Balloon-assisted endoluminal prosthesis deployment

Abstract

The present application relates to balloon-assisted endoluminal prosthesis deployment. A delivery system embodiment for treating a vascular defect of a patient's vasculature may include an endoluminal prosthesis loaded on a delivery catheter. In some cases, an inflatable balloon for facilitating deployment of the endoluminal prosthesis may be placed within the inner lumen of a tubular graft portion of the endoluminal prosthesis.

Description

[0001] Information about divisional applications

[0002] This case is a divisional application. The parent case of the divisional application is an invention patent application with application date of May 26, 2016, application number 201680036853.8, and invention name “Balloon-assisted intraluminal prosthesis deployment”.

[0003] Related patent applications

[0004] This patent application claims the benefit of U.S. Provisional Patent Application No. 62 / 167,247, filed on May 27, 2015, entitled “BALLOON ASSISTED ENDOLUMINAL PROSTHESIS DEPLOYMENT” and having Agent File No. TRI-1708-PV, with Mark Geusen as the inventor. The entire text of the U.S. Provisional Patent Application (including all text and drawings) is incorporated herein by reference. Background Art

[0005] An aneurysm is a vascular defect that is usually indicated by a dilation and weakening of a patient's arterial wall. Aneurysms can occur at various locations within a patient's body. A thoracic aortic aneurysm (TAA) or abdominal aortic aneurysm (AAA) is manifested by a dilation and weakening of the aorta, which is a serious and life-threatening condition that often requires intervention. Current methods of treating aneurysms involve invasive surgical procedures that replace or reinforce the affected blood vessel or body lumen with a graft.

[0006] Surgery to treat aortic aneurysms can have relatively high morbidity and mortality because of the risk factors inherent to surgical repair of this disease as well as the long hospital stay and painful recovery. This is particularly true for surgical repair of TAAs, which are generally considered to involve higher risks and greater difficulty than surgical repair of AAAs. Examples of surgical procedures involving the repair of AAAs are described in the book entitled "Surgical Treatment of Aortic Aneurysms" by Denton A. Cooley, MD, published in 1986 by WB Saunders.

[0007] Because of the inherent risks and complexity of surgical repair of aortic aneurysms, minimally invasive endovascular repair has become a widely used alternative, especially in the treatment of AAA. Early work in this area was exemplified by Lawrence, Jr. et al., "Percutaneous Endovascular Graft: Experimental Evaluation" (May 1987) and by Mirich et al., "Percutaneously Placed Endovascular Grafts for Aortic Aneurysms: Feasibility Study" Radiology (March 1989).

[0008] When deploying endoluminal prosthesis type devices by catheter or other suitable instruments, it may be advantageous to have flexible and low-profile endoluminal prostheses (e.g., stent grafts and delivery systems) for use through various guide catheters and the sometimes twisted anatomy of patients. Although many of the existing endovascular devices and methods for treating aneurysms have shown significant progress over previous devices and methods, they use systems with relatively large transverse profiles, typically up to 24 French. Moreover, such existing systems have greater transverse stiffness than desired, which can complicate the delivery process, especially when used to treat vascular defects that include high curvature or angles. Even with a more flexible low-profile delivery system, deploying endovascular prostheses in highly angled and curved vessels can still be problematic due to the difficulty of visualizing or imaging the orientation of the prosthesis during the deployment process. In some instances, it may also be challenging to achieve a proper seal between the outer surface of the endovascular prosthesis and the inner surface of the vessel being treated after the endovascular prosthesis is deployed. As such, minimally invasive endovascular treatment of aneurysms may not be available to many patients who would benefit from such a procedure and may be difficult to perform in those patients who require such a procedure.

[0009] There is a need for endoluminal prostheses and suitable delivery catheters that are adaptable 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

[0010] Some embodiments of a delivery system for treating a vascular defect may include an endoluminal prosthesis for treating a vascular defect 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 have a self-expanding anchoring component having a proximal portion and a distal portion. The distal end of the distal portion may be fastened to the proximal end of the tubular main graft portion and the distal end of the proximal portion may be fastened to the proximal end of the distal portion. In addition, the endoluminal prosthesis may also have a plurality of radiopaque markers disposed circumferentially adjacent to the proximal end of the tubular main graft portion. For some embodiments, the delivery catheter of the delivery system may include an elongated shaft having a column strength sufficient to be percutaneously advanced into the vasculature of a patient, the elongated shaft also having a proximal section and a distal section. A plurality of releasable bands may be disposed on the proximal section of the elongated shaft and configured to releasably constrain the self-expanding anchoring member of the endoluminal prosthesis. A plurality of elongated release members may be disposed in operative communication with the distal end of the elongated shaft and the elongated release members may each include a proximal section configured to releasably secure the releasable band when at least one respective releasable band is in a configuration that constrains at least a portion of the self-expanding anchoring member of the endoluminal prosthesis. An inflatable balloon may be secured to the elongated shaft within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis. In some examples, the inflatable balloon may be disposed in an axial position wherein the proximal end of the inflatable section of the inflatable balloon is adjacent to the self-expanding anchoring member but is located distal to the self-expanding anchoring member. In some examples, the inflatable balloon may be positioned in an axial position wherein the proximal end of the inflatable section of the inflatable balloon is positioned adjacent to the radiopaque marker but distal to the radiopaque marker. For some inflatable balloon embodiments, the proximal neck portion (the portion of the tubular member of the inflatable balloon tube that contacts the outer surface of the shaft) of some inflatable balloon embodiments may be positioned proximal to the radiopaque marker, as long as the proximal angled portion or proximal taper of the inflatable balloon and any pleats of the inflatable balloon material are positioned distal to the radiopaque marker.

[0011] Some embodiments of a method of deploying an endoluminal prosthesis may include: advancing a delivery system into the vasculature of a patient, the delivery system including an elongated shaft and an endoluminal prosthesis releasably secured to the elongated shaft. The method may also include: releasing an outer constraint from a main graft portion of the endoluminal prosthesis and partially releasing an outer radial constraint from a self-expanding anchoring member of the endoluminal prosthesis to allow the self-expanding anchoring member to be partially deployed. Thereafter, an inflatable balloon may be inflated and radially expanded to radially expand a portion of the graft portion of the endoluminal prosthesis, the portion being axially disposed adjacent to and coextensively with the inflatable balloon. In some cases, the inflatable balloon may be disposed within a main inner lumen of the main graft portion of the endoluminal prosthesis, wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent to but distal to the self-expanding anchoring member. In some cases, the inflatable balloon may be disposed within a main inner lumen of a main graft portion of the endoluminal prosthesis, wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent to but distal to a plurality of radiopaque markers, the plurality of radiopaque markers being disposed circumferentially adjacent to a proximal edge of the main graft portion of the endoluminal prosthesis. The outer radial constraint on the self-expanding anchoring component may then be fully released to fully deploy the self-expanding anchoring component 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 to an 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 to the inflatable balloon is urged into contact with an inner surface of the patient's vasculature.

[0012] Some embodiments of a delivery system for treating a vascular defect may include an endoluminal prosthesis for treating a vascular defect 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 anchoring member, wherein the distal end of the self-expanding anchoring member is secured to the proximal end of the tubular main graft portion. The delivery catheter may include an elongated shaft having a distal section and a proximal section, wherein the proximal section is configured to releasably secure the endoluminal prosthesis in a constrained state. The delivery catheter may also include an inflatable balloon secured to the elongated shaft in an axial position and disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis, wherein the proximal end of the inflatable section of the inflatable balloon is disposed adjacent to the self-expanding anchoring member but distal to the self-expanding anchoring member. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is an elevation view in partial section of an embodiment of a delivery system being advanced over a guidewire into the aorta of a patient's vasculature.

[0014] Figure 1A is advanced over a guidewire into the patient's vasculature in the abdominal aorta. Figure 1 Elevation view of a partial section of a delivery system.

[0015] Figure 2 yes Figure 1 An elevational view of a delivery system embodiment of the invention with the outer sheath of the delivery catheter of the delivery system embodiment retracted.

[0016] Figure 3 yes Figure 2 The delivery system embodiment of the Figure 2 An enlarged view of the proximal portion indicated by the circled portion 3-3 in FIG.

