 56 contacts the second ratchet member 30, which pivots to disengage from the thumbwheel 22. A second end 59 of the second ratchet member 30 disengages from an inner ridge 60 spaced along an inner circumferential surface 62 of the thumbwheel 22. The second end 57 of the first ratchet member 28 engages the inner ridge 60 of the thumbwheel 22, thereby allowing the thumbwheel to rotate only in a forward direction.

[0029] As the selector member 24 pivots, the second cam 56 slides along the curved second cam surface 55 and the second ratchet member 30 pivots to disengage the second end 59 from the inner ridge 60 of the thumbwheel 22. As can be seen in FIG. 17, the second cam 56 presses against and slides along the second cam surface 55, bending the second spring wire 66, which imparts a spring force to the bent second spring wire 66. When the selector tab is moved to the locked position (FIG. 19), the second spring wire 66 generally straightens, imparting a spring force to the second ratchet member to push its second end into engagement with the inner ridge 60 of the thumbwheel 22 and maintain the spring force until the selector tab 26 is again moved to the forward position 51. 17, the first ratchet member 28 remains engaged with the thumbwheel 22, and as the thumbwheel 22 rotates in a forward direction, the second end 57 of the first ratchet member 28 engages and ratchets along the inner ridges 60 of the thumbwheel. The first spring wire 65 generally straightens, exerting a spring force on the first ratchet member 28, causing the second end 57 to engage the inner ridges 60. As the thumbwheel 22 is rotated in the forward direction 51 to deploy the stent, the physician receives tactile feedback as the second end 57 of the first ratchet member 28 ratches and slides over each of the inner ridges 60 of the thumbwheel 22.

[0030] To pull the self-expanding stent 11 back into the sheath 38, the selector tab 26 is moved to the reverse position 50 (FIG. 18), which pivots the selector member 24 so that the first cam 54 contacts the first ratchet member 28, which pivots to disengage from the thumbwheel 22. The second end 57 of the first ratchet member 28 disengages from the inner ridge 60 of the thumbwheel 22. The second end 59 of the second ratchet member 30 engages the inner ridge 60 of the thumbwheel 22, allowing the thumbwheel to rotate only in the reverse direction. As shown in FIG. 18, as the thumbwheel 22 rotates in the reverse direction (in the direction of the arrow), the sheath spool 32 and the pusher spool 40 also rotate in the reverse direction. The first cam 54 on the selector member 24 presses against and slides along the first cam surface 53 on the first ratchet member 28, causing the first ratchet member 28 to pivot and disengage the second end 57 from the inner ridge 60. At the same time, as the first cam 54 presses against and slides along the first cam surface 53, the first spring wire 65 bends and creates a spring force on the first spring wire 65. The second end 59 of the second ratchet member 30 remains engaged with the inner ridge 60, and the substantially straightened second spring wire 66 uses its remaining spring force to apply a continuing force on the second end 59. As the physician rotates the thumbwheel 22 in a reverse direction, the sheath spool 32 rotates in a reverse direction and unwinds the sheath wire 34 from the sheath spool 32, which advances the sheath wire 34 distally and pushes the sheath 38 distally to retrieve the self-expanding stent. The pusher spool 40 also rotates in a reverse direction and winds the pusher wire 42 onto the pusher spool 40, which retracts the pusher wire 42 proximally and pulls the pusher member 46 proximally. The self-expanding stent is removably attached to the pusher member 46 such that the self-expanding stent is pulled proximally back into the sheath 38. Retrieval of the self-expanding stent 11 occurs until the stent begins to disengage from the projections 47 on the pusher member 46, which may be up to 90% of the deployment length.In other words, in order for the self-expanding stent 11 to be pulled back into the sheath, the stent must still be engaged with the projections 47 .

