Balloon-assisted endoluminal prosthesis deployment

Abstract

To provide balloon assisted endoluminal prosthesis deployment.SOLUTION: The invention provides delivery system embodiments for treatment of a vascular defect of a patient's vasculature that may include an endoluminal prosthesis loaded on a delivery catheter. In some cases, an inflatable balloon used to facilitate deployment of the endoluminal prosthesis may be disposed within an inner lumen of a tubular graft portion of the endoluminal prosthesis. In one embodiment, the endoluminal prosthesis further comprises a plurality of radiopaque markers which are circumferentially disposed adjacently to the proximal end of the tubular main graft portion, and a proximal end of the inflatable section of the inflatable balloon is disposed adjacently but distal to the radiopaque markers.SELECTED DRAWING: Figure 10

Description

[Background technology]

[0001] (Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 167,247, filed May 27, 2015, inventor: Mark Geusen, entitled "BALLOON ASSISTED ENDOLUMINAL PROSTHESIS DEPLOYMENT," Attorney Docket No. TRI-1708-PV, the entire contents of which, including all of the text and drawings, are incorporated herein by reference.

[0002] (background) Aneurysms are generally vascular disorders that are manifested by the dilation and weakening of the walls of a patient's arteries. Aneurysms can develop at various locations within a patient's body. Thoracic aortic aneurysms (TAA) or abdominal aortic aneurysms (AAA) are manifested by the dilation and weakening of the aorta, and are serious and fatal diseases for which intervention is generally indicated. Existing methods for treating aneurysms include invasive surgical procedures that involve graft replacement of the affected blood vessel or body lumen or reinforcement of the blood vessel with a graft.

[0003] Surgical procedures for treating aortic aneurysms can have relatively high morbidity and mortality rates due to risk factors inherent in surgical repair of the disease as well as long hospital stays and painful recoveries. This is particularly true for surgical repair of TAAs, which are generally considered to involve higher risks and additional difficulties compared to surgical repair of AAAs. Examples of surgical procedures involving the repair of AAAs are described in a book entitled "Surgical Treatment of Aortic Aneurysms" by Denton A. Cooley, MD, published in 1986 by WB Saunders Company.

[0004] Due to the inherent risks and complexities of surgical repair of aortic aneurysms, minimally invasive endovascular repair has become a widely used alternative therapy, especially in treating AAA. Early studies in this field are illustrated by Lawrence, Jr., et al. in "Percutaneous Endovascular Graft: Experimental Evaluation" (Radiology) (May 1987) and by Mirich, et al. in "Percutaneously Placed Endovascular Grafts for Aortic Aneurysms: Feasibility Study" (Radiology) (March 1989).

[0005] When deploying endoluminal prosthesis type devices by catheters or other suitable instruments, it may be advantageous to have flexible and low-profile endoluminal prostheses and delivery systems, such as various guide catheters and stent grafts for passage through the sometimes tortuous anatomy of the patient. While many of the existing endovascular devices and methods for treating aneurysms represent significant advances over previous devices and methods, they often use systems with relatively large transverse profiles of up to 24 French. Furthermore, such existing systems have more lateral stiffness than desired, which may complicate the delivery process, especially for use in treating vascular defect sites that include a high degree of curvature or angulation. Even with more flexible low-profile delivery systems, deployment of endovascular prostheses in highly angular and curved vessels may be problematic due to difficulties in visualizing or imaging the orientation of the prosthesis during the deployment process. Achieving a proper seal between the outer surface of the endovascular prosthesis and the inner surface of the vessel being treated after deployment of the endovascular prosthesis may also be difficult in some cases. Thus, minimally invasive endovascular treatment of aneurysms may not be available to many patients who would benefit from such procedures and may be more difficult to perform for those patients for whom the procedures are indicated.

[0006] What is needed is an endoluminal prosthesis and suitable delivery catheter that can be adapted to a wide range of patient anatomies and that can be safely and reliably deployed using a flexible, low profile system. Summary of the Invention [Means for solving the problem]

[0007] Some embodiments of a delivery system for the treatment of vascular disorders may include an endoluminal prosthesis for the treatment of vascular disorders and a delivery catheter. The endoluminal prosthesis may include a tubular main graft portion with a thin flexible material, a main inner lumen, a proximal end, and a distal end. The endoluminal prosthesis may also have a self-expanding anchor member having a proximal portion and a distal portion. The distal end of the distal portion may be secured to the proximal end of the tubular main graft portion, and the distal end of the proximal portion may be secured to the proximal end of the distal portion. In addition, the endoluminal prosthesis may also have a plurality of radiopaque markers circumferentially disposed adjacent the proximal end of the tubular main graft portion. For some embodiments, the delivery catheter of the delivery system includes an elongated shaft member with sufficient column strength for percutaneous advancement within a patient's vasculature, and the elongated shaft may also have a proximal section and a distal section. A plurality of releasable belts may be disposed on the proximal section of the elongate shaft and configured to releasably restrain the self-expanding anchor member of the endoluminal prosthesis. A plurality of elongate release members may be disposed in operable communication with the distal end of the elongate shaft, each including a proximal section configured to releasably secure at least one respective releasable belt while the releasable belt is in a configuration restraining at least a portion of the self-expanding anchor member of the endoluminal prosthesis. The inflatable balloon may be secured to the elongate shaft within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis. In some cases, the inflatable balloon may be disposed at an axial location where a proximal end of the inflatable section of the inflatable balloon is adjacent to but distal to the self-expanding anchor member. In some cases, the inflatable balloon may be disposed at an axial location where a proximal end of the inflatable section of the inflatable balloon is adjacent to but distal to the radiopaque marker. For some inflatable balloon embodiments, the proximal neck portion of some inflatable balloon embodiments (the portion of the tubular member of the inflatable balloon tube that contacts the outer surface of the shaft) may be positioned proximal to the radiopaque marker, so long as the proximal angled portion or proximal cone of the inflatable balloon and any pleats of the inflatable balloon material are positioned distal to the radiopaque marker.

[0008] Some embodiments of a method of deploying an endoluminal prosthesis may include advancing into a patient's vasculature a delivery system including an elongate shaft and an endoluminal prosthesis releasably secured to the elongate shaft. The method may also include releasing an external restraint from a main graft portion of the endoluminal prosthesis to allow the self-expanding anchor member to partially deploy, and partially releasing an external radial restraint from the self-expanding anchor member of the endoluminal prosthesis. An inflatable balloon may then be inflated and radially expanded to radially expand a portion of the graft portion of the endoluminal prosthesis disposed adjacent to and axially coextensive with the inflatable balloon. In some cases, the inflatable balloon may be disposed within the main inner lumen of the main graft portion of the endoluminal prosthesis, and a proximal end of an inflatable section of the inflatable balloon may be disposed adjacent to but distal to the self-expanding anchor member. In some cases, the inflatable balloon is disposed within the main inner lumen of the main graft portion of the endoluminal prosthesis, and a proximal end of the inflatable section of the inflatable balloon may be disposed adjacent to, but distal to, a plurality of radiopaque markers that may be disposed circumferentially adjacent a proximal edge of the main graft portion of the endoluminal prosthesis. The outer radial restraint on the self-expanding anchor member may then be fully released to fully deploy the self-expanding anchor member of the endoluminal prosthesis. In some cases, inflating and radially expanding the inflatable balloon may include inflating and radially expanding the inflatable balloon to apply an outward radial force on the inner surface of the main inner lumen of the main graft portion of the endoluminal prosthesis until an outer surface of the main graft portion adjacent the inflatable balloon is brought into contact with an inner surface of the patient's vessel.

