Material for creating multi-layered films and methods for making the same
View Patent ↗The present invention provides multilayered materials, such as films usable in particular in medical devices in the form of vascular grafts, biocompatible coverings, and/or inflatable bladders, prosthesis for the endoluminal treatment of aneurysms, particularly aortic aneurysms including both abdominal aortic aneurysms (AAA's) and thoracic aortic aneurysms (TAA's).
1. A device for treating an aneurysm, said device comprising:
a fillable containment bag having two opposing sheets sealed together, each sheet comprising at least one first layer and at least one second layer, the first layer formed from a first material comprising a fluorinated material, and the second layer formed from a second material comprising a polymeric material, wherein the first and second layers are disposed adjacent one another, wherein the elongation properties of one or more layers dominates that of the other layers, such that the device does not elongate more than about 120%, and wherein the inflatable containment bag further comprises a single through lumen and filling access, and the containment bag is adapted to conform to the aneurysm.
2. The device according to claim 1 , wherein the first and the second layers are formed from different materials.
3. The device according to claim 1 , wherein the first and the second layers are formed from the same material.
4. The device according to claim 1 , wherein the polymer material of the second layer is formed from a group consisting of thermoplastic and thermoset polymers.
5. The device according to claim 1 , wherein the polymer material of the second layer is formed from a thermoplastic polymer.
6. The device according to claim 1 , wherein the polymer material of the second layer is formed from a polyolefin.
7. The device according to claim 1 , wherein the fluorinated material of the first layer is formed from expanded-polytetrafluoroethylene (ePTFE).
8. The device according to claim 1 , wherein the first and the second layers are disposed contiguous with one another.
9. The device according to claim 1 , wherein at least a portion of the second material impregnates a portion of the first layer.
10. The device according to claim 9 , wherein at least a portion of the second material impregnates the first layer in an amount ranging from about 0.1 to about 95%.
11. The device according to claim 9 , wherein at least a portion of the second material impregnates the first layer in an amount ranging from about 5 to about 95%.
12. The device according to claim 9 , wherein at least a portion of the second material impregnates the first layer in an amount ranging from about 5 to about 70%.
13. The device according to claim 1 , wherein the first and second layers have compatible elongation properties which allow the structure to elongate without separation of layers.
14. The device according to claim 1 , wherein the device has a first axis and a second axis, and wherein tensile strength is higher along the first axis than tensile strength along the second axis, and wherein elongation is lower along the first axis than elongation along the second axis.
15. The device according to claim 1 , wherein the adjacent layers of the first and second layers are not completely contiguous with one another.
16. The device according to claim 1 , wherein at least one of the surfaces of the first layer has been activated to improve its surface energy.
17. The device according to claim 16 , wherein the fluorinated material of the first layer comprises ePTFE having a surface which has been activated by any one or more of plasma treatment, laser roughening, wet chemical treatment, biological treatment, and any combinations thereof.
18. The device according to claim 17 , wherein the biologically activated surface of the ePTFE is the surface which is opposite the first layer's surface which is disposed adjacent the second layer.
19. The device according to claim 18 , wherein the biologically activated surface of the ePTFE is activated to promote thrombogenesis and/or healing.
20. The device according to claim 1 , wherein the second layer is laminated on the first layer.
21. The device according to claim 20 , wherein the lamination is by way of thermal lamination.
22. The device according to claim 1 , wherein a surface of the second layer which is opposite the surface adjacent the first layer comprises an additive to minimize adhering of the second layer onto itself.
23. The device according to claim 22 , wherein the non-adhering additive comprises alumina, tantalum, or combinations thereof.
24. The device according to claim 1 , wherein the composite film is configured for diagnostic visibility.
25. The device according to claim 1 , wherein the composite film is echo-lucent, radio-lucent, ultrasound-lucent, CT-lucent, fluoro-lucent, or any combination thereof.
26. The device according to claim 1 , wherein the second layer is configured for diagnostic visibility by ultrasound, CT, fluoroscopy, or any combination thereof.
27. The device according to claim 1 , wherein the second layer is disposed on the first surface by way of film casting.
28. The device according to claim 1 , wherein at least a portion of the second material further includes markers to enhance identification of the location of the composite film when disposed within a patient.
29. The device according to claim 1 , wherein the second material forms from about 1 to about 99 percent of the total thickness of the composite material.
30. The device according to claim 1 , wherein the second material forms from about 10 to about 90 percent of the total thickness of the composite material.
31. The device according to claim 1 , wherein the second material is sealable to another material at a temperature ranging from about 100° C. to about 400° C.
32. The device according to claim 1 , wherein at least one supporting element is incorporated into the composite film.
33. The device according to claim 32 , wherein the supporting element includes metallic materials, polymeric materials, and combinations thereof.
34. The device according to claim 32 , wherein the supporting element is a rigid element.
35. The device according to claim 32 , wherein the supporting element is a flexible element.
36. The device according to claim 32 , wherein the supporting element is incorporated into the first layer.
37. The device according to claim 32 , wherein the supporting element comprises shape memory materials, stainless steel, cobalt chromium alloys, and any combinations thereof.
38. The device according to claim 32 , wherein the supporting element is a stent.
39. The device according to claim 32 , wherein the supporting element is a polymeric mesh-like structure.
40. The device according to claim 1 , wherein the device includes a structural element to aid in any one or more of the delivery, placement, visualization, and fixation of the device in the aneurysm.
41. The device according to claim 40 , wherein the structural element comprises a marker for diagnostic visualization.
42. The device according to claim 40 , wherein the structural element is disposed between the first and second layers of the composite film.