Processed tissue for medical device formation

• US 20030229394A1
• Filed: 06/06/2002
• Published: 12/11/2003
• Est. Priority Date: 06/06/2002
• Status: Abandoned Application

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ogle, Matthew F., Kruse, Steven D.
• Application Number:
  US10/164,725
• Publication Number:
  US 20030229394A1
• Time in Patent Office: Days
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

In some embodiments, a method for processing tissue comprises the application of a directional load to modify the properties of the tissue. In particular, the directional force is sufficient to increase the rigidity of the tissue asymmetrically relative to an unaligned tissue equivalently processed without being subjected to a load. In some embodiments, a sufficient directional load is applied to increase the rigidity of the tissue relative to an unaligned tissue equivalently processed that is not subjected to the load, in which the load is applied with a load applicator. A connector transfers the load from the load applicator to the tissue. Selectively aligned tissue having asymmetric mechanical properties can be used to form a prosthetic valve. The leaflets are matched with respect to each of their properties to have improved coaptation relative to corresponding tissue leaflets with symmetrical mechanical properties.

Claims

1. A method for processing tissue, the method comprising applying a sufficient directional load to the tissue to increase the rigidity of the tissue asymmetrically relative to an unaligned tissue equivalently processed that is not subjected to the load.

2. The method of claim 1 wherein the tissue is generally planar.

3. The method of claim 1 wherein the tissue is curved.

4. The method of claim 1 wherein the directional load has a magnitude from about 1 gram/centimeter (g/cm) to about 1000 g/cm.

5. The method of claim 1 wherein the load is applied for at least about 10 minutes.

6. The method of claim 1 wherein the load is applied for from about 1 hours to about 48 hours.

7. The method of claim 1 wherein a round 1.75 inch (44.45 mm) diameter section of the tissue prior to applying the direction load drapes vertically down over a rod with a diameter of 0.2 inches (5.08 mm).

8. The method of claim 1 wherein a round 1.75 inch (44.45 mm) diameter section of the tissue after applying the directional load, when draped over a 0.2 inch (5.08 mm) diameter rod, hangs at least about 20 degrees closer to the horizontal relative to an equivalent section of the tissue without application of a load.

9. The method of claim 1 wherein a round 1.75 inch (44.45 mm) diameter section of the tissue after applying the direction load when draped over a 0.25 inch (6.35 mm) diameter rod hangs at least about 40 degrees closer to the horizontal relative to an equivalent section of the tissue without application of a load.

10. The method of claim 1 wherein the tissue is contacted with a crosslinking agent while the load is applied, thereby crosslinking the tissue simultaneously while increasing the rigidity of the tissue.

11. The method of claim 1 further comprising crosslinking the tissue following completion of applying the directional load to the tissue.

12. The method of claim 1 wherein the tissue is maintained in a hydrated state while applying the load.

13. The method of claim 1 wherein the tissue is immersed in a liquid while applying the load.

14. The method of claim 1 further comprising associating the tissue with a growth factor.

15. The method of claim 1 wherein the directional load is applied continuously.

16. The method of claim 1 wherein the directional load is applied with a periodic oscillation.

17. The method of claim 1 wherein the directional load is applied with a weight.

18. The method of claim 1 wherein the directional load is applied with a motor.

19. The method of claim 1 wherein the directional load is applied by anchoring the tissue under tension.

20. The method of claim 1 wherein the tissue is gripped with a clamp while applying the load.

21. A method for processing tissue, the method comprising applying a sufficient load to the tissue to increase the rigidity of the tissue relative to an unaligned tissue equivalently processed that is not subjected to the load, wherein a load applicator applies the load to the tissue and wherein a connector transfers load from the load applicator to the tissue.

22. A method for forming a prosthetic valve, the method comprising assembling a plurality of leaflets to form a valve, wherein the tissue leaflet comprises selectively aligned tissue having asymmetric mechanical properties.

23. The method of claim 22 wherein the leaflets are oriented within the valve to have improved coaptation relative to a structure with corresponding tissue leaflets that do not have aligned properties.

24. The method of claim 22 wherein assembling the plurality of leaflets comprises connecting a tissue leaflet to a leaflet support structure.

25. The method of claim 24 wherein the leaflet support structure comprises a stent and wherein the tissue leaflet is fastened to the stent along an attached edge.

