Rotating handle stent delivery system and method

Abstract

A delivery device according to the principles described herein includes a catheter having 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 the outer sheath. A timing belt having a plurality of teeth on its surface is coupled to the outer sheath over a medical device or stent located over the inner core such that movement of the timing belt links causes the outer sheath to move from its position over the medical device or stent. The delivery device is actuated by rotation of a thumb wheel coupled to a cylinder having a plurality of teeth such that rotation of the thumb wheel causes movement of the cylinder such that the cylinder teeth engage the belt teeth to cause movement of the timing belt, which causes movement of the outer sheath.

Description

Technical Field

[0001] Embodiments of the present invention relate to a stent delivery device, and more particularly to a one-hand-operated thumbwheel-driven delivery handle. Background Art

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

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

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

[0005] Stents are typically delivered using a catheter delivery system. A common type of delivery system for delivering self-expanding stents is known as a pull-back delivery system. This type of delivery system utilizes two concentrically arranged catheters or shafts, one of which surrounds the other. The stent is delivered axially around the distal end of the inner catheter or shaft. The stent is delivered to the delivery site at the distal end of the delivery device and is held in its compressed delivery position by the outer shaft or catheter. Once the desired placement site is reached, the outer shaft is pulled back, thereby releasing the stent to self-expand. Summary of the invention

[0006] Accordingly, the present invention is directed to a rotating handle stent delivery system and method that obviates one or more problems due to limitations and disadvantages of the related art.

[0007] In accordance with one or more objects of the present invention, as embodied and broadly described herein, on the one hand, the present invention relates to a delivery device according to the principles described herein, the delivery device comprising a catheter having three concentric shafts, the three concentric shafts comprising an inner core, an outer sheath sleeved on the inner core, and an outer support shaft; a synchronous belt having a plurality of belt teeth on its surface; a synchronous belt link, the synchronous belt link being coupled to the outer sheath so that movement of the synchronous belt link causes movement of the outer sheath; a cylinder having cylinder teeth corresponding to the belt teeth; and a thumb wheel coupled to the cylinder so that rotation of the thumb wheel causes movement of the cylinder, so that the cylinder teeth engage with the belt teeth to cause movement of the synchronous belt, thereby causing movement of the outer sheath.

[0008] On the other hand, a system for delivering an intraluminal stent according to the principles described herein includes a delivery device having a catheter having three concentric shafts, the three concentric shafts including an inner core having the intraluminal stent thereon; an outer sheath sleeved over the stent, the stent being in an unexpanded state on the inner core therein, the outer sheath maintaining the stent in the unexpanded state, the outer sheath being capable of coaxially translating 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 synchronous belt having a plurality of belt teeth on a surface of the synchronous belt; a synchronous belt link coupled to the outer sheath so that movement of the synchronous belt link causes movement of the outer sheath to expose the intraluminal stent; a cylinder having cylinder teeth corresponding to the belt teeth; and a thumb wheel coupled to the cylinder so that rotation of the thumb wheel causes movement of the cylinder so that the cylinder teeth engage with the belt teeth to cause movement of the synchronous belt, thereby causing movement of the outer sheath.

[0009] In yet another aspect, a method for delivering a medical device into the body according to the principles described herein uses a delivery device having a catheter having three concentric shafts, the three concentric shafts comprising an inner core, an outer sheath sleeved on the inner core, and an outer support shaft; a synchronous belt having a plurality of belt teeth on its surface; a synchronous belt link coupled to the outer sheath so that movement of the synchronous belt link causes movement of the outer sheath; a cylinder having cylinder teeth corresponding to the belt teeth; and a thumb wheel coupled to the cylinder so that the thumb wheel is moved. The method comprises the steps of: rotating the thumb wheel in a predetermined direction to cause the synchronous belt to move in a direction associated with the predetermined direction of rotation of the thumb wheel, so that the synchronous belt links move the outer sheath in a desired direction; and deploying the medical device from the distal end of the inner core into the body as the outer sheath moves in the desired direction.

[0010] Additional advantages will be described in part in the following description and in part will be apparent from the description or may be learned through the practice of the invention. The advantages of the invention will be realized and obtained by means of the elements and combinations particularly pointed out in the appended claims. It should be understood that the general description above and the detailed description below are only exemplary and explanatory and are not limitations of the invention claimed.

[0011] Other embodiments, features, and advantages of the rotating handle stent delivery system and method, as well as the structure and operation of 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 both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0014] 1(a)-(c) illustrate various embodiments of a stent delivery handle according to the principles described herein.

[0015] Figure 2 Exemplary catheter configurations according to the principles described herein are shown.

[0016] Figure 3 An exploded view of features of a delivery handle according to principles described herein is shown.

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

[0018] Figure 5 is a cross-sectional view showing the movement of the thumb wheel and the timing belt.

[0019] 6(a)-(c) are cross-sectional views of a delivery device according to principles described herein and illustrating movement of the timing belt links and outer sheath as the thumb wheel moves.

