Abdominal aortic aneurysms: systems and methods of use

A stent graft delivery system includes an internal lead screw assembly within a track of a handle. The internal lead screw assembly is moveable along a major axis of the handle by rotation of a lead screw nut that extends about the handle and is threadably engaged with the threaded portion of the internal lead screw assembly. The lead screw nut is also slidable along the handle while engaged with the internal lead screw assembly. A stent graft system includes a proximal stent adjacent to a bare stent of angled struts joined by proximal and distal apices, wherein the proximal stent is nested within the bare stent.

BACKGROUND OF THE INVENTION

Stent graft delivery systems have been designed to treat abdominal aortic aneurysm (AAA) to minimize the diameter or “French” size of the portion to be inserted into the patient. This usually results in severe compression of very large stents into small diameter tubes or catheters. The drastic inward compression results in high longitudinal forces for loading the stent graft—pushing the pre-compressed stent into the delivery system sheath—and in high deployment forces—occurring when the stent graft is unsheathed at the time of clinical deployment. Other factors cumulatively add to this deployment force including, for example, friction between components of the delivery system handle and the amount of tortuosity in which the sheath is navigated through the patient's vessels.

Deployment accuracy is a term referring to the ability of a physician to choose a target site for stent graft placement within the patient and the ability to “accurately” deliver the stent at the implantation site, the accuracy being measured with respect to both the longitudinal and rotational position of the stent graft. High deployment forces reduce a physician's ability to control deployment accuracy. Other factors can adversely affect deployment accuracy and present additional problems that the physician must address or for which the physician must compensate. These include quality of viewing equipment (fluoroscopy) and rapid blood flow. It would be desirable, therefore, to provide a system that increases stent graft deployment accuracy.

“Pin-and-pull” is a term that has been used in the art to describe many early types of stent/stent graft delivery systems. In pin-and-pull systems, there are two main components: an inner support catheter (e.g., a tube or a rod); and an outer sheath. The outer sheath longitudinally slides over the inner support catheter and can be freely rotated around the inner support catheter (i.e., rotation is independent of longitudinal outer sheath motion). To load a stent graft therein, the inner support catheter is drawn proximally (towards user) so that an interior chamber is created at the distal end of the outer sheath. The stent graft is compressed radially and inserted into this chamber so that the outer sheath houses the compressed stent graft inside its distal end. In this configuration, the inner support catheter prevents the stent graft from moving in a direction towards the physician (proximally) when the outer sheath is retracted. Deployment of the stent graft occurs naturally when the outer sheath is refracted because the individual stents of the stent graft have an outward bias towards their respective fully expanded state.

When the physician is using a pin-and-pull device, the stent graft is maneuvered to the deployment site using fluoroscopy, for example. At this point, the physician is prepared to release the stent graft. The stent graft is deployed in the vessel by “pinning” the inner support catheter relative to the patient and “pulling” back on the outer sheath—thus deriving from these actions the “pin-and-pull” nomenclature.

Because the outer sheath is compressing the stent graft, movement of the outer sheath towards the physician tends to draw the stent graft in this direction. Thus, without the inner support catheter, the stent graft will not be deployed. Minimizing the deployment force allows the sheath to retract with greater ease. It is, therefore, desirable to have the sheath retract as easily as possible.

With high deployment forces, the physician has less control over the placement accuracy. The highest deployment force occurs when the sheath first begins to retract. Once the user has overcome the initial friction between the sheath and the compressed stent, the force then needed for deployment plummets. This rapid decline is almost instantaneous and, often, the physician is not able to react quickly enough to lower the force being supplied to the delivery system. This failure to react results in deployment of more of the stent graft than intended by the physician or in a deployment that fails to hit the intended target site (i.e., low deployment accuracy).

Some mechanisms have been employed to add control to stent graft deployment and minimize this rapid release of stored energy within the delivery system. These mechanisms include screw-type refraction of the stent sheath and/or incorporation of “stops” which prevent inadvertent release of the stent. The screw-type mechanisms slow down the release of the stored energy and help maintain better control of stent release. These screw-type mechanisms also can impart a mechanical advantage by converting the linear force to a torque force. Stop-type mechanisms do not affect conversion or lowering of the deployment force, but help by preventing any over-compensation of the force and any instantaneous release of the force. Neither of these, however, significantly increase deployment accuracy and an improvement in performance would be desirable.

Modular disassociation creates serious type III endoleaks, which can have significant clinical consequences. Creating a mechanical interaction, the modular pull out force will exceed clinical requirements. This type of securement significantly reduces the likelihood of this event. Also, this system does not require rotational alignment between the receiving and inserting components. This makes the mechanism substantially invisible to the doctor and does not add any complexity to the procedure. Further, the system prevents adverse complications during the procedure. By using a proximally facing fold in the graft, there is virtually no chance of accidental ensnarement of a guide wire during the procedure. (If loops or holes were placed in the first member, then a guidewire could potentially get caught without the physician being aware of that ensnarement.) Moreover, the folds in the graft create extra layers of material. Thus, if a securing component were to wear through some of the graft, there multiple layers of the graft will remain to prevent an endoleak. This includes the layer of graft on the inserting member. It is unlikely that wearing of the graft to create an endoleak would occur in both the catheter and catheter direction through three to four layers of material. Significantly, by having multiple engaging members of the second (inserting) stent graft, there is redundancy in the vessel repair system. Therefore, even if some members miss the pockets or even if some members fracture, the overall integrity of the system will still be intact. Further redundancy in the vessel repair system is present by providing multiple sets of folds in the first component. These folds can be at the very end of the stent graft as well as multiple folds moving up the length of the stent graft. This configuration and variants thereof can cover any leg prosthesis stent graft.

Thus, there is a need to develop new, useful and effective delivery systems, components and methods to treat AAA.

SUMMARY OF THE INVENTION

The present invention relates to delivery systems, components of delivery systems and methods of using the delivery systems and its components to treat vascular damage, in particular AAA.

In an embodiment, the invention is an apex capture device, comprising a proximal apex capture portion that includes a nose, wherein the nose defines at least one radial restraint that is substantially parallel to a major axis of the proximal capture portion, and a plurality of tines extending distally from the nose, the tines radially distributed about the major axis radial to a most proximal radial restraint and substantially parallel to the major axis; a distal apex capture portion defining slots distributed radially about the major axis, the slots mateable with the tines by relative movement of the proximal and distal apex capture portions along the major axis; a plurality of bosses extending radially from the major axis between the nose and the distal apex capture portion and aligned with the slots along the major axis in non-interfering relation with movement of the tines into mating relation with the slots; an elongate member to which the distal apex capture portion is fixed, the elongate member extending through the proximal apex capture portion and the plurality of bosses; and a catheter to which the proximal apex capture portion is fixed, through which the elongate member extends, whereby movement of the catheter causes movement of the proximal apex capture portion along the major axis between a first position, in which the tines are mated with the slots and overlie the bosses, and a second position, in which the tines are not mated with the slots and do not overlie the bosses.

In another embodiment, the invention is a method of releasing a bare stent of a stent graft, comprising the steps of moving a catheter to which a proximal apex capture portion of an apex capture device is fixed, the proximal apex capture portion defining a radial restraint, along a major axis between a first position, in which tines of the proximal apex capture portion are mated with slots of a distal apex capture portion and overlie bosses extending radially from a major axis of the apex capture device, and a second position, in which the tines are not mated with the slots and do not overlie the bosses, thereby releasing apices of a bare stent from a space defined by the tines, the bosses and the distal apex capture portion.

In a further embodiment, the invention is an apex capture device assembly, comprising a proximal apex capture portion that includes a nose, wherein the nose defines at least one radial restraint that is substantially parallel to a major axis of the proximal capture portion, and a plurality of tines extending distally from the nose, the tines radially distributed about the major axis radial to a most proximal radial restraint and substantially parallel to the major axis; a distal apex capture portion defining slots distributed radially about the major axis, the slots mateable with the tines by relative movement of the proximal and distal apex capture portions along the major axis; a plurality of bosses extending radially from the major axis between the nose and the distal apex capture portion and aligned with the slots along the major axis in non-interfering relation with movement of the times into mating relation with the slots; an elongate member to which the distal apex capture portion is fixed, the elongate member extending through the proximal apex capture portion and the plurality of bosses; a catheter to which the proximal apex capture portion is fixed, through which the elongate member extends, whereby movement of the catheter causes movement of the proximal apex portion along the major axis between a first position, in which the tines are mated with the slots and overlie the bosses, and a second position, in which the tines are not mated with the slots and do not overlie the bosses; a bare stent that includes struts linked by apices, the struts extending between the tines, a portion of the apices extending between the bosses and the distal apex capture portion when the times are mated to the slots; and at least one suprarenal barb extending from the stent into the radial restraint.

In yet another embodiment, the invention is a stent graft system, comprising a luminal graft component; a bare stent component including a plurality of struts joined by proximal and distal apices connecting the struts, the bare stent component fixed to a proximal end of the luminal graft component and extending proximally from the proximal end; an infrarenal stent component proximate to the bare stent component, wherein the infrarenal stent component is distal to the bare stent component and spans a circumferential line defined by apices of the bare stent component fixed to the luminal graft component; at least one suprarenal barb extending distally from at least one suprarenal portion of the bare stent component; and at least one infrarenal barb extending distally from at least one infrarenal portion of the bare stent.

In another embodiment, the invention is a stent graft delivery system, comprising a handle that includes a distal grip, and a handle body extending from one end of the distal grip, the handle defining a conduit and a track along a portion of the length of the distal grip and the handle body; an internal lead screw assembly within the track, the internal lead screw assembly being moveable along a major axis of the conduit, and including a threaded portion that extends through the track; a lead screw nut that extends about the handle body and threadably engaged with the threaded portion of the internal lead screw assembly, whereby rotation of the lead screw nut while abutting the distal grip causes movement of the internal lead screw assembly relative to the handle and wherein the lead screw nut simultaneously is 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 assembly relative to the handle.

An additional embodiment of the invention is a slider for a stent graft delivery system, the slider comprising a slider body defining a central orifice through which a support member extends and a flush valve orifice extending substantially normal to the central orifice, the slider body being detachably fixable to an internal lead screw assembly; a slider cap coupled to a proximal end of the slider body, the slider cap defining a central orifice that is substantially aligned with the central orifice of the slider body and through which the support member extends; a sheath extending from a distal end of the slider cap, the sheath defining a catheter that is substantially aligned with the central opening of the slider body and through which the support member extends and a valve at the central orifice that provides hemostasis to the sheath. Optionally, the slide can include a wiper valve at the central opening of the slider body proximal to the flush valve orifice, the wiper valve forming a seal about the support member; an x-valve at the central opening of the slider body proximal to the wiper valve, the x-valve forming a seal about a catheter upon withdrawal of the support member from the slider body; and a sheath valve at the central opening of the slider body and proximal to the x-valve, the sheath valve being operable by activation of the slider cap to seal the central opening.

In yet another embodiment, the invention is a stent graft system, comprising a first stent graft that includes a first luminal graft component, a plurality of outside stents extending along and fixed to an outside surface of the first luminal graft component, and an inside stent between two outside stents, one of which is at a distal end of the first luminal graft component, the inside stent fixed to an inside surface of the first luminal graft component, and having a plurality of barbs pointed generally proximally within the first luminal graft component; and a second stent graft that includes a second luminal graft component and a plurality of outside stents extending along and fixed to an outside surface of the first luminal graft component, whereby insertion of the second stent graft into the distal end of the first luminal graft component to overlap at least two stents of each of the first and second stent grafts will cause interfering relation between at least a portion of the barbs with a stent or the second luminal graft component of the second stent graft.

Another embodiment of the invention is a stent graft system, comprising a luminal graft component; a bare stent extending from a proximal end of the luminal graft component; at least one proximal barb extending distally from a proximal end of the bare stent; and at least one distal barb extending distally from a distal end of the bare stent, the distance between the proximal and distal barbs along a major axis of the luminal graft component being in a range of between about 6 mm and about 40 mm.

An additional embodiment of the invention is a leg clasp, comprising a barrel; a spool extending from the barrel along a major axis of the barrel; and a rim at an end of the spool, the rim having a diameter greater than that of the spool but less than that of the barrel.

In yet another embodiment, the invention is a stent graft delivery system, comprising a leg clasp that includes a barrel, a spool extending from the barrel along a major axis of the barrel, and a rim at an end of the spool, the rim having a diameter greater than that of the spool but less than that of the barrel; a support tube fixed to the barrel and extending from the barrel in a direction opposite that of the spool; and a sheath having an internal diameter greater than that of the barrel and slideably moveable between a first position that covers the spool and rim and a second position that exposes the spool and rim.

