Patent Description:
The invention relates generally to devices that are retained inside a body passage and in one particular application to vascular devices used in repairing arterial dilations, e.g. aneurysms. More particularly, the invention is directed toward devices that can be adjusted during deployment, thereby allowing at least one of a longitudinal or radial repositioning of the device prior to final placement of the device.

The invention will be discussed generally with respect to deployment of a bifurcated stent graft into the abdominal aorta but is not so limited and may apply to device deployment into other body lumens. When delivering a stent graft by intraluminal or endovascular methods, it is important to know the precise location of the device in the vasculature, Controlling this precise location is particularly important when the device is intended to be deployed in close proximity to branch vessels or adjacent to weakened portions of the aortic wall. Typical stent grafts used to repair an aortic aneurysm incorporate a proximal (i.e. portion of the stent graft closest to the heart) anchoring system intended to limit longitudinal displacement of the stent graft. Often this anchoring system must be precisely placed to avoid occlusion of a branch vessel or to avoid placement within a compromised and damaged portion of the aortic wall.

<CIT> discloses a graft apparatus, delivery devices and methods for use in stent-graft systems for use in treating aneurysms occurring in hollow-body organs or vessels, and for treating arteriovenous fistulas. An apparatus for use with a stent for treating an aneurysm is disclosed, the apparatus comprising a graft; a delivery device including an introducer catheter and a manipulation lead, the manipulation lead disposed within and extending distally from the introducer catheter; and means for releasably engaging the graft to the manipulation lead for adjusting the position of the graft after the graft is deployed from the introducer catheter.

An improved delivery system for such stent grafts would include a means for allowing precise longitudinal and rotational placement of the stent graft and anchoring system. The precise position of the stent graft and anchoring system would be adjusted and visualized prior to full deployment of the device. Ideally the delivery system would allow the device to be repositioned if the prior deployment position was undesirable.

The present invention is directed to a controlled deployable medical device according to claim <NUM>.

The accompanying drawings are included to provide a further understanding of the invention and illustrate certain aspects of the invention.

The invention relates generally to a novel medical apparatus that includes a device capable of being retained inside a body passage and in one particular application to vascular devices. More particularly,the invention is directed toward devices that can be adjusted during deployment, thereby allowing at least one of a longitudinal or radial repositioning of the device.

In an embodiment of the invention, the medical apparatus includes a catheter assembly having a proximal end portion and distal end portion. A hub can optionally be arranged on the distal end portion of the catheter assembly. A stent is arranged on the proximal end portion of the catheter. The stent has an inner surface and an outer surface. The stent can be any suitable configuration. In one embodiment, the stent is configured from multiple turns of an undulating element. A graft member can be arranged about at least a portion of the stent. The stent may be self-expandable, balloon-expandable or a combination of self-expandable and balloon-expandable.

A tube extends from the proximal end portion to the distal end portion of the catheter. A first movable element, having a first and second end, is arranged around the outer surface of the stent. The first and second end of the first movable element are capable of extending out the distal end portion of the tube and the first movable element is capable of radially compressing at least a portion of the stent.

Optionally, a second movable element can be in communication with the first movable element, wherein the second movable element is arranged around the outer surface of stent and the first movable element is looped over the second movable element. A sheath material can cover at least a portion of the stent, wherein the sheath material is capable of holding the stent at a first diameter. A filament can surround the stent and a pin can extend from the tube and is capable of holding the filament surrounding the stent at a second diameter which is greater than the first diameter. The pin extending from the tube is capable of releasing the filament surrounding the stent to a third diameter which is greater than the second diameter.

In some embodiments, the stents can be used to at least fix the medical apparatus inside a portion of patient's anatomy. The stent can be constructed from materials that are flexible and strong. The stent can be formed from, for example, degradable bioabsorable materials, biodigestible materials, polymeric materials, metallic materials and combinations thereof. In addition, these materials may be reinforced and/or coated with other materials, such as polymeric materials and the like. The coating may be chosen to reduce acidic or basic effects of the gastrointestinal tract, e.g., with a thermoplastic coating such as ePTFE and the like.

