WO2022243077A1

WO2022243077A1 - Stent delivery system with selective stiffness control

Info

Publication number: WO2022243077A1
Application number: PCT/EP2022/062417
Authority: WO
Inventors: Andrew Scherer; Cedar Decker; Scott Robert Wilson; Jake MERTENS
Original assignee: Koninklijke Philips N.V.
Priority date: 2021-05-18
Filing date: 2022-05-09
Publication date: 2022-11-24

Abstract

A delivery device (10) for delivering an associated self-expanding vascular therapy device (2) into a blood vessel includes a catheter (12). A containment sheath (14) has a sheath opening (16) disposed at an end thereof. The catheter is disposed inside the containment sheath and movable through the containment sheath. An annular lumen (22) is defined between the catheter and the containment sheath and configured to contain a self-expanding vascular therapy device (2). A gearing mechanism (28) is configured to control forward movement of the catheter through the containment sheath and backward movement of the containment sheath in an opposing direction from the forward movement of the catheter. The gearing mechanism is configured to adjust a ratio of a speed of the forward movement of the catheter and a speed of the backward movement of the containment sheath.

Description

STENT DELIVERY SYSTEM WITH SELECTIVE STIFFNESS CONTROL

FIELD

[0001] The following relates generally to the catheter arts, thrombectomy arts, atherectomy arts, catheter deployment arts, and related arts.

BACKGROUND

[0002] Expandable, metal support structures delivered via intravascular devices are commonly used in the treatment of intravascular disease (i.e., arterial and venous), as well as in larger regions of the anatomy such as the esophagus, biliary, and pulmonary systems. The optimal mechanical properties of the support structure differ for treatment of different anatomical areas and different disease states. Even within a single anatomical location and treatment site, there is sometimes the desire to have a structure with varied properties along its length to optimally treat the disease state. In current expandable metal support structures, the profile of mechanical properties for the structure is pre-defmed by the design of the structure and cannot be readily manipulated during deployment to be customized to an individual disease state.

[0003] The following discloses certain improvements.

SUMMARY

[0004] In some embodiments disclosed herein, a delivery device for delivering an associated self-expanding vascular therapy device into a blood vessel includes a catheter. A containment sheath has a sheath opening disposed at an end thereof. The catheter is disposed inside the containment sheath and movable through the containment sheath. An annular lumen is defined between the catheter and the containment sheath and configured to contain a self expanding vascular therapy device. A gearing mechanism is configured to control forward movement of the catheter through the containment sheath and backward movement of the containment sheath in an opposing direction from the forward movement of the catheter. The gearing mechanism is configured to adjust a ratio of a speed of the forward movement of the catheter and a speed of the backward movement of the containment sheath.

[0005] In some embodiments disclosed herein, a vascular therapy apparatus includes a self-expanding vascular therapy device, and a delivery device for delivering the self-expanding vascular therapy device into a blood vessel. The delivery device includes a catheter and a containment sheath having a sheath opening disposed at an end thereof. The catheter is disposed inside the containment sheath and movable through the containment sheath. An annular lumen is defined between the catheter and the containment sheath and configured to contain the self expanding vascular therapy device. A gearing mechanism is configured to control forward movement of the catheter through the containment sheath and backward movement of the containment sheath in an opposing direction from the forward movement of the catheter. The gearing mechanism is configured to adjust a ratio of a speed of the forward movement of the catheter and a speed of the backward movement of the containment sheath.

[0006] In some embodiments disclosed herein, a delivery device for delivering an associated self-expanding vascular therapy device into a body lumen includes a catheter. A containment sheath has a sheath opening disposed at an end thereof. The catheter is disposed inside the containment sheath and movable through the containment sheath. An annular lumen is defined between the catheter and the containment sheath and configured to contain a self expanding vascular therapy device. A gearing mechanism is configured to control forward movement of the catheter through the containment sheath and backward movement of the containment sheath in an opposing direction from the forward movement of the catheter. The gearing mechanism is configured to adjust a ratio of a speed of the forward movement of the catheter and a speed of the backward movement of the containment sheath.

[0007] One advantage resides in providing an intravascular support structure having mechanical properties along its length that can be varied during deployment.

[0008] Another advantage resides in providing an intravascular support structure having mechanical properties along its length that can be varied at an intravascular treatment site.

[0009] Another advantage resides in providing the surgeon with increased flexibility in deployment of an intravascular support structure.

[0010] Another advantage resides in providing an intravascular delivery device in which can vary the relative speeds of the catheter and the outer containment sheath moving in opposing directions.