A further embodiment of the invention is a stent graft system, comprising a luminal graft component; a bare stent of angled struts joined by proximal and distal apices, and extending from a proximal end of the luminal graft component; a proximal stent adjacent the bare stent and within the luminal graft, the proximal stent including angled struts joined by apices; and at least one barb extending distally from a distal apex and through the luminal graft component.

In still another embodiment, the invention is a telescoping stent graft system, comprising a bifurcated first stent graft that includes a bifurcated first luminal graft component, a plurality of stents extending along and fixed to a surface of one of two legs of the bifurcated first luminal graft component; a second stent graft that includes a second luminal graft component and a plurality of stents extending along and fixed to a surface of the first luminal graft component, whereby the second stent graft can be inserted into the distal end of a first of two leg components of the bifurcated first luminal graft component to overlap at least two stents of each of the first and second stent grafts; a plurality of stents extending along and fixed to a surface of a second leg of the bifurcated first luminal stent graft, wherein the first leg is shorter than the second leg, and wherein the first leg includes at least one more stent than is required for overlap of at least two stents of the second stent graft.

In yet another embodiment, the invention is a method for treating an abdominal aortic aneurysm, comprising steps of directing a sheath and distal tip of a delivery system to an abdominal aortic aneurysm of a patient through an artery of the patient, the sheath containing a bifurcated stent graft; rotating a lead screw nut of the delivery system that is threadably linked to the sheath to thereby retract the sheath at least partially from the bifurcated stent graft; and sliding the lead screw nut along a handle body of the delivery device while the lead screw nut is threadably linked to the sheath to thereby further retract the sheath, whereby the bifurcated stent graft is at least partially deployed in the abdominal aortic aneurysm, thereby treating the abdominal aortic aneurysm.

In still another embodiment, the invention is a stent graft delivery device, comprising, an apex capture device assembly that includes a proximal apex capture portion that includes a nose, wherein the nose defines at least one radial restraint that is substantially parallel to a major axis of the proximal capture portion and a plurality of tines extending distally from the nose, the tines radially distributed about the major axis radial to a most proximal radial restraint and substantially parallel to the major axis, a distal apex capture portion defining slots distributed radially about the major axis, the slots mateable with the times by relative movement of the proximal and distal apex capture portions along the major axis, a plurality of bosses extending radially from the major axis between the nose and the distal apex capture portion and aligned with the slots along the major axis in non-interfering relation with movement of the tines into mating relation with the slots, an elongate member to which the distal apex capture portion is fixed, the elongate member extending through the proximal apex capture portion and the plurality of bosses, a catheter to which the proximal apex capture portion is fixed, through which the elongate member extends, whereby movement of the catheter causes movement of the proximal apex portion along the major axis between a first position, in which the tines are mated with the slots and overlie the bosses, and a second position, in which the tines are not mated with the slots and do not overlie the bosses, a bare stent that includes struts linked by apices, the struts extending between the tines, a portion of the apices extending between the bosses and the distal apex capture portion when the tines are mated to the slots and at least one suprarenal barb extending from the stent into the radial restraint; and a leg clasp through which the elongate member and catheter extend, the leg clasp including, a barrel, a spool extending from the barrel along a major axis of the barrel, and a rim at an end of the spool, the rim having a diameter greater than that of the spool but less than that of the barrel.

An additional embodiment of the invention is an x-valve assembly, comprising an x-valve and a gasket supporting the x-valve.

The delivery systems, components of delivery systems and methods of the invention can be employed to treat aortic aneurysms, such as abdominal aortic aneurysms. Advantages of the claimed delivery systems, components of delivery devices and methods of the invention include, for example, the following.

Benefits achieved by the invention are represented, for example, byFIGS. 1 to 15, specificallyFIGS. 15A, 15B, and 15C. Current pin-and-pull systems have an undesired force to the inner stabilizing member during deployment because there is a tendency to flex where gripped thereon (seeFIGS. 15A and 15B). This flexing caused misalignment of the sheath hub and the inner stabilizing member, which, in turn, required the physician to increase deployment forces for retracting the outer sheath, thus, correspondingly increasing the force against the inner stabilizing member (a damaging cycle). The telescopic systems of the invention, in contrast, offer protection of the inner stabilizing member because the force is not directly applied to the inner stabilizing member. The two-rigid-tube telescopic system of the invention incorporates two hard surfaces that retract on one another over the inner stabilizing member and, thereby, reduce any chance of buckling of the inner stabilizing member. During the retraction process, the force is transmitted uniformly over the inner stabilizing member.

By creating a mechanical interaction, the modular pull out force can exceed clinical requirements. Modular disassociation creates serious type III endoleaks, which can have significant clinical consequences. This type of securement significantly reduces the likelihood of this event. Also, this system does not require rotational alignment between the receiving and inserting components. This makes the mechanism substantially invisible to the doctor and does not add any complexity to the procedure. Further, the system prevents adverse complications during the procedure. By using a proximally facing fold in the graft, there is virtually no chance of accidental ensnarement of a guide wire during the procedure. If loops or holes were placed in the first member, then a guidewire could potentially get caught without the physician being aware of that ensnarement.

Moreover, the folds in the graft create extra layers of material. Therefore, even if a securing component were to wear through some of the graft, there still will be multiple layers of the graft left to prevent an endoleak. This includes the layer of graft on the inserting member. It is very unlikely that wearing of the graft to create an endoleak would occur in both the catheter and albumen direction through three to four layers of material. Significantly, by having multiple engaging members of the second (inserting) stent graft, there is redundancy in the vessel repair system. Therefore, even if some members miss the pockets or even if some members fracture, the overall integrity of the system will still be intact. Further redundancy in the vessel repair system is present by providing multiple sets of folds in the first component. These folds can be at the very end of the stent graft as well as multiple folds moving up the length of the stent graft. This configuration and variants thereof can cover any leg prosthesis stent graft.

In addition, barbs located at suprarenal and infrarenal positions, may provide positive fixation and the leg clasp of the invention may provide for accurate control of the graft systems during cannulation and placement of the graft system in the vasculature.

Thus, the delivery systems, components of delivery systems and methods of the invention can be used to treat AAA and, therefore, avoid complications and death consequent to life threatening vascular conditions.

DETAILED DESCRIPTION OF THE INVENTION

The features and other details of the invention, either as steps of the invention or as combinations of parts of the invention, will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principle features of this invention can be employed in various embodiments without departing from the scope of the invention.

In an embodiment, represented byFIGS. 1 through 57, as an example, the invention is a stent graft delivery system5500, comprising a handle that includes distal grip5530and handle body5540extending from one end of distal grip5530, the handle defining conduit and track5542along a portion of the length of distal grip5530and handle body5540; an internal lead screw assembly5510within the conduit, the internal lead screw assembly5510being moveable along a major axis of the conduit, and including a threaded portion5512that extends through the track5542; a lead screw nut5520that extends about the handle body5540and threadably engaged with the threaded portion5512of the internal lead screw assembly5510, whereby rotation of the lead screw nut5520while abutting the distal grip5530causes movement of the internal lead screw assembly5510relative to the handle and wherein the lead screw nut5520simultaneously is slidable along the handle body5540while engaged with the internal lead screw assembly5510, thereby providing at least two mechanisms for causing movement of the internal lead screw assembly5510relative to the handle.

Referring toFIG. 57A, the stent graft delivery system can further include a support member5740fixed to the handle body, and an outer sheath5550extending about a portion of the support member5740and fixed, either directly or through slider5700, to the internal lead screw assembly5510, whereby relative movement of the handle body5540and the internal lead screw assembly5510causes relative movement of the support member5740and the outer sheath5550.

The internal lead screw assembly5510of the stent graft delivery system5500of the invention can define an opening essentially coaxial with the handle, wherein the support member extends through the internal lead screw assembly, as shown inFIG. 55A.

As can be seen in the inset ofFIG. 57A, support member5740includes a hypo-tube5742and a support tube5744within the hypo-tube5742. Hypo-tube5742typically is formed of stainless steel, while support tube5744typically is formed of nylon, such as VESTAMID®. Hypo-tube5742is fixed to the handle body, such as at proximal end cap5544, as shown inFIG. 56(also shown as proximal end cap3350inFIG. 33). Also shown in the inset toFIG. 57A, but not part of support member5740, are elongate member8614, which is connected to distal apex capture portion8610, and catheter8613, which is connected to proximal apex capture portion8600a, all of which are shown inFIG. 86D.

The stent graft delivery system of the invention can further include a slider5700. The slider5700of the stent graft delivery system comprises a slider body5720defining a central orifice through which the support member5740extends and a flush valve orifice5712extending substantially normal to the central orifice, the slider body5720being detachably fixable to the internal lead screw assembly5510(FIG. 55Aby suitable means, such as, for example, release pin6210, which extends through internal lead screw assembly into slider, as shown inFIGS. 62 and 63); a slider cap5710coupled to a distal end of the slider body5720, the slider cap5710defining a central orifice that is substantially aligned with the central orifice of the slider body5720and through which the support member5740extends; a sheath valve knob5790threadably coupled to slider body5720, an outer sheath5550extending from a distal end of the slider cap5710, the outer sheath5550defining a catheter that is substantially aligned with the central opening of the slider body5720and through which the support member5740extends; a wiper valve5750at the central opening of the slider body proximal to the flush valve orifice5712, the wiper valve5750forming a seal about the support member; an x-valve assembly5760at the central opening of the slider body proximal to the wiper valve5750, the x-valve assembly5760forming a seal about a guidewire within support tube5744upon withdrawal of the support member from the slider body5720; and a sheath valve5770at the central opening of the slider body5720and proximal to the x-valve assembly5760, the sheath valve5770being operable by activation of sheath valve knob5790to seal the central opening.

In an embodiment, the x-valve assembly5760includes a nitinol gasket as shown inFIGS. 57B through 57F.

“Proximal” means, when reference is made to a delivery system or a component of a delivery system, such as an apex capture device, a slider for a stent graft delivery system or a leg clasp, closest to the clinician using device. Likewise, “distal” means, when reference is made to a delivery system or a component of a delivery system, such as an apex capture device, a slider for a stent graft delivery system or a leg clasp, away from the clinician using the device.

When reference is made to a “stent” or a “stent graft system,” “proximal” means that end of the stent or stent graft system that is towards the head of the patient and “distal” means that end of the stent or stent graft system that is away from the head of the patient.

In another embodiment, the invention is a slider5700for a stent graft delivery system, the slider5700comprising a slider body5720defining a central orifice through which a support member5740extends and a flush valve orifice5712extending substantially normal to the central orifice, the slider body5720being detachably fixable to an internal lead screw assembly5510(FIGS. 55 and 56); a slider cap5710(FIG. 57A) coupled to a distal end of the slider body, the slider cap5710defining a central orifice that is substantially aligned with the central orifice of the slider body5720and through which the support member extends; a sheath valve knob5790threadably coupled to slider body5720, an outer sheath5550extending from a distal end of the slider cap5710, the outer sheath5550defining a lumen that is substantially aligned with the central opening of the slider body5720and through which the support member5740extends; a wiper valve5750at the central opening of the slider body5720proximal to the flush valve orifice5712, the wiper valve5750forming a seal about the support member5740; an x-valve assembly5760at the central opening of the slider body5720proximal to the wiper valve5750, the x-valve assembly5760forming a seal about a guidewire within support tube5744upon withdrawal of the support member5740from the slider body5720; and a sheath valve5770at the central opening of the slider body5720and proximal to the x-valve assembly5760, the sheath valve5770being operable by activation of the sheath valve knob5790to seal the central opening.

FIGS. 61-64Bare embodiments of a delivery system of the invention.

Referring now toFIGS. 1 to 3, an exemplary embodiment of an improved pin-and-pull delivery system100according to the present invention is shown. The pin-and-pull delivery system100provides an inner catheter110that is slidably disposed within an outer sheath control catheter120. This configuration of the catheter110,120can also be referred to as a telescopic assembly. The outer sheath control catheter120is longitudinally and rotationally fixed to a sheath130that is used to house the non-illustrated stent graft.

In an exemplary embodiment, the outer sheath control catheter120is an aluminum tube attached to a sheath hub140, which is attached to the sheath130. The inner catheter110is polycarbonate tube having a longitudinally cut slot310(e.g., seeFIG. 3). The inner catheter110is longitudinally and rotationally fixed to a pushrod150(e.g., a stainless steel hypo-tube). By attaching the outer sheath control catheter120to the sheath hub140, the inner catheter110can be retracted into the outer sheath control catheter120and will maintain rotational alignment of the catheters110,120by the presence of a setscrew320engaged in the slot310. The groove and set-screw configuration will prevent the sheath130from rotating when the stent graft is deployed, which movement undesirably twists the prosthesis from a desired implantation position. This device is beneficial when used with a detachable sheath because the hemostasis160, over the push rod150, is in front of the catheters110,120.

