Flowable matrix compositions and methods

• US 9,744,266 B2
• Filed: 09/18/2015
• Issued: 08/29/2017
• Est. Priority Date: 12/19/2011
• Status: Active Grant

• Current Assignee: AlloSource
• Original Assignee: AlloSource
• Inventors: Stilwell, Reginald L., Samaniego, Adrian C., Atkinson, Brent
• Primary Examiner(s): Underdahl, Thane
• Assistant Examiner(s): Pyla, Yvonne
• Application Number:
  US14/858,295
• Publication Number:
  US 20160008515A1
• Time in Patent Office: 711 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61K 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 35/51 Umbilical cord; Umbilical cord blood; Umbilical stem cells
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• 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 27/362 Skin, e.g. dermal papillae
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3662 Ligaments, tendons
• 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 27/38 containing added animal cells organs or tissue containing native cells A61L27/36

Abstract

Flowable matrix compositions and methods of their use and manufacture are provided. Exemplary compositions may include a flowable, syringeable, putty-like form of acellular human dermal matrix. In some cases, compositions may include a moldable acellular collagen extracellular matrix. In use, the matrix compositions can be used to fill or treat skin voids, channel wounds, and other soft tissue deficiencies.

Claims

1. A soft tissue matrix composition for use in a patient treatment, the composition consisting of:

a cryofractured human soft tissue material having a mechanically disrupted extracellular matrix collagen or macrostructure and a partially disrupted collagen microfibrillar architecture, wherein the cryofractured tissue material is in a hydrated state, the hydration comprising the natural interstitial water of the cryofractured soft tissue material that is present prior to cryofractionation; and

a wetting agent, wherein the wetting agent is at least one wetting agent selected from the group consisting of water, saline solution, phosphate buffered saline (PBS), sodium dodecyl sulfate, sodium stearate, benzalkonium chloride, 3-[(3-cholamidopropyl)dimethylammonio]-1-propanesulfonate (CHAPS), lecithin, (p-t-Octylphenoxy)polyethoxyethanol, and nonoxynol-9.

2. The soft tissue matrix composition according to claim 1, wherein the soft tissue matrix composition is present in an applicator assembly.

3. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is acellular.

4. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is at least partially decellularized.

5. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is not partially or completely decellularized.

6. The soft tissue matrix composition according to claim 1, wherein the soft tissue matrix composition does not adhere to a surgical glove material.

7. The soft tissue matrix composition according to claim 1, wherein the soft tissue matrix composition does not adhere to a material selected from the group consisting of latex, neoprene, vinyl, and nitrile.

8. The soft tissue matrix composition according to claim 1, wherein the soft tissue matrix composition has a putty consistency.

9. The soft tissue matrix composition according to claim 1, wherein the soft tissue matrix composition has a shear resistance of 250-2,500 Pascal seconds at room temperature.

10. The soft tissue matrix composition according to claim 1, wherein the soft tissue matrix composition has a shear resistance of 1,000-2,000 Pascal seconds at room temperature.

11. The soft tissue matrix composition according to claim 1, wherein the soft tissue matrix composition can pass through a bore hole of a 18 g needle and not through a bore hole of a 26 g needle.

12. The soft tissue matrix composition according to claim 1, wherein the cryofractured tissue material is in a naturally hydrated state.

13. The soft tissue matrix composition according to claim 1, wherein the cryofractured tissue material is in a partially hydrated state.

14. The soft tissue matrix composition according to claim 1, wherein the wetting agent is water.

15. The soft tissue matrix composition according to claim 1, wherein the wetting agent is a saline solution.

16. The soft tissue matrix composition according to claim 1, wherein the wetting agent is a 0.9% sterile saline solution.

17. The soft tissue matrix composition according to claim 1, wherein the wetting agent is phosphate buffered saline (PBS).

18. The soft tissue matrix composition according to claim 1, wherein the wetting agent is sodium dodecyl sulfate.

19. The soft tissue matrix composition according to claim 1, wherein the wetting agent is sodium stearate.

20. The soft tissue matrix composition according to claim 1, wherein the wetting agent is benzalkonium chloride.

21. The soft tissue matrix composition according to claim 1, wherein the wetting agent is 3-[(3-cholamidopropyl)dimetylammonio]-1-propanesulfonate (CHAPS).

22. The soft tissue matrix composition according to claim 1, wherein the wetting agent is lecithin.

23. The soft tissue matrix composition according to claim 1, wherein the wetting agent is (p-t-Octylphenoxy)polyethoxyethanol.

24. The soft tissue matrix composition according to claim 1, wherein the wetting agent is nonoxynol-9.

25. The soft tissue matrix composition according to claim 1, wherein at least a portion of the human soft tissue material is in minced or sliced pieces.

