阅读说明：本技术 具有精细指轮控制和快速曲柄手柄的支架递送导管 (Stent delivery catheter with fine thumbwheel control and quick crank handle ) 是由 P.哈伯特 M.吉尔 S.希金森 于 2018-09-12 设计创作，主要内容包括：用于支架递送设备的各种实施例,该支架递送设备在诸如支架或支架移植物的自扩张植入设备的递送过程中使用第一致动模式用于外护套的缓慢撤回并且使用第二致动模式用于外护套的快速撤回。(Various embodiments for a stent delivery apparatus that uses a first actuation mode for slow withdrawal of an outer sheath and a second actuation mode for rapid withdrawal of the outer sheath during delivery of a self-expanding implant device such as a stent or stent graft.)

1. A stent delivery system comprising

A catheter tip coupled to and disposed between the inner and outer sheaths, the inner and outer sheaths extending from the distal end to the proximal end;

a housing extending along a longitudinal axis from a first end to a second end;

a sharp member disposed in the housing and configured to cut the outer sheath along a surface of the outer sheath;

a spool hub mounted in the housing and configured to wind the outer sheath after the outer sheath is cut by the sharp member; and

a wheel mounted on the housing and coupled to the hub such that rotation of the wheel causes the outer sheath to move relative to the inner shaft along the longitudinal axis toward the second end, wherein the wheel is configured for a first actuation mode that ergonomically facilitates translation of the outer shaft at a first rate, and for a second actuation mode that ergonomically facilitates translation of the outer shaft at a second rate that is greater than the first rate.

2. The stent delivery system of claim 1, further comprising a crank arm mounted to the wheel such that continuous rotation of the crank arm causes the outer sheath to move along the longitudinal axis toward the second end relative to the inner shaft, wherein the first actuation mode comprises directly manipulating the wheel and the second actuation mode comprises manipulating the crank arm.

3. The stent delivery system of claim 2, wherein the crank arm is mounted to the wheel and the crank arm has a length at least equal to a radius of the wheel.

4. The stent delivery system of claim 2, wherein the crank arm is mounted on a pivot near the circumference of the wheel such that the crank arm can be folded into a groove formed on the wheel surface to present a substantially continuous surface.

5. The stent delivery system of claim 1, wherein the tubular member is coupled to the outer sheath at a location distal to the sharp member.

6. The stent delivery system of claim 1, wherein the hypotube is coupled to the outer sheath at a location distal to the sharp member.

7. The stent delivery system of claim 1, wherein the coil spring is mounted in the housing, one end of the coil spring is connected to the wheel, and the other end of the coil spring is connected to the housing or the outer sheath.

8. The stent delivery system of claim 1, wherein the wheel is mounted substantially flush with respect to a side surface of the housing.

9. A stent delivery system comprising:

a housing extending along a longitudinal axis from a first end to a second end;

an outer sheath configured to move along a longitudinal axis and to hold a stent;

a sharp member disposed in the housing and configured to separate the outer sheath along a surface of the outer sheath;

a spool hub mounted in the housing and configured to wind the outer sheath after the outer sheath is cut by the sharp member; and

a wheel mounted on the housing and coupled to the hub such that rotation of the wheel causes the outer sheath to move relative to the inner shaft along the longitudinal axis toward the second end to release the stent, wherein the wheel is configured for a first actuation mode that ergonomically facilitates translation of the outer shaft at a first rate and for a second actuation mode that ergonomically facilitates translation of the outer shaft at a second rate that is greater than the first rate.

10. The stent delivery system of claim 9, further comprising a crank arm mounted to the wheel such that continuous rotation of the crank arm causes the outer sheath to move along the longitudinal axis toward the second end relative to the inner shaft, wherein the first actuation mode comprises directly manipulating the wheel and the second actuation mode comprises manipulating the crank arm.

11. The stent delivery system of claim 10, wherein the crank arm is mounted to the wheel and the crank arm has a length at least equal to a radius of the wheel.

12. The stent delivery system of claim 10, wherein the crank arm is mounted on a pivot near the circumference of the wheel such that the crank arm can be folded into a groove formed on the wheel surface to present a substantially continuous surface.

13. The stent delivery system of claim 9, wherein the tubular member is coupled to the outer sheath at a location distal to the sharp member.

14. The stent delivery system of claim 9, wherein the hypotube is coupled to the outer sheath at a location distal to the sharp member.

