Graft Materials for Surgical Breast Procedures

• US 20110022171A1
• Filed: 07/21/2009
• Published: 01/27/2011
• Est. Priority Date: 07/21/2009
• Status: Active Grant

• Current Assignee: Lifecell Corporation (Abbvie Incorporated)
• Original Assignee: Kinetic Concepts Incorporated (3M Company)
• Inventors: Friedman, Evan, Richter, Melissa, Bachrach, Nathaniel, Barere, Aaron
• Granted Patent: US 8,986,377 B2
• Time in Patent Office: Days
• US Class Current: 623/8
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/04 for mammary reconstruction
• CPC Class Codes: A61L 27/362 Skin, e.g. dermal papillae
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3637 characterised by the origin of the biological material other than human or animal, e.g. plant extracts, algae
• 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 27/3695 characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: Y10T 29/49995 Shaping one-piece blank by removing material

Abstract

Graft materials and devices for surgical breast procedures, as well as methods of making graft devices are described.

Claims

1. A medical device for surgical breast procedures, comprising:

a sample of biocompatible material, wherein the sample of biocompatible material includes a first edge and a second edge, and wherein the first edge includes a convex portion that curves away from the second edge and the second edge includes a convex portion that curves away from the first edge.

2. The medical device of claim 1, wherein the sample of biocompatible material is biconvex in shape.

3. The medical device of claim 1, wherein the first edge is substantially parabolicly curved.

4. The medical device of claim 1, wherein the second edge is substantially parabolicly curved.

5. The medical device of claim 1, wherein the first edge further includes a nonconvex portion.

6. The medical device of claim 1, wherein the second edge further includes a nonconvex portion.

7. The medical device of claim 1, wherein the second edge further includes a substantially straight portion.

8. The medical device of claim 1, wherein the second edge further includes a concave portion.

9. The medical device of claim 1, wherein the first edge and the second edge are joined at an apex.

10. The medical device of claim 9, wherein the apex is rounded.

11. The medical device of claim 9, wherein the apex is squared.

12. The medical device of claim 1, wherein the sample of biocompatible material is symmetrical about at least one axis.

13. The medical device of claim 1, wherein the sample of biocompatible material is asymmetrical.

14. The medical device of claim 1, wherein:

the first edge is substantially parabolicly curved, having a focus and a vertex separated by a first length;

the second edge is substantially parabolicly curved, having a focus and a vertex separated by a second length;

the second length is greater than the first length; and

the first edge and the second edge join at two pointed apexes.

15. The medical device of claim 1, wherein:

the first edge and the second edge are joined at a first apex and a second apex;

the convex portion of the first edge and the convex portion of the second edge are joined at the first apex;

the first edge has a nonconvex portion;

the second edge has a nonconvex portion; and

the nonconvex portion of the first edge and the nonconvex portion of the second edge converge at the second apex.

16. The medical device of claim 1, wherein the sample of biocompatible material comprises an acellular tissue matrix.

17. The medical device of claim 16, wherein the acellular tissue matrix comprises a decellularized collagen-containing tissue matrix from a nonhuman animal.

18. The medical device of claim 16, wherein the acellular tissue matrix lacks or substantially lacks epithelial basement membrane.

19. The medical device of claim 16, wherein the acellular tissue matrix is a dermal tissue matrix.

20. The medical device of claim 17, wherein the animal is a pig.

21. The medical device of claim 17, wherein the animal is genetically modified such that tissues in the animal lack, or substantially lack, galactose α

-1,3-galactose epitopes.

22. A medical device for surgical breast procedures, comprising:

a sample of biocompatible material and a set of perforations forming an arcuate pattern across at least a portion of the sample of biocompatible material.

