Patent Description:
The use of delivery devices or introducers employing catheters has long been known for a variety of medical procedures, including procedures for establishing, reestablishing or maintaining passages, cavities or lumens in vessels, organs or ducts in human and veterinary patients, occlusion of such vessels, delivering medical treatments, and other interventions. For these procedures, it has also long been known to deliver an implantable medical device by means of a catheter, often intraluminally. For example, a stent, stent-graft, vena cava filter or occlusion device may be delivered intraluminally from the femoral artery, via a transapical approach and/or using other acceptable delivery locations and methods for deployment of the prosthesis.

For procedures in which a prosthesis or other medical device is implanted into a patient, the prosthesis to be implanted is normally held on a carrier catheter or cannula of the introducer in a compressed state and then released from the cannula so as to expand to its normal operating state, prior to withdrawal of the cannula from the patient to leave the implant in position. In many devices, the steps to carry out the implantation my occur, for example, first by retracting a retractable sheath to expand or partially expand the prosthesis, and then performing further steps to, for example, release one or both ends of the prosthesis, deploy an anchoring stent, or the like.

The prosthesis which is to be implanted within a patient's vasculature by the delivery device may vary depending on various factors including the procedure being performed and the portion of the vasculature being treated.

According to the invention, there is provided a handle assembly as in claim <NUM>.

In an embodiment, there is provided a handle assembly comprising a trigger wire actuation mechanism for delivering and deploying an endovascular graft into one or more vessels. In one example, a handle assembly for a prosthesis delivery device is disclosed. The handle assembly comprises a stationary main handle having a proximal end and a distal end and an outer surface extending therebetween. A first helical groove is formed in at least a portion of the outer surface of the main handle and a first trigger wire actuation mechanism disposed about the main handle and rotatably moveable relative to the main handle. A first trigger wire is operatively connected to the first trigger wire actuation mechanism, the first trigger wire having a prosthesis capture condition and a prosthesis release condition. Movement of the first trigger wire actuation mechanism causes movement of the first trigger wire thereby moving the first trigger wire from the prosthesis capture condition to the prosthesis release condition.

The handle assembly further comprises a second trigger wire actuation mechanism disposed about the main handle and rotatably moveable relative to the main handle. A second trigger wire is operatively connected to the second trigger wire actuation mechanism, the second trigger wire having a prosthesis capture condition and a prosthesis release condition. Movement of the second trigger wire actuation mechanism causes movement of the second trigger wire thereby moving the second trigger wire from the prosthesis capture condition to the prosthesis release condition.

The delivery device according to embodiments described herein comprises a modular handle assembly that can be configured to deploy a wide range of different prostheses including, but not limited to cuffs, single lumen tubular stent grafts, bifurcated AAA stent grafts, branched or fenestrated stent grafts and combinations thereof. In addition to facilitating the delivery of a wide range of prostheses, the modular handle also allows a variety of delivery approaches to be utilized, including but not limited to transapical or femoral approaches. More specifically, the modular handle comprises various components that have standardized interfaces, allowing the components to be configured and assembled in differing ways, thus providing a delivery device capable of delivering and deploying a full range of prostheses, thus providing high quality patient care with cost savings in production and manufacture.

While embodiments of this invention may be generally discussed in relation to a delivery device for a stent graft for deployment into one or more specific arteries, including the aorta and iliac arteries, it is also contemplated that the invention is not so limited and embodiments may relate to any prosthesis and/or any body or vessel lumen in which such a deployment is necessary or desired.

Embodiments of the invention are described below, by way of example only, with reference to the accompanying drawings.

In this description, when referring to a prosthesis delivery device, "proximal" refers to the part of the delivery device that is furthest from the operator and intended for insertion in a patient's body and "distal" refers to that part of the delivery device closest to the operator. With regard to the prosthesis, the term "proximal" refers to that part of the prosthesis that is closest to the proximal end of the delivery device and "distal" refers to the opposite end of the prosthesis. The term "ipsilateral" is used to indicate that the diseased vessel(s) being accessed during a given procedure are on the same side of the body (right or left) as the vascular access delivery device/introducer, while "contralateral" signifies that the vessel(s) of interest are on the opposite side of the body.

In general and described in more detail below with reference to the reference numbers and figures, the delivery device <NUM> includes a proximal end <NUM> and a distal end <NUM> as shown generally in <FIG> and <FIG>. A handle assembly <NUM> is located adjacent the distal end of the device. As shown in an exploded view in <FIG>, the handle assembly <NUM> generally includes first or main handle <NUM>, a second or front handle <NUM> and a third or rear handle <NUM>. The main handle <NUM> is fixed relative to the delivery device <NUM>. In one example, the main handle <NUM> may also be fixed relative to the front handle <NUM> and/or to the rear handle <NUM>, with the front handle <NUM> and the rear handle <NUM> being separately and independently rotatable relative to the main handle <NUM>.

As shown in <FIG>, <FIG> and <FIG>, the front handle <NUM> extends proximally from the main handle <NUM> and has a greater longitudinal length than the rear handle <NUM> which has a relatively shorter longitudinally length and extends distally from the main handle <NUM>. However, the handle assembly <NUM> may be modular, in that the handle assembly <NUM> is made up of various parts (including, but not limited to the front handle <NUM>, the main handle <NUM> and the rear handle <NUM>) that can be assembled, connected or otherwise combined during manufacture in a variety of ways. Accordingly, as shown in <FIG>, it is also possible to assemble the handle assembly <NUM> in which the front handle <NUM> and rear handle <NUM> are switched, so that the relatively shorter handle <NUM> extends proximally from the main handle <NUM> while the relatively longer handle <NUM> extends distally from the main handle <NUM>. The modular design of the handle assembly <NUM> allows it to be configured in a variety of ways depending on the procedure being performed and the particular prosthesis that is being delivered using the device. In some procedures it is advantageous to have the longer front handle <NUM> extending proximally from the main handle <NUM> and the shorter rear handle <NUM> extending distally from the main handle as shown in <FIG>, while in other procedures to deliver a different prosthesis it may be advantageous to configure the modular handle differently, such as is illustrated in <FIG>, as will be described in further detail below.

In one non-limiting example, if the prosthesis being delivered and deployed has a relatively shorter longitudinal length, then it may be advantageous to provide a handle assembly <NUM> in which the relatively shorter handle <NUM> is in front and extends proximally from the main handle <NUM>, while the relatively longer handle <NUM> extends distally from the main handle <NUM> as <FIG> illustrates.

As shown in <FIG>, <FIG>, the proximal end <NUM> of the delivery device <NUM> includes retention region <NUM> upon which a variety of prostheses <NUM> can be releasably coupled and a tapered nose cone dilator <NUM> having a proximal tip <NUM> and a reverse distal taper at its distal end <NUM>. The nose cone dilator <NUM> presents a smooth tapered surface to facilitate entry into and movement through a body vessel. Nose cone dilator <NUM> may include radiopaque material or be equipped with a radiopaque marker (not shown) to facilitate visualization of the nose cone dilator <NUM> in use provided by desired imaging modality (i.e., by fluoroscopy, MRI, 3D or other imaging techniques). An inner cannula <NUM> extends the longitudinal length of the delivery device <NUM>, from a pin vice <NUM> at the distal end <NUM> of the device <NUM> to the tapered nose cone dilator <NUM> at the proximal end <NUM> of the device <NUM>. Inner cannula <NUM> has an inner lumen <NUM> which may accommodate a guide wire <NUM> for tracking the delivery device <NUM> to a desired position within a patient's vasculature and which may also be used for flushing or injection of fluids as shown in <FIG>. The inner cannula <NUM> may be made of a variety of suitable materials that are stiff, yet flexible enough to allow the inner cannula <NUM> to conform to the tortious anatomy of a patient during use, and may be either straight or have a curve imparted to a portion of it. For example, the inner cannula <NUM> may be constructed of polymers, metals and/or alloys, including nitinol or stainless steel.

A stiffening cannula, sometimes referred to as a pusher or positioner <NUM> may be disposed coaxially over at least a portion of the inner cannula <NUM>. The positioner <NUM> may be constructed from various materials, and in one example, a proximal portion <NUM> of the positioner which is introduced into the patient may comprise a polymer, sometimes referred to as VRDT (or vinyl radiopaque dilator tubing), plastics, metals, alloys or a combination thereof, whereas a distal portion <NUM> of the positioner <NUM> may comprise the same material as the proximal portion <NUM> of the positioner <NUM> or it may be a different material including but not limited to plastics, polymers, alloys, metals or a combination thereof, that provide sufficient maneuverability and stiffness to the positioner <NUM> as necessary and desired. The positioner <NUM> may extend from a location just distal of the stent-graft retention region <NUM> coaxial with a length of the inner cannula <NUM> and terminate at a distal end <NUM> within the main handle <NUM>.

As shown in <FIG>, the distal end <NUM> of the positioner <NUM> may be attached or coupled to a valve <NUM> located within the main handle <NUM> by various means, including threaded attachment, adhesives, welding, and/or other suitable attachment mechanisms and a silicone sleeve <NUM> is disposed over the distal end <NUM> of the positioner to secure it to a proximal portion of the valve <NUM>. For a length of the positioner <NUM>, a stiffening rod (not shown) may be disposed over the inner cannula <NUM> and/or over the positioner <NUM> for additional stability and maneuverability.

The valve <NUM> has multiple openings or ports. The distal end <NUM> of the positioner <NUM> is attached to a proximal port <NUM>. Just distal of the proximal port <NUM> is a first side port <NUM> and a second side port <NUM> which extend radially outwardly from the center of the valve <NUM>. Between the first and second side ports <NUM>, <NUM> is a central port <NUM>, while a distal port <NUM> extends rearward from the valve <NUM>. While the valve <NUM> shown includes at least these five ports <NUM>-<NUM>, it is also contemplated the valve <NUM> may include more or fewer ports as necessary and desired. The ports may serve various purposes during use, depending on the particular procedure being performed, as described below.

As previously mentioned, the positioner <NUM> is coupled to and extends proximally from the proximal port <NUM>. In a non-limiting example, as shown in <FIG>, one of the first and second side ports <NUM>, <NUM> may be used for flushing various fluids in and through the device, such as through an auxiliary catheter <NUM>, while the other of the first and second ports may accommodate a second auxiliary catheter <NUM>, sometimes referred to herein as a "cannulating catheter <NUM>. " The second auxiliary catheter <NUM> or "cannulating catheter" may be used for cannulating a branched or fenestrated stent graft carried by the device and/or for cannulating one or more branch vessels during a procedure as will be described in further detail below. The inner cannula <NUM> extends longitudinally through the valve <NUM> passing through the proximal port <NUM> and the distal port <NUM>. The central port <NUM> may provide a passage for one or more trigger wires or diameter reducing ties as will be described in further detail below.

Each of the respective ports of valve <NUM> may be male or female, may be threaded either on the inner surface or outer surface thereof, thereby facilitating the attachment and/or coupling of one or more secondary devices, including but not limited to catheters, tubing, wires, or other devices that may be necessary to couple and/or to introduce into or through any one of the ports during a procedure. Each of the respective ports may also contain a seal (not shown) therein to prevent back flow of fluid or unintended leakage through the ports. The seal(s) may be rings, discs or other suitable valving mechanisms made from silicones, rubbers, plastics or other materials.

Referring now to <FIG>, at least three exemplary prostheses <NUM> are shown, which may be delivered to and deployed within a patient in a controlled and sequential manner using the delivery device <NUM> described herein. As previously mentioned, the modular handle assembly <NUM> can be configured to deliver and deploy a wide variety of prostheses <NUM>, including variously sized and shaped stent grafts, and as such, <FIG> illustrates one exemplary prosthesis <NUM> in dashed lines to indicate that it is a generic prosthesis for illustrative purposes and that any one or more different prostheses can be interchanged with stent graft <NUM> and be releasably coupled to the proximal end of the inner cannula <NUM> in a similar fashion. As such, the prostheses <NUM> shown in <FIG> are only several examples of a wide range of prostheses that can be introduced into a patient's vasculature and deployed therein with the device <NUM>.

