Aortic prosthesis delivery system and method of use

Abstract

A stent graft for treating an aneurysm includes loops secured to struts of a stent, the struts defining distal and proximal apices. The ends of the strings may be connected by wires within a stent graft delivery system that thread anchor loops that run longitudinally through the ends of the strings to maintain the stent in a radially contracted position during delivery to the aneurysm. A delivery system and method for implanting a stent graft prosthesis includes a torque component at the distal end of the stent graft prosthesis, using which, after advancement of the stent graft in a constrained or partially constrained configuration to the surgical site, torque is applied to the torque component to rotationally align the stent graft about its longitudinal axis, and then deploy the stent graft in the correct rotational alignment. The delivery system and method of use include an apex capture assembly, leg clasps, and leg stops to capture the stent graft during orientation and stabilization at the implantation site of the surgical site.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefit of the following U.S. Provisional Applications: U.S. Provisional Application No. 63 / 111,357, filed on November 9, 2020; U.S. Provisional Application No. 63 / 153,701, filed on February 25, 2021; and U.S. Provisional Application No. 63 / 210,381, filed on June 14, 2021, the entire teachings of each of which are incorporated herein by reference.

Background Art

[0002] Background of the Invention Arterial pathologies such as aortic aneurysms can be treated by open surgical reconstruction or, alternatively, by endovascular repair, which is minimally invasive instead of open surgical repair. However, optimizing the successful outcome of endovascular repair requires an assessment of the patient's anatomical structure, and in the case of an artery or more specifically an aortic aneurysm, appropriate stents spanning the proximal and distal ends of the aneurysm are required to secure the stent graft to the aorta and minimize endoleak, ensuring essentially complete exclusion of the aneurysm sac. Endoleak and postoperative expansion at the aneurysm site often require further repair to seal any dilation of the aneurysm sac and generally must be performed without significantly impairing blood flow to the surrounding viscera and associated structures through the surgical site.

[0003] Therefore, there is a need for new and improved endovascular repair devices and methods for treating arterial pathologies such as aortic aneurysms.

Summary of the Invention

[0004] Summary of the Invention The present invention relates to an aortic prosthesis system for use in the treatment and repair of vascular damage associated with aortic and other arterial vascular injuries, such as aortic aneurysms in the region of the aorta that has arterial branches supplying blood to vital organs and tissues, including thoracic aortic aneurysms, abdominal aortic aneurysms, thoracoabdominal aortic aneurysms, pararenal aortic aneurysms, and short-neck abdominal aortic aneurysms.

[0005] In one embodiment, the present invention is an aortic prosthesis system comprising a luminal graft component having a proximal open end and a distal open end. Multiple stents are distributed longitudinally along the luminal graft component, and at least one of the stents has struts connected to define the proximal and distal apex. At least one loop is fixed to at least one of the struts. At least one cord extends through the loop and crosses at least a portion of at least one strut of the stent. The cord includes ends that, when connected, at least partially radially contract the respective corresponding stent. A pair of anchor loops in the luminal graft component span longitudinally to the ends of their respective associated cords when connected to radially contract the corresponding stent.

[0006] In another embodiment, the present invention is a stent graft delivery system comprising a stent graft. The stent graft comprises a lumen graft component having a proximal open end and a distal open end, defining a lumen. Multiple stents are distributed longitudinally along the lumen graft component, and at least one of the stents has a strut connected to define the proximal and distal apex. At least one loop is fixed to at least one of the struts. At least one cord extends through the loop and crosses at least a portion of the strut. The cord includes an end that, when connected, causes the stent to contract at least partially radially. A pair of anchor loops of the lumen graft component extend longitudinally to the ends of their respective associated cords when connected to cause the corresponding stent to contract radially. The wire extends longitudinally along the lumen graft components and through the anchor loop, connecting its ends, so that the wire radially contracts at least one portion of the stent in the stent graft, and the pulling of the wire from at least one end of the wire releases the end of the stent graft from the contraction by at least one wire.

[0007] In yet another embodiment, the present invention relates to a method for implanting a stent graft into an arterial aneurysm of a subject. The method comprises the steps of advancing a stent graft into the aneurysm of a subject, wherein the stent graft includes at least one cord extending around the periphery of the stent graft, the cord extending through at least one loop fixed to at least one radial stent support of the stent graft, and having an end connected by a wire extending through an anchor loop parallel to and connected to the longitudinal axis of the stent graft, thereby maintaining the stent graft in a radially contracted position. The wire is pulled in from at least one cord and the anchor loop, consequently releasing the ends of the cord from each other, and the stent graft radially expands from the radially contracted position to a radially expanded position, thereby implanting the stent graft into the aneurysm of the subject.

[0008] In another embodiment, the present invention is an aortic prosthesis system comprising a luminal graft component having a proximal open end and a distal open end. Multiple stents are distributed longitudinally along the luminal graft component, and at least one of the stents has a strut connected to define the proximal and distal apex. At least one loop is fixed to at least one of the struts. At least one cord extends through the loop, and each cord crosses the strut of at least one stent, where the cord includes an end that, when connected, at least partially radially contracts the respective corresponding stent.

[0009] In another embodiment, the present invention is an aortic prosthesis system comprising a luminal graft component having a proximal open end and a distal open end. Multiple stents are distributed longitudinally along the luminal graft component, and at least one of the stents has a strut connected to define the proximal and distal apex. At least one loop is fixed to at least one of the struts. At least one cord extends through the loop, each cord crossing the multiple struts of the stent to which the loop is attached, and the cords restrain the stent against outward radial expansion, thereby contracting the stent graft.

[0010] In yet another embodiment, the present invention relates to a delivery system for implanting a stent graft comprising a longitudinal body defining a longitudinal axis having a proximal handle and a distal handle, a guidewire catheter extending from the distal handle of the longitudinal body having a proximal end and a distal end, a nose cone fixed at the distal end of the guidewire catheter, wherein the nose cone has a proximal end, and an internal keyed extrusion. The internal keyed extrusion comprises a proximal end, a distal end, an internal surface defining a lumen through which the guidewire catheter extends, and an external surface that is non-circular in cross-section along at least a portion of the length of the internal keyed extrusion. The apex capture device in this embodiment includes an apex capture device having a distal component at the proximal end of a nose cone and a proximal component fixed to the distal end of an internal keyed projection, the distal and proximal components together capturing the proximal apex of the stent at the proximal end of the stent graft prosthesis extending around the internal keyed projection in a first position, and defining an opening that releases the proximal apex in a second position of the apex capture device. The torque component in this embodiment includes an external keyed projection fixed to a proximal handle around the internal keyed projection and extending from the proximal handle, the external keyed projection being non-circular in cross-section and defining an internal surface in which axial rotation and interference relationship with respect to the internal keyed projection, at least two arms arranged radially around the external keyed projection and extending distally from the external keyed projection, each arm being movable from a retracted state to an extended state, the torque component exhibiting radial extension. The radial restraint extends around the external keyed projection, and the stent graft extending between the external keyed projection and the radial restraint can be captured at the distal end of the stent graft, and the stent graft is rotated around the longitudinal axis by applying a torque force to the torque component by rotation of the proximal handle around the longitudinal axis.

[0011] In another embodiment, the delivery system for implanting the stent graft includes a proximal handle, a guidewire catheter extending from the proximal handle and having proximal and distal ends at the proximal handle, a nose cone fixed to the distal end of the guidewire catheter, and an internal keyed projection. The internal keyed projection has a proximal end, a distal end, an internal surface defining the lumen through which the guidewire catheter extends, and an external surface that is non-circular in cross-section along at least a portion of the length of the internal keyed projection. The stent graft includes a lumen graft component that extends around the guidewire catheter and has an outer surface, an inner surface, a proximal open end, a distal open end, and defines a plurality of stents that extend longitudinally along the lumen and lumen wall. The radial restraint in this embodiment radially restrains the stent graft and extends around the guidewire catheter, where the release of the radial restraint allows for radial expansion of the stent graft, thereby at least partially deploying the stent graft. The apex capture device in this embodiment includes a distal component fixed at the proximal end of a nose cone and a proximal component fixed at the distal end of an internal keyed projection, the distal and proximal components together define an opening that captures the proximal apex of the stent at the proximal end of a stent graft prosthesis extending around the internal keyed projection in a first position and releases the proximal apex in a second position of the apex capture device. The torque component of this embodiment of the present invention extends around the guidewire catheter and includes an external keyed projection extending distally from the proximal handle around an internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface that is in axial rotational interference relationship with respect to the internal keyed projection, and at least two arms are radially positioned around the external keyed projection and extend distally from the external keyed projection, each arm being movable from a retracted state to an extended state, the torque component exhibiting radial expansion, and the stent graft is rotated around the longitudinal axis by the application of a torque force to the torque component by the rotation of the proximal handle around the longitudinal axis.

[0012] In another embodiment of the present invention, a method for implanting a stent graft in an aneurysm site of a subject comprises the step of oriented the stent graft in an aneurysm site of the subject, the stent graft being held in a contracted position by a radial restraint and extending around an internal keyed projection, the internal keyed projection extending around a guidewire catheter and distally from the distal handle of the longitudinal body of a delivery device and within the stent graft, the stent graft having a proximal end and a distal end, the distal end of the stent graft being rotationally fixed to a torque component, the torque component including an external keyed projection extending around the internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface in which axial rotation with respect to the internal keyed projection and at least two arms extending distally and radially from the keyed projection, each arm being movable from a contracted to an extended state, the torque component exhibiting radial expansion. The proximal handle of the longitudinal body is rotated, thereby rotating the external keyed projection and aligning the stent graft in the rotational direction within the aneurysm site. The external keyed projection is rotated to rotate itself, and the proximal component of the apical capture device fixed to the distal end of the external keyed projection is separated from the distal component of the apical capture device fixed to the distal end of the guidewire catheter, thereby releasing the stent at the proximal end of the stent graft captured by the apical capture device. The radial restraint is retracted, thereby releasing the stent graft at the aneurysm site. The guidewire catheter and torque component are retracted from the subject, thereby implanting the stent graft into the aneurysm site of the subject.

[0013] In yet another embodiment of the present invention, a method for implanting a stent graft into an aneurysm site of a subject includes the steps of: advancing a stent graft, which is maintained in a contracted state by a radial restraint, to the aneurysm site; rotating the stent graft to align it in the rotational direction with at least partial assistance of a torque component at the distal end of the stent graft, wherein the stent graft retracts an internal keyed projection having a proximal component of a apical capture device fixed to the distal end of a apical capture device, which is keyed to an apical capture device that captures the stent at the proximal end of the stent graft, thereby releasing the stent at the proximal end of the stent graft; and removing the radial restraint from the stent graft, thereby implanting the stent graft into the aneurysm site.

[0014] In yet another embodiment, the present invention relates to a delivery system for implanting a stent graft, comprising a proximal handle, a guidewire catheter extending from the proximal handle and having proximal and distal ends at the proximal handle, and a nose cone fixed at the distal end of the guidewire catheter. The internal keyed projection in this embodiment includes a proximal end, a distal end, an internal surface defining a lumen into which the guidewire catheter extends, and an external surface that is non-circular in cross-section along at least a portion of the length of the internal keyed projection. The stent graft in this embodiment extends around the guidewire catheter, and the stent graft comprises a lumen graft component having an outer surface, an internal surface, a proximal open end, a distal open end and defining a lumen, and a plurality of stents extending longitudinally along the lumen graft component. The apex capture device in this embodiment includes a distal component at the proximal end of a nose cone and a proximal component fixed to the distal end of an internal keyed projection, the distal and proximal components together define an opening that captures the proximal apex of the stent at the proximal end of a stent graft prosthesis extending around the internal keyed projection in a first position and releases the proximal apex in a second position of the apex capture device. A radial restraint in the stent graft includes at least one cord that crosses at least a portion of the stent struts of the stent graft, the cord having ends that, when connected, contract the stent at least partially radially. The wire extends longitudinally along the lumen graft component, connecting the cord ends and thereby contracting at least a portion of the stent in the stent graft radially, and the radial contraction by at least one cord is released by pulling the wire from the end of at least one cord. The torque component in this embodiment includes an external keyed projection that extends around the guidewire catheter, is fixed to a proximal handle and extends from there, and extends around the internal keyed projection. The external keyed projection is non-circular in cross-section and defines an inner surface that is in an axial rotational interference relationship with respect to the internal keyed projection.At least two arms are positioned radially around an external keyed projection, extending distally therefrom, with each arm movable from a retracted to an extended state, the torque component exhibiting radial extension, and the stent graft is rotated around the longitudinal axis by applying torque force to the torque component through rotation of the proximal handle and external keyed projection around the longitudinal axis.

[0015] In yet another embodiment of the present invention, a delivery system for implanting a stent graft includes a proximal handle, a guidewire catheter extending from the proximal handle and having a proximal end and a distal end at the proximal handle, and a nose cone fixed at the distal end of the guidewire catheter, the nose cone having a proximal end and a distal end. The internal keyed projection in this embodiment includes a proximal end, a distal end, an internal surface defining the lumen into which the guidewire catheter extends, and an external surface that is non-circular in cross-section along at least a portion of the length of the internal keyed projection. The stent graft in this embodiment extends around the guidewire catheter and includes a lumen graft component that defines the lumen, having an outer surface, an internal surface, a proximal open end, and a distal open end. Multiple stents extend longitudinally along the lumen graft component, with a bare stent at the proximal open end of the lumen graft component. The bare stent includes struts defining its proximal and distal apex, where the bare stent is fixed to a lumen graft component at its distal apex. The radial restraint in this embodiment of the stent graft includes at least one cord that crosses at least a portion of the struts of the stent graft, the cord having ends that, when connected, at least partially contract the stent radially. The wire in this embodiment extends longitudinally along the lumen graft component, connecting the cord ends and thereby radially contracting at least a portion of the stent in the stent graft, and the retraction of the wire from the end of at least one cord releases the radial contraction by at least one cord. The apex capture device in this embodiment at the distal end of the guidewire catheter releasably captures the proximal apex of the bare stent and includes a distal component fixed to the distal end of the nose cone and the distal end of the internal keyed projection. The distal and proximal components together define an opening that captures the proximal apex of the stent at the proximal end of the stent graft prosthesis extending around the internal keyed projection at a first position, and releases the proximal apex at a second position of the apex capture device.The torque component of this embodiment of the present invention includes an external keyed projection extending around the guidewire catheter and distally from the proximal handle, around an internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface and at least two arms radially positioned around the external keyed projection and extending distally therefrom, each arm being movable from a retracted to an extended state, the torque component exhibiting radial expansion, and the stent graft is rotated around the longitudinal axis by the application of a torque force to the torque component by the rotation of the proximal handle and external keyed projection around the longitudinal axis.

[0016] In yet another embodiment, the present invention relates to a method for implanting a stent graft into an aneurysm of a subject, the method comprising the steps of orienting the stent graft into the aneurysm of the subject, wherein the stent graft comprises a luminal graft component and a plurality of radial stents distributed longitudinally along the luminal graft component, at least one of the stents having a strut connected to define a proximal and distal apex, the stent graft being held in a position constrained by a radial restraint, the radial restraint comprising at least one cord crossing at least a portion of the struts of the stent graft, the cord having an end that, when connected, at least partially contracts the stent radially, the radial restraint also comprising a wire extending longitudinally along the luminal graft component and connecting the ends of the cord, thereby reducing a portion of the stent of the stent graft At least a portion of the string is contracted radially, and the radial contraction by at least one string is released by pulling in the wire from the end of at least one string; the longitudinal body of the delivery device extends distally from the distal handle and extends around the guidewire catheter within the stent graft, the stent graft having a proximal end and a distal end, the distal end of the stent graft being rotationally fixed to a torque component that extends proximally from the proximal handle and around the guidewire catheter and extends around the internal keyed projection within the stent graft, the guidewire catheter and the internal keyed projection each include one component of a two-component apical capture device at their distal ends, the internal keyed projection having a non-circular cross-section and the external keyed projection having a non-circular cross-section that is in rotational and interfering relationship with the internal keyed projection. The proximal handle of the longitudinal body is rotated in this manner, thereby rotating the external keyed projection, and the apical capture device rotationally aligns with the stent graft within the aneurysm site. The external keyed projection is retracted, thereby separating the two components of the apical capture device and releasing the stent at the proximal end of the stent graft. The torque component is retracted, thereby releasing the stent graft at the aneurysm site.The radial restraint and guidewire catheter are then withdrawn from the subject, thereby implanting the stent graft into the aneurysm site of the subject.

[0017] In another embodiment, the present invention relates to a delivery system for implanting a stent graft, the delivery system comprising a longitudinal body having a longitudinal axis and a proximal and distal handle, a guidewire catheter having a proximal end and a distal end and extending from the distal handle of the longitudinal body, and an internal keyed projection. The internal keyed projection comprises a proximal end, a distal end, an internal surface defining the lumen through which the guidewire catheter extends, and an external surface that is non-circular in cross-section along at least a portion of the length of the internal keyed projection. The stent graft extends around the guidewire catheter and comprises a lumen graft component having an outer surface, an inner surface, a proximal surface, a proximal open end, and a distal open end and defining the lumen. Multiple stents include struts that extend longitudinally along the lumen graft component and are connected at their opposite ends to define the apex. The radial restraint in this embodiment is located on the stent graft and includes at least one loop fixed to at least a portion of the stent struts and at least one cord that crosses at least one of the stents and passes through the loop fixed to the stent struts. The apical capture device in this embodiment is located at the distal end of the guidewire catheter and releasably captures the proximal apex of a bare stent. The apical capture device includes a distal component at the proximal end of the nose cone and a proximal component fixed to the distal end of the internal keyed projection, the distal and proximal components together capture the proximal apex of the stent at the proximal end of the stent graft prosthesis extending around the internal keyed projection in a first position and define an opening that releases the proximal apex at a second position of the apical capture device. The torque component includes an external keyed projection extending distally from a proximal handle around an internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface in which it is in axial rotational interference with respect to the internal keyed projection, and at least two arms positioned radially around the external keyed projection and extending distally therefrom, each arm being movable from a retracted to an extended state, the torque component exhibiting radial expansion, and the application of torque force to the torque component by rotation of the proximal handle and external keyed projection around the longitudinal axis causes the stent graft to rotate around the longitudinal axis.

[0018] In another embodiment, the present invention is a stent graft delivery system comprising: a handle; an internal lead screw assembly; a lead screw nut; a support member fixed to the handle body and extending through the internal lead screw assembly; a sliding body located around the support member and releasably fixed to the internal lead screw assembly; an introducer sheath located around a portion of the support member and extending distally from the sliding body, and fixed to the sliding body; a leg clasp fixed to a support tube and extending distally from the support tube; and a removable leg stop located in a slot in the handle and proximal to the internal lead screw assembly. The handle includes a distal grip and a handle body portion extending proximal from one end of the distal grip. The handle defines a conduit and a slot along a portion of the length of the distal grip and the handle body portion, the handle body portion defining a longitudinal axis. The internal lead screw assembly is located within the handle body portion and is movable along the main axis of the conduit. The internal lead screw assembly also includes a threaded portion that extends through a slot and defines an opening that is essentially coaxial with the longitudinal axis of the handle. The lead screw nut extends around the handle body and engages thread-wise with the threaded portion of the internal lead screw assembly, and rotation of the lead screw nut causes movement of the internal lead screw assembly relative to the handle while adjacent to the distal grip, where the lead screw nut is simultaneously slidable along the handle body while engaged with the internal lead screw assembly, thereby providing at least two mechanisms for causing movement of the internal lead screw relative to the handle. The support member includes a support tube extending through the handle body and a lower tube (hypo-tube) extending around the circumference of the support tube. The sliding body includes a hemostatic valve. The introducer sheath is fixed to the sliding body, and relative movement of the handle body and the lead screw assembly causes movement of the introducer sheath relative to the support member. The leg clasp includes a barrel-shaped portion fixed to a support tube; a spool portion extending distally from the barrel-shaped portion along its longitudinal axis, the spool portion having a diameter smaller than the diameter of the barrel-shaped portion; and a rim portion at the end of the spool portion, the rim portion having a diameter larger than the diameter of the spool portion and smaller than the diameter of the barrel-shaped portion.The removable legstop includes a legstop body portion having a longitudinal axis and located in a slot in the proximal handle body portion of the internal lead screw assembly, and a flexible spring extending radially from the longitudinal axis of the legstop body portion. The spring extends at least partially around the handle body portion, holding the legstop body portion in place in the slot of the handle body portion, and the legstop body portion is removable from the slot by spreading the flexible spring from around the handle body portion.

[0019] The present invention offers numerous advantages. For example, the loop attached to the stent support by the present invention provides improved control by the physician during implantation. More specifically, the loop through which the retractable cord passes is fixed to the support of the stent graft being implanted, thereby allowing the physician to better rotate or reposition the stent graft after partially deploying the stent graft to align the fenestrations and branching vessels within the stent graft. The physician can also partially retract the wire that radially retracts the stent graft, thereby providing greater control over the delivery system, which can only position the stent graft before deployment begins. Furthermore, the physician can rotate the stent graft after it has been partially deployed, for example, by partially removing the radial restraint. In addition, the torque component allows torque to be transmitted to the distal end of the stent graft during delivery, thereby providing greater control over the delivery system, which can only apply torque to the proximal end of the stent graft. As a result, stent grafts can be deployed more accurately, with less risk of injury to the subject's vascular system, and without a significant risk of distorting the intended shape of the stent graft when implanted at the surgical site.

