Patent Publication Number: US-2015073523-A1

Title: Endoleak isolation sleeves and methods of use

Description:
RELATED APPLICATIONS  
     This application claims priority under 35 U.S.C. 119(e) from U.S. Provisional Patent Application Ser. No. 61/875,881, filed Sep. 10, 2013, by Michael Chobotov, titled “Endoleak Isolation Sleeves and Methods of Use”, which is incorporated by reference herein in its entirety. 
    
    
     BACKGROUND  
     An aneurysm is a medical condition indicated generally by an expansion and weakening of the wall of an artery of a patient. Aneurysms can develop at various sites within a patient&#39;s body. Thoracic aortic aneurysms (TAAs) or abdominal aortic aneurysms (AAAs) are manifested by an expansion and weakening of the aorta which is a serious and life threatening condition for which intervention is generally indicated. Existing methods of treating aneurysms include invasive surgical procedures with graft replacement of the affected vessel or body lumen or reinforcement of the vessel with a graft. 
     Surgical procedures to treat aortic aneurysms can have relatively high morbidity and mortality rates due to the risk factors inherent to surgical repair of this disease as well as long hospital stays and painful recoveries. This is especially true for surgical repair of TAAs, which is generally regarded as involving higher risk and more difficulty when compared to surgical repair of AAAs. An example of a surgical procedure involving repair of a AAA is described in a book titled Surgical Treatment of Aortic Aneurysms by Denton A. Cooley, M.D., published in 1986 by W. B. Saunders Company. 
     Due to the inherent risks and complexities of surgical repair of aortic aneurysms, endovascular repair has become a widely-used alternative therapy, most notably in treating AAAs. Early work in this field is exemplified 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). Commercially available endoprostheses for the endovascular treatment of AAAs include the AneuRx® stent graft manufactured by Medtronic, Inc. of Minneapolis, Minn., the Zenith® stent graft system sold by Cook, Inc. of Bloomington, Ind., the PowerLink® stent-graft system manufactured by Endologix, Inc. of Irvine, Calif., and the Excluder® stent graft system manufactured by W.L. Gore &amp; Associates, Inc. of Newark, Del.. A commercially available stent graft for the treatment of TAAs is the TAG™ system manufactured by W.L. Gore &amp; Associates, Inc. 
     Even after successful deployment of an endoprosthesis, continued pressurization of an abdominal aortic aneurysm sac following exclusion using an endograft can contribute to sac enlargement in some instances. In cases where sac enlargement occurs, persistent sac inflow of blood following flow reversal in a patent inferior mesenteric artery (IMA) or lumbar arteries may occur in some patients. Some of these patients may ultimately require a secondary procedure to occlude such a type II endoleak. What have been needed are devices and methods for preventing such endoleaks or reducing the negative effects thereof. 
     SUMMARY  
     Some embodiments of a self-expanding tubular isolation sleeve for treatment of an aneurysm and reduction of endoleaks, may include a self-expanding resilient frame. The self-expanding resilient frame may include one or more resilient strands formed into a tubular structure that is configured to expand from a radially constrained state to a radially expanded state and conform to an irregular morphology of an abdominal aortic aneurysm. The tubular isolation sleeve may also include at least one tubular layer of thin flexible sheet material disposed on the resilient frame, the flexible sheet material optionally having an outside surface that is configured to seal against an inner wall of an aneurysm and isolate a feeder vessel of the aneurysm. 
     Some embodiments of a method of treating an aneurysm include advancing a tubular isolation sleeve delivery system within a patient&#39;s vasculature to a treatment site that includes an aneurysm having a feeder vessel. The tubular isolation sleeve may then be deployed from the delivery system within the aneurysm such that an outer surface of the tubular isolation sleeve seals off the feeder vessel from an interior volume of the aneurysm. Thereafter, an endograft may be deployed at the aneurysm and within an interior lumen of the deployed tubular isolation sleeve. 
