Rotating handle stent delivery system and method

Abstract

A delivery device according to the principles described herein includes a catheter with three concentric shafts, including an inner core, an outer sheath over the inner core, and an outer support shaft extending at least partially over the inner core and outer sheath. A timing belt having multiple belt teeth on its surface is coupled to the outer sheath over the medical device or stent on the inner core, such that movement of the timing belt links causes movement of the outer sheath from its position over the medical device or stent. The delivery device is actuated by rotation of a thumbwheel coupled to a barrel having multiple teeth, which moves the barrel, engaging the barrel teeth with the belt teeth, moving the timing belt and, therefore, the outer sheath. [Selection diagram] Figure 5

Description

[Technical field]

[0001] Embodiments of the present invention relate to a stent delivery device, and in particular to a one-handed thumbwheel actuated delivery handle. [Background technology]

[0002] There are many medical conditions and procedures in which a device, such as a stent, is placed in the body to create or maintain a passageway. There are a wide variety of stents used for different purposes, from expandable coronary, vascular and biliary stents, to plastic stents used to allow urine flow between the kidneys and bladder.

[0003] Self-expanding stents, as well as balloon-expandable stents, may be used to treat a variety of problems with the vascular system, including but not limited to May-Turner syndrome and economy class syndrome.

[0004] A stent is usually delivered to the target site in a compressed state and then deployed in an expanded state at that location to support the blood vessel and help keep it in an open position. A delivery system is used to insert or deploy the stent at the target site within the diseased blood vessel using a delivery system.

[0005] Stents are commonly 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 catheters or shafts that are positioned concentrically with one another. The stent is carried axially around the distal end of the inner catheter or shaft. The stent is brought to the delivery site on the distal end of the delivery device and held in its compressed delivery position by the outer shaft or catheter. Once at the desired placement site, the outer shaft is pulled back, releasing the stent to self-expand. Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE PRESENTLY PREFERRED EMBODIMENTS Accordingly, the present invention is directed to a rotating handle stent delivery system and method that obviates one or more of the problems resulting from limitations and disadvantages of the related art. [Means for solving the problem]

[0007] In accordance with the purposes of the invention, as embodied and broadly described herein, the invention, in one aspect, relates to a delivery device in accordance with the principles described herein, including a catheter having three concentric shafts including an inner core, an outer sheath over the inner core, and an outer support shaft; a timing belt having a plurality of belt teeth on a surface of the timing belt, timing belt links coupled to the outer sheath such that movement of the timing belt links causes movement of the outer sheath; a barrel having barrel teeth corresponding to the belt teeth; and a thumbwheel coupled to the barrel such that rotation of the thumbwheel moves the barrel, the barrel teeth engaging the belt teeth, moving the timing belt and moving the outer sheath.

[0008] In another aspect, a system for delivery of an intraluminal stent in accordance with the principles described herein includes a delivery device having a catheter having three concentric shafts including an inner core having an intraluminal stent thereon, an outer sheath over the stent in an unexpanded state on the inner core, the outer sheath retaining the stent in an unexpanded state and the outer sheath being coaxially translatable over the inner core and the intraluminal stent, and an outer support shaft extending at least partially over the inner core and the outer sheath, a timing belt having a plurality of belt teeth on a surface of the timing belt, timing belt links coupled to the outer sheath such that movement of the timing belt links moves the outer sheath to expose the intraluminal stent, a barrel having barrel teeth corresponding to the belt teeth, and a thumbwheel coupled to the barrel such that rotation of the thumbwheel moves the barrel, the barrel teeth engaging the belt teeth to move the timing belt and move the outer sheath.

[0009] In yet another aspect, a method of delivering a medical device to a body according to the principles described herein includes using a delivery device having a catheter having three concentric shafts including an inner core, an outer sheath over the inner core, and an outer support shaft; a timing belt having a plurality of belt teeth on a surface of the timing belt; a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a barrel having barrel teeth corresponding to the belt teeth; a thumbwheel coupled to the barrel such that rotation of the thumbwheel moves the barrel such that the barrel teeth engage the belt teeth, moving the timing belt, and moving the outer sheath; and a medical device on an outer diameter of the inner core, the method including rotating the thumbwheel in a predetermined direction to move the timing belt in a direction associated with the predetermined direction of rotation of the thumbwheel, causing the timing belt link to move the outer sheath in a desired direction; and positioning the medical device from a distal end of the inner core to the body as the outer sheath moves in the desired direction.