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

[0021] Figure 8 Shown is a perspective view of a delivery device including a catheter device according to principles described herein.

[0022] Fig. 9 is a cross-sectional line drawing showing details of an exemplary embodiment of a thumb wheel assembly. DETAILED DESCRIPTION

[0023] Embodiments of a rotating handle stent delivery system and method will now be described in detail with reference to the accompanying drawings. Various embodiments disclosed herein illustrate an apparatus and associated methods for delivering an expandable stent or other medical device to implant or deploy the stent or other medical device to a target site in a diseased vessel.

[0024] 1(a)-(c) illustrate various embodiments of a stent delivery handle according to the principles described herein. As shown, the handle 10 includes a housing 14 and a thumbwheel / thumbwheel assembly 18, wherein a triaxial catheter 22 extends from the thumbwheel / thumbwheel assembly. The catheter may extend from the housing 10 through a strain relief 26. The strain relief 26 may take any form, such as made of polyolefin or other similar flexible material.

[0025] refer to Figure 2 , the catheter 22 includes three concentric or "coaxial" tubes / axes (triaxial design): an inner core 42, an outer sheath 34, and an outer support shaft 38. Figure 2 As shown, the outer sheath 34 may be tapered or stepped, or may not be tapered, depending on the application. The outer support shaft 38 may be a PEEK (polyaryletheretherketone) tubing extrusion or other similar structure. The outer support shaft 38 may be made of any semi-rigid material. PEEK exhibits good mechanical properties to provide support for an outer sheath of smaller diameter, and has flexibility. PEEK is also a readily available component. Materials other than PEEK may be used to form the outer support sheath, and the invention described herein is not limited to PEEK for the outer support shaft 38. Functionally, the outer support shaft 38 and the inner core are fixed in place at the proximal end of the delivery system, and the outer sheath coaxially translates on the inner core and inside the outer support shaft 38. Medical devices such as self-expanding stents (not shown) are maintained in a reduced delivery configuration so as to be inserted through a body cavity and delivered to a predetermined site for deployment. The stent (not shown) is transported axially around the inner core 42 and is maintained in its reduced delivery state by the outer sheath 34. The inner core 42 may be a braided reinforced tube extending from the distal end of the device to the proximal end. In some embodiments, the inner core 42 may extend from the farthest end to the proximal end (e.g., from one end all the way to the other end). The inner diameter of the tube of the inner core 42 is sized to be tracked by a guidewire, and the outer diameter of the tube of the inner core 42 at the distal end is where the stent (not shown) will be curled between the inner core band markings (50). The outer support shaft 38 is used to stiffen the delivery device so that when the outer sheath 34 is pulled back to release the stent (not shown) to a self-expanding state, the curvature of the inner core 42 does not change in vitro. The outer support shaft 38 is connected to the handle 10 at the proximal end of the device, which stiffens the delivery system and reduces friction at the treatment insertion site so that the inner core 42 is not pushed forward as the intermediate shaft / outer sheath 34 is pulled back. As Figure 2As shown, 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 the self-expanding stent is crimped and loaded at the distal end of the catheter and is located on the inner core between two inner core marker bands 50 ( Figure 2 The crimped and loaded self-expanding stent is constrained in the circumferential direction by the outer sheath 34. The outer sheath 34 may also include an outer sheath marker band 54.

[0026] Compared with the traditional 2 coaxial delivery system, the three-axis design allows the best delivery system stability and accurate placement during the stent deployment. The system is introduced into the body at the entry position by an inserter sheath with a hemostatic valve. At the position where the stent delivery system makes the inserter sheath enter the human body, friction is generated at the hemostatic valve. Therefore, during the deployment of the traditional 2-axis system, as the outer sheath retracts, due to friction, it is desired to move relative to the inserter sheath, thereby causing the inner core to push the stent out, rather than retracting the outer sheath. The operator needs to compensate for this and move the entire delivery catheter to maintain consistent placement during the deployment when the stent is deployed. For long high radial force stents (such as venous stents), this may cause the entire delivery system to move distally / proximally (accordion effect) during the deployment of the stent, and may cause the stent to be deployed inaccurately or misplaced. As the outer support shaft 38 is inserted through the inserter sheath, the three-axis design alleviates this effect, thereby eliminating the friction between the outer sheath translation and the inserter sheath hemostatic valve.

[0027] Figure 3 An exploded view of features of a delivery handle according to principles described herein is shown. Figure 3 The exemplary embodiment shown includes a two-piece housing 114a and 114b, wherein the respective two parts 114a and 114b can be snap-fitted together for assembly. The thumb wheel 18 can include two thumb wheels 118a and 118b, axle 58 and bearing 62. The thumb wheels 118a and 118b can include teeth on their inner cylinders 66. Although in Figure 3 Only one inner cylinder on roller 118b is shown, but roller 118a may also include an inner cylinder with teeth. The size of the teeth on the inner cylinder 66 is designed 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 formed of PEEK or other suitable materials. Figure 3 The exemplary handle further includes at least one idler pulley 82 for tensioning and guiding the timing belt. Figure 3 It is also shown in Figure 3 The idler gear 82 of the embodiment corresponds to the idler gear shaft 86 . Figure 3The exemplary delivery handle of further includes a tensioner assembly 90, which includes a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm shaft 106, and a tensioner pulley shaft 112. In the currently described embodiment, the synchronous belt has teeth on one side of the belt (outer diameter or periphery), and the inner diameter (inner surface) is smooth or substantially smooth or flat. The smooth or flat surface of the synchronous belt 70 contacts the idler 82 and the tensioner pulley 102.