The stents can be fabricated using any suitable methods and materials. For example, stents can be fabricated according to the teachings as generally disclosed in <CIT>, <CIT> and <CIT> For example, stents can have various configurations as known in the art and can be fabricated, for example, from cut tubes, wound wires (or ribbons), flat patterned sheets rolled into a tubular form, combinations thereof, and the like. Stents can be formed from metallic, polymeric or natural materials and can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicone polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol and biologically derived materials such as bovine arteries/veins, pericardium and collagen. Stents can also comprise bioresorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactones), poly(lactic/glycolic acid) polymers, poly(hydroxybutyrates) and poly(orthoesters).

The stents can be formed into a variety of different geometric configurations having constant and/or varied thickness as known in the art. The geometric configurations may include many conventional stent configurations such as a helically wrapped stent, z-shape stent, tapered stent, coil stent, combinations thereof, and the like. The stents can be formed in a variety of patterns, such as, a helix pattern, ring pattern, combinations thereof, and the like.

Grafts can have various configurations as known in the art and can be fabricated, for example, from tubes, sheets or films formed into tubular shapes, woven or knitted fibers or ribbons or combinations thereof. Graft materials can include, for example, conventional medical grade materials such as nylon, polyester, polyethylene, polypropylene, polytetrafluoroethylene, polyvinylchloride, polyurethane and elastomeric organosilicone polymers.

Stents can be used alone or in combination with graft materials. Stents can be configured on the external or internal surface of a graft or may be incorporated into the internal wall structure of a graft. Stent or stent grafts can be delivered endoluminally by various catheter based procedures known in the art. For example self-expanding endoluminal devices can be compressed and maintained in a constrained state by an external sheath. The sheath can be folded to form a tube positioned external to the compressed device. The sheath edges can be sewn together with a deployment cord that forms a "chain stitch". To release and deploy the constrained device, one end of the deployment cord can be pulled to disrupt the chain stitch, allowing the sheath edges to separate and release the constrained device. Constraining sheaths and deployment cord stitching can be configured to release a self-expanding device in several ways. For example a constraining sheath may release a device starting from the proximal device end, terminating at the distal device end. In other configurations the device may be released starting from the distal end. Self expanding devices may also be released from the device center as the sheath disrupts toward the device distal and proximal ends.

Details relating to constraining sheath materials, sheath methods of manufacture and stent graft compression techniques can be found in, for example, <CIT>. , and <CIT>.

The catheter and hub assemblies can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyether block amide or thermoplastic copolyether, polyvinylchloride, polyurethane, elastomeric organosilicone polymers, and metals such as stainless steels and nitinol.

Turning to the figures, <FIG> is a medical apparatus according to an embodiment of the invention. <FIG> is an enlarged simplified view of a portion of the medical apparatus shown in <FIG>.

Referring to <FIG>, the medical apparatus is generally depicted as reference numeral 100A. The medical apparatus 100A includes catheter assembly <NUM>, stent <NUM> arranged on the proximal end portion of the catheter assembly <NUM>. The stent <NUM> has an inner surface, an outer surface, and in this embodiment is configured from multiple turns of an undulating element <NUM>. The undulating element <NUM> can be configured, for example, in a ring or helical pattern.

The stent <NUM> has a proximal end portion <NUM> and distal end portion <NUM>. The distal end portion <NUM> is formed into a branch having a first leg <NUM> and a second leg <NUM>.

A graft member <NUM> is arranged about the stent <NUM>.

The stent <NUM> and graft member <NUM> are constrained into a compacted delivery state by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released, allowing at least a portion of the stent <NUM> to expand as shown. The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

A tube <NUM> extends from a proximal end portion to a distal end portion of the catheter assembly <NUM>. In the figure, the tube <NUM> is positioned adjacent the outer surface of the stent <NUM> and graft <NUM>. The tube <NUM> is attached to the catheter assembly <NUM> and not attached to the stent <NUM> or graft <NUM>, A movable element <NUM> (e.g., a fiber cord, string, wire, etc.) having a first end <NUM> and second end <NUM> surrounds the stent <NUM> and graft member <NUM>. The first end <NUM> and second end <NUM> of the movable element <NUM> extend out a distal end portion of the tube <NUM>. For example, the movable element <NUM> is threaded through the tube from a distal end to a proximal end and is looped around the proximal end portion <NUM> of the stent <NUM> and graft member <NUM>. As shown in <FIG>, by pulling the first end <NUM> and the second end <NUM> in a distal direction the movable element <NUM> is capable of radially compressing at least a portion of the stent <NUM> as indicated by arrows <NUM>.