[0010] Additional advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not intended to be restrictive of the invention.

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

[0012] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not intended to be restrictive of the invention.

[0013] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate a rotatable handle stent delivery system and method. Together with the description, the drawings further serve to explain the principles of the rotatable handle stent delivery system and method described herein, thereby enabling one of ordinary skill in the relevant art to make and use the rotatable handle stent delivery system and method. [Brief description of the drawings]

[0014] [Figure 1] 1A-1D illustrate various embodiments of stent delivery handles according to the principles described herein.

[0015] [Diagram 2] 1A-1C illustrate exemplary catheter configurations in accordance with the principles described herein.

[0016] [Diagram 3] FIG. 1 illustrates an exploded view of features of a delivery handle in accordance with the principles described herein.

[0017] [Figure 4] FIG. 2 is a cross-sectional view of an assembled handle according to the principles described herein.

[0018] [Diagram 5] A cross-sectional view showing the movement of the thumbwheel and timing belt.

[0019] [Figure 6] FIG. 2 is a cross-sectional view of a delivery device according to the principles described herein, illustrating the movement of the timing belt links and outer sheath in response to movement of the thumbwheel.

[0020] [Figure 7] FIG. 1 is a plan view of a delivery device according to the principles described herein.

[0021] [Figure 8] FIG. 1 shows a perspective view of a delivery device, including a catheter device, in accordance with the principles described herein.

[0022] [Figure 9] 1 is a cross-sectional line drawing showing details of an exemplary embodiment of a thumbwheel assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Reference will now be made in detail to embodiments of the rotating handle stent delivery system and method with reference to the accompanying figures. Various embodiments disclosed herein depict devices and associated methods for delivering an expandable stent or other medical device for insertion or placement at a target site within a diseased blood vessel.

[0024] 1(a)-(c) show various embodiments of a stent delivery handle in accordance with the principles described herein. As shown, the handle 10 includes a housing 14 and a thumbwheel / thumbwheel assembly 18 with a triaxial catheter 22 extending therefrom. The catheter may extend from the housing 10 through a strain relief 26. The strain relief 26 may be of any shape and may be made, for example, of a polyolefin or other similar flexible material.

[0025] With reference to FIG. 2, the catheter 22 includes an inner core 42 of three concentric or "coaxial" tubes / shafts (a triaxial design), an outer sheath 34, and an outer support shaft 38. The outer sheath 34 may be tapered or stepped, as shown in FIG. 2, or may be non-tapered depending on the application. The outer support shaft 38 may be a PEEK (polyaryletheretherketone) tubing extrusion or other similar construction. The outer support shaft 38 may be manufactured from any semi-rigid material. PEEK exhibits good mechanical properties, supports smaller diameters of the outer sheath, and is flexible. PEEK is also a readily available component. Materials other than PEEK may be used to manufacture the outer support shaft. shaft, and the invention described herein is not limited to the use of PEEK for the outer support shaft 38. Functionally, the outer support shaft 38 and the inner core are fixed at a location at the proximal end of the delivery system, and the outer sheath translates coaxially over the inner core and inside the outer support shaft 38. A medical device, such as a self-expanding stent (not shown), is held in a reduced delivery configuration for insertion and delivery through a body lumen to a predetermined location for placement. The stent (not shown) is carried axially around the inner core 42 and held in its reduced delivery configuration by the outer sheath 34. The inner core 42 may be a braided reinforced tube that extends from the distal end to the proximal end of the device. In some embodiments, the inner core 42 may extend from the most distal end to the most proximal end (e.g., all the way from end to end). The inner diameter of the inner core 42 tube is sized for advancement over a guidewire, and the outer diameter of the inner core 42 tube at the distal end is where a stent (not shown) is crimped between the inner core band markers (50). When the outer sheath 34 is pulled back, releasing the stent (not shown) for self-expansion, the outer support shaft 38 is used to stiffen the delivery device so that the arc of the inner core 42 does not change outside the body. The outer support shaft 38 is connected to the handle 10 at the proximal end of the device to stiffen the delivery system and reduce friction at the insertion site of the procedure so that the inner core 42 is not forced forward when the midshaft / outer sheath 34 is pulled backward. As shown in FIG. 2, the catheter 22 may include a distal tip 46. The inner core 42 may further include at least one inner core marker band 50 so that a self-expanding stent is crimped and mounted at the distal end of the catheter and positioned over the inner core between two inner core marker bands 50 (only one is shown in FIG. 2) to prevent axial migration of the stent. The crimped and mounted self-expanding stent is circumferentially restrained by the outer sheath 34. The outer sheath 34 may also include an outer sheath marker band 54.

