WO2014022213A1

WO2014022213A1 - Expandable graft and associated methods for deployment

Info

Publication number: WO2014022213A1
Application number: PCT/US2013/052222
Authority: WO
Inventors: M.D. Amy C. DWYER
Original assignee: University Of Louisville Research Foundation, Inc.
Priority date: 2012-07-31
Filing date: 2013-07-26
Publication date: 2014-02-06

Abstract

The present invention relates to devices, systems and methods for implanting a radially extendable endoluminal graft. In certain aspects, the devices, systems, and methods of the present invention include a radially expandable endoluminal graft mounted on a delivery tube and having a distal end and a proximal end. A first retention element is also mounted on the delivery tube at or adjacent to the distal end of the expandable endoluminal device, and a second retention element is mounted on the delivery tube at or adjacent to the proximal end of the expandable endoluminal device. Expansion of the first and/or second retention elements reduces or prevents migration of the graft during and immediately after graft deployment.

Description

EXPANDABLE GRAFT AND ASSOCIATED METHODS FOR DEPLOYMENT

CROSS REFERENCES TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional Application Ser. No.

61/677,821, filed on July 31, 2012, and to U.S. Provisional Application Ser. No. 61/691,065, filed August 20, 2012, the contents of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to devices, systems, and methods for reducing or preventing the migration of a radially extendable graft during implantation in a lumen, bodily conduit, or vasculature of a patient or subject.

BACKGROUND OF THE INVENTION

Implantable medical grafts (such as stents) used for the repair or reinforcement of cardiac and vascular structures are well-known in the art. Such devices are implanted on an interior side of a vascular lumen often using standard interventional or endovascular techniques. By way of example, the target site of the vascular lumen is surgically accessed by an arterial or venous point of entry. A distal end of a medical device (e.g. catheter) that contains the graft is threaded from this point along the artery or vein to the targeted region. The implantable component is then deployed and affixed to the vascular lumen wall (often using an expandable graft and/or angioplasty balloon), and the remainder of the distal portion of the medical device assembly is removed. In one application, such grafts are provided to maintain vascular access during long-term hemodialysis and to counteract the stenosis commonly observed as a side-effect. This is often accomplished by implanting of one or multiple grafts in either or both arterial and venous structures being used in the procedure. With the former, the arterial vessel walls can act as a natural barrier preventing graft migration during implantation. That is, blood flowing through the artery may cause the graft to migrate away from the target site. But even if this is observed, vessel narrowing will eventually impede the progress of the graft.

This is not the case with the venous system, however. As a graft is deployed using many of the currently existing systems, methods or devices, it may migrate with the blood flow toward the heart. This is particularly true in instances where blood flow rate is much higher, i.e. at target locations closer to the heart. Stent migration in such cases can have dire consequences for the patient and, in certain cases, can be fatal. Accordingly, a device, system, and method for reducing or preventing graft migration prior to and during graft deployment is desirable.

U.S. Patent No. 6,984,242 ("the '242 patent") discloses an applicator for a stent that contains barrier elements 67 and 68 adjacent to the stent's distal and proximal ends. While these barrier elements are intended to assist in confining the stent to the delivery catheter. It fails to provide a barrier element that prevents stent migration as or immediately after it is deployed. That is, as the stent is expanded beyond the diameter of these elements but before it is affixed to the vessel wall, the stent may still migrate with the blood flow over barrier elements 67 or 68 and away from the targeted site. Accordingly, at least as it pertains to the problem identified herein, the '242 patent does not provide an adequate solution. SUMMARY OF THE INVENTION

In certain non-limiting aspects, the present invention relates to a graft delivery assembly for implanting a radially extendable endoluminal graft. The assembly includes at least (a) a radially expandable endoluminal graft mounted on an external surface of a delivery tube, the graft having a distal end and a proximal end; (b) a first retention element mounted on the delivery tube at or adjacent to the distal end of the expandable endoluminal graft and over a first opening in the tube; and (c) a second retention element mounted on the delivery tube at or adjacent to the proximal end of the expandable endoluminal graft and over a second opening in the tube.