     Some embodiments of a self-expanding tubular isolation sleeve for treatment of an aneurysm and reduction of endoleaks include a self-expanding resilient frame having one or more resilient strands formed into a tubular structure that is configured to expand from a radially constrained state to a radially expanded state. The self-expanding resilient frame may also be configured to conform to an irregular morphology of an abdominal aortic aneurysm. The tubular isolation sleeve may also have at least one tubular layer of thin flexible sheet material disposed on the resilient frame, the thin flexible sheet material having an outside surface that is configured to seal against an inner wall of an aneurysm and isolate a feeder vessel of the aneurysm. In addition, the tubular isolation sleeve may have a fusiform configuration wherein an outer profile of the tubular isolation sleeve in a relaxed unconstrained state is configured to roughly approximate a profile of an interior surface of a typical abdominal aortic aneurysm and wherein the outer profile includes a proximal reduced transverse dimension section at a proximal end thereof, a distal reduced transverse dimension section at a distal end thereof and an enlarged center section of greater transverse dimension than the proximal and distal reduced transverse dimension sections. 
     Some embodiments of a method of treating an aneurysm include advancing a tubular isolation sleeve delivery system within a patient&#39;s vasculature to a treatment site that includes an aneurysm having a feeder vessel and deploying a tubular isolation sleeve from the tubular isolation sleeve delivery system within the aneurysm such that an outer surface of the tubular isolation sleeve interrupts blood flow from the feeder vessel to the aneurysm. Thereafter, an endograft may be deployed at the aneurysm and within an interior lumen of the deployed tubular isolation sleeve. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an elevation view of an embodiment of a tubular isolation sleeve in a radially constrained configuration. 
         FIG. 2  is a transverse cross section view of the tubular isolation sleeve embodiment of  FIG. 1  taken along lines  2 - 2  of  FIG. 1 . 
         FIG. 3  is a transverse cross section view an embodiment of a tubular isolation sleeve having two inner layers of flexible sheet material and a single outer layer of flexible sheet material. 
         FIG. 4  is a transverse cross section view of an embodiment of a tubular isolation sleeve having two outer layers of flexible sheet material and a single inner layer of flexible sheet material. 
         FIG. 5  is an elevation view of the tubular isolation sleeve embodiment of  FIG. 1  in a radially expanded and relaxed state. 
         FIG. 5A  is an elevation view of a tubular isolation sleeve embodiment having a fusiform configuration in a radially expanded and relaxed state. 
         FIG. 6  shows a distal section of a tubular isolation sleeve delivery system embodiment disposed over a guidewire embodiment and within a patient&#39;s abdominal aorta at a treatment site that includes an abdominal aortic aneurysm. 
         FIG. 7  shows the tubular isolation sleeve delivery system embodiment of  FIG. 6  with an outer sheath of the delivery system partially retracted and the tubular isolation sleeve embodiment partially expanded in a radial direction and partially deployed within the aneurysm. 
         FIG. 8  shows the tubular isolation sleeve embodiment of  FIG. 7  fully deployed within the aneurysm so as to fluidly isolate an IMA feeder vessel from an interior volume of aneurysm. 
         FIG. 9  shows a modular bifurcated endograft embodiment fully deployed within the aneurysm and within an interior lumen of the tubular isolation sleeve. 
     
    
    
     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 an understanding of particular embodiments. 
     DETAILED DESCRIPTION 
     As discussed above, continued pressurization of an abdominal aortic aneurysm sac following exclusion using an endograft can contribute to sac enlargement in some instances. In cases where sac enlargement occurs, persistent sac inflow of blood following flow reversal in patent IMA or lumbar arteries which may be acting as feeder arteries, may occur in some patients. Some such patients ultimately may receive a secondary procedure to occlude such a type II endoleak caused by feeder vessels or other causes. As a preventative measure, or for any other suitable indication, a tubular isolation sleeve, such as the tubular isolation sleeve embodiment  10  shown in  FIG. 1 , may be deployed within an aneurysm sac, such as the aneurysm sac  20  shown in  FIG. 6 . Such tubular isolation sleeve embodiments  10  may be percutaneously delivered at a treatment site (such as an aneurysm  12 ) in order to isolate or seal off one or more feeder vessels prior to deployment of a standard or otherwise commercially available endograft. An example of such a modular bifurcated endograft  30  is shown in a deployed state in  FIG. 9  with the endograft  30  deployed within an inner lumen of the tubular isolation sleeve embodiment  10 . In some cases, the tubular isolation sleeve  10  may be deployed prior to deployment of the endograft  30 , with both the tubular isolation sleeve  10  and endograft  30  being deployed during a single procedure for treating a patient. 