[0009] Some embodiments of a delivery system for the treatment of vascular disorders may include an endoluminal prosthesis for the treatment of vascular disorders and a delivery catheter. The endoluminal prosthesis may include a tubular main graft portion having a thin flexible material, a main inner lumen, a proximal end, and a distal end. The endoluminal prosthesis may also include a self-expanding anchor member whose distal end is secured to the proximal end of the tubular main graft portion. The delivery catheter may include an elongate shaft having a distal section and a proximal section, the proximal section may be configured to releasably secure the endoluminal prosthesis in a restrained state. The delivery catheter may also include an inflatable balloon secured to the elongate shaft and disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis at an axial location where the proximal end of the inflatable section of the inflatable balloon is disposed adjacent to, but distal to, the self-expanding anchor member. The present specification also provides, for example, the following items: (Item 1) 1. A delivery system for the treatment of a vascular disorder, the delivery system comprising: 2. An intraluminal prosthesis for the treatment of a vascular disorder, comprising: a tubular main graft portion including a thin, flexible material, a main inner lumen, a proximal end, and a distal end; a self-expanding anchor member comprising a proximal portion and a distal portion, the distal end of the distal portion being secured to the proximal end of the tubular main graft portion and the distal end of the proximal portion being secured to the proximal end of the distal portion; an endoluminal prosthesis comprising: A delivery catheter Equipped with The delivery catheter comprises: an elongate shaft member with sufficient column strength for percutaneous advancement within a patient's vasculature, said elongate shaft including a proximal section and a distal section; a plurality of releasable belts disposed on a proximal section of the elongate shaft, the plurality of releasable belts configured to releasably restrain a self-expanding anchor member of the endoluminal prosthesis; a plurality of elongate release members in communication with a distal end of the elongate shaft, the plurality of elongate release members including a proximal section configured to releasably secure at least one respective releasable belt while the releasable belt is in a configuration that restrains at least a portion of the self-expanding anchor member; an inflatable balloon secured to the elongate shaft within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis at an axial location where a proximal end of an inflatable section of the inflatable balloon is adjacent to the self-expanding anchor member but distal to the self-expanding anchor member; A delivery system comprising: (Item 2) 2. The delivery system of claim 1, wherein the endoluminal prosthesis further comprises a plurality of radiopaque markers circumferentially disposed adjacent to a proximal end of the tubular main graft portion, and a proximal end of the inflatable section of the inflatable balloon is disposed adjacent to but distal to the radiopaque markers. (Item 3) 2. The delivery system of claim 1, wherein a proximal portion of the main graft portion of the endoluminal prosthesis comprises an inflatable cuff, and the inflatable balloon is axially positioned such that a working length of the inflatable balloon is axially coextensive with the inflatable cuff. (Item 4) 2. The delivery system of claim 1, wherein the delivery catheter further comprises an outer sheath disposed over the elongate shaft, the outer sheath configured to removably cover the endoluminal prosthesis in a constrained state. (Item 5) Item 1, wherein the elongate release member comprises an elongate release wire. (Item 6) 2. The delivery system of claim 1, wherein the endoluminal prosthesis comprises an expandable portion of an expandable endoluminal prosthesis, and the delivery catheter further comprises a filling tube including a filling tube lumen in fluid communication with the expandable portion of the expandable endoluminal prosthesis, the filling tube lumen extending axially within the elongate shaft. (Item 7) 2. The delivery system of claim 1, wherein the elongate shaft comprises an elongate multi-lumen member extending from a distal section of the elongate shaft to a proximal section of the elongate shaft, the multi-lumen member comprising a guidewire lumen, a release member lumen for each release member, and an inflation lumen for inflation of the inflatable balloon. (Item 8) Item 9. The delivery system of item 1, wherein the self-expanding anchor member comprises a superelastic metal. 2. The delivery system of claim 1, wherein the proximal portion of the self-expanding anchor member comprises a cylindrical stent including elongated superelastic elements arranged in a zigzag configuration, and the distal portion of the self-expanding anchor member comprises a cylindrical stent including elongated superelastic elements arranged in a zigzag configuration. (Item 10) 2. The delivery system of claim 1, wherein the self-expanding anchor member has a monolithic construction, and both the proximal and distal portions are formed from a single piece of continuous material without any joints formed between the portions. (Item 11) 2. The delivery system of claim 1, wherein the self-expanding anchor member is provided with barbs including sharp tissue-piercing tips. (Item 12) 2. The delivery system of item 1, wherein the inflatable balloon has an outer transverse dimension of about 10 mm to about 26 mm. (Item 13) 2. The delivery system of claim 1, wherein the inflatable balloon has a working length of about 15 mm to about 40 mm. (Item 14) Item 1 , the delivery system of item 1 , wherein the inflatable balloon comprises a stretchable material. (Item 15) 2. The delivery system of claim 1, wherein the inflatable balloon comprises a substantially non-elastic material. (Item 16) 2. The delivery system of claim 1, wherein the inflatable balloon comprises a material selected from the group consisting of polyethylene terephthalate, polyamide, polyether block amide, polyethylene, polyurethane, and polyvinyl chloride. (Item 17) 2. The delivery system of claim 1, wherein the inflatable balloon has a double wall thickness of about 0.001 inches to about 0.003 inches. (Item 18) 1. A delivery system for the treatment of a vascular disorder, the delivery system comprising: 2. An intraluminal prosthesis for the treatment of a vascular disorder, comprising: a tubular main graft portion including a thin, flexible material, a main inner lumen, a proximal end, and a distal end; a self-expanding anchor member, a distal end of the self-expanding anchor member being secured to the proximal end of the tubular main graft portion; an endoluminal prosthesis comprising: A delivery catheter Equipped with The delivery catheter comprises: an elongate shaft including a distal section and a proximal section, the proximal section configured to releasably secure the endoluminal prosthesis in a constrained state; an inflatable balloon secured to the elongate shaft at an axial location where a proximal end of an inflatable section of the inflatable balloon is adjacent to but distal to the self-expanding anchor member, the inflatable balloon being disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis; A delivery system comprising: (Item 19) Item 19. The delivery system of item 18, wherein the endoluminal prosthesis further comprises a plurality of radiopaque markers circumferentially disposed adjacent to a proximal end of the tubular main graft portion, and a proximal end of the inflatable section of the inflatable balloon is disposed adjacent to but distal to the radiopaque markers. (Item 20) Item 19. The delivery system of item 18, wherein a proximal portion of the main graft portion of the endoluminal prosthesis comprises an inflatable cuff, and the inflatable balloon is axially positioned such that a working length of the inflatable balloon is axially coextensive with the inflatable cuff. (Item 21) 20. The delivery system of claim 18, wherein the delivery catheter further comprises an outer sheath disposed over the elongate shaft, the outer sheath configured to removably cover the endoluminal prosthesis in a constrained state. (Item 22) Item 19. The delivery system of item 18, wherein the endoluminal prosthesis comprises an expandable portion of an expandable endoluminal prosthesis, and the delivery catheter further comprises a filling tube including a filling tube lumen in fluid communication with the expandable portion of the expandable endoluminal prosthesis, the filling tube lumen extending axially within the elongate shaft. (Item 23) Item 19. The delivery system of item 18, wherein the elongate shaft comprises an elongate multi-lumen member extending from a distal section of the elongate shaft to a proximal section of the elongate shaft, the multi-lumen member comprising an inflation lumen for inflation of the inflatable balloon, a guidewire lumen, and a release member lumen. (Item 24) 24. The delivery system of claim 23, wherein the inflation lumen has an oval cross-section. (Item 25) 20. The delivery system of claim 18, wherein the self-expanding anchor member comprises a superelastic metal. (Item 26) 20. The delivery system of claim 18, wherein the self-expanding anchor member comprises a cylindrical stent including elongated superelastic elements arranged in a zigzag configuration. (Item 27) 20. The delivery system of claim 18, wherein the self-expanding anchor member comprises a monolithic structure formed from a single piece of continuous material without any joints formed therein. (Item 28) 20. The delivery system of claim 18, wherein the self-expanding anchor member is provided with barbs including sharp tissue-piercing tips. (Item 29) Item 19. The delivery system of item 18, wherein the inflatable balloon has an outer transverse dimension of about 10 mm to about 26 mm. (Item 30) Item 19. The delivery system of item 18, wherein the inflatable balloon has a working length of about 15 mm to about 40 mm. (Item 31) Item 32. The delivery system of item 18, wherein the inflatable balloon comprises a stretchable material. 20. The delivery system of claim 18, wherein the inflatable balloon comprises a substantially non-elastic material. (Item 33) 20. The delivery system of claim 18, wherein the inflatable balloon comprises a material selected from the group consisting of polyethylene terephthalate, polyamide, polyether block amide, polyethylene, polyurethane, and polyvinyl chloride. (Item 34) Item 19. The delivery system of item 18, wherein the inflatable balloon has a double wall thickness of about 0.001 inches to about 0.003 inches. (Item 35) 1. A method of deploying an endoluminal prosthesis, the method comprising: advancing a delivery system into a patient's vessel, the delivery system including an elongate shaft and an endoluminal prosthesis releasably secured to the elongate shaft; partially releasing an outer radial constraint from a self-expanding anchor member of the endoluminal prosthesis to allow the self-expanding anchor member to partially deploy; inflating and radially expanding an inflatable balloon disposed within a main inner lumen of a main graft portion of the endoluminal prosthesis, the proximal end of an inflatable section of the inflatable balloon being disposed adjacent but distal to the self-expanding anchor member of the endoluminal prosthesis; completely releasing the outer radial constraint on the self-expanding anchor member and fully deploying the self-expanding anchor member. A method comprising: (Item 36) Item 36. The method of item 35, further comprising inflating the inflatable balloon to radially expand, wherein a proximal end of the inflatable section of the inflatable balloon is adjacent to but distal to a plurality of radiopaque markers that are circumferentially disposed adjacent a proximal edge of the main graft portion of the endoluminal prosthesis. (Item 37) 36. The method of claim 35, further comprising releasing an external constraint from the graft portion of the endoluminal prosthesis. (Item 38) 36. The method of claim 35, wherein inflating and radially expanding the inflatable balloon comprises inflating and radially expanding the inflatable balloon to apply an outward radial force on an inner surface of a main inner lumen of the graft portion of the endoluminal prosthesis until an outer surface of the graft portion adjacent the inflatable balloon is forced into contact with an inner surface of the patient's vessel. (Item 39) Item 36. The method of item 35, wherein inflating the inflatable balloon comprises inflating the inflatable balloon to a pressure of about 3 psi to about 9 psi. (Item 40) 36. The method of claim 35, wherein inflating the inflatable balloon comprises inflating the inflatable balloon to a pressure up to about 1 atmosphere. (Item 41) Item 36. The method of item 35, further comprising repositioning the endoluminal prosthesis after partially deploying the self-expanding anchor member and before fully deploying the self-expanding anchor member. (Item 42) 42. The method of claim 41, further comprising deflating the inflatable balloon prior to repositioning the endoluminal prosthesis. (Item 43) 36. The method of claim 35, further comprising expanding the expandable portion of the endoluminal prosthesis with a hardenable filling material. (Item 44) Item 44. The method of item 43, wherein the expandable portion of the endoluminal prosthesis is inflated with a hardenable filling material after inflation of the inflatable balloon to promote sealing and conforming to an outer surface of the endoluminal prosthesis. (Item 45) 36. The method of claim 35, further comprising deploying one or more chimney-type endoluminal prostheses in fluid communication between the patient's side branch arteries and the aorta prior to deploying the endoluminal prosthesis. (Item 46) Item 46. The method of item 45, further comprising inflating the inflatable balloon adjacent to the one or more chimney-type endoluminal prostheses to enhance a seal between an outer surface of the chimney prosthesis and an outer surface of the main graft portion and an inner surface of the aorta. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is an elevational view in partial section of a delivery system embodiment being advanced over a guidewire into an aorta of a patient's vasculature. [Figure 1A] FIG. 1A is an elevational view in partial section of the delivery system of FIG. 1 being advanced over a guidewire into the abdominal aorta of a patient's vasculature. [Diagram 2] 2 is an elevational view of the delivery system embodiment of FIG. 1 in which the outer sheath of the delivery catheter of the delivery system embodiment is retracted. [Diagram 3] FIG. 3 is an enlarged view of the proximal portion of the delivery system embodiment of FIG. 2, as indicated by enclosed portion 3-3 of FIG. [Figure 4] 4 is a cross-sectional view of the delivery system embodiment of FIG. 3 taken along line 4-4 of FIG. [Diagram 5] 5 is a cross-sectional view of the delivery system embodiment of FIG. 3 taken along line 5-5 of FIG. [Figure 6] FIG. 6 is an elevational view of a pleated embodiment of an inflatable balloon. [Figure 7] 7 is a cross-sectional view of the delivery system embodiment of FIG. 3 taken along line 7-7 of FIG. [Figure 8] 8 is a close-up view of a release wire embodiment disposed within an end loop of a releasable belt embodiment of the delivery catheter of the delivery system embodiment of FIG. [Figure 9] FIG. 9 is an elevational view of the delivery system embodiment of FIG. 1 with the self-expanding anchor member partially deployed and the outer radial constraint on the distal portion of the self-expanding anchor member removed. [Figure 10] FIG. 10 is an elevational view of the delivery system embodiment of FIG. 9 with an inflatable balloon disposed within the main inner lumen of the graft portion of the endoluminal prosthesis being inflated. [Figure 11] FIG. 11 is an elevational view of an embodiment of an inflatable balloon of the delivery system embodiment of FIG. 1 in an inflated state and showing the cone angle of the proximal end surface of the inflatable balloon embodiment. [Figure 12] 12 is an elevational view of a distal adapter assembly and distal portion of a delivery catheter of the delivery system embodiment of FIG. 1. FIG. [Figure 13] FIG. 13 is a schematic diagram in cross section of a perfusion expandable balloon embodiment. [Figure 14] FIG. 14 is a schematic diagram in cross section of a perfusion expandable balloon embodiment. [Figure 15] FIG. 15 is an elevational view of a delivery system embodiment. [Figure 16] FIG. 16 is a perspective view of a portion of the delivery system embodiment of FIG. 15, without the outer sheath shown. [Figure 17]17 is a cross-section of the delivery system embodiment of FIG. 16 taken along line 17-17 of FIG. [Figure 18] 18 is a cross-section of the delivery system embodiment of FIG. 16 taken along line 18-18 of FIG. [Figure 19] 19 is a perspective view of a portion of the delivery system embodiment of FIG. [Figure 20] FIG. 20 is a perspective view of an embodiment of a distal adaptor. [Figure 21] FIG. 21 is a perspective view of an embodiment of a distal adaptor. [Figure 22] 22 is a perspective view in partial cross-section of a portion of an elongate shaft embodiment of the delivery system of FIG. 15. [Diagram 23] 23 is an elevational view of an inflatable balloon portion embodiment of the delivery system of FIG. [Figure 24] FIG. 24 is a cross-section of the inflatable balloon portion of FIG. 23 taken along line 24-24. [Diagram 25] FIG. 25 is a cross-section of the inflatable balloon portion of FIG. 23 taken along line 25-25. [Figure 26] FIG. 26 is a cross-section of the inflatable balloon portion of FIG. 23 taken along line 26-26. [Figure 27] FIG. 27 is a perspective view of an embodiment of a multi-lumen member for a multi-lumen delivery catheter embodiment. [Figure 28] FIG. 28 is a perspective view of an embodiment of a multi-lumen member for a multi-lumen delivery catheter embodiment. [Figure 29] 29 is a perspective view of an embodiment of the multi-lumen member embodiment of FIG. [Diagram 30] FIG. 30 is a perspective view of an embodiment of a distal adapter with a crossover port at the bottom, an inflation port for an inflatable balloon at the top, and a fill port for an optional inflatable portion of an endoluminal prosthesis on the side of the adapter. [Diagram 31] FIG. 31 is a perspective view of an embodiment of a multi-lumen member. [Diagram 32] 32 is a perspective view of the multi-lumen member of FIG. [Diagram 33] 33 is a perspective view of the multi-lumen member of FIG. 31. FIG. [Diagram 34] FIG. 34 is an elevational view of an embodiment of an endoluminal prosthesis system including an inflatable balloon and a pair of opposing chimney graft sections deployed within a patient's vasculature to maintain patency of the patient's renal arteries. [Diagram 35] 35 is a cross-sectional view of the endoluminal prosthetic system embodiment of FIG. 34 taken along line 35-35 of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The drawings illustrate embodiments of the present invention and are not limiting. For clarity and ease of illustration, the drawings have not been made to scale and in some instances various aspects may be shown exaggerated or enlarged to facilitate an understanding of particular embodiments.