Turning to <FIG>, one example of a stent graft <NUM> is shown, which may be releasably coupled to the prosthesis retention region <NUM> of the delivery device <NUM>. The stent graft <NUM> has a proximal end <NUM>, a distal end <NUM>, and a series of stents <NUM> extending the length of the stent graft <NUM> and attached to the graft material <NUM>. The proximal end <NUM> of the stent graft <NUM> may include a sealing stent <NUM>. Sealing stent <NUM> may be internal or external to the graft material <NUM>. A series of body stents <NUM> also are attached to the graft material <NUM> and may be sutured to the graft material or held to the graft material in other known ways. The series of body stents <NUM> may be internal or external to the graft material <NUM>, or both. As shown in <FIG>, all of the stents are external to the graft material <NUM> with the exception of the distal-most stent which is internal to the graft material <NUM>.

As shown in <FIG> and <FIG>, the stent graft <NUM> may comprise a side arm or limb <NUM> extending from the tubular main body <NUM>. The side arm <NUM> may be integrally formed with the main tubular body <NUM> and extend from the tubular main body at bifurcation <NUM>. In other embodiments, the side arm <NUM> may be separately formed and attached to the main tubular body <NUM>, and in one example, the side arm <NUM> may extend from a fenestration (not shown) formed in the wall of the main tubular body <NUM> as shown in <FIG>. The side arm <NUM> may also include one or more stents <NUM> along its length, either internal or external or both. Although <FIG> and <FIG> show a stent graft <NUM> having a single side arm <NUM> extending therefrom, the stent graft <NUM> may also be a single non-bifurcated tube and/or the stent graft may have one or more fenestrations formed in the graft material <NUM> and/or one or more additional side branches or arms extending therefrom. Radiopaque markers (not shown) may be placed on various parts of the stent graft <NUM> to aid in tracking and locating the device at a desired location during a procedure and one or more barbs (not shown) may extend from any one of the body stents <NUM> or the sealing stent <NUM> to help anchor the stent graft <NUM> to the vessel wall. In one non-limiting example, the main body <NUM> of the stent graft <NUM> shown in <FIG> is configured for delivery to and deployment within the common and external iliac arteries, while the side arm <NUM> is configured to extend towards and/or into the internal iliac artery.

Referring now to <FIG>, another exemplary stent graft <NUM> that can be delivered and deployed using device <NUM> is shown. The stent graft <NUM> in <FIG> is releasably coupled to the inner cannula <NUM> at the prosthesis retention region <NUM>. The stent graft <NUM> also has a proximal end <NUM> (that end with the bare stent <NUM> extending therefrom), a distal end <NUM>, and a series of stents <NUM> extending the length of the stent graft <NUM> and attached to the graft material <NUM>. Extending from the proximal end <NUM> of the stent graft <NUM> is an exposed or bare anchoring stent <NUM>. Anchoring stent <NUM> is attached to the graft material <NUM> by, for example, suturing the distal apices of the anchoring stent <NUM> to the graft material <NUM>. Anchoring stent <NUM> may have one or more barbs (not shown) for attaching the stent graft <NUM> to a body vessel. Radiopaque markers <NUM> may be placed on various parts of the device to aid in visualizing the position of the stent graft <NUM> during a procedure.

Next, just distal to the bare stent <NUM> is one or more sealing stents <NUM>. Sealing stent(s) <NUM> may be internal or external to the graft material <NUM>. The series of body stents <NUM> also are attached to the graft material <NUM> and may be sutured to the graft material or held to the graft material in other known ways. The series of body stents <NUM> may be internal or external to the graft material <NUM>, or both. As shown in <FIG>, the sealing stent <NUM> is internal and body stents <NUM> are external to the graft material <NUM>. As shown in <FIG>, stent graft <NUM> is bifurcated having two limbs <NUM>, <NUM> extending from the tubular main body <NUM> at bifurcation <NUM>. One of the limbs <NUM> may be shorter than the other limb <NUM>, or both may be the same length. Limbs <NUM> and <NUM> may also have a series of stents <NUM> along their length, either internal or external, or both. The stent graft <NUM> illustrated in <FIG> may, in one non-limiting example, be configured for placement within the abdominal aorta, with bifurcation <NUM> seated adjacent to the aortic bifurcation and each of the respective limbs <NUM>, <NUM> extending distally towards the common iliac arteries.

Turning to <FIG>, another non-limiting example of a stent graft <NUM> that can be delivered and deployed using device <NUM> is shown. The stent graft <NUM> in <FIG> may be releasably coupled to the inner cannula <NUM> at the prosthesis retention region <NUM>. The stent graft <NUM> may be a generally singular tube-like configuration having a proximal end <NUM> and a distal end <NUM> and may comprise one or more openings or fenestrations <NUM> formed in the graft body <NUM>. There may also be an internal side branch <NUM> extending within the lumen <NUM> of the graft body <NUM> as illustrated in <FIG> although other configurations are also contemplated. A series of stents <NUM> may be attached to the graft body <NUM> and extend along all of, or at least part of, the length of the stent graft <NUM>. The stents <NUM> may be sutured to the graft material <NUM> or held to the graft material <NUM> in other known ways. The series of body stents <NUM> may be internal or external to the graft body <NUM>, or both. Radiopaque markers (not shown) may be placed on various parts of the stent graft <NUM> to aid the user in positioning the stent graft during deployment. The stent graft <NUM> shown in <FIG> may, in one example, be configured for delivery to and deployment within the aorta, with the fenestration <NUM> and/or internal side branch <NUM> at least partially aligned with one or more branch vessels extending from the aortic arch, including but not limited to the brachiocephalic artery, the left common carotid artery and/or the left subclavian artery.

The stents connected to any of the stent grafts described above may be zig-zag shaped as shown in the figures, although other stent configurations are known and may be used alone or in combination with the zig-zag stents and/or have other configurations as known in the art. The stents may be constructed of a self-expanding shape memory material, such as Nitinol, or they may be balloon expandable, or a combination of both depending on the particular characteristics desired of the prosthesis <NUM>.

An exemplary coupling of the prosthesis <NUM> to the delivery device is shown in <FIG> (including any one of the above described prostheses) although other prostheses not specifically described herein may also be releasably coupled to the delivery device depending on the particular procedure being performed. In fact, the modular handle assembly <NUM> described herein is designed so as to be able to be configured in a variety of ways to facilitate the delivery of a full range of prostheses, including but not limited to the full line of endovascular prostheses offered by Cook Medical Technologies LLC of Bloomington, Indiana, for example.

<FIG> illustrate a proximal end portion <NUM> of the delivery device <NUM> and one non-limiting example of an attachment and release mechanism for the proximal end of a stent graft <NUM>. For exemplary purposes only, reference numbers used for the branched iliac stent graft <NUM> shown in <FIG> will be used, but the same attachment and release mechanism can be used for any prosthesis <NUM> if desired. The attachment and release mechanism can be operated and manipulated using the handle assembly <NUM> described herein. The description of the coupling of stent graft <NUM> to the delivery device <NUM> is for exemplary purposes, and shall not be considered limiting, as different prostheses may be releasably coupled to the delivery device in different ways, and the proximal end and distal end of a particular prosthesis may be coupled to the delivery device in different ways.

As shown in <FIG> an exemplary prosthesis attachment mechanism releasably couples the proximal end <NUM> of the stent graft <NUM> to the inner cannula <NUM>. In a non-limiting example, as shown in enlarged view in <FIG>, the attachment mechanism comprises at least one proximal trigger wire <NUM> having a proximal end <NUM> and a distal end <NUM> (see <FIG>). However, other attachment mechanisms, including an additional proximal trigger wire <NUM> also having a proximal end <NUM> and a distal end <NUM> (see <FIG>) may also be used to releasably couple the proximal end <NUM> of the stent graft <NUM> to the inner cannula <NUM>. Other attachment mechanisms, in addition to the one or more proximal trigger wires <NUM>, <NUM>, may also be used to couple the proximal end <NUM> of the stent graft <NUM> to the delivery device <NUM>, such as diameter reducing ties, a retractable sheath, sutures and the like as will be recognized by one of skill in the art. <CIT>, describes one example of a releasable diameter reducing tie, which is incorporated by reference herein in its entirety.

In one non-limiting example, the proximal trigger wires <NUM> and <NUM> may extend proximally within positioner <NUM> from the handle assembly <NUM> to the proximal end <NUM> of the stent graft. More particularly, the distal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> may be coupled to the inner surface of one or more trigger wire release mechanisms or rotatable rings <NUM>, <NUM> that are disposed about and/or around at least a portion of the main handle <NUM> (as will be described in further detail below in connection with <FIG>). In one example, the distal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> may be coupled to the inner surface <NUM> of the first or proximal rotatable ring <NUM> by a set screw, by adhesives, welding or any other suitable attachment mechanisms as shown in <FIG>. From the attachment point on the inner surface <NUM> of the first rotatable trigger wire ring <NUM>, the proximal trigger wires <NUM>, <NUM> extend through one or more openings or apertures <NUM>, <NUM> formed in the main handle <NUM>, shown in <FIG>. For example, as shown in <FIG>, <FIG>, main handle <NUM> has two spaced apart apertures <NUM>, <NUM> through which one or both of the proximal trigger wires <NUM>, <NUM> may extend through and into the interior housing of main handle <NUM>. In one example, both of the proximal trigger wires <NUM>, <NUM>, extend through one of the holes <NUM> or <NUM>, or in another example, one of the proximal trigger wires <NUM>, <NUM> can extend through one of the holes <NUM> or <NUM> formed in the main handle <NUM> while the other of the proximal trigger wires <NUM>, <NUM> extend through the other hole <NUM> or <NUM>. The proximal trigger wires <NUM>, <NUM> may then extend through one of the ports of the valve <NUM> such as the central port <NUM>. The proximal trigger wires <NUM>, <NUM> can then extend proximally through the valve <NUM> and exit the valve through the proximal port <NUM> and extend further proximally through the positioner <NUM> to the proximal end <NUM> of the stent graft <NUM> as shown in <FIG>. The proximal ends <NUM>, <NUM> of the trigger wires <NUM>, <NUM> are releasably coupled to the proximal end <NUM> of the stent graft <NUM> as shown in <FIG>.

In one example, the proximal trigger wires <NUM>, <NUM> may be directly or indirectly attached to the proximal end <NUM> of the stent graft <NUM>. For example, the proximal trigger wires <NUM>, <NUM> may engage a suture loop (not shown) which is attached to the proximal end <NUM> of the stent graft <NUM>. In this way, the trigger wires do not weave directly through the graft material <NUM>. In other examples, the proximal trigger wires <NUM>, <NUM> may be woven directly through or removably attached to the graft material <NUM> or woven over or through one or more stents <NUM> at the proximal end <NUM> of the graft <NUM>. As <FIG> shows, the proximal trigger wires <NUM>, <NUM> are woven directly through the graft material <NUM> at the proximal end <NUM> of the stent graft <NUM> at two spaced apart points around the periphery of the tubular graft body such that when those points are retained by the trigger wires <NUM>, <NUM> against the inner cannula <NUM>, the stent graft <NUM> generally forms a "<FIG>" formation with one lobe of the "<FIG>" being slightly larger than the other lobe of the "<FIG>. " Of course, other points of attachment may also be used to releasably couple the stent graft <NUM> to the inner cannula <NUM> to form various configurations at the proximal end <NUM> of the stent graft <NUM>. Again, branched iliac stent graft <NUM> is used for exemplary purposes only in this particular description of proximal stent graft attachment, but any type of prosthesis can be releasably coupled to the inner cannula in this manner. In the event that a stent graft such as that shown in <FIG> is coupled to the delivery device, the one or more trigger wires my weave over and/or through the proximal bare stent <NUM> to releasably couple the proximal end of the stent graft <NUM> to the inner cannula <NUM>.

As <FIG> shows, the proximal ends <NUM>, <NUM> of the trigger wires <NUM>, <NUM> may be retained within the distal end <NUM> of the nose cone, such as by friction fit or other suitable attachment means that allow for the trigger wires to be pulled distally and released from the inner cannula <NUM> when deployment of the proximal end of the stent graft <NUM> is necessary or desired. Other suitable attachment methods or mechanisms may be used to removably attach the proximal trigger wires <NUM>, <NUM> to the proximal end of the stent graft <NUM> as would be recognized by one of skill in the art. In one non-limiting example, the proximal end of the inner cannula <NUM> may include a covering or sleeve (not shown) disposed over at least a portion of it, with the sleeve extending proximally from the proximal end <NUM> of the positioner <NUM>, through the stent graft lumen and to the distal end <NUM> of the nose cone dilator <NUM>. The sleeve may be silicone, vinyl, rubber, nylon and/or other suitable materials that snugly fit over and around and coaxial with the inner cannula <NUM>.