15. The stent delivery system of claim 9, wherein the coil spring is mounted in the housing, one end of the coil spring is connected to the wheel, and the other end of the coil spring is connected to the housing or the outer sheath.

16. The stent delivery system of claim 9, wherein the wheel is mounted substantially flush with respect to a side surface of the housing.

17. A method of delivering a self-expanding stent to a selected location in a body vessel, the method comprising:

moving a stent to a selected location in the body vessel, the stent disposed near the catheter tip and constrained between the inner shaft and the outer sheath at the distal end of the delivery system;

winding the outer sheath such that the outer sheath is moved relative to the inner shaft in a proximal direction from the distal end of the delivery system using a first actuation mode that ergonomically facilitates translating the outer shaft at a first rate to allow a portion of the self-expanding stent to expand into a bodily vessel;

cutting through at least an outer surface of the outer jacket to substantially flatten the outer jacket; and is

The substantially flattened outer sheath is rotated using a second mode of actuation that ergonomically facilitates translating the outer shaft at a second rate that is greater than the first rate, thereby moving the outer sheath relative to the inner shaft in a proximal direction from the distal end of the delivery system to allow full deployment of the self-expanding stent in the bodily vessel.

18. The method of claim 17, wherein the first actuation mode comprises directly manipulating the wheel to cause the outer sheath to move relative to the inner shaft, further comprising reconfiguring the wheel, wherein the second actuation mode comprises manipulating the reconfigured wheel.

19. The method of claim 18, wherein reconfiguring the wheel comprises deploying a crank arm of the wheel.

20. The method of claim 17, further comprising winding the substantially flattened outer sheath using the first actuation mode prior to rotating the substantially flattened outer sheath using the second actuation mode.

Background

Various endovascular endoprostheses using percutaneous delivery are known for treating various diseases of the body's blood vessels. These types of endoprostheses are commonly referred to as "stents". Stents (including covered stents or stent grafts) are generally longitudinal tubular devices of biocompatible materials (e.g., stainless steel, cobalt-chromium alloys, nickel-titanium alloys or biodegradable materials) with holes or slots cut therein to define a flexible framework so that they can be radially expanded by a balloon catheter or the like, or alternatively self-expanded within a biological vessel due to the shape memory properties of their materials. The holder is typically constructed as a series of hoops, each hoop being defined by a cylindrical frame. The frame is typically a series of alternating sequences of struts with one apex between each pair of struts and is configured such that the apexes of one hoop facing the apexes of an adjacent hoop may be connected together. The struts are configured to move and thereby allow the stent to be compressed or "crimped" into a smaller outer diameter so that it can be installed inside a delivery system.

The delivery system is used to deliver the stents to the desired treatment site and then deploy them into position. Many such stents are resiliently compressed to a smaller initial size for containment, protection, storage, and eventual delivery from within the catheter system. Upon deployment, the stent may elastically self-expand to a larger deployed size.

A successful example of a delivery catheter system for a self-expanding stent in this case is described in U.S. patent No.6,019,778 entitled "delivery instrument for a self-expanding stent" to Wilson et al, 2/1/2000. The disclosure of this patent is incorporated by reference into the present application and generally discloses a flexible catheter system (which is shown in representative schematic form in fig. 10 of Wilson) comprising coaxially arranged inner and outer catheter members, each having a hub attached to its proximal end. The outer sheath is described in the' 778 patent as an elongated tubular member having a distal end and a proximal end made of an outer polymer layer, an inner polymer layer, and a braided reinforcing layer therebetween. The inner shaft is described in the' 778 patent as being coaxially located within the outer sheath and having a flexible, tapered distal end that extends generally distally beyond the distal end of the outer sheath. The inner shaft member is also shown to include a stop positioned proximal to the distal end of the outer sheath. The self-expanding stent is positioned within the outer sheath and between a stop on the inner shaft member and a distal end of the outer sheath. To deploy the stent, the outer sheath is retracted in a proximal direction by the physician while the inner shaft member is held in place.

Other examples of different types of known self-expanding stent delivery systems are in U.S. patent No.4,580,568 to Gianturco at 8/4 1986; and U.S. patent No.4,732,152 issued to Wallsten et al on 3, 22 of 1988.

In operation, these known stent delivery systems are typically advanced within a patient along a desired vascular path or other body passageway until the stent within the catheter system is at a desired treatment location. When viewing the relative position of the stent and catheter system components with respect to a stenosis (stenosis) on a video X-ray fluoroscopic screen, the physician holds the proximal hub attached to the inner shaft member in a fixed position with one hand while gently withdrawing the proximal hub attached to the outer tubular sheath with the other hand.