[0031] When the selector tab 26 is in the locked position 52 (FIG. 19), the first cam 54 and the second cam 56 of the selector member 24 do not contact the first ratchet member 28 and the second ratchet member 30, respectively, so that the second end 57 of the first ratchet member 28 and the second end 59 of the second ratchet member 30 engage the inner ridge 60, respectively, thereby preventing rotation of the thumbwheel 22. In FIG. 19, the first spring wire 65 and the second spring wire 66 are substantially straight, providing a continuous spring force to the first and second ratchet members 28, 30, respectively, to keep the second ends 57, 59 firmly engaged with the inner ridges, so that the thumbwheel 22 remains in the locked position 52.

[0032] When deploying and implanting the self-expanding stent 11 disclosed herein, it is important to note that in a compressed configuration disposed within a sheath 38, the self-expanding stent 11 is significantly longer than when expanded and implanted within a body lumen due to the woven wire design. Thus, when deploying and implanting the self-expanding stent 11 as shown in Figures 1-27B, and particularly Figures 27A / 27B, the ratio of the length of the self-expanding stent 11 in a compressed configuration having a compressed length 86 to the expanded implanted length 82 is in the range of 1.5:1 to 4:1. By way of example, a self-expanding stent 11 having a compressed length 86 of 11.81 inches (300 mm) and an implanted length 82 of 3.94 inches (100 mm) has a ratio of 3:1. In this example, for a 3.94 inch (100 mm) long self-expanding stent 11, simultaneously, the sheath 38 is retracted proximally 3.94 inches (100 mm) and the pusher member 46 is advanced distally 7.87 inches (200 mm), pushing the self-expanding stent 11 distally out of the proximally moving sheath 38. Thus, the combined 3.94 inches (100 mm) of proximal movement of the sheath 38 and the 7.87 inches (200 mm) of distal movement of the pusher member 46 results in a total movement of 11.81 inches (300 mm), a 3:1 ratio compared to the implantation length 82 of 3.94 inches (100 mm). Since the self-expanding stent 11 immediately self-expands and contacts the vessel wall upon exiting the sheath 38, it is crucial that the pusher member 46 moves distally to push the self-expanding stent 11 out of the sheath 38 and the sheath 38 moves proximally at the same time. This procedure ensures that the self-expanding stent 11 is implanted in the exact portion of the vessel selected by the physician. Additionally, a crucial feature of the disclosed embodiments is that the physician can use the handle assembly 12 with only one hand and that the handle assembly 12 can remain stationary relative to the patient during delivery and placement of the self-expanding stent 11. In some circumstances, it may be desirable for the physician to move the handle assembly 12 distally or proximally during delivery to shorten or lengthen the delivered stent.A stationary handle assembly 12 during delivery results in a nominal length of deployed self-expanding stent 11. Moving the handle assembly 12 distally during deployment shortens the deployed length of the self-expanding stent, and moving the handle assembly 12 proximally during deployment lengthens the deployed length of the self-expanding stent.

[0033] All of these embodiments are intended to be within the scope of the invention disclosed herein. These and other embodiments will become readily apparent to those of ordinary skill in the art from the following detailed description taken in conjunction with the accompanying drawings, and the invention is not limited to the specific embodiments disclosed.

[0034] Although certain delivery systems are described herein in relation to self-expanding stents, the delivery systems described herein can be used to deliver self-expanding or balloon-expandable stents having any configuration (e.g., woven, laser cut, or non-plain woven) constructed from any material (e.g., metal or polymer). For example, in some embodiments, the stent can include multiple biodegradable filaments (e.g., made from polyglycolic acid, poly-L-lactic acid, polyorthoesters, polyanhydrides, polyiminopolyiminocarbonates, or calcium phosphates) woven together to form a self-expanding stent. In some embodiments, the stent can be coated with a drug or the drug can be incorporated into the strands.

[0035] The relative terms "proximal" and "distal" as used herein shall be defined from the perspective of the delivery system, whereby proximal refers to the direction of the handle portion of the delivery system and distal refers to the direction of the distal tip.

[0036] Although specific embodiments and examples are described herein, those skilled in the art will appreciate that many aspects of the delivery system shown and described in this disclosure can be variously combined and / or modified to form further embodiments or acceptable examples. All such modifications and variations are intended to be within the scope of the present disclosure. Numerous designs and approaches are possible. No feature, structure, or step disclosed herein is essential or critical.