After exiting the proximal end <NUM> of the positioner <NUM>, the proximal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> may extend through at least a portion of the sleeve, exit the sleeve through one or more openings or apertures, weave through the proximal end of the graft <NUM> (or over one or more stents or suture loops at the proximal end of the stent graft <NUM>) and then the proximal trigger wires <NUM>, <NUM> can extend back through the sleeve where the proximal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> can be releasably retained, such as by friction fit, between the inner surface of the sleeve and the outer surface of the inner cannula <NUM>. In other words, if present, the sleeve provides a mechanism for the proximal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> to be releasably retained in a position against the inner cannula <NUM>, thus holding the proximal end of the stent graft <NUM> in a radially inwardly contracted delivery configuration.

When deployment is desired, distal retraction of the proximal trigger wires <NUM>, <NUM>, (such as by manipulation of one or both of trigger wire release mechanisms or rotatable rings <NUM>, <NUM> as will be described in further detail below) allows the proximal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> to be released from the proximal end of the stent graft <NUM> and pulled distally through the positioner <NUM>, allowing the proximal end of the stent graft <NUM> to at least partially deploy radially outwardly within a vessel. If other diameter reducing ties are being used to radially restrain the proximal end of the stent graft <NUM>, those ties must also be removed by manipulation of one or both of the trigger wire release mechanisms or rotatable rings <NUM>, <NUM> to allow the proximal end of the stent graft to fully deploy from the inner cannula <NUM> within the vessel.

As shown in <FIG>, and <FIG>, various exemplary prosthesis attachment mechanism releasably couples the distal end of a stent graft <NUM> to the inner cannula <NUM>. In a non-limiting example, the long leg <NUM> of the abdominal aorta stent graft <NUM> of <FIG> is used for exemplary purposes to illustrate the distal attachment mechanism, and as shown in enlarged view in <FIG>, the attachment mechanism comprises at least one distal trigger wire <NUM> having a proximal end <NUM> and a distal end <NUM> (see <FIG>). However, other attachment mechanisms, including an additional distal trigger wire may also be used to releasably couple the distal end of the stent graft <NUM> to the inner cannula <NUM>. The distal attachment mechanism can be operated and manipulated using the handle assembly <NUM> described herein. The description of the coupling of the distal end of the stent graft <NUM> to the delivery device <NUM> is for exemplary purposes, and shall not be considered limiting, as different prostheses may be releasably coupled to the delivery device in different ways, and the proximal end and distal end of a particular prosthesis may be coupled to the delivery device in different ways.

In one non-limiting example, the distal trigger wire <NUM> may extend from the handle assembly <NUM>, within positioner <NUM>, to the distal end of the stent graft <NUM>. More particularly, the distal end <NUM> of the distal trigger wire <NUM> may be coupled to the inner surface <NUM> of the first rotatable ring <NUM>, or, may be coupled to the inner surface <NUM> of a second trigger wire release mechanism or distal rotatable ring <NUM> that is disposed about and/or around at least a portion of the main handle <NUM> just distal to the first or proximal rotatable trigger wire release ring <NUM> as shown in <FIG>. The distal rotatable ring <NUM> may be adjacent to or abut the first rotatable ring <NUM> or, as shown in <FIG>, a spacer element, such as a stationary spacer ring <NUM> may be positioned between the first and second rotatable rings <NUM>, <NUM>. If present, the stationary spacer ring <NUM> may be coupled to the outer surface of the main handle <NUM> such as by adhesives, bonding, snap-fit, screws or other suitable attachment mechanisms. The presence of a spacer ring <NUM> may reduce the risk of the user inadvertently rotating the first rotatable ring <NUM> and the second rotatable ring <NUM> at the same time, if simultaneous rotation of the respective rotatable rings is not desired.

The distal end <NUM> of the distal trigger wire <NUM> may be coupled to the inner surface <NUM> of the second rotatable ring <NUM> by a set screw (see <FIG>), by adhesives, welding or any other suitable attachment mechanisms. From the attachment point on the inner surface <NUM> of the second rotatable ring <NUM>, the distal trigger wire <NUM> extends through one or more openings or apertures <NUM>, <NUM> formed in the main handle <NUM>. In one example, the distal trigger wire <NUM> may extend through one of the same holes <NUM>, <NUM> through which one or both of the proximal trigger wires <NUM>, <NUM> extends, or, the distal trigger wire <NUM> can extend through one of the other holes <NUM>, <NUM> formed in the main handle <NUM>. The distal trigger wire <NUM> may then extend through one of the ports of the valve <NUM> such as the central port <NUM>. The distal trigger wire <NUM> can then extend proximally through the valve <NUM> and exit the valve through the front port <NUM> and extend further proximally through the positioner <NUM> to the distal end of the stent graft <NUM>.

The proximal end <NUM> of the distal trigger wire <NUM> may be directly or indirectly attached to the distal end <NUM> of the stent graft <NUM>. For example, the distal trigger wire <NUM> may engage a suture loop <NUM> which is attached to the distal end <NUM> of the stent graft <NUM> as shown in <FIG>. In another example, the distal trigger wire <NUM> may be woven directly through or removably attached to the graft material <NUM> or may be woven around or over one or more stents <NUM> at the distal end of the graft <NUM> as shown in <FIG>. Other suitable attachment methods or mechanisms may be used to removably attach the distal trigger wire <NUM> to the distal end of the stent graft <NUM>, thereby coupling the stent graft to the inner cannula until the trigger wire(s) are released during deployment, as would be recognized by one of skill in the art.

As shown in <FIG>, a prosthesis, such as stent graft <NUM>, is disposed on the inner cannula <NUM> at the proximal end <NUM> of the delivery device <NUM> at prosthesis retention region <NUM>. The stent graft <NUM> has an uncoupled state in which the graft is positioned coaxially over the inner cannula <NUM> with the proximal end of the stent graft <NUM> in longitudinal proximity relative to the distal end <NUM> of the nose cone dilator <NUM>. During assembly, the proximal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> and the proximal end <NUM> of the distal trigger wire <NUM> can be coupled to the respective proximal and distal ends of the stent graft <NUM> as generally described above. After being coupled to the stent graft <NUM>, the proximal ends <NUM>, <NUM>, of the trigger wires <NUM>, <NUM> may extend proximally into the nose cone, or, extend back into the inner cannula <NUM> through one or more apertures (not shown) formed in the inner cannula or extend back into the sleeve (not shown) that is coaxial with the inner cannula <NUM>.

The proximal ends <NUM>, <NUM> of the proximal trigger wires <NUM>, <NUM> may be releasably held in place there, either within the nose cone or within the inner cannula lumen or within the sleeve by friction fit, adhesives or by other releasable attachment mechanisms. When deployment of the stent graft is desired, retraction of the proximal trigger wires <NUM>, <NUM> and retraction of the distal trigger wire <NUM> (along with any other additional diameter reducing ties, etc.) by manipulating one or both of the trigger wire release mechanisms or rotatable rings <NUM>, <NUM> on the handle assembly <NUM>, allows the stent graft <NUM> to move from a radially inwardly constrained delivery configuration to a radially outwardly expanded configuration within a vessel, as described further below.

The coupling shown in <FIG> releasably secures the stent graft <NUM> to the inner cannula <NUM> to radially inwardly restrain the stent graft <NUM> in a manner that may subsequently facilitate insertion of the subassembly comprising the inner cannula <NUM> and the stent graft <NUM> into an outer sheath, such as sheath <NUM> described below. As will be apparent, the outer sheath <NUM> is configured to radially restrain other regions of the stent graft <NUM> for delivery in a low-profile configuration to a target site within a patient's anatomy.

As shown in <FIG> and <FIG>, the longitudinally slideable and retractable sheath <NUM> extends along the length of the delivery device <NUM> from the front handle <NUM> to the nose cone dilator <NUM>. The sheath <NUM> is configured to cover and assist in retaining a prosthesis, such as stent graft <NUM>, in a radially inwardly compressed, low-profile configuration during delivery of the prosthesis to a target site within a patient's anatomy. The distal end <NUM> of the sheath <NUM> is connected within the front handle <NUM> to a first follower <NUM>, as shown in <FIG>. In one example, the distal end <NUM> of the sheath <NUM> may be slightly tapered to facilitate attachment of the sheath <NUM> within a correspondingly shaped proximal end <NUM> of the first follower <NUM> as shown in <FIG>, or the sheath <NUM> may be flared to fit about the outer surface of the proximal end <NUM> of the first follower <NUM>. The distal end <NUM> of the sheath <NUM> may be secured to the proximal end <NUM> of the first follower <NUM> by a friction fit, threaded engagement, adhesives or other attachment mechanisms or combination thereof. The first follower <NUM> has at least one lumen <NUM> extending from its proximal end <NUM> to its distal end <NUM> as shown in <FIG> which allows for the positioner <NUM> to extend longitudinally there through. A sleeve <NUM> may be disposed over both the distal end <NUM> of the sheath <NUM> and the proximal end <NUM> of the first follower <NUM> so as to secure the respective components to each other and to prevent the distal end <NUM> of the sheath <NUM> from separating or otherwise detaching from the first follower <NUM>.

As previously noted, the main handle <NUM> is fixed or stationary, while the front handle <NUM> is rotatable relative to the main handle <NUM>. As shown in <FIG>, the front handle <NUM> has a proximal end <NUM> and a distal end <NUM> and an outer surface <NUM> extending there between to form a front handle interior <NUM>. The front handle may be provided in various lengths to accommodate varying sheath pull-back or retraction requirements, depending on, for example, the particular stent graft being deployed and the procedure being performed. In one example, the longitudinal length of the front handle may be in the range of about <NUM> to about <NUM>. The front handle <NUM> may be constructed or molded from various materials, including, for example, acrylonitrile butadiene styrene (ABS) or a similar thermoset plastic, polymers, metals, including aluminum or stainless steel and composites (i.e., carbon, fiberglass). As shown in <FIG>, <FIG>, the front handle <NUM> may be molded in two separate halves which are then secured together such as by welding, bonding and/or adhesives to form the front handle <NUM> having a threaded internal surface <NUM>. In one example, an end cap <NUM> may be provided that may be fitted around and about the proximal end <NUM> of the front handle <NUM> to securely retain the separate halves of the front handle <NUM> together, if desired. At least a portion of the outer surface <NUM> of the front handle <NUM> may include a gripping portion for a physician to grip with one hand while manipulating the front handle <NUM>. The gripping portion <NUM> of the front handle <NUM> is preferably ergonomically shaped for user comfort, and may be covered in a layer of softer plastic or rubber or have a gripping surface to ensure a stable grip.

The distal end <NUM> of the front handle <NUM> may include a channel <NUM> that extends circumferentially around the outer surface <NUM>, while an inner surface of the main handle <NUM> comprises a correspondingly shaped collar <NUM> or one or more protrusions that extend radially inwardly from the inner surface of the main handle <NUM> at a location just distal of the proximal end of the main handle <NUM>. The protrusions or collar <NUM> can be received by the circumferential channel <NUM> formed in the front handle <NUM> as shown in <FIG>. The engagement between the channel <NUM> formed in the distal end <NUM> of the front handle <NUM> and the collar <NUM> extending radially inwardly from the inner surface of the main handle <NUM> allows for the front handle <NUM> to rotate with respect to the main handle <NUM>, yet prevents the front handle <NUM> from sliding longitudinally (either proximally or distally) with respect to the main handle <NUM>. Other mechanisms which allow for rotation of the front handle <NUM> but which prevent longitudinal movement or sliding relative to the main handle <NUM> may also be used as one of skill in the art would appreciate.