FIGS. 4 to 6illustrate how the delivery system ofFIGS. 1 to 3can be used to implant a bifurcated stent graft. When the compressed bifurcated stent graft410is positioned at a target site, the delivery system is pinned with respect to the patient. The outer sheath control catheter120is drawn proximally from the position shown inFIG. 4to the position shown inFIG. 5. With the outer sheath control catheter120in the fully retracted position (FIG. 5), the stent graft410is almost completely deployed in the patient's vessel. The only remaining control of the stent graft410is the releasable grasping of bare stent apices412by the apex capture device510of the delivery system. Control of the apex capture device510occurs from the proximal-most end of the pushrod150. One exemplary embodiment of the apex capture device510and its control assembly is disclosed in the family of applications beginning with U.S. Provisional Patent Application Ser. No. 60/499,652, filed Sep. 3, 2003, and U.S. patent application Ser. No. 10/784,462, filed Feb. 23, 2004, which applications and the entire family thereof is hereby incorporated by reference herein in its entirety. In such an embodiment, a non-illustrated control rod internal to the pushrod150is moved relative (arrow A inFIG. 6) to the pushrod150to separate the tines grasping one or more of the exposed bare stent apices412from control surfaces. This movement creates a gap therebetween to free the bare stent apices412from their controlled capture.

An alternative embodiment to that illustrated inFIGS. 5 and 6is shown inFIGS. 7 to 9. This delivery system700improves the control and accuracy of deployment of the stent graft by adding mechanical advantage to the retraction of the introducer outer sheath. Mechanical advantage allows for a “smooth” retraction of the outer sheath by not allowing the build up of potential energy, stored in the compressed stent graft, to cause an unexpected jumping or jerking motion during outer sheath retraction. More specifically, the delivery system700has two interconnecting parts: a hollow outer sheath handle710and an inner screw handle720. The proximal end of the outer sheath handle710has an interior cavity for receiving therein the distal end of the inner screw handle720.

One exemplary embodiment for connecting the outer sheath handle710to the inner screw handle720is illustrated inFIGS. 10 and 11. A thread engagement portion712of the outer sheath handle710has two opposing threaded engagement devices714,716longitudinally offset from one another as illustrated inFIG. 10. One of the threaded engagement devices714can be, for example, a ball screw, and the other threaded engagement device716can be a set screw. The inner surface of the hollow outer sheath handle710is smooth in this particular embodiment. Engagement of the outer sheath handle710to the threads726of the inner screw handle720is made by having the threaded engagement devices714,716ride in the threads of the inner screw handle720. Thus, turning of the inner screw handle720causes the outer sheath handle710to retract over or extend from the distal end of the inner screw handle720in a controlled fashion. Turning can be assisted with a proximal turn knob722rotationally fixed to the inner screw handle720.

Threads726extends for a longitudinal length that is greater than the amount that is necessary to overcome the greatest force required for stent graft deployment. Once that greatest point of force is overcome, the chance of handle jerk or slippage decreases and, therefore, the two handle portions710,720can be moved longitudinally freely with respect to one another. To achieve the transition from longitudinal controlled and slow movement to longitudinal free movement (and speedy if desired), at the proximal end of the threads of the inner screw handle720, screw channels724can be cut into the handle body to allow the threaded engagement device716to fall into one of the screw channels724and the threaded engagement device714to fall into the other channel (not illustrated) on the opposite side of the inner screw handle720. A threaded engagement device714can be, for example, a ball screw, which would be desirable in this configuration because it can be used to center the threads against the relatively harder threaded engagement device716, such as a set screw. Changing the force the threaded engagement devices714,716impart against the threads can be accomplished by adjusting the tension on a ball of the ball set screw or by decreasing the depth of a set screw into the handle710.

Functioning of the delivery system700is illustrated, for example, in the diagrams ofFIGS. 12, 13, 14, 15A, 15B, 15C and 15D. Before the inner screw handle720is turned to retract the outer sheath handle710, the outer sheath catheter1210completely covers the stent graft1220, which is loaded therein just behind (proximal of) the nose cone1230. The turn knob722is rotated to move the outer sheath handle710proximally and begin to deploy the stent graft1220from the outer sheath catheter1210. The user holds the inner screw handle720longitudinally stationary while turning so that the outer sheath catheter1210moves proximally. This step is shown inFIG. 13. Once the threads726(FIG. 12) are completely disengaged from the thread engagement portion712of the outer sheath handle710, the outer sheath handle710will rotationally lock into the screw channels724while still being longitudinally free to move with respect to the inner screw handle720. At this point, the bare stent1310and the first sealing stent1320are exposed. After channel lock occurs, the proximal end of the stent graft1220is exposed from the outer sheath catheter1210as shown inFIG. 13. With the opposing threaded engagement devices714,716(FIG. 11) locked into the screw channels724(FIG. 12), the outer sheath handle710can no longer rotate with respect to the inner screw handle720and, now, can be moved proximally as desired by the user. Accordingly, the outer sheath catheter1210can be retracted so that the entire body of the stent graft1220is exposed as shown inFIG. 14. At this point, the outer sheath handle720is positioned over the inner screw handle710and up to the turn knob722and the stent graft1220is only held to the delivery system700by the apex clasp device1410. With release of the apex clasp device1410, the stent graft1220is released from the delivery system700and, thereafter, the delivery system700can be removed from the patient without impacting the implantation of the stent graft1220.

The delivery system700ofFIGS. 12, 13, 14, 15A, 15B, 15C and 15Dcan be loaded with a 28 mm×150 mm graft into a 19.5 French OD braided introducer sheath, for example. In this configuration, the delivery system can deploy the bifurcated stent graft1220utilizing the mechanical advantage applied by the screw mechanism to release the first section of the graft (bare stent1310and first sealing stent1320). The remainder of the stent graft can, then, be deployed by the pin-and-pull assembly of the device after the threads726are disengaged. This configuration eliminates any requirement to have the physician actively disengage the threads.

Benefits achieved by the telescopic configurations shown inFIGS. 1 to 15are illustrated with regard toFIGS. 15A, 15B, 15C and 15D. The pin-and-pull systems of the prior art experienced an undesired force to the inner stabilizing member during deployment because there is a tendency to flex where gripped thereon (FIGS. 15A, 15B, 15C and 15D). This flexing caused misalignment of the sheath hub and the inner stabilizing member, which, in turn, required the physician to increase deployment forces for retracting the outer sheath, thus, correspondingly increasing the force against the inner stabilizing member (a damaging cycle).

An alternative to the two-part controlled deployment ofFIGS. 7, 8, 9, 10, 11, 12, 13, 14, 15A, 15B, 15C and 15Dfor connecting the outer sheath handle710to the inner screw handle720is illustrated inFIGS. 16 to 23. These figures illustrate a delivery system1600that aids in the controlled, accurate deployment of a stent graft. This configuration adds mechanical advantage to the retraction of the introducer sheath, which allows for a “smooth” retraction of the outer sheath by not permitting the build up of potential energy, stored in the compressed stent graft, to cause an unexpected jumping or jerking motion during outer sheath retraction.

A distal engagement portion1612of the outer sheath handle1610has an internally threaded bore for receiving therein a threaded portion1622of the inner screw handle1620. In an exemplary embodiment, the distal engagement portion1612is made of DELRIN®. Engagement of the outer sheath handle1610to the inner screw handle720(FIG. 7) is made by turning the outer sheath handle1610with respect to the inner screw handle1620. This causes the outer sheath handle1610to retract over or extend from the distal end of the inner screw handle1620in a controlled fashion. Turning can be assisted with a proximal turn knob1624rotationally fixed to the inner screw handle1620.

The threaded portion1622extends for a longitudinal length that is greater than the amount that is necessary to overcome greatest force required for stent graft deployment. Once that greatest point of force is overcome, the chance of handle jerk or slippage decreases and, therefore, the two handle portions1610,1620can be moved longitudinally freely with respect to one another. To achieve the transition from longitudinal controlled and slow movement to longitudinal free movement (and speedy if desired), at the proximal end of the threads of the inner screw handle1620, a channel1626(or more channels, e.g., two opposing channels) can be cut into the inner screw handle1620. A non-illustrated set screw is located at the distal engagement portion1612to protrude into the interior and engage the threaded portion1622. When the two handle portions1610,1620are rotated sufficiently far to move the interiorly projecting set screw proximal of the threaded portion1622, the set screw will ride directly into the channel1626(or the set screws directly into the channels1626). A set screw is desirable in this configuration because it can be used to increase and decrease tension for rotating the two handle portions1610,1620with respect to one another. Changing the force imparted against the threaded portion1622can be accomplished by decreasing/increasing the depth of the set screw into the distal engagement portion1612.

Functioning of the delivery system1600is illustrated, for example, in the diagrams ofFIGS. 20 to 23. Before the inner screw handle1620is turned to retract the outer sheath handle1610, the outer sheath catheter2010completely covers the stent graft2020, which is loaded therein just behind (proximal of) the nose cone2030. The turn knob1624is rotated to move the outer sheath handle1610proximally and begin to deploy the stent graft2020from the outer sheath catheter2010. The user holds the inner screw handle1620longitudinally stationary while turning so that the outer sheath catheter2010moves proximally. An embodiment of the step is shown inFIG. 21. Once the channels1626are completely disengaged from distal engagement portion1612of the outer sheath handle1610, the outer sheath handle1610will rotationally lock into the channel(s)1626while still being longitudinally free to move with respect to the inner screw handle1620. At this point, the bare stent2110and the first sealing stent2120are exposed. After channel lock occurs, the proximal end of the stent graft2020is exposed from the outer sheath catheter2010as shown inFIG. 21. With the set screw(s) locked into the channel(s)1624, the outer sheath handle1610can no longer rotate with respect to the inner screw handle1620and, now, can be moved proximally as desired by the user. Accordingly, the outer sheath catheter2010can be refracted so that the entire body of the stent graft2020is exposed as shown inFIG. 22. At this point, the outer sheath handle1610is positioned over the inner screw handle1620and up to the turn knob1624and the stent graft2020is only held to the delivery system1600by the apex clasp device2210. With release of the apex clasp device2210, the stent graft2020is freed from the delivery system1600and, thereafter, the delivery system1600can be removed from the patient without impacting the implantation of the stent graft2020.

The delivery system1600ofFIGS. 16 to 23can be loaded with a 28 mm×150 mm graft into a 19.5 French OD braided introducer sheath, for example. In this configuration, the delivery system1600can deploy the bifurcated stent graft2020utilizing the mechanical advantage applied by the screw mechanism to release the first section of the graft (bare stent2110and sealing stent2120). The remainder of the stent graft2020can, then, be deployed by the pin-and-pull assembly of the device after the channels1626are disengaged. This configuration eliminates any requirement to have the physician actively disengage the threads.

A further alternative to the two- or multi-part controlled deployment ofFIGS. 7 through 23is illustrated inFIGS. 24 through 32. In general, these figures describe a “jogged slot” handle that aids in the controlled, accurate deployment of a stent graft. As set forth above, handles to be used on the delivery system of an AAA device need to gain better control over placement accuracy and/or to better fixate the AAA graft during graft placement. The present invention provides a “jogged slot” (which can be configured in a similar manner as an automatic transmission shifter slot (i.e., stair steps)) to improve placement accuracy. The “jogged slot” in this example utilizes stent graft delivery system features described in the family of applications beginning with U.S. Provisional Patent Application Ser. No. 60/499,652, filed Sep. 3, 2003, and U.S. patent application Ser. No. 10/784,462, filed Feb. 23, 2004, incorporated herein and including a slotted aluminum handle body, a distal handle grip, a proximal handle grip and the proximal clasp assembly. The invention, however, is not limited to this particular embodiment. If desired, the actuation knob can be replaced with an end cap that serves to fixate the internal hypotube.

As shown inFIGS. 24 and 25, the internal mechanism of the delivery system2400includes an internal tube2500with a jogged slot2510in which the slider assembly2600(FIG. 26) can slide from the distal portion of the delivery system2400(shown inFIG. 24) to the proximal portion of the delivery system2400during stent graft deployment. During deployment of the stent graft, the delivery system2400with the jogged slot2510only permits the handle parts to move to a particular extent that is less than the total movement required for complete deployment of the stent graft. The jog2512or “Z” in the slot2510has a circumferential or transverse portion2514preventing the proximal handle grip2410from moving all the way back to the end cap2420without first having to be rotated circumferentially/transversely around the jog2512.FIGS. 26 and 27show that the slider assembly2600can be, in an exemplary embodiment, a cylindrical hub with a barbed fitting at its distal end to receive the outer stent sheath2610. At the proximal end of the slider assembly2600is an o-ring through which the support member hypotube passes. The slider assembly2600serves as both an attachment point for the outer stent sheath2610to the handle and as a hemostasis port for flushing of the sheath catheter. Exiting from the side of the slider assembly2600is a “boss”2700that extends outward, through the slot2442in the handle body2440, and attaches to the proximal handle grip2410. The flush port runs through this boss2700and attaches to the flush port tubing and valve2710.