<FIG> is a medical apparatus according to an embodiment of the invention, <FIG> is an enlarged simplified view of a portion of the medical apparatus shown as <FIG>.

Referring to <FIG>, the medical apparatus is generally depicted as reference numeral 100B, The medical apparatus of <FIG> is similar to the medical apparatus as shown in <FIG>. The medical apparatus includes catheter assembly <NUM>, stent <NUM> arranged on the proximal end portion of catheter assembly <NUM>. Stent <NUM> has an inner surface, an outer surface, and is configured from multiple turns of an undulating element <NUM>. The undulating element <NUM> may be configured, for example, in a ring or helical pattern.

A graft member <NUM> is arranged about the stent <NUM>,.

The stent <NUM> and graft member <NUM> are constrained into a compacted delivery state by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released allowing at least a portion of the stent to expand as shown The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

A tube <NUM> extends from a proximal end portion to a distal end portion of the catheter assembly <NUM>. The tube <NUM> is positioned adjacent the outer surface of the stent <NUM> and graft <NUM>. The tube <NUM> is attached to the catheter assembly <NUM> and not attached to the stent <NUM> or graft <NUM>. A movable element 122A having a first end <NUM> and second end <NUM> surrounds the stent <NUM> and graft member <NUM>. The first end <NUM> and second end <NUM> of the movable element 122A extend out a distal end portion of the tube <NUM>. For example, the movable element 122A is threaded through the tube from a distal end to a proximal end and is looped around the proximal end portion <NUM> of the stent <NUM> and graft member <NUM>.

Moreover, an additional movable element 122B having first end <NUM> and second end <NUM> surrounds the stent <NUM> and graft member <NUM>. The first end <NUM> and second end <NUM> of the additional movable element 122B extend out a distal end portion of the tube <NUM>. The additional movable element 122B is threaded through the tube from a distal end to an intermediate opening <NUM> in the tube <NUM> and is looped around an intermediate portion of the stent <NUM> and graft member <NUM>. As shown in <FIG>, by pulling the ends of the moveable elements in a distal direction the movable element 122A and the additional movable element 122B are capable of radially compressing at least a portion of the stent <NUM> as indicated by arrows <NUM>, It should be understood that additional moveable elements can be provided.

<FIG> is a medical apparatus according to an embodiment of the invention, shown in a partially deployed state. <FIG> is an enlarged simplified view of a portion of the medical apparatus shown in <FIG>.

Referring to <FIG>, the medical apparatus is generally depicted by reference numeral 200A. The medical apparatus 200A includes a catheter assembly <NUM>, and stent <NUM> arranged on the proximal end portion of the catheter assembly <NUM>. The stent <NUM> has an inner surface, an outer surface, and is configured from multiple turns of an undulating element <NUM>. The undulating element <NUM> can be configured, for example, in a ring or helical pattern.

The stent <NUM> and graft member <NUM> are constrained into a compacted delivery state by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released allowing at least a portion of the stent to expand. The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

A tube <NUM> extends from a proximal end portion to a distal end portion of the catheter assembly <NUM>. In this embodiment, the tube <NUM> is positioned adjacent the outer surface of the stent <NUM> and graft <NUM>. In this embodiment, the tube <NUM> is attached to the catheter assembly <NUM> and not attached to the stent <NUM> or graft <NUM>.

A second movable element <NUM> is in communication with a first movable element <NUM>. The second movable element <NUM> surrounds the stent <NUM> and the first movable element <NUM> is looped through the second movable element <NUM>.

The first end <NUM> and second end <NUM> of the first movable element <NUM> extend out a distal end portion of the tube <NUM>. For example, the first movable element <NUM> is threaded through the tube from a distal end to a proximal end and is looped through the second movable element <NUM>.

As shown in <FIG>, when the two ends <NUM> and <NUM> of the first movable element are pulled in a distal direction, the movable element <NUM> pulls on the second movable element <NUM>, radially compressing at least a portion of the stent <NUM> as indicated by arrows <NUM>.