[0020] As a result, stent grafts can be deployed more accurately, with less risk of injury to the subject's vascular system, and without a significant risk of distorting the intended shape of the stent graft when implanted at the surgical site. [Brief explanation of the drawing]

[0021] Brief explanation of the drawing The aforementioned points are evident from the following more specific descriptions of exemplary embodiments, as illustrated in the attached drawings, where similar reference symbols refer to the same parts through different drawings. The drawings are not necessarily made to a fixed scale, and instead the emphasis is on describing the embodiments. The same numbers present in different drawings represent the same item. [Figure 1] Figure 1A is a side view of one embodiment of the aortic prosthesis delivery system of the present invention, in which the stent graft is held in a radially contracted position by a cord extending through a loop fixed to the stent support of the aortic prosthesis delivery system, and the wire that maintains the stent graft in the radially contracted position is stabilized by an anchor loop. Figure 1B is a terminal view of the aortic prosthesis delivery system of Figure 1A having a diameter D', obtained along line 1B-1B. Figure 1C is a side view of the proximal end of the stent graft of Figure 1B, obtained along line 1C-1C. Figure 1D is a side view of the proximal end of the stent graft of Figure 1B, obtained along line 1D-1D. Figure 1E is a side view of the proximal end of the stent graft of Figure 1B, obtained along line 1E-1E. Figure 1F is a side view of the proximal end of the stent graft of Figure 1B, obtained along line 1F-1F. [Figure 2]Figure 2A is a side view of the stent graft shown in Figures 1A-1F after the wire connecting the string that holds the stent graft in a radially contracted position has been withdrawn. Figure 2B is a terminal view of the proximal end of the stent graft in the uncontracted position shown in Figure 2A, with an expanded diameter D'', obtained along line 2B-2B. Figure 2C is a side view of the proximal end of the stent graft shown in Figure 2B, obtained along line 2C-2C. Figure 2D is a side view of the proximal end of the stent graft shown in the cross-section of 2B, obtained along line 2D-2D. Figure 2E is a side view of the proximal end of the stent graft shown in Figure 2A and in the cross-section of Figure 2B, obtained along line 2E-2E. Figure 2F is a side view of the proximal end of the stent graft shown in Figure 2B, obtained along line 2F-2F. [Figure 3] Figure 3A shows another embodiment of the aortic prosthesis delivery system of the present invention, in which the stent graft is held in a radially contracted position by a cord extending through a loop fixed to the stent support of the aortic prosthesis delivery system, the stent graft is held in a radially contracted position by a wire stabilized by an anchor loop, the cord is also stabilized by cord loops distributed laterally on both sides of the wire. Figure 3B is a terminal view of the stent graft delivery system shown in Figure 3A, showing a stent graft with a contracted diameter D' obtained along line 3B-3B. Figure 3C is a side view of the proximal end of the stent graft shown in Figure 3B, obtained along line 3C-3C. Figure 3D is a side view of the proximal end of the stent graft shown in Figure 3B, obtained along line 3D-3D. Figure 3E is a side view of the proximal end of the stent graft shown in Figure 3B, obtained along line 3E-3E. Figure 3F is a side view of the proximal end of the stent graft shown in Figure 3B, obtained along line 3F-3F. [Figure 4]Figure 4A is a side view of the stent graft of the aortic prosthesis delivery system shown in Figures 3A-3F after the wire components of the aortic prosthesis delivery system have been retracted from the end loop and anchor loop of the wire, thereby expanding the stent graft to a position where it has expanded in diameter. Figure 4B is a terminal view of the stent graft shown in Figure 4A with an expanded diameter D'', obtained along line 4B-4B. Figure 4C is a side view of the proximal end of the stent graft shown in Figure 4B, obtained along line 4C-4C. Figure 4D is a side view of the proximal end of the stent graft shown in Figure 4B, obtained along line 4D-4D. Figure 4E is a side view of the proximal end of the stent graft shown in Figure 4B, obtained along line 4E-4E. Figure 4F is a side view of the proximal end of the stent graft shown in Figure 4B, obtained along line 4F-4F. [Figure 5] Figure 5A is a side view of another embodiment of the aortic prosthesis delivery system of the present invention, in which the cord extends through a loop that is fixed to the stent support of the stent graft, but does not fully enclose the stent graft when the prosthesis is in a radially contracted position. Figure 5B is a terminal view of the aortic prosthesis delivery system shown in Figure 5A, showing a stent graft with a contracted diameter D', obtained along line 5B-5B. Figure 5C is a side view of the proximal end of the stent graft shown in Figure 5B, obtained along line 5C-5C. Figure 5D is a side view of the proximal end of the stent graft shown in Figure 5B, obtained along line 5D-5D. Figure 5E is a side view of the proximal end of the stent graft shown in Figure 5B, obtained along line 5E-5E. Figure 5F is a side view of the proximal end of the stent graft shown in Figure 9B, obtained along line 5F-5F. [Figure 6]Figure 6A is a side view of the stent graft of the aortic prosthesis delivery system shown in FIGS. 5A-5F after the wire connecting the end of the string is retracted to hold the stent graft in a radially contracted position. By retracting the wire from the anchor loop, the stent graft expands radially to an expanded diameter. Figure 6B is an end view of the proximal end of the stent graft shown in Figure 6A, showing the diameter of the stent graft expanded radially as D'' obtained along line 6B-6B. Figure 6C is a side view of the proximal end of the stent graft shown in Figure 6B obtained along line 6C-6C. Figure 6D is a side view of the proximal end of the stent graft shown in Figure 6B obtained along line 6D-6D. Figure 6E is a side view of the proximal end of the stent graft shown in Figure 6 obtained along line 6E-6E. Figure 6F is a side view of the proximal end of the stent graft shown in Figure 6B obtained along line 6F-6F. [Figure 7] Figure 7A is a side view of yet another aspect of the aortic prosthesis delivery system of the present invention. The string that radially contracts the stent graft is circular and extends through loops fixed to the circumference of the stent graft and the struts of the stent of the stent graft. The diametrically opposite points of the string are connected by a wire stabilized by an anchor loop. Figure 7B is an end view of the aortic prosthesis delivery system of Figure 7A having a diameter D' obtained along line 7B-7B. Figure 7C is a side view of the proximal end of the stent graft shown in Figure 7B obtained along line 7C-7C. Figure 7D is a side view of the proximal end of the stent graft shown in Figure 7B obtained along line 7D-7D. Figure 7E is a side view of the proximal end of the stent graft shown in Figure 7B obtained along line 7E-7E. Figure 7F is a side view of the proximal end of the stent graft shown in Figure 7B obtained along line 7F-7F. [Figure 8-1]Figure 8A is a side view of another embodiment of the aortic prosthesis delivery system of the present invention, in which the stent graft includes a fenestration and the cord extends through a loop that is secured to the stent support of the stent graft. Figure 8B is a side view of yet another embodiment of the aortic prosthesis delivery system of the present invention, in which the proximal open end includes a scalloped edge and the cord extends through a loop that is secured to the stent support of the stent graft. [Figure 8-2] Figure 8C is a side view of a further embodiment of the aortic prosthesis delivery system of the present invention, in which the distal open end includes a scalloped edge and the cord extends through a loop that is secured to the stent support of the stent graft. Figure 8D is a side view of a further embodiment of the aortic prosthesis delivery system of the present invention, in which both the proximal and distal open ends include scalloped edges and the cord extends through a loop that is secured to the stent support of the stent graft. [Figure 9] Figure 9 is an exploded side view of one embodiment of the aortic prosthesis delivery system of the present invention. [Figure 10]Figure 10A is a side view of the aortic prosthesis delivery system in an assembled form as shown in Figure 9. The introducer sheath including the stent graft of the aortic prosthesis delivery system of the present invention has been delivered to the patient's aneurysm. Figure 10B is a side view of the aortic prosthesis delivery system of Figure 10A after proximal retraction of the introducer sheath along the stent graft delivery device, whereby the stent graft is exposed and held in a radially contracted position by the wire of the stent graft delivery system. Figure 10C is a side view of the aortic prosthesis delivery system shown in Figures 10A and 10B after partial retraction of the wire from the string, which holds the stent graft in a partially radially contracted position when connected by the wire and the remainder of the stent graft is in a radially expanded position. Figure 10D is a side view of the aortic prosthesis delivery system shown in Figures 10A to 10C after complete retraction of the wire from the stent graft, and the stent graft is in a radially expanded position along its entire length. Figure 10E is a side view of the aortic prosthesis delivery system shown in Figures 10A to 10D after further retraction of the remaining part of the stent graft delivery system that is not implanted in the aneurysm and after implantation of another branched stent graft into the branched blood vessel through the fenestration of the stent graft, and the implantation of the stent graft and the branched stent graft in the patient's aneurysm is completed. [Figure 11] Figure 11 is a side view of one aspect of the aortic prosthesis of the present invention, and the box represents a specific aspect of the present invention shown in Figures 12 to 24. [Figure 12] Figure 12 is a detail of one aspect of the aortic prosthesis delivery system of the present invention, and the string includes two component parts. [Figure 13] Figure 13 is a detail of another aspect of the aortic prosthesis system of the present invention, and the end of each string loop is fixed to the strut, and the second string loop extends around the strut and through the graft component of the stent graft. [Figure 14]Figure 14 details another embodiment of the aortic prosthesis system of the present invention, in which the loop is fixed to the strut and maintains the longitudinal position of the cord along the length of the strut along the length of the stent graft, and the cord extends through the loop and around the stent graft. [Figure 15] Figure 15 details yet another embodiment of another aortic prosthesis system of the present invention, in which multiple cords define the boundary of the stent graft. [Figure 16] Figure 16 shows details of an embodiment of the aortic prosthesis system of the present invention, where the cord is a flattened hoop, such as those shown in Figures 7A-7F, which flatten to form two ends connected by a wire, just as shown in Figures 7A-7F. [Figure 17] Figure 17 shows details of an aspect of the aortic prosthesis system of the present invention, in which multiple cords form flattened hoops that define the boundaries of the stent graft at different longitudinal positions of the stent. [Figure 18] Figure 18 shows details of an aspect of the aortic prosthesis system of the present invention, in which the graft components of the stent graft define an opening, which is nested between the strata at the proximal end of the stent graft. [Figure 19] Figure 19 details another embodiment of the aortic prosthesis system of the present invention, in which the graft material of the stent graft component of the aortic prosthesis system includes two fenestrations, each fenestration nested between the different stent supports of the stent graft but very close to each other. [Figure 20] Figure 20 details yet another embodiment of the aortic prosthesis system of the present invention, in which the graft material of the stent graft component of the aortic prosthesis system includes two openings, each nested between the pillars of a single stent. [Figure 21-1] Figure 21 shows an embodiment of the present invention shown in Figure 18, where the opening is at least partially collapsed when the stent graft is radially constrained by the collapsed hoop. [Figure 21-2]Figures 21A and 21B are diagrams obtained along lines AA and BB, respectively, in Figure 21, showing that the area around the opening rises from the outer surface of the stent graft. Figure 21C is a detail of Figure 21A. Figure 21D is a detail of Figure 21B. [Figure 22-1] Figure 22 shows the configuration of Figure 20 when the wire connecting the ends of the crushed hoop is removed, thereby freeing the stent graft from the radially contracted position shown in Figure 20. [Figure 22-2] Figures 22A and 22B are detailed profiles of Figure 22 obtained along lines AA and BB, respectively, in Figure 22. [Figure 23] Figure 23 shows another embodiment of the aortic prosthesis system of the present invention, in which the fenestration defined by the graft components of the stent graft of the aortic prosthesis system is partially nested between the supports at the proximal and distal sides of the stent components of the stent graft, and the cord is a flattened hoop connected by a wire, thereby constraining the stent graft and flattening the fenestration at least partially. [Figure 24] Figure 24 shows the configuration shown in Figure 23 after the wire connecting the ends of the string has been removed. [Figure 25] Figure 25 shows another embodiment of the aortic prosthesis of the present invention, in which the fenestration defined by the graft components of the stent graft of the aortic prosthesis system is partially nested both distally between the supports of the stent components of the stent graft, and the cord is a flattened hoop connected by a wire, thereby constraining the stent graft and flattening the fenestration at least partially. [Figure 26] Figure 26 shows the configuration shown in Figure 25 after the wire connecting the ends of the string has been removed. [Figure 27-1] Figure 27 is a perspective view of one embodiment of the delivery system of the present invention for implanting an arterial stent graft. [Figure 27-2] Figure 27A is a perspective view of the proximal end of one embodiment of the delivery device of the present invention. [Figure 27-3]Figure 27B is a cross-sectional view of the proximal end of the delivery device shown in Figure 27A. Figure 27C is a detailed view of the cross-sectional view shown in Figure 27B. [Figure 27-4] Figure 27D is a perspective view of a portion of the proximal end of the delivery device shown in Figure 27A. Figure 27E is a detail of a portion of the perspective view shown in Figure 27D. Figure 27F is a perspective view of the proximal gasket shown in Figures 27A-27E. Figure 27G is an end view of the proximal gasket shown in Figure 27F. [Figure 28] Figure 28 is a perspective view of the delivery system in Figure 27, showing two options for drawing the introducer sheath away from around the arterial stent graft. [Figure 29] Figure 29 is a cross-sectional view of the delivery system shown in Figure 27 before deployment of a stent graft that is radially contracted according to one aspect of the method and system of the present invention. [Figure 30] Figure 30 is a cross-sectional view of one aspect of the distal end of a torque component of a delivery system suitable for the delivery of an arterial prosthesis that is radially retracted by the method and system of the present invention. [Figure 31] Figure 31 is a cross-sectional view of the arm of the torque component shown in Figure 30, obtained along line AA. [Figure 32] Figure 32 is a cross-sectional view of another embodiment of the distal end of a torque component of a delivery system suitable for the delivery of an arterial prosthesis that is radially contracted by the method and system of the present invention. [Figure 33] Figure 33 is a side view of an alternative prior art embodiment of the distal end of a torque component suitable for delivery of an arterial prosthesis that is radially retracted by the method and system of the present invention, wherein the arms of the torque component are connected by joints. [Figure 34] Figure 34 is a perspective view of another prior art embodiment of a torque component suitable for use according to an embodiment of the present invention, wherein the arms of the torque component define an opening. [Figure 35] Figure 35 is a perspective view of the arm of the torque component shown in Figure 32, with the suture ring extending from the opening. [Figure 36]Figure 36 is a side view of another diagram of the arm and suture ring configuration shown in Figure 35, wherein the arm extends into a pocket at the distal end of the stent graft, the suture ring, fixed to a claw of a torque component, extends from the claw through an opening defined by the pocket at the distal end of the stent graft, and the release wire extends through the suture ring according to one aspect of the present invention. [Figure 37] Figure 37 is a three-dimensional representation of the torque component shown in Figure 34, combined with the distal end of the stent graft, and the stent graft is radially constrained according to an embodiment of the system of the present invention. [Figure 38] Figure 38 is a three-dimensional representation of the torque component shown in Figure 34, combined with the distal end of a stent graft that is radially constrained according to another embodiment of the system of the present invention. [Figure 39] Figure 39 is a cross-sectional view of the delivery system of the present invention, including a flexible sheath extending around the stent graft and within the introducer sheath. Figure 39A is a cross-section of the embodiment shown in Figure 39, obtained along line AA, showing the configuration of the keyed internal and externally protruding components of the torque component. [Figure 40] Figure 40 is a cross-sectional view of the delivery system of the present invention shown in Figure 39, in which the introducer sheath is partially retracted from the stent graft. [Figure 41] Figure 41 is a cross-section of an embodiment of the delivery system shown in Figure 40, in which the introducer sheath is fully retracted from the stent graft and also from the arms of the torque component of the delivery system of the present invention. [Figure 42] Figure 42 is a cross-sectional view of the delivery system of the present invention shown in Figure 41, in which the stent graft is rotated around the guidewire catheter. [Figure 43] Figure 43 is a cross-sectional view of the delivery system of the present invention shown in Figure 42, in which a wire extending through the suture and radially constraining the stent graft is partially retracted from the suture, partially releasing the stent graft. [Figure 44]Figure 44 is a cross-sectional view of the delivery system and stent graft of the present invention shown in Figure 43, in which the wires that radially restrain the stent graft are completely retracted from the sutures, thereby completely releasing the stent graft. [Figure 45] Figure 45 is a cross-sectional view of the delivery system of the present invention for the stent graft shown in Figure 44, wherein the apical clasp component of the delivery system is open to release the proximal apex of the proximal bare stent of the stent graft. [Figure 46] Figure 46 is a cross-sectional view of the delivery system of the present invention for the stent graft shown in Figure 45, in which the distal torque component is drawn from the partially deployed stent graft and into the introducer sheath of the delivery system, thereby fully deploying the stent graft. [Figure 47] Figure 47 is a cross-sectional view of the delivery system shown in Figure 46, where the delivery system is partially retracted from the fully deployed stent graft. [Figure 48] Figure 48 is an exploded view of another embodiment of the delivery system of the present invention. [Figure 49] Figure 49A is a side view of the delivery system configuration shown in Figure 48 in its assembled state before deployment of the radially constrained stent graft. Figure 49B is a side view of the delivery system in Figures 48 and 47A after the radial constrainers have been retracted from the stent graft. Figure 49C is a side view of the delivery system in Figures 48, 49A and 49B after the release of the torque components from the distal end of the stent graft and the removal of the delivery system from the stent graft, thereby allowing the stent graft to be implanted. [Figure 50]Figure 50A is a perspective view of another embodiment of the present invention, in which a wire connects the opposite ends of a flattened suture wrap or circular cord, and the suture wrap passes through a loop on the stent support of a stent graft according to an embodiment of the present invention. Figure 50B is a detail of the circular cord shown in Figure 50A. Figure 50C is a detail of the circular cord in Figures 50A and 50B in which the circular cord is secured by aligning the opposite ends of the circular cord in the diametrical direction so as to be connected by a wire, thereby constraining the stent graft radially. [Figure 51] Figure 51 is an exploded view of another embodiment of the stent graft delivery system of the present invention, which includes, in addition to the torque component, a circular cord, a radial restraint around the stent graft, the opposite ends of the flattened cord in the diametrical direction connected by a wire, the flattened cord wraps around the stent graft, and the stent graft includes a proximal bare stent which can be releasedly secured to an apical capture device at the nose cone of the stent graft delivery system, with the flattened cord including a loop on a stent support from which it can stretch. [Figure 52] Figure 52A is a side view of the assembled stent graft delivery system shown in Figure 51 after the introducer sheath of the stent graft delivery system has been directed to the aneurysm across the arterial bifurcation of the subject. Figure 52B is a side view of the embodiment shown in Figure 52A after the introduction of the introducer sheath from the stent graft, thereby exposing the stent graft in a contracted position. Figure 52C is a side view of the embodiments shown in Figures 52A and 52B after the retraction of the wire connecting the opposite ends in the diametrical direction of the circular cord extending around the stent graft, thereby releasing the stent graft radially. Figure 52D is a side view of the embodiments shown in Figures 52A-52C after the release of the bare stent from the apical capture device. Figure 52E is a side view of the configuration shown in Figures 52A–52D, after the traction components are retracted from the distal end of the stent graft and the remaining delivery system is not implanted in the aneurysm site from the stent graft, and after the branching prosthesis is implanted through the window into the arterial bifurcation through which the aneurysm passes. [Figure 53]Figure 53 is a cross-sectional view of an embodiment of the present invention shown in Figures 50A and 50B, in which the stent graft is radially retracted by a two-stage radial release component including a flexible sheath and a wire connecting the ends of radially retractable sutures. Figure 53A is a cross-sectional view of the embodiment shown in Figure 53 obtained along line AA. [Figure 54] Figure 54 is a cross-section of the configuration shown in Figure 53 after proximal retraction of the introducer sheath and before activation of the two-stage radial release component, with the stent graft in the first intermediate radially extended position. [Figure 55] Figure 55 shows a cross-section of the configuration shown in Figure 54 after partial retraction of the flexible sheath, which is positioned between the stent graft and the introducer sheath when it is not deployed but is exposed during retraction. [Figure 56] Figure 56 is a cross-section of the embodiments of Figures 54 and 55, where the stent graft remains in a second intermediate radially expanded position after the complete withdrawal of the flexible sheath. [Figure 57] Figure 57 shows cross-sections of the embodiments shown in Figures 54, 55, and 56 after partial retraction of the wires connecting the ends of the cords that restrain the stent graft radially. [Figure 58] Figure 58 shows cross-sections of the embodiments of Figures 54, 55, 56, and 57 after the wire has been fully retracted from the string holding the stent graft in a second intermediate radially expanded position, thereby placing the stent graft in a fully radially expanded position, but still being captured by the delivery device at the proximal and distal ends of the stent graft. [Figure 59] Figure 59 shows cross-sections of the embodiments of Figures 54, 55, 56, 57, and 58 after the activation of the top capture component of the delivery device of the present invention. [Figure 60] Figure 60 shows cross-sections of embodiments of Figures 54, 55, 56, 57, 58, and 59 after the retraction of the torque component of the delivery device of the present invention, and the subsequent complete release and deployment of the stent graft from the delivery device. [Figure 61]Figure 61 shows cross-sections of embodiments of Figures 54, 55, 56, 57, 58, 59, and 60 during the removal of the delivery device from the deployed stent graft. [Figure 62] Figure 62 is a side view of another embodiment of the present invention, which includes a bifurcated stent graft having an opening window combined with a delivery system. [Figure 63] Figure 63 is a perspective view of one embodiment of the leg clasp of the present invention suitable for use according to the present invention. [Figure 64] Figure 64 is a cross-sectional view of the leg clasp shown in Figure 63, which fastens the leg of a bifurcated stent graft according to one aspect of the present invention. [Figure 65] Figure 65 is a perspective view of the introducer sheath, leg clasp, push rod (or support tube), and external control tube combination of the present invention, in which the wire extends through an opening in the push rod. [Figure 66] Figure 66 is a perspective view of the top-capture device of the delivery device according to the present invention. [Figure 67] Figure 67 is a side view of an example of a bifurcated stent graft suitable for implantation using the delivery device of the present invention, after implantation. [Figure 68] Figure 68 is a perspective view of a apex capture device suitable for use as a component of the delivery device of the present invention, in which the proximal apex capture portion is partially retracted from the distal apex capture portion of the apex capture device, thereby releasing the proximal apex and barb of the bare stent of the bifurcated stent graft shown in Figure 67. [Figure 69] Figure 69 is a perspective view of the apex capture device shown in Figure 68 before the proximal apex capture component is retracted and the proximal apex and barb of the proximal bare stent of the bifurcated stent graft shown in Figure 67 is exposed. [Figure 70] Figure 70 is a perspective view of the proximal apex capture portion of the apex capture device shown in Figure 68. [Figure 71] Figure 71 is a side view of the distal end of the delivery device of the present invention while the proximal end of a stent graft suitable for delivery by the delivery device of the present invention is held in a captured state. [Figure 72] Figure 72 is a perspective view of a sliding body suitable for use with the delivery device of the present invention, the other components of the delivery device extending through the sliding body before the release of the bifurcated stent graft at the surgical site. Figure 72A is a detail of the movement of the wire from the distal end of the sliding body, and specifically from along the outer surface of the push rod component of the support member to the inner surface of the lower tube component of the support member. Figure 72B is a detail of the display in Figure 72 showing the lower tube of the support member extending proximal from the sliding body. [Figure 73] Figure 73 is a perspective view of one embodiment of the present invention, showing a delivery device in the position of a stent graft, such as a bifurcated stent graft, before deployment. [Figure 74] Figure 74 is a perspective view of an embodiment of the present invention shown in Figure 73, after the introducer sheath of the delivery device has been withdrawn from all of the stent graft except for one leg held between the leg clasp and the introducer sheath. [Figure 75] Figure 75 is a perspective view of one embodiment of the legstop component of the delivery device of the present invention. [Figure 76] Figure 76 is another perspective view of the leg clasp shown in Figure 75. [Figure 77] Figure 77A is a perspective view of a clasp for releasing a bare stent from a stent graft using the delivery device of the present invention, with the clasp in a position to capture the bare stent. Figure 77B is a perspective view of the clasp of Figure 77A after reorientation of the clasp to enable release of the bare stent. Figure 77C is a perspective view of the clasps of Figures 77A and 77B after activation and resulting release of the bare stent from a stent graft delivered by the delivery system of the present invention. [Figure 78] Figure 78 is a perspective view of the delivery device shown in Figures 73 and 74 when the bare stent is released from the top-holding device by the operation of the clasp shown in Figures 77A-77B. [Figure 79]Figure 79A is a detail of a perspective view of the delivery device of Figures 73, 74, and 78 after partial retraction of the introducer sheath from the stent graft and after activation of the clasp to release the bare stent of the stent graft, while the legs of the bifurcated stent are still held by the leg clasp component of the delivery device of the present invention. Figure 79B is a perspective detail of Figure 79A after removal of the leg stop component of the delivery device of the present invention. Figure 79C is a perspective detail of Figures 79A and 79B after complete retraction of the introducer sheath from the stent graft, thereby releasing the stent graft and completing implantation. [Figure 80] Figure 80 is a perspective view of the delivery device of the present invention shown in Figures 73, 74, and 78, after the release of the legs of the bifurcated stent graft by the method of the present invention. [Figure 81] Figure 81A shows details of the delivery device before the introducer sheath of the delivery device is retracted from the stent graft. Figure 81B shows details of the delivery device after the introducer sheath is retracted from the stent graft and the stent graft is released from the delivery device, but before the release lever is activated, thereby allowing the sliding body to be separated from the rest of the delivery device. The sliding body may be left after the rest of the delivery device is removed from the subject and may be used in further treatment steps such as attaching an extension to a leg of a previously implanted bifurcated stent graft or implanting at least one branch into an implanted stent graft. Figure 81C shows details of the representations in Figures 81A and 81B after the release lever has been activated. [Figure 82] Figure 82A is a perspective view of the delivery device from Figures 73, 74, and 78 after the sliding body has been separated from the rest of the delivery device. Figure 82B is a detail of Figure 82A, showing the sliding body of the delivery device from Figure 82A. [Figure 83] Figure 83 is an exploded view of one embodiment of a stent graft having an opening window suitable for implantation using the delivery device of the present invention. [Figure 84] Figure 84 is a side view of the stent graft having the opening shown in Figure 83. [Modes for carrying out the invention]

[0022] Detailed description of the invention An example of a typical embodiment is described below.