     Some tubular isolation sleeve embodiments  10  may be configured to have a self-expanding configuration and self-expand in an outward radial direction from a radially constrained state to a radially expanded state. In some cases, such outward radial expansion may be facilitated by the use of superelastic materials for the strands  26 . It should be noted that although the tubular isolation sleeve  10  is allowed to expand radially upon deployment, the tubular isolation sleeve  10  in many cases may not expand to a fully expanded state. That is, after deployment, some or all of the tubular isolation sleeve  10  may remain constrained by an inner surface of the aneurysm in which it is deployed. In addition, some tubular isolation sleeve embodiments  10  may have a non-self-expanding arrangement and be expandable by suitable devices configured to exert an outward radial force on the wall of the tubular isolation sleeve from within, such as an inflatable balloon. 
     An optional external anchoring stent  11  that may or may not include tissue engaging barbs  13  may be secured to and extend proximally from a proximal end of the tubular isolation sleeve  10 . Such an optional anchoring stent may include a self-expanding configuration which may also be facilitated by the use of superelastic materials such as NiTi. The barbs  13  may have sharpened tips which are disposed at an angle with respect to the anchoring stent to engage tissue disposed about the anchoring stent  11  in a deployed state and prevent distal migration of the tubular isolation sleeve  10  once deployed. In some cases, the barbs may be generally oriented in a distal direction. Anchoring stent embodiments are discussed in more detail in the commonly owned patent applications which are incorporated by reference herein. Any suitable stent configuration discussed in these incorporated applications may be used as the anchoring stent  11 . 
     Tubular isolation sleeve embodiments  10  may typically be larger in a transverse dimension  14  in an expanded state (as shown in  FIG. 5 ) than in a radially constrained state (as shown in  FIG. 1 ). It should be noted that for embodiments discussed herein, reference to a transverse dimension  14  may include a transverse diameter for embodiments having a round transverse cross section. The tubular isolation sleeve  10  may self-expand from the radially constrained state to a radially expanded state such that an outer surface of the tubular isolation sleeve  10  contacts an inner wall surface  16  of a body lumen such as an inner surface of an infrarenal aortic lumen or abdominal aorta. In such a procedure, the ostium  18  (see  FIG. 6 ) of any potential type II feeder vessels, such as an IMA  22 , communicating with the aneurysm sac  20  may be isolated, sealed off or otherwise occluded by a wall layer  24  (see  FIG. 1 ) of the tubular isolation sleeve  10 . Suitable isolation of these type II feeder vessels may include a complete or nearly complete sealing of the outer wall  24  of the tubular isolation sleeve  10  to the inner wall surface  16 . However, suitable isolation may also include interrupting a flow of blood from the feeder vessels (without a complete or nearly complete seal) which is sufficient to promote thrombosis within the feeder vessel. Such isolation of the feeder vessel  22  may then promote thrombosis of blood within these feeder vessels and occlude these feeder vessels so as to preclude them from causing type II endoleaks at the treatment site  12 . 
     Some suitable tubular isolation sleeve embodiments  10  (particularly those that have a self-expanding configuration) may be constructed from a combination of high strength resilient strands  26 , including superelastic strands  26  made from a material such as a Nitinol alloy (NiTi) or the like. In addition to the resilient strands  26 , the construction of some tubular isolation sleeve embodiments  10  may include a thin flexible sheet material  28  disposed in a tubular configuration. The thin flexible sheet material  28  may be configured to restrict or prevent the passage of body fluids such as blood therethrough and may include polytetrafluoroethylene (PTFE), nylon materials such as Dacron® and the like. 