This deployment operation may require a certain degree of sophistication for a number of reasons. For example, among these reasons, the dynamic blood flow at the desired treatment location, which may be further disrupted by the presence of the lesion or stenosis to be treated. Another factor is the gradual elastic expansion of the stent as the outer sheath is withdrawn. This gradual expansion provides an opportunity for the possible opposite "watermelon seed" phenomenon to occur. This opposing watermelon seed effect may cause the resilient stent to tend to push the outer sheath back in the proximal direction with a force that tends to vary as the sheath is gradually withdrawn.

Thus, the physician may need to accurately hold the two proximal hubs in a particular relative position, holding them against this distraction force, while attempting to very accurately position the stent up until contact with the anatomical structure (anatomi). One possibility that may affect the positioning of the deployed stent is that the inner shaft should preferably remain stationary in the desired position. If the physician's hand holding the inner shaft hub does accidentally move during deployment, the stent may be deployed in a less than optimal position.

Another possible factor is that the inner catheter shaft member and the outer catheter shaft member do not have infinite column strength like any other elongated object, which may provide an opportunity for the position and movement of each proximal hub to be different from the position and movement of the respective distal ends of the inner and outer shaft members. Yet another factor is that the position of the stent may be adjusted until a portion of the stent's expanded portion is in contact with the sidewall of the body passageway, and therefore the position of the stent should preferably be carefully adjusted until just before the portion of the stent contacts the anatomical structure.

Some known catheter systems require two-handed operation, such as a catheter system having a pair of independent hubs, one on each of the inner and outer shaft members. Other known catheter systems include a pistol and trigger grip, with a single deployment mode involving a single trigger pull to deploy an associated stent.

Disclosure of Invention

Applicants have designed a stent delivery system that includes a catheter tip, a housing, and a wheel. The catheter tip is coupled to the inner shaft and the outer sheath, and the stent is disposed between the inner shaft and the outer sheath. The inner and outer sheaths extend from the distal end to the proximal end. The catheter tip is coupled to the inner shaft and the outer sheath, and the stent is disposed between the inner shaft and the outer sheath. The housing extends along a longitudinal axis from a first end to a second end. A sharp member is disposed in the housing and is configured to cut the outer sheath along a surface of the outer sheath. The spool hub is mounted in the housing and is configured to wind the outer sheath after the outer sheath is cut by the sharp member. A wheel mounted on the housing and coupled to the hub such that rotation of the wheel causes the outer sheath to move along the longitudinal axis toward the second end relative to the inner shaft, wherein the wheel is configured for a first actuation mode that ergonomically facilitates translation of the outer shaft at a first rate and a second actuation mode that ergonomically facilitates translation of the outer shaft at a second rate that is greater than the first rate.

The method of delivering a self-expanding stent to a selected location in a body vessel may be accomplished by: moving a stent disposed near the catheter tip and constrained between the inner shaft and the outer sheath at the distal end of the delivery system to a selected location in the body vessel; winding the outer sheath such that the outer sheath moves relative to the inner shaft at a first rate of distance change in a direction from the distal end toward the proximal end of the delivery system to allow a portion of the self-expanding stent to expand into the bodily vessel; cutting through at least an outer surface of the outer jacket to substantially flatten the outer jacket; and rotating the substantially flattened outer sheath using a second actuation mode that ergonomically facilitates translating the outer shaft at a second rate greater than the first rate to move the outer sheath relative to the inner shaft in a proximal direction from the distal end of the delivery system to allow full deployment of the self-expanding stent in the bodily vessel.

For each of the embodiments described above, the following features may be used with each embodiment in various arrangements. For example, the wheel has a crank arm mounted such that continued rotation of the crank arm causes the outer sheath to move relative to the inner shaft along the longitudinal axis towards the second end, wherein the first actuation mode comprises directly manipulating the wheel and the second actuation mode comprises manipulating the crank arm; a crank arm mounted to the wheel, the crank arm having a length at least equal to a radius of the wheel; the crank arm is mounted on a pivot near the circumference of the wheel so that the crank arm can be folded into a groove formed on the wheel surface to present a substantially continuous surface; the tubular member is coupled to the outer sheath at a location distal to the sharp member; a hypotube coupled to the outer sheath at a location distal to the sharp member; a coil spring is installed in the housing, one end of the coil spring being connected to the wheel and the other end of the coil spring being connected to the housing; a helical spring is disposed in a hub defined by the wheel; the wheel is mounted offset with respect to the longitudinal axis; the wheels are mounted orthogonally with respect to the longitudinal axis; the wheels are mounted flush with respect to the side surface of the housing.