23. The medical device of claim 22, wherein the set of perforations is arranged in a semicircular pattern.

24. The medical device of claim 22, wherein the set of perforations creates a mesh pattern.

25. The medical device of claim 22, wherein the set of perforations comprises a series of parallel slits, wherein the slits have a generally uniform length, a generally uniform gap distance longitudinally separates adjacent slits, and a generally uniform horizontal separation distance separates adjacent parallel slits.

26. The medical device of claim 25, wherein the length is between 0.1 and 20 mm.

27. The medical device of claim 25, wherein the length is between 4 and 8 mm.

28. The medical device of claim 25, wherein the gap distance is between 0.1 and 20 mm.

29. The medical device of claim 25, wherein the gap distance is between 2 and 6 mm.

30. The medical device of claim 25, wherein the horizontal separation distance is between 0.1 and 20 mm.

31. The medical device of claim 25, wherein the horizontal separation distance is between 2 and 6 mm.

32. The medical device of claim 25, wherein adjacent parallel slits are offset longitudinally with respect to each other.

33. The medical device of claim 22, wherein the individual perforations are arcuate.

34. The medical device of claim 22, wherein the sample of biocompatible material comprises an acellular tissue matrix.

35. The medical device of claim 34, wherein the acellular tissue matrix comprises a decellularized collagen-containing tissue matrix from a nonhuman animal.

36. The medical device of claim 34, wherein the acellular tissue matrix lacks, or substantially lacks, epithelial basement membrane.

37. The medical device of claim 34, wherein the acellular tissue matrix is a dermal tissue matrix.

38. The medical device of claim 35, wherein the animal is a pig.

39. The medical device of claim 35, wherein the animal is genetically modified such that tissues in the animal lack, or substantially lack, galactose α

-1,3-galactose epitopes.

40. A method of making one or more graft devices, comprising:

providing a sheet of biocompatible material and cutting one or more samples from the biocompatible material that are sized and shaped for conforming to a portion of a surface of a breast implant having a predetermined volume.

41. The method of claim 40, wherein the cutting one or more samples comprises creating a first edge and a second edge in the biocompatible material such that the first edge includes a convex portion that curves away from the second edge and the second edge includes a convex portion that curves away from the first edge.

42. The method of claim 40, further comprising forming a set of perforations such that the set forms an arcuate pattern across at least a portion of the one or more graft devices.

43. The method of claim 40, wherein the breast implant is a round implant.

44. The method of claim 40, wherein the breast implant is an anatomical implant.

45. The method of claim 40, wherein the volume of the breast implant is between 400 and 550 cc.

46. The method of claim 40, wherein the volume of the breast implant is between 250 and 400 cc.

47. The method of claim 40, wherein the volume of the breast implant is between 100 and 250 cc.

48. The method of claim 40, wherein the providing a sheet of biocompatible material comprises:

providing a collagen-containing tissue from a nonhuman animal; and

processing the tissue so as to render the tissue acellular and lacking, or substantially lacking, an epithelial basement membrane, the process resulting in the production of an acellular tissue matrix.

49. The method of claim 48, wherein the animal is a pig.

50. The method of claim 48, wherein the tissue is dermis.

51. The method of claim 48, wherein the animal is genetically modified so that tissues in the animal lack, or substantially lack, galactose α

-1,3-galactose epitopes.

52. A method of treating tissue comprising:

providing a sample of biocompatible material, wherein the sample of biocompatible material includes a first edge and a second edge, and wherein the first edge includes a convex portion that curves away from the second edge and the second edge includes a convex portion that curves away from the first edge;

selecting a tissue site of interest; and

applying the sample of biocompatible material to the tissue site of interest.

53. The method of claim 52, further comprising suturing the sample of biocompatible material to the tissue site of interest.

54. The method of claim 52, wherein the tissue site of interest is breast tissue.

55. The method of claim 54, further comprising:

suturing a portion of the first edge to a lateral fold of the breast tissue;

suturing a portion of the first edge to an inframammary fold of the breast tissue; and

suturing a portion of the second edge to an inferior edge of a pectoralis major muscle.