[0011] A given embodiment may provide none, one, two, more, or all of the foregoing advantages, and/or may provide other advantages as will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the disclosure. [0013] FIGURE 1 diagrammatically illustrates a vascular therapy apparatus in accordance with the present disclosure.

[0014] FIGURE 2 diagrammatically illustrates a delivery device of the apparatus of

FIGURE 1.

[0015] FIGURE 3 diagrammatically illustrates another view of the delivery device of

FIGURE 2.

[0016] FIGURE 4 diagrammatically illustrates another view of the delivery device of

FIGURE 2.

[0017] FIGURE 5 diagrammatically illustrates a therapy device disposed in a patient.

[0018] FIGURE 6 diagrammatically illustrates another view of a clutch of the delivery device of FIGURE 2.

[0019] FIGURE 7 diagrammatically illustrates another embodiment of the delivery device of FIGURE 2.

[0020] FIGURE 8 diagrammatically illustrates a method of performing a vascular therapy method using the apparatus of FIGURE 1.

DETAILED DESCRIPTION

[0021] The following relates to systems and methods for delivering a self-expanding stent or other self-expanding vascular therapy device (e.g., a self-expanding filter). Existing stent delivery systems typically include an inner catheter and an outer containment sheath. The stent is collapsed to fit inside the outer sheath, and the inner catheter includes a stopping feature (e.g., a ledge) that limits how far the stent can move into the interior of the sheath. When the catheter reaches the deployment location, the handle provides a mechanism for pulling the sheath back, thus deploying the stent. Hence, the usual design simply includes a lever or equivalent mechanism for drawing the sheath back.

[0022] Such delivery devices can have a problem known as foreshortening, in which the expansion of the self-expanding stent causes the length of the stent to decrease. Since the foreshortening occurs at the open end of the sheath where the stent is expanding, the overall effect is to move the stent away from the original target placement location. To address this, a gearing mechanism that moves the inner catheter forward concurrently with the sheath being drawn back can be provided. By designing the mechanism to provide an optimal ratio of forward movement of the inner catheter versus backward (withdrawal) movement of the sheath, the result is that the foreshortening effect is reduced or eliminated. [0023] In some embodiments disclosed herein, a modified mechanism is disclosed, which can be used to remediate foreshortening but can additionally or alternatively address a different problem. Depending on the deployment site, it is recognized herein that it is often beneficial for the stiffness of the stent to vary along the length of the stent. For example, if the stent is being placed in a vein that is being compressed by a crossing artery, then increased stiffness at that crossing would be beneficial. Existing deployment approaches cannot provide user-controlled stiffness variation along the deployed stent.

[0024] The present approaches for enabling the surgeon or other operator to control stiffness along the deployed self-expanding vascular therapy device are based on certain observations. If the inner catheter (sometimes referred to herein as the “catheter”) is moved forward while the outer sheath (sometimes referred to herein as the “containment sheath”) is held fixed, then this action pushes the stent out, leading to local bunching up of the stent. As recognized herein, this beneficially produces increased stiffness in those areas of local bunching of the deployed stent. To accomplish this, a mechanism to remediate foreshortening is modified so that the ratio of movement speed of the inner catheter and outer sheath is adjustable. In one approach, a user-operable clutch (e.g., engaged by pressing a button on the handle) is provided to disengage and stop the sheath withdrawal while continuing the advancement of the inner catheter. The clutch can take various forms, such as an illustrative approach in which the push button drives a wedge against the outer sheath pulley gear to move it off the rotating axis. Other clutch designs could employ split axles for the inner catheter and sheath pulleys, or so forth. [0025] In other embodiments disclosed herein, the handle may provide separate rotary controls for advancing the inner catheter and for drawing back the outer sheath. In this approach, the operator can independently control the catheter advancement and the containment sheath withdrawal, and hence can manually introduce bunching by dexterous control of the two rotary controls. The stent deployment is usually done under fluorescence image-guidance, which has sufficient resolution of the stent to enable the operator to see the bunching of the stent.

[0026] While designed for stent deployment in arteries or veins, the disclosed approaches could be used for other self-expanding implants such as filters, and/or for implanting a stent or other self-expanding implant in another anatomical region such as an esophagus.