[0028] exist Figure 3 In an exemplary embodiment of the invention, the outer support shaft 38 is fixed to the handle housing 14, and the inner core 42 and the outer sheath 34 are both contained in the inner diameter of the outer shaft 38. The inner core 42 will be coupled to the female Luer connector 116 at the proximal end together with the metal (e.g., stainless steel) shaft 30, which is connected or crimped into the handle body 14. In one aspect of the invention, the metal shaft 30 can be coupled to the outer diameter of the inner core 42 to provide support / rigidity at the proximal end where the inner core 42 is not supported in the handle body 10. The support of the metal shaft 30 on the inner core 42 alleviates the potential deformation / buckling of the proximal unsupported inner core 42 during stent deployment. As the outer sheath 34 is pulled back to release / deploy the stent, the inner core 42 is compressed, so the unsupported proximal end of the inner core may deform. The coupled metal shaft 30 provides support and breaking strength for the unsupported proximal inner core 42. The metal shaft 30 can be sized so that it can slide over the outer diameter of the inner core 42 and pass through the inner diameter of the outer sheath 34. The metal shaft 30 does not affect the inner diameter of the inner core 42, so a guide wire (not shown) can still pass through the entire assembly. Materials other than metal can be used to support the shaft, and the invention described herein is not limited to metals used to support the shaft 30.

[0029] The outer sheath 34 is coupled or incorporated to the timing belt link 74 to deliver the stent by retracting the outer sheath 34 due to the movement of the thumb wheel, which in turn engages the teeth of the timing belt 70 via the inner cylinder 66 and the teeth on the inner cylinder 66. The metal shaft 30 coupled or incorporated with the inner core 42 / female Luer connector 116 is a guide rail over which the outer sheath 34 and timing belt link 74 move proximally during deployment.

[0030] Figure 4 is a cross-sectional view of an assembled handle according to the principles described herein. Figure 4 The exemplary embodiment shown shows one component 114b of a two-piece housing, wherein the respective two components can be snap-fitted together for assembly. Other assembly methods can be used to fit the two components together, such as welding, bonding, gluing, or other methods. It is contemplated that each side of the two-piece housing is symmetrical and complementary, but such a configuration is not required. The components of the thumb wheel assembly 18 can be formed by molding, such as injection molding. The housing 14 can be integral.

[0031] Figure 4 One thumb wheel of the thumb wheel assembly 18 is shown, which may include two thumb wheels 118a and 118b, axle 58, and bearing 62. The bearing may include a ball bearing with inner and outer grooved bearing races. The bearing is used to reduce the rotational friction between the thumb wheel and the axle, and if the friction is acceptable, the bearing may eliminate the friction. Acetal bushings or other friction reduction methods may be used in place of bearing 62.

[0032] Rollers 118a and 118b may include teeth on their inner cylinders 66. Figure 4 Only one inner cylinder on the roller 118b is shown in the figure, but the roller 118a may also include an inner cylinder with teeth. The size of the teeth on the inner cylinder 66 is designed to correspond to the timing belt 70. The inner cylinder can be formed by molding such as injection molding, and the teeth can be formed as part of the molding or other method so that the teeth are integral with the inner cylinder 66. On the other hand, the teeth can be separated from the inner cylinder 66.

[0033] As shown, the timing belt links 74 connect the outer sheath 34 to the timing belt 70 . Figure 4 The exemplary handle further includes at least one idler pulley 82 for tensioning and guiding the timing belt 74. Figure 4 It is also shown that Figure 4 The idler gear 82 of the embodiment corresponds to the idler gear shaft 86 . Figure 4 The exemplary delivery handle of further includes a tensioner assembly 90, which includes a torsion spring 94, a tensioner arm 98, a tensioner pulley 102, a tensioner arm shaft 106, and a tensioner pulley shaft 112. Figure 4 In the exemplary embodiment of the invention, the outer support shaft 38 is fixed to the handle housing 14, and the inner core 42 and the outer sheath 34 are both contained within the inner diameter of the outer shaft 38. The inner core 42 will be coupled at the proximal end along with the metal (e.g., stainless steel) shaft 30 to a female Luer connector 116 that is coupled or crimped into the handle body 14.