FIGS. 28 to 30illustrate the attachment of the slider assembly2600to the proximal handle grip2410, which attachment allows actuation of the delivery system2400and deployment of the stent graft from the outer stent sheath2610. The outer stent sheath2610, which is attached to the slider assembly2600, is retracted in a proximal sliding motion (indicated by arrows A inFIG. 28) over the stent graft. More specifically, in this exemplary embodiment, the distal handle2430is held stationary while the proximal handle grip2410is moved back (proximally) to deploy the stent graft. The internal support member that is located coaxially within the outer stent sheath2610(seeFIGS. 29 and 30) serves as a platform or anchor to prevent the stent graft from retracting along with the outer stent sheath2610.

Significantly, the internal tube2500of the delivery system2400provides advantages to permit controlled deployment (unsheathing) of the stent graft. The internal tube2500in this exemplary embodiment is made from polycarbonate material and is sized so that it can move freely within the slotted aluminum handle body2440. The slider assembly2600is sized so that it can move freely within the internal tube2500. The internal tube2500has a straight tube running the full length of the delivery system2400. Machined through the wall of the internal tube2500is the slot2510which is “jogged” in the manner of an automobile transmission shifter. As such, the circumferential or transverse portion2514of the jogged slot2510provides a so-called stop (or stops) that control deployment of the stent graft at different points during the stent graft deployment sequence. The jog(s)2512that is/are cut into the internal tube2500only allows the slider assembly2600to move within that particular jog segment of the internal tube2500. Further retraction of the outer stent sheath2610requires the user to actively turn the end cap2420to a next setting, thus allowing further proximal movement of the slider assembly2600. The boss2700of the slider assembly extends through the jogged slot2510of the internal tube2500and through the slot2442of the handle body2440. The boss2700is, then, connected to the proximal handle grip2410. The internal tube2500is attached at the distal end of the delivery system2400to the distal handle2430. Rotation of the distal handle2430allows rotation of the internal tube2500within the handle body2440.

FIGS. 31 and 32show one exemplary embodiment for indicating a position of the internal tube2500in the various stop positions. The indicator can be realized through either a viewing window3200with numbers/letters or by color coded dots. From the package in which the system is delivered, the delivery system2400can be in a locked position (indicated, for example, with an “L”) of the jogged slot2510. In this orientation, the clinician could remove the delivery system2400from the package and perform flushing procedures without a concern of prematurely deploying the stent graft during handling. The clinician keeps the delivery system2400in the locked position/state during insertion of the device into the patient's artery and while tracking to the site of stent graft deployment. The stop mechanism prevents any possibility of inadvertent proximal movement of the outer stent sheath2610, which could partially deploy the stent graft.

Once the clinician identifies the deployment site and is ready to deploy the stent graft, he/she turns the distal handle2430until, for example, stop position1is obtained. With the device in stop position1, the jogged slot2510of the internal tube2500and the slot2442of the handle body2440will be aligned, thus allowing the proximal handle grip2410to be slid proximally to allow partial stent graft deployment. Positioning of the next exemplary jog or stop on the internal tube2500is set so that the supra-renal struts and at least two stent graft springs (i.e., stents) are deployed from the outer stent sheath2610. With the stent graft partially deployed, but with the suprarenal struts (i.e., of the bare stent) still captured in the distal clasp mechanism, the stent graft can still be maneuvered proximally or distally within the aorta to establish sealing site positioning.

At this point, the clinician can fix the delivery system2400relative to the patient to maintain the stent graft position relative to the aorta. Then, the clinician can move the distal handle2430to stop position2and continue to move the proximal handle grip2410in a proximal direction until, for example, the contralateral leg of a bifurcated stent graft is released from the outer stent sheath2610. The stop on the delivery system2400at the end of stop position2can, in an exemplary embodiment, prevent the ipsilateral leg from deploying from the outer stent sheath2610. Then, the clinician can rotate the delivery system2400to orient the stent graft's contralateral leg to align with the patient's arterial anatomy. Once the stent graft is oriented properly, the clinician can actuate the distal clasp assembly and release the suprarenal struts. The captured ipsilateral leg, along with the anchored supra-renal strut and proximal seal serve as fixation during crossing of the guidewire into the contralateral leg and subsequent placement of the contralateral leg graft placement. Once contralateral leg graft placement is achieved, the delivery system2400is moved to stop position3and the proximal handle grip2410is pushed proximally to fully release the stent graft. The particular placement/configuration of the stop positions is determined based upon various factors, including the size of the prosthesis and the features of the vessel in which the prosthesis is to be placed.

Yet another alternative to the multi-step controlled deployment ofFIGS. 7 to 32is illustrated inFIGS. 33 to 51. These figures describe, in general, an internal lead screw handle that aids in the controlled, accurate deployment of a stent graft. As indicated above, it is desirable to gain better control over placement accuracy of an AAA graft during stent graft placement with an AAA delivery system. The internal lead screw embodiment described herein increases placement accuracy by allowing the operator to have more control over the initial deployment of the stent graft.

An exemplary embodiment of a delivery system3300with an internal lead screw that deploys a stent graft from a sheath is shown beginning withFIG. 33and ending withFIG. 51. The delivery system3300has an internal lead screw3310(seeFIGS. 34, 35, 37), a lead screw nut3320(seeFIGS. 35 and 37), a lead screw rail3330(seeFIGS. 36 and 37), a distal handle grip3340, a flush port and a proximal end cap3350. This configuration utilizes a support member3360with a hypotube at its proximal end and a distal clasp assembly similar to the stent graft delivery system described in the patent family previously incorporated herein by reference. The lead screw nut3320can be actuated in different ways to deploy the stent graft from the outer sheath3370. One exemplary actuation rotates the lead screw nut slowly to pull back on the outer sheath3370using the threads of the internal lead screw3310. Another exemplary actuation simply pulls back on the lead screw nut3320to deploy the stent graft. By housing the internal lead screw3310(which is formed, in this example, from cutting material on outer portions of a round threaded screw to a rectangular cross-section with threads on only one side, i.e., a partial lead screw) within the lead screw rail3330, the system can bypass the need to always use the first exemplary actuation process.

The support member3360is coaxially contained within the delivery system3300. The support member3360is attached at its proximal end to the proximal end cap3350of the delivery system3300. The support member3360travels coaxially through the internal lead screw3310, the flush port, and the outer sheath3370. At the distal end of the support member3360is a capture pod that holds the proximal (caudal) end of the stent graft. A guidewire catheter and the distal clasp assembly tubing (FIG. 39) travel coaxially within the support member3360along the full length of the delivery system3300. Contained within the distal end of the outer sheath3370can be the crimped stent graft and the distal clasp assembly. The distal clasp assembly terminates at the distal end with a flexible tip4100, shown inFIG. 41.

The internal lead screw3310(FIG. 33) used in this exemplary embodiment can be made from a 1-inch diameter lead screw with a 0.400 inch linear lead per rotation of the lead screw nut. The internal lead screw3310is approximately 14 cm in length and is machined so that most of the threads are cut away from the circumference. Machining of the internal lead screw3310is performed to allow the internal lead screw3310to fit in the lead screw rail3330and to allow the lead screw rail3330to fit between the internal lead screw3310and the lead screw nut3320. The lead screw rail3330acts to center the lead screw nut3320on the partial internal lead screw3310. The diameter of the lead screw rail3330is approximately equivalent to the minor diameter of the lead screw nut3320. By locating the lead screw rail3330in this configuration, the internal lead screw3310can slide within the groove3530of the lead screw rail3330(FIG. 35).

Attached to the distal end of the internal lead screw3310is a flush port (FIG. 38). An O-ring is contained in the proximal end of the flush port, which seals around the support member hypotube. At the distal end of the flush port is a nipple that attaches to the outer sheath3370.

During assembly of the delivery system3300(shown, in part, inFIGS. 39 to 41), the stent graft is first loaded into the outer sheath3370along with the distal clasp assembly and the guidewire catheter. Then, the flexible tip4100is threaded onto the distal clasp assembly. As shown inFIGS. 42 and 43, the pre-assembled support member3360is then loaded into the outer sheath3370. Then, the support member3360is guided through the flush port and the internal lead screw3310. The outer sheath3370is, then, attached to the flush port and is clamped (seeFIG. 38). As shown inFIG. 44, the handle body is assembled by first attaching the distal handle grip3340to the lead screw rail3330. Then, as shown inFIGS. 45 to 46, the sub-assembly of the outer sheath3370/flush port/internal lead screw3310is threaded through the opening in the front of the distal handle grip3340and the internal lead screw3310is set in the groove3530of the lead screw rail3330.FIGS. 47 to 48show that the lead screw nut3320is passed over the lead screw rail3330and mated with the internal lead screw3310. The outer sheath3370is moved forward and the lead screw nut3320is threaded forward until it contacts the distal handle grip3340. As illustrated inFIGS. 49 to 51, the proximal end cap3350is, then, placed over the support member3360and attached to the lead screw rail3330. The support member3360is secured to the proximal end cap3350and the distal clasp mechanism hardware is installed.

In use, the clinician first flushes the delivery system3300by forcing saline through the flush port. The saline fills the annular space between the outer sheath3370and the support member3360, permeates through the crimped stent graft, and exits between the outer sheath3370and the flexible tip4100. The o-ring in the flush port seals the hypotube of the support member3360and prevents leakage through the delivery system3300. Then, the clinician feeds the delivery system3300over an indwelling guidewire and tracks the device to the stent graft deployment site.

At this point, the clinician has the option to either slowly release the stent graft by rotating the lead screw nut3320or rapidly release the stent graft by pulling back on lead screw nut3320and, thereby, sliding the internal lead screw3310down the lead screw rail3330. At some point in the deployment of the stent graft, the release can be stopped to actuate the distal clasp assembly and release the leading struts (bare stent) of the stent graft. Because the stent graft is usually severely constrained within the outer sheath3370, deployment forces with AAA devices can be quite high.

The internal lead screw of the invention has the advantage of incorporating a screw system to convert the linear force to a torque force. The torque force that the clinician must exert on the lead screw nut to deploy the stent graft is ergonomically less difficult than the linear pull force. In addition to the mechanical advantage obtained with the lead screw nut, the screw type mechanism allows for greater control in the release of the stent graft. In a linear pin-and-pull system, the largest force to deploy the stent graft is at the initial release of friction between the stent graft and the sheath. As soon as that initial friction is overcome, the deployment force quickly declines. From an ergonomic point of view, it is very difficult for a clinician to maintain control and speed of the deployment at the moment when the frictional forces are overcome. It is very common for the stent graft to be un-sheathed more than was desired due to this loss of control. A screw type mechanism according to the present exemplary embodiment allows the clinician to have more control over this initial release of the stent graft, which is a critical factor for stent placement accuracy.

FIGS. 52 to 54illustrate an improvement to the lead screw embodiment of the previous figures. In the above embodiment, the user was required to grip and turn the handle knob with one hand while holding the sheath handle grip with the other hand. SeeFIG. 52. Actuation of this handle required the user to concentrate on two motions at once for deployment of the stent graft. Also, there was a possibility of turning the hypotube/inner member out of alignment with the sheath hub, which misalignment could decrease stent graft placement accuracy. Therefore, a second handle5300was added behind (proximal) the turn knob5310(FIGS. 53 and 54). The second handle5300is attached to the bearing engagement that is affixed to the inner member5360(hypotube). The user grips the second handle5300and turns the lead screw knob with the thumb and pointer finger. Now, the user's hand is pinned in one location as the knob is turned and the sheath handle is retracted back over the lead screw.

