Amnion tissue grafts and methods of preparing and using same

Patent metadata

Field	Value
Publication number	US-11577001-B2
Application number	US-201716346607-A
Country	US
Kind code	B2
Filing date	Nov 2, 2017
Priority date	Nov 2, 2016
Publication date	Feb 14, 2023
Grant date	Feb 14, 2023

Abstract

The invention provides method for preparing amnion tissue grafts, as well as the grafts themselves. In specific embodiments, the tissue graft comprises a single layer of dried amnion from an umbilical cord.

First claim

I claim:

1. A method for preparing a dried amnion tissue graft from an umbilical cord, the method comprising the steps of:
making a longitudinal cut in an amnion of the umbilical cord that has a lumen in order to expose contents of the lumen;
removing, from the contents of the lumen, blood vessels and more than 50%, but not all, of Wharton's jelly to produce a debrided amnion;
incubating the debrided amnion in a holding solution before washing the debrided amnion in the holding solution, and wherein the remaining Wharton's jelly substantially or completely fills valleys between ridges on a surface of the amnion, wherein the dried amnion tissue graft from the umbilical cord has a thickness in a range of 175 um to 225 um, and wherein the thickness varies by less than 1% across a surface of the dried amnion tissue graft;
rinsing the washed amnion one or more times in a rinsing solution; and
drying the rinsed amnion.

2. The method of claim 1 , wherein the holding solution comprises:
polyethylene glycol sorbitan monolaurate at 0.4% to 0.6% (v/v),
an antimicrobial compound,
NaCl at 7 to 10 g/L, and
a buffer at pH of 6.5 to 7.0.

3. The method of claim 1 , wherein the step of washing is conducted for two to five hours and comprises agitation performed at 100 to 200 rotations per minute.

4. The method of claim 1 , wherein the rinsing solution has a pH of 7 to 8.8 and comprises:
NaCI at 7 to 10 g/L,
Na 2 HPO 4 at 0.5 to 1.5 g/L, and
KH 2 PO 4 at 0.1 to 0.2 g/L.

5. The method of claim 1 , wherein the step of rinsing is performed for three to five times in the rinsing solution and each rinsing step is performed at 100 rotations per minute to 200 rotations per minute.

6. The method of claim 1 , wherein the debrided amnion is stored at 4° C. before the washing step.

7. The method of claim 1 , wherein the step of drying is performed at a temperature of 30° C. to 40° C.

8. A method for obtaining a dried amnion membrane from an umbilical cord, the method comprising the steps of:
removing blood vessels and more than 50%, but not all, of Wharton's jelly from an amnion obtained from the umbilical cord to produce a debrided amnion;
washing the debrided amnion in a holding solution;
rinsing the washed amnion one or more times in a rinsing solution; and
drying the rinsed amnion,
wherein the dried amnion membrane from the umbilical cord has a thickness in a range of 175 μm and 225 μm, wherein the thickness varies by less than 20% across a surface of the dried amnion membrane, and wherein the Wharton's jelly that remains in the dried amnion membrane substantially or completely fills valleys between ridges on the surface of the dried amnion membrane.

9. The method of claim 8 , wherein the obtained amnion is a partially-debrided amnion in a frozen state and the method further comprises thawing the frozen partially-debrided amnion, and
wherein the thickness varies by less than 1% across a surface of the dried amnion tissue graft.

10. The method of claim 8 , further comprising:
incubating the debrided amnion in the holding solution before washing the debrided amnion in the holding solution.

11. The method of claim 8 , wherein the holding solution comprises:
polyethylene glycol sorbitan monolaurate at 0.4% to 0.6% (v/v), an antimicrobial compound,
NaCl at 7 to 10 g/L, and
a buffer at pH of 6.5 to 7.0.

12. The method of claim 8 , wherein the step of washing is conducted for two to five hours and comprises agitation performed at 100 rotations per minute to 200 rotations per minute.

13. The method of claim 8 , wherein the rinsing solution has a pH of 7 to 8 . 8 and comprises:
NaCl at 7 to 10 g/L,
Na 2 HPO 4 at 0.5 to 1.5 g/L, and
KH 2 PO 4 at 0.1 to 0.2 g/L.

14. The method of claim 8 , wherein the step of rinsing is performed for three to five times in a rinsing solution and wherein each rinsing step is performed at 100 rotations per minute to 200 rotations per minute.

15. The method of claim 8 , wherein the debrided amnion is stored at 4° C. before the washing step.

16. The method of claim 8 , wherein the step of drying is performed at a temperature of between about 30° C. to 40° C.

Assignees

• Axogen Corp

Inventors

• Deister Curt

Classifications

• A61L27/38 Primary

  containing added animal cells (organs or tissue containing native cells A61L27/36) · CPC title

• A61L27/3683

  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 title

• A61L2430/22

  for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus · CPC title

• A61L2430/40

  Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking · CPC title

• A61L27/3687

  characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents · CPC title