[0037] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not all such advantages are necessarily achieved in accordance with a particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure can be embodied or carried out in a manner that achieves one advantage or group of advantages taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0038] Furthermore, while exemplary embodiments are described herein, the scope of any and all embodiments includes equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations, and / or alterations that would be understood by one of ordinary skill in the art based on the present disclosure. Any limitations in the claims should be interpreted broadly based on the language employed in the claims, and not limited to the examples described herein or pending prosecution of the application, which examples should be interpreted as non-exclusive. Furthermore, the actions of the disclosed processes and methods may be modified in any manner, including changing the order of actions and / or inserting additional actions and / or deleting actions. Accordingly, it is intended that the specification and examples be considered merely as illustrative, with the true scope and spirit being indicated by the full scope of the claims and their equivalents.

[0039] In particular, conditional language used herein, such as "may," "potential," "could," "for example," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to generally convey that certain features, elements, and / or conditions are included in some embodiments and not in other embodiments. Thus, such conditional language is not intended to generally imply that features, elements, blocks, and / or conditions are more or less required in one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or conditions are included in or performed in a particular embodiment, with or without author input or prompting.

[0040] Although the methods disclosed herein may include specific actions taken by a practitioner, the methods may also include, explicitly or implicitly, third-party instruction of those actions. For example, an action such as "advance a self-expanding stent" includes "instructing to advance the self-expanding stent."

[0041] Ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Words such as "up to," "at least," "greater than," "less than," "between," and the like, are inclusive of the recited numbers. Numbers preceded by terms such as "about" or "approximately" are inclusive of the recited numbers and should be interpreted in the context (e.g., as precisely as reasonably possible under the circumstances, e.g., ±1%, ±5%, ±10%, ±15%, etc.). For example, "about 0.01 inch" includes "0.01 inch." Words preceded by terms such as "substantially" are inclusive of the recited numbers and should be interpreted in the context (e.g., as little or as much as reasonably possible under the circumstances). For example, "substantially linear" includes "linear."

[0042] In some embodiments, the method includes delivering a stent into an anatomical structure, and when the device used to accomplish the method is at a desired location within the patient to begin advancing the stent, thumbwheel movement (e.g., ratcheting movement) can begin such that the distal end of the stent (which may also be marked with one or more radiopaque markers to more easily identify its location during the procedure) emerges from the sheath of the device, but does not extend far enough to contact the anatomical structure. For example, during deployment, the last 10 mm of the stent can be deployed, and the stent can also be retrieved and retracted into the sheath. When the distal end of the stent is proximal to the operator's desired location, the stent can be pulled proximally to retract the stent back into the sheath and the device can be repositioned, and when the stent is distal to the operator's desired location, the entire device can be retracted proximally and the deployment process can continue.

[0043] The features of the devices described herein can be made from commercially available medical grade materials. The sheath 38 can include braided polyether block amide (including, for example, braided Pebax® resin). The handle top 14 and handle base 16 can include acrylonitrile butadiene styrene (ABS) plastic, polycarbonate, Delrin® acetal resin (available from DuPont®), and the like. The catheter shaft 12 can include polyimide (or a series of shafts constructed from polyimide, or constructed from hypotubes including nickel titanium alloy). Additionally, steps can be taken to reduce friction between parts that contact or may contact each other during use of the devices of the present invention, such as contact between a stent and a sheath.

[0044] The devices described herein can be used to deliver self-expanding woven stents, including woven stents from multiple strands such as wires. Some examples of weaving techniques that can be used include those described in U.S. Patent Nos. 6,792,979 and 7,048,014, each of which is incorporated herein by reference in its entirety. The strands of the woven stent can be terminated with the ends of the strands (e.g., the ends of the wires) bundled together using small segments of material such as Nitinol hypotubes when the strands of the stent are wires made from Nitinol. The stent can be passivated through any suitable technique to remove oxide layers from the surface of the stent that may form during heat treatment and annealing, thus improving the surface finish and corrosion resistance of the stent material.