     As discussed above, it may be desirable to interrupt flow of feeder vessels  22  or occlude feeder vessels  22  by causing thrombosis of blood within an inner lumen of feeder vessels  22 . As such, in some instances, it may be desirable to include a thrombogenic or clotting agent  27  on an outside surface of any of the tubular isolation sleeve embodiments discussed herein. In particular, it may be desirable to include a clotting agent  27  such as thrombin or the like on an outside surface of the resilient strands  26  or the thin flexible sheet material  28  of the tubular isolation sleeve  10 . In some cases, a clotting agent  27  may be disposed on an entire surface of the resilient strands  26 , flexible sheet material  28 , or both the resilient strands  26  and flexible sheet material  28 . In other cases, the clotting agent  27  may be disposed only on selected a selected portion or portions of the outside surface of either or both the resilient strands  26  or flexible sheet material  28 . 
     The selected portion or portions to be coated with clotting agent  27  may include those portions of the tubular isolation sleeve  10  that are configured to cover or be near an ostium of a feeder vessel  27  when the tubular isolation sleeve  10  is deployed. It should also be noted that although the use of a clotting agent  27  has been discussed in terms of coating a portion or portions of the tubular isolation sleeve  10 , the clotting agent  27  may be disposed on any portion of the tubular isolation sleeve  10  where it will eventually be in fluid communication with an outside surface of a desired portion of the tubular isolation sleeve  10 . Thus, the clotting agent  27  need not necessarily be coated on an outside surface and may be disposed within the structure of the tubular isolation sleeve  10  so long as fluid such as blood may carry the clotting agent  27  to a position outwardly adjacent the outer surface of the tubular isolation sleeve  10 . 
     For some embodiments, the resilient strands  26  may include a fine gauge wire having a transverse dimension of about 0.006 inches to about 0.010 inches and such wire may be formed into a stent-like structure over a tool such as mandrel in a helical pattern (as shown in the embodiment  10  of  FIG. 1 ) with periodic undulations such as is shown and discussed with regard to the endograft extensions discussed in U.S. Patent Publication No. 2009/0099649, filed Oct. 3, 2008, titled “Modular Vascular Graft for Low Profile Percutaneous Delivery”, which is incorporated by reference herein in its entirety. 
     The resilient strands  26  so formed into a generally tubular stent-like shape may also be encapsulated by one or more layers of the thin flexible sheet material  28  (such as PTFE or ePTFE film) so as to form a tubular structure having a central lumen  29  with self-expanding walls  24 . The self-expanding walls  24  may be resistant to a flow of body fluids such as blood from a location inside the central lumen  29  to a location outside the tubular isolation sleeve  10 . That is, the self-expanding walls  24  may be impervious or substantially impervious to a flow of liquids such as blood therethrough. In some cases, the tubular isolation sleeve  10  may include about 1 layer to about 3 layers of thin flexible sheet material  28  disposed about the stent-like tubular structure (which may also be referred to as a frame  32 ) of the resilient strand or strands  26 . 
       FIG. 2  shows the tubular isolation sleeve embodiment  10  having a single outer layer of flexible sheet material  28  disposed on an outside surface of the frame  32  and a single inner layer of flexible sheet material  28  disposed on an inside surface of the frame  32 .  FIG. 3  shows a tubular isolation sleeve embodiment  10 ′ having two inner layers of flexible sheet material  28  disposed on an inside surface of the frame  32  and a single outer layer of flexible sheet material  28  disposed on an outside surface of the frame  32 .  FIG. 4  shows a tubular isolation sleeve embodiment  10 ″ having two outer layers of flexible sheet material  28  disposed on an outside surface of the frame  32  and a single inner layer of flexible sheet material  28  disposed on an inside surface of the frame  32 . 