[0034] Figure 5 Further illustrated is the movement of the thumb wheel 18, the timing belt 70, and the timing belt links 74 for deploying the stand according to the principles described herein. Figure 5As shown, by rotating the thumb wheel in the direction of the arrow, the outer sheath 34 is translated proximally on the guide tube / inner core 42 by the timing belt 70. The timing belt 70 is driven by the operator via the dual thumb wheel assembly 18, which may include integrally molded gear teeth whose pitch and shape correspond to the teeth of the timing belt 70 for synchronizing / engaging the timing belt and causing the movement of the timing belt to cause the movement of the timing belt chain link, which is connected to the outer sheath 34 to cause its movement, thereby unsheathing (deploying) the stent disposed therein. The diameter of the inner cylinder 66, the number of teeth on the timing belt 70, and the pitch / frequency of the teeth on the timing belt 70 can each be adjusted / modified to allow variable mechanical advantage and variable translation ratio to be achieved during stent deployment. In addition, variable speed delivery can also be achieved by actuating the thumb wheel assembly 18 at a desired speed.

[0035] exist Figure 5 In the illustrated embodiment, the proximal rotation (in the direction of the arrow) of a portion of the thumb wheel 18 outside the handle causes the upper portion of a portion of the timing belt adjacent to the portion of the thumb wheel inside the handle to move distally (in the direction of the arrow). The timing belt 70 extends around the idler wheel 82, so that a portion of the timing belt 70 adjacent to the timing belt link 74 moves proximally (in the direction of the arrow), thereby engaging with the timing belt link 74 to move the timing belt link 74 proximally, which moves the outer sheath 34 coupled thereto proximally, thereby unsheathing the stent for deployment. After the stent is deployed, the movement can be reversed for re-sheathing.

[0036] 6(a)-(c) are cross-sectional views of a delivery device according to the principles described herein, and illustrate the movement of the timing belt link 74 and the outer sheath 34 as the thumb wheel 18 moves counterclockwise in the context of FIG. 6(a)-(c). It should be understood that the thumb wheel rotational direction described herein is described in the context of the cross-section provided, but it is contemplated that a portion of the thumb wheel that is external to the handle 14 will rotate rearwardly (in a proximal direction). It is also contemplated that the configuration of the timing belt 70 can be adjusted (e.g., looped on the thumb wheel) to modify the rotational direction of the thumb wheel to correspond to the proximal movement (retraction) of the outer sheath 34.

[0037] As shown in Fig. 6 (a), in the introduction position, the synchronous belt link is located at the distal end of the handle housing. As the thumb wheel 18 is actuated in a predetermined direction, for example, in the background of the cross section shown, it is actuated in a counterclockwise direction, and the synchronous belt link / shuttle 74 moves proximally. Because the synchronous belt link / shuttle 74 is connected to the outer sheath 34, the outer sheath moves proximally with the synchronous belt link / shuttle to expose the stent or other medical device (not shown) mounted on the inner core 42. Fig. 6 (b) shows the positioning of the synchronous belt link / shuttle in a partially deployed position (for example, the stent is partially deployed (not shown)). As the thumb wheel 18 is further rotated, the synchronous belt link / shuttle 74 is further translated proximally to allow the stent or medical device to be fully deployed from the inner core 42, as shown in Fig. 6 (c). In the embodiment described herein, the thumb wheel 18 is actuated so that the upper side (outside) of the thumb wheel rotates proximally to cause the synchronous belt link / shuttle 74 to be transmitted proximally. It should be understood that the configuration / path of the timing belt 70 can be configured such that distal rotation of the upper (outer) side of the thumb wheel 18 can cause the timing belt link / shuttle 74 to be transported proximally to cause the outer sheath 34 to retract from the inner core 42 to allow the medical device (not shown) to be deployed.

[0038] Although not shown in the figures, the thumb wheel may be a single thumb wheel with appropriate teeth corresponding to the teeth of the timing belt. Figure 7 As shown in the top view of FIG, the thumb wheel including two thumb wheels allows for a balanced design in which the catheter can exit the handle at the center portion of the distal end of the handle. Figure 7 The assembled handle 10 and housing 14 are shown, along with the thumb wheel assembly 18 having a first thumb wheel 118a and a second thumb wheel 118b separated by an inner cylinder 66. This configuration facilitates operation of the delivery device by gripping the handle from either the left or right side, thereby enabling similar operation regardless of whether the operator is left-handed or right-handed.

[0039] Figure 8 A perspective view of a delivery device including a catheter device according to the principles described herein is shown. Figure 8 As shown, 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. The torsion spring 94 on the tensioner arm shaft 106 maintains tension on the timing belt, which urges the tensioner pulley 102 into contact with the timing belt 70 via the tensioner arm 98.