[0027] With reference to FIGURE 1, an illustrative vascular therapy (i.e., thrombectomy or atherectomy) apparatus 1 is diagrammatically shown. As shown in FIGURE 1, the apparatus 1 includes a delivery device 10 for delivering a self-expanding vascular therapy device 2 (e.g., a self-expanding stent, a self-expanding filter, and so forth) into a blood vessel. The delivery device 10 includes a catheter 12 surrounded by a containment catheter (also referred to herein as a containment sheath, or simply as a sheath) 14. The illustrative containment catheter 14 surrounds the catheter 12 (i.e., the catheter 12 is an inner catheter relative to the containment sheath 14). The catheter 12 is movable in a longitudinal forward (i.e., advancement) translation direction F denoted in FIGURE 1 within the containment sheath 14. The containment sheath 14 is movable in an opposite longitudinal backward (i.e. withdrawal) translation direction B denoted in FIGURE 1. At one end of the containment sheath 14 is a sheath opening 16 through which the distal end of the catheter 12 can move into and out of the containment sheath 14. Additionally, a stop 20 secured to the catheter 12 prevents the self-expanding vascular therapy device 2 from moving backward along the catheter 12 beyond the point of the stop 20. Hence, as the catheter 12 advances along the forward direction F the self-expanding vascular therapy device 2 is carried along with the moving catheter 12 in the forward direction F; and similarly, the stop 20 prevents the opposite backward movement B of the containment sheath 14 from dragging the self-expanding vascular therapy device 2 backward past the stop 20.

[0028] An annular lumen 22 is defined between the catheter 12 and the containment sheath 14. The annual lumen 22 is configured (e.g., of suitable inner and outer diameters as defined by the outer diameter of the catheter 12 and inner diameter of the sheath 14 respectively) to contain the self-expanding vascular therapy device 2. In some embodiments, one or both of the catheter 12 and/or the containment sheath 14 can comprise a radiopaque material viewable during fluorescence image-guidance of the self-expanding vascular therapy device 2 through a target tissue (i.e., arterial tissue, venous tissue, the esophagus, the biliary system, the pulmonary system, and so forth).

[0029] With reference now to FIGURE 2, and with continuing reference to FIGURE 1, the delivery device 10 also includes a handle 24, and the catheter 12 and the containment sheath 14 are operatively connected to a distal end of the handle 24. The handle 24 includes a button 26 pressable by a user to control motion of the catheter 12 and/or the containment sheath 14, as described herein. The forward movement F of the catheter 12 and the backward movement B of the containment sheath 14 can be viewed as measured relative to the position of the handle 24. Put another way, the advancement of the catheter 12 in the forward direction F can be viewed as extending the catheter 12 out of the handle 24; while the backward movement B of the sheath 14 can be viewed as retracting the sheath 14 back into the handle 14.

[0030] FIGURE 2 also shows a gearing mechanism 28 configured to control forward movement of the catheter 12 through the containment sheath 14 and backward movement of the containment sheath 14 in an opposing direction from the forward movement of the catheter 12. The movement of both the catheter 12 and the containment sheath 14 is relative to the handle 24 (i.e., into, out of, or through the handle 24 The gearing mechanism 28 can be disposed on or in a portion of the handle 24 0031 With continuing reference to FIGURES 1 and 2, FIGURE 3 shows the delivery device 10 with a portion of the handle 24 (i.e., a cover) removed, and internal components of the

5 delivery device 10 are shown. The gearing mechanism 28 is configured to adjust a ratio of a speed of the forward movement of the catheter 12 and a speed of the backward movement of the containment sheath 14 To do so, the gearing mechanism 28 can include a thumbwheel 32 disposed externally on a portion of the handle 26 The thumbwheel 32 is operatively connected or engaged with one or more components disposed in internally in a portion of the handle 26 for

10 example by way of control wires, to drive movement of the catheter 12 and the containment sheath 14 As shown in FIGURE 3, the gearing mechanism 28 includes a containment sheath pulley or gear 34 operatively engaged with the containment sheath 14 (not shown in FIGURE 3) by way of a control wire and driven by a first rotating axle 36 A first shuttle 38 is connected to the containment sheath 14 and configured to drive backward movement of the containment

15 sheath 14 relative to the handle 24 while a user manually moves the thumbwheel 32 The gearing mechanism 28 also includes a catheter pulley or gear 40 operatively engaged with the catheter 12 (not shown in FIGURE 3) by way of a control wire and driven by a second rotating axle 42 A second shuttle 44 is connected to the catheter 12 and configured to drive forward movement of the catheter 12 relative to the handle 24 while a user manually moves the

20 thumbwheel 32 0032 FIGURE 4 shows the button 26 and the gearing mechanism 28 in more detail.

