Methods of drying sheets of donor-provided human birth tissue

• US 9,795,707 B2
• Filed: 12/05/2014
• Issued: 10/24/2017
• Est. Priority Date: 12/06/2013
• Status: Active Grant

• Current Assignee: AlloSource
• Original Assignee: AlloSource
• Inventors: Samaniego, Adrian C., Southard, Matthew
• Primary Examiner(s): Gitomer, Ralph
• Application Number:
  US14/562,353
• Publication Number:
  US 20150157761A1
• Time in Patent Office: 1,054 Days
• Field of Search: None
• CPC Class Codes: A61L 26/0061 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 27/362 Skin, e.g. dermal papillae
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

Embodiments of the technology may involve a method of processing the human donor tissue for administration to a recipient. This method may include the step of contacting the human donor tissue with a backing layer, where the human donor tissue and the backing layer contain a saline solution. This saline solution may include a solvent and a disassociated salt. The method may further include evaporating a portion of the solvent from a surface of the backing layer. The evaporation of the solvent may move a portion of the disassociated salt from the donor tissue to the backing layer. This process may then result in a tissue that is mostly dry and free of salt crystals.

Claims

1. A method of processing an amniotic tissue for administration to a recipient patient, comprising the steps of

treating the amniotic tissue with a glutaraldehyde solution;

rinsing the amniotic tissue with a first saline solution;

contacting the amniotic tissue with a first backing layer and a second backing layer, wherein the amniotic tissue contains a second saline solution comprising a solvent and a dissociated salt;

restraining the amniotic tissue and the first and second backing layers between a first plate and a second plate;

pressing together the amniotic tissue and the first and second backing layers; and

evaporating a portion of the solvent from a surface of the first or the second backing layer, so as to move a portion of the dissociated salt from the amniotic tissue into the first backing layer or the second backing layer, wherein;

the second saline solution is formed in part by the first saline solution,

evaporating comprises maintaining a temperature around the amniotic tissue at below about 40°

C.,

evaporating the portion of the solvent forms a processed amniotic tissue, and

the processed amniotic tissue is pliable.

15. The method of claim 1, wherein the processed amniotic tissue has a moisture content of less than about 10%.

16. The method of claim 1, wherein the human donor tissue comprises multiple layers of tissues.

17. The method of claim 1, wherein pressing together the amniotic tissue and the first and second backing layers comprises restraining the amniotic tissue and the first and second backing layers between a first plate and a second plate.

18. The method of claim 1, wherein evaporating the portion of the solvent from the surface of the first or second backing layer comprises flowing gas across the amniotic tissue.

2. A method of processing a human donor tissue for administration to a recipient patient, comprising of the steps of

contacting the human donor tissue with a backing layer, wherein the human donor tissue and the backing layer contain a saline solution comprising a solvent and a dissociated salt;

and

evaporating a portion of the solvent from a surface of the backing layer to form a dry tissue, so as to move a portion of the dissociated salt from the human donor tissue into the backing layer, wherein;

the human donor tissue is birth tissue,

the dry tissue has a moisture content of less than about 10%, and

the dry tissue is pliable.

3. The method of claim 2, wherein:

the saline solution is a first saline solution,

before contacting the human donor tissue with the backing layer, the human donor tissue is treated with a glutaraldehyde solution and then rinsed with a second saline solution, and

the second saline solution is the same or different as the first saline solution.

4. The method of claim 2, wherein the human donor tissue comprises multiple layers of tissues.

5. The method of claim 2, further comprising contacting the human donor tissue with a second backing layer.

6. The method of claim 2, further comprising pressing together the human donor tissue and the backing layer to reduce air pockets and excess moisture.

7. The method of claim 2, wherein the human donor tissue and the backing layer are restrained between a first plate and a second plate.

8. The method of claim 7, wherein at least one of the first plate or the second plate is perforated.

9. The method of claim 2, wherein the step of evaporating a portion of the solvent comprises using flowing gas across the human donor tissue.

10. The method of claim 2, wherein the step of evaporating includes maintaining a temperature around the human donor tissue at below about 40°

C.

11. The method of claim 9, wherein the step of evaporating includes no heating of the flowing gas.

12. The method of claim 7, wherein evaporating includes moving the first plate and the second plate in a chamber.

13. The method of claim 2, wherein the dry tissue has a moisture content of less than about 5%.

14. The method of claim 2, wherein after evaporating, the human donor tissue is rehydrated.

19. The method of claim 2, wherein the human donor tissue is amniotic tissue, chorion tissue, placental tissue, umbilical cord tissue, or the cells of fluid contained therein.

20. The method of claim 2, wherein the human donor tissue is amniotic tissue.