[0040] Fig. 9 is a cross-sectional view showing details of an exemplary embodiment of the thumb wheel assembly 18 and the timing belt link 74. Fig. 9As shown, one component 118b of the two-piece thumb wheel 18 has an outer surface 122, which may be textured for ease of use. The thumb wheel component 118b may also include an inner surface or rim 126. An inner cylinder 66 extends from the thumb wheel component 118b and has a plurality of cylindrical teeth 130 thereon. The cylindrical teeth 130 on the inner cylinder 66 are sized to correspond to a timing belt (not shown). Although not shown, the cylindrical teeth 130 may have a standard periodicity (pitch) or may have a variable periodicity (pitch) such that when a first periodicity of cylindrical teeth engages with the timing belt (not shown), actuation of the thumb wheel assembly may cause movement of the timing belt (not shown) and translation of the outer sheath 34 at a first rate, and movement of the timing belt (not shown) and translation of the outer sheath at a second rate when a second periodicity of cylindrical teeth engages with the timing belt (not shown). As an alternative or in addition to having different spacing / periodicity / pitch of the cylinder teeth 130 on the inner cylinder 66, such variable speed may be imparted by having different spacing / periodicity / pitch of the teeth on the timing belt. Fig. 9 The thumb wheel bearing 62 and thumb wheel shaft 58 are further shown.

[0041] A safety lockout feature (not shown) may be incorporated into the handle design to mitigate accidental actuation of the handle during transport and storage. The safety lockout feature may be a removal / disposal or toggle feature that engages with teeth on the inner cylinder to lock it in place and prevent rotation. The safety lockout feature may also be a feature that engages with a timing belt link to prevent it from translating.

[0042] It will be 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, the present invention is intended to cover modifications and variations of the present invention as long as they are within the scope of the appended claims and their equivalents.

[0043] Although various embodiments of the present invention are described above, it should be understood that these embodiments are presented only as examples and not as limitations. It should be understood by those skilled in the relevant art that various changes in form and details can be made without departing from the spirit and scope of the present invention. Therefore, the breadth and scope of the present invention should not be limited by any of the above exemplary embodiments, but should only be limited according to the following claims and their equivalents.

Claims

1. A delivery device comprising: a catheter having three concentric shafts including an inner core, an outer sheath over the inner core, and an outer support shaft, the outer support shaft being fixed in place at the proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A synchronous belt having a plurality of belt teeth on its 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 cylinder having cylinder teeth corresponding to the belt teeth; and A thumb wheel is coupled to the cylinder such that rotation of the thumb wheel causes movement of the cylinder such that the cylinder teeth engage the belt teeth to cause movement of the timing belt and thereby the outer sheath.

2. The delivery device of claim 1, further comprising a housing, wherein a portion of the thumb wheel is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the timing belt is interior to the housing.

3. The delivery device of claim 1, wherein the belt teeth are located on an outer surface of the timing belt.

4. The delivery device of claim 1 further comprising at least one pulley, the timing belt extending around the pulley such that a rotational direction of the thumb wheel imparts a desired translational direction to the outer sheath.

5. The delivery device of claim 1, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley.

6. The delivery device of claim 5, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

7. The delivery device of claim 1, wherein the three concentric axes comprise: the inner core, the inner core being sized to receive a medical device thereon; the outer sheath being sized to receive and retain the medical device in an unexpanded state on the inner core, the outer sheath being coaxially translatable on the inner core; and The outer support shaft extends at least partially over the inner core and the outer sheath.

8. 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.

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

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

11. The delivery device of claim 9, wherein the metal shaft comprises stainless steel.

12. The delivery device of claim 1, wherein the thumb wheel is rotatable in a forward direction and a reverse direction such that when the thumb wheel is rotated in the forward direction, the outer sheath translates in a first direction, and when the thumb wheel is rotated in the reverse direction, the outer sheath translates in a second direction.

13. A system for delivering an intraluminal stent, comprising: A delivery device, the delivery device comprising: A catheter having three concentric axes, the three concentric axes comprising: An inner core, wherein the inner core has the intraluminal stent; an outer sheath sleeved over the intraluminal stent, wherein the intraluminal stent is in an unexpanded state on the inner core therein, the outer sheath retaining the intraluminal stent in the unexpanded state, the outer sheath being capable of coaxially translating 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, the outer support shaft being fixed in place at a proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A synchronous belt having a plurality of belt teeth on its surface; a timing belt link coupled to the outer sheath so that movement of the timing belt link causes movement of the outer sheath to expose the intraluminal stent; a cylinder having cylinder teeth corresponding to the belt teeth; and A thumb wheel is coupled to the cylinder such that rotation of the thumb wheel causes movement of the cylinder such that the cylinder teeth engage the belt teeth to cause movement of the timing belt and thereby the outer sheath.

14. The system of claim 13, further comprising a housing, wherein a portion of the thumb wheel is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the timing belt is interior to the housing.

15. The system of claim 13, wherein the belt teeth are located on an outer surface of the timing belt.

16. The system of claim 13, further comprising at least one pulley, the timing belt extending around the pulley such that a rotational direction of the thumb wheel imparts a desired translational direction to the outer sheath.

17. The system of claim 13, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley.

18. The system of claim 17, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

19. The system of claim 13, further comprising a metal shaft at an outer diameter of the inner core.

20. The system of claim 19, wherein the metal shaft is bonded to the outer diameter of the inner core.

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

22. The system of claim 19, wherein the thumb wheel is rotatable in a forward direction and a reverse direction such that when the thumb wheel is rotated in the forward direction, the sheath translates in a first direction, and when the thumb wheel is rotated in the reverse direction, the sheath translates in a second direction.