In one aspect of the invention, the expandable endoluminal graft is encoated at least partially on at least one side with a biocompatible material, which may include ePTFE. In further embodiments, the graft is self-deployable and may be provided on the delivery tube at a first diameter, where the graft is covered with a removable sheath to constrain at least a portion of the graft from radially expanding. When the sheath is removed, the graft deploys or is deployable in that its diameter expands radially.

In further aspects of the invention, the first retention element and the second retention element are mounted to an exterior side of the delivery tube such that the first retention element encloses the first opening and the second retention element encloses the second opening. Each of the first retention element and second retention element may be formed from an elastic material, and may receive fluid through the first and second openings, respectively. Fluid may be provided, in certain aspects, through a single lumen in the delivery tube, which delivers fluid to both openings. In alternative aspects, the fluid is provided to the first and second retention elements by independent lumens in the delivery tube. While not limited thereto, the fluid may include saline or a radiopaque dye.

In even further aspects, at least one of the first and second retention elements are provided with one or more radiopaque markers. Such markers may be provided as one or more circumferential bands that aid in the visualization of the retention elements during graft deployment.

In a further non-limiting embodiment, the present invention also relates to a method for inserting a radially extendable endoluminal graft within a vascular lumen. This method includes at least the steps of (a) providing graft delivery assembly in accordance with any of the foregoing embodiments or any of the embodiments provided herein; (b) inserting a distal end of the delivery tube into a bodily conduit of a subject or patient; (c) expanding at least one of the first and second retention elements radially using a fluid that is provided through the first and/or second openings; (d) expanding the graft radially; and (e) deflating the expanded first and/or second retention elements.

In certain aspects, the bodily conduit is a vein or artery. In further aspects, the expansion of the first and/or second retention elements substantially reduces or prevents fluid flow through the bodily conduit, at least between the two retention elements. As the element(s) is expanding, the operator may adjust its location to ensure adequate placement within the body of the patient. In certain embodiments, the first and/or second retention elements may be adjusted by the visualization of one or more radiopaque markers on the first and/or the second element. As provided in greater detail below, methods of using the present invention contemplate expansion of one retention element or both retention elements (simultaneously or staggered). One of skill in the art would readily appreciate that the determination of which retention element will be deployed or the time frame in which the two retention elements will be deployed may be dependent upon one or more of a wide-array of circumstances surrounding the deployment process.

Applicants assert that the foregoing embodiments, and advantages to such embodiments, are not limiting to the present invention. Additional embodiments, and advantages will be readily apparent to one of skill of the art on the basis of at least the remaining disclosure provided herein.

BRIEF DESCRIPTION OF THE FIGURES FIG. 1 provides a side view of one embodiment of the graft delivery assembly of the present invention.

FIG. 2 provides a cross-sectional view of the delivery tube of FIG. 1, along line 2-2 of that figure.

FIGS. 3A-F sequentially illustrate one embodiment of an implantation method for using a graft delivery assembly to implant a graft within a lumen or bodily conduit of a patient.

DETAILED DESCRIPTION OF THE INVENTION

In certain aspects, the present invention relates to a device, system and associated methods for reducing or preventing migration of a graft during and immediately post-deployment within a bodily conduit or lumen. Referring to FIG. 1, one embodiment of a device 2 in accordance with the present invention is illustrated. Generally speaking, the device includes a delivery mechanism 4, a graft 6, a pair of expandable graft retention elements 8 and 10, and a graft deployment handle 12. In one aspect, the delivery mechanism 4 is a longitudinal tube, such as but not limited to a catheter, of sufficient length to reach from a point of entry in a patient to the targeted site of graft deployment. The tube 4 is hollow and contains one or multiple separate lumens. A distal end 26 of the tube is adapted to enter into the vasculature, bodily lumen, or conduit of a patient and be threaded within the body to the target site. A proximal end 28 of the tube 4 is adapted to be received by the deployment handle 12, which has one or more ports adapted to provide access the lumen(s) of the tube.