[0045] Although the present invention has been disclosed in connection with certain embodiments and examples, those skilled in the art will understand that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention, as well as obvious modifications and equivalents thereof. Moreover, while several variations of the embodiments of the present invention have been shown and described in detail, other modifications that are within the scope of the present invention will be readily apparent to those skilled in the art based on this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present invention. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another to make various modes of embodiment of the disclosed invention. It is therefore intended that the scope of the invention disclosed herein should not be limited by the specific embodiments described above.

Claims

1. 1. A handle assembly for delivering and implanting a self-expanding stent into a body lumen, comprising: a handle having a thumbwheel and a selector tab for selecting rotation of the thumbwheel; a selector member pivotally mounted within said thumbwheel and attached to said selector tab; a first ratchet member and a second ratchet member pivotally mounted within the thumbwheel such that the selector member can be rotated to engage either the first ratchet member or the second ratchet member, or neither; a sheath spool mounted on the handle, the sheath spool having a sheath wire wound thereon, the distal end of the sheath wire being attached to a sheath; a pusher spool disposed in the handle, the pusher spool having a pusher wire wound thereon, the pusher wire having a distal end attached to a pusher member; a self-expanding stent disposed within a distal portion of the sheath and disposed distally of the pusher member; A handle assembly comprising: a handle assembly in which, with the selector tab moved to a forward position on the handle, the selector member pivots to contact the second ratchet member, which then pivots to disengage from the thumbwheel so that the thumbwheel can only rotate in a forward direction, simultaneously retracting the sheath proximally and pushing the pusher member distally to push the self-expanding stent distally and implanting the self-expanding stent into the body lumen.

2. The handle assembly of claim 1 , wherein the pusher spool and the sheath spool are configured to rotate in the same direction as the thumbwheel.

3. The handle assembly of claim 2 , wherein when said thumbwheel rotates in said forward direction with said selector tab disposed in said forward position, said pusher spool rotates in said forward direction.

4. The handle assembly of claim 3, wherein a distal end of the pusher wire is attached to the pusher member, and when the pusher spool rotates in the forward direction, the pusher wire advances distally to advance the pusher member distally, thus pushing the self-expanding stent distally.

5. The handle assembly of claim 4 , wherein the pusher wire is wound onto the pusher spool during assembly, and when the pusher spool is rotated in the forward direction, the pusher wire is unwound from the pusher spool.

6. The handle assembly of claim 2 , wherein when the selector tab is disposed in the forward position, the sheath spool rotates in the forward direction when the thumbwheel rotates in the forward direction.

7. 7. The handle assembly of claim 6, wherein a distal end of the sheath wire is attached to the sheath member, and when the sheath spool rotates in the forward direction, the sheath wire is retracted proximally to pull the sheath member proximally, thus deploying the self-expanding stent.

8. The handle assembly of claim 7 , wherein the sheath wire is wound onto the sheath spool during assembly, and when the sheath spool is rotated in the forward direction, the sheath wire is wound onto the sheath spool.

9. The handle assembly of claim 1 , wherein the selector member includes a first cam and a second cam.

10. 10. The handle assembly of claim 9, wherein with the selector tab moved to the forward position, the selector member pivots so that the second cam contacts a second cam surface on the second ratchet member and the second ratchet member pivots out of engagement with the thumb wheel.

11. The handle assembly of claim 10 , wherein a second end of the second ratchet member disengages from inner ridges spaced along an inner circumferential surface of the thumbwheel.

12. 12. The handle assembly of claim 11, wherein the second end is disengaged from an inner ridge of the thumbwheel such that the thumbwheel can only rotate in the forward direction.

13. 10. The handle assembly of claim 9, wherein with the selector tab moved to the reverse position, the selector member pivots so that the first cam contacts a first cam surface on the first ratchet member and the first ratchet member pivots out of engagement with the thumb wheel.