[0012] As discussed above, there is a need for an endoluminal prosthesis delivery system with a small flexible delivery profile. It may also be useful for such a delivery system to be configured to reliably open a portion of the endoluminal prosthesis that includes a radiopaque marker and visualize the endoluminal prosthesis for proper placement under fluoroscopic imaging or the like. To achieve these objectives, the embodiments discussed herein may include an inflatable device, such as an inflatable balloon, that may be used to apply an outward radial force to the inner surface of the endoluminal prosthesis at a specific axial location during the deployment process. Such an inflatable balloon disposed within a graft portion of an endoluminal prosthesis that includes a self-expanding anchor member may be useful in improving the opening and deployment of the prosthesis. Improved deployment may be particularly useful in angulated vessels 9 of the patient being treated. Such an inflatable balloon component may also be useful to help seal the outer surface of the endoluminal prosthesis to the inner surface of the lumen being treated.

[0013] For the delivery system embodiments discussed herein, including endoluminal prostheses, delivery catheter embodiments, and associated structures and methods, the term "proximal" refers to a location toward the patient's heart, away from an operator who is using the delivery system to deploy the endoluminal prosthesis. The term "distal" refers to a location away from the patient's heart, toward the operator.

[0014] Referring to the figures, an embodiment of a delivery system 10 for the treatment of a vascular defect, such as an aneurysm 8, is shown in FIGS. 1-12. The exemplary aneurysm 8 shown in a patient's vasculature 9 is a thoracic-type aortic aneurysm, however, the devices and methods as discussed herein and illustrated in the corresponding figures may also be used for any other suitable type of vascular defect, such as an abdominal aortic aneurysm (shown in FIG. 1A). The delivery system embodiment 10 may include an endoluminal prosthesis 12 for the treatment of a vascular defect 8 and a delivery catheter 14. The endoluminal prosthesis may include a tubular main graft portion 16 made of a thin, flexible material and including a main inner lumen 18, a proximal end 20, and a distal end 22. The graft body may be formed of a flexible and compliant graft material, such as PTFE, and may have a main fluid flow lumen disposed within the main graft portion of the graft body. For some embodiments, the flexible graft material including PTFE may include expanded PTFE or ePTFE.

[0015] Referring to FIG. 3, the endoluminal prosthesis 12 also has a self-expanding anchor member 24 having a proximal portion 26 and a distal portion 28, the distal end of which may be fixed to the proximal end 20 of the tubular main graft portion and the distal end of the proximal portion may be fixed to the proximal end of the distal portion. The self-expanding anchor member embodiment 24 shown in FIG. 2 has a generally cylindrical configuration with a free non-fixed end at its proximal end and a distal end fixed to the proximal end of the main graft body. The proximal portion 26 of the self-expanding anchor member 24 may include a cylindrical stent including elongated superelastic elements arranged in a zigzag configuration, and the distal portion of the self-expanding anchor member comprises a cylindrical stent including elongated superelastic elements arranged in a zigzag configuration. An optional connector ring (not shown) may be embedded into the structure of the proximal end of the main graft portion and coupled to the distal end of the proximal self-expanding anchor member 24. In some cases, such connector rings may include a self-expanding zigzag shape made from a superelastic material, such as a nickel-titanium alloy. The deployment assistance provided by the inflatable balloon due to the outward radial force provided by the inflatable balloon may be particularly useful in endoluminal prosthesis embodiments that do not include a self-expanding connector ring. In some cases, such connector rings may be useful to provide an opening force to the proximal end of the graft portion of the endoluminal prosthesis during deployment.

[0016] In some cases, the proximal self-expanding anchor member 24, including its proximal and distal portions, may have a monolithic construction, with both the proximal and distal portions being formed from a single piece of continuous material without any joints being formed between the portions. In some cases, embodiments of the self-expanding anchor member 24 may be made from a superelastic metal, including a superelastic metal such as a nickel-titanium alloy.

[0017] The proximal self-expanding anchor member 24 may include outwardly extending barbs (not shown) that may be integrally formed with the struts of the stent structure of one or both of the proximal and distal portions 26, 28 of the self-expanding anchor member 24. Such barbs may have sharp or sharpened tissue-piercing tips configured to penetrate into tissue of the inner surface 30 of the lumen into which the proximal self-expanding anchor member 24 may be deployed in the expanded state. Such a barb configuration may be used to facilitate fixation of the self-expanding anchor member 24 to the inner surface 30 or other luminal surface of the patient's vessel 9.

[0018] The self-expanding anchor members discussed herein may include a proximal portion and a distal portion, although other embodiments may be used. In addition, similar expanding anchor members may be used that are configured to be inelastically expanded with an outward radial pressure, such as may be generated by expansion of a radially expandable inflatable balloon from within one or both of the proximal and distal portions of the proximal self-expanding anchor member. Otherwise, such inelastically expandable anchor members may have the same characteristics, dimensions, and configurations as those of the self-expanding anchor members discussed herein.

[0019] In addition, the endoluminal prosthesis 12 may also have a plurality of radiopaque markers 32 disposed circumferentially about the tubular configuration of the endoluminal prosthesis 12 adjacent the proximal end 20 of the tubular main graft portion. In some cases, the plurality of radiopaque markers 32 may be substantially equally spaced around the circumference of the tubular portion of the endoluminal prosthesis 12 and all lie in a common plane that is generally perpendicular to the longitudinal axis 34 of the proximal self-expanding anchor member and main graft portion of the endoluminal prosthesis 24. In some cases, the radiopaque markers 32 may be disposed around the circumference of the self-expanding anchor member 24 at the distal end of the self-expanding anchor member 24. Such an arrangement may be useful in visualizing the alignment of the endoluminal prosthesis during the deployment process. Some endoluminal prosthesis embodiments include about 4 to about 12, more specifically about 5 to about 8, such circumferentially spaced radiopaque markers 32 disposed in a common plane, which may optionally be perpendicular to the longitudinal axis 34 of the main graft portion of the endoluminal prosthesis.

[0020] For some embodiments, the delivery catheter 14 of the delivery system 10 includes an elongated shaft member 36 with sufficient column strength for percutaneous advancement within the patient's vessel 8, the elongated shaft 36 may also have a proximal section 38 and a distal section 40. A plurality of releasable belts may be disposed on the proximal section 38 of the elongated shaft 36 and configured to releasably restrain the self-expanding anchor members of the endoluminal prosthesis. A plurality of appropriately sized cylindrical bushings or pads 33 may be secured on the elongated shaft adjacent one or more of the releasable belts to appropriately space the self-expanding anchor members 24 or portions thereof during a restrained state. A plurality of elongated release members may be disposed in operative communication with the distal section of the elongated shaft 36, each of which may include a proximal section configured to releasably secure at least one respective releasable belt while the releasable belt is in a configuration restraining at least a portion of the self-expanding anchor members 24 of the endoluminal prosthesis 12.

[0021] A plurality of releasable belts configured to releasably restrain the proximal self-expanding anchor member 24 of the endoluminal prosthesis 10 may be secured along the proximal section 38 of the elongate shaft 36. With reference to FIG. 2 , a first proximal releasable belt 42 and a second proximal releasable belt 44 are secured about the proximal portion 26 of the self-expanding anchor member 24. A first distal releasable belt 46 and a second distal releasable belt 48 are secured about the distal portion 28 of the self-expanding anchor member 24.