In certain aspects, and referring to FIG.2, the tube 4 contains at least three lumens 14, 16, and 18, each lumen may provide an independent function to deployment of the graft. Lumen 14, for example, may be adapted to receive a guide wire, or similar device, that assists in guiding the longitudinal tube 4 into the body of the patient or subject to the targeted site for graft deployment. To this end, the lumen 14 may extend from a proximal end 28 of the tube 4 to a opening (not illustrated) in the tube's distal end 26. At the proximal end, the lumen 14 is placed into fluid communication with a corresponding port 32 of the handle 12. The hole at the distal end of the tube 4 is provided to allow the guide wire (or similar guiding element) to pass therethrough and facilitate placement of the tube 4 in the bodily conduit or vasculature. The diameter of the lumen and each lumen opening at the distal and proximal end of the tube 4 may be of any size or shape (uniform, tapered, or otherwise), so long as it is able to be received by the handle and allow movement of the guide wire through the tube 4 in accordance with the methods of using the present invention, as described in greater detail below.

The second lumen 16 of tube 4 may be provided for access to the graft device 6 and to facilitate deployment of it once it has reached the target site. Specific mechanisms of such deployment are discussed in greater detail below. The lumen may be of any diameter, size, or shape to facilitate deployment in accordance with the embodiments of the present invention.

The third lumen 18 may be provided to effectuate expansion of the graft retention elements 8 and 10. One lumen may be provided, as illustrated, to access both expandable graft retention elements 8, 10. Alternatively, two separate lumens may be provided where each is independently in communication with only one of the two graft retention elements. Specific mechanisms of retention element expansion are discussed in greater detail below. The lumen may be of any diameter, size, or shape to facilitate expansion in accordance with the

embodiments of the present invention.

One of skill in the art will readily appreciate that the present invention is not limited to the foregoing three lumen structure or the corresponding uses or configurations of each that are provided herein. Rather, one of skill in the art would readily appreciate that more or fewer lumens may be provided in accordance with the present invention and that alternative uses or configurations may also be provided to effectuate graft delivery in accordance with the various embodiments provided herein.

The graft 6 may be manufactured from any material and provided in any configuration known in the art, particularly, though not exclusively, a material and configuration having the strength and elasticity to permit radial expansion and resistance radial collapse. As illustrated in FIG. I, in one embodiment, the graft 6 is provided as a hollow element 20 having a distal end 22, a proximal end 24 and forming an interior surface and exterior surface. It is expandable in that it can be contained at a smaller diameter for insertion into a body conduit or lumen and

subsequently expanded to a larger diameter, where it is maintained. The diameter (both smaller and larger) may be uniform, or in certain aspects may be flared at one or both ends. While the graft 6 may be manufactured from a solid, but expandable material, in certain aspects, it is provided as wire mesh. The wires may be formed from a biocompatible or inert material including, but not limited to, stainless steel, nickel-titanium alloy (nitinol), tantalum, elgiloy, various polymer materials, such as poly(ethylene terephthalate) (PET) or

polytetrafluoroethylene (PTFE), or bioresorbable materials, such as levorotatory polylactic acid (L-PLA) or polyglycolic acid (PGA). In certain aspects, the material comprises a superelastic material, such as nitinol metal, that can withstand tight compression in a compacted

configuration and then self-expand to a deployed configuration once released in place.

Alternatively, the graft 6 of the present invention may be constructed from a material (e.g., stainless steel) that can be mechanically enlarged in place, such as through balloon expansion.

The graft 6 may be coated on at least a portion of either or both its interior surface and/or exterior surface with a biocompatible coating. The coating may be provided to insulate the material of the graft, e.g. the wire mesh, from contacting the surface of a patient's body, thereby reducing risk of injury or an immunogenic reaction. The coating, in certain aspects, is provided substantially across the entire interior and exterior surface of the graft 6. In such a configuration, it provides a substantially smooth and inert biocompatible surface that may be affixed to the wall of a vasculature, bodily conduit, or lumen within a patient. Such materials, in certain

embodiments, have the strength and structural elasticity to permit radial expansion of the graft 6. One non-limiting example of such a coating material that is well-known in the art at includes expanded polytetrafluoroethyulene (ePTFE).

