ENDOLEAK ISOLATION SLEEVES AND METHODS OF USE
Devices and methods for reducing or eliminating endoleaks by isolating feeder vessels from an aneurysm of a patient. In some cases, a tubular isolation sleeve may be deployed in a patient's aneurysm prior to deployment of an endograft such as a modular bifurcated endograft.
1 . A self-expanding tubular isolation sleeve for treatment of an aneurysm and reduction of endoleaks, comprising:
a self-expanding resilient frame including 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;
at least one tubular layer of thin flexible sheet material disposed on the resilient frame which has an outside surface that is configured to seal against an inner wall of an aneurysm and isolate a feeder vessel of the aneurysm; and
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.
2 . The tubular isolation sleeve of claim 1 wherein the enlarged center section has a transverse dimension up to about 4 times the transverse dimension of the proximal reduced diameter section and the distal reduced diameter section.
3 . The tubular isolation sleeve of claim 1 wherein the enlarged center section has a transverse dimension that is about 1.4 times to about 3 times the transverse dimension of proximal reduced diameter section and the distal reduced diameter section.
4 . The tubular isolation sleeve of claim 1 wherein an axial length of the tubular isolation sleeve is about 8 cm to about 12 cm.
5 . The tubular isolation sleeve of claim 1 further comprising a self-expanding anchoring stent secured to and extending proximally from a proximal end of the tubular isolation sleeve.
6 . The tubular isolation sleeve of claim 5 wherein the self-expanding anchoring stent further comprises tissue engaging barbs with sharpened tips which are disposed at an angle with respect to the anchoring stent.
7 . The tubular isolation sleeve of claim 1 wherein a transverse dimension of the tubular isolation sleeve in an unconstrained free state is up to about 80% oversized relative to an inner transverse dimension of an aneurysm sac that is to be treated.
8 . The tubular isolation sleeve of claim 1 wherein the one or more resilient strands are formed into an undulating helical configuration.
9 . The tubular isolation sleeve of claim 1 wherein the one or more resilient strands comprise a superelastic material.
10 . The tubular isolation sleeve of claim 9 wherein the superelastic material comprises NiTi.
11 . The tubular isolation sleeve of claim 1 wherein the tubular layer of flexible sheet material comprises PTFE.
12 . The tubular isolation sleeve of claim 1 comprising an outer layer of flexible sheet material disposed on an outer surface of the frame and an inner layer of flexible sheet material disposed on an inner surface of the frame.
13 . A method of treating an aneurysm, comprising:
advancing a tubular isolation sleeve delivery system within a patient's vasculature to a treatment site that includes an aneurysm having a feeder vessel;
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; and
subsequently deploying an endograft at the aneurysm and within an interior lumen of the deployed tubular isolation sleeve.
14 . The method of claim 13 wherein interrupting blood flow from the feeder vessel comprises sealing the feeder vessel from a sac of the aneurysm.
15 . The method of claim 13 wherein interrupting blood flow from the feeder vessel comprises interrupting the blood flow sufficiently to cause thrombosis of blood within the feeder vessel and seal the feeder vessel from a sac of the aneurysm.
16 . The method of claim 13 wherein subsequently deploying the endograft at the aneurysm and within the interior lumen of the deployed tubular isolation sleeve comprises so deploying a bifurcated endograft.
17 . The method of claim 13 wherein the tubular isolation sleeve comprises a thrombogenic agent and deploying the tubular isolation sleeve comprises positioning the thrombogenic agent of the tubular isolation sleeve in fluid communication with blood within the feeder vessel upon deployment.
18 . The method of claim 13 wherein the tubular isolation sleeve delivery system includes an inflatable balloon and further comprising expanding the inflatable balloon proximally of the tubular isolation sleeve to temporarily occlude blood flow in a parent artery of the aneurysm proximal to the tubular isolation sleeve and prior to deploying the tubular isolation sleeve.
19 . The method of claim 13 wherein the tubular isolation sleeve is deployed such that the outer surface of the tubular isolation sleeve approximates an ostium of the feeder vessel to interrupt blood flow therefrom.