<FIG> is a medical apparatus according to an embodiment of the invention. <FIG> is an enlarged simplified view of a portion of the medical apparatus shown in <FIG>.

Referring to <FIG>, the medical apparatus is generally depicted by reference numeral 200B. The medical apparatus of <FIG> is similar to the medical apparatus as shown in <FIG>.

Shown in <FIG>, a second movable element 236A is in communication with a first movable element 222A. The second movable element 236A surrounds the stent <NUM> and the first movable element 222A is looped through the second movable element 236A.

An additional first movable element 222B along with an additional second movable element 236B are incorporated into the medical apparatus 200B.

As shown in <FIG>, when tension is applied to the two ends <NUM> and <NUM> of the first movable element 222A, the first movable element 222A pulls on the second movable element 236A, radially compressing at least a portion of the stent <NUM> as indicated by arrows <NUM>. Similarly, when tension is applied to the two ends <NUM> and <NUM> of the additional first movable element 222B, the additional first movable element 222B pulls on the additional second movable element 236B, radially compressing at least a portion of the stent <NUM> as indicated by arrows <NUM>,.

<FIG> is a medical apparatus according to an aspect of the invention. <FIG> is an enlarged simplified view of a portion of the medical apparatus shown in <FIG>.

Referring to <FIG>, the medical apparatus is generally depicted by reference numeral 300A. The medical apparatus 300A includes a catheter assembly <NUM>, and stent <NUM> arranged on the proximal end portion of the catheter assembly <NUM>. The stent <NUM> has an inner surface, an outer surface, and is configured from multiple turns of an undulating element <NUM>. The undulating element <NUM> may be configured in a ring or helical pattern.

A graft <NUM> is arranged about the stent <NUM>,.

In one preferred embodiment, the stent <NUM> and graft <NUM> are constrained into a compacted delivery state by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released allowing at least a portion of the stent <NUM> to expand as shown. The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

A tube <NUM> extends from a proximal end portion to a distal end portion of the catheter assembly <NUM>, The tube <NUM> is positioned within and surrounded by the stent <NUM>. The tube <NUM> is attached to the catheter assembly <NUM> and not attached to the stent <NUM> or graft <NUM>. A movable element <NUM> having a first end <NUM> and second end <NUM> surrounds the stent <NUM> and graft <NUM>. The first end <NUM> and second end <NUM> of the movable element <NUM> extend out a distal end portion of the tube <NUM>. The movable element <NUM> is threaded through the tube from a distal end to a proximal end and is looped around the proximal end portion <NUM> of the stent <NUM> and graft <NUM>. A further embodiment for "surrounding" the stent with the moveable element includes threading the moveable element <NUM> through the graft <NUM> or through the stent <NUM> as shown in <FIG>. As shown in <FIG>, the movable element <NUM> is capable of radially compressing at least a portion of the stent <NUM> as indicated by arrows <NUM> when tension is applied to the movable element ends <NUM> and <NUM>. Additional movable elements may be added similar to those configurations described in <FIG> and <FIG>.

<FIG> is an enlarged simplified view of a portion of a medical apparatus according to an embodiment of the invention. As shown in <FIG>, second movable element <NUM> is in communication with first movable element <NUM>. The second movable element <NUM> surrounds the stent member <NUM> and the first movable element <NUM> is looped through the second movable element <NUM>. The second movable element <NUM> may also be threaded through the graft <NUM> or threaded through the stent <NUM> as shown in <FIG>.

As shown in <FIG>, when tension is applied to the two ends <NUM> and <NUM> of the first movable element <NUM>, the first movable element <NUM> pulls on the second movable element <NUM>, radially compressing at least a portion of the stent <NUM> as indicated by arrows <NUM>. Additional movable elements may be added similar to those configurations described in <FIG> and <FIG>.

Referring to <FIG>, the medical apparatus is generally depicted by reference numeral <NUM>. The medical apparatus <NUM> includes a catheter assembly <NUM>, and stent <NUM> arranged on the proximal end portion of the catheter assembly <NUM>, The stent <NUM> has an inner surface, an outer surface, and is configured from multiple turns of an undulating element <NUM>. The undulating element <NUM> may be configured in a ring or helical pattern.