FIGS. 55A through 57illustrate another exemplary embodiment of the delivery systems of the present invention. This example of the delivery system5500includes features of the pin-and-pull telescopic systems100,700,1600,2400and the delivery system3300. The delivery system5500has an internal lead screw5510, a lead screw nut5520, a hollow distal grip handle (also referred to herein as “distal grip”)5530, and a hollow interior body5540(also referred to herein as “handle body”). The internal lead screw (also referred to herein as “internal lead screw assembly”)5510rides within a track5542of the hollow interior body5540. The lead screw nut5520has a non-illustrated interior thread having a pitch corresponding to upper thread portions (also referred to herein as “threaded portion”)5512to cause longitudinal movement of the internal lead screw5510when rotated about the hollow interior body5540. Thus, the lead screw nut5520is rotatably freely mounted about the hollow interior body5540. The lead screw nut5520is also longitudinally freely mounted about the hollow interior body (also referred to herein as “handle body”)5540. In this configuration, the clinician has the ability to rotate the lead screw nut5520to any desired retraction of the internal lead screw5510. At any time before, during, or after such rotation, the clinician can move the lead screw nut5520longitudinally proximal, taking the internal lead screw5510along with it at the same speed of proximal movement of the lead screw nut5520. The internal lead screw5510is longitudinally fixed to the outer sheath5550, which is longitudinally free from the hollow distal grip handle5530and the hollow interior body5540. In this manner, rotation of the lead screw nut5520moves the outer sheath5550relatively slowly (dependent upon the pitch of the upper thread portion5512), and longitudinal movement of the lead screw nut5520moves the outer sheath5550relatively fast.

The difference betweenFIGS. 55A and 56illustrates the relative positions of the internal lead screw5510, the hollow distal grip handle5530, the hollow interior body5540, and the outer sheath5550after the lead screw nut5520has been moved proximally to (about) its proximal-most position. InFIG. 55A, the outer sheath5550surrounds the push rod5560and completely covers the cavity within the outer sheath5550in which the non-illustrated stent graft is stored (compressed) prior to implantation. The outer sheath5550extends all the way to touch the nose cone5570and form a seal therewith to reliably secure the stent graft therein. InFIG. 56, in comparison, the outer sheath5550can be seen completely retracted from the nose cone5570to clear the indented boss7000at the distal end of the push rod5560. The apex capture assembly5568for removably securing the bare stent (e.g.,2310) of the stent graft is shown just proximal of the nose cone5570and in the closed (secured) position of the apex capture assembly5568. Actuation of the apex release device5580moves the inner catheter5590connected to the proximal apex capture portion5572(with its bare-stent-capturing tines) proximally to create a space through which the individual proximal apices of the bare stent can escape.

It is noted that the entire device disposed in the interior of the hollow distal grip handle5530shown inFIG. 55Ais not shown inFIG. 56. This device, slider5700, is shown, in enlarged detail, inFIG. 57A. From distal to proximal, the outer sheath5550is secured by a sheath clip5702to a distal nipple of a slider cap5710. The slider cap5710has a check or flush valve (also referred to herein as “flush valve orifice”)5712fluidically connecting the inner chamber of the slider cap5710to the environment outside the flush valve orifice5712. An intermediate slider body assembly (also referred to herein as “slider body”)5720is secured to the slider cap5710with an o-ring5730therebetween to keep the respective interior chamber fluidically connected to one another and fluidically sealed from the environment outside the two parts slider cap5710, and slider body assembly5720.

A release5514(e.g., a thumbscrew) removably secures the slider5700inside the hollow distal grip handle5530and hollow interior body5540when the release is placed inside a blind hole5722of the slider body assembly5720. With the release5514removed/actuated, all of the parts illustrated inFIG. 56can be removed from the slider5700except for the outer sheath (also referred to herein “sheath”)5550—this includes the entire distal section with the support member5740, the apex release device5580and the nose cone5570.

As the above delivery systems, a support member5740runs entirely through the slider body assembly5720and all the way back to the apex release device5580. This support member5740needs to be sealed to the slider5700so that blood flow outside the member is not allowed. To effect this seal, a wiper gasket seal (also referred to herein as “wiper valve”)5750is provided inside the cavity of the slider body assembly5720. The seal is enhanced with the use of an x-valve assembly5760.

The apex capture device assembly of the invention can be employed in conjunction with the leg clasp of the invention, as shown inFIG. 128. The catheter8613and elongate member8614extends from apex capture delivery device assembly12802through leg clasp12810. Bifurcated stent graft12803extends from apex capture device12804to leg clasp12810, and is secured at each of apex capture device12804and at leg clasp12810as described above, and for release according to the method of the invention, as also described above.

In an embodiment, the invention is a stent graft delivery device, comprising, an apex capture device assembly, including (1) a proximal apex capture portion, including a nose, wherein the nose defines at least one radial restraint that is substantially parallel to a major axis of the proximal capture portion; and a plurality of tines extending distally from the nose, the tines radially distributed about the major axis radial to a most proximal radial restraint and substantially parallel to the major axis, (2) a distal apex capture portion defining slots distributed radially about the major axis, the slots mateable with the times by relative movement of the proximal and distal apex capture portions along the major axis, (3) a plurality of bosses extending radially from the major axis between the nose and the distal apex capture portion and aligned with the slots along the major axis in non-interfering relation with movement of the tines into mating relation with the slots, (4) an elongate member8614, otherwise known as an inner control tube, to which the distal apex capture portion is fixed, the elongate member extending through the proximal apex capture portion and the plurality of bosses, (5) a catheter8613, otherwise referred to as an outer control tube, to which the proximal apex capture portion is fixed, through which the elongate member extends, whereby movement of the catheter causes movement of the proximal apex portion along the major axis between a first position, in which the tines are mated with the slots and overlie the bosses, and a second position, in which the tines are not mated with the slots and do not overlie the bosses, (6) a bare stent that includes struts linked by apices, the struts extending between the tines, a portion of the apices extending between the bosses and the distal apex capture portion when the tines are mated to the slots and (7) at least one suprarenal barb extending from the stent into the radial restraint; and a leg clasp through which the elongate member and catheter extend, the leg clasp including, (1) a barrel, (2) a spool extending from the barrel along a major axis of the barrel, and (3) a rim at an end of the spool, the rim having a diameter greater than that of the spool but less than that of the barrel.

In another embodiment, the invention is an x-valve assembly, comprising an x-valve; and a gasket supporting the x-valve. The gasket includes a peripherial support and at least one arm extending inwardly from the peripherial support. In an embodiment, the gasket includes at least two pairs of arms, along intersecting major axes. In an embodiment, each pair of arms is aligned. At least two of the axes of the x-valve assembly can be normal to each other. The pairs of arms in the x-valve assembly can lie in a plane. The gasket of the x-valve assembly can include a superelastic metal, which can include nitinol.

X-valve assembly5760can be seen in greater detail inFIG. 57B. As shown therein, x-valve assembly5760includes gasket support5762and valve5764. Gasket support5762is shown separately inFIG. 57C. Gasket support5762typically includes superelastic metal, such as nickel titanium (i.e., nitinol). Valve5764is shown separately inFIG. 57D. Valve5764typically is formed of silicone. A partially exploded view of x-valve assembly5760slider body assembly5720is shown inFIG. 57E. Another perspective of a partially exploded view of x-valve assembly5760in slider body assembly5720is shown inFIG. 57F. Slider body assembly5720components shown inFIGS. 57E and 57Finclude slider body5766and gasket spacer5768. The slider body and gasket spacer typically formed of polyetheretherketone (PEEK). With this configuration, when the support member5740is in the slider5700as shown inFIG. 57A, blood flow outside the slider5700is substantially prevented when the proximal end of the support member5740is sealed). The flush valve orifice5712, therefore, is the only way for blood flow to occur, but only if the blood surrounds the support member5740.

As set forth above, the support member5740can be removed from within the slider5700. While the wiper valve5750and the x-valve assembly5760form some or even a substantial measure of sealing capability, the blood-tight seal needs to be ensured. Accordingly, a sealing assembly is provided at the proximal end of the slider5700, which sealing assembly is comprised, in one exemplary embodiment, of a sheath valve5770, a sheath valve washer5780, and a sheath valve knob5790. As described in the following text, the sheath valve washer5780is not necessary but is included in this embodiment. The sheath valve5770here is formed as a cylindrical piece of silicone but can take any shape or material so long as, when compressed inside the slider body assembly5720, it creates a blood-tight seal inside the blind hole5722of the slider body assembly5720. With the configuration shown inFIG. 57A, the sheath valve knob5790is connected into the proximal end of the slider body assembly (also referred to herein as “slider body”)5720with a thread so that, when rotated with respect to the slide assembly5720, the sheath valve knob5790enters into or removes therefrom. Thus, after removal of the interior assemblage, (as the nose cone is being withdrawn from the slider body assembly5720, with appropriate rotation, the knob5790pushes the sheath valve washer5780inwards against the sheath valve5770to compress the sheath valve5770on itself and seal up the hole left after the support member5740and all of the interior assemblage is removed. In a particular embodiment of the sheath valve5770, an annular groove5772on the outside diameter of an intermediate portion of the sheath valve improves a self-sealing collapse of the sheath valve5770. Easier collapse is desired because of the strain that the user experiences when having to rotate the sheath valve knob5790with greater resistance. The groove5772significantly reduces the force required and the number of knob turns required.

FIGS. 58 to 60illustrate exemplary embodiments of the nose cone of the delivery systems of the present invention.

A passive hemostasis valve for the delivery systems100,700,1600,2400,3300,5500can replace the sheath valve5770in the slider5700ofFIG. 57A. Hemostasis can be maintained by two components. First, a seal on the guidewire can be made by a “duckbill” type valve. The duckbill can have mechanical assist, for example, such as by two spring-loaded rollers, to ensure the seal. The seal on the sheath of the second device is maintained by a rubber disc having a hole slightly smaller than the sheath it will receive. This component also maintains hemostasis for the main system.

FIGS. 65 to 69illustrate an exemplary embodiment of a leg-extension delivery system according to the invention (as compared to the main or bifurcated delivery system as shown, for example, inFIGS. 55A to 57. The measurements shown in these figures are not to be taken as the only embodiment and, instead, should be taken as only exemplary for the invention.

The above-described delivery systems100,700,1600,2400,3300,5500each require the stent graft to be loaded within the outer sheath catheter and each have an interior device that both prevents the stent graft from being inserted too far into the outer sheath catheter and keeps the stent graft longitudinally fixed when the outer sheath is being retracted over the stent graft. When implanting a bifurcated stent graft, it is desirable to ensure that the last two springs (e.g., stents) of the ipsilateral leg are not prematurely released from the outer sheath during deployment. The invention, shown inFIGS. 70A, 70B and 70C, allows the capture of the stent graft's ipsilateral leg while the contralateral leg is cannulated. Such a configuration ensures stability of the stent graft during the cannulation of the contralateral leg.

An additional embodiment of the invention shown inFIGS. 70A, 70B and 70C, as an example, is a leg clasp7001, comprising a barrel7002; a spool7004extending from the barrel7002along a major axis of the barrel7002; and a rim7006at an end of the spool7004, the rim7006having a diameter greater than that of the spool7004but less than that of the barrel7002, as shown inFIGS. 70A, 70B and 70C.

The leg clasp7001of the invention can formed, at least in part, of at least one component selected from the group consisting of stainless steel, polyester, polyetheretherketone (PEEK) and acrylonitrile butadiene styrene (ABS). The rim7006of the leg clasp7001of the invention can include radially extending spokes12502, as shown inFIGS. 125 and 126.

In still another embodiment, the invention is a stent graft delivery system, comprising a leg clasp7001that includes a barrel7002, a spool7004extending from the barrel7002along a major axis of the barrel7002and a rim7006at an end of the spool7004, the rim7006having a diameter greater than that of the spool7004but less than that of the barrel7002; a support tube7010fixed to the barrel7002and extending from the barrel7002in a direction opposite that of the spool7004; and an outer sheath7030(FIGS. 70A and 70C) having an internal diameter relative to that of the barrel to permit movement between a first position that covers the spool7004and rim7006and a second position that exposes the spool7004and rim7006. It is to be understood that support tube7010is also represented as support tube5744inFIG. 57A, and that, in an alternative embodiment, some other component of support member5740, shown inFIG. 57A, can be fixed to barrel7002, such as hypo-tube5742, also shown inFIG. 57A, and that support tube7010can be fixed directly to hollow interior body5540, shown inFIG. 56.

The stent graft delivery system of the invention can further include a stent graft7020, wherein a distal most stent7024of the stent graft extends about the spool7004in interfering relation with the rim7006when the outer sheath7030is in the first position, and a tubular graft component7032to which the stent is fixed extends between the rim and the sheath, whereby movement of the sheath from the first to the second position releases the stent graft from the leg clasp.

In particular, an indented boss7000is placed at the distal end of the push rod (also referred to herein as “support tube”)7010, which prevents the stent graft7020from being inserted too far into the outer sheath7030and keeps the stent graft7020longitudinally fixed when the outer sheath7030is being retracted over the stent graft7020. The indented boss7000has a proximal flange (also referred to herein as a “barrel”)7002, an intermediate span (also referred to herein as a “spool”)7004, and a distal flange (also referred herein as a “rim”)7006. The outer diameters of the proximal and distal flanges7002,7006are larger than the outer diameter of the intermediate span7004to create an annular cavity7008therebetween. If the stent graft leg7022is placed over the distal flange7006sufficiently far to have the distal-most stent7024within the annular cavity7008, the indented boss7000creates an interference fit between the stent graft leg7022and the outer sheath7030. Once the outer sheath7030is completely retracted, the interference fit disappears. It can be said that the fixation of the distal-most stent7024is passive due to the fact that, after the outer sheath7030is retracted, the fixation is lost. This configuration can be used to better control and grasp the stent graft7020by preventing longitudinal movement thereof when the outer sheath7030is retracted (to the left ofFIG. 70A).

