Method and apparatus for repairing vascular abnormalities and/or other body lumen abnormalities using an endoluminal approach and a flowable forming material
Apparatus and method for repairing an abnormality in the wall of a body lumen, the method comprising isolating the abnormality in the wall of the body lumen from flow in the body lumen; positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen, and the apparatus comprising a supply of flowable forming material; zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.
1. A method for repairing an abnormality in the wall of a body lumen, the method comprising:
providing an access system comprising:
an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen;
an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen, the erectable distal isolation barrier being formed separately from the erectable proximal isolation barrier;
a bypass channel secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass channel comprising a lumen communicating with the region of the body lumen proximal to the proximal isolation barrier and with the region of the body lumen distal to the distal isolation barrier so that fluid can be passed from the region of the body lumen proximal to the proximal isolation barrier through the bypass channel and to the region of the body lumen distal to the distal isolation barrier;
a working catheter passing through the proximal isolation barrier and into the region between the proximal isolation barrier and the distal isolation barrier, the working catheter providing a central lumen for providing access to the wall of the body lumen between the proximal isolation barrier and the distal isolation barrier;
a supply catheter extendible out of the working catheter; and
a mold structure extending between the proximal isolation barrier and the distal isolation barrier, the mold structure comprising a substantially continuous film;
isolating the abnormality in the wall of the body lumen from fluid flowing through the body lumen, while still allowing fluid to flow between the region of the body lumen proximal to the proximal isolation barrier and the region of the body lumen distal to the distal isolation barrier, by positioning the access system within the body lumen and erecting the distal isolation barrier and the proximal isolation barrier so that the proximal isolation barrier makes a sealing engagement with the wall of the body lumen proximal to the abnormality, the distal isolation barrier makes a sealing engagement with the wall of the body lumen distal to the abnormality, and the bypass channel provides the only fluid flow between the region of the body lumen proximal to the proximal isolation barrier and the region of the body lumen distal to the distal isolation barrier, with the mold structure isolating the abnormality from the region of the body lumen between the proximal isolation barrier and the distal isolation barrier, and with the mold structure following a cylindrical geometry so as to conform to the adjacent body lumen;
positioning flowable forming material adjacent to the abnormality in the wall of the body lumen by advancing the supply catheter out of the working catheter and through the mold structure and by passing the flowable forming material into the space between the wall of the body lumen and the mold structure; and
transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen.
2. A method according to claim 1 wherein the body lumen comprises a vascular structure.
3. A method according to claim 1 wherein the body lumen comprises one from the group consisting of arterial structure, venous structure, other vascular structure, esophagus, stomach, small bowel, large bowel, ureter, bladder, urethra, bronchus, bile duct, ear, nose and fallopian tube.
4. A method according to claim 1 wherein the abnormality comprises an aneurysm.
5. A method according to claim 4 wherein the aneurysm comprises at least one from the group consisting of a fusiform aneurysm, a saccular aneurysm and a lateral aneurysm.
6. A method according to claim 4 wherein the aneurysm is located in one from the group consisting of the aorta, an iliac branch, a femoral artery, a cerebral artery and a carotid artery.
7. A method according to claim 4 wherein the flowable forming material is positioned within the interior of the aneurysm.
8. A method according to claim 7 wherein the flowable forming material is positioned within the interior of the aneurysm and within at least a portion of the interior of the body lumen.
9. A method according to claim 1 wherein the erectable proximal isolation barrier and the erectable distal isolation barrier are constructed so as to be capable of assuming a diametrically-reduced configuration and a diametrically-expanded configuration, and further wherein the erectable proximal isolation barrier and the erectable distal isolation barrier are in their diametrically-expanded configuration when making a sealing engagement with the wall of the body lumen.
10. A method according to claim 1 wherein at least one of the erectable proximal isolation barrier and the erectable distal isolation barrier comprises an upstream isolation barrier, and further wherein the upstream isolation barrier is configured to channel blood flow into the bypass channel.
11. A method according to claim 1 wherein the proximal isolation barrier comprises an inflatable/deflatable balloon.
12. A method according to claim 11 wherein the inflatable/deflatable balloon comprises a torus with a membrane closing off its center opening.
13. A method according to claim 11 wherein the proximal isolation barrier comprises a plurality of inflatable/deflatable balloons.
14. A method according to claim 13 wherein the balloons communicate with one another.
15. A method according to claim 1 wherein the proximal isolation barrier comprises a compressible/expandable superelastic shape memory alloy ring.
16. A method according to claim 15 wherein the compressible/expandable superelastic shape memory alloy ring comprises a torus with a membrane closing off its center opening.
17. A method according to claim 1 wherein the distal isolation barrier comprises an inflatable/deflatable balloon.
18. A method according to claim 17 wherein the inflatable/deflatable balloon comprises a torus with a membrane, closing off its center opening.
19. A method according to claim 17 wherein the distal isolation barrier comprises a plurality of inflatable/deflatable balloons.
20. A method according to claim 19 wherein the balloons communicate with one another.
21. A method according to claim 1 wherein the distal isolation barrier comprises a compressible/expandable superelastic shape memory alloy ring.
22. A method according to claim 21 wherein the compressible/expandable superelastic shape memory alloy ring comprises a torus with a membrane closing off its center opening.
23. A method according to claim 1 wherein the access system is deployed into the body lumen over a guidewire.
24. A method according to claim 1 comprising the additional step of detaching the working catheter from the proximal isolation barrier.
25. A method according to claim 1 further comprising removing debris from the body lumen.
26. A method according to 25 wherein the debris is removed while the proximal isolation barrier and the distal isolation barrier are erected.
27. A method according to 26 wherein the debris is removed by applying suction via the working catheter.
28. A method according to claim 25 wherein the erectable proximal isolation barrier is constructed so as to be capable of assuming a diametrically-reduced configuration and a diametrically-expanded configuration, wherein the erectable proximal isolation barrier is placed in its diametrically-expanded configuration when making a sealing engagement with the wall of the body lumen, and further wherein the erectable proximal isolation barrier is placed in its diametrically-reduced configuration before the debris is removed.
29. A method according to claim 1 wherein the native fluid located between the erectable distal isolation barrier and the erectable proximal isolation barrier is replaced with a substitute fluid.
30. A method according to claim 29 wherein the substitute fluid comprises saline.
31. A method according to claim 29 wherein the substitute fluid comprises air.
32. A method according to claim 29 wherein an endoscope is advanced to the zone located between the proximal isolation barrier and the distal isolation barrier via the working catheter.
33. A method according to claim 1 wherein the flowable forming material comprises a resorbable material.
34. A method according to claim 33 wherein the flowable forming material comprises a resorbable organic polymer ambient temperature cure resin.
35. A method according to claim 34 wherein the flowable forming material comprises at least one selected from the group consisting of a bioresorbable and a resorbable hydroxyethylmethacrylate ester (HEMAE) liquid monomer.
36. A method according to claim 1 wherein the substantially continuous film is in the form of a cylinder.
37. A method according to claim 1 wherein the mold structure comprises a circumferential configuration.