14. The handle assembly of claim 13, wherein the second end of the first ratchet member disengages from inner ridges spaced along an inner circumferential surface of the thumbwheel.

15. 15. The handle assembly of claim 14, wherein the second end is disengaged from an inner ridge of the thumbwheel such that the thumbwheel can only rotate in the reverse direction.

16. 10. The handle assembly of claim 9, wherein with the selector tab in the locked position, the first and second cams of the selector member do not contact the first and second ratchet members, respectively, and the second ends of the first and second ratchet members engage inner ridges spaced along an inner circumferential surface of the thumbwheel, thereby preventing rotation of the thumbwheel.

17. The handle assembly of claim 1 , wherein the sheath spool is mounted in a sheath receiving cup.

18. The handle assembly of claim 17, wherein the sheath receiving cup has a flange that helps retain the sheath wire on the sheath spool.

19. The handle assembly of claim 1 , wherein the pusher spool is mounted in a pusher receiving cup.

20. The handle assembly of claim 19, wherein the pusher receiving cup has a flange that helps retain the pusher wire on the pusher spool.

21. The handle assembly of claim 1 , wherein the sheath spool has a first sheath spool diameter and the pusher spool has a first pusher spool diameter.

22. The handle assembly of claim 21, wherein the first pusher spool diameter is either greater than, less than, or equal to the first sheath spool diameter.

23. 23. The handle assembly of claim 22, wherein the first pusher spool diameter is within a range of 0.39 inches to 2.0 inches and the first sheath spool diameter is within a range of 0.39 inches to 2.0 inches.

24. The handle assembly of claim 1 , wherein a stabilizer is fixedly attached to a distal end of the handle.

25. The handle assembly of claim 24, wherein the stabilizer has a stabilizer lumen dimensioned to slidingly receive the sheath.

26. 1. A handle assembly for delivering and implanting a self-expanding stent into a body lumen, comprising: a handle having a handle top and a handle base and a thumb wheel attached to the handle base; a selector member pivotally mounted within said thumbwheel and attached to a selector tab; a first ratchet member and a second ratchet member pivotally mounted within the thumbwheel such that the selector member can be rotated to engage either the first ratchet member or the second ratchet member, or neither; a sheath spool mounted on the handle, the sheath spool having a sheath wire wound thereon, the distal end of the sheath wire being attached to a sheath; a pusher spool disposed in the handle, the pusher spool having a pusher wire wound thereon, the pusher wire having a distal end attached to a pusher member; a self-expanding stent disposed within a distal portion of the sheath and disposed distally of the pusher member; A handle assembly comprising: With the selector tab moved to a forward position on the handle, the selector member pivots to contact the second ratchet member, which then pivots to disengage from the thumbwheel so that the thumbwheel can only rotate in a forward direction, thereby simultaneously retracting the sheath proximally and pushing the pusher member distally to push the self-expanding stent distally and implanting the self-expanding stent into a body lumen, said handle assembly.

27. 27. The handle assembly of claim 26, wherein the thumbwheel, the pusher spool, and the sheath spool are all mounted on a splined hub and configured to rotate in the same direction.

28. 28. The handle assembly of claim 27, wherein with the selector tab disposed in the forward position, when the thumbwheel rotates in the forward direction, the pusher spool rotates in the forward direction.

29. 29. The handle assembly of claim 28, wherein a distal end of the pusher wire is attached to the pusher member, and when the pusher spool rotates in the forward direction, the pusher wire advances distally to advance the pusher member distally, thus pushing the self-expanding stent distally.

30. 30. The handle assembly of claim 29, wherein the pusher wire is wound onto the pusher spool during assembly, and wherein the pusher wire is unwound from the pusher spool as the pusher spool rotates in the forward direction.

31. 28. The handle assembly of claim 27, wherein with the selector tab disposed in the forward position, when the thumbwheel rotates in the forward direction, the sheath spool rotates in the forward direction.