The button 26 includes a clutch 46 configured to prevent the backward movement of the containment sheath 14 while continuing the forward movement of the catheter 12 during movement of the thumbwheel 32 by the user. The clutch 46 is engaged when the user presses

25 the button 26 As shown in FIGURE, 4 the clutch 46 includes a wedge 48 engageable with the containment sheath gear 34 and the catheter gear 40 (not shown in FIGURE 4 but is disposed “behind” the thumbwheel 32 when the user presses the button 26 to alter disengage a corresponding one of the containment sheath 14 and the catheter 12 from the respective first rotating axle 36 or the second rotating axle 42

30 0033 In a particular example, upon a first pressing of the button 26 by the user, the wedge 48 is pressed against, for example, the containment sheath gear 34 to alter a path of the selected containment sheath gear 34 off a rotating axis defined by the first rotating axle 36 (i.e., the containment sheath 14 is now “locked” and cannot move). The user can then operate the thumbwheel 32 to control movement of the catheter 12 relative to the handle 24 The user can then press the button 26 a second time, in which case the wedge 48 disengages the containment sheath gear 34 and is pressed against the catheter gear 40 to alter a path of the catheter gear 40 off a rotating axis defined by the second rotating axle 36. The user can then operate the thumbwheel 32 to move the containment sheath 14, while the catheter 12 is now “locked” and cannot move. Advantageously, this helps prevent foreshortening of the containment sheath 14. It will be appreciated that the order in this example can be reserved (i.e., the catheter 12 is locked first while the containment sheath 14 is moved, and then the containment sheath 14 is locked while the catheter 12 is moved).

[0034] FIGURE 5 depicts a concept of controlling a stiffness of the self-expanding vascular therapy device 2 along a length thereof. As shown in FIGURE 5, a self-expanding vascular therapy device 2 is shown disposed in a vein V, located under artery A. The self expanding vascular therapy device 2 has an “uncompressed” configuration U at both ends thereof, and a middle portion M in a “compressed” configuration C against an artery A. The independent forward movement of the catheter 12, while independently holding the containment sheath 14 fixed, creates a compressed or “bunched” configuration section, which increases the stiffness of the self-expanding vascular therapy device 2 under the artery A.

[0035] FIGURE 6 shows another embodiment of the clutch 46. As shown in FIGURE 6, the clutch 46 includes the wedge 48 disposed on the button 26. A first slot 50 is disposed on a portion of the containment sheath gear 34 (two of which are shown in FIGURE 6), and a second slot 52 is disposed on a portion of the button 26, and a second wedge 54 is disposed on a portion catheter gear 40. Both slots 50, 52 are sized and dimensioned to accommodate a corresponding wedge 48, 54. Upon a first pressing of the button 26, the wedge 48 on the button 26 engages the first slot 50 on the containment sheath gear 34, thereby locking the containment sheath 14. The catheter 12 can then be moved by operating the thumbwheel 32 (not shown in FIGURE 6). Upon a second pressing of the button 26, the wedge 48 on the button 26 disengages the first slot 50 on the containment sheath gear 34, and the second wedge 52 engages the second slot 50, thereby locking the catheter 12. As shown in FIGURE 6, the button 26, the containment sheath gear 34, and the catheter gear 40 are mounted on a third axle 56.

[0036] FIGURE 7 shows another embodiment of the delivery device 10 As shown in

FIGURE 6, the button 26 and the thumbwheel 32 are replaced with a catheter rotary control 58 configured to control the forward movement of the catheter 12 by way of a pulley 59 driving a guide wire connected with the catheter 12 (not shown in FIGURE 7), and a containment sheath rotary control 60 configured to control the backward movement of the containment sheath 14 by way of a pulley 61 driving a guide wire connected with the catheter 12 (not shown in FIGURE 7). independently of the forward movement of the catheter 12. Both the catheter rotary control 58 and the containment sheath rotary control 60 are manually operable by a user to control movement of the catheter 12 and the containment sheath 14, respectively. The catheter rotary control 58 is configured to engage with the catheter gear 40 (not shown in FIGURE 7) to control movement of the catheter 12, and the containment sheath rotary control 60 is configured to engage with the containment sheath gear 34 (not shown in FIGURE 7) to control movement of the containment sheath 14. In the illustrative embodiment, the catheter rotary control 58 and the sheath rotary control 60 are placed in a line so as to be intuitively positioned, i.e., moving the forward-positioned catheter rotary control 58 moves the catheter 12 in the forward direction F, while moving the rearward-positioned sheath rotary control 60 moves the sheath 14 in the backward (i.e., retraction) direction B ( cf FIGURE 1).