23. The system of claim 13, wherein the outer support shaft and the inner core are fixed relative to the proximal end of the delivery device.

24. A delivery device comprising: a catheter having three concentric shafts including an inner core, an outer sheath over the inner core, and an outer support shaft, the outer support shaft being fixed in place at the proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A flexible synchronous belt, wherein a plurality of belt teeth are provided on the surface of the flexible synchronous belt; a timing belt link directly coupled to the flexible timing belt and to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a cylinder having cylinder teeth corresponding to the belt teeth for directly engaging the belt teeth; a thumb wheel assembly having two thumb wheels, wherein at least a portion of the thumb wheel assembly is integrated with the cylinder such that rotation of the thumb wheel assembly causes movement of the cylinder such that the cylinder teeth directly engage the belt teeth to cause movement of the flexible timing belt and the timing belt links, thereby causing movement of the outer sheath; and wherein the cylinder is between the two thumb wheels, and the flexible timing belt is engaged with the cylinder between the two thumb wheels; and The cylinder and the two thumb wheels are rotatable about a common axis.

25. The delivery device of claim 24, further comprising a housing, wherein a portion of the thumb wheel assembly is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the flexible timing belt is interior to the housing.

26. The delivery device of claim 24, wherein the belt teeth are located on an outer surface of the flexible timing belt.

27. The delivery device of claim 24, further comprising at least one pulley, the flexible timing belt extending around the pulley such that a rotational direction of the thumbwheel assembly imparts a desired translational direction to the outer sheath.

28. The delivery device of claim 24, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley.

29. The delivery device of claim 28, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

30. The delivery device of claim 24, wherein the three concentric axes comprise: the inner core, the inner core being sized to receive a medical device thereon; the outer sheath being sized to receive and retain the medical device in an unexpanded state on the inner core, the outer sheath being coaxially translatable on the inner core; and The outer support shaft extends at least partially over the inner core and the outer sheath.

31. The delivery device of claim 24, wherein the inner core and the outer support shaft are fixed relative to a proximal end of the delivery device.

32. The delivery device of claim 24, further comprising a metal shaft at an outer diameter of the inner core.

33. The delivery device of claim 32, wherein the metal shaft is bonded to the outer diameter of the inner core.

34. The delivery device of claim 32, wherein the metal shaft comprises stainless steel.

35. The delivery device of claim 24, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that when the thumbwheel assembly is rotated in the forward direction, the outer sheath translates in a first direction, and when the thumbwheel assembly is rotated in the reverse direction, the outer sheath translates in a second direction.

36. A system for delivering an intraluminal stent, comprising: A delivery device, the delivery device comprising: A catheter having three concentric axes, the three concentric axes comprising: An inner core, wherein the inner core has the intraluminal stent; an outer sheath sleeved over the intraluminal stent, wherein the intraluminal stent is in an unexpanded state on the inner core therein, the outer sheath retaining the intraluminal stent in the unexpanded state, the outer sheath being capable of coaxially translating 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, the outer support shaft being fixed in place at a proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A flexible synchronous belt, wherein a plurality of belt teeth are provided on the surface of the flexible synchronous belt; a timing belt link directly coupled to the flexible timing belt and to the outer sheath such that movement of the timing belt link causes movement of the outer sheath to expose the intraluminal stent; a cylinder having cylinder teeth corresponding to the belt teeth; a thumb wheel assembly having two thumb wheels, wherein at least a portion of the thumb wheel assembly is integrated with the cylinder such that rotation of the thumb wheel assembly causes movement of the cylinder such that the cylinder teeth directly engage the belt teeth to cause movement of the flexible timing belt, thereby causing movement of the outer sheath; and wherein the cylinder is between the two thumb wheels, and the flexible timing belt is engaged with the cylinder between the two thumb wheels; and The cylinder and the two thumb wheels are rotatable about a common axis.

37. The system of claim 36, further comprising a housing, wherein a portion of the thumb wheel assembly is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the flexible timing belt is interior to the housing.

38. The system of claim 36, wherein the belt teeth are located on an outer surface of the flexible timing belt.

39. The system of claim 36, further comprising at least one pulley, the flexible timing belt extending around the pulley such that a rotational direction of the thumb wheel assembly imparts a desired translational direction to the outer sheath.

40. The system of claim 36, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley.

41. The system of claim 40, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

42. The system of claim 36, further comprising a metal shaft at an outer diameter of the inner core.

43. The system of claim 42, wherein the metal shaft is bonded to the outer diameter of the inner core.

44. The system of claim 42, wherein the metal shaft comprises stainless steel.

45. The system of claim 42, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that when the thumbwheel assembly is rotated in the forward direction, the outer sheath translates in a first direction, and when the thumbwheel assembly is rotated in the reverse direction, the outer sheath translates in a second direction.