[0023] The present invention generally relates to aortic prostheses such as stent grafts, and to a delivery system comprising a plurality of wires extending through the lumen of the aortic prosthesis such as a stent graft and onto the respective sides of the fenestrations within the stent graft. The present invention also relates to the use of the stent graft and delivery system of the present invention. The stent graft delivery system and its use treat aortic vascular injuries such as vascular injuries associated with aortic aneurysms, including those in the region of the aorta that has arterial branches supplying blood to life-sustaining organs and tissues, such as thoracic aortic aneurysms, abdominal aortic aneurysms, and thoracoabdominal aortic aneurysms, including pararenal aortic aneurysms and short-neck abdominal aortic aneurysms.

[0024] When referring to an aortic prosthesis, such as a "stent graft" or "vascular prosthesis" or other prostheses delivered to or implanted in a patient, the term "proximal" means the portion of the prosthesis or component of the prosthesis that is relatively close to the patient's heart, and "distal" means the portion of the prosthesis or component of the prosthesis that is relatively far from the patient's heart.

[0025] However, when referring to a delivery system or component of a delivery system used for the delivery or implantation of a prosthesis, the word “proximal” means, as used herein, closer to the clinician using the delivery system. When referring to a delivery system or component of a delivery system, “distal” means, as used herein, further away from the clinician using the delivery system.

[0026] For clarity, the word “nearest neighbor” means “close,” contrary to the meanings derived from “proximal” or “distal” as described above in relation to either a prosthesis or delivery system.

[0027] One embodiment of the stent graft delivery system of the present invention is shown in Figures 1A to 1F. As shown therein, the stent graft delivery system 10 includes the stent graft 12 of the present invention. The stent graft 12 includes a tubular graft component 14 having a proximal open end 16, a distal open end 18, and an outer surface 20. The inner surface 22 defines a lumen 24 around the longitudinal axis 26. The tubular graft component 14 is made of a suitable material, such as those known in the art. Examples of suitable materials include stretched polytetrafluoroethylene (ePTFE) and polyethylene terephthalate (PET), and woven polyester, for example.

[0028] The stent 28 of the stent graft 12 is distributed radially around the lumen graft component 14 and longitudinally along the lumen graft component 14. The stent 28 includes a strut 30, which is connected at either end to define a proximal apex 32 and a distal apex 34. The stent 28 is made of a suitable material, such as those known in the art. In one embodiment, the stent 28 is made of a material that allows the stent 28 to self-expand radially upon release from a radial restraint. Examples of suitable materials for a radially self-expanding stent include shape memory alloys, such as nitinol. Examples of stents not formed from shape memory alloys include those made from stainless steel. In embodiments of the invention that do not use shape memory alloys or otherwise do not self-expand radially, a balloon catheter may be used, for example, as known in the art, to radially expand the stent after it has been released from radial contraction. The stent 28 may also include radiopaque components known in the art, such as at least one radioopacifier selected from the group consisting of barium sulfate, bismuth, tungsten, platinum-iridium, and tantalum-tungsten.

[0029] Loop 35 is secured to the support 30 by suitable means such as thread or suture material, e.g., polyester or nylon. A cord 36, such as a single-strand cord opposite to the flattened hoop shown below, extends around the lumen graft component 14 and includes ends 38, 40. The cord 36 is formed of a suitable material, such as those known in the art. Examples of suitable materials for the cord 36 include polyester and nylon, or shape memory alloys such as Nitinol. As shown in Figure 1A, the ends of the cord 36 include cord loops 42, 44. The cord loops 42, 44 are connected by a wire 46, etc., as shown in Figure 1A, to reduce the diameter of the stent graft 12. The cord 36 extends through loop 35 and crosses the support 30 of the stent 28. On the plane immediately adjacent to either of the wires 46, the cord 36 crosses the support 30 by passing over the radially outward portion 48 of the support 30.

[0030] Similarly, the anchor loops 50, 52 are formed from a suitable material, such as a material suitable for fabricating the cord 36. The anchor loops 50, 52 are distributed longitudinally over the wire 46 on both sides of the cord loops 42, 44 of the cord 36, and consequently, across the cord loops 42, 44, at least partially stabilize the wire 46 from lateral movement of the wire 46 around the stent graft 12, keeping the ends 38, 40 of the cord 36 very close to the stent graft 12. In some other embodiment, for example, the cord 36 is stabilized at the stent graft 12 by passing the cord between the lumen graft component 14 and the support 30, thereby substantially preventing lateral movement of the wire 46 when the ends 38, 40 of the cord 36 are connected, in which case the anchor loops 50, 52 are not present.

[0031] Returning to Figure 1A, the wire 46 extends through loops 42, 44 of the cord 36, thereby connecting the ends 38, 40 of the cord 36 and maintaining the stent graft 12 in a radially contracted position. If the stent 28 is formed of a shape memory metal alloy such as Nitinol, it is understood that the cord 36 holds the stent 28 in a radially contracted position, and the radially self-expanding stent 28 exerts a radially outward force relative to the cord 36. In an alternative embodiment, it is also understood that the cord 36 may cross the strut 30 between the strut 30 and the lumen graft component 14 or in an arrangement different from that shown in Figure 1A, around the radially outward portion 48 of the strut 30. Furthermore, it is understood that the cord 36 may pass through the fabric of the lumen graft component 14 into the lumen 24 in various embodiments, such as the wire 46 extending through the lumen 24 and toward the inner surface of the lumen graft component 14, opposite to the outer surface 20 of the lumen graft component 14. Alternatively, in one embodiment (not shown), the stent 28 may be fixed to the lumen graft component 14 at its inner surface 22, in which case the wire 46 extends into the lumen 24 and the cord 36 crosses the support 30 between the support 30 and the inner surface of the lumen graft component 14. Other arrangements of the wire 46, cord 36 and stent 28 are also possible.

[0032] Figure 1B is a terminal view of the stent graft 12 shown in Figure 1A, obtained along line 1B-1B. As can be seen in Figure 1B, the contracted open stent graft 12 has an inner diameter of D'. Figure 1C is a side view of the stent and lumen graft components at the proximal open end 16 of the stent graft 12 shown in Figure 1A, obtained along line 1C-1C in Figure 1B. Similarly, Figures 1D, 1E, and 1F show side views of the most proximal stent of the stent graft 12 shown in the terminal view of Figure 1B, obtained along lines 1D-1D, 1E-1E, and 1F-1F, respectively. In summary, Figures 1A-1F show a cord 36 extending around the periphery of the stent graft 12, where the cord 36 passes beyond the outward-facing portion 48 of the strut 30.

[0033] Figure 2A is a side view of the stent graft 12 shown in Figure 1A, but after the wire 46 has been pulled in from the anchor loops 50, 52 and the loops 42, 44 of the cord 36, thereby enabling radial expansion of the stent 28 from the contracted position shown in Figures 1A-1F to the expanded position shown in Figure 2A. Radial expansion of the stent 28, such as the expansion of a radially self-expanding stent 28 made of Nitinol, separates the end 38, 40 and specifically the loops 42, 44 of the cord 36 from each other and from the anchor loops 50, 52 that run longitudinally to the wire loops 42, 44, where the wire 46 previously connected the loops 42, 44 between the anchor loops 50, 52. Figure 2B is an end view of the stent graft 12 of Figure 2A obtained along line 2B-2B, showing the expanded internal diameter D'' after the stent graft 12 has been released from the radially contracted position shown in Figures 1A-1F. Figures 2C, 2D, 2E, and 2F show side views of the most proximal stent and the lumen graft components at the proximal open end 16, as shown in Figure 2B, obtained along the lines 2C-2C, 2D-2D, 2E-2E, and 2F-2F, respectively.

[0034] Figure 3A is a side view of another embodiment of the stent graft delivery system of the present invention. As shown therein, the stent graft delivery system 60 further supports the stent graft 12 by string sutures 62, 64 between each loop 42, 44 and the support 30, and these strings traverse each side of the wire 46. The arrangement of the string sutures 62, 64 between the loops 42, 44 and each support 30 traversed by the string 36 stabilizes the connection of the loops 42, 44 by the wire 46. In yet another embodiment, it is understood that string sutures 62, 64 may be used instead of anchor loops 50, 52 to stabilize the loops 42, 44 when connected by the wire 46. Figure 3B is a terminal view of the proximal open end 16 of the stent graft 12 shown in Figure 3A, obtained along line 3B-3B and showing the internal diameter D' of the most radially contracted stent graft 12. Figures 3C, 3D, 3E, and 3F show side views of the tubular graft components at the most proximal stent 28 and the proximal open end 16, as shown in the cross-section in Figure 3B, obtained along the lines 3C-3C, 3D-3D, 3E-3E, and 3F-3F, respectively.

[0035] Figure 4A is a side view of the stent graft delivery system 60 shown in Figure 3A, after the wire 46 (not shown) has been pulled in and out from the anchor loops 50, 52 and loops 42, 44. As can be seen there, the radial expansion of the stent 28 from a radially contracted position to a radially expanded position separates loops 42, 44 laterally from each other and pulls them in from the sutures 62, 64, respectively, as shown in Figure 4A. Figure 4B is a terminal view of the stent graft at the radially expanded position shown in Figure 4A, obtained along line 4B-4B, showing the expanded internal diameter D'' after the radial expansion of the stent 28 in that section. Figures 4C, 4D, 4E, and 4F show the most proximal stent 28 and the luminal graft components 14 at the most proximal stent 28, as shown in the cross-section of Figure 4B obtained along the lines 4C-4C, 4D-4D, 4E-4E, and 4F-4F, respectively.

[0036] Figure 5A is a side view of yet another embodiment of the stent graft delivery system of the present invention. As shown in Figure 5A, the stent graft delivery system 70 includes a cord 72 in each stent 74 of the stent graft 94. The stent graft 94 includes a stent 74 and a lumen graft component 96. The lumen graft component defines a lumen 98. The cord 72 includes two component portions 76, 78, each secured by another support 80, 82 of each stent 74. The cord 72 includes loops 84, 86 at each end, which are aligned by a wire 92 passing through the loops 84, 86, thereby maintaining the stent graft 94 in a contracted position. When the wire 92 passes through the loops 84, 86, thereby contracting the stent 74 radially, the cord portions 76, 78 are stabilized by longitudinal anchor loops 100, 102 in the loops 84, 86. Although not shown, it is understood that sutures may also be optionally used, as described with respect to Figures 1A and 3A. Figure 5B is a terminal view of the stent graft delivery system 70 shown in Figure 5A, obtained along line 5B-5B, showing the internal diameter D' of the stent graft 94 in a radially contracted position. Figures 5C, 5D, 5E, and 5F show side views of the most proximal stent 74 shown in Figure 5B and portions of the luminal graft components at the most proximal stent 74, obtained along lines 5C-5C, 5D-5D, 5E-5E, and 5F-5F, respectively.

[0037] Figure 6A is a side view of the stent graft 94 shown in Figure 5A, after the wire 92 (not shown), anchor loops 100, 102, and string 72 loops 84, 86 have been pulled in, thereby radially expanding the stent graft 94 from the radially contracted position shown in Figures 5A-5F to the radially expanded position shown in Figure 6A. As can be seen in Figure 6A, loops 84, 86 separate laterally from each other and from anchor loops 100, 102 during the radial expansion of the stent graft 94 from the radially contracted state to the expanded state. Figure 6B is a terminal view of the stent graft 94 shown in Figure 6B, obtained along line 6B-6B, showing the radially expanded internal diameter D'' of the stent graft 94. Figures 6C, 6D, 6E, and 6F show side views of the most proximal stent 74 and the portion of the lumen graft component 96 closest to the most proximal stent 74, as shown in Figure 6B, obtained along the lines 6C-6C, 6D-6D, 6E-6E, and 6F-6F, respectively.

[0038] In another embodiment, the cord is in the form of a flattened hoop 104, which extends around the periphery of the stent graft 12 and forms opposite ends 106, 107 distal to the flattened hoop 104 connected by a wire 46. The wire 46 is stabilized in the stent graft by an anchor loop 108 as shown in Figures 7A, 7F.

[0039] As shown in Figures 8A–8D, the stent graft 10 of Figures 1A–1F may include at least one proximal opening 53 (Figure 8A), and optionally a scalloped proximal open end 54 (Figure 8B), a scalloped distal open end 55 (Figure 8C), and scalloped proximal and distal open ends 54, 55, respectively (Figure 8D). Not shown, the stent graft 10 may include at least one opening combined with at least one of the scalloped proximal open end and the scalloped distal open end. In a further embodiment, the stent graft of the present invention may include a bare stent at at least one of the proximal open end and the distal open end, which may optionally include barbs at their respective proximal or distal apex (not shown).

[0040] Figure 9 is an exploded side view of another embodiment of the stent graft delivery system of the present invention. As seen therein, the stent graft delivery system 110 includes a guidewire catheter 112 having a proximal end 114 and a distal end 116. A proximal handle 118 is fixed to the proximal end 114 of the guidewire catheter 112. A nose cone 120 is fixed to the distal end 116 of the guidewire catheter 112. A wire 122 includes a proximal end 124 and a distal end 126. The wire 122 may be made of a suitable material, such as nitinol or some other shape memory alloy known in the art, for example. The wire 122 is sufficiently flexible so as not to injure the patient as it progresses to the patient's aortic aneurysm. A wire handle 128 is fixed to the proximal end 124 of the wire 122. The introducer sheath 130 includes a proximal end 132 and a distal end 134, and the distal handle 136 is fixed to the proximal end 132 of the introducer sheath 130. The stent graft 138 includes a proximal end 140, a distal end 142, a lumen graft component 144, a stent 146 distributed along the lumen graft component 144, and a cord 148, arranged and configured as discussed above.

[0041] Figure 10A is an assembled side view of the stent graft delivery system 110 shown in Figure 9, in which the stent graft 138 is loaded into the distal end 134 of the introducer sheath 130 and at least partially contracted radially by a wire 122 threaded through a loop 150 at the end of the aforementioned string 148. In one embodiment, the stent graft 138 includes a window 139. In the method of the present invention, the stent graft delivery system 110 is advanced into the patient's aneurysm 152. In one embodiment shown in Figure 10A, the introducer sheath 130 is advanced into the aneurysm site 152, thereby positioning the stent graft 138 in the aneurysm 152. As can be seen in Figure 10B, the distal handle 136 is pulled in the proximal direction indicated by the arrow 160 toward the proximal handle 118, thereby pulling the introducer sheath 130 away from the stent graft 138 at the aneurysm 152. As can be seen in Figure 10B, regardless of the retraction of the introducer sheath 130, the stent graft 138 is maintained in a radially contracted position by a wire 122 extending through a string loop 150 of the string 148 that crosses the support of the stent 146 distributed longitudinally along the stent graft 138. However, in an alternative embodiment, the stent graft delivery system 110 may be advanced within the artery to a distal position of the aneurysm 152, and the stent graft 138 is directed toward the aneurysm 152 by the distal advance of the proximal handle 118 and wire handle 128, indicated by the arrow 162 toward the distal handle 136, thereby directing the radially contracted stent graft 118 from the introducer sheath 130 toward the aneurysm 152.

[0042] Following the orientation of the stent graft to its position across the aneurysm 152, and at least partial rotational and axial alignment of the stent graft at the aneurysm 152, the wire 122 is partially pulled out from the cord loop 150. The proximal pull of the wire handle 128 to the proximal handle 118 in the direction indicated by the arrow 160 can be seen in Figure 10C. The continuous pull of the wire 122 pulls the wire 122 out of the entire suture loop 150 of the cord 148, thereby allowing the stent graft 138 to fully expand from its radially contracted state shown in Figure 10B to its radially expanded state shown in Figure 10D. In one embodiment, the stent graft 138 is positioned so that the fenestration 139 is properly aligned with the arterial bifurcation 154 for the subsequent placement of the bifurcation prosthesis 156 through the fenestration 139 to the arterial bifurcation 154. Subsequently, the stent graft 138 is fully implanted within the aneurysm, and the remainder of the stent graft delivery device 110 is withdrawn from the stent graft 138 and the patient, as shown in Figure 10E, thereby completing the treatment of the patient's aneurysm site 152 by the method of the present invention.

[0043] Figure 11 is a side view of one embodiment 170 of the aortic prosthesis delivery system of the present invention. As can be seen in Figure 11, the bifurcated stent graft 171 includes an open proximal end 172 and an open distal end 174. However, the stent graft does not necessarily have to be bifurcated, but rather it is understood to be, for example, a single luminal conduit. The bare stent 176 extends proximally from the proximal end 178 of the tubular graft component 180 of the bifurcated stent graft 171 and nests with the proximal stent 182. Legs 184 and 186 extend distally from the tubular graft component 180. Stent 188 supports both legs 184 and 186. The tubular graft component 180 tapers at the distal end 195 of the tubular graft component 180 in transition to legs 184 and 186. The transition section 192 of the tubular graft component 180 is supported by the transition stent 194. The bare stent 176, the proximal stent 182, the transition stent 194, and the legs 184 and the stent 188 supporting the legs 186 all contain struts that meet at both ends and form the proximal and distal apex. Barbs 190 and 192 extend distally from the proximal apex 191 and distal apex 193 of the bare stent 176, respectively. Generally, the distal apex 193 of the bare stent is sutured to the outer surface of the tubular graft component 180, and the proximal stent 182 is typically sutured to the inner surface of the tubular graft component 180. The transition stent 194 is typically sutured to the outer surface, but alternatively, it may be on the inner surface of the tubular graft component 180. The stent 196 is distributed longitudinally along the length of the tubular graft component 180 and on its outer surface. The tubular graft component 180 may define fenestrations 198. At least one fenestration 198 may be located anywhere along the tubular graft component 180 and may be nested between the stent struts as shown. Alternatively, the fenestrations 198 may define, for example, two, three, four, or five fenestrations. Box A shows alternative embodiments of the stent positioned between the proximal stent 182 and the transition stent 194, such that these embodiments are shown in Figures 12-24 below and thus constitute embodiments of the aortic prosthesis delivery system of the present invention.

[0044] Figure 12 is a detail of one embodiment 200 of the aortic prosthesis delivery system generally shown as "A" in Figure 11 of the present invention, wherein the cord 202 includes two component parts 204, 206. The component parts include cord loops 208, 210 at their respective ends 212, 214 and are secured to the stent 216 at the support 218 at their respective opposite ends 220, 222. The cord component parts 204, 206 extend through loops 224, 226 which are secured to at least one support 218 at at least one point between their respective ends 212, 220 and 214, 222. The loops 224, 226 are secured to the support 218 by appropriate means, such as by tying the loops 224, 226 to the support 218 using a square knot. When a stent graft, such as the one shown in Figure 1A (Figure 12 is a detail of one embodiment), is restrained by a cord 202, the wire 228 extends through cord loops 208, 210, connecting cord component portions 204, 206, thereby radially restraining the stent 216 and the stent graft.

[0045] Figure 13 details another embodiment 230 of the aortic prosthesis system of the present invention. In this embodiment, the cord 232 includes component portions 234, 236, each having cord loops 238, 240 connected by a wire 228. Second cord loops 242, 244 extend through and connect to a graft component 180 of the stent graft.

[0046] Figure 14 details another embodiment 250 of the aortic prosthesis system of the present invention. In this embodiment 250, the cord 252 extends through a loop 254 which is fixed to the stent 256 by a strut 258, maintaining the longitudinal position of the cord along the length of the stent graft and along the longitudinal distance of the strut 258, which is detailed in Figure 13. The cord 252 extends around the stent graft through the loop 254. On the other hand, as shown in Figure 14, the loop may be on each strut of the stent in alternative embodiments not shown, and the loop may be on some portion of the struts 258 of the stent 256, for example, on just one strut or on all the other struts 258. The cord loops 260, 262 of the cord are connected by a wire 228 which radially restrains the stent 256 and the stent graft. By removing the wire 228 from the string loops 260 and 262, the stent 256 and the stent graft are released from the radial restraints.