[0037] FIGURE 8 shows an example of a flowchart showing a vascular therapy method

100 using the therapy apparatus 1. To begin the method 100, in an operation 102 the delivery device 10 is inserted into a target tissue (e.g., an artery or vein or esophagus of the patient). The operator typically observes the position of the self-expanding vascular therapy device 2 under fluorescence image-guidance during the operation 102 as it approaches the delivery site (for example, an obstruction in the artery in the case of an atherectomy procedure). When the device 2 is at the delivery site, at an operation 104, the catheter 12 is moved forward in the target tissue. At an operation 106 performed simultaneously with the operation 104, the containment sheath 14 is moved backwards in the target tissue. In an operation 108 concurrent with the simultaneous operations 104, 106, the operator observes the deployment of the self-expanding vascular therapy device 2 via fluorescence image guidance or another suitable imaging modality. The fluorescence image-guidance 108 preferably images the self-expanding vascular therapy device 2 with sufficient resolution of to enable the operator to see the extent of (or lack of) bunching of the self-expanding vascular therapy device 2 during the delivery. At an operation 110, the operator adjusts the ratio of the speed of the forward movement of the catheter in operation 104 and the speed of the backward movement of the containment sheath in the operation 106 to achieve a desired amount of bunching, with more bunching being provided in areas where the operator decides the self-expanding vascular therapy device 2 should have greater stiffness and less (or no) bunching in areas where the operator decides the self-expanding vascular therapy device 2 should have less stiffness. The concurrent operations 104, 106, 108, 110 are performed until the self-expanding vascular therapy device 2 is completely deployed, after which in an operation 112 the delivery device is retracted (e.g., withdrawn from the artery into which it was inserted). [0038] The disclosure has been described with reference to the preferred embodiments.

Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiment be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

CLAIMS:

1. A delivery device (10) for delivering an associated self-expanding vascular therapy device (2) into a blood vessel, the delivery device comprising: a catheter (12); a containment sheath (14) having a sheath opening (16) disposed at an end thereof, the catheter being disposed inside the containment sheath and movable through the containment sheath; an annular lumen (22) defined between the catheter and the containment sheath and configured to contain a self-expanding vascular therapy device (2); and a gearing mechanism (28) configured to control forward movement of the catheter through the containment sheath and backward movement of the containment sheath in an opposing direction from the forward movement of the catheter; wherein the gearing mechanism is configured to adjust a ratio of a speed of the forward movement of the catheter and a speed of the backward movement of the containment sheath.

2. The delivery device (10) of claim 1, further comprising: a handle (24); wherein the catheter (12) and the containment sheath (14) are operatively connected to a distal end of the handle, and the gearing mechanism (28) is disposed on or in a portion of the handle.

3. The delivery device (10) of claim 2, wherein the gearing mechanism (28) comprises: a clutch (46) configured to prevent the backward movement of the containment sheath (14) while continuing the forward movement of the catheter (12).

4. The delivery device (10) of claim 3, wherein the handle (24) includes a button (26) pressable by a user; wherein the clutch (46) is engaged when a user presses the button.

5. The delivery device (10) of claim 4, wherein: the gearing mechanism (28) includes a containment sheath pulley or gear (34) operatively engaged with the containment sheath (14) and driven by a rotating axle (36); and the clutch (46) comprises a wedge (48) pressed against the containment sheath pulley or gear when a user presses the button (26) to disengage the containment sheath pulley or gear from the rotating axle.

6. The delivery device (10) of claim 5, wherein the gearing mechanism (28) includes: a catheter pulley or gear (40) operatively engaged with the catheter (12); a first axle (42) operatively engaged with the catheter pulley or gear (40); and a second axle (36) operatively engaged with the containment sheath pulley or gear.

7. The delivery device (10) of claim 6, wherein, upon a first pressing of the button (26) by the user, the wedge (48) is pressed against a selected one of the containment sheath pulley or gear (34) and the catheter pulley or gear (40) to alter a path of the selected pulley gear off a rotating axis; and upon a second pressing of the button by the user, the wedge is pressed against the other one of the containment sheath pulley gear and the catheter pulley gear to alter a path of the other pulley gear off a rotating axis.

8. The delivery device (10) of claim 2, wherein the gearing mechanism (28) comprises: a catheter rotary control (58) configured to control the forward movement of the catheter (12); and a containment sheath rotary control (60) configured to control the backward movement of the containment sheath (14) independently of the forward movement of the catheter.

