Claims
- 1. A sutureless bioprosthetic stent graft adapted to be implanted in a patient, comprising:
a stent frame having a length and defining a lumen; and a sheath of biomaterial suturelessly attached to and substantially covering said stent frame.
- 2. The stent graft of claim 1, wherein the sheath of biomaterial comprises an outer graft surface.
- 3. The stent graft of claim 1, wherein the sheath of biomaterial comprises an inner graft surface.
- 4. The stent graft of claim 1, wherein the sheath comprises a plurality of layers of biomaterial.
- 5. The stent graft of claim 3, wherein said plurality of layers of biomaterial form the inner graft surface.
- 6. The stent graft of claim 3, wherein said plurality of layers of biomaterial form the outer graft surface.
- 7. The stent graft of claim 1, wherein the sheath of biomaterial consists essentially of a synthetic biomaterial.
- 8. The stent graft of claim 1, wherein the sheath of biomaterial consists essentially of a natural biomaterial.
- 9. The stent graft of claim 1, wherein said sheet is substantially comprised of collagen.
- 10. The stent graft of claim 1, wherein said sheet consists essentially of small intestine submucosa.
- 11. The stent graft of claim 1, wherein said sheet is constructed to a selected thickness.
- 12. The stent graft of claim 1, wherein the stent frame consists of shape memory material.
- 13. A method for manufacturing a sutureless bioprosthetic stent graft suitable for physiological implantation, comprising:
wrapping a sheet of biomaterial on a mandrel to form a biomaterial roll having a first end, a second end, an inward-facing surface, an outward-facing surface and an at least partial overlap of the biomaterial; positioning a stent frame over the outer surface of the biomaterial roll and intermediate the first and second ends of the biomaterial roll; encasing the stent frame within the biomaterial; suturelessly bonding the biomaterial by irradiating the biomaterial roll with energy; and removing the biomaterial roll from the mandrel.
- 14. The method of claims 13, wherein wrapping comprises aligning a first edge of the biomaterial sheet along the mandrel and rolling said mandrel.
- 15. The method of claim 13, wherein encasing the stent frame comprises everting the first end of the biomaterial roll over the stent frame to approximate said first end with one of the outward-facing surface or the second end.
- 16. The method of claim 13, wherein encasing the stent frame comprises everting the first end and the second end of the biomaterial roll over the stent frame to approximate said first end with one of the second end or the inward-facing surface.
- 17. The method of claim 16, wherein suturelessly bonding comprises suturelessly bonding the overlapped first and second ends of the biomaterial.
- 18. The method of claim 13, wherein suturelessly bonding the biomaterial comprises photo-chemically cross-linking the biomaterial using a crosslinking agent.
- 19. The method of claim 18, wherein the crosslinking agent is methylene blue.
- 20. The method of claim 19, wherein irradiating the biomaterial roll with energy comprises irradiating the biomaterial roll with visible light.
- 21. The method of claim 19, wherein irradiating the biomaterial roll with energy comprises irradiating the biomaterial roll with ultraviolet light.
- 22. The method of claim 13, wherein suturelessly bonding the biomaterial comprises irradiating the biomaterial roll with energy sufficient to at least partially thermally fuse the biomaterial sheet.
- 23. The method of claim 22, wherein irradiating the biomaterial roll with energy sufficient to at least partially thermally fuse the biomaterial sheet comprises irradiating the biomaterial roll with energy generated by a laser.
- 24. The method of claim 23, wherein said laser emits light having a wavelength of about 800 nm.
- 25. The method of claim 22, further comprising applying an energy-absorbing material that is energy-absorptive within a predetermined range of light wavelengths.
- 26. The method of claim 25, wherein the energy-absorbing material is indocyanine green.
- 27. The method of claim 22, wherein irradiating the biomaterial roll with energy sufficient to at least partially thermally fuse the biomaterial sheet comprises irradiating the biomaterial roll and a tissue solder.
- 28. The method of claim 22, wherein irradiating the biomaterial roll with energy sufficient to at least partially thermally fuse the biomaterial sheet comprises irradiating the biomaterial roll and a tissue welding patch.
- 29. The method of claim 22, wherein irradiating the biomaterial roll with energy sufficient to at least partially thermally fuse the biomaterial sheet comprises irradiating the biomaterial roll with energy generated by a radio-frequency energy source.
- 30. The method of claim 22, wherein irradiating the biomaterial roll with energy sufficient to at least partially thermally fuse the biomaterial sheet comprises irradiating the biomaterial roll with energy generated by an ultrasound energy source.
- 31. The method of claim 13, further comprising rotating the covered stent during irradiating.
- 32. The method of claim 13, further comprising dehydrating the biomaterial prior to suturelessly bonding; and rehydrating the biomaterial contemporaneous with suturelessly bonding.
- 33. The method of claim 13, wherein irradiating the biomaterial roll comprises irradiating substantially the entire outward-facing surface of the biomaterial roll.
- 34. The method of claim 13, wherein irradiating the biomaterial roll comprises irradiating substantially the entire inward-facing surface of the biomaterial roll.
- 35. The method of claim 13, wherein the biomaterial sheet consists essentially of collagen.
- 36. The method of claim 13, wherein the biomaterial consists essentially of small intestine submucosa.
- 37. The method of claim 13, wherein the biomaterial has incorporated therein a drug.
- 38. A device adapted to manufacture a sutureless bioprosthetic stent graft, comprising:
a mandrel having a selected diameter and adapted to have positioned thereon a stent graft having a biomaterial sheath; and means for irradiating the biomaterial sheath with energy when said biomaterial sheath is positioned on the mandrel.
- 39. The device of claim 38, further comprising means for moistening the biomaterial sheath of the stent structure when positioned on the mandrel.
- 40. The device of claim 38, further comprising means for rotating the mandrel.
- 41. The device of claim 38, wherein means for irradiating the biomaterial sheath with energy is a light source.
- 42. The device of claim 41, wherein means for irradiating the biomaterial sheath with energy is a laser.
- 43. The device of claim 42, wherein the laser is a diode laser operative at a wavelength of about 800 nm.
- 44. The device of claim 41, wherein means for irradiating the biomaterial sheath with energy is an ultraviolet light source.
- 45. The device of claim 41, wherein means for irradiating the biomaterial sheath with energy is a white light source.
- 46. The device of claim 38, wherein means for irradiating the biomaterial sheath with energy is an ultrasound energy source.
- 47. The device of claim 38, wherein means for irradiating the biomaterial sheath with energy is a radio-frequency energy source.
- 48. The device of claim 38, wherein means for irradiating the biomaterial sheath with energy is a contact electro-thermal transducer.
- 49. The device of claim 38, wherein means for irradiating the biomaterial sheath with energy is housed within the mandrel.
- 50. The device of claim 49, wherein means for irradiating the biomaterial sheath with energy is a light energy source.
- 51. The device of claim 50, wherein the mandrel includes a fiberoptic element adapted to transmit light from a light source to an inward-facing surface of a biomaterial sheath positioned on the mandrel.
- 52. The device of claim 49, wherein means for irradiating the biomaterial sheath with energy is a radio-frequency energy source.
- 53. The device of claim 49, wherein means for irradiating the biomaterial sheath with energy is an ultrasound energy source.
- 55. The device of claim 49, wherein means for irradiating the biomaterial sheath with energy is a contact electro-thermal transducer.
Government Interests
[0001] This invention was made with the U.S. Government support under Grant Number DAMD17-96-1-6006, awarded by the Army Medical Research and Materiel Command. The U.S. Government may have certain rights in the invention.