     For some embodiments, the transverse dimension  14  ( FIG. 5 ) of the tubular isolation sleeve  10  in an unconstrained state (which may also be referred to as a free state) may be configured to be somewhat greater than a nominal internal transverse dimension  40  ( FIG. 6 ) of a lumen of an aneurysm sac  20  to be treated. For example, if an abdominal aortic aneurysm sac  20  that is to be treated has an inner lumen with a maximum transverse dimension  40  of about 6 cm, a tubular isolation sleeve embodiment  10  having a nominal transverse dimension  14  (when in an unconstrained state) of about 7 cm to about 8 cm may be sufficiently oversized to ensure stability of the tubular isolation sleeve  10  once deployed within the aneurysm sac  20 . In some cases, tubular isolation sleeves  10  may have a transverse dimension  14  in an unconstrained free state that is up to about 80% oversized relative to an inner transverse dimension of the aneurysm sac that is to be treated. As aneurysms are typically non-uniform in their inner transverse dimension, the oversizing of the tubular isolation sleeve  10  may be configured in a segmented fashion whereby one or more axial segments or sections of tubular isolation sleeve may each be oversized by a desired amount relative to a corresponding axial section of an aneurysm to be treated. 
     It may be important in some cases for tubular isolation sleeve embodiments  10  to remain in a stable position with respect to the aneurysm sac  20  for the time period between deployment of the tubular isolation sleeve  10  and subsequent deployment of an endograft  30  at the same treatment site  12 . In some cases, tubular isolation sleeve embodiments  10  may be sized with regard to an axial length  42  (see  FIG. 5 ) of the tubular isolation sleeve  10  to span an axial length  44  (see  FIG. 6 ) from a neck of the aneurysm being treated to the aortic bifurcation of the iliac arteries. For some patients, this distance  44  may be about 8 cm to about 12 cm. Thus, for some embodiments, the tubular isolation sleeve  10  may have an axial length  42  of about 8 cm to about 12 cm. In some instances, it may only be desirable to stock a small number of sizes of tubular isolation sleeves  10  (axial length  42  and transverse dimension  14 ) in an operating room or catheter lab in order to treat the typical range of abdominal aortic aneurysm morphologies. 
     Some embodiments of a tubular isolation sleeve may also include a fusiform type shape in the relaxed expanded state with a reduced transverse dimension at a proximal end and distal end thereof.  FIG. 5A  shows such an embodiment wherein the outer profile of the tubular isolation sleeve  10 ″′ is configured to roughly approximate a profile of an interior surface of a typical abdominal aortic aneurysm. Such a profile may be useful in order for an outer surface of the tubular isolation sleeve  10  to conform to and approximate the inner surface of an aneurysm  20  being treated such that the flow of blood from feeder vessels  22  may be sufficiently interrupted or otherwise sealed off from the lumen of the host artery to prevent endoleaks. This profile as shown includes a reduced transverse dimension  31  at a proximal reduced transverse dimension section  33  thereof and a reduced transverse dimension  35  at a distal reduced transverse dimension section  37  thereof. The outer profile of the tubular isolation sleeve  10 ″′ may have a smooth and continuous curve from an enlarged center section  39  of greater transverse dimension relative to the reduced transverse dimension sections  31  and  35  at the proximal end and distal end of the tubular isolation sleeve  10 ″′. The enlarged center section  39  has a transverse dimension  41  that may be up to about 4 times the transverse dimension of reduced diameter section  31  of the proximal end  33 , the reduced diameter section  35  of the distal end  37 , or both the reduced diameter section  31  and reduced diameter section  35 . In some cases, the enlarged center section  39  may have a transverse dimension  41  that is about 1 times to about 4 times the transverse dimension of reduced diameter section  31  of the proximal end  33 , the reduced diameter section  35  of the distal end  37 , or both the reduced diameter section  31  and reduced diameter section  35 . In some cases, the enlarged center section  39  may have a transverse dimension  41  that is about 1.4 times to about 3 times the transverse dimension of reduced diameter section  31  of the proximal end  33 , the reduced diameter section  35  of the distal end  37 , or both the reduced diameter section  31  and reduced diameter section  35 . 