To facilitate placement of the graft 6, a series of radiopaque markers 42, such as circumferential bands, may be provided along its length. In certain embodiments, and as illustrated, the radiopaque markers 42 may be provided on at least the distal and/or proximal ends 22, 24 of the graft. Such elements are well-understood to facilitate fluoroscopic visualization of the graft during deployment and to ensure correct positioning. The graft also may be imbibed with various pharmaceutical agents, biological agents, or genetic therapies for targeted delivery (luminally or otherwise) of these substances. Non-limiting examples of such substances may include anti-thrombogenic agents, anti-microbial agents (e.g. antibiotics, antiviral, anti-fungal, anti-parasitics, etc.), anti-septic agents, anti-proliferative agents, antiinflammatory agents, anti-neoplactic agents, anti-miotic agents, anesthetic agents, anticoagulants, anti-oxidants, angiogenic agents, or any other therapeutic compound, substance, biologic, or agent otherwise known in the art. Following deployment of the graft 6, these agents can be released over time.

The graft 6 may be expandable by any mechanism known in the art. While in certain aspects, the graft 6 may be expanded manually, such as with an angioplasty balloon or similar device, in other aspects, the graft 6 is self-deployable. To this end, the graft 6 is provided at a reduced diameter, which may be at or slightly larger than the diameter of the delivery tube 4. Encapsulating the graft 6 is an exterior constraining sheath 40, which retains the graft 6 in its reduced diameter configuration. The constraining sheath 40 may be manufactured from any material that is able to constrain the expandable graft 6 and may be easily released or removed prior to deployment in the body. In certain non-limiting embodiments, for example, the sheath 40 is manufactured from an biocompatible, inert material, such as ePTFE or any similar polymeric material discussed herein or otherwise known in the art.

Any mechanism for removing the sheath 40 during deployment of the graft may be used. In one aspect, the sheath 40 can be configured to be removed in place and to remain with the graft 6. For example, the sheath 40 may be provided with a line of perforations through its wall, which are along its length. When pressure is applied on the interior walls of the graft 6, such as with a balloon, the sheath 40 splits along the perforations and the graft 6 is allowed to expand radially. The sheath 40 may be left in place or removed using standard means known in the art.

In an alternative embodiment, the sheath 40 can be withdrawn from the graft 6 so as to effectuate graft deployment. That is, the sheath 40 may be provided with a deployment line (not illustrated) extending from a portion of the sheath adjacent or near the proximal end 24 or distal end 22 of graft 6 through a lumen 16 of the tube and out of port 30 of handle 12 where it can be manipulated by an operator. As illustrated in FIG. 3C, deployment line is pulled in a direction away from the graft 6, first exposing the graft's distal end 22, which deploys. The operator continues to pull the deployment line of sheath 40 until the entire graft 6 is exposed and expanded radially.

In certain embodiments, such as that disclosed in U.S. Patent No. 7,556,641, the contents of which are incorporated herein by reference in its entirety, a double-walled tubular sheath is used. That is, the walls of the sheath are folded over once such that the folded end is at or near to the distal end 22 of the graft 20. Double walls enable the sheath to be retracted from around an expandable medical device by sliding one wall past the other wall. As the sheath is retracted or unrolled away from the distal end 22 of the graft 20, the sheath portion does not rub or scrape against the underlying expandable medical device.

Though not illustrated, the sheath 40 also may be provided with one or a series of radiopaque markers, such as circumferential bands, along its length and/or at its ends. Such elements are well-understood to facilitate fluoroscopic visualization of the graft during deployment and to ensure correct positioning. The pair of expandable graft retention elements 8 and 10 are proximate or adjacent to the distal end 22 and proximal end 24 of the graft 6. In certain aspects, these elements are made from an elastic or expandable material that is adapted to expand to the approximate

circumference of the surrounding vasculature. That is, elements 8 and 10 each may be adapted to prevent or reduce blood or fluid flow from moving or migrating the graft 6 as it is deployed into place.