[0022] 3, at least a first elongate release member 50 and a second elongate release member 52, which for some embodiments may include an elongate release wire, may extend to a distal end of and be in communication with the elongate shaft 36. For some embodiments, three or more release wires may be used. For some embodiments, additional release wires (not shown) may be used to provide a releasable coupling for connecting or coupling between the filling tube 69 and the inflatable portion of the inflatable embodiment of the endoluminal prosthesis 12. The first release member 50 and the second release member 52 may have a proximal section configured to releasably secure at least one respective releasable belt, such as the first proximal releasable belt 42, the second proximal releasable belt 44, the first distal releasable belt 46, or the second distal releasable belt 48, while the releasable belt is in a configuration that restrains at least a portion of the endoluminal prosthesis 10, such as the proximal self-expanding anchor member 24. The release members 50 , 52 may be configured to deploy the self-expanding anchor member 24 at the proximal end of the endoluminal prosthesis 12 .

[0023] 2 and 3, a first release wire 50 is shown coupled to the first proximal releasable belt 42 and the second proximal releasable belt 44, and can thereby be used to deploy the first proximal releasable belt 42 and the second proximal releasable belt 44 (in that order) by distally retracting the first release member 50 by a mechanism in the distal adapter 54 (shown in FIG. 12) or any other suitable method. A second release member 52 is shown coupled to the first distal releasable belt 46 and the second distal releasable belt 48, and can thereby be used to deploy the first distal releasable belt 46 and the second distal releasable belt 48 (in that order) by distally retracting the second release member 52 by a mechanism in the distal adapter 54 or any other suitable method.

[0024] In some instances, friction generated by axial movement of the first and second release members 50, 52 may be minimized by using a multi-lumen configuration within the elongate shaft 36 of the delivery catheter 14. Such a delivery catheter embodiment 14 may include an elongate shaft 36 with one or more release member lumens 58 extending within a release member sleeve 67, a guidewire lumen 56 extending within a guidewire tube 57 for passage of a guidewire 49, an inflation lumen 60 extending within an inflation tube 61 for inflation of an inflatable balloon 62, and an optional filling lumen 64 extending within a filling tube 69 for filling an optional inflatable portion of the endoluminal prosthesis 12. The cross section of the elongate shaft 36 of the delivery catheter embodiment 14 shown in FIG. 5 illustrates the release member lumen 58 and the guidewire lumen 56 surrounded by the guidewire tube 57. The cross section in FIG. 4 includes an inflation lumen 60 surrounded by an inflation tube 61.

[0025] For some embodiments, the inflation tube 61 may have an inflation lumen 60 with a generally round inner cross-section, and for other embodiments, the inflation lumen 60 may have a cross-section that is oval in shape. In some cases, the round inflation lumen embodiments may have an inner diameter of about 0.01 inches to about 0.03 inches, more specifically, about 0.014 inches to about 0.016 inches, 0.01 inches to about 0.02 inches, 0.02 inches to about 0.025 inches, about 0.015 inches, or any other suitable inner diameter. Some oval inflation lumen embodiments 60 may have a major inner transverse dimension of about 0.055 inches to about 0.060 inches and a minor inner transverse dimension of about 0.024 inches to about 0.028 inches. The inflation tube lumen embodiments 61A, 61A', and 61A'' shown in Figures 27-33 are configured to accommodate the respective inflation tubes 61 and 61'. Each of these lumen embodiments 56, 58, 60, 64 and tube or sleeve embodiments 57, 61, 67, 69 may extend axially along or within the elongate shaft 36 of the delivery catheter 14 from its proximal section to its distal end, including to the distal adapter 54 at the distal end of the elongate shaft 36. In some cases, the release member may be coupled to a respective deployment knob 66 ​​disposed on the distal adapter 54 shown in FIG.

[0026] An inflatable balloon 62, which may be integrally formed with the elongate shaft 36, may be operably secured to the elongate shaft 36 of the delivery catheter 14 within the main inner lumen 18 (shown in FIG. 7) of the tubular main graft portion 16 of the endoluminal prosthesis 12. In some instances, the inflatable balloon 62 may be disposed in an axial position where the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is positioned adjacent to, but distal to, the radiopaque marker 32. In some cases, as shown in FIGS. 3, 9, and 10, the inflatable balloon 62 may be disposed within the non-deployment constrained endoluminal prosthesis 12 in an axial position where the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is positioned adjacent to, but distal to, a self-expanding anchor member structure, such as the self-expanding anchor member 24. The inflatable section 55 of the inflatable balloon 62 may also be positioned with a proximal end 68 of the inflatable section 55 adjacent to, but positioned distal to, any other high strength resilient structure, such as a connector ring, that may be associated with securing the anchor member portion of the endoluminal prosthesis 12 to the main graft portion 16 of the endoluminal prosthesis 12. Additionally, in some cases, the inflatable section 55 of the inflatable balloon 62 may be axially positioned such that it does not axially overlap or lie in the same horizontal plane as the self-expanding anchor member 24 or any other high strength structure associated with the self-expanding anchor member 24.

[0027] With respect to the relative axial positioning of the inflatable balloon 62, the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 may be considered adjacent to, but distal to, a structure such as the radiopaque marker 32 or the self-expanding anchor member 24 if, for some embodiments, the optional axial gap between these respective elements is at most about 5 mm, and more specifically, at most about 2 mm. Figures 3, 10, and 23 (discussed below) show examples of such optional axial gaps, as indicated by arrow 55'. Figures 3 and 10 illustrate the optional axial gap between the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 and the distal-most portion of the radiopaque marker 32. For the embodiment of Figure 23, the radiopaque marker 132 overlaps a structure at the distal end of the self-expanding anchor member 124. Accordingly, FIG. 23 illustrates an optional gap 55' disposed between the proximal end of the inflatable section 55 of the inflatable balloon 62 and both the distal-most end of the radiopaque marker 132 and the distal-most end of the self-expanding anchor member 124.

[0028] For some embodiments, the molded tubular wall material of the inflatable balloon 62 may be secured or joined to the elongate shaft 36 at the neck portion by adhesives such as ultraviolet curable adhesives, laser bonding or welding, thermal bonding or welding, or any other suitable method. For some embodiments, to achieve a high burst strength of the inflatable balloon 62, it may be desirable to use a material for the inflatable balloon 62 that is the same as or similar to that of the balloon shaft section 59 of the elongate shaft 36 to facilitate thermal bonding, welding, or the like between these two elements. The balloon shaft section 59 of the elongate shaft 36 comprises a generally tubular portion of the elongate shaft 36 that extends axially within the inflatable balloon 62 and may include an outer surface suitable for bonding the balloon 62 and providing a liquid-tight barrier to the interior volume of the inflatable balloon 62. With regard to material selection, some embodiments may include the balloon shaft section 59 and the inflatable balloon 62, both of which are made from polyurethane. For some inflatable balloon embodiments 62, the proximal neck portion 63 of some inflatable balloon embodiments 62 may be positioned proximal to the radiopaque marker 32 and / or the self-expanding anchor member 24, so long as the proximal angled portion or proximal cone of the inflatable balloon 62 and any pleats of the inflatable balloon 62 are located distal to the radiopaque marker 32 and / or the self-expanding anchor member 24. The proximal neck portion 63 is the portion of the tubular member of the inflatable balloon 62 that contacts the outer surface of the elongate shaft 36 and is typically where the proximal end of the inflatable balloon 62 is bonded to the elongate shaft 36. The distal end of the inflatable balloon 62 is similarly bonded to the elongate shaft 36 over the distal neck portion 63'. These bonded portions 63 and 63' may have lengths selected to provide the necessary bond strength to support the desired inflation pressure while minimizing the length of the bonded portions to reduce the amount of material and overall profile of the delivery system 10. For some embodiments, the proximal neck portion 63 and the distal neck portion 63' may have an axial length of at least about 4 mm, and more specifically, from about 4 mm to about 8 mm.

[0029] In some cases, the inflatable balloon 62 may be formed into a pleated configuration while in the uninflated state to keep the uninflated profile of the inflatable balloon 62 to a minimum. In some instances, the inflatable balloon embodiment 62 may be mechanically folded (or folded by any other suitable means) to include between about 5 pleats and about 10 pleats, more specifically, between about 6 pleats and about 8 pleats, as shown in FIG. 6. For some such embodiments, the distal ends of the pleats may be folded over a distal neck portion 63' of the inflatable balloon 62 to shift a portion of the bulk of the inflatable balloon away from the structure of the radiopaque marker 32 and / or the self-expanding anchor member 24 while in the uninflated state. Generally, in order to keep the outer size profile of the delivery system 10 to a minimum and to minimize the risk of damage to the expandable section 55 of the expandable balloon 62 due to contact with the self-expanding anchor member 24, it may be desirable to avoid overlap of either the radiopaque marker 32 of the expandable section 55 of the expandable balloon 62 with the self-expanding anchor member 24.

[0030] With respect to the dimensions of the inflatable balloon embodiment 62 discussed herein, both the working length and the overall length of the inflatable balloon 62 may be considered. The working length extends along the entire diametric length of the inflatable balloon 62, the outer surface of the inflatable balloon 62 being configured to contact and exert an outward pressure against the inner surface of the endoluminal prosthesis 12 when the inflatable balloon is in an inflated state. The overall length includes all of the inflatable sections 55, including the tapered cone-type sections at one or both ends of the inflatable balloon 62. For purposes of discussion herein, the working length of the inflatable balloon 62 is indicated by arrow 51 in FIG. 11, and the overall length of the inflatable balloon 62 is indicated by arrow 53.

[0031] For some embodiments, the inflatable balloon 62 may include an outer transverse dimension / diameter of about 10 mm to about 26 mm, and a working length of about 15 mm to about 50 mm, more specifically, about 15 mm to about 40 mm. Some embodiments may include a working length of about 15 mm to about 25 mm, more specifically, about 18 mm to about 22 mm. In some cases, inflatable balloon embodiments 62 made from a substantially non-stretchable material may have an outer diameter of about 26 mm for use with an endoluminal prosthesis 12 having a tubular main graft portion with an inner lumen diameter of about 26 mm. Some inflatable balloon embodiments 62 made from a substantially non-stretchable material may have an outer diameter of about 15 mm to about 22 mm and an axial length of about 16 mm to about 20 mm for use with an endoluminal prosthesis embodiment 12 having a main graft portion with an inner lumen diameter of about 15 mm to about 22 mm. In some cases, an inflatable balloon 62 made from a stretchable material having an outer diameter of about 16 mm to about 19 mm and a working length of about 16 mm to about 20 mm may be used with a delivery system embodiment 10 having an endoluminal prosthesis 12 with a main graft portion with an inner lumen diameter of about 26 mm. Some inflatable balloon embodiments 62 may have a working length of about 18 mm to about 21 mm, a total length of about 32 mm to about 38 mm, and an outer diameter of about 15 mm to about 26 mm. Some embodiments of the inflatable balloon 62 may be made from a stretchable material with an outer diameter of about 16 mm to about 20 mm, a working length of about 16 mm to about 20 mm, and a total length of about 32 mm to about 38 mm. Such an inflatable balloon embodiment 62 may in some cases be used with an endoluminal prosthesis 12 with an inner lumen diameter of about 15 mm to about 26 mm.