[0017] Figure 4 It is along Figure 3 The line 4-4 in Figure 3 Transverse cross-sectional view of an embodiment of a delivery system.

[0018] Figure 5 It is along Figure 3 The line 5-5 in Figure 3 Transverse cross-sectional view of an embodiment of a delivery system.

[0019] Figure 6 is an elevation view of a pleated embodiment of an inflatable balloon.

[0020] Figure 7 It is along Figure 3 The line 7-7 in Figure 3 Transverse cross-sectional view of an embodiment of a delivery system.

[0021] Figure 8 is placed in Figure 3 An enlarged view of a release wire embodiment within an end ring of a releasable band embodiment of a delivery catheter of a delivery system embodiment.

[0022] Fig. 9 yes Figure 1 An elevational view of an embodiment of a delivery system in which a self-expanding anchor component is partially deployed and wherein an outer radial constraint on a distal portion of the self-expanding anchor component has been removed.

[0023] Fig.10 yes Fig. 9 An elevational view of an embodiment of a delivery system of FIG. 1 in which an inflatable balloon disposed within a major inner lumen of a graft portion of an endoluminal prosthesis has been inflated.

[0024] Fig.11 It is in an inflated state Figure 1 An embodiment of an inflatable balloon of an embodiment of a delivery system of the invention and an elevation view showing the taper angle of the proximal surface of the inflatable balloon embodiment.

[0025] Fig.12 is the distal adapter assembly and Figure 1 An elevational view of a distal portion of a delivery catheter of an embodiment of a delivery system.

[0026] Fig.13 is a schematic diagram in lateral section of an embodiment of a perfused inflatable balloon.

[0027] Fig.14 is a schematic diagram in lateral section of an embodiment of a perfused inflatable balloon.

[0028] Fig.15 is an elevation view of an embodiment of a delivery system.

[0029] Fig.16 yes Fig.15 A perspective view of a portion of an embodiment of a delivery system of , with the outer sheath not shown.

[0030] Fig.17 It is along Fig.16 The line 17-17 is intercepted Fig.16 A transverse cross-section of an embodiment of a delivery system.

[0031] Fig.18 It is along Fig.16 The line 18-18 is intercepted Fig.16 A transverse cross-section of an embodiment of a delivery system.

[0032] Fig.19 yes Fig.15 A perspective view of a portion of an embodiment of a delivery system.

[0033] Fig. 20 is a perspective view of an embodiment of a distal adapter.

[0034] Fig.21 is a perspective view of an embodiment of a distal adapter.

[0035] Fig. 22 yes Fig.15 A perspective view of a partial section of a portion of an elongated shaft embodiment of a delivery system.

[0036] Fig.23 yes Fig.15 An elevation view of an embodiment of an inflatable balloon portion of a delivery system.

[0037] Fig.24 It is taken along line 24-24 Fig.23A transverse cross-section of the inflatable balloon portion.

[0038] Fig.25 It is taken along line 25-25 Fig.23 A transverse cross-section of the inflatable balloon portion.

[0039] Fig.26 It is taken along line 26-26 Fig.23 A transverse cross-section of the inflatable balloon portion.

[0040] Fig. 27 is a perspective view of an embodiment of a multi-lumen component for use with an embodiment of a multi-lumen delivery catheter.

[0041] Fig.28 is a perspective view of an embodiment of a multi-lumen component for use with an embodiment of a multi-lumen delivery catheter.

[0042] Fig.29 yes Fig.28 A perspective view of an embodiment of an embodiment of a multi-lumen component.

[0043] Fig.30 is a perspective view of an embodiment of a distal adapter having a cross-port at the bottom, an inflation port for an inflatable balloon at the top, and a filling port at the side of the adapter for an optional inflatable portion of an endoluminal prosthesis.

[0044] Fig.31 is a perspective view of an embodiment of a multi-lumen component.

[0045] Fig.32 yes Fig.31 A perspective view of a multi-lumen component.

[0046] Fig.33 yes Fig.31 A perspective view of a multi-lumen component.

[0047] Fig.34 is an elevational view of an endoluminal prosthesis system embodiment comprising an inflatable balloon and a pair of opposing chimney graft portions deployed within the vasculature of a patient to maintain patency of a renal artery of the patient.

[0048] Fig.35 It is along Fig.34 The line 35-35 is intercepted Fig.34 A transverse cross-sectional view of an embodiment of an endoluminal prosthesis system.

[0049] The drawings illustrate embodiments of the invention and are not limiting. For clarity and ease of illustration, the drawings are not made to scale and in some instances, various aspects may be shown exaggerated or enlarged to facilitate understanding of particular embodiments. DETAILED DESCRIPTION

[0050] As discussed above, there is a need for an endoluminal prosthesis delivery system with a less flexible delivery profile. It may also be useful to configure such a delivery system to reliably open a portion of an endoluminal prosthesis containing a radiopaque marker so as to visualize the endoluminal prosthesis under fluoroscopic imaging, etc., to achieve proper placement. The embodiments discussed herein may include an inflatable device (e.g., an inflatable balloon) that can be used to apply an outward radial force to the inside surface of the endoluminal prosthesis at a specific axial position during the deployment process in order to achieve these goals. This inflatable balloon disposed within the graft portion of the endoluminal prosthesis containing a self-expanding anchoring component can be used to improve the opening and deployment of the prosthesis. The improved deployment can be particularly useful in angled vessels 9 of the patient being treated. This inflatable balloon assembly can also be used to help seal the outer surface of the endoluminal prosthesis to the inner surface of the lumen being treated.

[0051] With respect to the delivery system embodiments discussed herein (including endoluminal prostheses, delivery catheter embodiments, and associated structures and methods), the term "proximal" refers to a position toward the patient's heart and away from an operator who is using the delivery system to deploy the endoluminal prosthesis. The term "distal" refers to a position away from the patient's heart and toward the operator.

[0052] Refer to the figures, Figures 1 to 12 1 shows an embodiment of a delivery system 10 for treating a vascular defect, such as an aneurysm 8. Although the exemplary aneurysm 8 shown in the patient's vasculature 9 is a thoracic aortic aneurysm, the devices and methods 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 ( Figure 1A ) and the like. The delivery system embodiment 10 may include an endoluminal prosthesis 12 for treating 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 pliable graft material such as PTFE and have a main fluid flow lumen disposed in the main graft portion therein. For some embodiments, the flexible graft material comprising PTFE may include expanded PTFE or ePTFE.

[0053] refer to Figure 3 The endoluminal prosthesis 12 may also have a self-expanding anchoring member 24 having a proximal portion 26 and a distal portion 28, wherein the distal end of the distal portion is secured to the proximal end 20 of the tubular main graft portion and the distal end of the proximal portion is secured to the proximal end of the distal portion. Figure 3The self-expanding anchoring member embodiment 24 shown in has a generally cylindrical configuration having a free, unfastened end at its proximal end and a distal end fastened to the proximal end of the main graft body. The proximal portion 26 of the self-expanding anchoring member 24 may include a cylindrical stent including an elongated superelastic element arranged in a zigzag configuration, and the distal portion of the self-expanding anchoring member includes a cylindrical stent including an elongated superelastic element arranged in a zigzag configuration. An optional connector ring (not shown) may be embedded in the structure of the proximal end of the main graft portion and may be coupled to the distal end of the proximal self-expanding anchoring member 24. In some cases, this connector ring may include a self-expanding zigzag shape made of a superelastic material (e.g., nickel-titanium alloy). The deployment assistance provided by the inflatable balloon due to the outward radial force supplied by the inflatable balloon may be particularly useful in endoluminal prosthesis embodiments that do not include a self-expanding connector ring. In some cases, this connector ring can be used to provide an opening force at the proximal end of the graft portion of the endoluminal prosthesis during deployment.

[0054] In some examples, the proximal self-expanding anchoring member 24 (including its proximal and distal portions) can have a unitary structure, wherein both the proximal and distal portions are formed from a single continuous piece of material without any joints formed between the portions. In some cases, embodiments of the self-expanding anchoring member 24 can be made of a superelastic metal (including a superelastic metal such as nickel-titanium alloy).