[0047] Figure 15 details yet another embodiment of another aortic prosthesis system of the present invention, in which multiple cords define the boundaries of the stent graft. Similar to the embodiment in Figure 14, in the aortic prosthesis system 280, the cord 282 includes cord loops 284, 286 connected by a wire 228, thereby radially constraining the stent graft of the aortic prosthesis system 280. Loop 288 is fixed to the stent 290 by a support 292, maintaining the longitudinal position of the cord 282 along the longitudinal distance of the stent graft and along the length of the support 292. The cord 282 extends through loop 288. On the other hand, as shown in Figure 15, the loops 288 are located on each of the struts 292 of the stent 290, and in alternative embodiments not shown, the loops 288 associated with each string 282 may be located on, for example, only one strut 292 or on several portions of the struts 292 of the stent 290, such as alternative struts 292 of the stent 290.

[0048] Figure 16 details an aspect of the present invention, an aortic prosthesis system 300, where the cord 302 is a flattened hoop, such as those shown in Figures 7A-7F, forming two ends 304, 306 connected by a wire 228, as shown in Figures 7A-7F. The hoop extends through a loop 308 in its flattened form, and the connection of the ends 304, 306 by the wire 228 radially restrains the stent graft until the wire 228 is detached, for example by longitudinal pulling of the cord 302 from the ends 304, 306, and they are no longer connected. On the other hand, as shown in Figure 16, the loop 308 may be on the stent 310 with a support 312, and in alternative embodiments not shown, the loop 308 associated with each cord 302 may be on, for example, only one support 312, or on several parts of the support 312 of the stent 310.

[0049] Figure 17 details an aspect of the aortic prosthesis system 320 of the present invention, in which multiple strings 322, 324 form a flattened hoop that defines the boundary of the stent graft of the aortic prosthesis system 320 at different longitudinal positions of the stent 326 along the stent graft. In the example of Figure 17, two strings 322, 324 define the boundary of the stent graft. Strings 322, 324 extend through a loop 328, and the respective connections of the ends 330, 332 and 334, 336 of strings 322, 324 by wire 228 radially restrain the stent graft until the wire 228 is removed, for example by longitudinal pulling of the wire 228 from the respective ends 330, 332 and 334, 336 of strings 322, 324, and they are no longer connected. As shown in Figure 17, the loops 328 may be on each of the struts 338 of the stent 326, but in alternative embodiments not shown, each rope and associated loop may be on some of the struts of the stent, such as just one strut or all of the other struts.

[0050] Figure 18 details an aspect of the present invention, an aortic prosthesis system 340, in which a graft component 180 of the stent graft defines an opening 344, which is nested in the stent 346 between supports 348, 350 at the proximal end 351 of the stent 346 of the stent graft. In this embodiment, a loop 352 is fixed to the support 350 in a position that prevents the first cord 354 from crossing the opening 344, thereby leaving the opening 344 open for placement in a branched vessel, for example, for subsequent cannula insertion. In this embodiment, the first cord 354 is a flattened hoop extending through the loop 352, and the ends 356, 358 of the first cord 354 are connected by a wire 228, thereby restraining the stent 346 and the stent graft in which the stent 346 is a component. The wire 228 is radially spaced from the window 344 to avoid occlusion of the window 344 during subsequent cannula insertion, for example, with a branched stent or stent graft, neither of which are shown. The window 344 is shown in the open position in Figure 18 and can be maintained in the open position by appropriate support, such as a circular support 360 extending around the circumference of the window 344, regardless of radial restraint by the cord 354. The circular support 360 may be made of a suitable material such as nitinol and can be fixed to the circumference of the window by appropriate means such as sutures as described above. Preferably, the circular support 360 is deformable or at least partially deformable during restraint by the cord 354. In this example, the circular support 360 may be formed of a suitable material such as nitinol. Furthermore, the loop 362 is fixed to the graft material 342 of the stent graft between the loop 352 which is fixed to the strut 350 toward the distal end of the stent 346. Loop 362 prevents the opening 344 within the outer circumference of the stent graft from collapsing, as described with reference to Figures 21 and 22 below. A second cord 366, though not necessarily present, extends from the first cord 354 and distally through loop 368 at a longitudinal distance. The second cord 366 also radially restrains the stent graft if its ends 370, 372 are connected by wire 228.In alternative embodiments not shown, the flattened hoop may be partially or completely replaced by a single-strand cord, as discussed in the embodiments above, where the cord partially or completely defines the boundary of the stent graft, and the cord loops are connected by wire. In another embodiment, the opening 344 may be nested between struts 448, 350 at the distal end 364 of the stent 346 of the stent graft. In this embodiment, the position of the flattened hoop (or cord) is reversed from that shown in Figure 18.

[0051] Figure 19 details another aspect of the present invention, an aortic prosthesis system 380, in which the graft material 180 of the stent graft component of the aortic prosthesis system 380 includes two openings 384, 386, each opening nested between the respective strata of different stents 388, 390 of the stent graft, but very close to each other. In this embodiment, the first opening 384 nested between strata 392, 394 at the distal end 396 of the first relatively proximal stent 388 of the stent graft, and the second opening 386 nested between strata 398, 400 at the proximal end 402 of the second relatively distal stent 390 of the stent graft. The openings 384 and 386 shown in Figure 19 form a radial step relative to each other, but the openings 384 and 386 may be aligned so that they are aligned with each other along the longitudinal length of the stent graft, in which case the proximal and distal apex of each stent may also be aligned with respect to the struts to avoid interference with the passage of the openings 384 and 386 or their cannula insertion. The strings 404 and 406 extend through loops 408 and 410, which are fixed to struts 412 and 414 of each stent 388 and 390, and pass around each opening 384 and 386. As also shown in Figure 18, the graft material 382 between loops 408 and 410, with loops 420 and 422 supporting the graft material 180 to prevent the openings 384 and 386 from collapsing into the stent graft. The cords 404 and 406 have their respective ends 424 and 426 connected by wire 228. The cords 428 and 430 extend around the respective opposite ends of the stents 388 and 390 through their respective loops 432 and 434 and are connected at ends 436 and 438, respectively. The connections of ends 424, 426, 436, and 438 by wire 228 constrain the stents 388 and 390 radially, and these can be released by pulling out wire 228 from ends 424, 426, 436, and 438. It is also understood that, as in Figure 18, each stent may also be constrained by cords extending through a second flattened hoop, or a set of loops fixed to a different support than the first flattened hoop or the set of loops from which the cords extend.Since the second string may have different lengths and may have ends connected by different wires, radial expansion of the stent graft may occur in stages by removing the first wire from the end of the first string, and then the second wire from the end of the second string. It is also understood that the flattened hoops or strings may each contain constituent parts, and each constituent part may be configured to extend only partially around the stent graft.

[0052] Figure 20 details yet another aspect of the present invention, an aortic prosthesis system 460, in which the graft material 180 of the stent graft component of the aortic prosthesis system 460 defines two openings 464, 466, each of which nests between the struts 468 of the stent 470. As shown in Figure 20, the first opening 464 nests between the struts 468 on the proximal side 472 of the stent 470, and the second opening 466 nests between the struts 468 on the distal side 474 of the stent 470. The first cord 476 is a flattened hoop extending through a loop 478 fixed to a support 468 at the distal end of the first opening 464 and through a loop 480 fixed to the graft material 180, and the second cord 482 is a flattened hoop extending through a loop 484 fixed to a support 468 at the proximal end of the second opening 466 and through a loop 486 fixed to the graft material 180. Wires 228, radially spaced from the first and second openings 464 and 466, connect the ends 488, 490 of the respective first cords 476 and second cords 482, thereby radially constraining the stent graft. As in the above embodiment, the flattened loops of the cords in this embodiment may be replaced with single-strand cords that at least partially surround the stent graft and are connected at their respective ends to radially constrain the stent graft.

[0053] Figure 21 shows an embodiment of the present invention shown in Figure 18, in which the opening 344 is at least partially collapsed when the stent graft is radially constrained by the strings 354, 366. As can be seen in Figure 21, the opening 344 is radially narrowed by a radial constrainer created by connecting the ends 356, 358 of the strings 354 and the ends 370, 372 of the strings 366 by the wire 228. Also, as shown in Figures 21A and 21B obtained along lines AA and BB in Figure 21, respectively, the periphery of the opening 344 is raised from the outer surface 345 of the stent graft. This raised profile is at least partially created between the loops 352 that are fixed to the support 350 and at the distal end 347 of the opening 344 by the loop 362 that is fixed to the graft material 342. Loop 362 supports the graft material 342, and the fenestration 344 is in a flattened position, thereby preventing the graft material 342 defining the fenestration 344 from creating a depression within the stent graft when the stent graft is radially constrained by the cords 354, 366. The raised profile of the graft material 342 defining the fenestration 344 assists in cannula insertion of the fenestration 344, for example, during implantation of a branched stent or stent graft. Figure 21C is a detail of Figure 21A showing suture ends 356, 358 connected by wire 228. Figure 21D is a detail of Figure 21B showing suture ends 370, 372 connected by wire 228.

[0054] Figure 22 shows the configuration of Figure 21 when the wire 228 connecting the ends 356, 358 of the first cord 354 and the ends 370, 372 of the second cord 366 is removed, thereby releasing the stent graft from the radially constrained position shown in Figure 21. As can be seen, the opening 344 takes a relaxed position when the stent graft is released from its radially constrained position. The anchor stitches 347, 349 hold the ends 356, 358 of the first cord 354, and the anchor stitches 353, 355 hold the ends 370, 372 of the second cord 366, so that the first cord 354 and the second cord 366 remain fixed to the stent graft after the release of the first cord 354 and the second cord 366 by maintaining the wire 228. Figures 22A and 22B are detailed profiles of Figure 22 obtained along lines AA and BB of Figure 22. As can be seen from Figures 22A and 22B, the graft material around the opening is no longer raised as in Figure 20A or wrinkled in loops as in Figure 21B.

[0055] Figure 23 shows another embodiment of the present invention, an aortic prosthesis system 500, where fenestrations 502, 504 are defined by graft components 180 of the stent graft 171 of the aortic prosthesis system 500. The fenestrations 502, 504 are partially nested between the struts 508 of the stent component 510 of the stent graft, and cords 512, 514 extend through loops 520 fixed to the struts 508 and are connected by wires 228, thereby constraining the stent graft radially and defining flattened hoops that define ends 516, 518, respectively, which at least partially flatten the fenestrations 502, 504. The fenestrations 502, 504 are located on the proximal and distal sides of the stent 510, respectively, and cords 512, 514 extend around the stent graft without occluding the fenestrations 502, 504. The anchor stitches 522 in the graft material 506 extend through the flattened loops of the cords 512, 514, and are intended to secure the cords 512, 514 to the stent graft once the wire 228 is pulled out, thereby releasing the ends 516, 518 of the cords 512, 514.

[0056] Figure 24 shows the configuration shown in Figure 23 after the removal of the wire 228 connecting the ends 516, 518 of the cords 512, 514. As can be seen, after the removal of the wire 228, the openings 502, 504, supported by the Nitinol hoop 524 around the periphery of the openings 502, 504 and fixed to the graft components 180 of the stent graft by appropriate means such as sewing or appropriate adhesive, expand to their fully open shape. Anchor stitches 522 extending through the ends 516, 518 hold the cords 512, 514 fairly close to the stent graft 171 after implantation is complete.

[0057] Figure 25 shows another embodiment of the present invention, an aortic prosthesis system 600, where the fenestrations 602, 604 are defined by the graft components 180 of the stent graft of the aortic prosthesis system 600. The fenestrations 602, 604 are partially nested between the struts 608 on one plane. In this case, the distal ends of the stent components 610 of the stent graft, and here the strings 612, 614, define the ends 616, 618 respectively, which are flattened hoops that extend through loops 620 fixed to struts 608 and connected by wires 228, thereby constraining the stent graft radially and flattening the fenestrations 602, 604 at least partially. The strings 612, 614 extend around the stent graft without occluding the fenestrations 602, 604. The anchor stitches 622 within the graft material 606 are intended to extend through the flattened loops of the cords 612 and 614, and once the wire 228 is pulled out, to secure the cords 612 and 614 to the stent graft, thereby releasing the ends 616 and 618 of the cords 612 and 614.

[0058] Figure 26 shows the configuration shown in Figure 25 after the removal of the wire 228 connecting the ends 616, 618 of the cords 612, 614. As can be seen, after the removal of the wire 228, the openings 602, 604, supported by nitinol hoops 624, 626 around their respective periphery and fixed to the graft component 180 of the stent graft by appropriate means such as sewing or appropriate adhesive, expand to their fully open shape. Anchor stitches 622 extending through the ends 616, 618 hold the cords 612, 614 very close to the stent graft 180 after the implantation is complete.

[0059] Generally, at least 3 millimeters are maintained between the window openings, between the window openings and the stent supports, and along the longitudinal direction of the stent graft; however, it should be noted that in some cases, the spacing is not required or maintained. Other optimal features of the delivery system include, for example: [Table 1] It may include.

[0060] The delivery and cannula insertion methods shown in Figures 11-26 are the same as those described above, such as the methods shown in Figures 10A-10E.

[0061] Another embodiment of the delivery system of the present invention for implanting a stent graft prosthesis is shown in Figure 27. As seen therein, the delivery system 700 includes a longitudinal body portion 712 having a proximal handle 714 and a distal handle 716 at the distal end 717 of the longitudinal body portion 712. An introducer sheath 718 (the introducer sheath is an embodiment of a radial restraint) extends distally from the distal handle 716 and includes a proximal end 720 and a distal end 722. A guidewire catheter 724 (Figure 29) includes a proximal end 726 and a distal end 728 (Figure 28) and extends from the distal end 716 of the longitudinal body portion 712. The guidewire catheter 724 extends through the longitudinal body portion 712 within the introducer sheath 718. The proximal end 726 (Figure 28) of the guidewire catheter 724 extends proximal to the proximal handle 714 of the longitudinal body portion 712.

[0062] The nose cone 730 is fixed to the distal end 728 (Figure 28) of the guidewire catheter 724. The guidewire catheter 724 and the nose cone 730 define a luminal channel from which the guidewire (not shown) can extend. The introducer sheath 718 is movable along the longitudinal axis 736 of the delivery system 700 in a proximal direction 702 to the surgeon operating the delivery system 700 by retracting the introducer sheath 718 against the distal handle 16 of the longitudinal body 712. The wire handle 803 is attached to the proximal end of the wire 800. The proximal clasp assembly 768 is located proximal to the proximal handle 714 and, according to aspects of the present invention, controls the release of the proximal apex of the bare stent 756 at the proximal end 740 of the stent graft 738.

[0063] Figure 27A shows details of the proximal handle 714 and proximal clasp assembly 768. As shown therein, the proximal handle 714 is fixed to the proximal end of the longitudinal body portion 712 and includes a proximal handle end cap 805 and a proximal handle body portion 807. The proximal stem 809 extends proximal from the proximal handle end cap 805 and defines a slot 811. The wire 800 extends through the slot 811 and is fixed to the wire handle 803 at the proximal end of the wire 800. The external coupling 1123 and fixed component 1125 interlock with each other at the proximal end of the proximal stem 809. The proximal end of the external control tube 1126 (shown in Figure 27C) is fixed to the external coupling 1123, and the proximal end 726 of the guidewire catheter 724 is fixed to the fixed component 1125. The proximal end of the proximal stem 809 is also fixed to the fixed component 1125. The guidewire catheter 724 extends through the longitudinal body 712, the proximal handle 714, the external coupling 1123, and the fixed component 1125. Details of Figure 27A are understood to be the same as those shown in Figures 77A, 77B, and 77C.

[0064] Figure 27B is a cross-section of the details shown in Figure 27A, and Figure 27C is a detail of Figure 27B. As can be seen in Figures 27B and 27C, the proximal handle 714 is fixed to the proximal end of the push rod 774. The external control tube 1126 and the proximal end 724 of the guidewire catheter 724 extend through the proximal handle 714 and the push rod 774. The wire 800 runs parallel to the external control tube 1126 and outward. As can be seen in Figures 27B, 27D, and 27E, the distal gasket 819 extends around the proximal end of the push rod 774, and as shown in Figure 27B, the distal gasket 819 seals the connection between the push rod 774 and the proximal handle body portion 807. As can be seen in Figures 27F and 27G, the proximal gasket 813 includes a large opening 815 and a small opening 817. As can be seen in Figures 27C and 27E, the external control tube 1126 extends through the large opening 815 of the proximal gasket 813, and the wire 800 extends through the small opening 817. As shown in Figure 27C, the large opening 815 seals the connection between the external control tube 1126 and the proximal handle body portion 807, and the small opening 817 seals the connection between the wire 800 and the proximal handle body portion 807. The proximal gasket 813 prevents blood leakage from the delivery system 700. It is understood that the proximal gasket may be used as a component of all embodiments of the delivery device of the present invention, including a guidewire catheter or a wire extending parallel to the external control tube of the present invention.

[0065] In one embodiment, as shown, for example, in Figure 28, the introducer sheath 718 may be retracted by the rotation of a threaded lead nut 732, which is configured to engage with a track 734 to which the introducer sheath 18 is fixed, either directly or indirectly. Option I in Figure 28 shows the lead nut 732 causing longitudinal movement of the track 734 in direction 702, thereby rotating the introducer sheath 718 along the longitudinal axis 736 of the delivery device 700. Alternatively, the lead nut 732 may be pulled back directly in direction 702 along the longitudinal body portion 712 without rotation, thereby retracting the introducer sheath 718 as shown in Option II. As can be seen, in either option, the retraction of the introducer sheath 718 exposes the stent graft 738 at least partially, while the guidewire catheter 724 and nose cone 730 remain fixed to the longitudinal body portion 712.

[0066] In an alternative embodiment, as described above, the longitudinal body portion 712 includes a proximal handle component that directs the guidewire catheter 724 and consequently the stent graft 738 distally from within the distal end 722 of the introducer sheath 718, thereby releasing the stent graft 738. As in the embodiments shown in Figures 27 and 28, once the stent graft 738 is released, the guidewire catheter 724, the nose cone 30, and the introducer sheath 718 are all retracted and withdrawn from the subject.

[0067] As shown in Figure 28, the stent graft 738 includes a proximal end 740 and a distal end 742. The lumen graft component 744 of the stent graft 738 defines a lumen 746. The stent 748 is self-expanding and is formed by struts 750 connected to form a proximal apex 752 and a distal apex 754. In one embodiment, the stent graft 738 includes a bare stent 756 at the proximal end 740. The bare stent 756 is fixed to the lumen graft component 744 at the proximal end 740 of the stent graft 738 by the distal apex 754 of the bare stent 756 using, for example, sutures, biocompatible adhesives or other suitable techniques known to those skilled in the art. The lumen graft component 744 defines a lumen extending from the proximal end 740 to the distal end 742. In one embodiment, the lumen graft component 744 may include scalloped portions 755, 757 at the proximal end 740 and the distal end 742, respectively. The lumen graft component 744 is formed from a suitable material known to those skilled in the art, such as stretched polytetrafluoroethylene (PTFE), ePTFE, and polyethylene terephthalate (PET), such as woven polyester. The stent 748 and bare stent 756 are formed from a suitable material, such as a shape memory alloy (nitinol) or stainless steel.

[0068] Figure 29 is a cross-sectional view of the distal portion of the delivery device 700 before deployment of the stent graft 738 from within the introducer sheath 718. In one specific embodiment, the bare stent 756 is in a first captured state, with its proximal apex secured to the apex capture assembly 758 of the delivery device 710. In one embodiment, the apex capture assembly 758 includes a proximal capture component 760 and a distal capture component 762. The proximal capture component 760 is located around the guidewire catheter 724 and includes a tine 764 extending distally from the apex capture catheter 766, which is secured to the guidewire catheter 724 at its proximal end 726 by a proximal clasp assembly 768 shown in Figure 28. When in the captured state shown in Figure 29, tooth 764 extends through the opening 770 (Figure 28) defined by the bare stent 756 at the luminal graft component 744 of the stent graft 738, thereby preventing radial expansion of the bare stent 756 at the proximal end 740 of the stent graft 738. Release of the apical capture catheter 766 from the guidewire catheter 724 at the proximal clasp assembly 768 allows for the proximal movement of the apical capture catheter 766 and the proximal capture component 760 from the distal capture component 762, thereby releasing the bare stent 756 from tooth 764, thereby releasing the bare stent 756 from the captured state to the released state.

[0069] The torque component 772 includes a push rod 774, a hub 776, and at least two arms 778. The push rod 774 has a proximal end (not shown) and a distal end 782, and extends around the guidewire catheter 724 and distally from the proximal handle 714 (Figure 28). Not shown, the proximal end of the push rod 774 is fixed to the proximal handle 714 of the longitudinal body 712. The proximal handle 714 is rotatable around the longitudinal body 712, thereby rotating the push rod 774 around the guidewire catheter 724. Optionally, the proximal handle 714 may be locked by the guidewire catheter 724 and the apical capture catheter 766, and rotation of the proximal handle 714 causes axial rotation of the guidewire catheter 724 and the apical capture catheter 766. The hub 776 defines the lumen 788 (Figure 30) and is fixed to the distal end 782 of the push rod 774. At least two arms 778 extend distally from the hub 776 and are distributed radially around the apical capture catheter 766.

[0070] Each arm 778 is expandable from the contracted state shown in Figure 29 to the extended state shown in Figure 30 by releasing the arm 778 from the contracted state shown in Figure 29. In one embodiment, the arm 778 self-extends from the contracted state to the extended state. The arm 778 is fixed to the hub 776 of the torque component 772, and then to the push rod 774 of the torque component 772.

[0071] As can be seen in Figure 31, the width (W) of the arm 778 is greater than the height (H) of the arm 778. When viewed at an angle perpendicular to the longitudinal axis of the hub, as shown in Figure 30, the arm has a curved shape in its extended state. In various embodiments, the torque component 772 may include two, three, or four arms. Each arm 778 has a proximal end 790 and a distal end 792. Optionally, the proximal ends 790 of the arms 778 are uniformly spaced around the circumference of the hub 776 and around the longitudinal axis 736. In one embodiment, each of the arms 778 independently has a length ranging from about 1 inch to about 5 inches. The hub 776 and the arms 778 are formed from a suitable material such as Nitinol or other suitable shape memory alloy, stainless steel, titanium, or plastic.

[0072] Figure 32 is a cross-sectional view of another embodiment of the torque component of Figure 30, but the torque component lacks a hub component. As shown therein, the torque component 773 includes an arm 785 or extension of the push rod 775 connected to the push rod 775. Alternatively, the torque component 777 includes an arm which is an articulated member 779, as shown in Figure 33. In this embodiment, the member 779 includes sections 781 connected to each other and to the push rod 775 by hinges 783. The member 779 is formed of a suitable material such as Nitinol or some other shape memory alloy, stainless steel, titanium or plastic.