[0032] To minimize inclusion of the inflatable balloon 62 in the main luminal channel 18 proximally beyond the proximal-most contact point between the inflatable balloon 62 and the main graft portion 24 of the endoluminal prosthesis 12, it may be desirable in some cases for the proximal end surface 70 of the balloon 62 to be relatively flat or have a cone angle approaching 180 degrees. For some embodiments, the inflatable balloon 62 may have a proximal end surface 70 with a cone angle 72 (as shown in FIG. 11 ) of about 160 degrees to about 180 degrees. Some embodiments may have a cone angle 72 of about 120 degrees to about 160 degrees, more specifically, about 125 degrees to about 135 degrees. Some embodiments may have a cone angle 72 of about 80 degrees to about 120 degrees, more specifically, about 80 degrees to about 100 degrees, and even more specifically, about 90 degrees to about 98 degrees.

[0033] For some inflatable balloon embodiments 62, the wall material of the inflatable balloon 62 may include a stretchable material, and for other embodiments, the wall material of the inflatable balloon 62 may include a substantially non-stretchable material. Some inflatable balloon embodiments 62 may also include a laminate structure with multiple layers of material that may include both stretchable and substantially non-stretchable materials. In some cases, the wall material of the inflatable balloon 62 may include materials such as polyethylene terephthalate (PET), polyamides such as Nylon®, polyether block amides such as Pebax®, polyethylene (PE), polyurethane (PU), polyvinyl chloride (PVC), and the like, or any combination thereof. Any of the inflatable balloon embodiments discussed herein may include a dual wall thickness of the balloon material of about 0.001 inches to about 0.003 inches. Some inflatable balloon embodiments 62 may have a dual wall thickness of about 0.0005 inches to about 0.002 inches, more specifically, about 0.00075 inches to about 0.0015 inches. The double wall thickness is a measurement derived from measuring the thickness of two of the walls of the inflatable balloon 62. In this manner, the wall thickness of the inflatable balloon 62 may be measured while keeping the inflatable balloon 62 intact.

[0034] The delivery catheter 14 may have an outer sheath 74 with an elongated tubular shape and thin wall that is disposed over the elongated shaft 36 and the endoluminal prosthesis 12. The outer sheath 34 may be configured to slide relative to the elongated shaft and the endoluminal prosthesis and to removably cover the endoluminal prosthesis 12 while in a constrained state. The delivery catheter 14 may also include a proximal nosecone 76, which may have a shoulder portion having a bullet-shaped profile and an outer surface that may be configured to slidingly receive an inner luminal surface of the retractable outer sheath 74.

[0035] The delivery system and method embodiments 10 discussed herein may be particularly useful for endoluminal prosthesis embodiments 12 that include one or more expandable portions. Such expandable endoluminal prosthesis embodiments 12 that may be deployed by the systems and methods discussed herein are discussed in U.S. Patent No. 7,147,660, entitled "Advanced Endovascular Graft," filed Dec. 20, 2002 by M. Chobotov, et al., which is incorporated herein by reference in its entirety.

[0036] For some embodiments, the optional inflatable portion 80 of the graft portion 16 of the endoluminal prosthesis may include one or more inflatable cuffs 82 and / or one or more inflatable channels (not shown) formed from the flexible material of the main graft portion and legs 84 (see branch legs shown in the embodiment of FIG. 34). For the embodiment shown, the inflatable cuffs 82 are disposed on a proximal portion of the main graft portion 16. A filling tube 69 may also be coupled to and configured for fluid communication with a distal end of a filling port 88 (shown in FIG. 9) of the inflatable portion 80 of the endoluminal prosthesis 12. The filling tube 69 may also be decoupled from the inflation port 88. The outer transverse dimension of the filling tube may be configured to slide into the inner lumen of the filling port 88 and provide a seal therebetween against viscous fluids. For such embodiments, the delivery catheter 14 may include a filling tube 69 that includes a filling lumen 64 extending axially within the elongate shaft 36 from the proximal section to the distal section of the elongate shaft 36 .

[0037] In some cases, the delivery system embodiments 10 discussed herein may include a delivery catheter 14 with an endoluminal prosthesis 12, such as a stent graft, releasably disposed on a proximal section 38 of the delivery catheter 14 in a radially constrained state. Such a delivery catheter 14 may be any of the commonly owned U.S. Patent Application Publication Nos. 2004 / 0138734, published July 15, 2004 and filed October 16, 2003 by Chobotov et al., entitled "Delivery System and Method for Bifurcated Graft," and 2005 / 0138734, published October 24, 2002 and filed April 11, 2001 by Chobotov et al., entitled "Delivery System and Method for Bifurcated Graft." The delivery system may include some or all of the features, dimensions, or materials discussed in PCT International Application No. WO 02 / 083038, entitled "System and Method for Bifurcated Grafts," each of which is incorporated herein by reference in its entirety.

[0038] The endoluminal prosthesis 12 or any other prosthesis discussed herein may include some or all of the features, dimensions, or materials of the prostheses discussed in commonly owned U.S. Patent Publication No. 2009 / 0099649, filed October 3, 2008 by Chobotov et al., entitled "Modular Vascular Graft for Low Profile Percutaneous Delivery," which is incorporated herein by reference in its entirety.

[0039] For some deployment methods, it may be useful to radially expand a portion of the endoluminal prosthesis 12 (such as the interface portion between the anchor member portion 24 and the main graft portion 16) that may include radiopaque markers 32 (such as circumferentially disposed radiopaque markers that lie in a common plane) in order to accurately visualize the partially deployed stent graft 12 prior to full deployment of the stent graft. In such cases, it may be useful to radially expand the circumferentially disposed radiopaque markers 32 in an outward direction from the position they occupy in their radially constrained state to a position that is in relatively close proximity to the inner surface of the vessel 9 in which the endoluminal prosthesis 12 is deployed. Such a deployment protocol may be particularly useful for endoluminal prosthesis embodiments 12, such as stent grafts that do not include a connector ring structure at the proximal end of the graft portion 16 of the stent graft 12. This is because the self-expanding type connector ring may be useful in some cases to aid in the outward radial expansion of the proximal end or flap of the graft portion of the stent-graft after the distal portion of the proximal self-expanding anchor member 24 is released. For some endoluminal prosthesis embodiments 12 that do not have a self-expanding connector ring, the proximal end or flap 20 of the graft portion 16 of the stent-graft may only open about 10 mm or so, which may not be conducive to accurate imaging and positioning using parallax viewing of the radiopaque markers 32 during deployment.

[0040] With respect to use of the delivery system embodiments 10 and 110 discussed herein, deploying the endoluminal prosthesis 12 may include advancing the delivery system 10, including the elongate shaft 36 and the endoluminal prosthesis 12 releasably secured to the elongate shaft 36, into the patient's vasculature. The method may also include releasing the outer restraint from the graft portion 16 of the endoluminal prosthesis 12, such as by retracting the outer sheath 74 of the delivery catheter 14. The outer radial restraint may then be partially released from the self-expanding anchor member 24 of the endoluminal prosthesis 12 (as shown in FIG. 9 ) by releasing the first and second distal releasable belts 46, 48 and allowing the self-expanding anchor member 24 to partially deploy. Thereafter, the inflatable balloon 62 may be inflated and radially expanded to radially expand a portion of the graft portion 16 of the endoluminal prosthesis 12 disposed adjacent the inflatable balloon 62. In some cases, the inflatable balloon 62 may be disposed within the main inner lumen 18 of the graft portion 16 of the endoluminal prosthesis 12, with the proximal end of the inflatable balloon 62 disposed adjacent to but distal to the self-expanding anchor member 24. In some cases, the inflatable balloon 62 may be disposed within the main inner lumen 18 of the graft portion 16 of the endoluminal prosthesis 12, with the proximal end of the inflatable balloon 62 disposed adjacent to but distal to the plurality of radiopaque markers 32, which may be circumferentially disposed adjacent to the proximal edge 20 of the graft portion of the endoluminal prosthesis 12. The outer radial constraint on the self-expanding anchor member 24 may then be fully released to fully deploy the self-expanding anchor member 24 of the endoluminal prosthesis 12.

[0041] In some cases, inflating and radially expanding the inflatable balloon 62 may include inflating and radially expanding the inflatable balloon 62 to apply an outward radial force on the inner surface of the main inner lumen 18 of the graft portion 16 of the endoluminal prosthesis 12 until the outer surface of the graft portion 16 adjacent the inflatable balloon 62 is forced into contact with the inner surface of the patient's vessel 8. Saline or other inflation fluid may then be injected through the inflation lumen 60 of the elongate shaft 36 and enter the interior volume of the inflatable balloon 62 at the desired pressure. In some cases, inflating the inflatable balloon 62 may include inflating the interior volume of the inflatable balloon 62 with a sterile, incompressible fluid, such as saline, within the inflation lumen 60 at a pressure of about 3 psi to about 9 psi, and in some cases up to a pressure of about 1 atmosphere. Pressurized saline may be injected using a device such as an Endoflator® or a standard syringe by coupling an inflation device to a connector, such as a Luer type connector, on the distal adapter 54. In some cases, the interior volume of the inflatable balloon 62 may be inflated with a mixture of saline and contrast agent to improve the ability to image the inflated or partially inflated inflatable balloon 62 using fluoroscopy or the like. For some embodiments, a mixture of about 25% contrast agent and about 75% saline may be used, and in other embodiments, a mixture of about 20% contrast agent and about 80% saline may be used. For inflation of some inflatable balloon embodiments 62, the interior volume of the inflatable balloon 62 may be from about 6 ml to about 20 ml.