[0055] The proximal self-expanding anchoring member 24 may include outwardly extending barbs (not shown) that may be integrally formed with the struts of the stent structure of either or both of the proximal and distal portions 26, 28 of the self-expanding anchoring member 24. Such barbs may have sharp or sharpened tissue-penetrating tips configured to penetrate into tissue of the inside surface 30 of the lumen within which the proximal self-expanding anchoring member 24 may be deployed in an expanded state. This barb configuration may be used to facilitate securing the self-expanding anchoring member 24 to the inside surface 30 or other luminal surface of the patient's vasculature 9.

[0056] While the self-expandable anchoring members discussed herein may include a proximal portion and a distal portion, other embodiments may be used. Additionally, similar expandable anchoring members may be used that are configured to expand non-elastically with the aid of outward radial pressure, such as may be generated by expansion of a radially expandable inflatable balloon from within either or both of the proximal and distal portions of the proximal self-expandable anchoring member. Such non-elastically expandable anchoring members may otherwise have the same features, dimensions, and configurations as the self-expandable anchoring members discussed herein.

[0057] In addition, the endoluminal prosthesis 12 may also have a plurality of radiopaque markers 32 disposed circumferentially around 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 located in a common plane that is substantially perpendicular to the longitudinal axis 34 of the proximal self-expanding anchor member and the main graft portion of the endoluminal prosthesis 12. 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. This arrangement may be used to visualize the alignment of the endoluminal prosthesis during the deployment process. Some endoluminal prosthesis embodiments may include about 4 to about 12, more specifically about 5 to about 8, such circumferentially spaced radiopaque markers 32 located in a common plane that is optionally perpendicular to the longitudinal axis 34 of the main graft portion of the endoluminal prosthesis.

[0058] For some embodiments, the delivery catheter 14 of the delivery system 10 may include an elongated shaft 36 having a column strength sufficient for percutaneous advancement into the vasculature 8 of a patient, the elongated shaft 36 also having a proximal section 38 and a distal section 40. A plurality of releasable bands may be disposed on the proximal section 38 of the elongated shaft 36 and configured to releasably constrain the self-expanding anchoring member of the endoluminal prosthesis. A plurality of appropriately sized cylindrical sleeves or pads 33 may be secured to the elongated shaft adjacent to one or more of the releasable bands so as to properly space the self-expanding anchoring member 24 or portions thereof when in a constrained state. A plurality of elongated release members may be disposed in operative communication with the distal section of the elongated shaft 36 and the elongated release members may each include a proximal section configured to releasably secure at least one respective releasable band when in a configuration that constrains at least a portion of the self-expanding anchoring member 24 of the endoluminal prosthesis 12.

[0059] A plurality of releasable bands configured to releasably constrain the proximal self-expanding anchoring member 24 of the endoluminal prosthesis 12 may be secured along the proximal section 38 of the elongated shaft 36. Figure 2 The first proximal releasable band 42 and the second proximal releasable band 44 are fastened around the proximal portion 26 of the self-expanding anchor member 24. The first distal releasable band 46 and the second distal releasable band 48 are fastened around the distal portion 28 of the self-expanding anchor member 24.

[0060] refer to Figure 3, at least a first elongated release member 50 and a second elongated release member 52 (which for some embodiments may include elongated release wires) may extend to and communicate with the distal end of the elongated 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 interlock for the connection 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 band (e.g., the first proximal releasable band 42, the second proximal releasable band 44, the first distal releasable band 46, or the second distal releasable band 48) when the releasable band is in a configuration that constrains at least a portion of the endoluminal prosthesis 12 (e.g., the proximal self-expanding anchoring member 24). The release members 50, 52 may be configured to deploy the self-expanding anchoring member 24 at the proximal end of the endoluminal prosthesis 12.

[0061] refer to Figure 2 and 3 , the first release line 50 shown is coupled to the first proximal releasable band 42 and the second proximal releasable band 44 and can thereby be used to release the proximal releasable band via a distal adapter 54 ( Fig.12 46 and the second distal releasable band 48 (in the order described). The second release member 52 shown is coupled to the first distal releasable band 46 and the second distal releasable band 48 and can thereby be used to deploy the first distal releasable band 46 and the second distal releasable band 48 (in the order described) by retracting the second release member 52 distally through a mechanism in the distal adapter 54 or any other suitable method.

[0062] In some examples, friction generated by axial movement of the first and second release members 50, 52 may be minimized by using a multi-lumen configuration in the elongated shaft 36 of the delivery catheter 14. This delivery catheter embodiment 14 may include an elongated shaft 36 having 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 extending within a filling tube 69 for filling an optional inflatable portion of the endoluminal prosthesis 12. Figure 5 The section of the elongated shaft 36 of the delivery catheter embodiment 14 shown in illustrative FIG. 5 illustrates a release member lumen 58 and a guidewire lumen 56 surrounded by a guidewire tube 57 . Figure 5 The section in also includes an inflation lumen 60 surrounded by an inflation tube 61.

[0063] For some embodiments, the inflation tube 61 can have an inflation lumen 60 with a generally circular inner transverse section, and for other embodiments, the inflation lumen 60 can have an elliptical shaped transverse section. In some cases, the circular inflation lumen embodiments can 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 elliptical inflation lumen embodiments 60 can have a large inner transverse dimension of about 0.055 inches to about 0.060 inches, and a small inner transverse dimension of about 0.024 inches to about 0.028 inches. Figures 27 to 33 The inflation tube lumen embodiments 61A, 61A' and 61A" shown in the figure are configured to accommodate the respective inflation tubes 61 and 61'. Each of these lumen embodiments 56, 58 and 60 and tube or sleeve embodiments 57, 61, 67 and 69 can extend axially along or within the elongated shaft 36 of the delivery catheter 14 from the proximal section of the elongated shaft to its distal end, including a distal adapter 54 extending to the distal end of the elongated shaft 36. In some cases, the release member can be coupled to a distal adapter disposed at the distal end of the elongated shaft 36. Fig.12 . A corresponding deployment knob 66 ​​on the distal adapter 54 is shown in FIG.

[0064] An inflatable balloon 62, which may be integrally formed with the elongated shaft 36, may be operably secured to the main inner lumen 18 ( Figure 7 36 of the delivery catheter 14 within the endoluminal prosthesis 12). In some instances, the inflatable balloon 62 may be disposed in an axial position wherein the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is adjacent to but distal to the radiopaque marker 32. In some instances, the inflatable balloon 62 may be disposed in an axial position within the undeployed constrained endoluminal prosthesis 12 wherein the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is adjacent to a self-expanding anchoring member structure (e.g., Figure 3 , 9 10) but disposed distally of the self-expanding anchoring member structure. The inflatable section 55 of the inflatable balloon 62 may also be disposed with the proximal end 68 of the inflatable section 55 adjacent to but disposed distally of any other high-strength elastic structure (e.g., a connector ring) that may be associated with securing the anchoring 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 so as to not axially overlap or be located in the same horizontal plane as the self-expanding anchoring member 24 or any other high-strength structure associated with the self-expanding anchoring member 24.

[0065] With respect to the relative axial positioning of the inflatable balloon 62, for some embodiments, the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 may be said to be adjacent to a structure (e.g., a radiopaque marker 32 or a self-expanding anchoring member 24) but distal to the structure if the optional axial gap between these respective elements is up to about 5 mm, more specifically up to about 2 mm. Figure 3 , 10 23 (discussed below) show an example of such an optional axial gap, as indicated by arrow 55'. Figure 3 and 10 An 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 is illustrated. Fig.23 In the embodiment of the present invention, the radiopaque marker 132 overlaps the structure of the self-expanding anchoring member 124. In this way, Fig.23 An optional gap 55 ′ disposed between the proximal end of the inflatable section 55 of the inflatable balloon 62 and the distal-most ends of the radiopaque marker 132 and the self-expanding anchoring member 124 is illustrated.