     The features, dimensions and materials of fusiform tubular isolation sleeve embodiments  10 ″′ may otherwise be the same as those of the non-fusiform tubular isolation sleeve embodiments  10  of  FIG. 1 . In particular, the sizing of the tubular isolation sleeve  10 ″′ may be oversized in its expanded relaxed state with respect to the transverse dimensions of the inner surface of the sac of the aneurysm being treated  20  in ratios which are the same as or similar to those of the other tubular isolation sleeve embodiments discussed herein. The tubular isolation sleeve embodiment  10 ″′ may have transverse dimensions  31 ,  35  and  41  in an unconstrained relaxed state which are up to about 80% oversized relative to respective transverse dimensions of an aneurysm to be treated. 
     The helical pattern of the resilient wires  26  of some tubular isolation sleeve embodiments  10  may allow for adjustment of axial length  42  ( FIG. 5 ) of the tubular isolation sleeve  10  such that a small number of device configurations of varying axial lengths may be capable of treating most anatomies. A suitable self-expanding tubular isolation sleeve embodiment  10  may also include a plurality of distinct and separate rings (not shown) of resilient strand material  26  that would also achieve a similar result of allowing for adjustment of axial length  42 . In some cases, it may only be desirable to use tubular isolation sleeve embodiments  10  having about 1 to about 3 different axial lengths  42  in order to treat a large percentage or majority of patient&#39;s requiring such a self-expanding tubular isolation sleeve  10 . In some cases, it may also not be necessary for a self-expanding tubular isolation sleeve embodiment  10  (once deployed) to cover the entire region or inner surface  16  of the aorta  12  extending from the inferior renal arteries to the bifurcation at the iliac arteries. In such cases, it may only be desirable that potential sac feeder vessels (such as IMA  22 ) be covered or otherwise isolated by the wall  24  of the tubular isolation sleeve  10  which is disposed over such vessels  22  and seals them from the interior lumen or volume of the parent aorta  12 . Such arrangements may be determined by pre-operative imaging. The subsequently deployed endograft  30  may be delivered, positioned and deployed in a normal manner, effectively trapping the deployed self-expanding tubular isolation sleeve  10  in the excluded aneurysm sac  12  as shown in  FIG. 9 . 
     Embodiments of tubular isolation sleeves  10  may be compatible with any or most endograft embodiments, and may be deployed in a pull-back sheath type delivery system such as shown in U.S. Patent Publication No. 2006/0009833, filed Aug. 15, 2005, titled “Delivery System and Method for Bifurcated Graft”, which is incorporated by reference herein in its entirety. Some embodiments of a method of treating an aneurysm  12  may include advancing a tubular isolation sleeve delivery system  50  over a guidewire  51  within a patient&#39;s vasculature to a treatment site  12  ( FIG. 6 ). A particularly suitable treatment site may include an aneurysm  12  having a feeder vessel such as IMA  22  or the like. The delivery system  50  includes a tubular isolation sleeve  10  in a radially constrained state with an inner surface of an outer sheath  52  exerting an inward radial constraining force on an outer surface of the tubular isolation sleeve  10 . The tubular isolation sleeve  10  may then be deployed within the aneurysm  12  by retracting the outer sheath  52  of the delivery system  50  so as to expose the tubular isolation sleeve  10 , release the radial constraining force of the inner surface of the outer sheath  52 , and allow self-expansion of the tubular isolation sleeve  10  to occur as the outer sheath  52  is retracted ( FIG. 7 ). The tubular isolation sleeve  10  may be allowed to self-expand towards the inner surface  16  of the aneurysm such that an outer surface  54  of the tubular isolation sleeve  10  contacts the inner surface of the aneurysm  12  and eventually seals off the feeder vessel  22  from an interior volume of the aneurysm  12  ( FIG. 8 ). As discussed above, once the tubular isolation sleeve  10  is deployed, blood flow from feeder vessels  22  may be interrupted such that the ostium  18  (see  FIG. 6 ) of any potential type II feeder vessels, such as an IMA  22 , communicating with the aneurysm sac  20  may be isolated, sealed off or otherwise occluded by a wall layer  24  (see  FIG. 1 ) of the tubular isolation sleeve  10 . Suitable isolation of these type II feeder vessels  22  may include approximating an outer surface of the tubular isolation sleeve  10  to the ostium  18  of a feeder vessel  22  so as to completely or nearly completely seal the outer wall  24  of the tubular isolation sleeve  10  to the inner wall surface  16  of the aneurysm around the ostium  18 . Suitable treatment of feeder vessels  22  may also include interrupting a flow of blood from the feeder vessels (without a complete or nearly complete seal) which is sufficient to promote thrombosis within the feeder vessel  22 . Such isolation of the feeder vessel  22  may then promote thrombosis of blood within these feeder vessels and occlude these feeder vessels so as to, e.g., preclude them from causing type II endoleaks at the treatment site  12 . Thereafter, an endograft  30  may be deployed at the aneurysm  12  and within an interior lumen of the deployed tubular isolation sleeve  10 . 
