Drexel University

Synthes Usa, LLC

Depuy Synthes Products, Inc.

Sonotech, Inc.

Ust, Inc.

Synthes Gmbh

Anthony M Lowman

Michele S Marcolongo

Garland W Fussell

Nigel G Smith

Kristin B Kita

Michael F Keane

Larry L Smith

Alastair J T Clemow

Edward Vresilovic

Valerie R Binetti

Meredith Hans

Andrea Jennifer Vernengo

Emily Y Ho

Nigel Gordon Smith

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.

Crosslinked hydrogels

A method of forming and the resulting hydrogel composition comprising poly(vinyl alcohol) at a final concentration of about 20% (w/w) to about 65% (w/w) and polyethylene glycol at a final concentration of about 2% (w/w) to about 20% (w/w), wherein the hydrogel composition has a total polymer content, above about 30% (w/w), higher than the total polymer content of a precursor polymer solution formulated prior to the formulation of the hydrogel composition. The hydrogel composition may further comprise poly(vinyl pyrrolidone) at a final concentration of about 0.10% (w/w) to about 0.75% (w/w).

Phase transitioning hydrogels

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.

Injectable cross-linked hydrogels for biomaterial applications

The present invention is directed to a bioadhesive thermogelling hydrogel composition for repairing and/or augmenting an intervertebral disc. The bioadhesive thermogelling hydrogel composition can be cross linked with the surrounding tissue so as to potentially serve as a nucleus pulposus replacement or augmentation along with serving to repair annular tears or fissure. The bioadhesive thermogelling hydrogel composition may include three main components: a thermal responsive polymer, an amine-containing polymer and a crosslinking component. All three components can be modified and combined in numerous ways to serve the need of the system as long as the amine-containing component is kept separate from the crosslinking component until the components are injected. The incorporation of a two-part crosslinking thermal responsive hydrogel permits smaller amounts of the crosslinking component to be used and enables the crosslinking dialdehyde to be delivered locally into the tissue that will react with the hydrogel. This helps prevent damage to tissues away from the hydrogel.

Method to repair a damaged intervertebral disc through the use of a bioadhesive, thermogelling hydrogel

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.

Bioadhesive hydrogels

A prosthesis for replacing or supplementing a nucleus pulposus of an intervertebral disk is an expandable container having flexible walls, the container being adapted to be inserted into a central cavity of an intervertebral disk through a narrow cannula, and the flexible walls are made from a biocompatible hydrogel. A preferred hydrogel is a cryogel formed from an aqueous solution of poly(vinyl alcohol) and poly(vinyl pyrrolidone). The prosthesis may be prepared by dip-coating a mandrel with an aqueous solution of a hydrogel-forming polymer or mixture of such polymers, gelling the coated solution by chilling, and subjecting the gelled coating to a series of repeated freeze-thaw treatments. In use, the prosthesis is inserted into a central cavity of an intervertebral disk and filled with biocompatible material, e.g., a biocompatible liquid, a biocompatible polymer, and a biocompatible hydrogel, particularly a thermogelling hydrogel.

Hydrogel balloon prosthesis for nucleus pulposus

Hydrogels comprising poly(N-alkylacrylamide), poly(alkyleneglyco)di-acrylate or methacrylate, cross-linking agent, a source of calcium ions, and water are described, as well as methods of their preparation and use.

Bioactive thermogelling polymer systems and methods of their use

A hydrogel coupling device for the transmission of ultrasound therethrough having a predetermined shape and comprising a hydrogen bonded composition comprising PVA, one or both of PVP and PEG, and the balance water. The predetermined shapes are formed and are then exposed to (a) one or more freeze/thaw cycles, (b) one or more dehydration/re-hydration cycles, or (c) one or more freeze/thaw cycles and one or more dehydration/re-hydration cycles. The shapes may further be irradiated with high energy radiation followed by heat treating.

Hydrogel compositions and manufacturing process for ultrasound couplants

Thermogelling polymers are described containing poly (n-isopropyl acrylamide). Solutions of this polymer, copolymers or mixtures of the polymer with a second polymer such as poly(ethylene glycol), poly (vinyl pyrrolidone) or poly(vinyl alcohol) are liquids at room temperature and solids at body temperature. Thus, also provided are methods of implanting a hydrogel into a mammal by injecting the solution as a liquid at a temperature below body temperature into a selected site in the mammal at a temperature below body temperature, which then undergoes thermal phase transition to form a solid hydrogel in situ in the body as the implant warms to body temperature. Methods for using these thermal gelling materials in various applications including nucleus pulposus replacement/augmentation, wound care, disk replacement, cartilage replacement, joint replacement, surgical barriers, gastrointestinal devices, cosmetic and reconstructive surgery, and breast enlargement are also provided.

Thermogelling polymer blends for biomaterial applications

A prosthetic nucleus prepared from blends of polyvinylalcohol and polyvinyl pyrollidone or its copolymers for replacement of the nucleus pulposus in intervertebral discs is provided. Also provided are methods of replacing the nucleus pulposus and treating disc degeneration-associated pain in mammals using this prosthetic nucleus.

Associating hydrogels for nucleus pulposus replacement in intervertebral discs

Method and formulations to extend the utility of ultrasound compliant adhesive hydrogel membranes from static to dynamic applications by modifying the surface of at least one face so as to transform the tactile nature of the surface from one that is adhesive and render it smooth and lubricious. Such modification thus provides one face that is smooth and lubricious and the other unmodified, hence providing one adhesive surface that can be attached to the skin of a patient, the face of an ultrasound probe or other surfaces that benefit from the adhesive/lubricious configuration of such modified adhesive hydrogels.

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Wallingford, PA, United States of America

Anthony M Lowman