The following sections discuss improvements to stent grafts, in particular, bifurcated AAA stent grafts intended to span the renal arteries. As shown inFIGS. 72A, 72B, 72CthroughFIG. 83, a stent graft system, such as bifurcated stent graft system7200, comprising a tubular graft component7201; a bare stent component7210including a plurality of struts7211joined by proximal apices7212and distal apices7213connecting the struts7211, the bare stent component7210fixed to a proximal end7214of the tubular graft component7201and extending proximally from the proximal end7214; an infrarenal stent component7215proximate to the bare stent component7210, wherein the infrarenal stent component7215is distal to the bare stent component7210and spans a circumferential line defined by distal apices7213of the bare stent component7210fixed to the tubular graft component7201; at least one suprarenal barb7220extending distally from at least one suprarenal portion7217of the bare stent component7210; and at least one infrarenal barb7230extending distally from at least one infrarenal portion7218of the bare stent component7210.

“Suprarenal,” as used herein in reference to a barb, means a barb that attaches to the aorta cranial to the ostium of the most superior renal artery.

“Infrarenal,” as used herein in reference to a barb, means a barb that attaches to the aorta caudal to the ostium of the most inferior renal artery.

In another embodiment, an infrarenal barb can be a first covered barb. Bare stent is also referred to as “uncovered” or “partially” covered stent.

“Barb” is also referred to herein as “hook.”

As shown inFIG. 73, in the stent graft system of the invention, the suprarenal portion of the bare stent7210can include a bridge7219between struts7211to define an eyelet7221that joins two struts7211, and wherein the suprarenal barb7220extends from the bridge7219.

The infrarenal barb7230of the stent graft system of the invention can extend from a distal apex7213that joins two struts7211.

Exemplary distances between the most proximal point of the suprarenal and infrarenal barbs of the stent graft system of the invention is in a range of between about 6 mm and about 40 mm (e.g., 6 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm).

At least one of the stents of the stent graft system of the invention can include a superelastic metal, such as nickel titanium.

In an embodiment, the distal apices of a bare stent of the stent graft system of the invention are fixed within the tubular graft component and wherein the infrarenal barb extends from the bare stent through the tubular graft component. At least one infrarenal stent of the invention can be fixed within the luminal graft component.

Another embodiment of the invention, shown inFIG. 105Cis a stent graft system10550, comprising a tubular graft component10560; a bare stent10570of angled struts10580joined by proximal apices10590and distal apices10591, and extending from a proximal end10592of the tubular graft component10560; a proximal stent10593adjacent the bare stent10570and within the tubular graft component10560, the proximal stent10593nested with the bare stent10570; and at least one barb10594extending distally from a distal apex10591and through the tubular graft component10560.

FIG. 71diagrammatically illustrates an abdominal aorta7100with an aneurysm7110between the renal arteries7120and the iliac arteries7130—the abdominal aorta7100branches, at its downstream end, and becomes the left and right common iliac arteries7130, carrying blood to the pelvis and legs.FIGS. 72A, 72B and 72Cdiagrammatically illustrates a stent graft system, such as a bifurcated stent graft system7200having a graft portion that extends from just downstream of the renal arteries7120towards the iliac arteries7130, splitting into two smaller graft portions, one of which extends into an iliac artery7130and the other ending before the other iliac artery7130. The bare stent7210of this bifurcated stent graft system7200is configured with both suprarenal barbs7220and infrarenal barbs7230.

Another embodiment, shown inFIG. 72Bthe invention is a bifurcated stent graft system7200, comprising a tubular graft component7201; a bare stent7210extending from a proximal end7214of the tubular graft component7201, such as a bifurcated tubular graft component; at least one suprarenal barb7220extending distally from a suprarenal portion7217of the bare stent7210; and at least one infrarenal barb7230extending distally from an infrarenal portion7218of the bare stent7210, the distance, a, between the suprarenal barb7220and infrarenal barb7230along a major axis of the tubular graft component being in a range of between about 6 mm and about 40 mm (e.g., 6 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm).

In the stent graft system of the invention, at least a portion of the barbs extend from the bare stent at an angle in a range of between about 20 degrees and about 60 degrees (e.g., 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees).

A bare stent of the stent graft system of the invention can be formed, at least in part, of a superelastic metal.

As shown inFIGS. 78 and 79, the stent graft systems of the invention can further include at least one radiopaque marker7800. At least one radiopaque marker attached to the stent graft systems of the invention, either to the stent or the graft material, can aid in the place of the stent graft in a patient by employing stent graft delivery systems of the invention, for example, in methods of treating abdominal aortic aneurysms.

FIGS. 73 to 75illustrate various features of a bare stent component7210with hooks or barbs7220,7230according to an exemplary embodiment of the invention an AAA stent-graft system. A 6-apex version is shown, although more or less apices could be used. This bare stent component7210has, as shown inFIG. 74, different length hooks7410,7420,7430that, for example, increase in length based upon the distance from the graft edge (of course, these lengths can decrease in this direction or be a combination of lengths). In an embodiment, the hooks7410,7420,7430increase in length the further away from the graft edge (i.e., B-1 is longer than B-2 and is longer than B-3) because, in an angled neck, hooks further from the graft line are more likely to be further from the aortic wall. Further, shorter hooks nearer to the renal arteries is safer for patients.

FIG. 75shows an orientation where hooks7510,7520,7530increase in length further away from the graft edge and are disposed at staggered positions along various circumferential planes at distances from the graft edge.

FIGS. 73 through 75 and 77illustrate an eyelet7700at each apex at the graft end (distal) of the bare stent. This feature assists in suturing the stent to the graft material. Benefits of the eyelet include suturing in an area of the stent with no stresses or strain during normal post-sewing process steps. Typically, stents are sewn around the intrados of the sinusoid of the stent. This area will be subjected to elastic deformation during post sewing process steps like crimping/loading and final deployment. Such movements can only have detrimental effects on the sutures. Additionally, during normal anatomical movements in the body, the intrados of the stent will have the most movement. An eyelet, as shown in these figures, will not be subject to any movement or plastic deformation that would beyond the general movement of the whole prosthesis. Suturing in the area of a stent that will not be subject to any stresses or strain is advantageous from a manufacturing perspective. During the sewing process, the needles can cause small gauges in the stent, which could become focal points for crack initiation and subsequent fracture. These gauges would be of much greater concern in the intrados than in a static area such as the eyelet7700. Should the suprarenal stent of the invention be subjected to a fracture after implant, the intrados area of the stent is likely to be a spot where the fracture would occur. If the suture is done in this spot, a fracture could result in the complete disassociation of the suprarenal stent from the graft. By sewing on this added eyelet feature, a fractured stent would still have one of the two struts attached to the graft after that fracture. Thus, once a fracture occurred, it would be far less likely for the second strut in the same area to also break away from the shared intrados. Having the inferior eyelets shown as the suture securement areas of the stent has significant advantages:

The stent can be cut from a 3 mm OD tube, for example. The width of the can be equivalent (but not need be equivalent) to the circumference of a 3 mm tube. The tubing wall can be, for example, 0.017″.FIGS. 81 to 85illustrate one exemplary embodiment of a laser-cut supra-renal stent with side hooks according to the invention with exemplary measurements for the stent when being manufactured from such a tube. This exemplary embodiment includes 6 superior and 6 inferior apices, although variants could have more or less. Strut thickness can be targeted to mimic a wire of approximately 0.016″ to 0.018″ diameter. But can be of varying diameters, for example, the wall thickness can be 0.017″.

Barbs can be bent out of plane and sharpened as part of a finishing process. All of the barbs, or only a subset of the barbs, may be included in the stent of the invention.

The bare stents described above are to be used with the delivery systems according to the invention, which systems include distal apex capture devices, an example of which is shown inFIG. 69. With the addition of the barbs, however, the spaces that previously existed between each of the stent arms8010(i.e., the lengths between the apices) is now taken up by the barbs. This can be seen, in particular, inFIGS. 80 and 84. Accordingly, the apex capture device previously used is modified to take account of the lost of “space” between the arms8010.

In an embodiment, the invention is an apex capture device8600, comprising a proximal apex capture portion8600athat includes a nose8601, wherein the nose defines at least one radial restraint, such as a pilot holes, represented as8011, inFIGS. 86C and 88, that is substantially parallel to a major axis of the proximal capture portion8600aand a plurality of tines8602extending distally from the nose8601, the tines8602are radially distributed about the major axis radial to a most proximal radial restraint and are substantially parallel to the major axis; a distal apex capture portion8610defining recesses8611distributed radially about the major axis, the recesses8611mateable with the tines8602by relative movement of the proximal8600aand distal8610apex capture portions along the major axis; a plurality of bosses8612extending radially from the major axis between the nose8601and the distal apex capture portion8610and aligned with the recesses8611along the major axis in non-interfering relation with movement of the tines8602into mating relation with the recesses8611; an elongate member8614, shown inFIG. 86D, (also known as an inner control tube) to which the distal apex capture portion8610is fixed, the elongate member8614extending through the plurality of bosses8612and the proximal apex capture portion8600a; and a catheter8613, also shown inFIG. 86D, (also referred to as an outer control tube) to which the proximal apex capture portion8600ais fixed, through which the elongate member extends, whereby movement of the catheter8613causes movement of the proximal apex capture portion8600aalong the major axis between a first position, in which the tines8602are mated with the recesses8611and overlie the bosses8612, and a second position, in which the tines8602are not mated with the slots and do not overlie the bosses8612.

“Radial restraint,” as used herein, means restricted movement in a direction normal to the major axis of the delivery system or the apex capture device, whereby, for example, a barb of a stent could be released between tines of the apex capture device.

“Non-interfering relation,” as used herein, means one object is moveable relative to another object.

The nose8601of the apex capture device of the invention can define grooves8603between the tines8602, wherein the grooves8603are aligned with spaces between the bosses8612.

In an embodiment, the plurality of bosses8612of the apex capture device of the invention are fixed relative to distal apex capture portion8610.

The nose, elongate member and each of the tines8602of the apex capture device of the invention can define a space.

In another embodiment, the invention is a method of releasing a bare stent of a stent graft, comprising the steps of moving a catheter, to which a proximal apex capture portion of an apex capture device is fixed, the proximal apex capture portion defines a radial restraint, along a major axis between a first position, in which tines of the proximal apex capture portion are mated with slots of a distal apex capture portion and overlie bosses extending radially from a major axis of the apex capture device, and a second position, in which the tines are not mated with the slots and do not overlie the bosses, thereby releasing apices of a bare stent from a space defined by the tines, the bosses and the distal apex capture portion.

In an embodiment, the apex capture device employed in the method of releasing a bare stent of a stent graft can further include an elongate member to which the distal apex capture portion is fixed, the elongate member extending through the proximal apex capture portion and the plurality of bosses.

In another embodiment, the apex capture device employed in the methods of the invention can further include a catheter to which the proximal apex capture portion is fixed, through which the elongate member extends, and by which the proximal apex capture portion is moved.

In yet another embodiment, the invention is an apex capture device assembly7600, comprising a proximal apex capture portion7610that includes a nose7615, wherein the nose defines at least one radial restraint, such as a pilot hole, previously described, that is substantially parallel to a major axis of the proximal capture portion and a plurality of tines, previously described extending distally from the nose7615, as shown, for example, inFIG. 76A, the tines radially distributed about the major axis radial to a most proximal radial restraint and substantially parallel to the major axis; a distal apex capture portion7620, as shown, for example, inFIG. 76A, defining slots distributed radially about the major axis, the slots mateable with the times by relative movement of the proximal and distal apex capture portions along the major axis; a plurality of bosses extending radially from the major axis between the nose and the distal apex capture portion and aligned with the slots along the major axis in non-interfering relation with movement of the times into mating relation with the slots; a elongate member to which the distal apex capture portion is fixed, the elongate member extending through the proximal apex capture portion7610and the plurality of bosses; a catheter to which the proximal apex capture portion7610is fixed, through which the elongate member extends, whereby movement of the catheter causes movement of the proximal apex portion along the major axis between a first position, in which the tines are mated with the slots and overlie the bosses, and a second position, in which the tines are not mated with the slots and do not overlie the bosses; a bare stent7630that includes struts7631linked by apices, the struts extending between the tines8602(FIG. 86B), a portion of the apices extending between the bosses and the distal apex capture portion when the tines are mated to the slots; and at least one suprarenal barb7632(FIG. 76B) extending from an eyelet of the stent into the radial restraint (not shown).

