Flowable matrix compositions and methods
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.
1. A soft tissue matrix composition for use in a patient treatment prepared by a method consisting of:
providing a human soft tissue material;
processing the human soft tissue material to mechanically disrupt the extracellular matrix collagen or macrostructure and partially disrupt the collagen microfibrillar architecture by a process selected from the group consisting of:
(i) cryofracturing the human soft tissue material;
(ii) cryofracturing and washing the human soft tissue material;
(iii) cryofracturing and triturating the human soft tissue material; and
(iv) cryofracturing, triturating, and washing the human soft tissue material,
wherein the processed tissue material is in a partially hydrated state, the partial hydration comprising a substantial amount of the natural interstitial water of the human soft tissue material.
2. The soft tissue matrix composition according to claim 1 , wherein the composition is present in an applicator assembly.
3. The soft tissue matrix composition according to claim 1 , wherein the human soft tissue material that is provided is acellular.
4. The soft tissue matrix composition according to claim 1 , wherein the human soft tissue material that is provided is at least partially decellularized.
5. The soft tissue matrix composition according to claim 1 , wherein the human soft tissue material that is provided 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 surgical glove material, and wherein the surgical glove material comprises a member selected from the group consisting of latex, neoprene, vinyl, and nitrile.
8. The soft tissue matrix composition according to claim 1 , wherein the composition has a putty consistency.
9. The soft tissue matrix composition according to claim 1 , wherein the 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 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 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 at least a portion of the soft tissue matrix composition is in comminuted form.
13. The soft tissue matrix composition according to claim 1 , wherein the processed tissue material is acellular.
14. The soft tissue matrix composition according to claim 1 , wherein the processed tissue material is at least partially decellularized.
15. The soft tissue matrix composition according to claim 1 , wherein the processed tissue material is not partially or completely decellularized.
16. 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.
17. The soft tissue matrix composition according to claim 1 , wherein the human soft tissue material is skin.
18. The soft tissue matrix composition according to claim 1 , wherein the human soft tissue material is full thickness skin or skin lacking an epidermal layer.
19. The soft tissue matrix composition according to claim 1 , wherein the processing is cryofracturing the human soft tissue material.
20. The soft tissue matrix composition according to claim 1 , wherein the processing is cryofracturing and washing the human soft tissue material.
21. The soft tissue matrix composition according to claim 1 , wherein the processing is cryofracturing and triturating the human soft tissue material.
22. The soft tissue matrix composition according to claim 1 , wherein the processing is cryofracturing, triturating, and washing the human soft tissue material.
23. 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.
24. 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 human soft tissue material is in a partially hydrated state, the partial hydration comprising a substantial amount of the natural interstitial water of the cryofractured human soft tissue material that is present prior to cryofractionation.
25. The soft tissue matrix composition according to claim 24 , wherein the composition is present in an applicator assembly.
26. The soft tissue matrix composition according to claim 24 , wherein the processed tissue material is acellular.
27. The soft tissue matrix composition according to claim 24 , wherein the processed tissue material is at least partially decellularized.
28. The soft tissue matrix composition according to claim 24 , wherein the processed tissue material is not partially or completely decellularized.
29. The soft tissue matrix composition according to claim 24 , wherein the soft tissue matrix composition does not adhere to a surgical glove material.
30. The soft tissue matrix composition according to claim 24 , wherein the soft tissue matrix composition does not adhere to a surgical glove material, and wherein the surgical glove material comprises a member selected from the group consisting of latex, neoprene, vinyl, and nitrile.
31. The soft tissue matrix composition according to claim 24 , wherein the composition has a putty consistency.
32. The soft tissue matrix composition according to claim 24 , wherein the composition has a shear resistance of 250-2,500 Pascal seconds at room temperature.
33. The soft tissue matrix composition according to claim 24 , wherein the composition has a shear resistance of 1,000-2,000 Pascal seconds at room temperature.
34. The soft tissue matrix composition according to claim 24 , wherein the composition can pass through a bore hole of a 18 g needle and not through a bore hole of a 26 g needle.
35. The soft tissue matrix composition according to claim 24 , wherein at least a portion of the soft tissue matrix composition is in comminuted form.
36. The soft tissue matrix composition according to claim 24 , 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.
37. The soft tissue matrix composition according to claim 24 , wherein the human soft tissue material is skin.
38. The soft tissue matrix composition according to claim 24 , wherein the human soft tissue material is full thickness skin or skin lacking an epidermal layer.
39. The soft tissue matrix composition according to claim 24 , wherein at least a portion of the human soft tissue material is in minced or sliced pieces.
40. 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 human soft tissue material is in a partially hydrated state, the partial hydration comprising a substantial amount of the natural interstitial water of the cryofractured human soft tissue material that is present prior to cryofractionation and trituration.
41. The soft tissue matrix composition according to claim 40 , wherein the composition is present in an applicator assembly.
42. The soft tissue matrix composition according to claim 40 , wherein the cryofractured and triturated tissue material is acellular.
43. The soft tissue matrix composition according to claim 40 , wherein the cryofractured and triturated tissue material is at least partially decellularized.
44. The soft tissue matrix composition according to claim 40 , wherein the cryofractured and triturated tissue material is not partially or completely decellularized.
45. The soft tissue matrix composition according to claim 40 , wherein the soft tissue matrix composition does not adhere to a surgical glove material.
46. The soft tissue matrix composition according to claim 40 , wherein the soft tissue matrix composition does not adhere to a surgical glove material, and wherein the surgical glove material comprises a member selected from the group consisting of latex, neoprene, vinyl, and nitrile.
47. The soft tissue matrix composition according to claim 40 , wherein the composition has a putty consistency.
48. The soft tissue matrix composition according to claim 40 , wherein the composition has a shear resistance of 250-2,500 Pascal seconds at room temperature.
49. The soft tissue matrix composition according to claim 40 , wherein the composition has a shear resistance of 1,000-2,000 Pascal seconds at room temperature.
50. The soft tissue matrix composition according to claim 40 , wherein the composition can pass through a bore hole of a 18 g needle and not through a bore hole of a 26 g needle.
51. The soft tissue matrix composition according to claim 40 , wherein at least a portion of the soft tissue matrix composition is in comminuted form.
52. The soft tissue matrix composition according to claim 40 , 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.
53. The soft tissue matrix composition according to claim 40 , wherein the human soft tissue material is skin.
54. The soft tissue matrix composition according to claim 40 , wherein the human soft tissue material is full thickness skin or skin lacking an epidermal layer.
55. The soft tissue matrix composition according to claim 40 , wherein at least a portion of the human soft tissue material is in minced or sliced pieces.