As shown generally in <FIG> and <FIG>, a front rail <NUM> is disposed within the front handle <NUM> and the first follower <NUM> is slideably disposed within the front rail <NUM>. The sheath <NUM> may be withdrawn back or distally by rotating the front handle <NUM> relative to the main handle <NUM>. As a threaded internal surface <NUM> of the front handle <NUM> engages one or more protrusions <NUM> extending radially outwardly from the first follower <NUM> and the rail <NUM> within the front handle <NUM> rotationally restrains or prevents the first follower <NUM> from rotating within the front rail <NUM>. Thus, rotation of the front handle <NUM> pulls the first follower <NUM> back or distally within the front handle <NUM> thereby simultaneously withdrawing or retracting the sheath <NUM> distally to expose at least a portion of the stent graft <NUM>. Interaction between the front handle <NUM>, the first follower <NUM> and the front rail <NUM> to facilitate retraction of the sheath <NUM> will be described in further detail below.

More particularly, as shown in <FIG> and <FIG>, the distal end <NUM> of the first follower <NUM> comprises at least one, and preferably two opposing ears or wings <NUM> extending from the outer surface of the first follower <NUM>. A raised surface or protrusion <NUM> extends even further radially outwardly from each of the respective wings <NUM>. Each of the wings <NUM> are shown as having a generally rectangular shape, each of which extend into and through two spaced apart longitudinal slots <NUM> formed in the front rail <NUM>. If, however, the first follower <NUM> only had a single wing <NUM>, then the front rail <NUM> may only have one slot <NUM> to accommodate the single wing <NUM>.

The longitudinal slot(s) <NUM> formed in the front rail <NUM> each comprise a proximal end <NUM> and a distal end <NUM>, and during sheath retraction, the first follower <NUM> will move or slide longitudinally from a proximal to distal direction within the front rail <NUM> while the wings <NUM> slide from the proximal end <NUM> of the longitudinal slot <NUM> to the distal end <NUM> of the slot. Thus, the front rail <NUM> allows the first follower <NUM> to slide longitudinally therein, while preventing rotation of the first follower. While the wings <NUM> are shown as having a generally rectangular shape and the longitudinal slots <NUM> formed in the front rail <NUM> are shown in <FIG> as having a generally corresponding elongated rectangular shape for receiving the wings <NUM> therein, it will be appreciated that the wings <NUM> and the longitudinal slots <NUM> may be of a variety of corresponding shapes so that the wings <NUM> can be received within and slide along the longitudinal slot <NUM> formed in the front rail <NUM> to prevent rotation of the first follower <NUM> yet allowing the first follower <NUM> to move longitudinally within the front rail <NUM> while simultaneously retracting the sheath <NUM>.

As shown in <FIG> and <FIG>, each of the respective protrusions <NUM> extending radially outwardly from the wings <NUM> are shown as having a generally conical, domed or rounded trapezoidal shape. The domed trapezoidal shape of the protrusions <NUM> are preferably received within and engage with threads <NUM> formed on the inner surface of the front handle <NUM>. Thus, the threads <NUM> on the inner surface of the front handle <NUM> may have a correspondingly shaped conical, domed or trapezoidal configuration which receives the protrusions <NUM> extending radially outwardly from the first follower <NUM>. While the protrusions <NUM> and the threads <NUM> may be formed in other shapes or configurations, it is desirable that the respective shapes of the protrusions <NUM> on the first follower <NUM> and the threads <NUM> formed on the inner surface of the front handle <NUM> can operatively engage smoothly and with minimal friction, thus allowing for ease of rotation of the front handle <NUM> regardless of whether the pitch of the threads <NUM> on the inner surface of the front handle <NUM> is constant or whether the pitch of the threads <NUM> changes or is otherwise varied.

In one example, the threads <NUM> on the internal surface of the front handle <NUM> may have a constant pitch along the longitudinal length of front handle <NUM>, so that a particular rotation (or rotations) of the front handle <NUM> relative to the main handle <NUM> will result in a consistent longitudinal displacement or movement of the first follower <NUM> within the front rail <NUM>, regardless of the position of the first follower <NUM> within the front rail <NUM>. In one example, when referring to the thread pitch herein, the thread pitch is the distance between threads expressed in a particular unit of measure (mm, cm, for example) measured along a particular length, such as the length of the front handle <NUM>. For example a thread pitch of <NUM> means that the distance between one thread <NUM> and the next adjacent thread <NUM> formed on the inner surface of the front handle <NUM> is <NUM>.

If the front handle <NUM> comprises threads <NUM> having a constant pitch, this pitch may be in the range of a pitch of about <NUM> to about <NUM> and more preferably a pitch in the range of about <NUM> to about <NUM>. The internal surface of the front handle <NUM> may have one thread with a single lead or point of origination, or, the inner surface of the front handle <NUM> may include multiple-lead threads (sometimes referred to as "dual start threads" where two or more points of origination for two or more helical thread elements corresponds to each point of origination). As shown in <FIG>, the front handle <NUM> is split into two halves, with the half shown in <FIG> having a first lead <NUM> for a first thread profile <NUM> and the second half shown in <FIG> having a second lead <NUM> spaced <NUM> degrees offset from the first lead <NUM> for a second thread profile <NUM>. Multiple-lead threads allow multiple protrusions <NUM> extending radially outwardly from the first follower <NUM> to engage the respective multiple threads, thereby increasing the engaging surfaces between the first follower <NUM> and the threaded internal surface <NUM> of the front handle <NUM> to reduce internal forces and which allows force to be distributed equally above and below the acting longitudinal axis of the delivery system which makes a comfortable rotational actuation of the handle by the user and converts it to a high force liner motion to facilitate sheath retraction.

In another example and in contrast to the constant-pitch threads described above, the handle assembly <NUM> may comprise a front handle <NUM> having variable pitch threads <NUM> formed on the inner surface thereof. As shown in <FIG>, the threads <NUM> formed on the inner surface of the proximal end <NUM> of the front handle <NUM> may have a relatively small pitch. In one example, the pitch of the threads <NUM> near the proximal end <NUM> of the front handle <NUM> may be in the range of about <NUM> to about <NUM>. With relatively smaller pitch threads, each rotation of the front handle <NUM> may serve to retract the sheath <NUM> distally a relatively small longitudinal distance thus allowing the proximal end of the stent graft <NUM> to be exposed and deployed very gradually during the initial phases of deployment to ensure accurate positioning of the stent graft <NUM> within a patient's vessel. The threads <NUM> formed on the inner surface of the distal end <NUM> of the front handle <NUM> have a relatively greater pitch than the threads at the proximal end <NUM> of the front handle <NUM>. The pitch of the distal threads will generally have a pitch of between about <NUM> and about <NUM>. As shown in <FIG>, the pitch of the threads <NUM> on the inner surface <NUM> of the front handle <NUM> generally increase from the proximal end <NUM> of the front handle <NUM> to the distal end <NUM> of the front handle <NUM>, thus providing a relatively greater mechanical advantage between the rotating front handle <NUM> and the sheath <NUM>. In other words, the front handle <NUM> facilitates a large amount of force to be exerted on to the sheath <NUM> with little required force by the user. Targeted variation in thread pitch along the handle <NUM> allows for large amounts of force and shorter longitudinal travel distance to be applied at a controllable rate for each rotation of the front handle <NUM> where required due to the tortuous anatomy or high device packing density while also maintaining a reasonable operating time by transitioning to a larger pitch for lower force and a longer longitudinal travel distance for each rotation of the front handle <NUM> as the first follower <NUM> engages with the threads <NUM> at the distal end <NUM> of the front handle <NUM>. The pitch of the threads <NUM> may increase gradually, may increase step-wise, or may change or increase in any other incremental or pre-determined distance from a proximal to distal direction.

More specifically, the relatively smaller pitch of the threads <NUM> near the proximal end <NUM> of the front handle <NUM> may result in distal longitudinal movement or retraction of the sheath <NUM> of about <NUM> to about <NUM> per each rotation of the front handle <NUM>, whereas the relatively greater pitch of the threads <NUM> near the distal end <NUM> of the front handle <NUM> may result in distal longitudinal movement or retraction of the sheath <NUM> of about <NUM> to about <NUM> per each rotation of the front handle <NUM>. Thus, the variable pitch threads may provide various advantages. In one non-limiting example, after the proximal end of a stent graft <NUM> has been deployed within the vessel lumen and proper positioning verified by the physician, it may be desirable to proceed with deployment of the distal end of the stent graft <NUM> more quickly. Thus, increasing the pitch of the threads <NUM> near the distal end <NUM> of the front handle <NUM> allows the physician to retract the sheath <NUM> distally more quickly and with fewer rotations of the front handle <NUM> (as distal longitudinal movement of the first follower <NUM> within the front rail <NUM>, which pulls the sheath <NUM> distally along with it) increases as the pitch of the threads <NUM> formed on the internal surface <NUM> of the front handle <NUM> increases) thus completing deployment of the distal end of the stent graft <NUM> more quickly with each rotation of the front handle <NUM> as compared to the distal longitudinal movement of the sheath <NUM> that results from each rotation of the front handle <NUM> during the initial stages of sheath retraction.

As shown in <FIG>, it is preferable that the front handle <NUM> be rotated in only one direction to facilitate sheath retraction. As <FIG> shows, the front handle <NUM> may be rotated in a clockwise direction to cause the first follower <NUM> to move longitudinally within the front rail <NUM> to cause sheath retraction, but the modular handle assembly <NUM> may be manufactured and assembled in other configurations so that rotation of the front handle <NUM> may proceed in a counter-clockwise direction if necessary or desired. Uni-directional rotation of the front handle <NUM> may be ensured by a ratcheting mechanism <NUM> as shown in <FIG> and <FIG>. The ratcheting mechanism <NUM> provides for "one-way" rotation of the front handle <NUM> during the deployment of the prosthesis.

Specifically, as shown in <FIG>, <FIG> and <FIG>, the ratchet mechanism <NUM> that ensures one-way rotation of the front handle <NUM> comprises, in one example, a ratchet ring <NUM> that is seated within the main handle <NUM> just distal to the distal end <NUM> of the front handle <NUM>. The ratchet ring <NUM> comprises a set of ratcheting teeth <NUM> that extend proximally from the ring <NUM>. The ratcheting teeth <NUM> are engaged with a corresponding set of ratcheting teeth <NUM> formed on the distal end <NUM> of the front handle <NUM>. One or more protrusions <NUM> extending radially outwardly from the ratcheting ring <NUM> are received within correspondingly shaped channels <NUM> (<FIG>) formed on the inner surface of the main handle <NUM>, thus preventing inadvertent rotation of the ratcheting ring <NUM> during rotation of the front handle <NUM>. At least one, and preferably two springs <NUM> are also positioned within the respective channels <NUM> formed on the inner surface of the main handle <NUM>. The springs <NUM> push proximally and up against the protrusions <NUM> extending from the ratcheting ring <NUM>, thus urging the ratchet ring <NUM> forward or proximally within the main handle <NUM>, to ensure engagement between the ratcheting teeth <NUM> on ring <NUM> and the ratcheting teeth <NUM> formed in the distal end <NUM> of the front handle <NUM>. The shape and angle of the ratcheting teeth <NUM> extending proximally from the ratcheting ring <NUM> and the correspondingly shaped ratcheting teeth <NUM> formed on the distal end <NUM> of the front handle <NUM> permit rotation of the front handle <NUM> in a first direction while restraining or otherwise preventing a second direction of front handle rotation, opposite to the first direction. In this way, rotation of the front handle <NUM> can only proceed in one direction (e.g. clockwise as shown in <FIG>), thus also preventing unintended counter-rotation of the front handle <NUM> during sheath retraction (such as that may occur due to build-up of torsional forces, friction or other forces that may cause the front handle <NUM> to rotate on its own). Thus, the ratcheting mechanism <NUM> also helps to maintain the distal travel distance of the sheath <NUM> after each rotation of the front handle <NUM> while reducing or eliminating recoil or unintended proximal migration of the sheath <NUM> if/when the user releases their grip or re-grips the front handle <NUM> during sheath retraction. While the ratcheting mechanism <NUM> for ensuring uni-directional rotation of the front handle <NUM> has been described in one non-limiting example as a ratcheting ring <NUM> that is operatively engaged with ratcheting teeth <NUM> formed in the distal end <NUM> of the front handle <NUM>, other mechanisms may be used in place of, or in combination with the above-described ratcheting mechanism <NUM> to ensure uni-directional rotation of the front handle <NUM> as would be appreciated by one of skill in the art.