[0026] The triaxial design allows for more optimal delivery system stability and accurate placement during stent placement compared to conventional biaxial delivery systems. The system is introduced into the body at the access location through an introducer sheath with a hemostatic valve. When the stent delivery system moves the introducer sheath into the body, friction occurs at the hemostatic valve. Therefore, during placement of a conventional biaxial system with the outer sheath retracted, the conventional biaxial system will want to move relative to the introducer sheath due to friction, and as a result, the inner core will push the stent out as the outer sheath is retracted. The operator must compensate for this and move the entire delivery catheter while placing the stent and maintaining consistent placement during placement. For long and high radial force stents (e.g. venous stents), this can result in distal / proximal movement (accordion effect) of the entire delivery system during placement of the stent, resulting in inaccurate placement or malpositioning of the stent. The triaxial design mitigates this effect when the outer support shaft 38 is inserted through the introducer sheath, therefore friction between the translation of the outer sheath and the introducer sheath hemostatic valve is eliminated.

[0027] FIG. 3 shows an exploded view of the features of a delivery handle according to the principles described herein. The exemplary embodiment shown in FIG. 3 includes a two-part housing 114a and 114b, each of which may be snap-fit ​​together for assembly. The thumbwheel 18 may include two wheels 118a and 118b, an axle 58, and a bearing 62. The wheels 118a and 118b may include teeth on their inner barrels 66. In FIG. 3, only one inner barrel is shown on the wheel 118b, but the wheel 118a may also include an inner barrel with teeth. The teeth on the inner barrel 66 are sized to correspond to the teeth on the timing belt 70. The 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 integral with the housing 14. The bushing may be made of PEEK or other suitable material. The exemplary handle of FIG. 3 further includes at least one idler pulley 82 for tensioning and directing the timing belt. Also shown in FIG. 3 is an idler pulley axle 86 that corresponds to the idler pulley 82 of the embodiment of FIG. 3. The exemplary delivery handle of FIG. 3 further includes a tensioner assembly 90 that includes a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm axle 106, and a tensioner pulley axle 112. In the embodiment described herein, the timing belt has teeth on one side of the belt (outer diameter or outer surface) and the 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.

[0028] In the exemplary embodiment of FIG. 3, 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 is joined at the proximal end to a female luer 116 with a metal (e.g., stainless steel) shaft 30 which is bonded or clamped within the handle body 14. In an aspect of the invention, the metal shaft 30 may be bonded to the outer diameter of the inner core 42 to provide support / rigidity at the proximal end where the inner core 42 is unsupported within the handle body 10. The support of the metal shaft 30 on the inner core 42 mitigates potential deformation / buckling of the unsupported inner core 42 at the proximal end 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 column strength to the unsupported proximal inner core 42. The metallic shaft 30 may be sized such that it slides over the outer diameter of the inner core 42 and through the inner diameter of the outer sheath 34. Because the metallic shaft 30 does not affect the inner diameter of the inner core 42, a guidewire (not shown) can still pass through the entire assembly. Materials other than metal may be used for the support shaft, and the invention described herein is not limited to the use of metals for the support shaft 30.

[0029] The outer sheath 34 is coupled or joined to the timing belt link 74 and delivers the stent by retracting the outer sheath 34 by movement of a thumbwheel which in turn engages teeth on the inner barrel 66 with teeth of the timing belt 70 through the inner barrel 66. The metal shaft 30 coupled or joined to the inner core 42 / female luer 116 is the guide rail along which the outer sheath 34 and timing belt link 74 move proximally during deployment.