The stent of the apex capture device assembly of the invention can further include at least one bridge between a pair of the struts to define an eyelet through which a boss extends when a tine is mated to a slot, and wherein the barb extends from the bridge.

In an alternative embodiment, shown inFIG. 76B, the struts7634are angled. The struts are angled as a result of clasping the bare stent and restraining the barbs thereby creating a deeper valley for at least one infrarenal barb.

Referring to bothFIGS. 76A and 76B, the suprarenal barb of the apex capture device assembly of the invention is angled (not shown) from a major plane of the eyelet sufficient to distend the struts to which the eyelet is attached toward the major axis.

The apex capture device of the invention can further include an infrarenal barb7635extending from a distal apex7636of the bare stent7630.

The apex capture device assembly of the invention can further include a luminal graft component7637fixed to a distal portion of the bare stent7630and an infrarenal stent7638adjacent and distal to the bare stent7630, the infrarenal stent7638including struts7639linked by proximal7640and distal7641apices, the distal apices7641being substantially aligned with distal apices7636of the bare stent7630. In an embodiment, the infrarenal stent7638of the apex capture device assembly7600of the invention is fixed within the tubular graft component7637. Distention of the bare stent struts7631,7634consequent to retention of the suprarenal barbs7632within the radial restraint, such as a pilot hole8011(FIG. 86C), can cause the infrarenal barb7635of the bare stent7630to be recessed between struts7639of the infrarenal stent7638.

For example, as shown inFIGS. 86A, 86B, 86C, 86D and 86E through 88, the proximal apex capture portion8600ahaving the tines8602is in the bare stent release position, in which it is separated from the distal apex capture portion8610(which is connected to the nose cone6860(FIG. 88A)). The upstream apices of the stent8620(FIG. 87A), while captured and before springing open upon final deployment, are wrapped around holding bosses8612that circumferentially align with a respective one of the tines8602and, therefore, extend radially outward to touch the respective tine8602, or come close enough to prevent any stent apex release when closed over by the tines8602. To complete the capture cavity for the stent apices, the distal apex capture portion8610has recesses8611that are shaped to fit snugly the distal-most ends of each one of the tines8602. Accordingly, the recesses8611of distal apex capture portion8610are circumferentially offset from the bosses8612, as represented inFIGS. 86A-86E. Elongate member8614extends from proximal capture portion8600a.

Prior art Z-stents are made of a single length of wire joined at the two ends. Provided herein, and shown in an exemplary embodiment inFIGS. 89 and 90, is a multiple-stent8900made with a plurality of circumferentially adjacent filaments. There are various features that exist with the multiple-stent8900that do not arise in prior art stents.

The multiple-stent8900is a wire form stent made from wire that is substantially smaller in diameter than used in prior art stents/stent grafts. In spite of this substantial reduction in diameter, the multiple turns around the circumference create a total metal cross-section on each strut of each stent similar to prior art stents. Having multiple turns in the multiple-stent8900creates multiple apices8910at each bend of the multiple-stent8900. These apices can be used to improve implantation on an interior wall of a vessel to be treated. Additionally, each of these apices8910can be used to catch onto the graft material of a second modular component, for example, on the graft material of a second part of a bifurcated stent graft that is to be deployed in the iliac artery opposite the long downstream leg of the bifurcated stent graft. One particular use is that these apices8910can be used to catch onto opposing apices of a stent from the second modular component. The multiple-stent8900can be used in any overlap region. Variations of the multiple-stent8900can include wire diameter, overall number of apices as well as the number of turns (filaments) used.

The multiple-stent8900can be made from a single wire circumferentially repeated as shown inFIGS. 89 through 94. The embodiment ofFIG. 89stacks the apices8910and the embodiment ofFIG. 91encircles the apices9100. Alternatively, the multiple-stent can be a plurality of independent Z-stents intertwined with one another.

To use the multiple-stent to connect two modular components of a stent-graft system, the graft and stent are assembled in a non-intuitive manner to achieve a high modular tensile strength. The graft is assembled such that its longitudinal length is shortened by folding the graft in on itself in a longitudinal direction. This is done so that the total effective graft is substantially unchanged, with respect to internal diameter. The ability to fold the graft in on itself is done by sewing consecutive leg stents further from one another than would normally be done.FIG. 95shows a cutaway graft with the surfaces on the bottom representing the portion of the graft that is folded into the upper catheter. Overall, the graft still defines a single lumen.FIG. 96is a close-up of the in-folded area of the graft. Significantly, this fold9600creates a pocket9610facing the proximal end of the graft, when in the catheter of the graft.FIG. 97is a photograph of an example of the configuration ofFIGS. 95 and 96applied to both iliac ends of a bifurcated stent graft. This particular example shows the fold between the last stent on the right and the stent immediately adjacent the last stent to the left in the figure. If desired, this configuration is set on both legs of the bifurcate as shown inFIG. 97.

These folds9600are placed in the areas of the stent graft that will receive modular components. Accordingly, the folds9600are made near the distal ends of stent graft components. These folds9600can be done at multiple points along the length, and can also be done at the very end, or at both locations. To keep the folds9600in place, longitudinal stitches are sewn through all the layers of the graft. These stitches are shown with reference “A” inFIG. 97. If the fold is at the end of a segment, like the stitch shown on the longer leg (top ofFIG. 97), there will be two layers of graft material. If, in comparison, the stitch A is between two stents (bottom ofFIG. 97), then three layers of graft material will be present. Folding of the graft components is done to create pockets on the catheter of the grafts. These pockets are used to receive the second component of the modular securement mechanism, the stent.

The multiple-stent that is attached to a graft is found at or near the proximal end of the inserting component. The multiple-stent is attached in a manner that leaves the distally facing apices9800unsewn, as shown inFIG. 98. Also shown here is the multiple-stent configuration. By leaving the distally facing apices unsewn, they can fit into the pockets9610created by folding the graft of the first component. In addition to using the unsewn apices of stents to fit into the pockets9610, a non-stent component can be added to the second component. Another alternative may include protruding features on the distal end of the stents. Some exemplary configurations of these features are shown inFIGS. 99 and 100. By having multiple filaments as depicted, it is more likely that at least some of the filaments' apices will engage with pockets9610in the connecting component. The total number of filaments is not critical, and a monofilament stent could also be sewn in the same manner.

The configuration shown inFIG. 99differs from the configuration shown inFIG. 98by having the sewing performed on a larger percentage of the proximal struts (adjacent the proximal apices). The extra sewing increases the security of the secure attachment to the stent graft of the engaging stent. Further, the distal apices9900are flared outward from the wall of the stent graft. The flaring of the distal apices9900is performed to increase the probability that some or all of the apices catch into the pockets of the opposing component. Additionally, some, but not all, of the filaments of the multi-filament stent are cut. The cutting of the filaments also creates additional independent catch points for the second component into the opposing first component. The concept behind cutting some (but not all) of the filaments is to maintain some radial force in that segment. The configuration shown inFIG. 100shows a cutting of all of the distal apices10000. This configuration creates a maximum number of catch points for the pockets9610(or other location). A trade off to this, as mentioned above, is that there is no radial strength in that area of the stent. The configuration ofFIG. 100only has a single apex cut. If desired, all or more than one apex could be cut in this matter.

The configuration shown inFIG. 101modifies the configuration ofFIGS. 98 to 100by providing a partially sewn stent10100sewn right next to a fully sewn stent10110. Two benefits to this modification immediately arise. First, radial strength is increased. This helps keep both stents against the graft material of the first component. Second, the configuration helps prevent possible in-folding of the second component that could block the lumen of the entire device. This type of in-folding would be the result of a poorly supported segment of the second component being placed under a significant axial load. If the distal apices or other protruding members have caught the pockets of the first component, then the top (proximal) apices could fold into the lumen. Another way to prevent this potential issue of in-folding due to an axial load could be to provide a fully supported stent proximal to the stent intended to engage with the first component.

The configuration shown inFIG. 102illustrates non-stent components10200used to engage the pockets9610(FIG. 96) of the first component. Here, a bio-compatible plastic or polymer is the shape of a closed ladder with interior steps, any of the steps can be connected to the stent graft. As shown inFIG. 102, the upstream-most step is connected to the cranial (upstream) stent at each of the upstream apices. Of course, less than the number of such apices of the component10200can be connected to non-stent component10200. A desirable shape has the distal end (downstream) curved outward to capture the pocket9610or vessel wall. One benefit of using a non-stent component10200is a non-metal reduces wear between adjacent components. These non-stent components10200can be put at some or all of the apices of some or all of the stents, or between stents.

Another exemplary embodiment of devices that can be used to connect into the pocket9610(FIG. 96) or the vessel wall is shown in the variations ofFIGS. 103 through 104. The stent10300with its downstream capture pegs10310can be used in the modular stent securement mechanisms described herein. In this embodiment, the distally facing pegs10310of the stent are flared out and are not sharpened. With this variation, the distally facing pegs10310are not intended to penetrate through the fabric of the first component in which the pegs10310are to be connected. In such a configuration, the distally facing pegs can end up in a pocket9610(FIG. 96) created in the first component.

In still another embodiment, and referring toFIGS. 78A and 78B, the invention is a stent graft system7809comprising a first stent graft7820that includes a first tubular graft component7840a plurality of outside stents extending along and fixed to an outside surface of the first tubular graft component7840and an inside stent7860between two outside stents7861,7871, one of which is at a distal end7880of the first tubular graft component7840the inside stent7860fixed to an inside surface of the first tubular graft component7840and having a plurality of barbs7863pointed generally proximally within the first luminal graft component7840; and a second stent graft7873that includes a second tubular graft component7874and a plurality of outside stents7875extending along and fixed to an outside surface of the second tubular graft component7874, whereby insertion of the second stent graft7873into the distal end7880of the first tubular graft component7840to overlap at least two stents of each of the first7820and second stent grafts7873will cause interfering relation between at least a portion of the barbs7863with a stent of the second tubular graft component7874of the second stent graft7873. Examples of maximum and minimum overlap of the first and second stent grafts are shown inFIGS. 79A and 79C.

The first tubular graft component7840of the stent graft system7809can be bifurcated and the inside stent7860located in one of two legs of the first tubular graft component7840.

The stent graft system of the invention can further include a plurality of outside stents7891extending along and fixed to an outside surface of a second leg7890of the bifurcated first luminal graft, and a second inside stent7892between two outside stents, one of which is at a distal end7893of the second leg7890, the second inside stent7892fixed to an inside surface of the second leg7890and having a plurality of barbs7894pointed generally proximally within the second leg7890.

A third stent graft7895, shown inFIG. 79Aincludes a third tubular graft component7896and a plurality of outside stents7897extending along and fixed to an outside surface of the third tubular graft component7896, whereby insertion of the third stent graft7895into the distal end7893of the second leg7890to overlap at least two stents of each of the second leg7890and third stent graft7895will cause interfering relation between at least a portion of the barbs7894with a stent or the third tubular graft component7896of the third stent graft7895.

Stents of the stent graft system of the invention can be formed, at least in part, of a superelastic metal, such as nitinol.

The variation shown inFIG. 105Ais a stent10500with pegs10510projecting downstream, not from the downstream apices10520, but from the upstream apices10530. In the variation shown inFIG. 106, the stent10600has sharpened legs10610projecting from the downstream apices10620. Caudally facing barbs can be disposed on any number or all apices of a leg stent. Sharpened barbs can penetrate the graft material of the prosthesis into which the graft is placed. In many cases, this configuration would be a bifurcate, but could also be a previously placed leg extension.

A further embodiment of the invention is a telescoping stent graft system, which is essentially identical to the stent graft system shown inFIGS. 79A and 79C, but lacks at least one set of barbs7863and7894. In this alternative embodiment, the bifurcated first stent graft includes a bifurcated first tubular graft component, a plurality of outside stents extending along and fixed to an outside surface of one of two legs of the bifurcated first tubular graft component. Optionally an inside stent extends between two outside stents, one of which is at a distal end of the first tubular graft component, the inside stent fixed to an inside surface of the first tubular graft component. A second stent graft that includes a second tubular graft component and a plurality of outside stents extending along and fixed to an outside surface of the first tubular graft component, whereby the second stent graft can be inserted into the distal end of a first of two leg components of the bifurcated first tubular graft component to overlap at least two stents of each of the first and second stent grafts; a plurality of stents (e.g., outside stents and/or inside stents) extending along and fixed to an a surface (e.g., outside surface and/or inside surface) of a second leg of the bifurcated first tubular stent graft. Optionally, a second inside stent is located between two outside stents, one of which is at a distal end of the second leg, the second inside stent fixed to an inside surface of the second leg. Also, optionally, a third stent graft is included having a third tubular graft component and a plurality of outside stents extending along and fixed to an outside surface of the third luminal graft component, whereby insertion of the third stent graft can be inserted into the distal end of the second leg of the bifurcated first tubular graft component to overlap at least two stents of each of the first and second stent grafts. Regardless, the first leg is shorter than the second leg, and the first leg includes at least one more stent than is required for overlap of at least two stents of each of the second stent graft.