[0066] For some embodiments, the formed tubular wall material of the inflatable balloon 62 may be fastened or joined to the elongated shaft 36 in the neck portion by an adhesive (e.g., an ultraviolet cured adhesive), 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 the same or similar material as the balloon shaft section 59 of the elongated shaft 36 for the inflatable balloon 62 to facilitate thermal bonding, welding, etc. between the two elements. The balloon shaft section 59 of the elongated shaft 36 may include a generally tubular portion of the elongated shaft 36 that extends axially within the inflatable balloon 62 and includes an outer surface suitable for engaging the balloon 62 and providing a fluid-tight barrier to the interior volume of the inflatable balloon 62. With respect to material selection, some embodiments may include the balloon shaft section 59 and the inflatable balloon 62 both being made of polyurethane. For some inflatable balloon embodiments 62, the proximal neck portion 63 of some inflatable balloon embodiments 62 can be positioned proximal to the radiopaque marker 32 and / or the self-expanding anchoring member 24, as long as the proximal angled portion or proximal taper of the inflatable balloon 62 and any folds of the inflatable balloon 62 are disposed distal to the radiopaque marker 32 and / or the self-expanding anchoring 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 elongated shaft 36 and at which the proximal end of the inflatable balloon 62 is typically joined to the elongated shaft 36. The distal end of the inflatable balloon 62 is similarly joined to the elongated shaft 36 via a distal neck portion 63'. These joined portions 63 and 63' can have a length selected to provide the necessary joining strength to support the desired inflation pressure while minimizing the length of the joined portions in order to reduce the amount of material and the overall profile of the delivery system 10. For some embodiments, the proximal and distal neck portions 63, 63' may have an axial length of at least about 4 mm, more specifically about 4 mm to about 8 mm.

[0067] In some cases, the inflatable balloon 62 can be formed into a pleated configuration when in the uninflated state in order to keep the uninflated profile of the inflatable balloon 62 to a minimum. In some examples, the inflatable balloon embodiment 62 can be machine folded (or folded by any other suitable means) to include about 5 pleats to about 10 pleats, more specifically about 6 pleats to about 8 pleats, such as Figure 6. For some such embodiments, the distal ends of the pleats may be folded over the distal neck portion 63' of the inflatable balloon 62 so as to displace some of the mass of the inflatable balloon away from the structure of the radiopaque marker 32 and / or the self-expanding anchoring member 24 when in the uninflated state. It may generally be desirable to avoid overlap of the inflatable section 55 of the inflatable balloon 62 with the radiopaque marker 32 or the self-expanding anchoring member 24 so as to keep the outer size profile of the delivery system 10 to a minimum and minimize the risk of damage to the inflatable section 55 of the inflatable balloon 62 due to contact with the self-expanding anchoring member 24.

[0068] With respect to the size of the inflatable balloon embodiments 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 full diameter length portion of the inflatable balloon 62, wherein the outer surface of the inflatable balloon 62 is configured to collapse and apply outward pressure to the inside surface of the endoluminal prosthesis 12 when the inflatable balloon is in an inflated state. The overall length includes all inflatable sections 55, including the tapered cone type sections at one or both ends of the inflatable balloon 62. For the purposes of discussion herein, the overall length is defined as follows: Fig.11 , the working length of the inflatable balloon 62 is indicated by arrow 51 and the overall length of the inflatable balloon 62 is indicated by arrow 53.

[0069] For some embodiments, the inflatable balloon 62 may include an outer transverse dimension / outer 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, an inflatable balloon embodiment 62 made of a substantially non-compliant material may have an outer diameter of about 26 mm for use with an endoluminal prosthesis 12 having a tubular main graft portion having an inner lumen diameter of about 26 mm. Some inflatable balloon embodiments 62 made of a substantially non-compliant 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 having an inner lumen diameter of about 15 mm to about 22 mm. In some cases, an inflatable balloon 62 made of a compliant 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 can be used with a delivery system embodiment 10 having an endoluminal prosthesis 12 having a main graft portion having an inner lumen diameter of about 26 mm. Some inflatable balloon embodiments 62 can have a working length of about 18 mm to about 21 mm, an overall 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 can be made of a compliant material, have an outer diameter of about 16 mm to about 20 mm, a working length of about 16 mm to about 20 mm, and an overall length of about 32 mm to about 38 mm. In some cases, this inflatable balloon embodiment 62 can be used with an endoluminal prosthesis 12 having an inner lumen diameter of about 15 mm to about 26 mm.

[0070] In order to minimize the length of the inflatable balloon 62 proximally extending into the main lumen passage 18 beyond the proximal 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 surface 70 of the balloon 62 to be relatively flat or to have a taper angle close to 180 degrees. For some embodiments, the inflatable balloon 62 may have a proximal surface 70 having a taper angle 72 of about 160 degrees to about 180 degrees (e.g., Fig.11 ). Some embodiments may have a taper angle 72 of about 120 to about 160 degrees, more specifically about 125 to about 135 degrees. Some embodiments may have a taper angle 72 of about 80 to about 120 degrees, more specifically about 80 to about 100 degrees, and even more specifically about 90 to about 98 degrees.

[0071] For some inflatable balloon embodiments 62, the wall material of the inflatable balloon 62 may include a compliant material and for other embodiments, the wall material of the inflatable balloon 62 may include a substantially non-compliant material. Some inflatable balloon embodiments 62 may also include a laminate structure having multiple layers of material that may include both compliant and substantially non-compliant materials. In some cases, the wall material of the inflatable balloon 62 may include a material such as polyethylene terephthalate (PET), a polyamide (e.g., ), polyether block amides (e.g. ), polyethylene (PE), polyurethane (PU), and polyvinyl chloride (PVC), among others, or any combination thereof. Any of the inflatable balloon embodiments discussed herein may include a double wall thickness of the balloon material of about 0.001 inches to about 0.003 inches. Some inflatable balloon embodiments 62 may have a double wall thickness of about 0.0005 inches to about 0.002 inches, more specifically about 0.00075 inches to about 0.0015 inches. Double wall thickness is a measurement derived from measuring the thickness of two thicknesses of the wall of the inflatable balloon 62. In this way, the wall thickness of the inflatable balloon 62 may be measured while the inflatable balloon 62 remains intact.

[0072] The delivery catheter 14 may have an outer sheath 74 having an elongated tubular shape and a thin wall disposed over the elongated shaft 36 and the endoluminal prosthesis 12. The outer sheath 74 may be configured to slide over and relative to the elongated shaft and the endoluminal prosthesis so as to removably cover the endoluminal prosthesis when the endoluminal prosthesis 12 is in a constrained state. The delivery catheter 14 may also include a proximal nose cone 76 that may have a bullet-shaped profile and a shoulder portion having an outer surface that may be configured to slidably receive an inner luminal surface of the retractable outer sheath 74.

[0073] The delivery system and method embodiments 10 discussed herein may be particularly useful for endoluminal prosthesis embodiments 12 that include one or more inflatable portions. Such inflatable endoluminal prosthesis embodiments 12 that may be deployed by the systems and methods discussed herein are discussed in U.S. Pat. No. 7,147,660, filed Dec. 20, 2002, by M. Chobotov et al., entitled “Advanced Endovascular Graft,” which is hereby incorporated herein by reference in its entirety.

[0074] 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) and legs 84 (see FIG. Fig.34For the illustrated embodiment, the inflatable cuff 82 is disposed on the proximal portion of the main graft portion 16. The filling tube 69 may also be configured to couple to the filling port 88 ( Fig. 9 88 and is in fluid communication with the distal end of the elongated shaft 36. 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 within the inner lumen of the filling port 88 and provide a seal for viscous fluids between the filling tube and the inner lumen. For such embodiments, the delivery catheter 14 may include a filling tube 69 including a filling lumen extending axially within the elongated shaft 36 from the proximal section of the elongated shaft 36 to the distal section of the elongated shaft.

[0075] In some cases, the delivery system embodiments 10 discussed herein may include a delivery catheter 14 having an endoluminal prosthesis 12 , such as a stent graft, in a radially constrained state releasably disposed on a proximal section 38 of the delivery catheter 14 . This delivery catheter 14 may include some or all of the features, dimensions, or materials of the delivery system discussed in co-owned U.S. Patent Application Publication No. 2004 / 0138734, filed by Hobotov et al. on October 16, 2003 and published on July 15, 2004, entitled "Delivery System and Method for Bifurcated Graft," and PCT International Publication No. WO 02 / 083038, filed by Hobotov et al. on April 11, 2001 and published on October 24, 2002, entitled "Delivery System and Method for Bifurcated Graft," each of which is incorporated herein by reference in its entirety.