[0042] In some cases, the endoluminal prosthesis 12 may be axially repositioned within the patient's vessel 9 after partially deploying the self-expanding anchor members 24 and before fully deploying the self-expanding anchor members 24. In such cases, it may be desirable to deflate the inflatable balloon 62 prior to repositioning the endoluminal prosthesis 12. For endoluminal prosthesis embodiments 12 including an inflatable portion 80, it may also be desirable to inflate the inflatable portion 80 of the endoluminal prosthesis 12 after inflation of the inflatable balloon 62 to facilitate sealing and conforming of the inflatable cuffs 82 (if present) to the interior surface of the patient's vessel 9. In such cases, it may be desirable for the working length (as indicated by arrow 51) of the inflatable balloon 62 to be positioned axially coextensive with the inflatable cuffs 82. For such embodiments, an outward radial force imparted by the outer surface of the inflatable balloon 62 in response to inflation may be useful to aid in sealing and apposition of one or more inflatable cuffs 82 against the inner luminal surface of the patient's vessel 9. In some cases, the inflatable balloon 62 may be used to radially expand one or more inflatable cuff embodiments 82 outwardly without similarly expanding the self-expanding anchor member 24. For some such embodiments, it may be desirable to have an inflatable balloon 62 as discussed herein disposed within the endoluminal prosthesis 12 such that the inflatable balloon 62 is axially coextensive with and axially overlaps a first inflatable cuff 82, but is not axially coextensive with or disposed so as not to axially overlap a second inflatable cuff 82 of the same endoluminal prosthesis 12.

[0043] For some deployment method embodiments, it may be desirable to align the endoluminal prosthesis 12 prior to deployment such that an imaginary plane intersecting the circumferentially disposed radiopaque markers 32 is perpendicular to the longitudinal axis of the target vessel 9 at the location of the circumferentially disposed radiopaque markers 32. Examples of deployment devices, alignment devices, radiopaque markers 32, delivery methods, etc. that may be used with any suitable system or components thereof discussed herein are described in "Fill Tube Manifold and Delivery Methods" filed on February 9, 2011 by M. Chobotov et al. No. 2011 / 0218609, filed Mar. 15, 2013 by J. Watson et al. and entitled "Delivery Catheter for Endovascular Device," and U.S. Patent Publication No. 2013 / 0268048, filed Mar. 13, 2013 by D. Parsons et al. and entitled "Durable Stent Graft with Tapered Struts and Stable Delivery Methods and Devices," each of which is incorporated herein by reference in its entirety.

[0044] For any of the delivery system embodiments 10 discussed above, an embodiment of the inflatable balloon 62, when in an inflated state, may have an axial length of about 25 to about 27 mm and a transverse diameter of about 16 mm to about 18 mm. Such an inflatable balloon 62 may be inflated through an inflation lumen 60 having an inner transverse lumen diameter of about 0.014 inches to about 0.016 inches.

[0045] For any of the embodiments of the delivery system 10 discussed above, the inflatable balloon 62 may be made of a stretchable material such as urethane with an outer diameter of about 25 mm to about 26 mm and an axial length of about 25 mm. An inflatable balloon 62 so sized may be useful for delivery of an endoluminal prosthesis 12 (including an Ovation® type stent graft device manufactured by TriVascular, Inc. (Santa Rosa, Calif.)) having an inner lumen diameter of 26 mm. The inflatable balloon 62 may be bonded or otherwise secured to the elongate shaft 36 proximal to the proximal end or proximal flap 20 of the main graft section 16 of the endoluminal prosthesis 12 with an ultraviolet curable adhesive. An axial length of about 25 mm for the inflatable balloon 62 may be sufficient in some embodiments to allow the inflatable balloon 62 to axially overlap an inflatable cuff 82 disposed on the distal section of the graft section 16 of the endoluminal prosthesis 12. For such embodiments, it may be desirable for the inflatable balloon 62 not to axially overlap the radiopaque marker 32 adjacent the proximal end 20 of the main graft section 16. The proximal end face 70 of the balloon embodiment may be flat (i.e., with a cone angle 72 of about 180 degrees) or even flared.

[0046] The inflation lumen 60 for the inflatable balloon 62 may be made from a thin wall material such as polyimide with an inner lumen diameter of about 0.01 inches to about 0.02 inches to allow filling of the inflatable balloon 62 in a few seconds, such as about 15 seconds, using a high flow rate fluid such as saline. In some embodiments, the inflation lumen 60 may have an inner lumen diameter of about 0.020 inches to about 0.025 inches to allow for more rapid filling and inflation of the inflatable balloon 62. Inflation of such inflatable balloon embodiments 62 may be performed with a syringe (not shown) connected to a Luer type fitting on the distal adapter 54.

[0047] In use, after the release wire 52 securing the first and second distal releasable belts 46, 48 is retracted to deploy the releasable belts, the inflatable balloon 62 may be manually inflated using a syringe or the like. In some cases, the inflatable balloon 62 may be initially inflated to an outer dimension or diameter of about 8 mm prior to the release of the release wire 52. In some cases, the inflatable balloon 62 may be inflated until the proximal end or proximal flap 20 of the graft portion 16 of the endoluminal prosthesis 12 and the radiopaque marker 32 disposed adjacent thereto are expanded radially outwardly to approximately the inner surface of the wall of the blood vessel 9 being treated. In some cases, the inflatable balloon 62 may be inflated to an outer transverse dimension or diameter of about 15 mm after the release of the release wire 52. After accurately positioning the endoluminal prosthesis 12 axially relative to the patient's renal arteries 92 (or any other suitable reference point), the other release wire 50 is also retracted and the proximal self-expanding anchor member can be fully deployed.

[0048] The inflatable balloon 62 may then be deflated prior to inflating the optional inflatable portion 80 of the endoluminal prosthesis 12. In some cases, the inflatable portion 80 of the endoluminal prosthesis 12 may be inflated while the inflatable balloon 62 is still inflated. For such cases, it may be desirable for the inflatable balloon 62 to be maintained at an internal inflation pressure that is below the inflation pressure of the filling material that has been injected into the optional inflatable portion 80 of the endoluminal prosthesis 12. After inflation of the inflatable portion 80 of the endoluminal prosthesis 12, the filling tube 69 may be disengaged and the elongate shaft 36 of the delivery catheter 14 may be distally withdrawn from within the endoluminal prosthesis 12. Using the inflatable balloon 62 to apply an outward radial force to the graft portion 16 of the endoluminal prosthesis 12 during deployment may also be useful in eliminating Type I endoleaks, if present, during the deployment process. This may be particularly true for embodiments that include an optional inflatable cuff 82 on the graft portion 16 of the endoluminal prosthesis 12 .

[0049] In some cases, the inflatable portion 80 of the endoluminal prosthesis 12 remains coupled to the filling lumen 69 for a predetermined amount of time after initiation of filling of the inflatable portion 80 with a filling material, such as a polymerizable or hardenable filling material. After the predetermined time has elapsed, the inflatable balloon 62 may then be positioned across both optional inflatable cuffs 82 and inflated to a suitable inflation pressure, such as about 3 psi to about 6 psi. In some cases, the predetermined amount of time that elapses prior to inflating the inflatable balloon to radially expand the filled cuffs 82 outward may be about 14 minutes, and in some cases exactly 14 minutes. Such a procedure may be useful for resolving endoleaks. Once resolved, or other suitable endpoints have been achieved, the inflatable balloon 62 may be deflated and the filling tube 69 may be disengaged from the filling port of the inflatable portion 80 of the endoluminal prosthesis 12.

[0050] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having a graft portion 16 with an inner diameter of about 29 mm when in an expanded state and a proximal self-expanding anchor member 24 with an outer diameter of about 34 mm when in an expanded state may be loaded into a delivery catheter having an outer sheath with an outer diameter of about 15 French. This combination resulted in an outer sheath retraction force of about 18 pounds against unsheathing movement of the outer sheath 74. In this particular example, the radial expansion achieved after release of the distal portion of the proximal self-expanding anchor member 24 and initial inflation of the balloon was about 10 mm to about 17 mm by about 11 mm. The inflatable balloon 62 also had a tapered configuration that ultimately achieved an expanded dimension of about 20 mm outer diameter and about 7 mm axial length. The inflatable balloon took about 1 minute to fill through an inflation lumen 60 having an inner diameter of about 0.015 inches. The delivery catheter 14 did not include a crossover lumen.

[0051] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having a graft portion 16 with an inner diameter of about 26 mm when in an expanded state and a proximal self-expanding anchor member 24 with an outer diameter of about 34 mm when in an expanded state may be loaded into a delivery catheter 14 having an outer sheath 74 with an outer diameter of about 15 French. This combination resulted in an outer sheath retraction force of about 7 pounds for unsheathing movement of the outer sheath 74. In this particular example, the radial expansion achieved after release of the distal portion 28 of the proximal self-expanding anchor member 24 and initial inflation of the balloon 62 was about 10 mm to about 25 mm. The inflatable balloon 62 also had a tapered configuration that ultimately achieved an expanded dimension of about 20 mm outer diameter and about 7 mm axial length. This inflatable balloon took about 16 seconds to fill with about 5 ml of saline through an inflation lumen 60 having an inner diameter of about 0.02 inches by manual injection. The delivery catheter 14 did not include a crossover lumen.

[0052] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having a graft portion 16 with an inner diameter of about 26 mm when in an expanded state and a proximal self-expanding anchor member 24 with an outer diameter of about 34 mm when in an expanded state may be loaded into a delivery catheter 14 having an outer sheath 74 with an outer diameter of about 15 French. This combination resulted in an outer sheath retraction force of about 9 pounds for unsheathing movement of the outer sheath 74. In this particular example, the radial expansion achieved after release of the distal portion of the proximal self-expanding anchor member 24 and initial inflation of the balloon 62 was from about 10 mm to about 19 mm, ultimately to about 25 mm at maximum inflation. The inflatable balloon 62 also had a tapered configuration that ultimately achieved an expanded dimension of about 20 mm outer diameter and about 7 mm axial length. This inflatable balloon took about 15 seconds to fill with about 6 ml of saline through an inflation lumen having an inner diameter of about 0.025 inches by manual injection. The delivery catheter 14 included a crossover lumen, a fill port at the distal adapter 54, such that retraction of the balloon 62 during this procedure was acceptable.

[0053] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having a graft portion 16 with an inner diameter of about 26 mm when in an expanded state and a proximal self-expanding anchor member 24 with an outer diameter of about 34 mm when in an expanded state may be loaded into a delivery catheter 14 having an outer sheath 74 with an outer diameter of about 14 French. This combination resulted in an outer sheath retraction force of about 13 pounds for unsheathing movement of the outer sheath 74. In this particular example, the radial expansion achieved after release of the distal portion of the proximal self-expanding anchor member 24 and initial inflation of the balloon 62 was about 10 mm to about 20 mm. The inflatable balloon 62 also had a standard configuration that ultimately achieved an inflated diameter of about 15 mm and an axial length of about 25 mm. The inflatable balloon was filled through an inflation lumen having an inner diameter of about 0.025 inches. The delivery catheter 14 included a crossover lumen 71 and a fill port in the distal adapter 54. This particular example was used with a chimney-type graft 90 (a 6 mm Viabahn® graft manufactured by Gore Enterprises, Flagstaff, AZ) and a flexible Coda® balloon model 32 mm manufactured by Cook Medical, located in Bloomington, Indiana, during filling, and no groove-type channels were observed in the Coda balloon when it was being inflated or deflated.