32. 32. The handle assembly of claim 31, wherein a distal end of the sheath wire is attached to the sheath member, and when the sheath spool rotates in the forward direction, the sheath wire is retracted proximally to pull the sheath member proximally, thus deploying the self-expanding stent.

33. 33. The handle assembly of claim 32, wherein the sheath wire is wound onto the sheath spool during assembly, and when the sheath spool is rotated in the forward direction, the sheath wire is wound onto the sheath spool.

34. The handle assembly of claim 26, wherein the selector member includes a first cam and a second cam.

35. 35. The handle assembly of claim 34, wherein with the selector tab moved to the forward position, the selector member pivots so that the second cam contacts a second cam surface on the second ratchet member and the second ratchet member pivots out of engagement with the thumb wheel.

36. 36. The handle assembly of claim 35, wherein a second end of the second ratchet member disengages from inner ridges spaced along an inner circumferential surface of the thumbwheel.

37. 37. The handle assembly of claim 36, wherein the second end is disengaged from an inner ridge of the thumbwheel such that the thumbwheel can only rotate in the forward direction.

38. 35. The handle assembly of claim 34, wherein with the selector tab moved to the reverse position, the selector member pivots so that the first cam contacts a first cam surface on the first ratchet member and the first ratchet member pivots out of engagement with the thumb wheel.

39. 39. The handle assembly of claim 38, wherein a second end of the first ratchet member disengages from inner ridges spaced along an inner circumferential surface of the thumbwheel.

40. 40. The handle assembly of claim 39, wherein the second end is disengaged from an inner ridge of the thumbwheel such that the thumbwheel can only rotate in the reverse direction.

41. 35. The handle assembly of claim 34, wherein with the selector tab in the locked position, the first and second cams of the selector member do not contact the first and second ratchet members, respectively, and the second ends of the first and second ratchet members engage inner ridges spaced along an inner circumferential surface of the thumbwheel, thereby preventing rotation of the thumbwheel.

42. The handle assembly of claim 26, wherein the sheath spool is mounted in a sheath receiving cup.

43. The handle assembly of claim 42, wherein the sheath receiving cup has a flange that assists in retaining the sheath wire on the sheath spool.

44. The handle assembly of claim 26, wherein the pusher spool is mounted to a pusher receiving cup.

45. 45. The handle assembly of claim 44, wherein the pusher receiving cup has a flange that helps retain the pusher wire on the pusher spool.

46. 27. The handle assembly of claim 26, wherein the sheath spool has a first sheath spool diameter and the pusher spool has a first pusher spool diameter.

47. 47. The handle assembly of claim 46, wherein the first pusher spool diameter is either greater than, less than, or equal to the first sheath spool diameter.

48. 48. The handle assembly of claim 47, wherein the first pusher spool diameter is within the range of 0.39 inches to 2.00 inches and the first sheath spool diameter is within the range of 0.39 inches to 2.00 inches.

49. The handle assembly of claim 26, wherein a stabilizer is fixedly attached to a distal end of the handle.

50. 50. The handle assembly of claim 49, wherein the stabilizer has a stabilizer lumen dimensioned to slidingly receive the sheath.

51. 1. A method for delivering and implanting a self-expanding stent into a body lumen, comprising: providing a handle assembly having a handle, a thumbwheel, and a selector tab for selecting rotation of the thumbwheel; pivotally mounting a selector member within said thumbwheel and attaching said selector tab to said selector member; pivotally mounting the first and second ratchet members within the thumbwheel such that rotation of the selector member can actuate either the first or second ratchet members or neither of the first or second ratchet members; placing a sheath spool on a splined hub of the handle, winding a sheath wire on the sheath spool, and attaching a distal end of the sheath wire to a sheath; installing a pusher spool on a splined hub of the handle, winding a pusher wire around the pusher spool, and attaching a distal end of the pusher wire to a pusher member; placing a self-expanding stent within the sheath and disposing the self-expanding stent distal to the pusher member; A method comprising: moving the selector tab to a forward position on the handle causes the selector member to pivot into contact with the second ratchet member which then pivots out of engagement with the thumbwheel so that the thumbwheel can only rotate in a forward direction; rotating the thumbwheel in a forward direction, which simultaneously retracts the sheath proximally and pushes the pusher member distally to push the self-expanding stent distally out of the sheath and implant the self-expanding stent into the body lumen.

