Injectable cross-linked hydrogels for biomaterial applications
Inventors
Binetti, Valerie R. • Kita, Kristin B. • Fussell, Garland W. • Lowman, Anthony M. • Marcolongo, Michele S.
Assignees
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Publication Number
US-8617519-B2
Publication Date
2013-12-31
Expiration Date
Abstract
An injectable hydrogel composition comprising: water; and poly(vinyl alcohol) chemically cross-linked with a second polymer to form a cross-linked resin, wherein the second polymer is selected from the group consisting of: a polyhydric alcohol compound, a polyvalent epoxy compound, a polyvalent amine compound, a dialdehyde compound, a diisocyanate compound, and mixtures thereof, wherein the cross-linked resin has a degree of cross-linking of from about 0.0001 mol/mL to about 0.002 mol/mL, and wherein the hydrogel is flowable when heated above its melting point.
Core Innovation
The invention relates to an injectable hydrogel composition that includes water and poly(vinyl alcohol) chemically cross-linked with a second polymer to form a cross-linked resin. The second polymer is selected from a polyhydric alcohol compound, a polyvalent epoxy compound, a polyvalent amine compound, a dialdehyde compound, a diisocyanate compound, or mixtures thereof. The hydrogel cross-linked resin has a degree of chemical cross-linking of about 0.0001 mol/mL to about 0.002 mol/mL.
The hydrogel composition is thermogelling, such that it is flowable when heated above its melting point and forms an elastic solid upon cooling to below its melting point. The composition also exhibits a swelling value of about 1.033 to about 1.79 in a 0.16 MPa osmotic solution.
The material is described in relation to minimally invasive injection and repair/replacement functionality in the intervertebral disc, specifically nucleus pulposus repair/replacement and nucleus pulposus implantation. The disclosed hydrogel is positioned as an injectable thermogelling platform for such applications, with optional radiopacity by addition of an imaging agent such as barium sulfate.
Claims Coverage
The independent claim is directed to an injectable thermogelling poly(vinyl alcohol) hydrogel with a chemically cross-linked resin. It specifies five inventive features: the identity of the second polymer cross-linker, a defined degree of chemical cross-linking, thermally induced flowability above melting point, and a defined swelling value in a 0.16 MPa osmotic solution. The remaining dependent claims refine the composition with further quantitative constraints and optional components.
Injectable hydrogel composition of water and chemically cross-linked poly(vinyl alcohol)
An injectable hydrogel composition comprising water; and poly(vinyl alcohol) chemically cross-linked with a second polymer to form a cross-linked resin.
Second polymer selected from specific cross-linker classes
The second polymer is selected from the group consisting of: a polyhydric alcohol compound, a polyvalent epoxy compound, a polyvalent amine compound, a dialdehyde compound, a diisocyanate compound, and mixtures thereof.
Defined degree of chemical cross-linking
The cross-linked resin has a degree of chemical cross-linking of from about 0.0001 mol/mL to about 0.002 mol/mL.
Thermogelling flowability above melting point
The hydrogel is flowable when heated above its melting point.
Swelling value in 0.16 MPa osmotic solution
The hydrogel composition exhibits a swelling value of from about 1.033 to about 1.79 in a 0.16 MPa osmotic solution.
Overall, claim coverage centers on a thermogelling injectable poly(vinyl alcohol) hydrogel made by chemically cross-linking with a second polymer chosen from defined classes, while controlling the degree of chemical cross-linking. The claim further requires flowability above the melting point and a specific swelling value range in a 0.16 MPa osmotic solution.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Intervertebral disc nucleus pulposus repair/replacement, including nucleus pulposus implantation, as described in the provided material context.
Minimally invasive injection application context, as described in the provided material context.
Radiopacity for imaging, by optional imaging agent use such as barium sulfate, as described in the provided material context.
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