Hydrogels and method of making the same
AssigneeRegeltec, Inc.
InventorsAnthony LOWMAN, Thomas P. SCHAER, Peter WILSON, Erik BREWER, Nigel Gordon SMITH
Life of this patent
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Abstract
The present disclosure relates to hydrogels and their use for repairing or supplementing body tissue. The hydrogels are capable of safe injection into patients through fine gauge needles and are suitable for repairing, supplementing, or replacing the nucleus pulposus of an intervertebral disc. Methods of manufacturing and methods of using the hydrogels of the present disclosure to repair or replace tissues are also disclosed.
Claims62
A hydrogel, comprising:
- about 12 wt. % to about 22 wt. % of polyvinyl alcohol;
- about 0.12 wt. percent to about 0.22 wt. % of polyvinylpyrrolidone;
- about 12 wt. % to about 22 wt. % non-functionalized polyethylene glycol having a Mw of about 800 Da to about 2,000 Da, wherein the hydrogel does not contain a chemically crosslinked polymer.
A method of repairing or supplementing a tissue in a patient in need thereof, comprising:
- (a) melting a hydrogel in a container, wherein the hydrogel comprises:
- about 12 wt. % to about 22 wt. % of polyvinyl alcohol;
- about 0.12 wt. percent to about 0.22 wt. % of polyvinylpyrrolidone;
- about 12 wt. % to about 22 wt. % non-functionalized polyethylene glycol having a Mw of about 800 Da to about 2,000 Da, wherein the hydrogel does not contain a chemically crosslinked polymer;
- and
- a solvent;
- (b) heating the step (a) mixture to from about 65° C. to about 80° C.,
- (c) inserting a 15 gauge or smaller needle into the tissue in need of repair or supplement;
- (d) connecting the needle to the container and
- (e) injecting a therapeutically effective amount of the step (b) mixture into the tissue to provide a tissue implant.
. A method of manufacturing a hydrogel comprising:
- (a) forming a mixture comprising polyvinyl alcohol, polyvinylpyrrolidone and water;
- (b) heating the mixture of Step (a) to form a solution;
- (c) heating non-functionalized polyethylene glycol (PEG) having a Mw of about 800 Da to about 2,000 Da;
- (d) adding the heated PEG from step (c) to the heated mixture of step (b);
- (e) cooling the mixture of step (d) to provide a hydrogel;
- (f) conducting a phase separation to provide an aqueous supernatant and a hydrogel;
- and
- (g) removing the aqueous supernatant to provide the hydrogel, wherein the hydrogel does not contain a chemically cross-linked polymer.
Dependencies are inferred from the claim text.