52. 52. The method of claim 51, wherein the thumbwheel, the pusher spool, and the sheath spool rotate in the same direction.

53. 53. The method of claim 52, wherein when the thumbwheel rotates in a forward direction with the selector tab pressed to the forward position, the pusher spool rotates in the forward direction.

54. 54. The method of claim 53, wherein a distal end of the pusher wire is attached to the pusher member such that when the pusher spool rotates in the forward direction, the pusher wire advances distally to advance the pusher member distally, thus pushing the self-expanding stent distally.

55. 55. The method of claim 54, wherein the pusher wire is wound onto the pusher spool during assembly, and when the pusher spool rotates in the forward direction, the pusher wire unwinds from the pusher spool.

56. 53. The method of claim 52, wherein when the thumbwheel rotates in a forward direction with the selector tab pressed into the forward position, the sheath spool rotates in the forward direction.

57. 57. The method of claim 56, wherein a distal end of the sheath wire is attached to the sheath member such that as the sheath spool rotates in the forward direction, the sheath wire is retracted proximally, pulling the sheath member proximally, thus deploying the self-expanding stent.

58. 58. The method of claim 57, wherein the sheath wire is wound onto the sheath spool during assembly, and when the sheath spool rotates in the forward direction, the sheath wire is wound onto the sheath spool.

59. 52. The method of claim 51 , wherein moving the selector tab to the forward position causes the selector member to pivot so that the second cam contacts a second cam surface on the second ratchet member and causes the second ratchet member to pivot out of engagement with the thumbwheel.

60. 60. The method of claim 59, wherein when the thumbwheel is rotated in the forward direction, a second end of the second ratchet member disengages from inner ridges spaced apart along an inner circumferential surface of the thumbwheel.

61. 61. The method of claim 60, wherein the second end is disengaged from an inner ridge of the thumbwheel such that the thumbwheel can only rotate in the forward direction.

62. 62. The method of claim 61 , wherein moving the selector tab to the forward position causes the selector member to pivot out of contact with the first ratchet member while a second end of the first ratchet member remains engaged with an inner ridge of the thumbwheel such that the thumbwheel can only rotate in the forward position.

63. 52. The method of claim 51 , wherein moving the selector tab to a reverse position causes the selector member to pivot so that a first cam on the selector member contacts a second cam surface on the first ratchet member and causes the first ratchet member to pivot out of engagement with the thumbwheel.

64. 64. The method of claim 63, wherein when the thumbwheel is rotated in a reverse direction, the second end of the first ratchet member disengages from inner ridges spaced along an inner circumferential surface of the thumbwheel.

65. 65. The method of claim 64, wherein the second end is disengaged from an inner ridge of the thumbwheel such that the thumbwheel can only rotate in the reverse direction.

66. 52. The method of claim 51, wherein with the selector tab moved to the locked position, first and second cams of the selector member do not contact the first and second ratchet members, respectively, and a second end of the first and second ratchet members engage inner ridges spaced along an inner circumferential surface of the thumbwheel, thereby preventing rotation of the thumbwheel.

67. 52. The method of claim 51, further comprising placing the sheath spool in a sheath receiving cup.

68. 68. The method of claim 67, wherein the sheath receiving cup has a flange that assists in returning the sheath wire to the sheath spool.

69. 52. The method of claim 51, further comprising: mounting the pusher spool in a pusher receiving cup.

70. 70. The method of claim 69, wherein the pusher receiving cup has a flange that helps retain the pusher wire on the pusher spool.

71. 52. The method of claim 51, further comprising fixedly attaching a stabilizer to a distal end of the handle.

72. 72. The method of claim 71, wherein the stabilizer has a stabilizer lumen dimensioned to slidingly receive the sheath.

Images