[0076] The endoluminal prosthesis 12 or any other prosthesis discussed herein may include some or all of the features, dimensions, or materials of the prosthesis discussed in commonly owned U.S. Patent Publication No. 2009 / 0099649, entitled “Modular Vascular Graft for Low Profile Percutaneous Delivery,” filed by Hobotov et al. on October 3, 2008, which is incorporated herein by reference in its entirety.

[0077] For some deployment methods, it may be helpful to radially expand a portion of the endoluminal prosthesis 12 (e.g., an interface portion between the anchoring member portion 24 and the main graft portion 16) that may contain a radiopaque marker 32 (e.g., a circumferentially disposed radiopaque marker located 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 helpful to radially expand the circumferentially disposed radiopaque marker 32 in an outward direction from a position occupied by the radiopaque marker in a radially constrained state to a position in relatively close proximity to the inner surface of the vessel 9 in which the endoluminal prosthesis 12 is deployed. This deployment scheme may be particularly useful for endoluminal prosthesis embodiments 12 (e.g., stent grafts) that do not contain a connector ring structure located in the proximal end of the graft portion 16 of the stent graft 12. This is because, in some cases, a self-expanding type connector ring may be used to assist 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 anchoring member 24 has been released. For some endoluminal prosthesis embodiments 12 without a self-expanding connector ring, the proximal end or flap 20 of the graft portion 16 of the stent-graft may only be opened about 10 mm or so, which may not facilitate accurate imaging and positioning using parallax viewing of the radiopaque markers 32 during deployment.

[0078] With regard to the use of the delivery system embodiments 10 and 110 discussed herein, deploying the endoluminal prosthesis 12 may include advancing the delivery system 10 into the vasculature of the patient, the delivery system including the elongated shaft 36 and the endoluminal prosthesis 12 releasably secured to the elongated shaft 36. The method may also include releasing the outer constraint from the graft portion 16 of the endoluminal prosthesis 12, for example, by retracting the outer sheath 74 of the delivery catheter 14. The endoluminal prosthesis 12 (e.g., the distal releasable band 46 and the second distal releasable band 48) may then be released from the endoluminal prosthesis 12. Fig. 9) partially releases the outer radial constraint to allow the self-expandable anchoring member 24 to be partially deployed. Thereafter, the inflatable balloon 62 may be inflated and radially expanded so as to radially expand a portion of the graft portion 16 of the endoluminal prosthesis 12 disposed adjacent to 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, wherein the proximal end of the inflatable balloon 62 is disposed adjacent to the self-expandable anchoring member 24 but distal to the self-expandable anchoring member. 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, wherein the proximal end of the inflatable balloon 62 is disposed adjacent to the self-expandable anchoring member 24 but distal to the self-expandable anchoring member. 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, wherein the proximal end of the inflatable balloon 62 is disposed adjacent to the plurality of radiopaque markers 32 (which may be disposed circumferentially adjacent to the proximal edge 20 of the graft portion of the endoluminal prosthesis 12) but distal to the plurality of radiopaque markers. The outer radial constraint on the self-expanding anchoring member 24 may then be fully released in order to fully deploy the self-expanding anchoring member 24 of the endoluminal prosthesis 12 .

[0079] In some cases, inflating and radially expanding the inflatable balloon 62 may include inflating and radially expanding the inflatable balloon 62 so as to apply an outward radial force to 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 to the inflatable balloon 62 is urged into contact with the inner surface of the patient's vasculature 8. Saline or other inflation fluid may then be injected through the inflation lumen 60 of the elongated shaft 36 and into the interior volume of the inflatable balloon 62 at a desired pressure. In some cases, inflating the inflatable balloon 62 includes inflating the interior volume of the inflatable balloon 62 with a sterile incompressible fluid (e.g., saline) within the inflation lumen 60 at a pressure of about 3 psi to about 9 psi, and in some cases up to about 1 atmosphere. The inflatable balloon 62 may be provided by coupling the inflation device to a connector (e.g., a Luer type connector) on the distal adapter 54, for example. The pressurized saline may be injected by a device such as a syringe or a standard syringe. In some examples, the interior volume of the inflatable balloon 62 may be inflated with a mixture of saline and contrast media 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 media and about 75% saline may be used, and in other embodiments, a mixture of about 20% contrast media and about 80% saline may be used. With respect to inflation of some inflatable balloon embodiments 62, the interior volume of the inflatable balloon 62 may be about 6 ml to about 20 ml.

[0080] In some cases, the endoluminal prosthesis 12 may be axially repositioned within the patient's vessel 9 after partially deploying the self-expanding anchoring member 24 and before fully deploying the self-expanding anchoring member 24. In such cases, it may be desirable to collapse the inflatable balloon 62 prior to repositioning the endoluminal prosthesis 12. For endoluminal prosthesis embodiments 12 that include an inflatable portion 80, it may also be desirable to inflate the inflatable portion 80 of the endoluminal prosthesis 12 after inflating the inflatable balloon 62 in order to promote sealing and conformity of the inflatable cuff 82 (if any) with the inner surface of the patient's vessel 9. In such cases, it may also be desirable to axially position the working length of the inflatable balloon 62 (as indicated by arrow 51) coextensively with the inflatable cuff 82. For such embodiments, the outward radial force imposed by the outer surface of the inflated inflatable balloon 62 may be used to assist in sealing and apposition of one or more inflatable cuffs 82 against the inner luminal surface of the patient's vasculature 9. In some cases, the inflatable balloon 62 may be used to expand one or more inflatable cuff embodiments 82 in an outward radial direction without similarly expanding the self-expanding anchoring member 24. For some such embodiments, it may be desirable to have an inflatable balloon 62, as discussed herein, disposed within an endoluminal prosthesis 12 such that the inflatable balloon 62 is disposed so as to be axially coextensive with and axially overlap with a first inflatable cuff 82, but not axially coextensive with or axially overlap with a second inflatable cuff 82 of the same endoluminal prosthesis 12.

[0081] 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 orthogonal to the longitudinal axis of the target vessel 9 at the locations of the circumferentially disposed radiopaque markers 32 . The invention can be found in commonly owned U.S. Patent Application No. 2011 / 0218609 filed on February 9, 2011 by M. Hobotov et al. and entitled “Fill Tube Manifold and Delivery Methods for Endovascular Graft” and U.S. Patent Publication No. 2013 / 0268048 filed on March 15, 2013 by J. Watson et al. and entitled “Delivery Catheter for Endovascular Device” and U.S. Patent Publication No. 2013 / 0268048 filed on March 15, 2013 by D. Parsons et al. and entitled “Durable Stent Graft with Tapered Struts and Stable Delivery Methods and Devices”. Examples of deployment devices, alignment devices, radiopaque markers 32, delivery methods, and the like that may be used in conjunction with any of the suitable systems or components discussed herein may be found in U.S. Patent Publication No. 2013 / 0268044 for "Devices"; each of which is hereby incorporated herein by reference in its entirety.

[0082] For any of the delivery system embodiments 10 discussed above, an embodiment of the inflatable balloon 62 can have an axial length of about 25 mm to about 27 mm and a transverse diameter of about 16 mm to about 18 mm when in an inflated state. This inflatable balloon 62 can be inflated through an inflation lumen 60 having an inner transverse lumen diameter of about 0.014 inches to about 0.016 inches.

[0083] For any of the embodiments of the delivery system 10 discussed above, the inflatable balloon 62 can be made of a compliant material (e.g., urethane) and have an outer diameter of about 25 mm to about 26 mm and an axial length of about 25 mm. The inflatable balloon 62 thus sized can be used to deliver an endoluminal prosthesis 12 having an inner lumen diameter of 26 mm (including the endoluminal prosthesis manufactured by TriVascular, Inc. of Santa Rosa, CA). The inflatable balloon 62 may be bonded or otherwise secured to the elongated shaft 36 of the proximal end or proximal cover sheet 20 proximal to the main graft section 16 of the endoluminal prosthesis 12 using a UV-curable adhesive. In some embodiments, the axial length of the inflatable balloon 62 of about 25 mm may be sufficient to allow the inflatable balloon 62 to axially overlap with the inflatable cuff 82 disposed at the distal section of the graft section 16 of the endoluminal prosthesis 12. For such embodiments, it may be desirable that the inflatable balloon 62 does not axially overlap with the radiopaque marker 32 adjacent to the proximal end 20 of the main graft portion 16. The proximal end face 70 of the balloon embodiment may be flat (i.e., having a taper angle 72 of about 180 degrees) or even overhanging.