As shown in <FIG>, the main handle <NUM> comprises a proximal end <NUM> and a distal end <NUM> with an outer surface or side wall <NUM> extending there between to form a handle interior <NUM>. As will be described below, the main handle interior <NUM> houses additional mechanical components that make up the handle assembly <NUM>. The main handle <NUM> may be injection molded as a single unitary structure or, as shown in <FIG>, the main handle <NUM> may comprise upper and lower parts or first and second halves that clam shell, lock, snap-fit or are otherwise securable to each other. The main handle <NUM> may be constructed of various materials including, but not limited to, acrylonitrile butadiene styrene (ABS) or a similar thermoset plastic, polymers, metals (aluminum, stainless steel) and/or composites (carbon, fiberglass) for example. As shown in <FIG> and <FIG>, the proximal end <NUM> of the main handle <NUM> includes threads <NUM> on the outer surface thereof. When the first and second halves of the main handle <NUM> are fitted together to form the main handle <NUM>, a proximal cap <NUM> having internal threads on the inner surface thereof can be fitted over and about the proximal end <NUM> of the main handle <NUM> to secure the respective first and second halves of the main handle <NUM> together. The proximal cap <NUM> may also serve to support the front rotating handle <NUM> in position at the proximal end <NUM> of the main handle <NUM>. In one example shown in <FIG>, an end cap <NUM> may additionally be provided that may be fitted around and about the distal end <NUM> of the main handle <NUM> to securely retain the separate halves of the main handle <NUM> together, if desired.

At least a portion of the outer surface <NUM> of the main handle <NUM> may include a gripping portion <NUM> for a physician to grip with one hand while manipulating the front handle <NUM> and or rear handle <NUM> (such as during sheath retraction with front handle <NUM> or during top cap removal with rear handle <NUM> during stent graft deployment). The gripping portion <NUM> of the main handle <NUM> is preferably ergonomically shaped for user comfort, and may be covered in a layer of softer plastic or rubber or have a gripping surface to ensure a stable grip. As shown in <FIG>, the gripping portion <NUM> may be distal to the two angled openings <NUM> formed generally in a center portion of the main handle <NUM>, which openings <NUM> may accommodate one or more of the first side port and/or second side ports <NUM>, <NUM> which extend radially outwardly from the valve <NUM>.

As shown in <FIG> and <FIG>, located just proximally of the angled openings <NUM> are a series of ratcheting teeth <NUM> formed on the outer surface <NUM> of the main handle <NUM> and which extend at least partially circumferentially around the outer surface of the main handle <NUM>. The ratcheting teeth <NUM> formed on the outer surface of the main handle <NUM> point in a proximal direction and are configured to engage in a correspondingly shaped set of distally facing ratcheting teeth <NUM> formed in a distal ratchet ring <NUM> that is positioned underneath and within the second or distal rotatable ring <NUM>. The distal ratchet ring <NUM> may be integrally formed with the inner surface of the second rotatable ring <NUM>, or the distal ratchet ring <NUM> may be a separately formed component which is received within the inner surface of the second rotatable ring <NUM> or otherwise secured (such as by adhesives, welding or other attachment mechanisms) to the inner surface of the second rotatable ring <NUM>. For example, as shown in <FIG>, the distal ratchet ring <NUM> has proximally facing extensions or arms <NUM> which are received within one or more recesses <NUM> formed in the inner surface of the second rotatable ring <NUM>. Thus, the distal ratchet ring <NUM> is a separately formed component from the second rotatable ring <NUM>, yet the distal ratchet ring <NUM> rotates along with the second rotatable ring <NUM> and ensures uni-directional rotation of the second rotatable ring <NUM> in a first direction while preventing the second rotatable ring <NUM> from rotating in a direction opposite to the first direction.

More specifically, the ratcheting teeth <NUM> on the distal ratchet ring <NUM> engage the ratcheting teeth <NUM> formed on the outer surface of the main handle <NUM> to ensure that the second rotatable ring <NUM> rotates in only one direction (such as clockwise, for example) while preventing counter-clockwise rotation of the second rotatable ring <NUM>. One or more springs <NUM> are seated within the channels <NUM> formed on the inner surface of the main handle <NUM> and push the teeth <NUM> on ratchet ring <NUM> into engagement with the teeth <NUM> formed on the outer surface of the main handle <NUM>. As such, unintended counter-rotation of the second rotatable ring <NUM> will be prevented. Thus, when the second rotatable ring <NUM> is rotated by the user, such as during retraction of one or more proximal or distal trigger wires, diameter reducing ties or other stent graft retention mechanisms, the rotation of the second rotatable ring <NUM> (and thus the progress of the simultaneous retraction of the trigger wires, ties, etc.) is maintained.

Similarly, as shown in <FIG> and <FIG>, the distal end of the proximal cap <NUM> comprises a set of ratcheting teeth <NUM> which extend at least partially circumferentially around the distal end of the proximal cap <NUM> and which point in a distal direction. The ratcheting teeth <NUM> which extend distally from the proximal cap <NUM> are configured to engage in a correspondingly shaped set of proximally facing ratcheting teeth <NUM> formed in a proximal ratchet ring <NUM> that is positioned underneath and within the first rotatable ring <NUM>. The proximal ratchet ring <NUM> may be integrally formed with the inner surface of the first rotatable ring <NUM>, or the proximal ratchet ring <NUM> may be a separately formed component which is received within the inner surface of the first rotatable ring <NUM> or otherwise secured (such as by adhesives, welding or other attachment mechanisms) to the inner surface of the first rotatable ring <NUM>. For example, as shown in <FIG> and <FIG>, the proximal ratchet ring <NUM> has distally facing extensions or arms <NUM> which are received within one or more recesses <NUM> formed in the inner surface of the first rotatable ring <NUM>. Thus, in this example, the proximal ratchet ring <NUM> is a separately formed component from the first rotatable ring <NUM>, yet the proximal ratchet ring <NUM> rotates along with the first rotatable ring <NUM> and ensures uni-directional rotation of the first rotatable ring <NUM> in a first direction while preventing the first rotatable ring <NUM> from rotating in a direction opposite to the first direction.

More specifically, the ratcheting teeth <NUM> on the proximal ratchet ring <NUM> engage the ratcheting teeth <NUM> formed on the distal end of the proximal cap <NUM> to ensure that the first rotatable ring <NUM> rotates in only one direction (such as clockwise, for example) while preventing counter-clockwise rotation of the first rotatable ring <NUM>. One or more springs <NUM> are seated within the one or more channels <NUM> formed in the inner surface of the main handle <NUM> to urge the teeth <NUM> of ratchet ring <NUM> into engagement with the teeth <NUM> formed on the distal end of the proximal cap <NUM>. As such, unintended counter-rotation of the first rotatable ring <NUM> will be prevented. Thus, when the first rotatable ring <NUM> is rotated by the user, such as during retraction of one or more proximal and/or distal trigger wires <NUM>, <NUM>, <NUM>, diameter reducing ties or other stent graft retention mechanisms, the rotation of the first rotatable ring <NUM> (and thus the progress of the simultaneous retraction of the trigger wires, ties, etc.) is maintained.

It can be seen in <FIG> and <FIG>, that the first rotatable ring <NUM> is a separately formed component from the second rotatable ring <NUM> and the first and second rotatable rings <NUM>, <NUM> can rotate separately and independently from each other. As such, separate ratcheting mechanisms, such as the proximal ratcheting ring <NUM> ensures uni-directional rotation of the first rotatable ring <NUM> while the distal ratcheting ring <NUM> ensures uni-directional rotation of the second rotatable ring <NUM>.

As mentioned previously, the first rotatable ring <NUM> is positioned just proximal to the second rotatable ring <NUM> about the outer surface of the main handle <NUM> and can be independently rotated about the main handle <NUM> during retraction and removal of one or more trigger wires, diameter reducing ties or other stent graft retention mechanisms during a stent graft deployment procedure. As shown in <FIG> and <FIG>, the main handle <NUM> comprises one or more grooves or threads <NUM> formed in the outer surface thereof at a location which is generally disposed under the first and second rotatable rings <NUM>, <NUM>. For example, the main handle <NUM> may comprise a set of proximal threads <NUM> and a set of distal threads <NUM>. In one example, the proximal threads <NUM> may be formed as a groove in the outer surface of the main handle <NUM> which wraps around the outer surface of the main handle <NUM> in a counter-clockwise direction. The point of origination <NUM> of the proximal threads <NUM> is longitudinally spaced from the point of termination <NUM> of the proximal threads <NUM>, with, in the example shown, the points of origination <NUM> and termination <NUM> longitudinally separated by two threads. The point of termination <NUM> of the proximal threads <NUM> includes an opening or aperture <NUM> formed in the main handle <NUM>, thus providing an opening through which one or more of the proximal trigger wires <NUM>, <NUM>, distal trigger wires <NUM> and/or diameter reducing ties can pass, allowing the wires and/or ties to extend from the inner surface of the first rotatable ring <NUM>, through the opening <NUM> formed at the point of termination <NUM> of the proximal threads <NUM> and into the centrally located port <NUM> in valve <NUM> located within the main handle <NUM>, from which point the wires and/or ties extend proximally through the positioner <NUM> to the stent graft <NUM>.

During a procedure, the user may rotate the first rotatable ring <NUM> (such as in a clockwise direction as shown in <FIG>) which causes any one or more of the trigger wires and/or diameter reducing ties which are secured to the inner surface of the first rotatable ring <NUM> to begin wrapping within the proximal threads <NUM>, as the wires and/or ties are retracted from the stent graft <NUM>. In one non-limiting example, the proximal trigger wires <NUM>, <NUM> may be secured to the inner surface of the first rotatable ring <NUM>, such as by a set screw, adhesives, or other attachment mechanisms, thus, as the user rotates the first rotatable ring <NUM>, the proximal trigger wires <NUM>, <NUM> begin to wrap around the outer surface of the main handle <NUM> within the helical groove provided by the proximal threads <NUM> as shown in <FIG>. As the first rotatable ring <NUM> continues to be rotated by the user, the proximal trigger wires <NUM>, <NUM> continue to follow the helical pathway and wrap within the proximal threads <NUM> until the proximal trigger wires <NUM>, <NUM> are released from the proximal end of the stent graft <NUM>. As such, tension in the wires is maintained while allowing the wires to remain "hidden" during retraction to eliminate the possibility of entanglement with each other or with other parts of the device or other surgical tools being used. The helical groove provided by the proximal threads <NUM> may be a pre-determined length that may be slightly longer than the required actuation length for the particular trigger wire(s) being retracted, thereby providing a positive mechanical stop as an indication to the user when the retraction of one or both of the proximal trigger wires <NUM>, <NUM> is complete.

The user may continue to rotate the first rotatable ring <NUM> until the proximal trigger wires <NUM>, <NUM> have fully wrapped around the outer surface of the main handle <NUM> within the proximal threads <NUM>, thereby maintaining the now-retracted proximal trigger wires <NUM>, <NUM> seated in position within the proximal threads <NUM> to prevent the proximal trigger wires <NUM>, <NUM> from tangling or catching on other portions of the device or interfering with subsequent steps of deployment. In other words, the proximal threads <NUM> provide a storage or holding place for the proximal trigger wires <NUM>, <NUM> during retraction as well as after they have been retracted and the proximal end of the stent graft <NUM> released.

Although rotation of the first rotatable ring <NUM> is described above as facilitating retraction of the proximal trigger wires <NUM>, <NUM>, it is also contemplated that both the proximal and distal trigger wires <NUM>, <NUM>, <NUM> may be secured to the inner surface of the first rotatable ring <NUM> such that rotation of the first rotatable ring <NUM> causes both the proximal and distal trigger wires <NUM>, <NUM>, <NUM> to wrap within the proximal threads <NUM> and remain there while the proximal and distal ends of the stent graft <NUM> are released.