[0030] FIG. 4 is a cross-sectional view of an assembled handle according to the principles described herein. The exemplary embodiment shown in FIG. 4 shows one part 114b of a two-part housing, where the two parts may be snap-fit ​​for assembly. Other assembly methods, such as welding, bonding, gluing, or other methods, may be used to connect the two parts together. Although it is contemplated that both sides of the two-part housing are symmetrical and complementary, this type of configuration is not required. The parts of the thumbwheel assembly 18 may be formed by molding, such as injection molding. The housing 14 may be unitary.

[0031] FIG. 4 shows one wheel of the thumbwheel assembly 18, which may include two wheels 118a and 118b, an axle 58, and a bearing 62. The bearing may include a ball bearing having internally and externally grooved bearing races. The bearing serves to reduce rotational friction between the thumbwheel and the axle, and may be eliminated if the frictional forces are acceptable. In place of the bearing 62, an acetal bushing or other method of friction reduction may be used.

[0032] Wheels 118a and 118b may include teeth on their inner barrels 66. In FIG. 4, only one inner barrel is shown on wheel 118b, but wheel 118a may also include an inner barrel with teeth. The teeth on the inner barrel 66 are sized to correspond to the timing belt 70. The inner barrel may be formed by molding, such as injection molding, and the teeth may be formed as part of the molding or other method where the teeth are integral to the inner barrel 66. In other embodiments, the teeth may be separable from the inner barrel 66.

[0033] As shown, a timing belt link 74 connects the outer sheath 34 to the timing belt 70. The exemplary handle of FIG. 4 further includes at least one idler pulley 82 for tensioning and directing the timing belt 74. Also shown in FIG. 4 is an idler pulley axle 86 that corresponds to the idler pulley 82 of the embodiment of FIG. 4. The exemplary delivery handle of FIG. 4 further includes a tensioner assembly 90 that includes a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm axle 106, and a tensioner pulley axle 112. In the exemplary embodiment of FIG. 4, 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 is joined at its proximal end to a metal (eg, stainless steel) shaft 30 as well as a female luer 116 which is bonded or clamped to the handle body 14 .

[0034] FIG. 5 further illustrates the movement of the thumbwheel 18, timing belt 70 and timing belt links 74 for deployment of a stent in accordance with the principles described herein. As shown in FIG. 5, the outer sheath 34 is translated proximally 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 the dual thumbwheel assembly 18, which may include integrally molded gear teeth whose pitch and shape correspond to the teeth of the timing belt 70, to synchronize / engage with and move the timing belt, which in turn moves the timing belt links, which are coupled to and move the outer sheath 34, unsheathing (deploying) the stent disposed 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 may each be adjusted / modified to allow for variable mechanical efficiency and variable translation rates during stent deployment. Additionally, variable speed delivery may be achieved by actuating the thumbwheel assembly 18 at the desired speed.

[0035] In the embodiment shown in FIG. 5, proximal (in the direction of the arrow) rotation of the thumbwheel 18 exterior to the handle causes the upper portion of the timing belt adjacent the thumbwheel interior to move distally (in the direction of the arrow). As the timing belt 70 extends around the idler pulley 82, the portion of the timing belt 70 adjacent to the timing belt link 74 moves proximally (in the direction of the arrow) engaging the timing belt link 74, which moves the proximally coupled outer sheath 34, thereby unsheathing the stent for deployment. The movement may be reversed to resheath the catheter after stent deployment.

[0036] 6(a)-(c) are cross-sectional views of a delivery device according to the principles described herein, and in the context of FIGS. 6(a)-(c) show the movement of the timing belt links 74 and outer sheath 34 in response to counterclockwise movement of the thumbwheel 18. It should be appreciated that the direction of thumbwheel rotation described herein is described in the context of a cross section, but that the portion of the thumbwheel external to the handle 14 is considered to rotate rearward (proximally). It is also contemplated that the configuration of the timing belt 70 may be adjusted (e.g., looped over the thumbwheel) to modify the direction of thumbwheel rotation corresponding to proximal movement (retraction) of the outer sheath 34.