[0084] The inflation lumen 60 of the inflatable balloon 62 may be made of a thin-walled material (e.g., polyimide) with an inner lumen diameter of about 0.01 inches to about 0.02 inches to enable filling of the inflatable balloon 62 in a few seconds (e.g., about 15 seconds) using a high flow fluid (e.g., saline, etc.). In some embodiments, the inflation lumen 60 may have an inner lumen diameter of about 0.020 inches to about 0.025 inches to enable faster filling and inflation of the inflatable balloon 62. Inflation of this inflatable balloon embodiment 62 may be performed using a syringe (not shown) connected to a Luer-type fitting on the distal adapter 54.

[0085] In use, the inflatable balloon 62 may be manually inflated using a syringe or the like after the release wire 52 securing the first and second distal releasable bands 46, 48 is retracted to deploy the releasable bands. In some cases, the inflatable balloon 62 may be initially inflated to an outer dimension or diameter of about 8 mm before releasing the release wire 52. In some cases, the inflatable balloon 62 may be inflated until the proximal or proximal cover sheet 20 of the graft portion 16 of the endoluminal prosthesis 12 and the radiopaque marker 32 disposed adjacent to the proximal or proximal cover sheet expand radially in an outward direction nearly to the inner surface of the wall of the blood vessel 9 being treated. In some examples, the inflatable balloon 62 may be inflated to an outer transverse dimension or diameter of about 15 mm after releasing the release wire 52. After the endoluminal prosthesis 12 is accurately positioned in the axial direction relative to the patient's renal artery 92 (or any other suitable reference point), the other release wire 50 can be retracted and the proximal self-expanding anchor component fully deployed.

[0086] Next, the inflatable balloon 62 may be collapsed prior to inflating the optional inflatable portion 80 of the endoluminal prosthesis 12. In some instances, the inflatable portion 80 of the endoluminal prosthesis 12 may be inflated while the inflatable balloon 62 is still inflated. For such situations, it may be desirable to maintain the inflatable balloon 62 at an internal inflation pressure that is less than the inflation pressure of the fill material 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 demate and the elongated shaft 36 of the delivery catheter 14 withdrawn from the endoluminal prosthesis 12 in the distal direction. The use of 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 used to eliminate type I endoleaks (if present) during the deployment process. This may be particularly true for embodiments that include an optional inflatable cuff 82 positioned over the graft portion 16 of the endoluminal prosthesis 12 .

[0087] In some cases, after initially filling the inflatable portion 80 of the endoluminal prosthesis 12 with a filling material (e.g., a polymerizable or curable filling material), the inflatable portion 80 remains coupled to the filling tube 69 for a predetermined amount of time. After the predetermined time has elapsed, the inflatable balloon 62 can then be positioned across the two optional inflatable cuffs 82 and inflated to a suitable inflation pressure (e.g., about 3 psi to about 6 psi). In some cases, the predetermined amount of time that elapses before the inflatable balloon is inflated so that the filled cuffs 82 expand in an outward radial direction can be about 14 minutes, in some instances, exactly 14 minutes. This procedure can be used to resolve an endoleak. Once resolved or other appropriate purposes are achieved, the inflatable balloon 62 can be collapsed and the filling tube 69 is detached from the filling port of the inflatable portion 80 of the endoluminal prosthesis 12.

[0088] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having: a graft portion 16 having an inner diameter of about 29 mm when in an expanded state; and a proximal self-expanding anchoring member 24 having an outer diameter of about 34 mm when in an expanded state can be loaded into a delivery catheter having an outer sheath having an outer diameter of about 15 French. This combination produces an outer sheath retraction force of about 18 pounds for the unsheathing movement of the outer sheath 74. In this particular example, radial expansion is achieved after the distal portion of the proximal self-expanding anchoring member 24 is released and the initial inflation of the balloon is from about 10 mm to about 17 mm x about 11 mm. The inflatable balloon 62 also has a tapered configuration that ultimately achieves an inflated size having an outer diameter of about 20 mm and an axial length of about 7 mm. This inflatable balloon takes about 1 minute to fill through the inflation lumen 60 having an inner diameter of about 0.015 inches. The delivery catheter 14 contains no cross-lumens.

[0089] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having: a graft portion 16 having an inner diameter of about 26 mm when in an expanded state; and a proximal self-expanding anchoring member 24 having an outer diameter of about 34 mm when in an expanded state can be loaded into a delivery catheter 14 having an outer sheath 74 having an outer diameter of about 15 French. This combination produces an outer sheath retraction force of about 7 pounds for the withdrawal movement of the outer sheath 74. In this particular example, radial expansion is achieved after the distal portion 28 of the proximal self-expanding anchoring member 24 is released and the initial inflation of the balloon 62 is from about 10 mm to about 25 mm. The inflatable balloon 62 also has a tapered configuration that ultimately achieves an inflated size having an outer diameter of about 20 mm and an axial length of about 7 mm. This inflatable balloon takes about 16 seconds to be filled with about 5 ml of saline via manual injection through the inflation lumen 60, which has an inner diameter of about 0.02 inches. The delivery catheter 14 does not include a cross lumen.

[0090] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having: a graft portion 16 having an inner diameter of about 26 mm when in an expanded state; and a proximal self-expanding anchoring member 24 having an outer diameter of about 34 mm when in an expanded state can be loaded into a delivery catheter 14 having an outer sheath 74 having an outer diameter of about 15 French. This combination produces an outer sheath retraction force of about 9 pounds for the withdrawal movement of the outer sheath 74. In this particular example, radial expansion is achieved after the distal portion of the proximal self-expanding anchoring member 24 is released and the initial inflation of the balloon 62 is from about 10 mm to about 19 mm and ultimately to about 25 mm at maximum inflation. The inflatable balloon 62 also has a tapered configuration that ultimately achieves an inflated size having an outer diameter of about 20 mm and an axial length of about 7 mm. This inflatable balloon takes about 15 seconds to be filled with about 6 ml of saline via manual injection through an inflation lumen having an inner diameter of about 0.025 inches. The delivery catheter 14 does include a cross-lumen at the distal adapter 54, a filling port, and retraction of the balloon 62 during the procedure is acceptable.

[0091] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having: a graft portion 16 having an inner diameter of about 26 mm when in an expanded state; and a proximal self-expanding anchoring member 24 having an outer diameter of about 34 mm when in an expanded state can be loaded into a delivery catheter 14 having an outer sheath 74 having an outer diameter of about 14 French. This combination produces an outer sheath retraction force of about 13 pounds for the withdrawal movement of the outer sheath 74. In this particular example, radial expansion is achieved after the distal portion of the proximal self-expanding anchoring member 24 is released and the initial inflation of the balloon 62 is from about 10 mm to about 20 mm. The inflatable balloon 62 also has a standard configuration that ultimately achieves an inflated diameter of about 15 mm and an axial length of about 25 mm. This inflatable balloon is filled through an inflation lumen having an inner diameter of about 0.025 inches. The delivery catheter 14 does include a cross lumen 71 and a filling port located at the distal adapter 54. This particular example incorporates a chimney-type graft 90 (6 mm manufactured by Gore Enterprises of Flagstaff, AZ) during filling. Grafts) and suppleness A balloon size 32 mm (manufactured by Cook Medical, Bloomington Indiana) was used, and no gutter type channels were observed with the Coda balloon either inflated or deflated.