[0073] In another embodiment shown in Figures 34-36, the torque component 772 includes at least one arm 778 that defines an opening 794 into which the suture ring 796 extends and into which the suture ring 796 is secured. The suture ring 796 also extends through the opening 798 defined by the stent graft 738. The release wire 800 extends longitudinally along the delivery device 700 and is packed into or beneath the nose cone 730 as shown in Figure 29, and extends through the suture ring 796 as shown in Figure 36, thereby securing the distal end 742 of the stent graft 738 to the arm 778. The advantage of the wire 800 extending through the suture loop 796 (Figure 36) is obtained when the guidewire catheter 724 and apical capture assembly 758, which hold the stent graft 738 in a captured state, are exposed by the retraction of the introducer sheath 718 and are moved longitudinally within the artery along the longitudinal axis 736 to properly position the stent graft 738 as shown in Figure 41. Referring back to Figures 34-36, the suture 796 is held in place by the wire 800 extending through the suture 796 at the position of the opening 798 defined by the pocket or sleeve 799 of the stent graft 738, thereby preventing longitudinal collapse of the stent graft 738 that would otherwise occur due to friction between the stent graft 738 and the arterial wall during longitudinal positioning, which would otherwise involve the proximal movement (towards the clinician) (Figure 41) of the guidewire catheter 724 and apical capture assembly 758.

[0074] As can be seen in Figure 37, the radial restraint 820 radially restrains the stent graft 738. In one embodiment, the radial restraint 820 includes a cord 822 or thread that extends through each of the stents 748 of the stent graft 738. A wire 800 extends through a loop 826 of each cord 822, and the retraction of the wire 800 from the cord 822 releases the stent graft 738 from the radial restraint 820. A push rod 774 defines a keyed external projection from which the apical capture catheter 766 and the guidewire catheter 724 extend. As can be seen in Figure 37, the apical capture catheter 766 has a key to the external projection of the push rod 774 and defines an internal projection component that is longitudinally movable with respect to it. The guidewire catheter 724 defines a guidewire lumen 725, extends through the apical capture catheter 766, and is longitudinally movable with respect to it. Wire 801 extends through sleeve 799 and suture ring 796. Wire 800 also extends through suture ring 796 as shown in Figures 35-37, 41-43 and 54-57, but is also a trigger wire that extends through loop 826, releasing loop 826 when wire 800 is withdrawn for the release of the stent graft from a radially contracted position.

[0075] In an alternative embodiment shown in Figure 38, the torque component 772 does not include the hub 776. In this embodiment, the arm 778 can be directly fixed to the distal end 782 of the push rod 774 or can be fabricated by selective machining or cutting of the distal end of the rod to form the arm 785 and push rod 775. In yet another embodiment (not shown), the wire 800 is located inside the stent graft 738 and extends through sutures 806 that extend into the interior of the stent graft through openings in each arm. As shown in Figure 36, in one embodiment, the retraction of the wire 800 also releases the stent graft 738 from the arm 785 of the torque component 772.

[0076] Alternatively, the radial restraint is a flexible sheath 828 that extends between the stent graft 738 and the introducer sheath 718 and is packed into or beneath the nose cone 730, as shown in Figure 39. Figure 39A is a cross-section obtained along line AA in Figure 39. As can be seen in Figure 39A, the introducer sheath 718 is circumferential to the longitudinal direction of the push rod 774. The push rod 774 defines an external keyed projection 774a. The apical capture catheter 766 is located within the push rod 774 and defines an internal keyed projection 766a. The apical capture catheter 766 also defines a lumen into which the guidewire catheter 724 extends and is movable longitudinally. The wire 800 extends between the introducer sheath 718 and the push rod 774. The guidewire catheter 724 defines the guidewire lumen 725 from which the guidewire (not shown) can extend.

[0077] In one embodiment of the method of the present invention, the stent graft 738, in a first restrained state as shown in Figure 38, is directed towards the aneurysm site of the subject. The introducer sheath 718 is then retracted by the rotation of the lead screw nut 732 around the track 734 of the handle body portion 712, as shown in Option I of Figure 28, and the adjacency of the lead screw nut 732 relative to the distal handle 716 moves the track 734 and the introducer sheath 718 to which the track 734 is attached proximal 702 relative to the surgeon. Alternatively or subsequently, the lead screw nut 732 may be pulled proximal 702 by the surgeon, as shown in Option II of Figure 28, to retract the introducer sheath 718 proximal 702 relative to the guidewire catheter 724 and the stent graft 738.

[0078] As can be seen in Figure 40, at least partial retraction of the introducer sheath 718 in the proximal direction 702 shifts the proximal end 740 of the stent graft 738 from the first constrained position shown in Figure 39 to a second constrained position maintained by the radial restraint 820. As shown in Figure 41, complete retraction of the introducer sheath 718 from the stent graft 738 and the torque component 772 causes the stent graft 738 to assume a second constrained position along its entire length. The second constrained position is maintained by the radial restraint 820. The shift from the first constrained position to the second constrained position also causes the torque component 772 to radially extend from the first constrained position shown in Figure 39 to a second constrained position, also referred to as an intermediate radially extended position, as shown in Figure 41. The application of torque force to the torque component 772 while at least partially retracting the introducer sheath 718 causes the stent graft 738 to rotate around the longitudinal axis 736.

[0079] For example, when the stent graft 738 is in the second constrained position shown in Figure 41, the torque component 772 can be rotated around the guidewire catheter 724 by rotating the proximal handle 714 (Figure 28) which rotates the push rod 774 (Figure 42) to which it is attached. This rotation of the torque component 772 allows for rotational alignment of at least one opening 739 of the stent graft 738, as shown in the transition from Figure 41 to Figure 42. The stent graft 738 can also be moved longitudinally along the longitudinal axis 736 (also referred to as axial movement) to properly position the stent graft 738 at the aneurysm site. As noted above, the suture 796, through the arm 778 and the luminal graft component 744, and through which the wire 800 extends, secures the distal end 742 of the stent graft 738 to the delivery system 710, thereby substantially preventing longitudinal collapse of the stent graft 738 due to friction between the distal end 742 of the stent graft 738 and the arterial wall during proximal movement (towards the clinician) of the apical capture assembly 758, which holds the proximal end 740 in the captured state shown in Figure 42.

[0080] In the embodiment shown in Figure 43, the wire 800 of the radial restraint 820 is retracted from the cord 822, thereby releasing the cord 822 of the radial restraint 820 and allowing the rest of the stent 738 to fully expand radially, as shown in Figure 44. This lands the stent 738 in their proper positions within the aorta without distortion of the stent graft 738 or damage to the surgical site. The apical capture assembly 758 is then actuated by releasing the apical capture catheter 766 from the guidewire catheter 724 at the proximal clasp assembly 768 (Figures 27 and 28) and by withdrawing the apical capture catheter 766 to which the proximal apical capture component 764 is fixed, as shown in Figure 45, thereby releasing the bare stent 756 from its captured state, as shown in Figure 44, to the released state, as shown in Figure 45. As a result of the release, the proximal end 740 of the stent graft 738 is grounded in its indicated position at the surgical site. The torque component 772 is then retracted from the distal end 742 of the stent graft 738, as shown in the transition from Figure 45 to Figure 46, thereby fully releasing and deploying the stent graft 738. As shown in Figure 47, the guidewire catheter 724 and the apical capture catheter 766 can then be retracted from the stent graft 738, and the delivery device 710 can be removed from the subject, thereby completing the procedure. As described above, the introducer sheath and hemostatic valve may be left in place to facilitate further prosthesis components, such as branched stent grafts, into the branched vessels through the opening 739.

[0081] It is understood that other delivery devices may be deployed to carry out the method of the present invention. For example, the stent graft 738 may be directed to the aneurysm site without the assistance of the introducer sheath 718. In one such embodiment, the stent graft 738 is implanted in the subject while being constrained only by the radial restraint 820 and not by the introducer sheath 718. In another embodiment, the method includes initially directing the stent graft 738 to a distal location of the aneurysm site while the stent graft is initially constrained and within the introducer sheath 718, and then advancing the stent graft from the distal end 722 of the introducer sheath 718 to the aneurysm site.

[0082] In another embodiment, the radial restraint is an introducer sheath. For example, as shown in Figure 48 as an exploded view, the delivery system 850 of the present invention for implanting a stent graft 852 (Figures 49A-49C) includes a proximal handle 854 and a distal handle 856. The guidewire catheter 858 includes a proximal end 860 and a distal end 862 and extends distally from the distal handle 854. The nose cone 864 and apical capture device 857 are fixed to the distal end 862 of the guidewire catheter 858. The torque component 866 includes a push rod 868 and at least two self-expanding arms 872 extending from the push rod. Optionally, a hub 870 is included as a link between the push rod 868 and the arms 872. The hub 870 defines a lumen around the longitudinal axis 876 and is fixed to the push rod 868. The arm 872 is radially positioned around the hub 870 and extends distally from the hub 870. In this embodiment, the radial restraint is an introducer sheath 874 that extends distally from the distal handle 856.

[0083] Figure 49A is a composite diagram of the delivery system 850 shown in Figure 48. As can be seen in Figures 49A-49C, each arm 872 is movable from a constrained state to an extended state. In one embodiment, the arm 872 of the torque component 866 exhibits radial self-expansion away from the longitudinal axis 876. The introducer sheath 874 extends longitudinally between the distal handle 856 and distal end 862 of the guidewire catheter 858, radially constraining the stent graft 852 which extends distally from the torque component 866 and around the guidewire catheter 858. The application of torque force to the arm 872 by the rotation of the torque component 866 around the longitudinal axis 876 rotates the fenestration 880 of the stent graft 852 around the longitudinal axis 876 until it is rotationally aligned with the branching vessel at the aneurysm site. In the method of the present invention, the advancement of the stent graft 852 into the aneurysm site within the introducer sheath 874 is followed by rotational alignment of at least one window 880. The rotation of the introducer sheath 874 may be independent of the rotation of either the guidewire catheter 858 or the proximal handle 854. Alternatively, the introducer sheath 874 may be associated with the rotation of the guidewire catheter 858, such as by locking a torque component 866 onto the proximal handle 854. As shown in Figure 49B, the stent graft 852 is releasably fixed to the distal end 862 of the guidewire catheter 858 with a bare stent 859 by a suitable apical capture device 857, such as one known in the art. The bare stent 859 is released from the guidewire catheter 858 by the operation of the apical capture device 857. The radial retraction of the restraint 866 from the stent graft 852 causes the radial expansion of the self-expanding arm 872 and the self-expanding of the stent graft 852, thereby releasing the stent graft 852, and the remainder of the delivery system 850 that is not implanted in the aneurysm is then retracted from the stent graft 852 and from the aneurysm site, as shown in Figure 49C.

[0084] In another embodiment shown in Figure 50A, the stent graft delivery system 898, an alternative embodiment of the one shown in Figure 37, includes a circular cord 900 extending around the circumference of the stent graft 738, forming ends 827, 829 opposite in the diametrical direction of the circular cord 900, which are connected by a wire 800. The wire 800 is stabilized by an anchor loop 902. During the retraction of the wire 800, the circular cord is secured to the lumen graft component by a suture 904. The wire 801 is stabilized at the claw 778 by a suture loop 796 extending from the claw 778 through the sleeve 799 of the stent graft 738. Figure 50B is a detail of the circular cord 900 shown in Figure 50A, configured as a circle when not wrapped around the stent graft 728. Figure 50C is a detail of the circular cord 900 when configured to be wrapped around the stent graft 728. As can be seen in Figures 50A-50C, the diametrically opposite ends 827 and 829 of the circular cord 900 secure the circular cord 900 around the stent graft 728 when they are connected by the wire 800.

[0085] Figure 51 is an exploded side view of another embodiment of the stent graft delivery system of the present invention. As shown therein, the stent graft delivery system 1010 includes a guidewire catheter 1012 having a proximal end 1014 and a distal end 1016. A proximal handle 1018 is fixed to the proximal end 1014 of the guidewire catheter 1012. A nose cone 1020 and a apical capture device 1021 are fixed to the distal end 1016 of the guidewire catheter 1012. A torque component 1066 includes a push rod 1068 and at least two self-expanding arms 1072 extending from the push rod 1068. Optionally, a hub 1070 is included as a link between the push rod 1068 and the arms 1072. The hub 1070 defines a lumen around the longitudinal axis 1076 and is fixed to the push rod 1068. Arm 1072 is radially positioned around hub 1070 and extends distally from hub 1070. Torque component handle 1069 is located at the proximal end of push rod 1068. Wire 1022 includes a proximal end 1024 and a distal end 1026. Wire 1022 may be made of suitable material known in the art, such as nitinol or some other shape memory alloys. Wire 1022 is sufficiently flexible so as not to injure the patient as it progresses to an aortic aneurysm. Wire handle 1028 is secured at the proximal end 1024 of wire 1022. Introducer sheath 1030 includes a proximal end 1032 and a distal end 1034, and the distal handle 1036 is secured at the proximal end 1032 of introducer sheath 1030. The stent graft 1038 includes a proximal end 1040, a distal end 1042, a luminal graft component 1044, and stents 1046 and ribs 1048 distributed along the luminal graft component 1044, arranged and configured as described above. A bare stent 1049 is fixed to the distal end of the stent graft 1038.

[0086] Figure 52A is an assembled side view of the stent graft delivery system 1010 shown in Figure 51, in which the stent graft 1038 is loaded into the distal end 1034 of the introducer sheath 1030 and is at least partially radially contracted by a wire 1022 that passes through the diametrically opposite ends of a circular cord 1048 as described above and a stabilizing anchor loop 1053. In this embodiment, the stent graft 1038 includes an opening 1039.

[0087] In the method of the present invention, the stent graft delivery system 1010 is advanced to the patient's aneurysm 1052. In one embodiment shown in Figure 52A, the introducer sheath 1030 is advanced to the aneurysm site 1052, thereby positioning the stent graft 1038 in the aneurysm 1052. As can be seen in Figure 52B, the distal handle 1036 is retracted proximal in the direction indicated by the arrow 1060 toward the proximal handle 1018, thereby retracting the introducer sheath 1030 from the stent graft 1038 at the aneurysm 1052. As can be seen in Figure 52B, regardless of the retraction of the introducer sheath 1030, the stent graft 1038 is maintained in a radially contracted position by a wire 1022 extending through a string loop 1050 of a string 1048 that crosses the struts of the stent 1046 distributed longitudinally along the stent graft 1038. However, in an alternative embodiment in which the wire 1022 is sufficiently rigid, the stent graft delivery system 1010 may be advanced within the artery to a distal position of the aneurysm 1052, and the stent graft 1038 is directed toward the aneurysm 1052 by the advancement of the proximal handle 1018 and wire handle 1028 distally, indicated by the arrow 1062 toward the distal handle 1036, thereby directing the radially contracted stent graft 1018 from the introducer sheath 1030 toward the aneurysm 1052.

[0088] By applying a torque force to the arm 1072 through the rotation of the torque component 1066 around the longitudinal axis 1076, the fenestration of the stent graft 1038 is rotated around the longitudinal axis 1076 until it is rotationally aligned with the branch vessel 1054 at the aneurysm site 1052. In the method of the present invention, the rotational alignment of at least one fenestration 1080 follows the advancement of the stent graft 1052 into the aneurysm 1052 within the radial restraint 1066.

[0089] Following the orientation of the stent graft to its position across the aneurysm 1052 and at least partial rotational and axial alignment of the stent graft 1038 at the aneurysm 1052, the wire 1022 is pulled out from the suture loop 1050 and anchor loop 1053 of the cord 1048. Proximal pull of the wire handle 1028 toward the proximal handle 1018 in the direction indicated by arrow 1060 pulls the wire 1022 out from the suture loop 1050 and anchor loop 1053 of the cord 1048, thereby allowing the stent graft 1038 to fully expand from its radially contracted state shown in Figure 52B to its radially expanded state shown in Figure 52C. As shown in Figure 52D, the stent graft 1052 is releasably secured to the distal end 1062 of the guidewire catheter 1058 with a bare stent 1059 by a suitable apical capture device 1057, such as those known in the art. The bare stent 1059 is released from the guidewire catheter 1058 by the activation of the apical capture device 1021. Then, as described above, the torque component is retracted from the distal end 1042 of the stent graft 1038, and the stent graft 1038 is fully embedded in the aneurysm, and the remainder of the stent graft delivery device 1010 is retracted from the stent graft 1038 and the patient, and separately, the branched stent graft 1056 is directed to the branched vessel 1054 through the opening 1039 of 1038 by appropriate means such as those known in the art as shown in Figure 52E, thereby completing the treatment of the patient's aneurysm 1052 by the method of the present invention.

[0090] In another embodiment of the stent graft delivery system of the present invention shown in Figures 53 and 54, the delivery system is similar to that shown in Figures 39-41 above, but is retractable and has a wire 800 in addition to a flexible sheath 828. In this embodiment, the radial restraint 820 includes a cord 822, a wire 800, and a flexible sheath 828. The cord 822 or thread passes over each of the stents 748 of the stent graft 738. The wire 800 extends through the loop 826 of each cord 822 (Figure 54), and the retraction of the wire 800 from the cord 822 releases the stent graft 738. However, alternatively, the cord 822 may be replaced with a cord 900, such as the one shown in Figure 50A, which is flattened to form ends 827, 829 connected by wire 800, in which case the cord 900 is secured to the rest of the stent graft 738 by stitch 904 to prevent the cord 900 from being released after the wire 800 is pulled in from ends 827, 829. The flexible sheath 828 extends between the stent graft 738 and the introducer sheath 718 and is packed into or beneath the nose cone 730.

[0091] Figure 53A, a cross-section of Figure 53 obtained along line AA in Figure 53, shows that the wire 800 extends between the introducer sheath 718 and the push rod 774. Figure 54 shows the stent graft delivery system of Figure 53 after the introduction of the introducer sheath 718, which in turn causes the flexible sheath 828 to radially contract the stent graft 820 at a first intermediate radially expanded position. This allows for a two-stage expansion of the stent graft 820, with the proximal retraction of the introducer sheath 718 being the first stage, which results in the radial contraction of the stent graft 838 by the flexible sheath 828 at a first intermediate radially expanded position, as shown in Figure 54. The second stage involves the retraction of the flexible sheath 828 from the stent graft 838 and the partial radial expansion of the stent graft 838 to a resulting second intermediate radially expanded position, as shown in the progression from Figure 54 to Figure 55 and from Figure 55 to Figure 56. Subsequently, the proximal retraction of the wire 800 from the cord 822 allows for the full radial expansion of the stent graft 838 (except for the release of the bare stent 756 and the retraction of the torque component 772), as can be seen in the progression from Figure 56 to Figure 57 and from Figure 57 to Figure 58. As shown in Figure 60, the proximal apical capture component 764 is retracted and separated from the proximal apical capture component 762, thereby releasing the bare stent 756. Subsequently, the torque component 772 is retracted from the stent graft 738, as shown in Figure 59, thereby fully deploying the stent graft 738 at the surgical site. The delivery device can then be removed from the surgical site, as shown in Figure 61.

[0092] Although not shown, it is understood that control rods may be used in the devices and methods of the present invention to independently radially contract various longitudinal portions of a stent graft, such as the proximal and distal portions of the stent graft. It is also understood that multiple control rods may be distributed radially around the stent graft in a uniform, uniform, or other pattern or non-uniform manner in relation to the openings within the stent graft. It is also understood that the stent graft delivery system of the present invention may include multiple control rods, each separately and independently controlling the radial expansion of the same portion of the stent, particularly the proximal portion of the stent. The multiple control rods are arranged laterally and longitudinally relative to each other around the circumference of the outer or inner surface (not shown) of the lumen graft component.

[0093] In another embodiment, the present invention is a combination of a leg stop, a leg clasp, and an introducer sheath. In one embodiment shown in Figure 62, the present invention is a stent graft delivery device 1100 which includes a leg clasp 1102 that captures the leg 1106 of a bifurcated stent graft 1108 in combination with an introducer sheath 1104, and a leg stop 1110 that restricts the proximal movement (towards the surgeon) of the introducer sheath 1104, either directly or indirectly, thereby preventing the premature release of the distal end 1112 of the bifurcated stent graft 1108 during implantation at the surgical site. The stent graft 1108 may include one or more openings 1109.

[0094] The configuration of the leg clasp 1102 shown in Figure 63 includes a barrel-shaped portion 1114, a spool portion 1116 extending from the barrel-shaped portion 1114 along the longitudinal axis of the barrel-shaped portion 1114, and a rim portion 1118 at the end of the spool portion 1116 opposite to that of the barrel-shaped portion 1114, wherein the rim portion 1118 has a diameter (radial diameter) that is larger than the diameter of the spool portion 1116 but smaller than the diameter of the barrel-shaped portion 1114.

[0095] As can be seen in Figures 63-65, the guidewire 724 extends from the apical capture device 1128 through the leg clasp 1102. The bifurcated stent graft 1108 extends from the apical capture device 1128 to the leg clasp 1102 and is secured at the apical capture device 1128 and the leg clasp 1102, respectively.

[0096] The edge portion 1118 of the leg clasp 1102 of the present invention may include radially extending spokes 1166, as shown in Figures 63 and 65. The leg clasp 1102 of the present invention may be formed, for example, at least in part, from at least one component selected from the group consisting of stainless steel, polyester, polyetheretherketone (PEEK), and acrylonitrile butadiene styrene (ABS).

[0097] The leg clasp 1102 captures the leg 1106, thereby adding stability to the bifurcated stent graft 1108 during cannula insertion of the leg 1164. As can be seen in Figure 64, the support member 1120, including the push rod 774 (or support tube) and the lower tube 1168 (shown, for example, in Figures 72, 72A, and 72B), is fixed to the barrel portion 1114 of the leg clasp 1102 by the push rod 774 and extends from the barrel portion 1114 in the opposite direction to that of the spool portion 1116. In embodiments of the present invention including the leg clasp 1102, the wire 800 extends through the opening 1107 in the push rod 774, as shown in Figure 64. The introducer sheath 1104 (Figure 65) has an inner diameter sufficient to allow movement between a first position covering the barrel-shaped portion 1114, the spool portion 1116, and the edge portion 1118, and a second position exposing the spool portion 1116 and the edge portion 1118.

[0098] The wire 800 extends along the outer surface of the stent graft 1108 and through the loop 1103 of the restraint 1105. The wire also extends proximal to the stent graft 1108 along the outer surface of the leg clasp 1102 and through the opening 1107 of the push rod 774, and through the push rod 774 and the lower tube 1168 (shown, for example, in Figure 72) until it connects to the wire handle 803 (Figure 27A).

