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US 12,708,648 B1Granted
Birth tissue compositions and methods of preparation
AssigneeConvatec Limited
InventorsKurt Klitzke, Jon G. Hargis
Life of this patent
Estimating the term…
Abstract
Methods of processing a mammalian placental tissue to form birth tissue compositions are provided. The birth tissue compositions may be a membrane-based construct or a powder formulation. Methods of treating a wound are also provided.
Claims18
A method of treating a wound, the method comprising the step of:
- introducing a birth tissue composition on or around the wound,
- wherein the birth tissue composition comprises a dehydrated, decellularized porcine placental membrane that is prepared by a method comprising:
- (i) a bioburden reduction step comprising contacting unprocessed porcine placental membrane with a 3M sodium chloride solution at about 20 mL per gram of porcine placental membrane for about 30 minutes to about 2 hours to reduce microbial load and form a bioburden reduced porcine placental membrane;
- (ii) decanting the sodium chloride solution;
- (iii) rinsing the sodium chloride solution from the bioburden reduced porcine placental membrane with water;
- (iv) a detergent rinse step comprising contacting the bioburden reduced porcine placental membrane after step (iii) with a detergent solution comprising at least one anionic detergent and at least one protease enzyme, wherein the anionic detergent is present at a concentration of about 0.25% to about 3% w/v, wherein the contacting occurs for about one hour to about three hours, for removal of cellular debris while preserving extracellular matrix integrity;
- and
- (v) decanting the detergent solution to form a detergent rinsed porcine placental membrane;
- (vi) rinsing the detergent solution from the detergent rinsed porcine placental membrane with water;
- (vii) a viral inactivation step comprising immersing the rinsed porcine placental membrane after step (vi) in a sodium hydroxide solution at a concentration of about 0.25M for about 15 minutes to about 45 minutes to form a viral inactivated porcine placental membrane;
- (viii) rinsing the sodium hydroxide solution from the viral inactivated porcine placental membrane with water;
- (ix) introducing from about 5 mL to about 50 mL of buffer solution per gram of porcine placental membrane to the rinsed porcine placental membrane after step (viii);
- (x) decanting the buffer solution;
- (xi) measuring the pH of the porcine placental membrane after step (x);
- (xii) repeating steps (ix)-(xi) until the pH of the porcine placental membrane is between about 6.8 and about 7.2;
- (xiii) rinsing the buffer solution from the porcine placental membrane after step (xii) with water;
- and
- (xiv) dehydrating the porcine placental membrane after (xiii) to form the dehydrated, decellularized porcine placental membrane,
- wherein the dehydrated, decellularized porcine placental membrane exhibits a final pH of between about 6.8 and about 7.2, and
- wherein the dehydrated, decellularized porcine placental membrane retains collagen I, collagen IV, elastin, laminin, fibronectin, and hyaluronic acid.
17 more elements
Dependencies are inferred from the claim text.