In an embodiment, one leg of the bifurcated stent graft of the invention can shorter in length (i.e., first or short leg) in the other leg (i.e., second or long leg) of the bifurcated stent graft, as shown inFIGS. 78A, 78B, 79A and 79C. When the bifurcated stent graft of the invention is placed in the abdominal aorta, the long leg of the bifurcated stent graft can be in the common iliac, as represented, for example, inFIG. 72A, or in the aorta.

As shown inFIGS. 78A and 78B, the bifurcated first stent graft of the telescoping stent graft system of the invention can include at least one radiopaque marker7800. In a particular embodiment, the shorter leg of the bifurcated first stent graft includes three lateral radiopaque markers7801,7802,7803, one of which is at the distal opening of the short leg, another of which is at the proximal end of the apex of an inside stent (i.e., second stent from the leg opening) and the third of which is at the point of bifurcated on the first stent graft. The radiopaque marker7802located at the apex of the inside stent can delineate the minimum (min) positioning of the third stent graft and the radiopaque marker7803can delineate the maximum (max) positioning of the third stent graft, as shown in reference to, for example,FIGS. 78A, 78B, 127A, 127B, 127C and 127D. Two additional radiopaque markers7804,7805are distributed about the distal opening of the short leg. Radiopaque marker7806is located at a proximal end of an inside stent in the long leg of the bifurcated first stent graft.

The delivery systems, components of delivery systems, stents, grafts and stent graft systems of the invention can be employed in methods of treating aortic aneurysms, such as abdominal aortic aneurysms.

In another embodiment, the invention is a method for treating an abdominal aortic aneurysm, comprising steps of directing a sheath and distal tip of a delivery system to an abdominal aortic aneurysm of a patient through an artery, such as a femoral artery that can subsequently pass through a common iliac artery, of the patient, the sheath containing a bifurcated stent graft; rotating a lead screw nut of the delivery system that is threadably linked to the sheath to thereby retract the sheath at least partially from the bifurcated stent graft; and sliding the lead screw nut along a handle body of the delivery device while the lead screw nut is threadably linked to the sheath to thereby further retract the sheath, whereby the bifurcated stent graft is at least partially deployed in the abdominal aortic aneurysm, thereby treating the abdominal aortic aneurysm.

The method of treating an abdominal aortic aneurysm can further including the step of opening a clasp at a distal end of the delivery device to release a bare stent at a proximal end of the bifurcated stent graft. A portion of a first leg of the bifurcated stent graft can be retained within the sheath when the clasp is opened to release the bare stent. The first leg of the bifurcated stent can be retained by fixing a stent at a distal end of the first leg between the sheath and a leg clasp. The first leg of the bifurcated is the longer of two legs of the bifurcated stent.

In another embodiment, the clasp employed in the method to treat an abdominal aortic aneurysm can distend struts of the proximal stent toward a major axis of the delivery system when the sheath has been retracted sufficient to expose the bare stent.

The method to treat an abdominal aortic aneurysm can further include the step of cannulating a second leg of the bifurcated stent with an extension stent graft while the first leg is being held at least partially within the sheath. During cannulation, the leg that is being held is longer than the leg that is being cannulated and, optionally, the cannulated leg is in telescoping relation with the extension stent graft. The cannulated leg can overlap the extension stent graft by at least two stents of each of the cannulated leg and the extension stent graft. The cannulated leg can include at least one more stent than is required to overlap the extension leg by two stents of each of the cannulated leg and the extension stent graft. A stent second from the distal end of the cannulated leg can be within the graft of the bifurcated stent graft. The stent second from the distal end of the bifurcated graft can include barbs that extend inwardly and proximally from the stent.

In another embodiment, the method of treating an abdominal aortic aneurysm can further include the steps of releasing the bifurcated stent graft from the leg clasp, and then detaching a slider and the sheath from the remainder of the delivery device and withdrawing the remainder of the device from the patient while leaving the slider and sheath substantially in place and, optionally, further including the step of deliverying a second extension through sheath and to the first leg and cannulating the first leg with the second extension. The cannulated second leg can overlap the extension stent graft by at least two stents of each of the cannulated first leg and the second extension. The cannulated first leg can include at least one more stent than is required to overlap the extension leg by two stents of each of the cannulated first leg and the second extension. A stent second from the distal end of the cannulated first leg can be within the graft of the bifurcated stent graft. The stent second from the distal end of the bifurcated graft includes barbs that can extend inwardly and proximally from the stent.

The methods of the invention have an advantage of repositioning of a graft (e.g., bifurcated graft, second stent graft, third stent graft) if, for example, a clinician determines initial positioning of the graft is less than optimal. The graft can be repositioned at its proximal and distal end and proximally and distally in an aorta or branch of an aorta, such as a common iliac artery.

FIGS. 105A, 105B and 105Crepresent embodiments of a stent and use of stent in a telescoping stent graft system of the invention.

FIGS. 107 to 109illustrate various configurations for incorporating hooks or barbs to Z-stents, in particular, bare stents, without using the material of the stent itself.FIG. 107illustrates an exemplary embodiment of a crimp hook10700according to the invention. A hook10710is attached to or integral with a crimp sleeve10720that is to become part of a bare stent10800(bare spring) on an endoluminal stent graft prosthesis. Many Z-stents are already connected at the two ends by a crimp sleeve to complete the circumference. The configuration adds active fixation of the stent graft assembly, once deployed, into the surrounding tissue of the vessel to prevent migration of the prosthesis post-deployment. To create the crimp hook10700, for example, the hook10710(which can be a pointed or sharpened wire if desired) can be welded onto the body of the crimp sleeve10720. The crimp hook10700is, then, attached to the ends of the bare stent10800by crimping (or welding) it to the strut10810. If multiple crimp hooks10700are desired, the crimp hooks10700can be connected to individual stent portions10820defined by one apex10830and two halves of struts10840, for example.

Alternative to the exemplary tubular structure shown inFIG. 107, the crimp sleeve10720can be a clamshell that is placed over two adjacent halves of a strut10840(or just a single, unbroken strut10840) and crimped thereon. After the bare stent10800is equipped with the crimp hooks10700, it can be affixed to the end of the stent graft10900as shown inFIG. 109. The crimp hooks10700inFIG. 109are shown as rotated around the respective struts10840of the bare stent10800so that they can be seen in the figure of this drawing. In use, however, the hooks10710will, for best apposition with the vessel wall, be pointed substantially radially outward from the longitudinal central axis of the stent graft.

In contrast to the bare stent crimp hooks above,FIGS. 110 and 111illustrate a crimp hook11000that is attached/affixed to the edge of the main body of the graft11200, as shown inFIGS. 112 and 113. With the configuration shown, the crimp hook11000slides over the edge of the graft material11100(illustrated with a dashed line) and is compressed so that the two edges11110,11120of the crimp pinch the graft material11100therebetween to create a mechanical lock onto the graft material11100. This configuration adds active fixation of the stent graft assembly, once deployed, into the surrounding tissue of the vessel to prevent migration of the prosthesis post-deployment. Like above, the crimp hook11000can be welded to the crimp body11020, for example, or can be integral therewith.

It is noted that providing barbs or hooks on the bare stent of the stent graft (tube or bifurcated) increases the possibility of disadvantageous puncture or scraping, whether to the outer sheath or to the interior of the vessel wall. In particular, with regard to the stent embodiments ofFIGS. 73 to 76, 79 to 85, and 103 to 106, for example, it would be desirable to entirely prevent the possibility of inadvertent damage to either the outer sheath or the vessel wall. To prevent such damage from occurring, the delivery system according to the invention employing bare stents having such barbs is provided with a material umbrella11400.

In one exemplary embodiment illustrated inFIG. 114, the umbrella11400is attached (slideably or fixedly) to the catheter11410controlling the proximal apex capture portion11420. When the stent graft11500is collapsed and loaded within the outer sheath11510, and is captured within the proximal apex capture device11420,11520(as shown inFIG. 115), the bare stent11530spans the distance between the leading edge of the graft and the apex capture device11420,11520. The umbrella11400can be disposed outside the stent graft (and inside the outer sheath11510) but, in the exemplary embodiment shown inFIGS. 114 and 115, the umbrella11400is held by the catheter11410interior to both the umbrella11400and the outer sheath11510. Arms11402of the umbrella11400extend therefrom between respective apices of the bare stent11530. The arms11402are relatively narrow at the intermediate portion where each is passing through the apices and expand to be relatively wide at their distal ends. In such a configuration, the distal ends of each arm11402can spread out over the adjacent bare stent apices and, if wide enough, overlap with adjacent other arms11402to canopy out around the entire circumference of the exposed bare stent11530as shown inFIG. 115. At least one passage11404is formed at the distal portion of the arm11402so that a respective tine of the proximal apex capture portion11420can extend therethrough. In this configuration, the wide distal portions of the arms11402are controlled and stay against the bare stent, protecting the outer sheath11510and interior vessel wall up until the time when the apex capture device11420,11520is actuated (a position that is shown inFIG. 115but the bare stent11530and the arms11402have not yet been released from the tines of the proximal apex capture portion11420).FIG. 116is photograph depicting how the umbrella11400protects the interior of the vessel wall11600before the delivery system has refracted the inner catheter11410. As the inner catheter11410is retracted, the umbrella11400will slide out from between the bare stent11530and the vessel wall11600.

In an exemplary embodiment where infra-renal barbs of the stent graft are not desired, they can be moved higher on the bare stent so that they can be covered by the fabric strips of the umbrella11400.

FIGS. 117 to 124illustrate a concept according to the invention that uses a proximal clasp to expand the taper tip and create/improve a seal between the nose cone/tip and the outer sheath, the interface eliminating pronouncement of the outer sheath edge by taking up the space between the tip and the outer sheath. The delivery systems described herein (e.g., AAA delivery systems), the concept of removing the inner components of the delivery system (tip/support member) while leaving the outer sheath behind requires the tip to be smaller than the ID of the outer sheath. Due to the smaller shape of the tip, the problem of “fish mouthing” can occur at the tip-sheath interface. “Fish mouthing” occurs when the edge of the sheath becomes pronounced when the tip sheath interface is navigating the vessel, which could potentially score the vessel wall, seeFIGS. 117 and 118. To solve the problem the space between the tip and the sheath needs to be eliminated but still allow for removal of the tip. SeeFIGS. 119 to 120. To accomplish this removal of material underneath the distal claps and allowing the proximal clasp to be moved more forward so that the taper tip can be expanded over the clasp taking lip the space between the sheath and tip.

FIGS. 125 and 126illustrate an exemplary embodiment of a passive proximal retainer device12500for the AAA bifurcated stent graft according to the invention, which retainer device12500is referred to herein as a spoked hub. A proximal retainer is required for the ipsilateral leg of the AAA bifurcated stent graft. The proximal fixation holds the stent graft in the deployment sheath during cannulation of the contralateral leg with the guidewire and the leg stent. The passive proximal retainer device12500is a hub fitted to the support member at the proximal end of the stent graft. The passive proximal retainer device12500has spokes12502radiating out from a central hub12504. The number of spokes is equivalent to the number of struts on the proximal end of the stent. The spokes are engaged and trapped by the individual struts of the stent during the loading process. The stent graft is loaded into the deployment sheath through the use of a funnel. When the proximal end of the stent is just about in the deployment sheath, the support member is loaded next to the graft and the spokes of the hub are engaged in the graft struts. The graft and support member are, then, pulled into the sheath. During deployment of the stent, the graft will not be released from the sheath until the sheath is fully retracted over the spoked hub. The outer diameter (OD) of the spokes are about 0.008 inches less than the inner diameter (ID) of the sheath, therefore, the stent struts are trapped by the spoked hub until the sheath is retracted.

The teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. The teaching of U.S. patent application Ser. Nos.: 10/884,136; 10/784,462; 11/348,176; 11/699,701; 11/699,700; 11/700,609; 11/449,337; 11/353,927; 11/701,867; 11/449,337; 11/700,510; 11/701,876; 11/828,653; 11/828,675; and 12/137,592 are also incorporated by reference herein in their entirety.