Similarly, as shown in <FIG> and <FIG>, the set of distal threads <NUM> may be formed as a groove in the outer surface of the main handle <NUM> which wraps around the outer surface of the main handle <NUM> in a counter-clockwise direction. In the example shown, the set of distal threads <NUM> are a mirror-image of the set of proximal threads <NUM> which may allow for both the first rotatable ring <NUM> and the second rotatable ring <NUM> in the same direction. The point of origination <NUM> of the distal threads <NUM> is longitudinally spaced from the point of termination <NUM> of the distal threads <NUM>, with, in the example shown, the points of origination <NUM> and termination <NUM> longitudinally separated by two threads. The point of termination <NUM> of the distal threads <NUM> includes an opening or aperture <NUM> formed in the main handle <NUM>, thus providing an opening through which one or more of the proximal trigger wires <NUM>, <NUM>, distal trigger wires <NUM> and/or diameter reducing ties can pass, allowing the wires and/or ties to extend from the inner surface of the second rotatable ring <NUM>, through the opening <NUM> formed at the point of termination <NUM> of the distal threads <NUM> and into the centrally located port <NUM> in valve <NUM> within the main handle <NUM>, from which point the wires and/or ties extend proximally through the positioner <NUM> to the stent graft <NUM>.

During a procedure, the user may rotate the second rotatable ring <NUM> (such as in a clockwise direction) which causes any one or more of the trigger wires and/or diameter reducing ties which are secured to the inner surface of the second rotatable ring <NUM> to begin wrapping within the distal threads <NUM>, as the wires and/or ties are retracted from the stent graft <NUM>. In one non-limiting example, the distal trigger wires <NUM> and any additional diameter reducing ties may be secured to the inner surface of the second rotatable ring <NUM>, such as by a set screw, adhesives, or other attachment mechanisms. Thus, as the user rotates the second rotatable ring <NUM>, the distal trigger wires <NUM> (and/or any other diameter reducing ties) begin to wrap around the outer surface of the main handle <NUM> within the helical groove provided by the distal threads <NUM>. As the second rotatable ring <NUM> continues to be rotated by the user, the distal trigger wires <NUM> (and/or any other diameter reducing ties) continue to wrap within the distal threads <NUM> until the distal trigger wires <NUM> (and/or ties) are released from the stent graft. As such, tension in the wires <NUM> is maintained while allowing the wires to remain "hidden" during retraction to eliminate the possibility of entanglement with other parts of the device or other surgical tools being used. The helical groove provided by the distal threads <NUM> may be a pre-determined length that may be slightly longer than the required actuation length for the particular trigger wire(s) being retracted, thereby providing a positive mechanical stop as an indication to the user when the retraction of one or both of the proximal trigger wires <NUM> is complete.

The user may continue to rotate the second rotatable ring <NUM> until the distal trigger wires <NUM> and/or any other diameter reducing ties have fully wrapped around the outer surface of the main handle <NUM> within the distal threads <NUM>, thereby maintaining the now-retracted distal trigger wires <NUM> and/or additional ties seated in position within the distal threads <NUM> to prevent the distal trigger wires <NUM> or any other diameter reducing ties from tangling or catching on other portions of the device or interfering with subsequent steps of deployment. In other words, the distal threads <NUM> provide a storage or holding place for the distal trigger wires <NUM> and/or any other diameter reducing ties during retraction and after they have been retracted and the stent graft released. Thus, like the first rotatable ring <NUM>, the second rotatable ring <NUM> also contains all parts associated with trigger wire retraction, including the trigger wires <NUM>, <NUM> and <NUM> themselves during and after actuation, while hiding the wires when retraction is complete.

Although rotation of the first rotatable ring <NUM> is described above as facilitating retraction of the proximal trigger wires <NUM>, <NUM>, it is also contemplated that both the proximal and distal trigger wires <NUM>, <NUM>, <NUM> and/or any other diameter reducing ties may be secured to the inner surface of the first rotatable ring <NUM> such that rotation of the first rotatable ring <NUM> causes both the proximal and distal trigger wires <NUM>, <NUM>, <NUM> (and/or other diameter reducing ties) to wrap within the proximal threads <NUM> and remain there as the proximal and distal ends of the stent graft <NUM> are released. Likewise, the second rotatable ring <NUM> may facilitate retraction of proximal and distal trigger wires <NUM>, <NUM>, <NUM> and/or any other diameter reducing ties. In other words, both the first rotatable ring <NUM> and the second rotatable ring <NUM> may be used to facilitate retraction and release of any one or more trigger wires, diameter reducing ties or combinations thereof. The function of the particular rotatable ring (either the first rotatable ring <NUM> or the second rotatable ring <NUM>) may be determined by which of the trigger wires or diameter reducing ties are secured to its inner surface, such that when the first rotatable ring <NUM> or the second rotatable ring <NUM> is rotated by the user, the particular trigger wire(s) or diameter reducing tie(s) which are attached to that particular rotatable ring will be retracted while the remaining trigger wire(s) or diameter reducing tie(s) would be retracted by separate and independent rotation of the other of the two rotatable rings during deployment.

Also, although the proximal and distal threads <NUM>, <NUM> are described above as being wrapped in a particular direction, either clockwise or counter-clockwise and having points of origination and points of termination at a specific location and being longitudinally spaced by a particular number of threads, it will be appreciated that the proximal and distal threads <NUM>, <NUM> can be helically wound in any direction about the outer surface of the main handle <NUM> and can comprise any number of threads (e.g. more or fewer threads than shown in the Figures and described above, with points of origination and termination formed in any location on the main handle <NUM> and separated by any number of threads as necessary or desired.

As shown in <FIG>, extending distally from the main handle <NUM> is rear handle <NUM>. The rear handle <NUM> has a proximal end <NUM>, a distal end <NUM>, and an outer wall <NUM> extending there between, thus forming a rear handle interior <NUM> as shown in <FIG>. The rear handle <NUM> is rotatable relative to the main handle <NUM>. Like the front handle <NUM>, the rear handle <NUM> may be injection molded as a single unitary structure or, as shown in <FIG>, the rear handle <NUM> may comprise upper and lower parts or halves that clam shell, lock, snap-fit or are otherwise securable to each other. The rear handle may be constructed of a variety of materials, including but not limited to acrylonitrile butadiene styrene (ABS) or a similar thermoset plastic, polymers, metals (aluminum, stainless steel) and composites (carbon, fiberglass). In one example, an end cap <NUM> may be provided that may be fitted around and about the distal end <NUM> of the rear handle <NUM> to securely retain the separate halves of the rear handle <NUM> together, if desired. At least a portion of the outer surface <NUM> of the rear handle <NUM> may include a gripping portion <NUM> for a physician to grip with one hand while manipulating the rear handle <NUM>. The gripping portion <NUM> of the rear handle <NUM> is preferably ergonomically shaped for user comfort, and may be covered in a layer of softer plastic or rubber or have a gripping surface to ensure a stable grip.

The proximal end <NUM> of the rear handle <NUM> may include a channel <NUM> that extends circumferentially around the outer surface <NUM> near the proximal end <NUM> of the rear handle <NUM>, while the inner surface of the main handle <NUM> comprises a correspondingly shaped collar <NUM> or one or more protrusions that extend radially inwardly from the inner surface of the main handle <NUM> at a location just proximal of the distal end <NUM> of the main handle <NUM>. The protrusions or collar <NUM> can be received by the circumferential channel <NUM> formed in the rear handle <NUM>. The engagement between the channel <NUM> formed in the rear handle <NUM> and the collar <NUM> extending radially inwardly from the inner surface of the main handle <NUM> allow for the rear handle <NUM> to rotate with respect to the main handle <NUM>, yet prevent the rear handle <NUM> from sliding longitudinally (either proximally or distally) with respect to the main handle <NUM>. Other mechanisms which allow for rotation of the rear handle <NUM> but which prevent longitudinal movement or sliding relative to the main handle <NUM> may also be used as one of skill in the art would appreciate. Further, the size, shape and configuration of the channel <NUM> and collar <NUM> are preferably the same as or similar to the size, shape and configuration of the channel <NUM> formed in the distal end <NUM> of the front handle <NUM> and the correspondingly shaped collar <NUM> formed on the inner surface of the main handle <NUM>. As such, the standardization between these respective engaging surfaces would allow the position of the front handle <NUM> and the rear handle <NUM> to be reversed or interchanged with respect to the main handle as shown in <FIG> and described in further detail below.

As shown generally in <FIG> and <FIG>, a rear rail <NUM> is disposed within the rear handle <NUM> and a second follower <NUM> is slideably disposed within the rear rail <NUM>. With reference to <FIG>, the inner cannula <NUM> extends longitudinally through the lumen <NUM> of the second follower <NUM>. The lumen <NUM> of the second follower <NUM> may have a larger internal diameter at a distal end <NUM> of the second follower and a relatively smaller internal diameter at a proximal end <NUM> of the second follower <NUM>. The pin vice <NUM> is secured to the distal end of the inner cannula <NUM> and the pin vice <NUM> may be coupled or secured to the second follower <NUM>, thus securing the second follower <NUM> to the distal end of the inner cannula <NUM>, although other suitable mechanisms for attaching the inner cannula <NUM> to the second follower <NUM> are also contemplated, including adhesives, welding and the like. In one example shown in <FIG>, the proximal end <NUM> of the pin vice <NUM> has external threads which may mate with and engage with internal threads <NUM> formed on the inner surface of the distal end <NUM> of the second follower <NUM>, thus securing the pin vice <NUM>, the inner cannula <NUM> and the second follower <NUM> to each other. As such, when the second follower <NUM> is moved longitudinally within the rear rail <NUM>, the inner cannula <NUM> is also moved longitudinally.

The inner cannula <NUM> may be pushed forward or proximally relative to the device <NUM> by rotating the rear handle <NUM> relative to the main handle <NUM>. As a threaded internal surface <NUM> of the rear handle <NUM> engages one or more protrusions <NUM> extending radially outwardly from the second follower <NUM>, the rear rail <NUM> within the rear handle <NUM> rotationally restrains or prevents the second follower <NUM> from rotating within the rear rail <NUM>. Thus, rotation of the rear handle <NUM> pulls the second follower <NUM> forward or proximally within the rear rail <NUM> inside of the rear handle <NUM> thereby simultaneously pushing the inner cannula <NUM> forward or proximally. Pushing the inner cannula <NUM> in a proximal direction simultaneously causes proximal longitudinal movement of the inner cannula <NUM> as well as proximal movement of the nose cone <NUM>. If a top cap <NUM> is present, as shown in <FIG>, the top cap <NUM> will also move proximally with the nose cone <NUM>. As the nose cone <NUM> and top cap <NUM> are pushed proximally, the top cap <NUM> is lifted off of the proximal stent, thus allowing the proximal stent to fully deploy, as shown in <FIG> and described in further detail below.

More particularly, the proximal end <NUM> of the second follower <NUM> comprises at least one, and preferably two opposing ears or wings <NUM> extending from the outer surface of the second follower. A raised surface or protrusion <NUM> extends even further radially outwardly from each of the respective wings <NUM>. Each of the wings <NUM> are shown as having a generally rectangular shape, each of which extend into and through two spaced apart longitudinal slots <NUM> formed in the rear rail <NUM>, as shown in <FIG> and <FIG>. If, however, the second follower <NUM> only had a single wing, then the rear rail <NUM> may only have one slot <NUM> to accommodate the single wing.

The longitudinal slot(s) <NUM> formed in the rear rail <NUM> each comprise a proximal end <NUM> and a distal end <NUM> and during rotation of the rear handle <NUM> the second follower <NUM> will move or slide longitudinally from a distal to proximal direction within the rear rail <NUM> while the wings <NUM> slide from the distal end <NUM> of the slot <NUM> to the proximal end <NUM> of the slot <NUM>. Thus, the rear rail <NUM> allows the second follower <NUM> to slide longitudinally therein, while preventing rotation of the second follower <NUM>. While the wings <NUM> are shown as having a generally rectangular shape and the longitudinal slots <NUM> formed in the rear rail <NUM> are shown as having a generally corresponding elongated rectangular shape for receiving the wings <NUM> therein, it will be appreciated that the wings <NUM> and the longitudinal slots <NUM> may be of a variety of corresponding shapes so that the wings <NUM> can be received within and slide along the longitudinal slot <NUM> formed in the rear rail <NUM> to prevent rotation of the second follower <NUM> yet allowing the second follower to move longitudinally within the rear rail <NUM> while simultaneously pushing the inner cannula <NUM> in a proximal direction.