[0054] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having a graft portion 16 with an inner diameter of about 22 mm when in an expanded state and a proximal self-expanding anchor member 24 with an outer diameter of about 29 mm when in an expanded state may be loaded into a delivery catheter 14 having an outer sheath 74 with an outer diameter of about 14 French. This combination resulted in an outer sheath retraction force of about 15 pounds for unsheathing movement of the outer sheath 74. In this particular example, the radial expansion achieved after release of the distal portion of the proximal self-expanding anchor member 24 and initial inflation of the balloon 62 was about 8 mm to about 21 mm. The inflatable balloon ultimately achieved an inflated diameter of about 10 mm and an axial length of about 15 mm. The inflatable balloon 62 was filled with water to an inflation pressure of about 6 psi through an inflation lumen 60 having an inner diameter of about 0.025 inches. The delivery catheter 14 included a crossover lumen 71 and a fill port in the distal adapter 54. This particular embodiment was used with a chimney type graft 90 (5 mm Tygon type tubing) and a non-compliant balloon 62, and during filling a good seal was created after disengaging the filling tube 69.

[0055] Some endoluminal prosthesis embodiments 12 may include a graft portion 16 with an inner diameter of about 26 mm when in an expanded state and a proximal self-expanding anchor member 24 with an outer diameter of about 34 mm when in an expanded state. Such an endoluminal prosthesis 12 may be loaded into a delivery catheter 14 having an outer sheath 74 with an outer diameter of about 15 French. The inflatable balloon 62 for this embodiment may be made from polyurethane with a durometer of about 90A and a double wall thickness of 0.001 inches. The inflatable balloon may include an outer diameter of about 18.5 mm, a working length of about 20 mm, and an overall length of about 38 mm. The inflatable balloon cone angle may be about 46 to about 48 degrees on each side for a full cone angle 72 of about 92 degrees to about 96 degrees. The elongate shaft 36 may be made from a polyurethane material with a durometer of about Shore 72D. The elongate shaft 36 may further have an outer diameter of about 0.105 inches and extend the entire axial length of the endoluminal prosthesis 12. Such an embodiment may provide a retraction force on the outer sheath 74 of about 11 pounds for unsheathing movement of the outer sheath 74. In this particular example, the radial expansion achieved after release of the distal portion of the proximal self-expanding anchor member 24 and initial inflation of the balloon 62 is about 8 mm to about 20 mm, and the interior volume of the inflatable balloon 62 may be partially inflated to about 10 ml. Such an inflatable balloon embodiment 62 may ultimately achieve an inflated diameter of about 26 mm, which may match the inner lumen size of the associated endoluminal prosthesis when filled to its maximum inflated volume of about 19 ml. This inflatable balloon 62 may be filled through an oval inflation lumen 60 having a minor inner transverse dimension of about 0.025 inches and a major inner transverse dimension of about 0.055 inches. Inflation of such an inflatable balloon embodiment 62 may take approximately 18 seconds to fill approximately 19 ml of a 4:1 saline:contrast mixture through the inflation lumen by manual injection. The corresponding delivery catheter 14 may include a crossover lumen 71 and a fill port in the distal adapter 54.

[0056] For any of the inflatable balloon embodiments discussed herein, it may be desirable to include a means (shown in FIGS. 13 and 14) for allowing blood perfusion past the inflatable balloon 62 while the inflatable balloon 62 is in an inflated state. This may be applicable for indications including treatment of thoracic aortic aneurysms and abdominal aortic aneurysms. This may be particularly true for the larger thoracic aorta, where such perfusion means including perfusion holes and a petal-shaped inflatable balloon 62' as shown in FIG. 13 or multiple smaller inflatable balloons 62'' as shown in FIG. 14 bundled together may be useful to avoid migration of the endoluminal prosthesis during deployment as well as to allow blood flow during inflation. For some embodiments, the number of petal-shaped inflatable balloons 62' or multiple smaller inflatable balloons 62'' disposed about the shaft 36 may be from about 3 to about 5 balloons 62''.

[0057] 15-26 illustrate an embodiment of a delivery system for treatment of a vascular defect, such as an aneurysm 8. The delivery system embodiment 110 may include an endoluminal prosthesis 12 for treatment of the vascular defect 8 and a delivery catheter 114. Generally, the delivery system 110 may include materials, dimensions, and features that are the same as or similar to those of the delivery system 10 discussed above. Where appropriate, like reference numbers will be used for like elements with respect to the delivery system 10 and delivery system 110 discussed above. As shown, the delivery system 110 includes a multi-lumen member 165, which may include an elongated multi-lumen member 165 for use within the elongated shaft 136 to facilitate various functions of the delivery catheter and its elements.

[0058] As discussed above, the endoluminal prosthesis 12 may include a tubular main graft section 16 made from a thin, flexible material and including a main inner lumen 18, a proximal end 20, and a distal end 22. The graft body may be formed from a flexible and pliable graft material, such as PTFE, and may have a main fluid flow lumen therein disposed within the main graft section.

[0059] For some embodiments, the delivery catheter 114 of the delivery system 110 includes an elongate shaft 136 with sufficient column strength for percutaneous advancement within the patient's vessel 8, which may also have a proximal section 138 and a distal section 140. A plurality of releasable belts may be disposed on the proximal section 138 of the elongate shaft 136 and configured to releasably restrain the self-expanding anchor members of the endoluminal prosthesis. A plurality of appropriately sized cylindrical bushings or pads 133 may be secured on the elongate shaft adjacent one or more of the releasable belts to appropriately space the self-expanding anchor members 124 or portions thereof during a restrained state. A plurality of elongate release members may be disposed in operative communication with the distal section of the elongate shaft 136, and the elongate release members may each include a proximal section configured to releasably secure at least one respective releasable belt while the releasable belt is in a configuration that restrains at least a portion of the self-expanding anchor member 124 of the endoluminal prosthesis 112.

[0060] The elongate shaft 136 of such a delivery catheter embodiment 114 may include one or more release member lumens 158 extending into a release member sleeve 167, a guidewire lumen 156 extending into a guidewire tube 157, an inflation lumen 160 extending into an inflation tube 161 for inflation of an inflatable balloon 162, and an optional filling lumen 164 extending into a filling tube 169 for filling an optional inflatable portion of the endoluminal prosthesis 112. A cross section of the elongate shaft 136 of the delivery catheter embodiment 114 illustrates the release member lumen 158 and the guidewire lumen 156 surrounded by the guidewire tube 157.

[0061] Each of these lumen embodiments 156, 158, 160, 164 and tube or sleeve embodiments 157, 161, 167, 169 may extend axially along or within the elongate shaft 136 of the delivery catheter 114 from its proximal section to its distal end, including to a distal adapter 154 at the distal end of the elongate shaft 136. In some cases, a release member (not shown) may be coupled to a respective deployment knob 166 disposed on the distal adapter 154.

[0062] The inflatable balloon 62, which may be integrally formed with the elongate shaft 136, may be operably secured to the elongate shaft 136 of the delivery catheter 114 within the main inner lumen 118 of the tubular main graft portion 116 of the endoluminal prosthesis 112. In some cases, the inflatable balloon 62 may be disposed in an axial position where the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is adjacent to but positioned distal to the radiopaque marker 132, with an optional axial gap of up to about 5 mm, and in some cases up to about 2 mm, therebetween, as indicated by the arrow 55' shown in FIG. 23 and discussed in more detail above with respect to the configurations shown in FIGS. 3 and 10. In some cases, the inflatable balloon 62 may be disposed within the non-deployment constrained endoluminal prosthesis 112 in an axial position where the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is disposed distal to a self-expanding anchor member structure, such as the self-expanding anchor member 124. The inflatable section 55 of the inflatable balloon 62 may also be positioned with the proximal end 68 of the inflatable section 55 adjacent to, but positioned distal to, any other high strength resilient structure, such as a connector ring, that may be associated with securing the anchor member portion of the endoluminal prosthesis 112 to the main graft portion 116 of the endoluminal prosthesis 112. As discussed above, in some cases, an optional axial gap of up to 5 mm, and more specifically, up to about 2 mm, may be present between the proximal end 68 of the inflatable section 55 and the distal end of the self-expanding anchor member 124.

[0063] For some embodiments, the inflatable balloon 62 may have a proximal end surface 70 with a cone angle 72 (as shown in FIG. 11) of about 80 degrees to about 120 degrees, more specifically, about 80 degrees to about 100 degrees, and even more specifically, about 90 degrees to about 98 degrees. The full diameter length of the inflatable balloon (indicated by arrow 51 in FIG. 11) may be indicated for imaging, such as under fluoroscopic imaging, using a pair of radiopaque markers 135 positioned axially coextensive with each respective proximal and distal end of the full diameter section, as shown in FIG. 23. These markers 1 may be useful in certain circumstances to axially align the inflatable balloon 62 with structures of the endoluminal prosthesis 112, such as the inflatable cuff 182 of the endoluminal prosthesis 112 discussed below.

[0064] Delivery catheter 114 may have an outer sheath 174 with an elongated tubular shape and a thin wall that is disposed over elongated shaft 136 and endoluminal prosthesis 112. Outer sheath 174 may be configured to slide relative to the elongated shaft and endoluminal prosthesis 112 to removably cover the endoluminal prosthesis 112 while in a constrained state. Delivery catheter 114 may also include a proximal nosecone 176 that may have a bullet-shaped profile and a shoulder portion having an outer surface that may be configured to slidingly receive an inner luminal surface of retractable outer sheath 174.

[0065] For some embodiments, the optional inflatable portion 180 of the graft portion 116 of the endoluminal prosthesis may include one or more inflatable cuffs 182 and / or one or more inflatable channels (not shown) formed from the flexible material of the main graft portion and legs 84 (see branch legs shown in the embodiment of FIG. 34). A filling tube 169 may also be configured to be coupled to and in fluid communication with a distal end of a filling port 88 (shown in FIG. 9) of the inflatable portion 80 of the endoluminal prosthesis 12. The filling tube 169 may also be decoupled from the inflation port 88. The outer transverse dimension of the filling tube may be configured to slide within the inner lumen of the filling port 88 and provide a seal against viscous fluids therebetween. For such embodiments, the delivery catheter 114 may include a filling tube 169 including a filling lumen 164 extending axially within the elongated shaft 136 from a proximal section to a distal section of the elongated shaft 136.

