IP Library Granted Patent US 11,154,641
Granted Patent B2
US 11,154,641 · App. 16/225,733 · Granted Oct 26, 2021

Translucent, dehydrated placental tissue and methods of producing and using the same

Inventors: John Daniel (Milton, GA); Sarah Griffiths (Sandy Springs, GA); Annelise Mowry Roy (Cumming, GA)
Assignee: STIMLABS LLC
A61L27/3604A61K35/50A61L27/3691A61L27/50A61L27/54A61P17/02A61L2430/40
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Quick Facts
Patent No.
US 11,154,641
App. No.
16/225,733
Granted
Oct 26, 2021
Kind
B2
Abstract

Compositions comprising translucent, dehydrated placental tissue and methods of preparing and using those tissues are provided. Repeated dehydration techniques may produce translucent, dehydrated placental tissues, including translucent, dehydrated placental membrane and umbilical cord, with improved visualization and/or handling characteristics. The present invention also includes methods of healing a wound of the skin, eye, nerve, tendon, muscle, dental region, or dura, including burns, comprising applying the translucent, dehydrated placental tissues of the invention to the wound.

Claims (32)

1. A dehydrated placental tissue comprising an intermediate layer, wherein the dehydrated placental tissue is translucent.

2. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue, a portion of the dehydrated placental tissue, substantially all of the dehydrated placental tissue, or at least 80% of the placental tissue

appears translucent by visual inspection, as determined by holding the dehydrated placental tissue between a visible light source and a surface having marking(s) and visually detected whether the marking(s) on the surface are visible through the tissue.

3. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue, a portion of the dehydrated placental tissue, substantially all of the dehydrated placental tissue, or at least 80% of the placental tissue has a light transmission of:

a) greater than 60% as determined by spectrophotometry at a wavelength of 360 nm, 370 nm, 380 nm, 390 nm, 400 nm, and/or 410 nm; and/or

b) greater than 80% as determined by spectrophotometry at a wavelength ranging from 580 nm to 750 nm, and/or at a wavelength of 580 nm, 590 nm, 600 nm, 610 nm, 620 nm, 630 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 690 nm, 700 nm, 710 nm, 720 nm, 730 nm, 740 nm, and/or 750 nm.

4. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue is from a human donor.

5. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue comprises unseparated amnion/chorion, amnion, and/or chorion.

6. The dehydrated placental tissue of claim 5 , wherein the dehydrated placental tissue comprises unseparated amnion/chorion that is perforated.

7. The dehydrated placental tissue of claim 5 , wherein the dehydrated placental tissue has a hemoglobin content of less than 13 μg/mg of dry mass of the tissue.

8. The dehydrated placental tissue of claim 5 , wherein the dehydrated placental tissue has a hemoglobin content of less than 10 μg/mg of dry mass of the tissue.

9. The dehydrated placental tissue of claim 5 , wherein the dehydrated placental tissue has a hemoglobin content of less than 5 μg/mg of dry mass of the tissue.

10. The dehydrated placental tissue of claim 5 , wherein the dehydrated placental tissue appears dry, feels dry to the touch, and/or has a moisture content of from 0.5% to 50%.

11. The dehydrated placental tissue of claim 5 , wherein the dehydrated placental tissue has a moisture content of from 0.5% to 50%.

12. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue comprises a substantial amount of intermediate layer and/or an intermediate layer having a mean thickness of from 1 μm to 400 μm.

13. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue is substantially free of blood remnants and/or has a hemoglobin content of less than 13 μg/mg of dry mass of the tissue.

14. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue appears dry, feels dry to the touch, and/or has a moisture content of from 0.5% to 50%.

15. A composition comprising the dehydrated placental tissue of claim 1 .

16. A method of treating or covering a wound of a subject comprising applying the dehydrated placental tissue of claim 1 to the wound of the subject.

17. The method of claim 16 , wherein the wound is a wound of the eye, a wound of the skin, a wound of a nerve, a wound of a tendon, a wound of the dura, a periodontal wound, a wound of the abdomen, or a wound of an internal organ.

18. The method of claim 17 , wherein the wound is a burn, a laceration, a corneal ulceration, a conjunctival lesion, a surgical wound, a diabetic ulcer, a venous ulcer, an arterial ulcer, or a decubitus ulcer.

19. The method of claim 16 , wherein the wound is a wound of the eye.

20. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue is sterile.

21. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue is perforated.

22. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue has a hemoglobin content of less than 13 μg/mg of dry mass of the tissue.

23. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue has a hemoglobin content of less than 10 μg/mg of dry mass of the tissue.

24. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue has a hemoglobin content of less than 5 μg/mg of dry mass of the tissue.

25. The dehydrated placental tissue of claim 1 , wherein the dehydrated placental tissue has a moisture content of from 0.5% to 50%.

26. The dehydrated placental tissue of claim 1 , wherein at least 80% of the placental tissue appears translucent by visual inspection, as determined by holding the dehydrated placental tissue between a visible light source and a surface having marking(s) and visually detected whether the marking(s) on the surface are visible through the tissue.

27. The dehydrated placental tissue of claim 1 , wherein at least 80% of the placental tissue has a light transmission of:

a) greater than 60% as determined by spectrophotometry at a wavelength of 360 nm, 370 nm, 380 nm, 390 nm, 400 nm, and/or 410 nm; and

b) greater than 80% as determined by spectrophotometry at a wavelength ranging from 580 nm to 750 nm, and/or at a wavelength of 580 nm, 590 nm, 600 nm, 610 nm, 620 nm, 630 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 690 nm, 700 nm, 710 nm, 720 nm, 730 nm, 740 nm, and/or 750 nm.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2019
From: DANIEL, JOHN; GRIFFITHS, SARAH; ROY, ANNELISE MOWRY
To: STIMLABS LLC
Reel/Frame 048162/0834 →
Continuity (2)
Provisional Application 62609771 · Dec 22, 2017
Related Publication 20190192734A1 · Jun 27, 2019
Cited By (2)
US 12,447,232 US 12,642,887