[0092] For some embodiments, an endoluminal prosthesis 12 in the form of a stent graft having: a graft portion 16 having an inner diameter of about 22 mm when in the expanded state; and a proximal self-expanding anchoring member 24 having an outer diameter of about 29 mm when in the expanded state can be loaded into a delivery catheter 14 having an outer sheath 74 having an outer diameter of about 14 French. This combination produces an outer sheath retraction force of about 15 pounds for the withdrawal movement of the outer sheath 74. In this particular example, radial expansion is achieved after the distal portion of the proximal self-expanding anchoring member 24 is released and the initial inflation of the balloon 62 is from about 8 mm to about 21 mm. The inflatable balloon ultimately achieves an inflated diameter of about 10 mm and an axial length of about 15 mm. This inflatable balloon 62 is 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 does include a cross lumen 71 and filling port at the distal adapter 54. This particular example is used in conjunction with a chimney type graft 90 (5 mm polyethylene type tubing) and a non-compliant balloon 62, and forms a good seal after the filling tube 69 is detached during filling.

[0093] Some endoluminal prosthesis embodiments 12 may include a graft portion 16 having an inner diameter of about 26 mm when in the expanded state, and a proximal self-expanding anchoring component 24 having an outer diameter of about 34 mm when in the expanded state. This endoluminal prosthesis 12 can be loaded into a delivery catheter 14 having an outer sheath 74 having an outer diameter of about 15 French. The inflatable balloon 62 of this embodiment can be made of polyurethane, with a hardness (durometer) of about 90A and a double wall thickness of 0.001 inches. The inflatable balloon can include an outer diameter of about 18.5 mm, a working length of about 20 mm, and an overall length of about 38 mm. For a full cone angle 72 of about 92 degrees to about 96 degrees, the inflatable balloon cone angle on each side can be about 46 degrees to about 48 degrees. The elongated shaft 36 can be made of a polyurethane material, with a hardness of about Shore 72D. The elongated shaft 36 may further have an outer diameter of about 0.105 inches and extend the entire axial length of the endoluminal prosthesis 12. This embodiment may generate a retraction force of about 11 pounds on the outer sheath 74 for the withdrawal movement of the outer sheath 74. In this particular example, radial expansion is achieved after the distal portion of the proximal self-expandable anchoring member 24 is released and the initial inflation of the balloon 62 may be from about 8 mm to about 20 mm, wherein the internal volume of the inflatable balloon 62 is partially inflated to about 10 ml. This inflatable balloon embodiment 62 may ultimately achieve an inflated diameter of about 26 mm, which may be consistent with 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 elliptical inflation lumen 60 having a small inner transverse dimension of about 0.025 inches and a large inner transverse dimension of about 0.055 inches. Inflation of this inflatable balloon embodiment 62 may take about 18 seconds to fill about 19 ml of a 4:1 saline and contrast mixture via manual injection through the inflation lumen. The corresponding delivery catheter 14 may include a cross-lumen 71 at the distal adapter 54 and a filling port.

[0094] For any of the inflatable balloon embodiments discussed herein, it may be desirable to include means for allowing blood to perfuse through the inflatable balloon 62 while the inflatable balloon 62 is in the inflated state ( Fig.13 and 14 This may be applicable to indications including treatment of thoracic aortic aneurysms and abdominal aortic aneurysms. This may be particularly true for larger thoracic aortas where such perfusion means include perfusion holes, such as Fig.13 The petal-shaped inflatable balloon 62' shown in Fig.14The multiple small inflatable balloons 62" bunched together as shown in the figure can be used to avoid migration of the endoluminal prosthesis during deployment and to allow blood flow during inflation. For some embodiments, the number of petal-shaped inflatable balloons 62' or multiple small inflatable balloons 62" arranged around the axis 36 can be about 3 to about 5 balloons 62".

[0095] Figures 15 to 26 An embodiment of a delivery system for treating a vascular defect such as an aneurysm 8 is illustrated. A delivery system embodiment 110 may include an endoluminal prosthesis 12 for treating a vascular defect 8 and a delivery catheter 114. In general, the delivery system 110 may include materials, dimensions, and features that are the same or similar to those of the delivery system 10 discussed above. Where appropriate, similar reference numbers will be used for similar elements with respect to the delivery system 10 and the 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 an elongated shaft 136 to facilitate various functions of the delivery catheter and its elements.

[0096] As discussed above, the endoluminal prosthesis 12 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 pliable graft material, such as PTFE, and have a main fluid flow lumen in the main graft portion disposed therein.

[0097] For some embodiments, the delivery catheter 114 of the delivery system 110 may include an elongated shaft 136 having a column strength sufficient for percutaneous advancement within the vasculature 8 of a patient, the elongated shaft 136 also having a proximal section 138 and a distal section 140. A plurality of releasable bands may be disposed on the proximal section 138 of the elongated shaft 136 and configured to releasably constrain the self-expanding anchoring member of the endoluminal prosthesis. A plurality of appropriately sized cylindrical sleeves or pads 133 may be secured to the elongated shaft adjacent one or more of the releasable bands so as to properly space the self-expanding anchoring member 124 or portions thereof when in a constrained state. A plurality of elongated release members may be positioned in operative communication with the distal segment of the elongated shaft 136 and the elongated release members may each include a proximal segment configured to releasably secure at least one corresponding releasable band when the releasable band is in a configuration that constrains at least a portion of the self-expanding anchoring member 124 of the endoluminal prosthesis 112.

[0098] The elongated shaft 136 of this delivery catheter embodiment 114 may include one or more release member lumens 158 extending within a release member sleeve 167, a guidewire lumen 156 extending within a guidewire tube 157, an inflation lumen 160 extending within an inflation tube 161 for inflation of an inflatable balloon 162, and an optional filling lumen 164 extending within a filling tube 169 for filling an optional inflatable portion of the endoluminal prosthesis 112. The section diagram of the elongated 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.

[0099] Each of these lumen embodiments 156, 158, 160, and 164 and tube or sleeve embodiments 157, 161, 167, and 169 can extend axially along or within the elongated shaft 136 of the delivery catheter 114 from a proximal section of the elongated shaft to a distal end thereof, including a distal adapter 154 extending to the distal end of the elongated shaft 136. In some cases, a release member (not shown) can be coupled to a corresponding deployment knob 166 disposed on the distal adapter 154.

[0100] The inflatable balloon 62, which may be integrally formed with the elongated shaft 136, is operably secured to the elongated 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 examples, the inflatable balloon 62 may be disposed in an axial position wherein the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is adjacent to but 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, between the proximal and distal ends, the optional axial gap being determined by the proximal end 68 of the inflatable section 55 of the inflatable balloon 62. Fig.23 The arrow 55' shown in FIG. Figure 3 and 10 . In some cases, the inflatable balloon 62 may be disposed within the undeployed constrained endoluminal prosthesis 112 in an axial position wherein the proximal end 68 of the inflatable section 55 of the inflatable balloon 62 is disposed distally of the self-expanding anchoring member structure, such as the self-expanding anchoring member 124. The inflatable section 55 of the inflatable balloon 62 may also be disposed wherein the proximal end 68 of the inflatable section 55 is adjacent to but distally of any other high-strength elastic structure, such as a connector ring, which may be associated with securing the anchoring member portion of the endoluminal prosthesis 112 to the main graft portion 116 of the endoluminal prosthesis 112. As discussed above, in some cases, there may be an optional axial gap of up to about 5 mm, more specifically up to about 2 mm, between the proximal end 68 of the inflatable section 55 and the distal end of the self-expanding anchoring member 124.

[0101] For some embodiments, the inflatable balloon 62 may have a proximal surface 70 having a taper 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 (e.g., Fig.11 The full diameter of the inflatable balloon (shown in Fig.11 51 in the figure) can be indicated for imaging under fluoroscopic imaging or the like using a pair of radiopaque markers 135 disposed axially coextensively with each respective proximal and distal end of the full diameter segment, such as Fig.23 In some cases, these markings 135 can be used to axially align the inflatable balloon 62 with a structure of the endoluminal prosthesis 112 (eg, the inflatable cuff 182 of the endoluminal prosthesis 112 discussed below).