[0066] In some cases, inflating and radially expanding the inflatable balloon 62 may include inflating and radially expanding the inflatable balloon 62 to apply an outward radial force to the inner surface of the main inner lumen 118 of the graft portion 116 of the endoluminal prosthesis 112 until the outer surface of the graft portion 116 adjacent the inflatable balloon 62 is forced into contact with the inner surface of the patient's vessel 8. Saline or other inflation fluid may then be injected through the inflation lumen 160 of the elongate shaft 136 and enter the interior volume of the inflatable balloon 62 at the desired pressure. In some cases, inflating the inflatable balloon 62 may include inflating the interior volume of the inflatable balloon 62 with a sterile, incompressible fluid, such as saline, within the inflation lumen 60 at a pressure of about 3 psi to about 9 psi, and in some cases up to a pressure of about 1 atmosphere. The pressurized saline may be injected using a device such as an Endoflator® or a standard syringe by coupling an inflation device to a connector, such as a Luer type connector, on the distal adapter 154. In some cases, the interior volume of the inflatable balloon 62 may be inflated with a mixture of saline and contrast agent to improve the ability to image the inflated or partially inflated inflatable balloon 62 using fluoroscopy, etc.

[0067] The inflation lumen 160 for the inflatable balloon 62 may be made from a thin wall material such as polyimide with an inner lumen having an oval cross section. As discussed above, some oval inflation lumen embodiments 160 may have a major inner transverse dimension of about 0.055 inches to about 0.060 inches and a minor inner transverse dimension of about 0.024 inches to about 0.028 inches. Inflation of such inflatable balloon embodiments 62 may be performed with a syringe (not shown) connected to a Luer type inflation port fitting 180 on the distal adapter 154. The delivery catheter 114 may further include a crossover lumen 182 and a fill port 184 in communication with the fill tube 169 in the distal adapter 154.

[0068] 27-29 and 31-33 illustrate several multi-lumen member embodiments 65, 65', and 65'', including various embodiments of guidewire tube lumen embodiments 57A, 57A', and 57A'', which accommodate guidewire tube 57. Release wire sleeve lumen embodiments 67A, 67A', and 67A'' may accommodate release wire sleeve 67. Multi-lumen member embodiments 65, 65', and 65'' may be configured as elongated multi-lumen member embodiments in some cases. Release wire sleeve embodiments 67A, 67A', and 67A'' may also be configured to accommodate crossover member 71 in some cases. Additionally, fill tube lumen embodiments 69A, 69A', and 69A'' of respective multi-lumen member embodiments 65, 65', and 65'' may be used to contain or surround fill tube 69. Because the filling tube 69 typically connects to a port at the distal end of the endoluminal prosthesis 12, a multi-lumen member embodiment including the aforementioned elements will typically be positioned distal to the endoluminal prosthesis 12 on the delivery system 14.

[0069] In some method embodiments, it may be desirable to deploy a "chimney" type endoluminal prosthesis 90 in fluid communication between the patient's renal arteries 92 (or any other suitable aortic side branch arteries and downstream vessels of the aorta, such as the SMA or celiac artery) and the aorta prior to deployment of the aortic endoluminal prosthesis 12, as shown in Figures 34 and 35. In such methods, particularly when an inflatable endoluminal prosthesis is used in the aorta, the inflatable balloon 62 may provide an enhanced seal between the outer surface of the chimney prosthesis 90, the outer surface of the main graft portion 16, the endoluminal prosthesis 12, and the inner surface of the patient's blood vessel 9 being treated. Such an enhanced seal may reduce or prevent leakage caused by groove-type channels formed between these surfaces during deployment of these prostheses 12. For some such chimney graft deployment embodiments, an inflatable balloon embodiment 62 made from a non-elastic material may be more useful to eliminate groove-type channels that form between these surfaces during deployment of these endoluminal prostheses 12.

[0070] Each patent, patent application, publication, and document referenced herein is hereby incorporated by reference in its entirety. Citation of the above patents, patent applications, publications, and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or dates of such publications or documents.

[0071] Modifications may be made to the foregoing without departing from the fundamental aspects of the embodiments discussed. Although the embodiments have been described in substantial detail with reference to one or more specific embodiments, those skilled in the art will recognize that changes may be made to the embodiments specifically disclosed herein, but that these modifications and improvements are within the scope and spirit of the present disclosure.

[0072] The embodiments preferably illustratively described herein may be practiced in the absence of any element not specifically disclosed herein. Thus, for example, in each instance herein, any of the terms "comprising", "consisting essentially of" and "consisting of" may be replaced with any of the other two terms. The terms and expressions employed are used as terms of description, not of limitation, and the use of such terms and expressions does not exclude any equivalents of the features shown and described, or portions thereof, and various modifications are possible. The terms "a" or "an" may refer to one or more of the elements it modifies (e.g., "a reagent" may mean one or more reagents), unless the context is clear that either one of the elements or more than one of the elements is being described. Thus, although the embodiments have been specifically disclosed by representative embodiments and optional features, it should be understood that modifications and variations of the concepts disclosed herein may be employed by those skilled in the art, and such modifications and variations are considered to be within the scope of the present disclosure.

[0073] Certain embodiments are set forth in the claims below.

Claims

1. 1. A delivery system for the treatment of a vascular disorder, comprising: the delivery system comprises an endoluminal prosthesis for treatment of the vascular defect; The intraluminal prosthesis comprises: a tubular main graft portion including a thin, flexible material, a main inner lumen, a proximal end, and a distal end; a self-expanding anchor member, a distal end of the self-expanding anchor member being secured to the proximal end of the tubular main graft section; A delivery catheter Including, The delivery catheter comprises: an elongate shaft including a distal section and a proximal section, the proximal section configured to releasably secure the endoluminal prosthesis in a constrained state; an inflatable balloon secured to the elongate shaft, the inflatable balloon being disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis prior to delivery of the endoluminal prosthesis to a deployment site; Including, the elongate shaft includes an elongate multi-lumen member extending from a distal section of the elongate shaft to a proximal section of the elongate shaft, the multi-lumen member including an inflation lumen for inflation of the inflatable balloon, a proximal portion of the tubular main graft portion of the endoluminal prosthesis including an inflatable cuff, the inflatable balloon being axially positioned such that a working length of the inflatable balloon is axially coextensive with the inflatable cuff; A delivery system wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent to but distal to the self-expanding anchor member.

2. The delivery system of claim 1 , wherein the multi-lumen member includes a guidewire lumen.

3. The delivery system of claim 2 , wherein the multi-lumen member includes a release wire lumen.

4. 2. The delivery system of claim 1, wherein the endoluminal prosthesis further comprises a plurality of radiopaque markers circumferentially disposed adjacent the proximal end of the tubular main graft portion, and the proximal end of the inflatable section of the inflatable balloon is disposed adjacent but distal to the plurality of radiopaque markers.

5. 1. A delivery system for the treatment of a vascular disorder, comprising: the delivery system comprises an endoluminal prosthesis for treatment of the vascular defect; The intraluminal prosthesis comprises: a tubular main graft portion including a thin, flexible material, a main inner lumen, a proximal end, and a distal end; a self-expanding anchor member, a distal end of the self-expanding anchor member being secured to the proximal end of the tubular main graft section; A delivery catheter Including, The delivery catheter comprises: an elongate shaft including a distal section and a proximal section, the proximal section configured to releasably secure the endoluminal prosthesis in a constrained state; an inflatable balloon secured to the elongate shaft, the inflatable balloon being disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis prior to delivery of the endoluminal prosthesis to a deployment site; Including, The delivery catheter further includes an outer sheath disposed over the elongate shaft, the outer sheath configured to removably cover the endoluminal prosthesis in the constrained state; A delivery system wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent to but distal to the self-expanding anchor member.

6. 1. A delivery system for the treatment of a vascular disorder, comprising: the delivery system comprises an endoluminal prosthesis for treatment of the vascular defect; The intraluminal prosthesis comprises: a tubular main graft portion including a thin, flexible material, a main inner lumen, a proximal end, and a distal end; a self-expanding anchor member, a distal end of the self-expanding anchor member being secured to the proximal end of the tubular main graft section; A delivery catheter Including, The delivery catheter comprises: an elongate shaft including a distal section and a proximal section, the proximal section configured to releasably secure the endoluminal prosthesis in a constrained state; an inflatable balloon secured to the elongate shaft, the inflatable balloon being disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis prior to delivery of the endoluminal prosthesis to a deployment site; Including, the endoluminal prosthesis includes an expandable portion, the delivery catheter further includes a fill tube including a fill tube lumen in fluid communication with the expandable portion of the expandable endoluminal prosthesis, the fill tube lumen extending axially within the elongate shaft; A delivery system wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent to but distal to the self-expanding anchor member.

7. The delivery system of claim 1 , wherein the self-expanding anchor member comprises a monolithic structure formed from a single piece of continuous material without any joints formed therein.

8. The delivery system of claim 1 , wherein the self-expanding anchor member includes a barb including a sharp tissue-piercing tip.

9. The delivery system of claim 1 , wherein the inflatable balloon is disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis at an axial position.

10. The delivery system of claim 1 , wherein the proximal end of the inflatable section of the inflatable balloon is disposed adjacent to the tubular main graft portion.

11. 1. A delivery system for the treatment of a vascular disorder, comprising: the delivery system comprises an endoluminal prosthesis for treatment of the vascular defect; The intraluminal prosthesis comprises: a tubular main graft portion including a thin, flexible material, a main inner lumen, a proximal end, and a distal end; a self-expanding anchor member, a distal end of the self-expanding anchor member being secured to the proximal end of the tubular main graft section; A delivery catheter Including, The delivery catheter comprises: an elongate shaft including a distal section and a proximal section, the proximal section configured to releasably secure the endoluminal prosthesis in a constrained state; an inflatable balloon secured to the elongate shaft, the inflatable balloon being disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis prior to delivery of the endoluminal prosthesis to a deployment site; Including, the elongate shaft includes an inflation lumen extending from a distal section of the elongate shaft to a proximal section of the elongate shaft, the endoluminal prosthesis includes an inflatable portion, and the delivery catheter further includes a fill tube including a fill tube lumen in fluid communication with the inflation lumen and the inflatable portion; A delivery system wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent to but distal to the self-expanding anchor member.

12. The delivery system of claim 11, wherein the elongated shaft includes an elongated multi-lumen member, the elongated multi-lumen member including an inflation lumen for inflation of the inflatable balloon.

13. The delivery system of claim 11 , wherein the fill tube lumen is in fluid communication with the expandable portion of the expandable endoluminal prosthesis and extends axially within the elongate shaft.

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