Bioadhesive hydrogels
Inventors
Kita, Kristin B. • Smith, Nigel G. • Lowman, Anthony M. • Fussell, Garland W.
Assignees
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Publication Number
US-8366778-B2
Publication Date
2013-02-05
Expiration Date
Abstract
A method of forming and the resulting bioadhesive hydrogel composition for repairing or supplementing a nucleus pulposus of an intervertebral disc comprises at least a first component, a second component and a third component, wherein the first component, the second component and the third component are crosslinked. The first component comprises an amine-containing polymer component at a concentration from about 0.1% weight by weight to about 13.65% weight by weight. The second component comprises a hydrophilic polymer or pre-polymer component at a concentration from about 3% weight by weight to about 35% weight by weight. The third component comprises an aldehyde component at a concentration from about 0.1% weight by weight to about 30% weight by weight. A method of repairing or supplementing a nucleus pulposus of an intervertebral disc comprises implanting the bioadhesive hydrogel composition in a patient.
Core Innovation
The invention provides a bioadhesive hydrogel composition for repairing or supplementing a nucleus pulposus of an intervertebral disc. The composition comprises at least a first component, a second component, and a third component that are crosslinked, with the first component including an amine-containing polymer component, the second component including a hydrophilic polymer or pre-polymer component comprising poly(vinyl alcohol), and the third component including an aldehyde component.
In the described composition, the concentration of each component is constrained within specified weight-by-weight ranges so that crosslinking occurs. The amine-containing polymer component and the aldehyde component are combined to achieve about a one to one molar ratio of reactive amine groups to aldehyde groups, and the system is described as a multi-component crosslinked network.
The invention further describes forming or using the hydrogel in a context suitable for nucleus pulposus repair, including kit-based preparation and implantation into a patient. In some embodiments, the composition is injectable immediately after mixing and can solidify in situ, while other embodiments include implanting by inserting a solidified composition.
Claims Coverage
The document contains four independent claims: one composition claim, two kit claims, and one method claim. Across these independent claims, the core coverage is a three-component crosslinked bioadhesive hydrogel using an amine-containing polymer, a poly(vinyl alcohol)-based hydrophilic polymer or pre-polymer, and an aldehyde component, with specified component concentration ranges and, in one claim, about a one-to-one molar ratio of reactive amine groups to aldehyde groups.
Three-component crosslinked bioadhesive hydrogel for nucleus pulposus repair
A bioadhesive hydrogel composition for repairing or supplementing a nucleus pulposus of an intervertebral disc comprising a first component with an amine-containing polymer component, a second component with poly(vinyl alcohol) hydrophilic polymer or pre-polymer, and a third component with an aldehyde component, wherein the first component, the second component and the third component are crosslinked.
Stoichiometric crosslinked amine-to-aldehyde nucleus pulposus hydrogel composition
A bioadhesive hydrogel composition comprising an amine-containing polymer component, a hydrophilic polymer or pre-polymer component comprising poly(vinyl alcohol), and an aldehyde component, wherein the components are crosslinked and the amine-containing polymer component and the aldehyde component are combined in such a way as to achieve about a one to one molar ratio of reactive amine groups to aldehyde groups.
Three-container kit for forming a crosslinked bioadhesive hydrogel
A kit comprising at least one first container with an amine-containing polymer component, at least one second container with a hydrophilic polymer or pre-polymer component comprising poly(vinyl alcohol), and at least one third container with an aldehyde component, wherein when the components are mixed the composition is crosslinked.
Two-container kit using an amine/PVA precursor crosslinked hydrogel plus an aldehyde component
A kit comprising at least one first container containing a precursor composition comprising an amine-containing polymer component crosslinked to a hydrophilic polymer or pre-polymer component comprising poly(vinyl alcohol), and at least one second container loaded with an aldehyde component, wherein when the components are mixed the composition is crosslinked.
Method of repairing or supplementing a nucleus pulposus by implanting a crosslinked bioadhesive hydrogel
A method of repairing or supplementing a nucleus pulposus of an intervertebral disc comprising providing a bioadhesive hydrogel composition with an amine-containing polymer component, a hydrophilic polymer or pre-polymer component comprising poly(vinyl alcohol), and an aldehyde component, wherein the components are crosslinked; and implanting the composition into a patient.
Overall, claim coverage is centered on a crosslinked, bioadhesive three-component hydrogel for nucleus pulposus repair or supplementation that includes an amine-containing polymer component, a poly(vinyl alcohol)-based hydrophilic polymer or pre-polymer component, and an aldehyde component. The independent claims also cover kit-based formation of the composition and implantation into a patient.
Stated Advantages
Enhanced self-adhesion and tissue adhesion when aldehyde is applied to PVA/PEI precursors.
Improved mechanical performance as indicated by increased compressive modulus after PEI pre-conditioning.
Stability or retention of PEI in PVA/PEI gels over about 60 days as assessed by FT-IR.
Documented Applications
Repairing or supplementing a nucleus pulposus of an intervertebral disc, including implanting the bioadhesive hydrogel composition into a patient.
Forming the bioadhesive hydrogel composition using kits with injectable-at-room-temperature or operating room conditions containers.
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