These and other embodiments, features and advantages will become apparent to those skilled in the art upon reference to the following more detailed description of the exemplary embodiments of the invention, taken in conjunction with the accompanying drawings, which are first briefly described. Also, it is intended that such embodiments, features and advantages be claimed in this or an additional application of the patent.

Drawings

The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention and, together with the general description given above and the detailed description given below, serve to explain features of the invention (with like reference numerals denoting like elements), in which:

FIG. 1 shows a perspective view of a handle according to an embodiment;

FIGS. 2A, 2B and 2C illustrate the internal operation of the handle of FIG. 1;

FIGS. 3A and 3B illustrate the external operation of the handle of FIG. 1;

4A, 4B and 4C illustrate another embodiment of the handle of FIG. 1 having the principles of FIGS. 1-3;

FIG. 5 is a schematic diagram according to an embodiment;

FIGS. 6A, 6B, 6C, 6D, 6E, 6F, 6G and 6H show further arrangements of the embodiment of FIG. 1;

fig. 7A and 7B illustrate the operation of the system.

Detailed Description

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically labeled. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

As used herein, the term "about" or "approximately" for any numerical value or range denotes a suitable dimensional tolerance that allows a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values that is ± 10% of the recited value, e.g., "about 90%" may refer to a range of values from 81% to 99%. In addition, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, although the use of the invention in human patients as discussed represents a preferred embodiment. The term "stent" is intended to encompass both uncovered frames as well as frames covered by a suitable material (e.g., a stent graft). The term "proximal" is used to refer to a location closer to the operator, while "distal" is used to refer to a location further from the operator or healthcare provider.

Referring now to the drawings, in which like numerals indicate like elements throughout the several views, there is shown in FIG. 1 a portion of a delivery system 10 in the form of a handle, which defines a housing 100. The housing 100 extends from a proximal end to a distal end along a longitudinal axis L-L. A wheel (e.g., thumbwheel) 102 is mounted to the housing 100. The outer sheath 108 is coupled to the wheel 102 to allow the sheath 108 to be withdrawn at the distal end. As will be described below, it is desirable to deploy a medical device such as a stent by releasing it at different rates. For example, during an initial positioning, the medical device may be released at a first rate, and then released at a second rate after the initial positioning is acceptable, where the second rate is greater than the first rate. Thus, the wheel 102 is configured for a first actuation mode for ergonomically facilitating translation of the outer shaft 108 at a first rate and for a second actuation mode for ergonomically facilitating translation of the outer shaft 108 at a second rate. In this embodiment, the first actuation mode involves directly steering the wheel 102. A crank arm 104 is mounted to the wheel 102 and is disposed in the slot 105 so that a flick of the crank arm can be popped up. Accordingly, the second actuation mode involves manipulating the crank arm 104.

At the distal end of the system 10, the catheter tip 90 (fig. 7A) is coupled to the inner shaft 80 and the outer sheath 108, and the stent 200 is disposed or constrained between the inner shaft 80 and the outer sheath 108. As can be seen in fig. 7A, the inner shaft 80 and the outer sheath 108 extend from a distal end adjacent the stent 200 to a proximal end at the housing 100.

Referring to fig. 4A, the housing 100 extends along an axis L-L from a first end (distal end) to a second end (proximal end). A sharp member 120 (in the form of a single blade) is disposed in the housing 100 and is configured to cut the outer sheath 108 along an outer surface of the generally tubular outer sheath 108. Following the blades 120 is a spool hub 110 mounted in the housing 100 and configured to wind the outer sheath 108 after it has been cut by the sharp member 120.

To explain the need for a blade or similar cutting tool (e.g., sharp member 120), please refer to figures 2A and 2B. In fig. 2A, it can be seen that in order to wind the tubular sheath 108 in a more compact configuration, it is suggested to substantially flatten the tubular shape by cutting through at least one outer surface of the tubular member (or alternatively, cutting through both surfaces as shown in fig. 2A). This allows for a more efficient technique to wind the outer sheath onto the hub 110 using the thumbwheel 102 in the first actuation mode or the crank arm 104 in the second actuation mode, as shown in fig. 2C.