A graft <NUM> is arranged about the stent <NUM>.

The stent <NUM> and graft <NUM> are constrained into a compacted delivery state by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released allowing at least a portion of the stent <NUM> to expand as shown. The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

A tube <NUM> extends from a proximal end portion to a distal end portion of the catheter assembly <NUM>. The tube <NUM> is positioned adjacent the outer surface of the stent <NUM> and graft <NUM>. The tube <NUM> is attached to the catheter assembly <NUM> and not attached to the stent <NUM> or graft <NUM>. A second movable element <NUM> is in communication with a first movable element <NUM>. The second movable element <NUM> surrounds the stent <NUM>. The second movable element <NUM> is looped through the first movable element <NUM>. A release pin <NUM> is threaded through the second movable element <NUM>, thereby releasably attaching the second movable element <NUM> to the first movable element <NUM>.

The first end <NUM> and second end <NUM> of the first movable element <NUM> extend out a distal end portion of the tube <NUM> along with the distal end of the release pin <NUM>.

As shown in <FIG>, when tension is applied to the two ends <NUM> and <NUM> of the first movable element <NUM>, the first movable element <NUM> pulls on the second movable element <NUM>, radially compressing at least a portion of the stent as previously shown, for example, in <FIG>.

The release pin <NUM> can be translated in a distal direction as shown by direction arrow <NUM>, thereby releasing the second movable element <NUM> from the first movable element <NUM>.

Referring to <FIG>, the medical apparatus is generally depicted as reference numeral <NUM>. The medical apparatus <NUM> includes a catheter assembly <NUM>, and stent <NUM> arranged on the proximal end portion of the catheter assembly <NUM>. The stent <NUM> has an inner surface, an outer surface, and is configured from multiple turns of an undulating element <NUM>. The undulating element <NUM> may be configured in a ring or helical pattern.

In a preferred embodiment, the stent <NUM> and graft <NUM> are constrained into a compacted delivery state by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released allowing at least a portion of the stent <NUM> to expand as shown. The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

A tube <NUM> extends from a proximal end portion to a distal end portion of the catheter assembly <NUM>. The tube <NUM> is positioned adjacent the outer surface of the stent <NUM> and graft <NUM>. The tube <NUM> is attached to the catheter assembly <NUM> and not attached to the stent <NUM> or graft <NUM>.

A movable element <NUM> is threaded through the tube <NUM> and is circumferentially arranged around the stent <NUM>. The movable element <NUM> is looped over release pin <NUM>, thereby releasably attaching the movable element <NUM> to the release pin <NUM>.

As shown in <FIG>, when tension is applied to the two ends <NUM> and <NUM> of the movable element, the movable element <NUM> radially compresses at least a portion of the stent as previously shown, for example, in <FIG>. When desired, the release pin <NUM> can be translated in a distal direction as shown by direction arrow <NUM>, thereby releasing the movable element <NUM> from the release pin <NUM> allowing the movable element <NUM> to be withdrawn.

A graft <NUM> is arranged about the stent <NUM>. The stent <NUM> and graft <NUM> are constrained into a compacted delivery state (or first diameter) by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released allowing at least a portion of the stent <NUM> to expand as shown. The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

After the release of the first sheath <NUM>, the stent <NUM> is allowed to self expand into a second diameter that is greater than the initial compacted first diameter. The second diameter is defined by a secondary constraint <NUM>. The secondary constraint <NUM> can be comprised, for example, of a flexible filament that encircles a proximal end portion <NUM> of the stent and graft. The secondary constraint <NUM> prevents further self expansion of the stent.

As shown in <FIG>, the secondary constraint <NUM> is looped around the stent (not shown) and is threaded through a first end of the secondary constraint <NUM>. The second end of the secondary constraint <NUM> is looped onto a release pin <NUM>. Once the apparatus <NUM> is properly positioned within a vessel target site, the secondary constraint <NUM> can be released by translating the release pin <NUM> in a distal direction as shown by direction arrow <NUM>. By translating the release pin <NUM>, the stent is released from the secondary constraint and thereby allowed to further expand into a third diameter that is greater than the second and first diameters.