As shown in <FIG> and <FIG>, each of the respective protrusions <NUM> extending radially outwardly from the wings <NUM> are shown as having a generally conical, domed or rounded trapezoidal shape. The domed trapezoidal shape of the protrusions <NUM> are preferably received within and engage with threads <NUM> formed on the inner surface of the rear handle <NUM>. Thus, the threads <NUM> on the inner surface of the rear handle <NUM> may have a correspondingly shaped conical, domed or trapezoidal configuration which receives the protrusions <NUM> extending radially outwardly from the second follower <NUM>. While the protrusions <NUM> and the threads <NUM> may be formed in other shapes or configurations, it is desirable that the respective shapes of the protrusions <NUM> on the second follower <NUM> and the threads <NUM> formed on the inner surface of the rear handle <NUM> can operatively engage smoothly and with minimal friction, thus allowing for ease of rotation of the rear handle <NUM> regardless of whether the pitch of the threads <NUM> on the inner surface of the rear handle <NUM> is constant or whether the pitch of the threads is variable or otherwise changes.

As shown in <FIG>, the threads <NUM> on the internal surface of the rear handle <NUM> may have a constant pitch along the longitudinal length of rear handle <NUM>, so that a particular rotation (or rotations) of the rear handle <NUM> relative to the main handle <NUM> will result in a consistent longitudinal displacement or movement of the second follower <NUM> within the rear rail <NUM>, regardless of the second follower's position within the rear rail <NUM>. If the rear handle <NUM> comprises threads <NUM> having a constant pitch, this pitch may be in the range of a pitch of about <NUM> to about <NUM>. Like the front handle <NUM> shown in <FIG>, the internal surface of the rear handle <NUM> may have one thread with a single lead or point of origination, or, the inner surface of the rear handle <NUM> may include multiple-lead threads (sometimes referred to as "dual start threads", where two or more points of origination for two or more helical thread elements corresponding to each point of origination). Multiple-lead threads allow multiple protrusions <NUM> extending radially outwardly from the second follower <NUM> to engage the respective multiple threads, thereby increasing the engaging surfaces between the second follower <NUM> and the threaded internal surface of the rear handle <NUM>.

In another example and in contrast to the constant-pitch threads described above, the rear handle <NUM> may have variable pitch threads formed on the inner surface thereof. For example, the threads <NUM> formed on the inner surface of the distal end <NUM> of the rear handle <NUM> may have a relatively small pitch. With relatively smaller pitch threads, each rotation of the rear handle <NUM> may serve to push the inner cannula <NUM> proximally a relatively small longitudinal distance at first, thus also pushing any top cap <NUM> (if present) off of the proximal apices of a proximal stent, such as bare stent <NUM> of stent graft <NUM> shown in <FIG> or the proximal apices of another proximal stent shown in <FIG>) allowing the proximal end <NUM> of the exemplary stent graft <NUM> to be released from the top cap <NUM> and deployed very gradually during the initial phases of top cap removal to ensure accurate positioning of the stent graft within a patient's vessel. The threads <NUM> formed on the inner surface of the proximal end <NUM> of the rear handle <NUM> may have a relatively greater pitch than the threads at the distal end <NUM> of the rear handle <NUM>. The pitch of the threads <NUM> may change gradually, and may increase step-wise, or may change or increase in any other incremental or pre-determined distance from a proximal to distal direction along the inner surface of the rear handle.

As already described in detail above, variable pitch threads may provide various advantages. In one non-limiting example, after the top cap <NUM> has been pushed proximally off of the proximal stent and proper positioning verified by the physician, it may be desirable to proceed with the final removal of the top cap <NUM> more quickly. Thus, increasing the pitch of the threads near the proximal end <NUM> of the rear handle <NUM> allows the physician to push the inner cannula <NUM> (and thus the top cap <NUM>) in a proximal direction more quickly and with fewer rotations of the rear handle <NUM> thus completing deployment more quickly with each rotation of the rear handle <NUM> as the second follower <NUM> engages the threads <NUM> with the relatively greater pitch.

As shown in <FIG>, it is preferable that the rear handle <NUM> be rotated in only one direction to facilitate proximal longitudinal movement of the inner cannula <NUM> and top cap <NUM> removal. In one example, the rear handle <NUM> may be rotated in a clockwise direction to cause the second follower <NUM> to move longitudinally within the rear rail <NUM> to cause proximal movement of the inner cannula <NUM>, but the modular handle assembly <NUM> may be manufactured and assembled in other configurations so that rotation of the rear handle <NUM> may proceed in a counter-clockwise direction if necessary or desired. Uni-directional rotation of the rear handle <NUM> may be ensured by a ratcheting mechanism <NUM> as shown in <FIG> and <FIG>. The ratcheting mechanism <NUM> provides for "one-way" rotation of the rear handle <NUM> during the deployment of the prosthesis.

Specifically, the ratchet mechanism <NUM> that ensures one-way rotation of the rear handle <NUM> comprises, in one example, a ratchet ring <NUM> that is seated within the main handle <NUM> just proximal to the distal end <NUM> of the main handle <NUM>. The ratchet ring <NUM> comprises a set of ratcheting teeth <NUM> that extend distally from the ring <NUM>. The ratcheting teeth <NUM> are engaged with a corresponding set of ratcheting teeth <NUM> formed on the proximal end <NUM> of the rear handle <NUM>. One or more protrusions <NUM> extending radially outwardly from the ratcheting ring <NUM> are received within correspondingly shaped channels <NUM> formed on the inner surface of the main handle <NUM>, thus preventing inadvertent rotation of the ratcheting ring <NUM> during rotation of the rear handle <NUM>. At least one, and preferably two springs <NUM> are also positioned within the respective channels <NUM> formed on the inner surface of the main handle <NUM>. The springs <NUM> push distally and up against the protrusions <NUM> extending from the ratcheting ring <NUM>, thus urging the ratchet ring <NUM> rearward or distally within the main handle <NUM>, to ensure engagement between the ratcheting teeth <NUM> on ring <NUM> and the ratcheting teeth <NUM> formed in the proximal end <NUM> of the rear handle <NUM>. The shape and angle of the ratcheting teeth <NUM> extending distally from the ratcheting ring <NUM> and the correspondingly shaped ratcheting teeth <NUM> formed on the proximal end <NUM> of the rear handle <NUM> permit rotation of the rear handle in a first direction while restraining or otherwise preventing a second direction of second handle rotation, opposite to the first direction. In this way, rotation of the rear handle <NUM> can only proceed in one direction (e.g. clockwise), thus also preventing unintended counter-rotation of the rear handle <NUM> during proximal longitudinal movement of the inner cannula <NUM> during removal of the top cap <NUM> (such as that may occur due to build-up of torsional forces, friction or other forces that may cause the rear handle <NUM> to rotate on its own). Thus, the ratcheting mechanism <NUM> also helps to maintain the proximal travel distance of the inner cannula <NUM> after each handle rotation while reducing or eliminating recoil or unintended distal migration of the inner cannula <NUM> if/when the user releases their grip or re-grips the rear handle <NUM> during top cap removal.

While the ratcheting mechanism <NUM> for ensuring uni-directional rotation of the rear handle <NUM> has been described in one non-limiting example as a ratcheting ring <NUM> that is operatively engaged with ratcheting teeth <NUM> formed in the proximal end <NUM> of the rear handle <NUM>, other mechanisms may be used in place of, or in combination with the above-described ratcheting mechanism <NUM> to ensure uni-directional rotation of the rear handle <NUM> as would be appreciated by one of skill in the art.

In one other configuration of the modular handle assembly <NUM>, as one of skill in the art would appreciate, rotation of the rear handle <NUM> may not always be necessary and/or desired for the delivery and deployment of certain prostheses <NUM> and/or during use of the device <NUM> in particular procedures. In one non-limiting example, if the device <NUM> is used to deliver a stent graft or other prosthesis <NUM> that does not utilize a top cap <NUM> to releasably constrain the proximal end of the stent graft <NUM>, then rotation of the rear handle <NUM> to facilitate proximal longitudinal movement of the inner cannula <NUM> to remove a top cap <NUM> may no longer be a necessary step in a deployment sequence. For example, a stent graft <NUM> configured for delivery and deployment to an iliac artery, such as that shown in <FIG>, does not include a proximal bare stent (such as bare stent <NUM> shown in <FIG>) that would require restraint by a top cap <NUM> in the delivery device <NUM>, thus a top cap <NUM> at the proximal end of the inner cannula <NUM> would not likely be present. In such a case, the rear handle <NUM> may be pre-rotated or otherwise locked during manufacture so that upon arrival to the end-user, rotation of the rear handle <NUM> (and thus longitudinal movement of the inner cannula <NUM>) is prevented.

For example, during manufacture the rear handle <NUM> may be rotated so that the second follower <NUM> is moved as far to the proximal end <NUM> of slot <NUM> formed in the rear rail <NUM> as far as possible. Thus, even if the user tried to rotate the rear handle <NUM> during use, the rear handle would be prevented from rotating because the second follower <NUM> (which is engaged with the threads <NUM> formed on the inner surface of the rear handle <NUM>) would be at the proximal-most position <NUM> within the rail <NUM>, thus serving as a stop or lock and preventing the rear handle <NUM> from any possible further rotation. In other words, if the second follower <NUM> cannot move or slide further longitudinally within the rear rail <NUM>, then rotation of the rear handle <NUM> cannot proceed. Rotation of the rear handle <NUM> in the opposite direction would also be prevented due to the ratcheting mechanism <NUM>. As such, manipulation (rotation) of the rear handle <NUM> can be prevented when the delivery device <NUM> is intended to be used with particular prostheses that do not require proximal longitudinal motion of the inner cannula <NUM>, including proximal longitudinal motion of the inner cannula <NUM> during removal of a top cap <NUM>, for example.

In another configuration, such as when the delivery device <NUM> is used to deliver a stent graft <NUM> having a side arm or fenestration (such as side arm <NUM> of stent graft <NUM> shown in <FIG>) that must be cannulated and/or when the device <NUM> is used to deliver a prosthesis <NUM> to a vessel having a branch vessel extending from a main vessel where cannulation of the branch vessel is necessary or desired, the delivery device <NUM> may comprise a cannulating catheter such as catheter <NUM> shown in <FIG>, <FIG> and <FIG>. In such a case, the nose cone <NUM> may be provided with a channel or groove <NUM>, such as that shown in <FIG>. The proximal end of the cannulating catheter <NUM> may extend through the groove <NUM> formed in the nose cone dilator <NUM> and conform to the shape and configuration of the groove <NUM>. The cannulating catheter <NUM> may be held securely in the groove <NUM> (such as by the surrounding sheath <NUM>) until the sheath <NUM> is retracted during deployment. The user may manipulate the cannulating catheter <NUM> at its distal end, such as where it exits side port <NUM>, to move the cannulating catheter <NUM> proximally and distally and/or otherwise maneuver it in order to cannulate a branch vessel. One example of cannulating a branch vessel using a cannulating catheter is described in <CIT> and <CIT>, which applications are incorporated by reference in their entireties. However, as <FIG> shows, the delivery device <NUM> may be used to deliver various types of prostheses or stent grafts (like the exemplary prosthesis <NUM> shown in dashed lines in <FIG>) illustrating that this is one of many types of stent grafts that may be releasably coupled to and deployed using the delivery device <NUM>), and in instances in which side arm or branch vessel cannulation is not necessary or desired (e.g. such as with the stent graft shown generally in <FIG> and/or <NUM>), then the cannulating catheter <NUM> may be eliminated from the device <NUM> and the particular side port <NUM> and/or <NUM> in the valve <NUM> through which it would have extended may be sealed or used for other purposes.

Also, as described above and shown in exemplary <FIG>, the modular handle assembly <NUM> may be assembled so that the relatively longer front handle <NUM> extends proximally from the main handle <NUM> while the relatively shorter rear handle <NUM> extends distally from the main handle <NUM>. Thus, the longitudinal length of travel of the sheath <NUM> during sheath retraction is generally equivalent to the length of travel of the first follower <NUM> in the front rail <NUM>. Likewise, the longitudinal length of proximal travel of the inner cannula <NUM> to push the nose cone <NUM> and top cap <NUM> proximally during deployment is generally equivalent to the distance of travel of the second follower <NUM> in the rear rail <NUM>.

