Flowable matrix compositions and methods

• US 9,801,975 B2
• Filed: 09/18/2015
• Issued: 10/31/2017
• 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:
  US14/858,919
• Publication Number:
  US 20160008511A1
• Time in Patent Office: 774 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 method for producing a soft tissue matrix composition for use in a patient treatment, the method comprising:

providing a human soft tissue material, wherein the human soft tissue material is in a partially hydrated state; and

processing the human soft tissue material by cryofracturing the human soft tissue material,

wherein the processing provides the soft tissue matrix composition, the soft tissue matrix composition comprising a substantial amount of the natural interstitial water of the human soft tissue material that is present prior to cryofractionation.

2. The method according to claim 1, wherein the human soft tissue material is acellular.

3. The method according to claim 1, wherein the human soft tissue material is at least partially decellularized.

4. The method according to claim 1, wherein the human soft tissue material is not partially or completely decellularized.

5. The method according to claim 1, wherein the processing further comprises triturating the cryofractured human soft tissue material.

6. The method according to claim 5, wherein the triturating comprises milling the cryofractured human soft tissue material.

7. The method according to claim 6, wherein the processing further comprises adding a wetting agent to the triturated soft tissue material.

8. The method according to claim 7, wherein the wetting agent comprises a saline solution.

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

10. The method according to claim 1, wherein the human soft tissue material is in a dehydrated state prior to processing.

11. The method according to claim 1, wherein the human soft tissue material comprises a member selected from the group consisting of an epidermal tissue, a dermal tissue, a placental derived tissue, an amnion tissue, a chorionic tissue, a tendon tissue, an umbilical cord tissue, an intestine tissue, and a musculoskeletal non-osseous tissue.

12. The method according to claim 1, wherein the human soft tissue material comprises a dermal tissue.

13. The method according to claim 1, wherein the cryofracturing comprises treating the human soft tissue material with liquid nitrogen.

14. The method according to claim 1, wherein the cryofracturing comprises treating the human soft tissue material with liquid nitrogen for a period of about less than one hour.

15. The method according to claim 1, wherein the cryofracturing comprises treating the human soft tissue material with liquid nitrogen for a period within a range from about 10 second to about 1 minute.

16. The method according to claim 1, wherein the cryofracturing renders the human soft tissue material stiff and friable.

17. The method according to claim 1, further comprising combining the human soft tissue material matrix composition with at least one of a biocompatible carrier, a thickener, and an adhesive.

18. The method according to claim 1, further comprising loading the human soft tissue material matrix composition into an applicator assembly.

19. The method according to claim 18, wherein the applicator assembly comprises a member selected from the group consisting of a syringe mechanism and a cannula mechanism.

20. The method according to claim 1, wherein the processing partially disrupts extracellular matrix collagen bundles within the human soft tissue material.

21. The method according to claim 1, wherein the processing disrupts the macro architecture of the extracellular matrix within the human soft tissue material.

22. The method according to claim 1, wherein the human soft tissue material comprises a delaminated dermal tissue.

23. The method according to claim 1, wherein the human soft tissue material comprises a non-delaminated dermal tissue.

24. The method according to claim 1, further comprising combining the soft tissue matrix composition with at least one member selected from the group consisting of a stromal volume fraction, a progenitor cell population, and a stem cell population.

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

26. The method according to claim 1, wherein the soft tissue matrix composition has a shear resistance of 1,000-2,000 Pascal seconds.

27. The method 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.

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

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

30. The method according to claim 7, wherein the wetting agent is at least one of water, a saline solution, phosphate buffered saline (PBS), sodium dodecyl sulfate, sodium stearate, benzalkonium chloride, 3-[(3-cholamidopropyl)dimetylammonio]-1-propanesulfonate (CHAPS), lecithin, (p-t-Octylphenoxy)polyethoxyethanol, or nonoxynol-9.

31. The method according to claim 1, further comprising adding a wetting agent to human soft tissue material prior to processing.

32. The method according to claim 31, wherein the wetting agent is at least one of water, a saline solution, phosphate buffered saline (PBS), sodium dodecyl sulfate, sodium stearate, benzalkonium chloride, 3-[(3- cholamidopropyl)dimetylammonio]-1-propanesulfonate (CHAPS), lecithin, (p-t-Octylphenoxy)polyethoxyethanol, or nonoxynol-9.

33. The method according to claim 1, wherein the processing further comprises adding a wetting agent to the processed tissue material.

34. The method according to claim 33, wherein the wetting agent is at least one of water, a saline solution, phosphate buffered saline (PBS), sodium dodecyl sulfate, sodium stearate, benzalkonium chloride, 3-[(3- cholamidopropyl)dimetylammonio]-1-propanesulfonate (CHAPS), lecithin, (p-t-Octylphenoxy)polyethoxyethanol, or nonoxynol-9.

35. The method according to claim 1, wherein the human soft tissue material is acellular.

36. The method according to claim 1, wherein the human soft tissue material is at least partially decellularized.

37. The method according to claim 1, wherein the human soft tissue material is not partially or completely decellularized.

38. The method according to claim 1, wherein the processing includes one or more washing steps.

39. A method for producing a soft tissue matrix composition for use in a patient treatment, the method comprising:

providing a human soft tissue material, wherein the human soft tissue material is in a naturally hydrated state; and

processing the human soft tissue material by cryofracturing the human soft tissue material,

wherein the processing provides the soft tissue matrix composition, the soft tissue matrix composition comprising the natural interstitial water of the human soft tissue material that is present prior to cryofractionation.