In one non-limiting embodiment, the tube 4 contains at least one opening at on each side of the graft 6 about which each retention element 8 and 10 is independently mounted. Each element 8 and 10 has a continuous diameter that surrounds an exterior side of the delivery tube 4 and encloses each opening in the delivery tube 4. Each element 8, 10 is independently secured to the tube 4 such that fluid that flows through each opening is contained within the retention element and allows the element to expand without the fluid leaking to the surrounding environment. Methods of securing the retention elements to a delivery tube 4 are well-known in the art and include, but are not limited to, crimping, welding, gluing, or the like. While the placement of the openings on the tube 4 is not necessarily limiting to the invention, in certain aspects the openings, and retention elements 8, 10, should be a sufficient distance from the ends of the graft 6 such that the retention elements, when expanded, will not interfere with graft 6 deployment or radial expansion.

The fluid provided to each retention element may include saline, a radiopaque or contrast dye, air, or any other fluid that is known in the art for use with balloon-based systems, or balloon-tipped catheters. In certain non-limiting aspects, the retention elements 8 and 10 are expanded using contrast dye, which enables operator visualization and control of retention element expansion. Although not illustrated, one or both retention elements 8, 10 also may be provided with one or a series of radiopaque markers, such as circumferential bands, along its length and/or at its ends. Such elements, as discussed herein, could further facilitate fluoroscopic visualization of the graft during deployment and ensure correct positioning of the assembly and/or of the graft.

As indicated above, both retention elements are illustrated as being expanded using a single lumen 18 of the tube 4. That is, through a port 34 in the deployment handle 12 the fluid may be provided such that retention elements 8 and 10 are simultaneously deployed. In alternative embodiments, however, each retention element 8 and 10 may be independently controlled by separate lumens in the delivery tube 4. To this end, the end operator can independently control fluid flow into each retention element and modify the rate at which each element expands or control the expansion of one retention element over the other.

Referring to FIGS. 3A-3F sequential illustration of one non-limiting method of using the present delivery assembly is illustrated. As illustrated in FIG. 3A, a guide wire 36 is inserted into a bodily conduit of a patient, generally represented by reference number 38, from an entry point in the body (not illustrated). The guide wire 36 is provided to a location past the target site. The distal end 26 of the delivery tube 4 is then threaded along the guide wire 36 by way of a lumen 14 until the graft tube 20 is positioned at the target site. The operator can visualize positioning of the graft 20 using the radiopaque markers on any of the grafting device 20, sheath 40, or retention elements 8 and/or 10.

Once in place, and as illustrated in FIG. 3B, the operator provides fluid to each of retention elements 8 and 10 by way of a port 34 in the handle 12 (illustrated in FIG. 1). The fluid travels through the lumen 18 (illustrated in FIG. 2) of the tube (or through each independent lumen in such embodiments) and begins expanding the circumference of each retention element 8 and 10. Both retention elements 8 and 10 are expanded until the circumference of each is approximately the same, or slightly larger or smaller than the circumference of the bodily conduit 38. This serves to substantially reduce or prevent fluid flow though the conduit 38.

As indicated above, the expansion of the retention elements 8, 10 may be independently controlled through separate lumens of the delivery device. Thus, the present invention is not limited to expansion of retention elements 8, 10 simultaneously during the graft deployment process. In certain aspects, the deployment of one or both retention elements 8, 10 may be temporally off-set where one of the two retention elements is deployed first, and the second deployed thereafter.

The present invention is also not limited to the expansion of both retention elements 8, 10 during the deployment process. In further aspects, only one of the two retention elements 8,10 is expanded. By way of non-limiting example, the retention element 10 most proximal to the handle can be expanded to prevent migration of the graft during graft deployment in an arterial vessel or to reduce/prevent fluid flow during deployment in a vein. Conversely, the retention element 8 most distal to the handle can be expanded to prevent migration of the graft during the deployment in an vein or to reduce/prevent fluid flow during deployment in an artery.