[0037] As shown in FIG. 6(a), in the introduction position, the timing belt link is at the distal end of the handle housing. As the thumbwheel 18 is actuated in a given direction, e.g., counterclockwise in the context of the cross-section shown, the timing belt link / shuttle 74 moves proximally. Because the timing belt link / shuttle 74 is coupled to the outer sheath 34, the outer sheath moves proximally with the timing belt link / shuttle, exposing the stent or other medical device (not shown) mounted on the inner core 42. FIG. 6(b) illustrates the positioning of the timing belt link / shuttle in a partially deployed position (e.g., the stent is partially deployed (not shown)). As shown in FIG. 6(c), further rotation of the thumbwheel 18 causes the timing belt link / shuttle 74 to translate further proximally, allowing for full deployment of the stent or other medical device mounted on the inner core 42. In the embodiment described herein, the thumbwheel 18 is actuated such that the upper (outer) portion of the thumbwheel rotates proximally, passing the timing belt link / shuttle 74 proximally. It should be appreciated that the configuration / path of the timing belt 70 may be configured such that distal rotation of the upper (outer) portion of the thumbwheel 18 passes the timing belt link / shuttle 74 proximally, retracting the outer sheath 34 from the inner core 42 and allowing placement of a medical device (not shown).

[0038] Although not shown, the thumbwheel may be a single thumbwheel with appropriate teeth that correspond to the teeth of the timing belt. As shown in the plan view of FIG. 7, a thumbwheel with two wheels allows for a balanced design that allows the catheter to exit the handle at a center of the distal end of the handle. FIG. 7 shows the assembled handle 10, housing 14, and thumbwheel assembly 18 having a first thumbwheel 118a and a second thumbwheel 118b separated by an inner barrel 66. This configuration facilitates operation of the delivery device by holding the handle from either the left or right side, allowing equal operation whether the operator is left or right handed.

[0039] 8 shows a perspective view of a delivery device, including a catheter device, according to the principles described herein. As shown in FIG. 8, the timing belt 70 extends around the idler pulley 82 and the tensioner pulley 102 of the tensioner 90. The tensioner pulley 102 is coupled to the torsion spring 94 via the tensioner arm 98. Tension is maintained on the timing belt by the torsion spring 94 on the tensioner arm axle 106, which urges the tensioner pulley 102 into contact with the timing belt 70 via the tensioner arm 98.

[0040] FIGURE 9 is a cross-sectional line drawing showing details of an exemplary embodiment of the thumbwheel assembly 18 and timing belt link 74. As shown in FIGURE 9, one portion 118b of the two-part thumbwheel 18 has an outer surface 122 that may be textured for ease of use. The thumbwheel portion 118b may include an inner surface or rim 126. An 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 period (pitch) or may have a variable period (pitch) so that actuation of the thumbwheel assembly moves a timing belt (not shown), and thus translates the outer sheath 34 at a first speed when a first period of barrel teeth engage the timing belt (not shown), and at a second speed when a second period of barrel teeth engage the timing belt (not shown). This type of variable speed may be provided by having different spacing / period / pitch of teeth on the timing belt instead of or in addition to having different spacing / period / pitch of barrel teeth 130 on the inner barrel 66. FIG. 9 further shows the thumbwheel bearing 62 and the thumbwheel axle 58.

[0041] A safety locking feature (not shown) can be incorporated into this type of handle design to mitigate inadvertent actuation of the handle during transport and storage. The safety locking feature may be a removal / handling or toggle feature that engages teeth on the inner barrel, locking it in place and preventing rotation. The safety locking feature may also be a feature that engages the timing belt link and prevents its translation.

[0042] It is apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the present invention. Therefore, it is intended that the present invention covers the modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents.

[0043] While various embodiments of the present invention have been described above, it should be understood that they are presented by way of example only, and not by way of limitation. It will be apparent to those skilled in the relevant art that various changes in form and detail can be made herein without departing from the spirit and scope of the present invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. a catheter having three concentric shafts including an inner core, an outer sheath over the inner core, and an outer support shaft; a timing belt forming a loop having an inner surface and an outer surface, the timing belt having a plurality of belt teeth on the outer surface; a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a barrel having barrel teeth that engage the belt teeth on the outer surface; a thumbwheel coupled to the barrel such that rotation of the thumbwheel moves the barrel, the barrel teeth engaging the belt teeth, moving the timing belt, and moving the outer sheath.