However, as previously mentioned, it may be advantageous, in certain circumstances and procedures and depending on the particular prosthesis being delivered by the device <NUM>, to configure and assemble the modular handle assembly <NUM> differently. In one example, the positions of the relatively longer front handle <NUM> and the shorter rear handle <NUM> can be switched or reversed relative to the main handle <NUM>, such that the longer "front" handle <NUM> now extends distally from the main handle <NUM> while the shorter "rear" handle <NUM> now extends proximally from the main handle <NUM>. This "reversed" configuration is shown generally in <FIG>.

In one example, the configuration of the handle assembly <NUM> shown in <FIG> may be desirable where the stent graft <NUM> being delivered by the device <NUM> has a relatively shorter length and does not require as great of a distance of longitudinal travel during sheath retraction to expose the graft as would be provided by the relatively longer front handle <NUM>. As such, the relatively shorter "rear" handle <NUM> may be positioned as the "front" handle extending proximally from the main handle <NUM> as <FIG> shows. Thus, during sheath retraction, the user would rotate the relatively shorter handle <NUM> (which is now serving as the "front" handle), and the distance of longitudinal sheath retraction would be substantially equivalent to the distance of travel of the second follower <NUM> within the rail <NUM> from a proximal position to a distal position within the rail <NUM> to expose the stent graft <NUM>.

In another example, the configuration of the handle assembly <NUM> shown in <FIG> may be desirable if the sheath <NUM> covering the stent graft <NUM> is a "split sheath," meaning that there is a split (not shown) at a point between the proximal and distal ends of the sheath <NUM>, resulting in a proximal sheath segment and a distal sheath segment that must both be removed to expose the stent graft <NUM>. A split sheath may be used, in one example, to radially restrain a stent graft such as that shown in <FIG>, which the split in the sheath generally aligned with fenestration <NUM> formed in the stent graft. This may allow cannulation of a branch vessel through fenestration <NUM> before one or both of the sheath segments are removed. Removal of the proximal sheath segment and the distal sheath segment often proceeds in two separate actions or manipulations of the handle assembly <NUM>. The first action is to retract the distal sheath segment distally to remove it from the distal end of the stent graft <NUM> with the front handle, while the second action is to push the proximal segment of the sheath <NUM> proximally to remove it from the proximal end of the stent graft <NUM> with the rear handle. In such a case, the distal sheath segment may be relatively shorter than the proximal sheath segment, thus the relatively shorter handle <NUM> may be better suited for providing the shorter longitudinal travel distance for retraction and removal of the distal sheath segment from the distal end of the stent graft <NUM>. Likewise, the relatively longer handle <NUM> may be better suited for providing the longer longitudinal travel distance for pushing the proximal sheath segment proximally to expose the proximal end of the stent graft <NUM>. More particularly, the proximal sheath segment may be attached at its proximal end to the distal end of the nose cone <NUM> (the proximal sheath segment thus being indirectly attached to the inner cannula <NUM> via the nose cone <NUM>). Thus, the modular handle assembly <NUM> may be assembled such that the relatively shorter "rear" handle <NUM> extends proximally from the main handle <NUM> (thus serving as a front handle) while the relatively longer "front" handle <NUM> extends distally from the main handle <NUM> (thus serving as a rear handle) as shown in <FIG>. Rotation of the relatively shorter handle <NUM> facilitates distal retraction of the shorter distal sheath segment, while subsequent rotation of the relatively longer handle <NUM> facilitates proximal longitudinal movement of the inner cannula <NUM> and nose cone <NUM>, thus simultaneously pushing the proximal sheath segment proximally with them to expose the proximal end of the stent graft <NUM> to complete deployment. Further details of a split sheath and manipulation thereof using a handle assembly <NUM> are described in <CIT>.

Thus, advantageously, the modular design of the handle assembly <NUM> facilitates the interchangeability of the front handle <NUM> and the rear handle <NUM> relative to the main handle <NUM> depending on the procedure being performed, the particular configuration of the prosthesis being deployed, the design of the sheath (unitary sheath or split sheath), the presence of a top cap, the presence of a cannulating cannula, as well as other factors. In other words, there is flexibility in the ways in which the various parts that make up the handle assembly <NUM> can be configured and assembled as desired or required by the user.

Before use of the delivery device <NUM> and when the delivery device is tracked to a desired location within a patient's body, the first follower <NUM> is disposed in a proximal-most position <NUM> within the front rail <NUM> (and if a top cap <NUM> is present to restrain the proximal end of the stent graft, then the second follower <NUM> is in the distal-most position <NUM> within the rear rail <NUM>) and the stent graft <NUM> at the proximal end <NUM> of the delivery device <NUM> is fully covered by sheath <NUM> and held in a radially inwardly contracted condition. To retract the sheath <NUM>, the front handle <NUM> is rotated by the user (such as in a clockwise direction) while the ratchet ring <NUM> prevents counter-rotation of the front handle <NUM>. If the threads <NUM> formed on the inner surface of the front handle <NUM> are variable pitch threads, then the distance of longitudinal travel during the initial stages of sheath retraction is smaller with each handle rotation as the first follower <NUM> engages the smaller pitch threads, while the distance of longitudinal travel of the sheath <NUM> during later stages of sheath retraction with each handle rotation increases as the first follower <NUM> engages the larger pitch threads towards the distal end <NUM> of the front handle <NUM>.

When the sheath <NUM> has been retracted distally a sufficient distance to expose at least the proximal end of the stent graft <NUM>, the user may proceed with removal of at least the proximal trigger wires <NUM>, <NUM> and any other diameter reducing ties that may be present at the proximal end of the stent graft <NUM>. To release the proximal trigger wires <NUM>, <NUM> and/or other diameter reducing ties, the user may rotate the first rotatable ring <NUM>. Rotation of the first rotatable ring <NUM> causes the proximal trigger wires <NUM>, <NUM> and/or additional proximal ties to wind around the outer surface of the main handle <NUM> within the proximal helical threads <NUM>. Rotation of the first rotatable ring <NUM> may continue until the proximal trigger wires <NUM>, <NUM> are fully wrapped within the proximal helical threads <NUM> and the first rotatable ring <NUM> can then no longer be rotated any further.

After removal of the proximal trigger wires <NUM>, <NUM> and/or proximal ties have been removed from the proximal end of the stent graft <NUM>, the user may manipulate the cannulating catheter <NUM>, if present, to cannulate any one or more branch vessels extending from a main vessel in which the stent graft <NUM> is being deployed. This particular step of a deployment sequence may only be desired in instances where the stent graft <NUM> being deployed comprises a fenestration or side arm (such as side arm <NUM> of stent graft <NUM> shown in <FIG>) and is configured to be deployed in a vessel where branch vessel cannulation is necessary or desired. In a non-limiting example, this particular step may be desirable for cannulation of a subclavian artery when the stent graft is being deployed in the aortic arch (such as the stent graft shown in <FIG>) or, for cannulation of an internal iliac artery when the stent graft is being deployed in the common and/or external iliac artery (such as the stent graft shown in <FIG>). Once a branch artery has been properly cannulated, an additional prosthesis, such as an extension graft (not shown) may be deployed over and/or through the pathway into the branch artery provided by the cannulating cannula <NUM>. This extension graft may extend from one or more fenestrations or side arms formed in the stent graft, such as the side arm <NUM> shown in <FIG> or side arm <NUM> shown in <FIG>.

At this time, the user may retract the sheath <NUM> further to expose the main body and/or the distal end of the stent graft <NUM> if this was not already done with the first stage of sheath retraction described above. When the sheath <NUM> has been sufficiently retracted to expose the distal end of the stent graft, the user may then rotate the second rotatable ring <NUM> to retract the distal trigger wires <NUM> and/or any other diameter reducing ties that may be present. Rotation of the second rotatable ring <NUM> causes the distal trigger wires <NUM> and/or additional distal ties to wind around the outer surface of the main handle <NUM> within the distal helical threads <NUM>. Rotation of the second rotatable ring <NUM> may continue until the distal trigger wires <NUM> are fully wrapped within the distal helical threads <NUM> and the second rotatable ring <NUM> can then no longer be rotated any further.

In this particular example of a method of use, rotation of the first rotatable ring <NUM> facilitates retraction of the proximal trigger wires <NUM>, <NUM> and any other proximal diameter reducing ties (if present), while rotation of the second rotatable ring <NUM> facilitates retraction of the distal trigger wires <NUM> and any other distal diameter reducing ties (if present). However, this is for exemplary purposes only, and the purpose and function of each of the respective first and second rotatable rings <NUM>, <NUM> can be changed or modified, such that rotation of any particular rotatable knob will facilitate retraction of the particular trigger wires or diameter reducing ties that are attached to the inner surface thereof.

At this point, the stent graft <NUM> should be fully deployed within the vessel, with the exception of a stent graft that may be fully deployed but the proximal-most stent (such as the bare stent <NUM> shown in <FIG>) is still contained within a top cap <NUM> as shown in <FIG>. In the case where a top cap <NUM> is present to contain the proximal stent <NUM>, the user may then grip the rear handle <NUM> and begin rotating the rear handle. As mentioned previously, rotation of the rear handle <NUM> causes the second follower <NUM> to move proximally within the rear rail <NUM> as the protrusions <NUM> extending radially outwardly from the second follower <NUM> engage the threads <NUM> formed on the inner surface of the rear handle <NUM>. As the second follower <NUM> moves proximally, it simultaneously causes proximal longitudinal movement of the inner cannula <NUM> as well as proximal movement of the nose cone <NUM> and top cap <NUM>. As the nose cone <NUM> and top cap <NUM> are pushed proximally, the top cap <NUM> is lifted off of the proximal stent <NUM>, thus allowing the proximal stent to fully deploy as <FIG> shows.

Once the stent graft <NUM> has been fully released from the delivery device <NUM>, the delivery device <NUM> can be removed from the patient's body. In one example, it may be desirable to once again cover the nose cone <NUM>, or at least the distal portion of the nose cone <NUM> and/or the top cap <NUM> with the sheath <NUM> before removing the device from the vessel lumen. The distal taper of the nose cone <NUM> may facilitate efficient and easy withdrawal of the delivery device <NUM> from the body with reduced risk of the nose cone <NUM>, the top cap <NUM>, or other portions of the delivery device <NUM> from snagging, catching or otherwise interfering with the deployed stent graft. The delivery device <NUM> can then be withdrawn distally, through the lumen of the stent graft and retracted further until the device has been safely removed from the patient's body.

Claim 1:
A handle assembly (<NUM>) for a prosthesis delivery device (<NUM>) comprising:
a stationary main handle (<NUM>) having a proximal end and a distal end and an outer surface extending therebetween;
a first trigger wire actuation mechanism disposed about the main handle (<NUM>) and rotatably moveable relative to the main handle (<NUM>);
a first trigger wire (<NUM>) operatively connected to the first trigger wire actuation mechanism, the first trigger wire (<NUM>) having a prosthesis capture condition and a prosthesis release condition;
a second trigger wire actuation mechanism disposed about the main handle (<NUM>) and rotatably moveable relative to the main handle (<NUM>);
a second trigger wire (<NUM>) operatively connected to the second trigger wire actuation mechanism, the second trigger wire (<NUM>) having a prosthesis capture condition and a prosthesis release condition;
a first ratcheting mechanism (<NUM>) that permits rotation of the first trigger wire actuation mechanism in a first direction and prevents rotation of the first trigger wire actuation mechanism in a second direction;
a second ratcheting mechanism that permits rotation of the second trigger wire actuation mechanism in a first direction and prevents rotation of the second trigger wire actuation mechanism in a second direction;
wherein movement of the first trigger wire actuation mechanism causes movement of the first trigger wire (<NUM>) thereby moving the first trigger wire from the prosthesis capture condition to the prosthesis release condition;
wherein movement of the second trigger wire actuation mechanism causes movement of the second trigger wire (<NUM>) thereby moving the second trigger wire from the prosthesis capture condition to the prosthesis release condition.