     In some cases, deploying the tubular isolation sleeve  10  may include expansion in an outward radial direction of the optional anchoring stent  11  so as to contact the inner wall surface  16 . In some cases, the tubular isolation sleeve delivery system may include an optional inflatable radially expanding balloon  53  and deployment of the tubular isolation sleeve  10  may include inflation of the optional inflatable radially expanding balloon  53  ( FIG. 7 ). The inflatable balloon  53  may be disposed on the delivery system  50  proximal of the tubular isolation sleeve  10  and be inflated in a position at the delivery site which is proximal to the position of the tubular isolation sleeve  10 . The optional inflatable balloon  53  may be used to slow or stop the flow of blood through a parent vessel of the aneurysm  12  and/or through the aneurysm  12  in order to allow the tubular isolation sleeve  10  to deploy without interference from the turbulence of flowing blood. This may be particularly desirable for deployment of a tubular isolation sleeve embodiments  10  having very thin walls and light gauge frames  32  or embodiments  10  without proximal anchor stents  11 . In some cases, deploying the endograft  30  may include deploying a bifurcated endograft embodiment  30  such as the endograft embodiment shown in  FIG. 9 . The bifurcated endograft, or portions thereof, may also be deployed within an inner lumen of the already deployed tubular isolation sleeve  10 . 
     In some cases, the tubular isolation sleeve embodiments  10  discussed herein may be useful for treating an aneurysm  12  which has ruptured. During such an emergency procedure, the tubular isolation sleeve  10  may be deployed prior to deployment of a standard endograft  30 . Such deployment of the tubular isolation sleeve  10  may allow a surgical team sufficient time to deploy the standard endograft  30  without concern about patient blood loss due to the rupture of the aneurysm  12 . Use of the tubular isolation sleeve  10  prior to deployment of a standard endograft  30  may be useful in that such a deployment of the tubular isolation sleeve  10  may be a quick and simple deployment procedure relative to the time and complexity of the deployment of a standard endograft  30 , particularly a multi-component bifurcated endograft  30 . 
     The entirety of each patent, patent application, publication and document referenced herein hereby is incorporated by reference. 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 date of these publications or documents. 
     Modifications may be made to the foregoing without departing from the basic aspects of the invention. Although embodiments of the invention have been described in substantial detail with reference to one or more specific embodiments, those of ordinary skill in the art will recognize that changes may be made to the embodiments specifically disclosed in this application, yet these modifications and improvements are within the scope and spirit of the invention. 
     Embodiments illustratively described herein suitably may be practiced in the absence of any element(s) 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 either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof, and various modifications are possible within the scope of the invention claimed. The term “a” or “an” can refer to one of or a plurality of the elements it modifies (e.g., “a reagent” can mean one or more reagents) unless it is contextually clear either one of the elements or more than one of the elements is described. Thus, it should be understood that although embodiments have been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered within the scope of this invention.