Optionally, a retrieval cord or filament <NUM> can be used to join the secondary constraint <NUM> to the release pin <NUM>. Therefore when the release pin is translated distally, the secondary constraint <NUM> is withdrawn along with the release pin <NUM>.

A graft <NUM> is arranged about the stent <NUM>. The stent <NUM> and graft <NUM> are constrained into a compacted delivery state (or first diameter) by a first sheath <NUM> and second sheath <NUM>. As shown in <FIG>, the first sheath <NUM> has been released allowing at least a portion of the stent <NUM> to expand as shown The second sheath <NUM> is coupling the second leg <NUM> to the catheter assembly <NUM> as shown.

After the release of the first sheath <NUM>, the stent <NUM> is allowed to self expand into a second diameter that is greater than the initial compacted first diameter. The second diameter is defined by a secondary constraint <NUM>. The secondary constraint <NUM> is comprised of a flexible band that encircles a proximal end portion <NUM> of the stent graft. The secondary constraint prevents further self expansion of the stent graft.

As shown in <FIG>, the secondary constraint <NUM> is looped around the stent and is threaded through a latch <NUM> located near a first end of the secondary constraint <NUM>. A release pin <NUM> is threaded through the latch <NUM> to prevent further expansion of the secondary constraint <NUM>. Once the apparatus <NUM> is properly positioned within a vessel target site, the secondary constraint <NUM> can be released by translating the release pin <NUM> in a distal direction as shown by direction arrow <NUM>. By translating the release pin <NUM>, the stent <NUM> is released from the secondary constraint <NUM> and thereby allowed to further expand into a third diameter that is greater than the second and first diameters. Optionally, a retrieval cord or filament <NUM> can be used to join the secondary constraint <NUM> to the release pin <NUM>. Therefore when the release pin is translated distally, the secondary constraint <NUM> is withdrawn along with the release pin <NUM>.

<FIG> depict a medical apparatus according to an embodiment of the invention.

Referring to <FIG>, the medical apparatus is generally depicted as reference numeral <NUM>. The medical apparatus <NUM> includes a catheter assembly <NUM>, and stent arranged on the proximal end portion of the catheter assembly <NUM>. As shown in <FIG> the medical apparatus <NUM> has a stent constrained into a small delivery diameter <NUM>. The stent is held in this small delivery diameter by constraining sheaths <NUM> and <NUM>. The sheath <NUM> constrains the trunk of the stent while the sheath <NUM> constrains the extended leg portion of the stent. A third constraining sheath <NUM> is contained within the sheath <NUM>.

Referring to <FIG>, when the medical apparatus <NUM> is positioned within a target site, the sheath <NUM> can be released, allowing at least a portion of the stent to expand to a diameter <NUM> that is larger than the initial small delivery diameter <NUM>. The sheath <NUM> therefore constrains the stent <NUM> to an intermediate diameter. The sheath <NUM> constrains the extended leg portion of the stent onto the catheter assembly <NUM>, thereby allowing the medical apparatus to be repositioned, rotated or precisely aligned to the target site. As shown in <FIG>, when the medical apparatus is precisely positioned, the sheath <NUM> can be released, allowing the stent to fully expand to a large deployed diameter <NUM>. The deployed diameter <NUM> is larger than the intermediate diameter <NUM>. The intermediate diameter <NUM> is larger than the delivery diameter <NUM> as shown in <FIG>. Stent anchoring barbs or hooks <NUM> (when provided) are therefore constrained to the intermediate diameter <NUM> during final manipulation and positioning of the medical apparatus and allowed to expand and engage a vessel when the constraining sheath <NUM> is released.

<FIG> is a partial side view of a medical apparatus <NUM>, having a constrained medical device <NUM> located near or at the distal end of a catheter assembly <NUM>. The catheter assembly <NUM> has a catheter shaft <NUM> and a distal guidewire port <NUM>. <FIG> is a cross-sectional view of the catheter shaft <NUM>. Shown contained within the catheter shaft <NUM> is a guidewire <NUM>, a release member <NUM> and an adjustment member <NUM>. The release member can be a cord, thread, wire, pin, tube or other element used to release a stent (or other medical device) from a constraint, thereby allowing the device to expand from a first compacted delivery profile to a second larger profile. The adjustment member can be a cord, thread, wire, pin, tube or other element used to alter the second profile of at least a portion of the medical device. A catheter used to deliver a medical apparatus can have one, two, three, four or five or more release members combined with one, two, three, four or five or more adjustment members. The release members and adjustment members can be contained in separate or shared lumens within the catheter shaft <NUM>.