46. ​​The system of claim 36, wherein the outer support shaft and the inner core are fixed relative to a proximal end of the delivery device.

47. A delivery device comprising: a catheter having three concentric shafts including an inner core, an outer sheath over the inner core, and an outer support shaft, the outer support shaft being fixed in place at the proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A flexible synchronous belt, wherein a plurality of belt teeth are provided on the surface of the flexible synchronous belt; a timing belt link coupled to the flexible timing belt and to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a cylinder having cylinder teeth corresponding to the belt teeth for directly engaging the belt teeth; and A thumb wheel assembly having two thumb wheels, wherein at least a portion of at least one of the thumb wheels is integrated with the cylinder, so that rotation of the thumb wheel assembly causes movement of the cylinder, so that the cylinder teeth directly engage the belt teeth to cause movement of the flexible timing belt and the timing belt chain links, thereby causing movement of the outer sheath, wherein the cylinder and the two thumb wheels are rotatable about a common axis.

48. The delivery device of claim 47, further comprising a housing, wherein a portion of the thumb wheel is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the flexible timing belt is interior to the housing.

49. The delivery device of claim 47, wherein the belt teeth are located on an outer surface of the flexible timing belt.

50. The delivery device of claim 47, further comprising at least one pulley, the flexible timing belt extending around the pulley such that a rotational direction of the thumb wheel imparts a desired translational direction to the outer sheath.

51. The delivery device of claim 47, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley, the belt tensioner contacting a portion of the flexible timing belt.

52. The delivery device of claim 51, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

53. The delivery device of claim 47, wherein the three concentric axes comprise: the inner core, the inner core being sized to receive a medical device thereon; the outer sheath being sized to receive and retain the medical device in an unexpanded state on the inner core, the outer sheath being coaxially translatable on the inner core; and The outer support shaft extends at least partially over the inner core and the outer sheath.

54. The delivery device of claim 47, wherein the inner core and the outer support shaft are fixed relative to a proximal end of the delivery device.

55. The delivery device of claim 47, further comprising a metal shaft at an outer diameter of the inner core.

56. The delivery device of claim 55, wherein the metal shaft is bonded to the outer diameter of the inner core.

57. The delivery device of claim 55, wherein the metal shaft comprises stainless steel.

58. The delivery device of claim 47, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that when the thumbwheel assembly is rotated in the forward direction, the outer sheath translates in a first direction, and when the thumbwheel assembly is rotated in the reverse direction, the outer sheath translates in a second direction.

59. A system for delivering an intraluminal stent, comprising: A delivery device, the delivery device comprising: A catheter having three concentric axes, the three concentric axes comprising: An inner core, wherein the inner core has the intraluminal stent; an outer sheath sleeved over the intraluminal stent, wherein the intraluminal stent is in an unexpanded state on the inner core therein, the outer sheath retaining the intraluminal stent in the unexpanded state, the outer sheath being capable of coaxially translating 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, the outer support shaft being fixed in place at a proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A flexible synchronous belt, wherein a plurality of belt teeth are provided on the surface of the flexible synchronous belt; a timing belt link coupled to the outer sheath so that movement of the timing belt link causes movement of the outer sheath to expose the intraluminal stent; a cylinder having cylinder teeth corresponding to the belt teeth; and A thumb wheel assembly having two thumb wheels, wherein at least a portion of at least one of the thumb wheels is integrated with the cylinder, so that rotation of the thumb wheel assembly causes movement of the cylinder, causing the cylinder teeth to engage with the belt teeth to cause movement of the flexible timing belt and the timing belt chain links, thereby causing movement of the outer sheath.

60. The system of claim 59, further comprising a housing, wherein a portion of the thumb wheel is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the flexible timing belt is interior to the housing.

61. The system of claim 59, wherein the belt teeth are located on an outer surface of the flexible timing belt.

62. The system of claim 59, further comprising at least one pulley, the flexible timing belt extending around the pulley such that a rotational direction of the thumb wheel assembly imparts a desired translational direction to the outer sheath.

63. The system of claim 59, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley, the belt tensioner contacting a portion of the flexible timing belt.

64. The system of claim 63, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

65. The system of claim 59, further comprising a metal shaft at an outer diameter of the inner core.

66. The system of claim 65, wherein the metal shaft is bonded to the outer diameter of the inner core.

67. The system of claim 65, wherein the metal shaft comprises stainless steel.

68. The system of claim 65, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that when the thumbwheel assembly is rotated in the forward direction, the sheath translates in a first direction, and when the thumbwheel assembly is rotated in the reverse direction, the sheath translates in a second direction.

69. The system of claim 59, wherein the outer support shaft and the inner core are fixed relative to the proximal end of the delivery device.