26. The soft tissue matrix composition according to claim 1, wherein at least a portion of the soft tissue matrix composition is in comminuted form.

27. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is selected from the group consisting of amnion tissue, umbilical cord tissue, chorionic tissue, intestine tissue, tendon tissue, and skin tissue.

28. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is skin.

29. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is full thickness skin or skin lacking the epidermal layer.

30. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is amnion tissue.

31. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is umbilical cord tissue.

32. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is chorionic tissue.

33. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is intestine tissue.

34. The soft tissue matrix composition according to claim 1, wherein the human soft tissue material is tendon tissue.

35. A soft tissue matrix composition for use in a patient treatment, the composition consisting of:

a cryofractured and triturated human soft tissue material having a mechanically disrupted extracellular matrix collagen or macrostructure and a partially disrupted collagen microfibrillar architecture, wherein the cryofractured and triturated tissue material is in a hydrated state, the hydration comprising the natural interstitial water of the cryofractured and triturated human soft tissue material that is present prior to cryofractionation and trituration; and

a wetting agent, wherein the wetting agent is at least one wetting agent selected from the group consisting of water, saline solution, phosphate buffered saline (PBS), sodium dodecyl sulfate, sodium stearate, benzalkonium chloride, 3-[(3-cholamidopropyl)dimetylammonio]-1-propanesulfonate (CHAPS), lecithin, (n-t-Octylphenoxy)polyethoxyethanol, and nonoxynol-9.

36. The soft tissue matrix composition according to claim 35, wherein the soft tissue matrix composition is present in an applicator assembly.

37. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is acellular.

38. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is at least partially decellularized.

39. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is not partially or completely decellularized.

40. The soft tissue matrix composition according to claim 35, wherein the soft tissue matrix composition does not adhere to a surgical glove material.

41. The soft tissue matrix composition according to claim 35, wherein the soft tissue matrix composition does not adhere to a material selected from the group consisting of latex, neoprene, vinyl, and nitrile.

42. The soft tissue matrix composition according to claim 35, wherein the soft tissue matrix composition has a putty consistency.

43. The soft tissue matrix composition according to claim 35, wherein the soft tissue matrix composition has a shear resistance of 250-2,500 Pascal seconds at room temperature.

44. The soft tissue matrix composition according to claim 35, wherein the soft tissue matrix composition has a shear resistance of 1,000-2,000 Pascal seconds at room temperature.

45. The soft tissue matrix composition according to claim 35, wherein the soft tissue matrix composition can pass through a bore hole of a 18 g needle and not through a bore hole of a 26 g needle.

46. The soft tissue matrix composition according to claim 35, wherein the cryofractured tissue material is in a naturally hydrated state.

47. The soft tissue matrix composition according to claim 35, wherein the cryofractured tissue material is in a partially hydrated state.

48. The soft tissue matrix composition according to claim 35, wherein the wetting agent is water.

49. The soft tissue matrix composition according to claim 35, wherein the wetting agent is a saline solution.

50. The soft tissue matrix composition according to claim 35, wherein the wetting agent is a 0.9% sterile saline solution.

51. The soft tissue matrix composition according to claim 35, wherein the wetting agent is phosphate buffered saline (PBS).

52. The soft tissue matrix composition according to claim 35, wherein the wetting agent is sodium dodecyl sulfate.

53. The soft tissue matrix composition according to claim 35, wherein the wetting agent is sodium stearate.

54. The soft tissue matrix composition according to claim 35, wherein the wetting agent is benzalkonium chloride.

55. The soft tissue matrix composition according to claim 35, wherein the wetting agent is 3-[(3-cholamidopropyl)dimetylammonio]-1-propanesulfonate (CHAPS).

56. The soft tissue matrix composition according to claim 35, wherein the wetting agent is lecithin.

57. The soft tissue matrix composition according to claim 35, wherein the wetting agent is (p-t-Octylphenoxy)polyethoxyethanol.

58. The soft tissue matrix composition according to claim 35, wherein the wetting agent is nonoxynol-9.

59. The soft tissue matrix composition according to claim 35, wherein at least a portion of the human soft tissue material is in minced or sliced pieces.

60. The soft tissue matrix composition according to claim 35, wherein at least a portion of the soft tissue matrix composition is in comminuted form.

61. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is selected from the group consisting of amnion tissue, umbilical cord tissue, chorionic tissue, intestine tissue, tendon tissue, and skin tissue.

62. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is skin.

63. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is full thickness skin or skin lacking the epidermal layer.

64. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is amnion tissue.

65. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is umbilical cord tissue.

66. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is chorionic tissue.

67. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is intestine tissue.

68. The soft tissue matrix composition according to claim 35, wherein the human soft tissue material is tendon tissue.