Fig. 3A and 3B illustrate external operation of the handle 100 to allow internal operation in fig. 2A-2C. Wheel 102 is mounted on housing 100 and coupled (either directly or via a gear train for further finer rotation) to hub 110 such that rotation of wheel 102 causes outer sheath 108 (at the distal end) to move along longitudinal axis L-L toward the second or proximal end relative to inner shaft 80. Direct steering of the wheel 102 using the first actuation mode, which ergonomically facilitates translation of the outer sheath 108 at the first rate of distance change (i.e., the first speed), may be imparted by the physician manipulating the wheel 102 with the thumb. To increase the winding speed, the second actuation mode involves reconfiguring the wheel 102 by tapping the crank arm 104 (from which the crank arm 104 can be flicked out in the slot 105 of the wheel 102), such that rotation of the crank arm 104 causes the outer sheath 108 to move relative to the inner shaft 80 along the longitudinal axis L-L towards the second (proximal) end. Manipulation of the crank arm 104 using the second actuation mode ergonomically facilitates translation of the outer sheath 108 at a second rate of change of distance (i.e., a second speed) that is faster than the first rate of change to more quickly complete release of the stent. This is due to the relative ease of turning the wheel 102 via the crank arms 104, as compared to pushing the wheel 102 with the physician's thumb, which is ergonomically efficient. Notably, from a human dynamics perspective, it is relatively easy to rotate the crank arm 104 to reach the second speed and withdraw the sheath 108 at a greater rate, while it is relatively easy to finely control the withdrawal of the sheath 108 by manipulating the wheel 102 with a thumb or similar appendage at the first speed.

In a preferred embodiment, the crank arm 104 is mounted to the wheel, and the crank arm has a length at least equal to the radius of the wheel, and more preferably at least equal to the diameter D of the wheel 102. As previously described, the crank arm 104 is mounted on a pivot (not shown) near the circumference of the wheel 102 so that the crank arm 104 can be folded into a slot 105 formed on the wheel surface. This provides a substantially continuous surface (fig. 1) so that the crank arm does not interfere with other components in its packaging.

To ensure the ability to deliver saline or irrigation equipment, as shown in fig. 4, a tubular member 112 is coupled to the outer sheath 108 at a location distal to the sharp member 120. Since the blade 120 is proximal relative to the tubular member 112, there is no separation and virtually no leakage through the coupling. In a preferred embodiment, a metal hypotube is used. Alternatively, suitable polymer tubing may be used to achieve the same function.

To assist an operator in winding outer sheath 108, coil spring 122 may be mounted in a housing, with one end of coil spring 122 connected to wheel 102 and the other end of coil spring 122 connected to housing 100 or outer sheath 108.

As can be seen in fig. 4B, the length of the crank arm 104 is about the same as the diameter D of the wheel. In one embodiment, the wheel 102 is mounted offset with respect to the longitudinal axis L-L. Alternatively, the wheel 102 may be mounted with its axis aligned with respect to the longitudinal axis L-L. To present an aesthetically pleasing appearance, the wheels 102 may be mounted flush with respect to the side surfaces of the housing, as shown in fig. 1, 6E, and 6F.

Fig. 5 illustrates an exemplary embodiment of the components previously discussed in fig. 1-4. Other design arrangements of the handle 100 with different ergonomic designs and arrangements of wheels and crank arms can be seen in fig. 6A-6H. The designs in fig. 6A-6H may use the components shown and described with respect to fig. 1-5.

In operation, the distal end of the medical device delivery system 10 is preferably introduced into the patient via the patient's body passageway 300. The medical device delivery system 10 may preferably be advanced along a guidewire (not shown) or through a previously placed guiding catheter (not shown) until the distal tip 90 is at a desired location for treatment in the bodily vessel 300. As shown in fig. 7A, the distal tip 90 preferably has already passed over the location of the lesion or stenosis 302. When the device is properly in the initial position (fig. 7A), the physician releases or disengages the locking of the handle (not shown for simplicity, and not required in all embodiments). The lock may be released only once, or may be repeatedly engaged and released. Such locking mechanisms preferably resist inadvertent or accidental movement or withdrawal of stent delivery system components during packaging, sterilization, shipping, storage, handling, and preparation.