70. A delivery device comprising: a catheter having three concentric shafts including an inner core, an outer sheath over the inner core, and an outer support shaft, the outer support shaft being fixed in place at the proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A flexible timing belt, wherein the flexible timing belt is a continuous loop having an inner surface and an outer surface and having a plurality of belt teeth; a timing belt link coupled to the flexible timing belt and to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a cylinder having cylinder teeth corresponding to the belt teeth for directly engaging the belt teeth; and wherein an outer surface of the flexible timing belt is adjacent the cylinder such that the cylinder is outside of the area defined by the continuous loop; and A thumb wheel assembly having two thumb wheels, wherein at least a portion of the thumb wheel assembly is integrated with the cylinder so that rotation of the thumb wheel assembly causes movement of the cylinder so that the cylinder teeth directly engage with the belt teeth to cause movement of the flexible timing belt and the timing belt chain links, thereby causing movement of the outer sheath, wherein the cylinder and the two thumb wheels are rotatable about a common axis.

71. The delivery device of claim 70, further comprising a housing, wherein a portion of the thumb wheel is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the flexible timing belt is interior to the housing.

72. The delivery device of claim 70, wherein the belt teeth are located on an outer surface of the flexible timing belt.

73. The delivery device of claim 70, further comprising at least one pulley, the flexible timing belt extending around the pulley such that a rotational direction of the thumb wheel imparts a desired translational direction to the outer sheath.

74. The delivery device of claim 70, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley.

75. The delivery device of claim 74, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

76. The delivery device of claim 70, wherein the three concentric axes comprise: the inner core, the inner core being sized to receive a medical device thereon; the outer sheath being sized to receive and retain the medical device in an unexpanded state on the inner core, the outer sheath being coaxially translatable on the inner core; and The outer support shaft extends at least partially over the inner core and the outer sheath.

77. The delivery device of claim 70, wherein the inner core and the outer support shaft are fixed relative to the proximal end of the delivery device.

78. The delivery device of claim 70, further comprising a metal shaft at an outer diameter of the inner core.

79. The delivery device of claim 78, wherein the metal shaft is bonded to the outer diameter of the inner core.

80. The delivery device of claim 78, wherein the metal shaft comprises stainless steel.

81. The delivery device of claim 70, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that when the thumbwheel assembly is rotated in the forward direction, the outer sheath translates in a first direction, and when the thumbwheel assembly is rotated in the reverse direction, the outer sheath translates in a second direction.

82. A system for delivering an intraluminal stent, comprising: A delivery device, the delivery device comprising: A catheter having three concentric axes, the three concentric axes comprising: An inner core, wherein the inner core has the intraluminal stent; an outer sheath sleeved over the intraluminal stent, wherein the intraluminal stent is in an unexpanded state on the inner core therein, the outer sheath retaining the intraluminal stent in the unexpanded state, the outer sheath being capable of coaxially translating 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, the outer support shaft being fixed in place at a proximal end of the delivery device and configured to stiffen the delivery device, the outer sheath being configured to coaxially translate over the inner core and within the outer support shaft; A flexible timing belt, wherein the flexible timing belt is a continuous loop having an inner surface and an outer surface and having a plurality of belt teeth; a timing belt link coupled to the outer sheath so that movement of the timing belt link causes movement of the outer sheath to expose the intraluminal stent; a cylinder having cylinder teeth corresponding to the belt teeth, and wherein an outer surface of the flexible timing belt is adjacent the cylinder such that the cylinder is outside of the area defined by the continuous loop; and A thumb wheel assembly having two thumb wheels, wherein at least a portion of the thumb wheel assembly is integrated with the cylinder, so that rotation of the thumb wheel assembly causes movement of the cylinder, so that the cylinder teeth directly engage with the belt teeth to cause movement of the flexible timing belt and the timing belt chain links, thereby causing movement of the outer sheath.

83. The system of claim 82, further comprising a housing, wherein a portion of the thumb wheel is exterior to the housing, wherein the cylinder is interior to the housing, and wherein the flexible timing belt is interior to the housing.

84. The system of claim 82, wherein the belt teeth are located on an outer surface of the flexible timing belt.

85. The system of claim 82, further comprising at least one pulley, the flexible timing belt extending around the pulley such that a rotational direction of the thumb wheel assembly imparts a desired translational direction to the outer sheath.

86. The system of claim 82, further comprising a belt tensioner comprising a torsion spring, a tensioner arm, and a tensioner pulley.

87. The system of claim 86, the belt tensioner further comprising a tensioner arm shaft and a tensioner pulley shaft.

88. The system of claim 82, further comprising a metal shaft at an outer diameter of the inner core.

89. The system of claim 88, wherein the metal shaft is bonded to the outer diameter of the inner core.

90. The system of claim 88, wherein the metal shaft comprises stainless steel.

91. The system of claim 82, wherein the thumbwheel assembly is rotatable in a forward direction and a reverse direction such that when the thumbwheel assembly is rotated in the forward direction, the sheath translates in a first direction, and when the thumbwheel assembly is rotated in the reverse direction, the sheath translates in a second direction.

92. The system of claim 82, wherein the outer support shaft and the inner core are fixed relative to a proximal end of the delivery device.

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