[0099] In an embodiment of the present invention relating to the leg clasp 1102 shown in Figure 62, the apex capture device 1128 of the present invention may be used. The apex capture device 1128 shown in Figure 66 includes a proximal apex capture portion 1130, which includes a nose portion 1132 and a plurality of teeth 1134 extending distally from the nose portion 1132. The teeth 1134 are radially distributed around the longitudinal axis 1136 of the delivery device 1100 (Figure 62). The distal apex capture portion 1138 defines slots 1140 that are radially distributed around the longitudinal axis 1134 and are mateable with the teeth 1134 by the relative movement of the proximal apex capture portion 1130 and the distal apex capture portion 1138 along the longitudinal axis 1134. A plurality of projections 1142 extend radially from the longitudinal axis 1136 between the nose portion 1132 and the distal apex capture portion 1138. The projection 1142 is aligned with the slot 1140 along the longitudinal axis 1136 and does not interfere with the movement of tooth 1134 when tooth 1134 is engaged with slot 1140 as shown in Figure 69. The guidewire catheter 724, to which the distal apical capture portion 1138 is fixed, extends through the external control tube 1126 and the proximal apical capture portion 1130. The external control tube 1126 is fixed to the proximal apical capture portion 1130, and the movement of the external control tube 1126 causes the proximal apical portion 1130 to move along the longitudinal axis 1136 between a first position in which tooth 1134 engages with slot 1140 and overlaps with projection 1142, and a second position in which tooth 1134 does not engage with slot 1140 and does not overlap with projection 1142. The nose cone 1146 extends distally from the guidewire catheter 724 and the distal apical capture portion 1138.

[0100] As can be seen in Figures 67 and 71, the bifurcated stent graft 1108 includes a tubular graft component 1148 having a proximal end 1150; a distal end 1112; a stent 1152 along the tubular graft component 1148; and a bare stent 1154 at the proximal end 1150. The clasp stent, in this case the bare stent 1154, includes a strut 1156 connected by a proximal apex 1158 and a distal apex 1159, the strut 1156 extending between the teeth 1134 as can be seen in Figure 69. The proximal apex 1158 of the bare stent 1154 extends proximally from the proximal end 1150 of the tubular graft component 1148. In the embodiment shown in Figure 67, which illustrates the stent graft 1108 after implantation, the suprarenal barb 1160 extends from the proximal apex 1158 of the bare stent 1154. The distal apex 1159 of the bare stent 1154 includes an infrared barb 1161. As can be seen in Figures 68-71, a portion of the proximal apex 1158 extends between the projection 1142 and the distal apex capture portion 1138 when the tooth 1134 engages with the slot 1140. As can be seen in Figure 68, the projection 1142 may extend into a hole 1141 defined by the proximal apex 1158 and the bridging portion 1143 at the proximal apex 1158 of the bare stent 1154. At least one suprarenal barb 1160 may extend from the bare stent 1154 to the radial restraint 1162 or pilot hole of the proximal capture portion 1130, as shown in Figure 70. The distal apex of the bare stent 1154 may be nested between the proximal apex of the most proximal stent 1163.

[0101] In another embodiment not shown, the proximal apex of the clasp stent does not extend proximal to the proximal end of the lumen graft component 1148, and the crown stent is positioned between the clasp stent and the proximal end 1150 of the lumen graft component 1148. Nevertheless in this embodiment, the proximal apex 1130 of the clasp stent is exposed, and they can be secured by the proximal apex capture portion 1130 and the distal apex capture portion 1138 when they are in an interlocking relationship.

[0102] In one embodiment, the stent graft delivery system of the present invention may further include a sliding body 1172, as shown in Figures 72, 72A, and 72B. The sliding body 1172 includes a sliding body portion 1174 that defines a central opening from which a support member 1120 extends. As shown in Figure 72A, the support member 1120 includes a push rod 774 and a lower tube 1168. The flush valve opening 1176 extends substantially perpendicular to the central opening. The sliding body portion 1174 is removablely fixed to the track 1178 by appropriate means, such as an opening lever 1180 (shown in Figures 73 and 74). A sliding body cap 1182 is connected to the distal end of the sliding body portion 1174. The sliding body cap 1182 defines a central opening that is substantially aligned with the central opening of the sliding body portion 1174 from which the support member 1120 extends. The sheath valve knob 1184 is threaded to the sliding body portion 1174. The introducer sheath 1104 is fixed to the distal end of the sliding cap 1182 and extends distally therefrom, defining a lumen that is substantially aligned with the central opening of the sliding body portion 1174 from which the support member 1120 extends. The wiper valve 1186 at the central opening of the sliding body portion 1174 is located proximal to the flush valve opening 1176 and forms a seal around the support member 1120. The x valve 1188 is located at the central opening of the sliding body portion 1174 proximal to the wiper valve 1186 and forms a seal around the support member 1120. The sheath valve 1190 is located proximal to the central opening of the sliding body portion 1174 and the x valve 1188. The sheath valve 1190 can be operated by the action of the knob 1184 to seal the central opening.

[0103] In one embodiment, the support tube 1122 (or push rod) is a component of the support member 1120 shown in Figures 72 and 72A. The lower tube 1168 of the support member 1120 also includes the lower tube 1168 shown in Figure 72A. In embodiments of the invention that include a torque component, such as those shown in Figures 28-60, the wire 800 extends proximal along the outer surface of the push rod 774, passes through an opening 1167 at the distal end of the lower tube 1168, and extends proximal within the lower tube 1168 until it reaches the proximal handle 714, as shown in Figures 27, 27A, 27B, and 27C. The support member 1120 can be fixed to the proximal handle 714 (Figure 27). In use, as can be seen in Figures 82A and 82B, the hemostatic valve 1172 can be held stationary, and the handle body 1200 (along with the support member 1120, and the rest of the delivery system excluding the hemostatic valve 1172 and introducer sheath 1104) can be removed from the surgical site and the patient.

[0104] Figure 73 shows a composite diagram of one aspect of the present invention. The method and function of the handle 1200 of the present invention are illustrated, for example, in the sequence of Figures 73 to 80. Before turning the lead screw nut 1202 to retract the introducer sheath 1104. The introducer sheath 1104 completely covers the bifurcated stent graft 1108 that is loaded therein near the nose cone 1146, as can be seen in Figure 73. The threads of the lead screw nut 1202 engage with the track 1178, and rotation of the lead screw nut 1202 while the lead screw nut 1202 is adjacent to the proximal end of the distal handle 1204 causes the track 1178, the sliding body 1172, and the introducer sheath 1104 to move proximal toward the proximal handle or proximal end 1111 of the housing 1210, thereby retracting the introducer sheath 1104 from the bifurcated stent graft 1108, as shown in Figure 74. The proximal movement of the track 1178 may continue until the proximal end 1206 of the track 1178 is adjacent to the leg stop 1110 and is removably fitted within the housing 1210 of the delivery device 1200, also referred to herein as the handle body. Upon contact between the track 1178 and the leg stop 1110, further rotation of the lead screw nut 1202 is prevented, as is the retraction of the introducer sheath 1104 from the bifurcated stent graft 1108. In this regard, the introducer sheath 1104 further covers the leg 1106 of the bifurcated stent graft 1108, thereby trapping at least one stent 1124 of the bifurcated stent graft 1108 between the leg clasp 1102 and the introducer sheath 1104, as previously shown in Figure 64. At the proximal end 1150 of the bifurcated stent graft 1108, the bare stent 1154 remains secured to the apex capture device 1128. By fixing the proximal end 1150 and distal end 1112 of the bifurcated stent graft 1108, the surgeon can better orient the bifurcated stent graft 1108 axially and longitudinally at the surgical site.

[0105] One embodiment of the legstop 1110 is shown in Figures 75-76. As can be seen in Figure 75, the legstop 1110 includes a body portion 1212 and a wing 1214 extending laterally from the body portion 1212. The wing 1214 partially wraps around the circumference of the handle body portion 1210 (Figure 74) of the delivery device 1200. The body portion 1212 fits within a slot 1216 defined by the handle body portion 1210 (Figure 73) and occupies a position on or partially around a support member 1120 extending through the handle body portion 1210 (see, for example, Figures 72 and 73). As can be seen in Figure 76, the body portion 1212 defines a channel 1218 into which the support member 1120 fits. The opening 1220 defined by the body portion 1212 is optional. The legstop 1110 is made of a suitable material, such as those known in the art. Examples of suitable materials include engineered plastics such as acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), and polysulfone. The leg stop 1110 may be made of an elastic or flexible material, and the wing 1214 may deform or expand slightly, thereby keeping the leg stop 1110 fixed in the slot 1216 of the handle body portion 1210 until it is removed by a physician. Once properly oriented, the bare stent 1154 can be released from the apical capture device 1128 by the operation of a clasp 1224 at the proximal end of the support member 1120, as shown in Figures 77-78. Specifically, in one embodiment shown in Figures 77A-77C, the proximal clasp assembly 1224 includes an interlocking external coupling 1123 and a fixed component 1125. The fixed component 1125 is fixed to the proximal end of the extension member guidewire catheter 724 shown in Figure 72A. The external coupling 1123 is fixed to the external control tube 1126. The release of the bare stent 1154 (Figure 71) is performed by first moving the external coupling 1123 distally to Figure 77A, and then rotating the fixed component 1125 by 90° as shown in the transition from Figure 77A to Figure 77B.Subsequently, the external coupling 1123 is moved proximal, and the claws 1127 of the external coupling 1123 engage with the slots 1129 of the fixed component, as shown in the transition from Figure 77B to Figure 77C. The proximal movement of the external coupling 1123 causes the proximal movement of the external control tube 1126, which in turn causes the proximal apical trapping portion 1130 (Figures 66 and 68-71) of the apical trapping device 1128 and the teeth 1134 of the proximal apical trapping portion 1130 to move proximal out of between the studs 1156 of the bare stent 1154, thereby releasing the bare stent 1154 from the apical trapping device 1128, as shown in Figure 78. The release of the bare stent 1154 causes the proximal apex to contact the vessel wall proximal to the surgical site, such as shown in Figure 67.

[0106] Referring again to Figure 78, since neither the leg clasp 1102 nor the introducer sheath 1104 moves relative to each other, they keep the bifurcated stent graft 1108 stable at the distal end of the stent graft 1112; the track 1178 is adjacent to the leg stop 1110, and the lead screw nut 1202 is prevented from rotating in either direction, in one direction by the leg stop 1110 and in the other direction by the resistance of the introducer sheath 1104, so that it does not advance in the reverse direction relative to the retracted bifurcated stent graft 1108. After the release of the bare stent 1154, as indicated by the position of the clasp 1224 shown in Figures 78 and 79A-79C. The leg stop 1110 can be removed by the surgeon, as shown in the transition from Figure 79A to 79B. Removal of the Legstop 1110 allows the track 1178 to be moved proximal to the surgeon by sliding the lead screw nut 1202 proximal or by rotating the lead screw nut 120, as shown in the transition from Figure 79B to 79C, thereby causing the introducer sheath 1104 to be retracted and the bifurcated stent graft 1108 to be released from the delivery device 1200, as shown in Figure 80. The delivery device 1200 can then be retracted from the bifurcated stent graft 1108 and the subject, thereby completing the implantation.

[0107] As can be seen in Figures 81A-81C, after the retraction of the track 1178, sliding body 1172, and introducer sheath 1204 from the stent graft 1108 as shown in the transition from Figure 81A to Figure 81B, and after the release of the bare stent 1154 and leg 1106 as described above, the release lever 1180 remains closed. The release lever 1180 is actuated by lifting, as shown in the transition from Figure 81B to 81C. The position of the lead screw nut 1202 is not important here, and the remaining distance moved by the track 1178 and introducer sheath 1172 to release leg 1106 from leg clasp 1102 can be achieved by either direct longitudinal movement of the lead screw nut 1202 (Figure 81B) or rotation of the lead screw nut 1202 (Figure 81C). In either case, the operation of the release lever 1180 allows the sliding body 1172 to be separated from the handle 1210 of the delivery device by proximal movement of the handle 1210, thereby removing the handle and attached component parts, leaving only the sliding body 1172 and the introducer sheath 1104, as shown in Figures 82A and 82B. The sliding body 1172 can then be sealed by rotating the sheath valve knob (Figure 72) until delivery is made, for example, through the introducer sheath 1104 of a stent graft leg extension or branched stent graft.

[0108] A method for treating an abdominal aortic aneurysm may further include the step of cannulating leg 1164 of a bifurcated stent graft 1108 together with an extension stent graft (not shown), while retaining leg 1106 at least partially within the introducer sheath 1104. A method for treating an abdominal aortic aneurysm may further include the step of releasing clasp 1224 at the proximal end of delivery device 1198 to release the bare stent 1154 at the proximal end 1150 of the bifurcated stent graft 1108. When the apical capture device 1128 is released and the bare stent 1154 is released, leg 1106 of the bifurcated stent graft 1108 is constrained within the introducer sheath 1104. Next, by removing the leg stop 1110, the leg 1106 is released, which allows for further retraction of the track 1178 and introducer sheath 1104, thereby exposing and releasing the trapped portion of the leg 1106.

[0109] In another embodiment, a method for treating an abdominal aortic aneurysm may further include the steps of removing the sliding body 1172 and introducer sheath 1104 from the remainder of the delivery device 1200, and then withdrawing the remainder of the device 1200 from the patient, leaving the sliding body 1172 and introducer sheath 1104 substantially in place. The extension stent graft (not shown) is then delivered to the leg 1106 through the introducer sheath 1104, and the leg 1106 can be cannula-inserted using the extension stent graft. The cannula-inserted leg 1106 overlaps with the extension stent graft by at least two stents each of the cannula-inserted leg 1106 and the extension stent graft. The cannula-inserted leg 1108 may contain at least one more stent, referred to as a "locking stent," which needs to overlap with the extension leg by the two stents of the cannula-inserted leg 1106 and the extension stent graft. The second stent of the cannula-inserted leg 1106 may be located within the graft material of the bifurcated stent graft. The second stent, at the distal end of the bifurcated stent graft 1108, may contain a barb that can extend inward and proximal from the stent.

[0110] Figure 83 is an exploded view of one embodiment of a modular, fenestrated bifurcated stent graft 1226 that can be delivered by the method of the present invention. As can be seen in Figure 83, the cuff 1228 is a stent graft defining the fenestration 1230. The bifurcated extension 1232 is also a stent graft. Figure 84 is a diagram of the fenestrated bifurcated stent graft 1226 assembled by the method of the present invention. Torque components having multiple claws, such as those described in U.S. serial number 16 / 433,823 filed June 6, 2019 and U.S. serial number 63 / 111,357 filed November 9, 2020, whose relevant teachings are incorporated herein by reference in their entirety, may be used during the delivery of the fenestrated cuff 1228 to the treatment site. Subsequently, the leg clasp 1102 shown in Figure 63 is used to deliver the bifurcated extension 1232 to the modular stent graft 1226 by capturing the distal end of one leg of the bifurcated extension 1232, as shown in Figure 64, by overlapping the cuff 1228 and the bifurcated extension 1232, and finally the bifurcated stent graft 1226 with modular openings is released and the delivery system is withdrawn from the patient.

[0111] The method of the present invention has the advantage of allowing a clinician to redeploy a graft (e.g., a bifurcated graft, a second stent graft, a third stent graft) if, for example, the initial positioning of the graft is determined to be less than optimal. The graft may be redeployed at its proximal and distal ends, as well as at the proximal and distal ends of the aorta or a branch of the aorta, such as the common iliac artery. It is understood that the various aspects of the present invention described herein may be combined, such as a combination of methods for restraining a stent graft, including the use of a delivery device claw for controlling rotation at the distal end of the stent graft and the use of the aforementioned leg clasp, introducer sheath, and leg stop for controlling implantation of a bifurcated stent graft.

[0112] While exemplary embodiments are specifically shown and described, it will be understood by those skilled in the art that various modifications in form and detail can be made in the present invention without departing from the scope of embodiments covered by the appended claims. For example, at least one opening of a stent graft used in the method or as a component of the delivery system of the present invention may include, but are not shown, an opening lock as described in PCT / US2018 / 019352; a movable opening as described in PCT / US2018 / 019353; an opening ring as described in PCT / US2018 / 019351; and a crimp adapter as described in PCT / US2018 / 019350, all of which are incorporated herein by reference in their entirety. Also, the relevant teachings in PCT / 2017 / 037157, PCT / US2017 / 044822 and PCT / US2018 / 052400 are incorporated herein by reference in their entirety. Furthermore, as described in PCT / US2018 / 019354, for example, but whose relevant teachings are incorporated herein by reference in their entirety, a flexible sheath for use in a delivery system of the present invention may include an opening having a lumen configuration having a contracted diameter and an alignment of a cord extending through the opening, the cord being configured to conform the opening to the alignment, thereby confirming the flexible sheath, the cord being retractable proximal to the opening, thereby releasing the flexible sheath from the contracted diameter.

[0113] Vascular prostheses implanted by the stent graft system and method of the present invention may be implanted, for example, via a transfemoral access. Further branched prostheses directed to the vascular prosthesis of the present invention may be implanted, for example, via a supraortic access (e.g., through the brachial artery) or via a transfemoral access or access from several other branches of a major vessel, including peripheral vessels.

[0114] All patents, published applications, and references cited herein are incorporated by reference in their entirety. All relevant patents, published applications, and references cited herein are incorporated by reference in their entirety. U.S. Patent Nos. 8,292,943; 7,763,063; 8,308,790; 8,070,790; 8,740,963; 8,007,605; 9,320,631; 8,062,349; 9,198,786; 8,062,345; 9,561,124; 9,173,755; 8,449,595; 8,636,788; 9,333,104; 9,408,734 No. 9,408,735; No. 8,500,792; No. 9,220,617; No. 9,364,314; No. 9,101,506; No. 8,998,970; No. 9,554,929; No. 9,439,751; No. No. 9,592,112; No. 9,655,712, No. 9,827,123, No. 9,877,857, No. 9,907,686; No. 10,105,248; No. 10,307,275; No. 10,524,893; No. No. 10,390,932; No. 10,213,291; No. 10,646,365; No. 10,390,932; US Patent Application No. 14 / 575,673; No. 14 / 272,818; No. 15 / 478,424; No. 15 / 604,032; No. 15 / 672,404; No. 15 / 816,772; No. 16 / 414,292; No. 15 / 478,424; PCT / US2017 / 025849; No. 15 / 478,737; No. 15 / The relevant teachings in issues 604,032; 15 / 672,404; 16 / 414,132; 16 / 379,423; 16 / 379,490; 16 / 379,354; 16 / 391,843; 16 / 391,995; 16 / 392,443; 16 / 414,208; 16 / 414.132; 16 / 433,654; and 16 / 433,823 are also incorporated by reference in their entirety.