9. The delivery device (10) of any one of claims 1-8, further comprising: a seat (20) attached to a distal end of the catheter (12), the seat engaging the associated self-expanding vascular therapy device (2) to prevent backward movement of the associated self- expanding vascular therapy device relative to the catheter during the forward movement of the catheter.

10. A vascular therapy apparatus (1), comprising: a self-expanding vascular therapy device (2); and a delivery device (10) for delivering the self-expanding vascular therapy device into a blood vessel, the delivery device comprising: a catheter (12); a containment sheath (14) having a sheath opening (16) disposed at an end thereof, the catheter being disposed inside the containment sheath and movable through the containment sheath; an annular lumen (22) defined between the catheter and the containment sheath and configured to contain the self-expanding vascular therapy device; and a gearing mechanism (28) configured to control forward movement of the catheter through the containment sheath and backward movement of the containment sheath in an opposing direction from the forward movement of the catheter; wherein the gearing mechanism is configured to adjust a ratio of a speed of the forward movement of the catheter and a speed of the backward movement of the containment sheath.

11. The vascular therapy apparatus (1) of claim 10, wherein the delivery device (10) further comprises: a handle (24); wherein the catheter (12) and the containment sheath (14) are operatively connected to a distal end of the handle, and the gearing mechanism (28) is disposed on or in a portion of the handle.

12. The vascular therapy apparatus (1) of claim 11, wherein the gearing mechanism (28) comprises: a clutch (46) configured to prevent the backward movement of the containment sheath (14) while continuing the forward movement of the catheter (12).

13. The vascular therapy apparatus (1) of claim 12, wherein the handle (24) includes a button (26) pressable by a user; wherein the clutch (46) is engaged when a user presses the button.

14. The vascular therapy apparatus (1) of claim 13, wherein: the gearing mechanism (28) includes a containment sheath pulley or gear (34) operatively engaged with the containment sheath (14) and driven by a rotating axle (36); and the clutch (46) comprises a wedge (48) pressed against the containment sheath pulley or gear when a user presses the button (26) to disengage the containment sheath pulley or gear from the rotating axle.

15. The vascular therapy apparatus (1) of claim 14, wherein the gearing mechanism (28) includes: a catheter pulley or gear (40) operatively engaged with the catheter (12); a first axle (42) operatively engaged with the catheter pulley or gear (40); and a second axle (36) operatively engaged with the containment sheath pulley or gear.

16. The vascular therapy apparatus (1) of claim 15, wherein, upon a first pressing of the button (26) by the user, the wedge (48) is pressed against a selected one of the containment sheath pulley or gear (34) and the catheter pulley or gear (40) to alter a path of the selected pulley gear off a rotating axis; and upon a second pressing of the button by the user, the wedge is pressed against the other one of the containment sheath pulley gear and the catheter pulley gear to alter a path of the other pulley gear off a rotating axis.

17. The vascular therapy apparatus (1) of claim 10, wherein the gearing mechanism (28) comprises: a catheter rotary control (58) configured to control the forward movement of the catheter (12); and a containment sheath rotary control (60) configured to control the backward movement of the containment sheath (14) independently of the forward movement of the catheter.

18. The vascular therapy apparatus (1) of any one of claims 10-17, wherein the delivery device (10) further comprises: a seat (20) attached to a distal end of the catheter (12), the seat engaging the associated self-expanding vascular therapy device (2) to prevent backward movement of the associated self- expanding vascular therapy device relative to the catheter during the forward movement of the catheter.

19. A delivery device (10) for delivering an associated self-expanding vascular therapy device (2) into a body lumen, the delivery device comprising: a catheter (12); a containment sheath (14) having a sheath opening (16) disposed at an end thereof, the catheter being disposed inside the containment sheath and movable through the containment sheath; an annular lumen (22) defined between the catheter and the containment sheath and configured to contain a self-expanding vascular therapy device (2); and a gearing mechanism (28) configured to control forward movement of the catheter through the containment sheath and backward movement of the containment sheath in an opposing direction from the forward movement of the catheter; wherein the gearing mechanism is configured to adjust a ratio of a speed of the forward movement of the catheter and a speed of the backward movement of the containment sheath.

20 The delivery device (10) of claim 19, further comprising: a handle (24); wherein the catheter (12) and the containment sheath (14) are operatively connected to a distal end of the handle, and the gearing mechanism (28) is disposed on or in a portion of the handle.