[0102] The delivery catheter 114 may have an outer sheath 174 having an elongated tubular shape and a thin wall disposed over the elongated shaft 136 and the endoluminal prosthesis 112. The outer sheath 174 may be configured to slide over and relative to the elongated shaft and the endoluminal prosthesis so as to removably cover the endoluminal prosthesis when the endoluminal prosthesis 112 is in a constrained state. The delivery catheter 114 may also include a proximal nose cone 176 that may have a bullet-shaped profile and a shoulder portion having an outer surface that may be configured to slidably receive an inner luminal surface of the retractable outer sheath 174.

[0103] 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 the legs 84 (see Fig.34 The filling tube 169 may also be configured to couple to the filling port 88 ( Fig. 9 88 and is in fluid communication with the distal end thereof. The filling tube 169 may also be decoupled from the inflation port 88. The outer transverse dimensions of the filling tube may be configured to slide within the inner lumen of the filling port 88 and provide a seal for 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 of the elongated shaft 136 to a distal section of the elongated shaft.

[0104] In some cases, inflating and radially expanding the inflatable balloon 62 may include inflating and radially expanding the inflatable balloon 62 so as 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 to the inflatable balloon 62 is urged into contact with the inner surface of the patient's vasculature 8. Saline or other inflation fluid may then be injected through the inflation lumen 160 of the elongated shaft 136 and into the interior volume of the inflatable balloon 62 at a desired pressure. In some cases, inflating the inflatable balloon 62 includes inflating the interior volume of the inflatable balloon 62 with a sterile incompressible fluid (e.g., saline) within the inflation lumen 60 at a pressure of about 3 psi to about 9 psi, and in some cases up to about 1 atmosphere. The inflatable balloon 62 may be provided by coupling the inflation device to a connector (e.g., a Luer-type connector) on the distal adapter 154, for example. Or a standard syringe or the like to inject pressurized saline. In some examples, the interior volume of the inflatable balloon 62 can be inflated with a mixture of saline and contrast media to improve the ability to image the inflated or partially inflated inflatable balloon 62 using fluoroscopy or the like.

[0105] The inflation lumen 160 of the inflatable balloon 62 can be made of a thin-walled material, such as polyimide, with an inner lumen having an oval transverse section. As discussed above, some oval inflation lumen embodiments 160 can have a large inner transverse dimension of about 0.055 inches to about 0.060 inches, and a small inner transverse dimension of about 0.024 inches to about 0.028 inches. Inflation of this inflatable balloon embodiment 62 can be performed using a syringe (not shown) connected to a Luer-type inflation port fitting 180 on the distal adapter 154. The delivery catheter 114 can further include a cross lumen 182 on the distal adapter 154 and a filling port 184 that communicates with the filling tube 169.

[0106] Figures 27 to 2931 to 33 illustrate several multi-lumen component embodiments 65, 65' and 65". of various embodiments including guidewire tube lumen embodiments 57A, 57A' and 57A" that accommodate guidewire tube 57. Release line sleeve lumen embodiments 67A, 67A' and 67A" can accommodate release line sleeve 67. In some cases, multi-lumen component embodiments 65, 65' and 65" can be configured as elongated multi-lumen component embodiments. In some cases, release line sleeve embodiments 67A, 67A' and 67A" can also be configured to accommodate cross member 71. In addition, filling tube lumen embodiments 69A, 69A' and 69A" of corresponding multi-lumen component embodiments 65, 65' and 65" can be used to accommodate or surround filling tube 69. Multi-lumen component embodiments including the aforementioned elements will typically be disposed distally of the endoluminal prosthesis 12 on the delivery system 10 because the filling tube 69 is typically coupled to a port at the distal end of the endoluminal prosthesis 12.

[0107] In some method embodiments, it may be desirable to deploy a "chimney" type endoluminal prosthesis 90 that provides fluid communication between the patient's renal arteries 92 (or any other suitable side branch artery of the aorta and downstream vessels of the aorta, such as the SMA or abdominal artery) and the aorta before deploying the aortic endoluminal prosthesis 12, such as Fig.34 and 35 In such methods, particularly where the inflatable endoluminal prosthesis is being used in the aorta, the inflatable balloon 62 can provide an enhanced seal between the outer surface of the chimney prosthesis 90, the outer surface of the main graft portion 16 of the endoluminal prosthesis 12, and the inner surface of the patient's blood vessel 9 being treated. This enhanced seal can reduce or prevent leakage caused by gutter-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 of a non-compliant material can be useful for eliminating gutter-type channels formed between these surfaces during deployment of these endoluminal prostheses 12.

[0108] The entire text of each patent, patent application, publication, and document mentioned herein is hereby incorporated by reference. The citation of the above patents, patent applications, publications, and documents is neither an admission that any of the aforementioned documents are relevant prior art nor does it constitute any admission as to the contents or date of these publications or documents.

[0109] Modifications may be made to the foregoing without departing from the basic aspects of the embodiments discussed. Although the embodiments have been described in considerable 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 in this application, and such modifications and improvements are within the scope and spirit of the invention.

[0110] The embodiments illustratively described herein may be suitably practiced in the absence of any element not specifically disclosed herein. Thus, for example, in each instance herein, any one of the terms "comprising", "consisting essentially of" and "consisting of" may be replaced with any one of the other two terms. The terms and expressions adopted are used as terms of description rather than limitation, and the use of such terms and expressions does not exclude any equivalents of the features or parts thereof shown and described, and various modifications are possible. The term "a or an" may refer to one or more elements modified by it (e.g., "reagent" may mean one or more reagents), unless the context clearly describes one or more of the elements. Therefore, it should be understood that, although the embodiments have been specifically disclosed by representative embodiments and optional features, modifications and changes to the concepts disclosed herein may be resorted to by those skilled in the art, and such modifications and changes are considered to be within the scope of the present invention.

[0111] Particular embodiments are set out in the appended claims.

Claims

1. A delivery system for treating vascular defects, comprising: An endoluminal prosthesis for treating the vascular defect, the endoluminal prosthesis comprising: a tubular main graft portion comprising a thin flexible material, a main inner lumen, a proximal end and a distal end, and a self-expanding anchor member having a distal end, the distal end of the self-expanding anchor member being secured to the proximal end of the tubular main graft portion, and A delivery catheter comprising: an elongated shaft comprising a distal section and a proximal section, the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state, and an inflatable balloon secured to the elongated shaft in an axial position and disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis, wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent to but distal to the proximal end of the tubular main graft such that inflation of the inflatable section of the inflatable balloon does not expand the self-expanding anchoring member in an outward radial direction, Wherein the elongated shaft comprises an elongated multi-lumen member extending from a distal section of the elongated shaft to a proximal section of the elongated shaft, the multi-lumen member comprising an inflation lumen for inflation of the inflatable balloon.

2. The system of claim 1, wherein a proximal end of the inflatable section of the inflatable balloon is disposed adjacent to but distal to the self-expanding anchoring member.

3. The system of claim 1, wherein the multi-lumen component comprises a guidewire lumen.

4. The system of claim 3, wherein the multi-lumen member comprises a release member lumen.

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

6. The 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 disposed such that a working length of the inflatable balloon extends axially together with the inflatable cuff.

7. The system of claim 1, wherein the delivery catheter further comprises an outer sheath disposed on the elongated shaft and configured to removably cover the endoluminal prosthesis in the constrained state.

8. The system of claim 1 , wherein the endoluminal prosthesis comprises an inflatable portion, and wherein the delivery catheter further comprises a filling tube including a filling tube lumen in fluid communication with the inflatable portion of the endoluminal prosthesis and extending axially within the elongated shaft.

9. The system of claim 1, wherein the self-expanding anchoring member comprises a unitary structure formed from a single continuous piece of material without any joints formed therein.

10. The system of claim 1, wherein the self-expanding anchoring member comprises a barb comprising a sharp tissue-penetrating tip.

11. The system of claim 1 , wherein the delivery catheter further comprises: a plurality of releasable bands disposed on the proximal section of the elongated shaft and configured to releasably constrain the self-expanding anchoring member of the endoluminal prosthesis; and A plurality of elongated release members are in communication with the distal end of the elongated shaft and include proximal sections configured to releasably secure at least one corresponding releasable band when the releasable band is in a configuration that constrains at least a portion of the self-expanding anchoring member.

12. The system of claim 1, wherein the inflatable balloon does not overlap the self-expanding anchoring component.

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