[0115] While exemplary embodiments are specifically shown and described, it will be understood by those skilled in the art that various modifications in form and detail can be made in the present invention without departing from the scope of embodiments included in the appended claims. The following are examples of aspects of the present invention. Item 1 a) Luminous graft components having a proximal open end and a distal open end; b) Multiple stents distributed longitudinally along the luminal graft components, at least one of the stents having struts connected to define the proximal and distal apex; c) At least one loop fixed to at least one of the posts; d) at least one cord extending through at least one loop, each cord crossing at least a portion of at least one support of the stent, and the cord having an end that, when connected, at least partially radially contracts the respective corresponding stent; and e) When the corresponding stent is connected to contract radially, a pair of anchor loops in the longitudinal lumen graft components are attached to the ends of each associated cord. Aortic prosthesis system, including... Section 2 The aortic prosthesis system according to item 1, wherein the cord extends completely around the circumference of the stent when its end is connected. Section 3 The aortic prosthesis system according to item 2, wherein each end of the cord includes a cord loop. Section 4 The aortic prosthesis system according to paragraph 3, wherein the ends of the wire are aligned to be connected by the wire loops when the wire extends longitudinally along the lumen graft component through each pair of anchor loops. Section 5 The aortic prosthesis system according to claim 1, wherein at least a portion of the cord is circular and can be connected by a wire passing through an anchor loop at a point on the diametrically opposite side when the cord is radially contracting a tubular graft component. Section 6 An aortic prosthesis system according to claim 1, further comprising a string suture aligned laterally in a luminal graft component through which the string ends pass, wherein the string suture is positioned on both sides of a wire passing through an anchor loop, and the string ends are connected by the wire between the string sutures. Section 7 The aortic prosthesis system according to item 1, wherein, when the ends are joined, the cord includes two cord component portions that partially extend around the circumference, and the ends of the cord are joined. Section 8 An aortic prosthesis system as described in item 7, wherein each end of the cord includes a cord loop. Section 9 The aortic prosthesis system according to item 8, wherein the two component portions of the cord are each fixed to a luminal graft component. Section 10 The aortic prosthesis system according to claim 8, further comprising two component parts of the cord, which are secured to a support at the opposite end of the cord loop of each component part of the cord. Section 11 An aortic prosthesis system according to claim 10, further comprising a string suture that is laterally aligned in a luminal graft component through which the string ends pass, wherein the string suture is positioned on both sides of a wire passing through an anchor loop, and the string ends can be connected by the wire between the string sutures. Section 12 The aortic prosthesis system according to paragraph 7, wherein each of the two component parts is a circular thread that is fixed to a tubular graft component or associated stent support at a point opposite in the diametrical direction of the point of the circular thread, where each component part of the thread is connected to the circular thread of the other component part of the thread. Section 13 An aortic prosthesis system as described in item 1, wherein the cord is a thread. Section 14 The aortic prosthesis system according to claim 13, wherein the thread comprises at least one member of the group consisting of polyester, nylon, stretched polytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF), and polypropylene. Item 15 An aortic prosthesis system according to item 1, wherein at least a portion of the stent comprises a shape memory alloy. Item 16 An aortic prosthesis system according to item 15, wherein the shape memory alloy contains nitinol. Section 17 An aortic prosthesis system according to item 16, wherein at least a portion of the stent is made of radiopaque material. Section 18 a) i) Lumen graft components having a proximal open end and a distal open end, defining the lumen, ii) Multiple stents distributed longitudinally along the luminal graft components, at least one of the stents having struts connected to define the proximal and distal apex, iii) At least one loop fixed to at least one of the posts, iv) at least one cord extending through at least one loop, each cord crossing at least a portion of the support, and the cords having ends that, when connected, at least partially contract the stent radially, and v) When the corresponding stents are connected to contract radially, a pair of anchor loops in the longitudinal lumen graft components are attached to the ends of each associated cord. including stent grafts, b) A wire extending longitudinally along the lumen graft component through an anchor loop and connecting its ends, the wire thereby radially contracting at least one portion of the stent of the stent graft, and the pulling of the wire from the end of at least one wire releasing the stent graft from radial contraction by at least one wire. Aortic prosthesis system, including... Section 19 a) A guidewire catheter into which a stent graft is releasably secured, the guidewire catheter extending along its longitudinal axis and having a proximal end and a distal end extending into the luminal graft component; b) Proximal handle to which the guidewire catheter is secured; c) A distal handle extending around the guidewire catheter, the distal handle being distal to the proximal handle; and d) An introducer sheath extending distally from the distal handle and around the stent graft. The aortic prosthesis system described in item 18, further including the following: Section 20 An aortic prosthesis system according to item 19, further comprising a gasket at a proximal handle, wherein the gasket defines a large opening through which a guidewire catheter extends, and the large opening through which the wire extends prevents fluid from passing through the proximal handle. Section 21 a) Steps of advancing a stent graft through an artery to an aneurysm of the subject, the stent graft including at least one cord extending at least partially around the periphery of the stent graft, the cord extending through at least one loop fixed to at least one radial stent support of the stent graft, the cord having an end connected to a longitudinally extending anchor loop parallel to and connected to the longitudinal axis of the stent graft, thereby maintaining the stent graft in a radially contracted position; and b) The step of pulling wires from at least one end of a cord and an anchor loop, thereby freeing the ends of the cords from each other, the stent graft radially expanding from a radially contracted position to a radially expanded position, thereby implanting the stent graft prosthesis into the aneurysm of the subject. A method of implanting a stent graft into the aneurysm site of a subject, including [specific example]. Section 22 a) Luminous graft components having a proximal open end and a distal open end; b) Multiple stents distributed longitudinally along the luminal graft components, at least one of the stents having struts connected to define the proximal and distal apex; c) at least one loop fixed to at least one of the posts; and d) At least one cord extending through at least one loop, each cord crossing at least one support of the stent, wherein the cord includes an end that, when connected, at least partially radially contracts the respective corresponding stent. Stent grafts, including... Section 23 a) Luminous stent graft components having a proximal end and a distal end; b) At least one stent in the luminal graft component, at least one of the stents having struts connected to define the proximal apex and distal apex; c) At least one loop fixed to at least one of the posts; d) A cord extending through the loop and crossing multiple supports of the stent to which the loop is attached, the cord having ends that, when connected, restrain the stent against outward radial expansion, thereby causing the stent to contract. Aortic prosthesis system, including... Section 24 An aortic prosthesis system as described in paragraph 23, wherein one end of the cord is fixed to the support of the stent. Section 25 The aortic prosthesis system according to paragraph 24, wherein the cord includes a first component fixed at one end to a first support and a second component fixed at the other end to a second support of the stent, and at least one of the first and second components extends through at least one loop, and when the opposite ends of the first and second components of the cord are joined, the radial expansion toward the stent is contracted. Section 26 The aortic prosthesis system according to paragraph 25, wherein the opposite ends of the first and second components of the cord define an opening, and the opposite ends are connected so that the stent can be deflated from radial expansion outward. Section 27 The aortic prosthesis system according to item 23, further comprising a wire that extends longitudinally along the luminal graft components and connects the ends of the cord, thereby contracting the stent. Section 28 The aortic prosthesis system according to paragraph 27, wherein the cord has a first end and a second end, extends around the circumference of the lumen graft component through at least a portion of the loop, and the connection of the first and second ends causes the cord to cross the support in the loop, thereby deflating the outward radial expansion of the stent. Section 29 The aortic prosthesis system according to paragraph 28, wherein the cord defines cord loops at each of the first and second ends, and the first and second ends can be connected by a wire at the cord loops. Section 30 The aortic prosthesis system according to paragraph 29, wherein the cord is a hoop that is flattened to define a first end and a second end, extends through at least a portion of the loop, and the connection of the first end and the second end causes the cord to cross the support in the loop, thereby deflating the outward radial expansion of the stent. Section 31 An aortic prosthesis system according to paragraph 30, comprising multiple loops in multiple supports of at least one stent of a stent graft. Section 32 An aortic prosthesis system according to paragraph 31, comprising at least one pair of loops in a pair of struts connected to form at least one proximal or distal apex, wherein contraction of the struts by a string brings the loops together on the struts so that the distance between the loops is closer than in the absence of string contraction. Item 33 The aortic prosthesis system according to claim 32, wherein a luminal graft component defines a fenestration between two adjacent strata of at least one stent of the stent graft, and a pair of loops are located distal to the distal end of the fenestration or proximal to the proximal end of the fenestration on the adjacent strata, the loops causing the stent to contract without obstructing the fenestration. Section 34 The aortic prosthesis system according to claim 33, further comprising a second pair of loops in a pair of struts, the second pair of loops extending across a fenestration, and the aortic prosthesis system further comprising loops in a luminal graft component between the loops distal to the distal end of the fenestration or proximal to the proximal end of the fenestration, the cord extending through the loops in the luminal graft component and contracting the fenestration without closing the fenestration, the luminal graft component in the fenestration being supported between struts to which the loops are fixed. Section 35 The aortic prosthesis system described in paragraph 34, wherein the ends of the cords are connected radially away from the fenestration. Section 36 An aortic prosthesis system according to paragraph 35, further comprising a loop with an adjacent support that defines the proximal apex of a distal apex that nests with a fenestration, or the proximal apex of a proximal apex that nests with a fenestration. Section 37 The aortic prosthesis system according to paragraph 36, further comprising at least one pair of anchor loops, each of which is a longitudinal lumen graft component, at the end of each associated cord, when the corresponding stent is connected to contract radially. Section 38 a) Steps of advancing a stent graft through an artery to an aneurysm of the subject, the stent graft including at least one cord extending at least partially around the periphery of the stent graft, the cord extending through at least one loop fixed to at least one radial stent support of the stent graft, the cord defining an end connected by a wire extending parallel to the longitudinal axis of the stent graft; and b) A step of pulling wires from at least one end of a cord and an anchor loop, thereby freeing the ends of the cords from each other, the stent graft radially expanding from a radially contracted position to a radially expanded position, thereby implanting the stent graft prosthesis into the aneurysm of the subject. A method of implanting a stent graft into the aneurysm site of a subject, including [specific example]. Section 39 a) A longitudinal body portion defining a longitudinal axis having a proximal handle and a distal handle; b) A guidewire catheter having a proximal and distal end, extending from the distal handle of the longitudinal body; c) A nose cone fixed to the distal end of a guidewire catheter, the nose cone having a proximal end; d) i) Proximal end ii) Distal end iii) The internal surface defining the lumen through which the guidewire catheter extends, and iv) External surfaces that are non-circular in cross-section along at least a portion of the length of the internal keyed projection Includes internal keyed protrusions; e) i) The distal components at the proximal end of the nose cone, and ii) A proximal component fixed to the distal end of the internal keyed projection, the distal and proximal components together define an opening that captures the proximal apex of the stent at the proximal end of the stent graft prosthesis extending around the internal keyed projection at a first position, and releases the proximal apex at a second position of the apex capture device. A top-level capture device, including; f) i) An external keyed projection fixed to the proximal handle and extending therefrom and around the internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface that is in an axial rotational and interfering relationship with the internal keyed projection, ii) At least two arms arranged radially around an external keyed projection and extending distally from the external keyed projection, each arm being movable from a retracted state to an extended state, and the torque component exhibits radial extension. Torque components including; and g) A radial restraint body extending around the external keyed projection, the stent graft extending between the external keyed projections, the radial restraint body may be captured at the distal end of the stent graft, and the stent graft is rotated around the longitudinal axis by applying torque force to the torque component by rotation of the proximal handle around the longitudinal axis. A delivery system for implanting stent grafts, including [specific components / features]. Section 40 The delivery system according to item 39, wherein the torque component includes at least three arms. Section 41 The delivery system according to item 40, wherein the torque component includes three arms. Section 42 The delivery system according to paragraph 39, further comprising a hub connecting external keyed protrusions to at least two arms. Section 43 The delivery system according to paragraph 39, wherein at least part of the arms are connected by joints. Section 44 The delivery system according to paragraph 39, wherein the arm self-extends from a retracted state to an extended state. Section 45 The delivery system according to paragraph 39, wherein each of at least two arms has an extended curved shape when viewed at an angle perpendicular to the longitudinal axis of the longitudinal body. Section 46 A delivery system according to claim 39, further comprising a stent graft, wherein the stent graft comprises a lumen graft component and a plurality of radially expandable stents distributed along the longitudinal length of the lumen graft component, the stents each comprising a plurality of struts connected at opposite ends to form a proximal and distal apex. Section 47 The delivery system according to claim 46, wherein the radial restraint comprises at least one of a combination of threads and wires and a flexible sheath extending around a stent graft, and the stent graft can be released from the restraint by pulling the wires from the threads or the flexible sheath from the stent graft. Section 48 The delivery system according to claim 47, wherein the radial restraint includes a delivery system comprising a combination of threads and wires, further comprising at least one loop fixed to at least a portion of the stent support of a stent graft. Section 49 The delivery system according to claim 48, further comprising a gasket at the proximal handle, wherein the gasket defines a large opening through which a guidewire catheter extends and a smaller opening through which the wire extends, thereby preventing fluid from passing through the proximal handle. Item 50 The delivery system according to paragraph 49, wherein at least one of the arms defines an opening at its distal end, a stent graft defines an opening, the delivery system further includes a suture fixed to the opening and extending through the opening, the stent graft extends from the opening, and the delivery system further includes a wire extending from the longitudinal body and through the suture to secure the stent graft to the arm, the retraction of the wire toward the handle releases the stent graft from the arm. Section 51 A delivery system according to claim 50, further comprising a stent graft having a proximal end and a distal end extending around an arm, wherein the stent graft is radially constrained by a radial restraint. Section 52 The delivery system according to claim 50, wherein the stent graft includes a sleeve from which each arm extends, the sleeve defining an opening from which a suture extends, and the delivery system further includes at least one further wire which extends through the suture, thereby fixing the arm from rotational motion relative to the stent graft, and the torque component is substantially prevented from rotating within the stent graft before deployment. Section 53 The delivery system according to claim 39, comprising an introducer sheath in which a radial restraint extends around the torque component and the stent graft and radially retracts the torque component and the stent graft, wherein the introducer sheath extends distally from the longitudinal body and is retractable from at least a portion of the stent graft and torque component by retraction of the introducer sheath and by at least one of an external keyed projection and the advancement of a guidewire catheter. Section 54 The delivery system according to item 39, further comprising a nose cone at the distal end of the guidewire catheter. Section 55 The delivery system according to claim 39, wherein each arm has a cross-section having a radial height less than the width in a cross-section along at least a portion of the length of at least one arm. Section 56 The delivery system according to paragraph 39, wherein three arms are fixed at the proximal end of each arm to the distal end of an external keyed projection. Section 57 The delivery system according to paragraph 56, wherein each of the three arms is spaced evenly apart from one another around the longitudinal axis of the external keyed projection. Section 58 The delivery system according to paragraph 39, wherein four arms are fixed to the distal end of a hub at the proximal end of each arm. Section 59 The delivery system according to paragraph 58, wherein each of the four arms is spaced evenly apart from one another around the longitudinal axis of the longitudinal body. Item 60 The delivery system according to paragraph 39, wherein at least two arms are independently having a length ranging from about 1 inch to about 5 inches. Section 61 The delivery system according to item 39, wherein the longitudinal body includes a handle body extending from a proximal handle to a distal handle, the proximal handle being fixed to an external keyed projection and capable of rotating around the handle body, thereby rotating a torque component. Section 62 The delivery system according to claim 61, further comprising an introducer sheath that extends around a track and torque components and a stent graft in a longitudinal body portion and restrains the torque components and the stent graft, wherein the introducer sheath extends distally from the track which can be retracted from the stent graft and torque components by retraction of the introducer sheath, and the delivery system further comprising a lead screw nut that extends around a handle body portion and is threaded to engage with the track, wherein the track and introducer sheath can be retracted by rotation of the lead screw nut around the longitudinal body portion or by retraction of the lead screw nut longitudinally along the handle body portion. Section 63 a) Proximal handle; b) A guidewire catheter extending from the proximal handle and having a proximal end and a distal end at the proximal handle; c) A nose cone fixed to the distal end of the guidewire catheter; d) i) Proximal end, ii) Distal end iii) The internal surface defining the lumen through which the guidewire catheter extends, and iv) External surfaces that are non-circular in cross-section along at least a portion of the length of the internal keyed projection Includes internal keyed protrusions; e) A stent graft extending around a guidewire catheter, the stent graft is i) Lumen graft components having an outer surface, an inner surface, a proximal open end, and a distal open end, defining the lumen, and ii) Multiple stents extending longitudinally along the lumen wall Includes; f) A radial restraint that constrains the stent graft radially and extends around the guidewire catheter, where release of the radial restraint allows for radial expansion of the stent graft, thereby partially deploying the stent graft; g) i) The distal components at the proximal end of the nose cone, and ii) A proximal component fixed to the distal end of the internal keyed projection, the distal component and the proximal component together define an opening that captures the proximal apex of the stent at the proximal end of a stent graft prosthesis extending around the internal keyed projection at a first position, and releases the proximal apex at a second position of the apex capture device. Including a top-level capture device; and h) A torque component extending around the guidewire catheter, the torque component being, i) An external keyed projection extending distally from the proximal handle and around the internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface that is in an axial rotational and interfering relationship with the internal keyed projection, and ii) At least two arms arranged radially around the external keyed projection and extending distally from the external keyed projection, each arm movable from a retracted to an extended state, the torque component exhibiting radial extension, and the application of torque force to the torque component by rotation of the proximal handle around the longitudinal axis causing the stent graft to rotate around the longitudinal axis. including, A delivery system for implanting stent grafts, including [specific components / features]. Section 64 The delivery system according to item 63, further comprising an external keyed projection and a hub connecting at least one arm. Section 65 The delivery system according to item 63, further comprising a distal handle extending around an external keyed projection. Section 66 The delivery system according to paragraph 63, wherein a radial restraint is fixed to a distal handle. Section 67 A delivery system according to claim 66, further comprising a stent graft, the stent graft comprising a lumen graft component and a plurality of radially expandable stents distributed along the longitudinal length of the lumen graft component, each stent comprising a plurality of struts connected at opposite ends to form a proximal and distal apex. Section 68 The delivery system according to claim 67, wherein the radial restraint comprises at least one of a combination of threads and wires and a flexible sheath extending around the stent graft, and the stent graft can be released from the restraint by pulling out the wires from the threads or the flexible sheath from the stent graft. Section 69 The delivery system according to claim 68, wherein the radial restraint includes a combination of threads and wires, and the delivery system further includes at least one loop that is fixed to at least a portion of the stent support of the stent graft. Section 70 The delivery system according to item 69, further comprising a gasket at the proximal handle, wherein the gasket defines a large opening through which a guidewire catheter extends and a smaller opening through which the wire extends, thereby preventing fluid from passing through the proximal handle. Section 71 a) The process of orienting the stent graft to the aneurysm site of the subject, the stent graft being held in a contracted position by a radial restraint and circumferentially extending distally around the guidewire catheter and distally from the distal handle of the longitudinal body of the delivery device, the internal keying projection being within the stent graft, the stent graft having a proximal end and a distal end, the distal end of the stent graft being rotationally fixed to a torque component, the torque component including an external keying projection extending around the internal keying projection, the external keying projection being non-circular in cross-section and defining an internal surface in which axial rotation with respect to the internal keying projection and at least two arms extending distally and radially from the keying projection, each arm being movable from a contracted to an extended state, the torque component exhibiting radial extension; b) A step of rotating the proximal handle of the longitudinal body, thereby rotating the external keyed projection and aligning the stent graft in the rotational direction within the aneurysm site; c) Retracting the external keyed projection: The proximal component of the apical capture device, which is fixed to the distal end of the external keyed projection, is separated from the distal component of the apical capture device, which is fixed to the distal end of the guidewire catheter, thereby releasing the stent at the proximal end of the stent graft captured by the apical capture device; d) The process of retracting a radial restraint, thereby releasing the stent graft at the aneurysm site; and e) The process of retracting the guidewire catheter and torque component from the subject, thereby implanting the stent graft into the aneurysm site of the subject. A method of implanting a stent graft into the aneurysm site of a subject, including [specific example]. Section 72 The method according to paragraph 71, wherein the radial restraint of the delivery device includes an introducer sheath extending distally from the longitudinal body and around the stent graft, the stent graft is restrained within the introducer sheath before being directed to the aneurysm site, the method further includes the step of at least partially exposing the stent graft, the stent graft being radially expanded to a second restrained position before the step of rotating the proximal handle and external keyed projection, thereby rotatably aligning the stent graft within the aneurysm. Section 73 The method according to paragraph 72, wherein the stent graft is at least partially exposed by advancing the stent graft from an introducer sheath and from a distal position to the aneurysm site to the aneurysm site. Section 74 The method according to paragraph 72, wherein the stent graft is at least partially exposed by retracting the introducer sheath from the stent graft. Section 75 The method according to paragraph 71, wherein at least a portion of the arms of the torque component are connected by an articulation. Section 76 The method according to paragraph 71, wherein the torque component further includes a hub connecting an external keyed projection to at least two or arms, the hub defining a lumen around a longitudinal axis, and each of the at least two arms having an extended curved shape when viewed at an angle perpendicular to the longitudinal axis of the hub. Section 77 A delivery system according to claim 71, further comprising a stent graft, the stent graft comprising a lumen graft component and a plurality of radially expandable stents distributed along the longitudinal length of the lumen graft component, each stent comprising a plurality of struts connected at opposite ends to form a proximal and distal apex. Section 78 The method according to paragraph 77, wherein the radial restraint comprises at least one combination of thread and wire, and a flexible sheath extending around the stent graft, and the stent graft can be released from the radial restraint by pulling the wire from the thread or flexible sheath toward the longitudinal body. Section 79 The method according to paragraph 78, wherein the radial restraint includes a combination of threads and wires, and the method further includes at least one loop that is fixed to at least a portion of the support of the stent graft. Section 80 The method according to paragraph 79, further comprising a gasket in the proximal handle, wherein the gasket defines a large opening through which the guidewire catheter extends and a small opening through which the wire extends, thereby preventing the passage of fluid from the proximal handle. Section 81 The method according to paragraph 71, wherein at least one of the arms defines an opening at its distal end, a suture is fixed to the claw and passed through the opening, and a wire extending from the longitudinal body and through the suture secures the stent graft to the arm, and the retraction of the wire toward the handle releases the stent graft from the arm. Section 82 The method according to paragraph 71, wherein the radial restraint of the delivery device includes an introducer sheath that extends around the torque component and the stent graft and restrains the torque component and the stent graft, and the introducer sheath is retractable from at least a portion of the stent graft and the torque component by at least one of the retraction of the introducer sheath and the advancement of an external keyed projection and a guidewire catheter. Section 83 The method according to item 71, further comprising a nose cone at the distal end of the guidewire catheter. Section 84 The method according to claim 71, wherein each arm has a cross-section along at least a portion of the length of at least one arm, having a radial height less than its width. Section 85 The method according to paragraph 71, wherein two arms extend distally from an external keyed projection. Section 86 The method according to paragraph 85, wherein each of the two arms is spaced evenly apart from one another around the longitudinal axis of the external keyed projection. Section 87 The method according to paragraph 71, wherein three arms extend distally from an external keyed projection. Section 88 The method according to paragraph 87, wherein each of the three arms is spaced evenly apart from one another around the longitudinal axis of the external keyed projection. Section 89 The method according to paragraph 71, wherein four arms extend distally from an external keyed projection. Section 90 The method according to paragraph 89, wherein each of the four arms is spaced evenly apart from one another around the longitudinal axis of the external keyed projection. Section 91 The method according to paragraph 71, wherein the stent graft includes a proximal end that is captured in the internal space of the apical capture assembly and a distal end that extends around the arm, and the stent graft is radially constrained by a radial restraint. Section 92 The method according to paragraph 91, wherein the stent graft includes a sleeve defining an opening, at least one arm extending into the sleeve, a suture extending through the opening, and a wire fixing a torque component from rotational motion relative to the stent graft, and the torque component being substantially prevented from rotation within the stent graft before deployment. Section 93 a) The process of advancing a stent graft, which is maintained in a contracted state by a radial restraint, to the site of the aneurysm; b) A step of rotating the stent graft to align it in the rotational direction with at least partial assistance of a torque component at the distal end of the stent graft, wherein the stent graft is keyed to a top-holding device that locks the stent at the proximal end of the stent graft; c) Retracting an internal keyed projection having a proximal component of the apical capture device fixed to the distal end of the apical capture device, thereby releasing the stent at the proximal end of the stent graft; and d) The process of removing the radial restraint from the stent graft and thereby implanting the stent graft into the aneurysm site. A method of implanting a stent graft into the aneurysm site of a subject, including [specific example]. Section 94 a) Proximal handle; b) A guidewire catheter extending from the proximal handle and having a proximal end and a distal end at the proximal handle; c) A nose cone fixed to the distal end of the guidewire catheter; d) i) Proximal end, ii) Distal end, iii) The internal surface defining the lumen through which the guidewire catheter extends, and iv) External surfaces that are non-circular in cross-section along at least a portion of the length of the internal keyed projection Includes internal keyed protrusions; e) A stent graft extending around a guidewire catheter, the stent graft is i) Lumen graft components having an outer surface, an inner surface, a proximal open end, and a distal open end, defining the lumen, and ii) Multiple stents extending longitudinally along the tubular graft components Includes; f) i) The distal components at the proximal end of the nose cone, and ii) A proximal component fixed to the distal end of the internal keyed projection, the distal and proximal components together define an opening that captures the proximal apex of the stent at the proximal end of the stent graft prosthesis extending around the internal keyed projection at a first position, and releases the proximal apex at a second position of the apex capture device. A top-level capture device, including; g) A radial restraint in a stent graft, the radial restraint comprising at least one cord that crosses at least a portion of the stent support of the stent graft, the cord comprising an end that, when connected, at least partially constricts the stent radially; h) A wire extending longitudinally along the lumen graft components, with its ends connected, thereby radially contracting at least a portion of the stent of the stent graft, where the pulling of the wire from at least one end releases the radial contraction by at least one of the ends; and i) A torque component extending around the guidewire catheter, the torque component being, i) An external keyed projection fixed to the proximal handle and extending from the proximal handle around the internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface that is in an axial rotational and interfering relationship with the internal keyed projection, and ii) At least two arms arranged radially around the external keyed projection and extending distally from the external keyed projection, each arm movable from a retracted to an extended state, the torque component exhibiting radial extension, and the stent graft being rotated around the longitudinal axis by the application of torque force to the torque component by the rotation of the proximal handle and the external keyed projection around the longitudinal axis. including, A delivery system for implanting stent grafts, including [specific components / features]. Section 95 The delivery system according to paragraph 94, further comprising a pair of anchor loops on the lumen graft component for securing the ends of each associated cord to the lumen graft component. Section 96 The delivery system according to paragraph 95, wherein at least a portion of the strings are circular and are connected at opposite points in the radial direction by a wire passed through an anchor loop when the strings are radially contracting the lumen graft components. Section 97 A delivery system according to claim 94, further comprising a stent graft, the stent graft comprising a luminal graft component and radially expandable stents distributed along the longitudinal length of the luminal graft component, the stents each comprising a plurality of struts connected at opposite ends to form a proximal and distal apex. Section 98 The delivery system according to paragraph 97, wherein the radial restraint comprises at least one of a combination of threads and wires and a flexible sheath extending around a stent graft, and the stent graft can be released from the restraint by pulling the wires from the threads or the flexible sheath from the stent graft. Section 99 The delivery system according to claim 98, wherein the radial restraint includes a combination of threads and wires, and the delivery system further includes at least one loop that is fixed to at least a portion of the support of the stent of the stent graft. Item 100 A delivery system according to item 99, further comprising a gasket at the proximal handle, wherein the gasket defines a large opening through which a guidewire catheter extends and a smaller opening through which the wire extends, thereby preventing fluid from passing through the proximal handle. Section 101 a) Proximal handle; b) A guidewire catheter extending from the proximal handle and having a proximal end and a distal end at the proximal handle; c) A nose cone fixed at the distal end of a guidewire catheter, the nose cone having a proximal end and a distal end; d) i) Proximal end ii) Distal end iii) The internal surface defining the lumen through which the guidewire catheter extends, and iv) External surfaces that are non-circular in cross-section along at least a portion of the length of the internal keyed projection Includes internal keyed protrusions; e) A stent graft extending around a guidewire catheter, the stent graft is i) Lumen graft components having an outer surface, an inner surface, a proximal open end, and a distal open end, defining the lumen, ii) Multiple stents extending longitudinally along the tubular graft components; and iii) A bare stent at the proximal open end of a lumen graft component, the bare stent including a support defining the proximal and distal apex, the bare stent being fixed to the lumen graft component at the distal apex of the bare stent. Includes; f) A radial restraint in a stent graft, the radial restraint comprising at least one cord that crosses at least a portion of the stent supports of the stent graft, the cord comprising an end that, when connected, at least partially constricts the stent radially; g) A wire that extends longitudinally along the lumen graft component, with its ends connected, thereby radially contracting at least a portion of the stent of the stent graft, where the pulling of the wire from at least one end releases the radial contraction by at least one of the ends; h) A apical capture device at the distal end of a guidewire catheter, the apical capture device releasably captures the proximal apex of a bare stent, the apical capture device, i) The distal components at the proximal end of the nose cone, and ii) A proximal component fixed to the distal end of the internal keyed projection, the distal and proximal components together define an opening that captures the proximal apex of the stent at the proximal end of the stent graft prosthesis extending around the internal keyed projection at a first position, and releases the proximal apex at a second position of the apex capture device. Including; and i) A torque component extending around the guidewire catheter, the torque component being, i) An external keyed projection extending distally from the proximal handle around the internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface that is in an interfering relationship with the axial rotation of the internal keyed projection, and ii) At least two arms arranged radially around the external keyed projection and extending distally from the external keyed projection, each arm movable from a retracted to an extended state, the torque component exhibiting radial extension, and the stent graft being rotated around the longitudinal axis by the application of torque force to the torque component by rotation of the proximal handle and external keyed projection around the longitudinal axis. including, A delivery system for implanting stent grafts, including [specific components / features]. Section 102 The delivery system according to item 101, further comprising a pair of anchor loops on a lumen graft component for securing the ends of each associated cord to the lumen graft component. Section 103 The delivery system according to paragraph 102, wherein at least a portion of the strings are circular and connected by a wire that passes through an anchor loop at a point opposite in the radial direction when the strings are radially contracting the lumen graft components. Section 104 A delivery system according to claim 101, further comprising a stent graft, the stent graft comprising a luminal graft component and radially expandable stents distributed along the longitudinal length of the luminal graft component, the stents each comprising a plurality of stents connected at opposite ends to form a proximal and distal apex. Section 105 The delivery system according to claim 104, wherein the radial restraint comprises at least one of a combination of threads and wires and a flexible sheath extending around the stent graft, and the stent graft can be released from the restraint by pulling the wires from the threads or the flexible sheath from the stent graft. Section 106 The delivery system according to claim 105, wherein the radial restraint includes a combination of threads and wires, and the delivery system further includes at least one loop that is fixed to at least a portion of the support of the stent of the stent graft. Section 107 The delivery system according to item 106, further comprising a gasket at the proximal handle, wherein the gasket defines a large opening through which a guidewire catheter extends and a smaller opening through which the wire extends, thereby preventing fluid from passing through the proximal handle. Section 108 a) The step of oriented the stent graft to the aneurysm of the subject, the stent graft comprising a luminal graft component and a plurality of radial stents distributed longitudinally along the luminal graft component, at least one of the stents having a strut connected to define the proximal and distal apex, the stent graft being held in a position constrained by a radial restraint, the radial restraint comprising at least one cord crossing at least a portion of the struts of the stent graft, the cord having an end that, when connected, at least partially contracts the stent radially, the radial restraint also comprising a wire extending longitudinally along the luminal graft component, connecting the cord end, thereby contracting at least a portion of the stent of the stent graft radially, the end of at least one cord The retraction of the wire from releases radial contraction by at least one string; extending distally from the distal handle of the longitudinal body of the delivery device and extending around the guidewire catheter within the stent graft, the stent graft having a proximal end and a distal end, the distal end of the stent graft being rotationally fixed to a torque component fixed proximally from the proximal handle and around an external keyed projection extending around the guidewire catheter and within the stent graft, the guidewire catheter and the internal keyed projection each containing one component of a two-component top-mounted capture device at their distal ends, the internal keyed projection having a non-circular cross-section and the external keyed projection having a non-circular cross-section in rotational and interfering relationship with the internal keyed projection; b) A step of rotating the proximal handle of the longitudinal body, thereby rotating the external keyed projection and apical capture device, and aligning the stent graft in the rotational direction within the aneurysm site; c) Retracting the external keyed projection, thereby separating the two components of the apical capture device and releasing the stent at the proximal end of the stent graft; d) The process of retracting a radial restraint, thereby releasing the stent graft at the aneurysm site; and e) The process of retracting the guidewire catheter and torque component from the subject, thereby implanting the stent graft into the aneurysm site of the subject. A method for implanting a stent graft into an aneurysm in a subject, including [specific example]. Section 109 The method according to paragraph 108, further comprising a pair of anchor loops on the lumen graft component for securing the ends of each related string to the lumen graft component. Section 110 The method according to paragraph 109, wherein at least a portion of the strings are circular and connected by a wire that passes through an anchor loop at a point opposite in the radial direction when the strings are radially contracting the lumen graft components. Section 111 A delivery system according to claim 110, further comprising a stent graft, the stent graft comprising a luminal graft component and radially expandable stents distributed along the longitudinal length of the luminal graft component, the stents each comprising a plurality of stents connected at opposite ends to form a proximal and distal apex. Section 112 The method according to paragraph 111, wherein the radial restraint comprises a combination of threads and wires, and at least one flexible sheath extending around the stent graft, and the stent graft can be released from the restraint by pulling the wires from the threads or the flexible sheath from the stent graft. Section 113 The method according to paragraph 112, wherein the radial restraint comprises a combination of threads and wires, the method further comprising at least one loop fixed to at least a portion of the support of the stent graft. Section 114 The method according to item 113, further comprising a gasket in the proximal handle, wherein the gasket defines a large opening through which the guidewire catheter extends and a smaller opening through which the wire extends, thereby preventing the passage of fluid from the proximal handle. Section 115 a) A longitudinal body section having a defined longitudinal axis and a proximal handle and a distal handle; b) A guidewire catheter having a proximal and distal end, extending from the distal handle of the longitudinal body; c) i) proximal end; ii) Distal end iii) The internal surface defining the lumen through which the guidewire catheter extends, and iv) External surfaces that are non-circular in cross-section along at least a portion of the length of the internal keyed projection Includes internal keyed protrusions; d) A radial restraint in the stent graft, the radial restraint is, i) At least one loop fixed to at least part of the stent support, and ii) At least one rope that crosses at least one stent and is secured to the stent's support through a loop. Includes; e) A apical capture device at the distal end of a guidewire catheter, the apical capture device releasably captures the proximal apex of a bare stent, and the apical capture device, i) The distal components at the proximal end of the nose cone, and ii) A proximal component fixed to the distal end of the internal keyed projection, the distal and proximal components together define an opening that captures the proximal apex of the stent at the proximal end of the stent graft prosthesis extending around the internal keyed projection at a first position, and releases the proximal apex at a second position of the apex capture device. Including; and f) i) An external keyed projection extending distally from the proximal handle around the internal keyed projection, the external keyed projection being non-circular in cross-section and defining an internal surface that is in an axial rotational and interfering relationship with the internal keyed projection; and ii) At least two arms radially positioned around the external keyed projection and extending distally from the external keyed projection, each arm movable from a retracted to an extended state, the torque component exhibiting radial extension, a proximal handle around the longitudinal axis, the application of torque force to the torque component by rotation of the external keyed projection, causing the stent graft to rotate around the longitudinal axis. Torque components including A delivery system for implanting stent grafts, including [specific components / features]. Section 116 A delivery system according to claim 115, further comprising a stent graft, the stent graft comprising a luminal graft component and radially expandable stents distributed along the longitudinal length of the luminal graft component, the stents each comprising a plurality of stents connected at opposite ends to form a proximal and distal apex. Section 117 The delivery system according to paragraph 116, wherein the stent graft includes a bare stent extending proximal to the proximal open end of a lumen graft component, the bare stent includes a support defining a proximal and distal apex, the bare stent is fixed at the distal apex to the proximal open end of the lumen graft component, and the apex capture component can releasably capture the proximal apex of the bare stent. Section 118 The delivery system according to paragraph 117, wherein the radial restraint comprises at least one combination of threads and wires and a flexible sheath extending around the stent graft, and the stent graft can be released from the restraint by pulling the wires from the threads or the flexible sheath from the stent graft. Section 119 A delivery system according to claim 118, wherein the radial restraint includes a combination of threads and wires, and the delivery system further includes at least one loop that is fixed to at least a portion of the support of the stent of the stent graft. Section 120 A delivery system according to item 119, further comprising a gasket at the proximal handle, wherein the gasket defines a large opening through which a guidewire catheter extends and a smaller opening through which the wire extends, thereby preventing fluid from passing through the proximal handle. Section 121 a) i. Distal grip, and ii. A handle body portion extending proximal to one end of the distal grip, the handle defining a conduit and defining a slot along part of the length of the distal grip and the handle body portion, the handle body portion defining a longitudinal axis, Includes, handle; b) An internal lead screw assembly within the handle body, the internal lead screw assembly being movable along the main axis of the conduit and including a threaded portion extending through a slot, the internal lead screw assembly defining an opening that is essentially coaxial with the longitudinal axis of the handle; c) A lead screw nut extends around the handle body and engages thread-wise with the threaded portion of the internal lead screw assembly; rotation of the lead screw nut adjacent to the distal grip causes movement of the internal lead screw assembly relative to the handle, where the lead screw nut is simultaneously slidable along the handle body while engaged with the internal lead screw assembly, thereby providing at least two mechanisms for causing movement of the internal lead screw relative to the handle; d) A support member fixed to the handle body and extending through the internal lead screw assembly, the support member is i. A support tube extending through the handle body, and ii. Lower tube extending around the circumference of the support tube Includes; e) A sliding body located around a support member and releasably fixed to an internal lead screw assembly, the sliding body including a hemostatic valve; f) Movement of the introducer sheath relative to the support member is caused by the relative movement of the introducer sheath, handle body, and lead screw assembly, which extend around a portion of the support member and distally from the sliding body and are fixed to the sliding body; f) A leg clasp fixed to a support tube and extending distally from the support tube, the leg clasp is i. Barrel-shaped portion fixed to the support pipe, ii. A spool portion extending distally from the barrel-shaped portion along the longitudinal axis, the spool portion having a diameter smaller than the diameter of the barrel-shaped portion, and iii. The edge portion at the end of the spool portion, the edge portion having a diameter greater than the diameter of the spool portion and smaller than the diameter of the barrel portion. Including; and g) Removable leg stop, the leg stop is, i. A leg stop body portion having a longitudinal axis and located in a slot in the handle body portion proximal to the internal lead screw assembly, and ii. A flexible spring extending radially from the longitudinal axis of the leg stop body, the spring extending at least partially around the handle body, the leg stop body being held in a position within the slot of the handle body, and the leg stop body being removable from the slot by spreading the flexible spring from around the handle body. including, A stent graft delivery system, including [specific component]. Section 122 a) An extension member that extends through the support member and has a proximal end near the handle body and a distal end near the leg clasp; b) Nose cone at the distal end of the extension member; c) Distal apical capture component; d) An external control tube extending radially around the extension member and within the support member, the external control tube including a proximal end near the handle and a distal end near the distal and distal top gripping portions of the leg clasp; and e) A proximal apex capturing portion fixed to the distal end of the external control tube and capable of engaging with the distal apex capturing component, the distal apex capturing component and the proximal apex capturing component defining at least one opening when they are in an interlocking relationship with each other, where the extension member and the external control tube are movable relative to each other. The stent graft delivery system described in paragraph 121, further comprising the above. Section 123 The stent graft delivery system according to paragraph 122, wherein the proximal apical capture portion includes a nose portion and at least one tooth extending distally from the nose portion, and the at least one tooth and the distal apical capture portion together define at least one opening. Section 124 The stent graft delivery system according to paragraph 123, wherein the distal apical capture portion defines at least one slot and includes at least one radially extending projection proximal to the slot, the at least one slot and at least one tooth align with at least one tooth, and the distal apical capture portion and the proximal apical capture portion are in an interlocking relationship. Section 125 A stent graft delivery system according to claim 124, further comprising a stent graft having a proximal and distal end, and comprising a luminal graft component and a plurality of stents distributed longitudinally between the proximal and distal ends, wherein the most distal stent of the stent graft is releasably captured between the barrel portion of a leg clasp and an introducer sheath, and the most proximal stent, the stent graft, is captured by the distal apex capture component and the proximal apex capture component when the distal apex capture component and the proximal apex capture component are in an interlocking relationship. Section 126 A stent graft delivery system according to claim 125, further comprising a clasping stent including struts defining a distal apex and a proximal apex, wherein the proximal apex is captured by the distal apex capturing portion and the proximal apex capturing portion when the distal apex capturing portion and the proximal apex capturing portion are in an interlocking relationship. Section 127 A stent graft delivery system according to claim 126, wherein the clasp stent is a bare stent, and the proximal apex of the bare stent is proximal to the proximal end of the graft lumen component of the stent graft, the stent graft delivery system further comprises a bridge-like portion and barbs extending distally to the bridge-like portion at each proximal apex of the bare stent. Section 128 The stent graft delivery system according to paragraph 127, wherein the distal apical trapping portion defines a hole, and the distal apical trapping portion and the proximal apical trapping portion are in an interlocking relationship, and a barb extending distally from the bridging portion at the proximal apex of the bare stent extends into the hole of the distal apical trapping portion. Section 129 A stent graft delivery system according to item 126, further comprising a crown stent between the most tightly crimped stent and the proximal end of the graft lumen component. Section 130 A stent graft delivery system according to paragraph 125, wherein the stent graft is bifurcated and the stent graft comprises two legs, one of which is trapped between a leg clasp and an introducer sheath. Section 131 Stent graft, i) Lumen graft components having a proximal open end and a distal open end, defining the lumen, ii) Multiple stents distributed longitudinally along the luminal graft components, at least one of the stents having struts connected to define the proximal and distal apex, iii) At least one loop fixed to at least one of the posts, iv) At least one cord extending through at least one loop, each cord crossing at least a portion of the support, and the cord having an end that, when connected, at least partially contracts the stent radially, and When the corresponding stents are connected to contract radially, a pair of anchor loops are attached to the ends of each associated cord with longitudinally extending lumen graft components. The delivery system includes, a) A wire extending longitudinally along the lumen graft components and through the anchor loop, with its ends connected, the wire thereby radially contracting at least one portion of the stent of the stent graft, and the stent graft being released from radial contraction by the pulling of the wire from the end of at least one of the wires, b) A guidewire catheter on which a stent graft is releasably secured, the guidewire catheter extending along its longitudinal axis and having a proximal and distal end, extending into the luminal graft component; c) Proximal handle to which the guidewire catheter is secured; d) A gasket at the proximal handle, the gasket defining a large opening through which the guidewire catheter and external control tube extend, and a small opening through which the wire extends, thereby preventing fluid from passing through the proximal handle. The stent graft delivery system described in paragraph 125, further comprising:

