Crosslinked hydrogels
Inventors
Kita, Kristin B. • Smith, Nigel G. • Lowman, Anthony M. • Fussell, Garland W. • Keane, Michael F.
Assignees
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Publication Number
US-9078953-B2
Publication Date
2015-07-14
Expiration Date
Abstract
The present invention preferably provides for a method of forming and the resulting solid polymer gel composition comprising polyethylene imine and at least one hydrogen bonding polymer. The composition has a greater viscosity than either of the polyethylene imine or the hydrogen bonding polymer alone and is injectable immediately after mixing of the polyethylene imine and the at least one hydrogen bonding polymer. A method of tissue repair may include mixing about 9.25% (w/w) to about 13.65% (w/w) polyethylene imine and about 18.02% (w/w) to about 26.62% (w/w) polyvinyl alcohol to form an injectable composition; injecting the injectable composition into a cavity within a human body; and allowing the composition to solidify in situ. A kit may include a multi-barrel syringe at least one barrel is loaded with polyethylene imine and at least another barrel is loaded with at least one hydrogen bonding polymer.
Core Innovation
The invention relates to a polymer gel composition comprising polyethylene imine and an aqueous polyvinyl alcohol solution, where the polyethylene imine and the aqueous polyvinyl alcohol solution are injectable prior to mixing. The composition has a greater viscosity than either the polyethylene imine or the aqueous polyvinyl alcohol solution alone, and is characterized as a hydrogen-bonded physically crosslinked polymer gel that is injectable immediately after mixing of the polyethylene imine and the aqueous polyvinyl alcohol solution.
The composition includes polyethylene imine at from about 9.25% (w/w) to about 13.65% (w/w) and polyvinyl alcohol at from about 18.02% (w/w) to about 26.62% (w/w). When the polyethylene imine is mixed with the polyvinyl alcohol, a solution of a single phase is formed, consistent with the hydrogen-bonded physically crosslinked polymer gel formed by combining the components.
The invention also includes a kit for forming the polymer gel composition, with at least one first container loaded with polyethylene imine at a sufficient concentration to be injectable at room temperature or under operating room conditions, and at least one second container loaded with polyvinyl alcohol at a sufficient concentration to be injectable at room temperature or under operating room conditions. The kit provides the components in sufficient concentrations and amounts so that, upon mixing, the resulting polymer gel composition is injectable for a predetermined amount of time and thereafter solidifies into a moldable form.
Claims Coverage
The document provides three independent claims. Across these claims, the inventive coverage is centered on hydrogen-bonded physically crosslinked polymer gel compositions and kits that combine polyethylene imine and polyvinyl alcohol to produce a higher-viscosity system that is injectable immediately after mixing, forms a single-phase solution upon mixing, and meets defined composition ranges; one claim also covers a kit in separate containers that enables injection for a predetermined time followed by solidification into a moldable form.
Hydrogen-bonded physically crosslinked polymer gel composition with injectable PEI and aqueous PVA prior to mixing
A polymer gel composition comprising polyethylene imine injectable prior to mixing and an aqueous polyvinyl alcohol solution injectable prior to mixing, where the composition has a greater viscosity than either component alone, is a hydrogen-bonded physically crosslinked polymer gel, is injectable immediately after mixing, and forms a single-phase solution when the polyethylene imine is mixed with the polyvinyl alcohol.
Specified PEI and PVA ranges with immediate injectability
A polymer gel composition comprising about 9.25% (w/w) to about 13.65% (w/w) polyethylene imine and about 18.02% (w/w) to about 26.62% (w/w) polyvinyl alcohol, wherein the composition is a hydrogen-bonded physically crosslinked polymer gel, has greater viscosity than either component alone, is injectable immediately after mixing, and forms a single-phase solution when the polyethylene imine is mixed with the polyvinyl alcohol.
Kit supplying separately injectable PEI and PVA
A kit for forming a polymer gel composition comprising at least one first container loaded with polyethylene imine and at least one second container loaded with polyvinyl alcohol, each at a sufficient concentration to be injectable at room temperature or under operating room conditions, wherein mixing yields a hydrogen-bonded physically crosslinked polymer gel that is injectable for a predetermined amount of time and thereafter solidifies into a moldable form, and forms a single-phase solution when the polyethylene imine is mixed with the polyvinyl alcohol.
Overall, the claims cover hydrogen-bonded physically crosslinked polymer gel compositions and kits that combine polyethylene imine and polyvinyl alcohol to produce a higher-viscosity system that is injectable immediately after mixing, forms a single-phase solution upon mixing, and meets defined polyethylene imine and polyvinyl alcohol weight-per-weight ranges; the kit additionally provides injection for a predetermined amount of time followed by solidification into a moldable form.
Stated Advantages
Greater viscosity than either the polyethylene imine or the aqueous polyvinyl alcohol solution alone.
Injectable immediately after mixing of polyethylene imine and the aqueous polyvinyl alcohol solution.
Forms a solution of a single phase when the polyethylene imine is mixed with the polyvinyl alcohol.
Injectable for a predetermined amount of time and thereafter solidifies into a moldable form.
Documented Applications
Tissue repair, including intervertebral disc/nucleus pulposus repair, including injection into a cavity.
Vertebroplasty.
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