One of skill in the art would readily appreciate that determination of which retention element will be deployed or a time in which one or both retention elements will be deployed can be dependent upon a wide-array of the circumstances surrounding the deployment process. Such circumstances may include, but are not limited to, the type of vessel (e.g. artery or vein), the proximity of the vessel to the heart or a vital organ, the rate of fluid flow through the vessel, the size of the graft, or the like. To this end, the present invention is not limited to any particular rationale for expanding only one retention element or for temporally staggering the expansion of the two retention elements. Rather, the present invention includes the expansion of only one retention element or of both retention elements for any reason during the graft deployment process.

As used herein, the terms "reduce," "reducing," or "reduction," when used in conjunction with fluid flow, refer to any measurable reduction in fluid flow through the bodily conduit, vasculature, or lumen of a patient, at least with respect to flow between the two retention elements 8 and 10. With respect to graft migration, these terms mean any measurable reduction in tendency of a graft to migrate, as compared to a device, system, or method not in accordance with the present invention, particularly, though not exclusively a device, system, or method lacking the retention elements 8 or 10. The term "substantially," when used in conjunction with these terms refers to decreasing the fluid flow or migration by at least about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85% to 100%.

The terms "prevent," "preventing," or "prevention," when used in conjunction with fluid flows refers to stopping entirely fluid flow through the bodily conduit, vasculature, or lumen of a patient, at least with respect to flow between the two retention elements 8 and 10. When used in conjunction with graft migration, these terms refer to stopping the graft from migrating at least beyond retention elements 8 or 10 during deployment of the graft.

The contrast fluid and/or radiopaque markers on the retention elements 8 and 10 may be used by the operator to ensure correct positioning of each as and immediately after the retention elements 8 and 10 are expanded.

Referring to FIG. 1 and FIG. 3C, the graft 20 is then deployed in accordance with the teachings herein. In one non-limiting aspect, a string on the sheath is pulled by the operator through lumen 16 of the delivery tube 4 and out of port 30 of the deployment handle 12. As the string is pulled, it retracts from the distal end 22 of graft tube 20 allowing this end of the graft 20 to expand. The graft is then fully expanded, as illustrated in FIG. 3D, after the sheath has been fully removed. The operator can then use the radiopaque markers to adjust the positioning of the graft 20, as necessary. Again, the present method, is not limited to this deployment technique and may be adapted in accordance with the type of sheath used, as discussed herein, and any alternative deployment techniques that are known in the art for use with such or similar sheaths discussed herein or otherwise known in the art.

While not illustrated, the operator can then ensure that the graft 20 is adequately secured to the wall 38 of the bodily conduit using standard means in the art, such as, but not limited to an angioplasty balloon. Once secured, and referring to FIG. 3E, the retention elements 8 and/or 10, whichever are deployed, are deflated by withdrawing the fluid through the lumen 18 (illustrated in FIG. 2) and port 34 of the handle 12 (illustrated in FIG. 1) using standard methods known in the art. These elements can be deflated simultaneously, where deflation is provided through one lumen, or separately, where separate lumens are used for each retention element. The delivery tube 4 and guide wire 36 are then removed from the patient with the graft 20 remaining in place, as illustrated in FIG. 3F.

One advantage to the foregoing device, system, and method is that migration of the graft 20 is minimized during deployment. The expansion of retention elements 8 and/or 10 prior to deployment of the graft 20, reduces or prevents the fluid flow through the conduit 38 as the graft 20 is deployed. This allows the operator to easily manipulate the graft 20, while minimizing the risk of graft 20 migration. This is particularly, though not exclusively, advantageous when the graft is being deployed in a vein or bodily conduit where fluid flows to a vital organ. In further embodiments, the assembly and methods are advantageous when a graft is desirable in a venous system, such as the deployment of such grafts to maintain hemodialysis vascular access. In such instances, the graft can be implanted in accordance with the present invention with significantly lower risk of migration toward or into the heart. Additional advantages and embodiments will be readily apparent to one of skill in the art, based on the disclosure provided herein.