Claims

1. a) i. Distal grip, and ii. A handle body portion extending proximal to one end of the distal grip, wherein the handle body portion defines a conduit, defines a slot along a portion of the length of the distal grip and the handle body portion, and defines a longitudinal axis. A handle, including; b) An internal lead screw assembly within the handle body, the internal lead screw assembly including a threaded portion that is movable along the main axis of the conduit and extends through a slot, the internal lead screw assembly defining an opening that is essentially coaxial with the longitudinal axis of the handle; c) A lead screw nut extends around the handle body and engages thread-wise with the threaded portion of the internal lead screw assembly, where rotation of the lead screw nut adjacent to the distal grip causes movement of the internal lead screw assembly relative to the handle, and the lead screw nut is simultaneously slidable along the handle body while engaged with the internal lead screw assembly; d) A support member fixed to the handle body and extending through the internal lead screw assembly, wherein the support member is i. A support tube extending through the handle body, and ii. Lower tube extending around the circumference of the support tube including; e) A sliding body located around the support member and releasably fixed to an internal lead screw assembly, wherein the sliding body includes a hemostatic valve; f) An introducer sheath extending around a portion of the support member and distally from the sliding body, and fixed to the sliding body, wherein the relative movement of the handle body and lead screw assembly causes the introducer sheath to move relative to the support member; g) A leg clasp fixed to a support tube and extending distally from the support tube, wherein the leg clasp is i. Barrel-shaped portion fixed to the support pipe, ii. A spool portion extending distally from the barrel-shaped portion along the longitudinal axis, wherein the spool portion has a diameter smaller than the diameter of the barrel-shaped portion, and iii. The edge portion at the end of the spool portion, wherein the edge portion has a diameter greater than the diameter of the spool portion and less than the diameter of the barrel-shaped portion. Including; and h) Removable leg stop, where the leg stop is, i. A leg stop body portion having a longitudinal axis and located in a slot in the handle body portion proximal to the internal lead screw assembly, and ii. A flexible spring extending radially from the longitudinal axis of the leg stop body, wherein the spring extends at least partially around the handle body, the leg stop body is held in a position within the slot of the handle body, and the leg stop body is removable from the slot by spreading the flexible spring from around the handle body. including, A stent graft delivery system, including [specific component].

2. a) An extension member that extends through the support member and has a proximal end near the handle body and a distal end near the leg clasp; b) Nose cone at the distal end of the extension member; c) Distal apex capture component; d) An external control tube extending radially around the extension member and within the support member, the external control tube including a proximal end near the handle and a distal end near the distal and distal top gripping portions of the leg clasp; and e) A proximal apex capturing portion fixed to the distal end of the external control tube and capable of engaging with the distal apex capturing component, where the extension member and the external control tube are movable relative to each other. The stent graft delivery system according to claim 1, further comprising:

3. The stent graft delivery system according to claim 2, wherein the proximal apical capture portion includes a nose portion and at least one tooth extending distally from the nose portion.

4. The stent graft delivery system according to claim 3, wherein the distal apical capture portion defines at least one slot and includes at least one radially extending projection proximal to the slot, the at least one slot and the at least one projection align with at least one tooth, and the distal apical capture portion and the proximal apical capture portion are in an interlocking relationship.

5. A stent graft delivery system further comprising a stent graft having a proximal end and a distal end, comprising a luminal graft component and a plurality of stents distributed longitudinally between the proximal and distal ends, wherein the most distal stent of the stent graft is releasably captured between the barrel portion of a leg clasp and an introducer sheath, and the most proximal stent of the stent graft is captured by the distal apex capture component and the proximal apex capture component when the distal apex capture component and the proximal apex capture component are in an interlocking relationship, according to claim 4.

6. A stent graft delivery system further comprising a clasping stent including a support that defines a distal apex and a proximal apex, wherein the proximal apex is captured by the distal apex capturing portion and the proximal apex capturing portion when the distal apex capturing portion and the proximal apex capturing portion are in an interlocking relationship.

7. A stent graft delivery system according to claim 6, wherein the clasp stent is a bare stent, and the proximal apex of the bare stent is proximal to the proximal end of the graft lumen component of the stent graft, the stent graft delivery system further comprises a bridge-like portion and barbs extending distally from the bridge-like portion at each proximal apex of the bare stent.

8. The stent graft delivery system according to claim 7, wherein when the distal apical capturing portion defines a hole and the distal apical capturing portion and the proximal apical capturing portion are in an interlocking relationship, a barb extending distally from the bridge portion at the proximal apex of the bare stent extends into the hole of the distal apical capturing portion.

9. The stent graft delivery system according to claim 5, wherein the stent graft is bifurcated and comprises two legs, one of which is trapped between a leg clasp and an introducer sheath.

10. Stent graft, i) Lumen graft components having a proximal open end and a distal open end, defining the lumen, ii) Multiple stents distributed longitudinally along the luminal graft components, wherein at least one of the stents has a strut connected to define the proximal and distal apex, iii) At least one loop fixed to at least one of the posts, iv) at least one cord extending through at least one loop, where each cord crosses at least a portion of the support, and the cord includes an end that, when connected, at least partially contracts the stent radially, and A pair of anchor loops located longitudinally on the lumen graft component, at the ends of each associated cord, when the corresponding stent is connected to contract radially. The delivery system includes, a) A wire extending longitudinally along the lumen graft components and through the anchor loop, with its ends connected, wherein the wire thereby radially contracts at least one portion of the stent of the stent graft, and the stent graft is released from radial contraction by the pulling of the wire from the end of at least one of the wires. b) A guidewire catheter on which the stent graft is releasably secured, the guidewire catheter extending along its longitudinal axis and having a proximal and distal end, extending into the luminal graft component; c) Proximal handle to which the guidewire catheter is secured; d) A gasket at the proximal handle, which defines a large opening through which the guidewire catheter and external control tube extend, and a small opening through which the wire extends, thereby preventing fluid from passing through the proximal handle. The stent graft delivery system according to claim 5, further comprising:

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