2. 2. The delivery device of claim 1, further comprising a housing, a portion of the thumbwheel being external to the housing, the barrel being internal to the housing, and the timing belt being internal to the housing.

3. 2. The delivery device of claim 1, further comprising at least one pulley, the timing belt extending around the pulley and the inner surface of the timing belt contacting the pulley such that a direction of rotation of the thumbwheel provides a desired direction of translation of the outer sheath.

4. 2. The delivery device of claim 1, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley, the inner surface of the timing belt contacting the tensioner pulley.

5. The delivery device of claim 4 , wherein the belt tensioner further comprises a tensioner arm axle and a tensioner pulley axle.

6. The three concentric shafts are the inner core sized to receive a medical device thereon; an outer sheath sized to receive and retain the medical device on the inner core in an unexpanded state therein, the outer sheath being coaxially translatable over the inner core; The delivery device of claim 1 , further comprising an outer support shaft extending at least partially over the inner core and the outer sheath.

7. The delivery device of claim 1 , wherein the inner core and the outer support shaft are fixed relative to a proximal end of the delivery device.

8. The delivery device of claim 1 , further comprising a metal shaft at an outer diameter of the inner core.

9. The delivery device of claim 8 , wherein the metal shaft is bonded to the outer diameter of the inner core.

10. The delivery device of claim 8 , wherein the metallic shaft comprises stainless steel.

11. 2. The delivery device of claim 1, wherein the thumbwheel is rotatable in a forward direction and a rearward direction such that when the thumbwheel is rotated in a forward direction, the outer sheath translates in a first direction and when the thumbwheel is rotated in a rearward direction, the outer sheath translates in a second direction.

12. 1. A system for delivery of an intraluminal stent comprising a delivery device, comprising: The delivery device comprises: a catheter having three concentric shafts, the three concentric shafts comprising: an inner core having the intraluminal stent thereon; an outer sheath over the intraluminal stent in an unexpanded state on the inner core therein, the outer sheath retaining the intraluminal stent in an unexpanded state, the outer sheath being coaxially translatable over the inner core and the intraluminal stent; an outer support shaft extending at least partially over the inner core and the outer sheath; The delivery device comprises: a timing belt forming a loop having an inner surface and an outer surface, the timing belt having a plurality of belt teeth on the outer surface; a timing belt link coupled to the outer sheath such that movement of the timing belt link moves the outer sheath to expose the intraluminal stent; a barrel having barrel teeth that engage the belt teeth on the outer surface; a thumbwheel coupled to the barrel such that rotation of the thumbwheel moves the barrel, with the barrel teeth engaging the belt teeth to move the timing belt and move the outer sheath.

13. 13. The system of claim 12, wherein the delivery device further comprises a housing, a portion of the thumbwheel being external to the housing, the barrel being internal to the housing, and the timing belt being internal to the housing.

14. 13. The system of claim 12, wherein the delivery device further comprises at least one pulley, the timing belt extending around the pulley and the inner surface of the timing belt contacting the pulley such that a direction of rotation of the thumbwheel provides a desired direction of translation of the outer sheath.

15. 13. The system of claim 12, wherein the delivery device further comprises a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley, and wherein the inner surface of the timing belt contacts the tensioner pulley.

16. 16. The system of claim 15, wherein the belt tensioner further comprises a tensioner arm axle and a tensioner pulley axle.

17. The system of claim 12 , wherein the delivery device further comprises a metal shaft at an outer diameter of the inner core.

18. The system of claim 17 , wherein the metal shaft is bonded to the outer diameter of the inner core.

19. The system of claim 18 , wherein the metal shaft comprises stainless steel.

20. 18. The system of claim 17, wherein the thumbwheel is rotatable in a forward direction and a reverse direction such that when the thumbwheel rotates in a forward direction, the outer sheath translates in a first direction and when the thumbwheel rotates in a reverse direction, the outer sheath translates in a second direction.

21. The system of claim 12 , wherein the outer support shaft and the inner core are fixed relative to a proximal end of the delivery device.

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