After releasing the lock, the wheel 102 may be slowly rotated, thus withdrawing the outer sheath 108 toward the operator by employing the first actuation mode. In this configuration, there is one-to-one feedback between the movement of the wheel 102 and the withdrawal of the outer sheath 108, which can be used by the physician to control the rate at which the stent 200 or other medical device is initially deployed. In particular, the use of the wheel 102 coupled to the outer sheath 108 allows for precise and sensitive adjustment to slightly pull back the outer sheath 108. This small movement exposes a small portion of the medical device, in this case the stent 200, as shown in fig. 7A. In this configuration, the handle 100 holds the outer sheath 108 in position relative to the inner wire 80 to resist further inadvertent expansion of the stent 200. The physician then has time and flexibility in steps to selectively optimize and make any final adjustments to the position of the medical device and delivery system within the desired site, as shown in fig. 7A. It is preferable that such precise adjustment of the position of the stent 200 be made before any portion of the stent 200 contacts the body passageway or blood vessel 300 in a manner that may inhibit further position adjustment.

When the physician is satisfied with the positioning, for example, as it appears on a fluoroscopic X-ray video screen, the physician may continue to rotate the wheel 102 using the first actuation mode to further retract the outer sheath 108, as shown in fig. 6A, by manipulating the wheel 102 primarily with the thumb or similar appendage rib.

Upon initial contact of the stent 200 with the vessel wall, or when the stent 200 expands sufficiently to independently maintain its position, or at any desired position, the physician may tap the eject crank arm 104 and use the second actuation mode jog wheel with greater ergonomic efficiency to achieve increased withdrawal speed, as shown in fig. 7B. This second mode of retracting the outer sheath 108 allows for relatively large scale and rapid movement at whatever speed the physician desires to rapidly deploy the medical device. Depending on the configuration, the outer sheath 108 may be cut by the sharp member 120 during the second mode of actuation or during a combination of the first and second modes of actuation.

Various materials may be selected for the components of the present invention, including any material having desired performance characteristics. In the particular embodiment shown in the drawings, the inner and outer shaft members and the strain relief means and distal tip may be made of any biocompatible and suitably flexible but sufficiently strong material, including various types of polymers. Possible choices for such materials include nylon or polyamide, polyimide, polyethylene, polyurethane, polyether, polyester, and the like. Alternatively, some or all of the inner and/or outer shaft members may be formed from a flexible metal, including, for example, stainless steel or nitinol hypotubes. The stent 200 is preferably made of any strong and rigid biocompatible material, including, for example, stainless steel, platinum, tungsten, and the like. The components of the handle of the present invention are preferably made of a strong and rigid material, including for example non-elastic polycarbonate, or even certain metal compositions. Further, the distal tip of the inner shaft member may preferably be provided with a through lumen adapted to accommodate a guidewire.

Of course, many different variations are included within the scope of the invention. Some of these variations or alternative embodiments include any possible arrangement of dimensions, materials and designs within the scope of the claims.

With the aid of the disclosure provided herein, methods of delivering self-expanding stents to selected locations in a body vessel may be used. The method can be realized by the following steps: moving a stent 200 to a selected location in a body vessel 300, the stent 200 disposed adjacent to the catheter tip 90 and constrained between the inner shaft 80 and the outer sheath 108 at the distal end of the delivery system 10; wrapping the outer sheath 108 using a first actuation pattern that ergonomically facilitates translating the outer shaft at a first rate, thereby moving the outer sheath relative to the inner shaft 80 in a proximal direction from the distal end of the delivery system 10 to allow a portion of the self-expanding stent 200 to expand into the bodily vessel 300; cutting through at least an outer surface of the outer sheath to substantially flatten the outer sheath 108; and rotating the substantially flattened outer sheath 108 using a second actuation mode that ergonomically facilitates translating the outer shaft 108 at a second rate that is greater than the first rate, thereby moving the outer sheath relative to the inner shaft 80 in a proximal direction from the distal end of the delivery system 10 to allow substantially full expansion of the self-expanding stent 200 in the body vessel 300. The first actuation mode involves directly manipulating the wheel 102 to cause the outer sheath to move relative to the inner shaft, then reconfiguring the wheel 102 and manipulating the reconfigured wheel using the second actuation mode. In one embodiment, reconfiguring the wheel involves deploying a crank of the wheel. As desired, the substantially flattened outer sheath is wound using the first actuation mode prior to rotating the substantially flattened outer sheath using the second actuation mode.

While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. Additionally, the methods and steps described above indicate that certain events occur in a certain order, but it is intended that certain steps need not be performed in the order described, but rather in any order, so long as the steps allow the embodiment to function for its intended purpose. Therefore, to the extent that certain modifications of the invention are within the spirit of this disclosure or equivalent to the invention in the claims, it is intended that this patent will also cover such modifications.