26. The method of claim 25 wherein the leaflet is oriented to have greater rigidity with respect to bending around axes extending from the attached edge to the free edge of the leaflet relative to bending around axes perpendicular to axes extending from the attached edge to the free edge.

27. The method of claim 22 wherein the leaflets are attached to chordae.

28. The method of claim 27 wherein the leaflet is oriented to have a greater flexibility with respect to bending around axes extending from the chordae to the free edge of the leaflet relative to bending around axes perpendicular to axes extending from the chordae to the free edge.

29. The method of claim 22 wherein assembling the plurality of leaflets comprises connecting a tissue leaflet to a leaflet support structure and wherein the connecting of the tissue to the leaflet support structure comprises suturing the tissue to the leaflet support structure.

30. The method of claim 22 further comprising cutting the tissue leaflet from a larger section of tissue.

31. The method of claim 30 wherein the larger section of tissue is generally planar.

32. The method of claim 30 wherein the larger section of tissue is curved.

33. The method of claim 22 wherein the prosthesis comprises a plurality of leaflets and the method further comprises connecting additional leaflets to the leaflet support structure to form the prosthesis with the plurality of leaflets.

34. Biocompatible tissue comprising selectively aligned tissue having an asymmetric flexibility, wherein the tissue comprises pericardial tissue, amniotic sac tissue, blood vessel tissue, cartilage, dura mater tissue, skin tissue, fascia tissue, submucosa tissue, or umbilical tissue.

35. The biocompatible tissue of claim 34 wherein the tissue is not crosslinked.

36. The biocompatible tissue of claim 34 wherein the tissue is crosslinked.

37. The biocompatible tissue of claim 36 wherein the tissue is crosslinked with a dialdehyde.

38. The biocompatible tissue of claim 36 wherein the tissue is crosslinked with a multifunctional epoxide.

39. The biocompatible tissue of claim 36 wherein the tissue is crosslinked with an epoxy amine.

40. The biocompatible tissue of claim 34 wherein the tissue comprises pericardial tissue.

41. The biocompatible tissue of claim 34 wherein the tissue comprises a multilayer composite.

42. The biocompatible tissue of claim 34 wherein the asymmetric flexibility is approximately oriented along an axis.

43. A prosthetic valve comprising the tissue of claim 34.

44. A prosthetic valve comprising a plurality of tissue leaflets wherein the tissue leaflets comprise selectively aligned tissue.

45. The prosthetic valve of claim 44 further comprising a leaflet support structure wherein the leaflets are attached to the leaflet support structure.

46. The prosthetic valve of claim 45 wherein the leaflets have less flexibility with respect to bending around axes extending from the attached edge to the free edge of the leaflet relative to bending around axes perpendicular to axes extending from the attached edge to the free edge.

47. The prosthetic valve of claim 45 wherein the leaflet support structure comprises a stent.

48. The prosthetic valve of claim 44 further comprising chordae attached to the leaflets.

49. The prosthetic valve of claim 48 wherein the leaflets have greater flexibility with respect to bending around axes extending from the attached edge of the leaflet to the chordae attachment point relative to bending around axes perpendicular to axes extending from the free edge to the chordae.

50. The prosthetic valve of claim 44 wherein the tissue comprises pericardium.

51. The prosthetic valve of claim 44 wherein the tissue is crosslinked.

52. An apparatus comprising tissue and a load applicator that applies a selected mechanical load to the tissue, wherein the load applicator comprises a gripper that grips adjacent a selected subsection of an edge of the tissue that does not approximate gripping the edge equally around the tissue.

53. The apparatus of claim 52 wherein the tissue comprises a generally flat section.

54. The apparatus of claim 52 wherein the load applicator comprises weights and connectors connecting the weights with the tissue.

55. The apparatus of claim 52 wherein the load applicator comprises a frame that grips the tissue under a load.

56. The apparatus of claim 52 wherein the load applicator comprises springs.

57. The apparatus of claim 52 wherein the load applicator comprises a motor.

58. The apparatus of claim 52 wherein the load applicator applied a load along a generally linear dimension of the tissue.

59. The apparatus of claim 52 further comprising a moisture source supplying moisture to maintain the tissue in a hydrated state.

60. The apparatus of claim 59 wherein the moisture comprises a crosslinking agent.

61. The apparatus of claim 60 wherein the crosslinking agent comprises a multifunctional composition selected from the group consisting of dialdehydes, polyepoxides and epoxyamines.