Claims

CLAIMS What is claimed is:

1. A graft delivery assembly for implanting a radially extendable endoluminal graft comprising:

a radially expandable endoluminal graft mounted on an external surface of a delivery tube, the graft having a distal end and a proximal end;

a first retention element mounted on the delivery tube at or adjacent to the distal end of the expandable endoluminal graft and over a first opening in the tube; and

a second retention element mounted on the delivery tube at or adjacent to the proximal end of the expandable endoluminal graft and over a second opening in the tube.

2. The graft delivery assembly of claim 1 , wherein the expandable endoluminal graft is encoated at least partially on one side with a biocompatible material.

3. The graft delivery assembly of claim 2, wherein the biocompatible material comprises ePTFE.

4. The graft delivery assembly of claim 1 , wherein the expandable endoluminal graft is self- deployable.

5. The graft delivery assembly of claim 4, wherein the expandable endoluminal graft is provided on the delivery tube at a first diameter and is covered with a removable sheath that constrains at least a portion of the graft from radial expansion.

6. The graft delivery assembly of claim 1 , wherein the first retention element and the second retention element are mounted to an exterior side of the delivery tube such that the first retention element encloses the first opening and the second retention element encloses the second opening.

7. The graft delivery assembly of claim 1 , wherein the first retention element and second retention element are formed from an elastic material.

8. The graft delivery assembly of claim 1 , wherein the first retention element and second retention element receive fluid through the first and second openings, respectively.

9. The graft delivery assembly of claim 8, wherein the fluid is provided to the first and second retention elements through a single lumen in the delivery tube.

10. The graft delivery assembly of claim 8, wherein the fluid is provided to the first and second retention elements by independent lumens in the delivery tube.

11. The graft delivery assembly of claim 8, wherein the fluid comprises saline or a radiopaque dye.

12. The graft delivery assembly of claim 1 , wherein at least one of the first and second retention elements are provided with one or more radiopaque markers.

13. The graft delivery assembly of claim 12, wherein radiopaque markers are provided as circumferential bands.

14. A method for inserting a radially extendable endo luminal graft within a vascular lumen comprising:

a. providing graft delivery assembly comprising: a radially expandable endoluminal graft mounted on a delivery tube and having a distal end and a proximal end; a first retention element mounted on the delivery tube at or adjacent to the distal end of the expandable endoluminal graft and over a first opening in the tube; and a second retention element mounted on the delivery tube at or adjacent to the proximal end of the expandable endoluminal graft and over a second opening in the tube; b. inserting a distal end of the delivery tube into a bodily conduit of a subject or patient;

c. expanding, radially, at least one of the first and second retention elements using a fluid that is provided through the first and/or second opening;

d. expanding, radially, the graft; and

e. deflating the expanded first and/or second retention element.

15. The method of claim 14, wherein the bodily conduit is a vein or artery.

16. The method of claim 14, wherein the expandable endoluminal graft is self-deployable and is provided at a first diameter and is covered with a removable sheath that constrains at least a portion of the device from radial expansion.

17. The method of claim 16, further comprising removing the sheath to radially expand the graft.

18. The method of claim 14, wherein the expanding of the first and/or second retention element substantially reduces fluid flow through the bodily conduit.

19. The method of claim 14, wherein the expanding of the first and/or second retention elements stops fluid flow through the bodily conduit between the two retention elements.

20. The method of claim 14, wherein the fluid is received in the first retention element and second retention element from a single lumen of the delivery tube.

21. The method of claim 14, wherein the fluid is received in the first retention element and second retention element from independent lumens of the delivery tube.

22. The method of claim 14, wherein the fluid comprises saline or a radiopaque dye.

23. The method of claim 14, further comprising adjusting the location of the first and/or second retention element as they are expanded.

24. The method of claim 23, wherein the first and second elements are adjusted by the visualization of one or more radiopaque markers on the first and/or the second element.

25. The method of claim 14, wherein the first retention element is expanded.

26. The method of claim 14, wherein the second retention element is expanded.

27. The method of claim 14, wherein the first and second retention elements are expanded.

28. The method of claim 27, wherein the first and second retention elements are expanded simultaneously.