<FIG> show generalized views of a medical apparatus according to an embodiment of the invention (previously described in <FIG>). Shown in <FIG> is a medical apparatus <NUM>, comprised of a stent <NUM> having anchor barbs or hooks <NUM>. Shown is a tube <NUM> having a first movable element <NUM> located therein. The first movable element <NUM> is shown looped through a second movable element <NUM>. As shown in <FIG>, when tension <NUM> is applied to the ends of the first movable element <NUM>, the second movable element <NUM> is drawn into the tube <NUM>. When the second movable element <NUM> is drawn into the tube <NUM>, the stent graft is compressed in the direction indicated by arrows <NUM>. The anchors or barbs <NUM> are therefore retracted and pulled inwardly away from a vessel wall. The retraction of the anchors or barbs will allow the medical apparatus <NUM> to be longitudinally and/or rotationally adjusted. When in the precise target area the tension <NUM> on the movable element can be removed, allowing the stent to self expand and engage the anchors or barbs into a vessel wall.

<FIG> show a generalized delivery sequence. Shown in <FIG> is a medical apparatus <NUM>, having a first constraining sheath <NUM>, a second constraining sheath <NUM> and a catheter assembly <NUM>. Constrained and contained within the first and second sheaths <NUM>, <NUM> is a bifurcated stent having a trunk, a first short leg and a second long leg. As shown in <FIG>, when the medical apparatus is positioned at a target site, the first constraining sheath <NUM> is released allowing a portion of the stent and first short leg to self expand. A portion of the stent is held in a constrained small diameter state by movable element <NUM>. The movable element <NUM> is located in tube <NUM>. The stent anchors or barbs <NUM> are constrained and pulled inwardly by the movable element <NUM>, so that the anchors or barbs do not engage a vessel wall. The second constraining sheath <NUM> compresses the stent graft second long leg onto the catheter assembly <NUM>. Thus the medical apparatus is captured by the catheter assembly, allowing subsequent repositioning of the medical apparatus.

As shown in <FIG>, the medical apparatus <NUM> can now be readjusted in the longitudinal direction <NUM> and/or in the angular direction <NUM> through manipulations of the catheter assembly <NUM>.

As shown in <FIG>, when the medical apparatus is precisely positioned, tension on first movable element <NUM> is relaxed, allowing second movable element <NUM> to expand. As second movable element <NUM> expands, the stent is allowed to further expand in the direction <NUM>, engaging the anchors or barbs <NUM> into a vessel wall.

As shown in <FIG>, the second constraining sheath <NUM> can be released, allowing the second long leg to self expand.

As shown in <FIG>, one end of first movable element <NUM> can be tensioned, allowing first movable element <NUM> to be un-looped from second movable element <NUM>. First movable element <NUM> can then be withdrawn through the tube <NUM>. The expanded stent graft is now unattached from the catheter assembly, allowing withdrawal <NUM> of the catheter assembly.

Claim 1:
An apparatus (<NUM>), comprising:
a catheter (<NUM>) having a proximal end portion and distal end portion;
a stent member (<NUM>) arranged on the proximal end portion of the catheter (<NUM>), wherein the stent member has an inner surface and an outer surface;
a tube (<NUM>) having a continuous lumen, the tube extending from the catheter proximal end portion to the distal end portion;
a first movable element (<NUM>) at least a portion of which is contained within the continuous lumen of the tube;
a second movable element (<NUM>) releasably attached to the first movable element and surrounding a portion of the stent member, wherein the second movable element (<NUM>) is capable of radially compressing the stent member (<NUM>); and
a release pin (<NUM>) contained within the tube lumen and extending from the catheter proximal end portion to the distal end portion, characterized in that the release pin is threaded through the second movable element, thereby releasably attaching the second movable element to the first movable element.