In vitro testing of endovascular device
View Patent ↗Some embodiments relate in part to endovascular devices such as prostheses and methods of testing same prior to deployment. Some embodiments may be directed more specifically to inflatable grafts or stent grafts and methods of in vitro leak testing of such grafts prior to in vivo deployment.
1. A method of in vitro testing of an endovascular prosthesis, comprising:
providing an endovascular prosthesis including an inflatable portion which is loaded onto a delivery system, the inflatable portion of the endovascular prosthesis being in an uninflated state and including an interior volume bounded by at least one flexible layer of material;
inflating an inflatable portion of the prosthesis through a fill tube with a sterile removable inflation material and maintaining the fill material at a pressure higher than ambient pressure with the delivery system in a deployment ready configuration;
inspecting the delivery system and endovascular prosthesis for leaks of fill material;
confirming that there are no leaks in the inflatable portion of the prosthesis; and
removing the inflation material from the inflatable portion.
2. The method of claim 1 wherein an interior volume of the inflatable portion of the endovascular prosthesis is surrounded by at least one layer of porous flexible material, and further comprising filling the pores of the porous flexible material by wetting the porous flexible material of the inflatable portion with a wetting agent and then inflating the inflatable portion with fill material.
3. The method of claim 2 wherein inflating the inflatable portion of the endovascular prosthesis with a sterile removable inflation material comprises inflating the inflatable portion of the prosthesis with isopropyl alcohol.
4. The method of claim 2 wherein inflating the inflatable portion of the endovascular prosthesis with a sterile removable inflation material comprises inflating the inflatable portion of the prosthesis with saline.
5. The method of claim 1 wherein inflating the inflatable portion of the prosthesis comprises inflating to a pressure of about 1 psig to about 10 psig.
6. The method of claim 1 wherein the inflatable portion of the endovascular prosthesis comprises a toroidal configuration.
7. The method of claim 1 wherein the at least one flexible layer of material of the inflatable portion comprises ePTFE.
8. The method of claim 1 wherein loading the endovascular prosthesis onto a delivery system comprises radially constraining the endovascular prosthesis with an outer tubular sheath disposed over the endovascular prosthesis such that an inner luminal surface of the outer tubular sheath restricts radial expansion of the prosthesis during inflation.
9. The method of claim 1 further comprising deploying the endovascular prosthesis at a target site within a patient's vasculature.
10. A method of in vitro testing of an endovascular prosthesis, comprising:
providing a double walled endovascular prosthesis including a toroidal inflatable portion which is loaded onto a delivery system, the inflatable portion of the endovascular prosthesis being in an uninflated state and including an interior volume bounded by at least one flexible layer of material;
inflating an inflatable portion of the prosthesis through a fill tube with a sterile removable inflation material and maintaining the inflation material at a pressure higher than ambient pressure with the delivery system in a deployment ready configuration;
inspecting the delivery system and endovascular prosthesis for leaks of inflation material;
confirming that there are no leaks in the inflatable portion of the prosthesis; and
removing the inflation material from the inflatable portion.
11. The method of claim 10 wherein an outer wall of the double walled endovascular prosthesis includes a compliant outer wall portion.
12. The method of claim 10 wherein an outer wall of the double walled endovascular prosthesis includes a non-compliant outer wall portion.
13. The method of claim 10 wherein loading the endovascular prosthesis onto a delivery system comprises radially constraining the endovascular prosthesis with an outer tubular sheath disposed over the endovascular prosthesis such that an inner luminal surface of the outer tubular sheath restricts radial expansion of the prosthesis during inflation.
14. The method of claim 10 wherein the flexible layer of material that bounds the interior volume of the inflatable portion comprises parylene.
15. The method of claim 10 further comprising deploying the endovascular prosthesis at a target site within a patient's vasculature.
16. A method of in vitro testing of an endovascular prosthesis, comprising:
providing an endovascular prosthesis including an inflatable portion which is loaded onto a delivery system, the inflatable portion of the endovascular prosthesis being in an uninflated state and including an interior volume bounded by at least one flexible layer of material, a longitudinal inflation channel and an inflatable cuff disposed at a proximal end of the prosthesis and including an interior volume in fluid communication with an interior volume of the longitudinal inflation channel;
inflating an inflatable portion of the prosthesis through a fill tube with a sterile removable inflation material and maintaining the inflation material at a pressure higher than atmospheric pressure with the delivery system in a deployment ready configuration;
inspecting the delivery system and endovascular prosthesis for leaks of inflation material;
confirming that there are no leaks in the inflatable portion of the prosthesis; and
removing the inflation material from the inflatable portion.
17. The method of claim 16 wherein an interior volume of the inflatable portion of the endovascular prosthesis is surrounded by at least one layer of porous flexible material and further comprising filling the pores of the porous flexible material with a wetting agent and then inflating the inflatable portion of the prosthesis with inflation material for leak testing.
18. The method of claim 17 wherein inflating the inflatable portion of the endovascular prosthesis with a sterile removable fill material comprises inflating the inflatable portion of the prosthesis with isopropyl alcohol.
19. The method of claim 17 wherein inflating the inflatable portion of the endovascular prosthesis with a sterile removable fill material comprises inflating the inflatable portion of the prosthesis with saline.
20. The method of claim 16 wherein inflating the inflatable portion of the prosthesis comprises inflating to a pressure of about 1 psig to about 20 psig.
21. The method of claim 16 wherein loading the endovascular prosthesis onto a delivery system comprises radially constraining the endovascular prosthesis with an outer tubular sheath disposed over the endovascular prosthesis such that an inner luminal surface of the outer tubular sheath restricts radial expansion of the prosthesis during inflation.
22. The method of claim 16 wherein the at least one flexible layer of material of the inflatable portion comprises ePTFE.
23. The method of claim 16 further comprising deploying the endovascular prosthesis at a target site within a patient's vasculature.