Kingston Technologies, L.p.

S.k.y. Polymers, Inc.

Replication Medical Inc.

Other

Kingston Technologies Limited Partnership

Health Products Research, Inc.

Hymedix International, Inc.

S.k.y. Polmers

S.k.y. Polymers, Ltd. (kingston Technologies)

Stoy, Vladimir A.

Vladimir A Stoy

George P Stoy

Jan Lovy

Francis T Delahanty

Petr Stehlicek

Tomas Drunecky

Zdena Kozlova

Gerald A Gontarz, Jr

Yatin B Thakore

Milos Chvapil

Charles K Kliment

Patrick Stoy

Randolph L Cooke

Shiu-Bor Tong

Karen L Swanson

The present invention is a prosthetic for replacement of at least a part of the nucleus of a intravertebral disc. The prosthetic device is composed of at least two essentially parallel soft layers of an elastically deformable hydrogel and at least one rigid layer, the rigid layer having less compressibility than the soft layers, being adjacent to the soft layers, parallel to them, and firmly attached to them. In some embodiments, the soft layers have the same thickness and composition. Typically, the prosthesis has more than one rigid layer and these rigid layers have the same thickness and composition. The number of soft layers is usually one more than the number of rigid layers, with, e.g., at least three soft layers. The invention also includes a method of prosthesis production, which involves prefabricating soft and rigid layers; stacking at least two prefabricated soft and at least one prefabricated rigid layer in a parallel fashion into their final form, and, permitting the layers to firmly connect to one another by mutual interaction. In this method, at least one type of the layers is prefabricated in the dehydrated state, which is done by dehydrating stretched foil in an apparatus preventing its contraction and thereby decreasing its area. There is at least partial dehydration of the prosthesis under pressure applied in a direction tangent to the planes of the layers. In preferred embodiments, while in the state of almost full dehydration, is sterilized using ionizing radiation or a gaseous chemical agent, after which it is partially rehydrated within the sterile wrapper using water vapor.

Hydrogel-based prosthetic device for replacing at least a part of the nucleus of a spinal disc

The present invention is a prosthetic for replacement of at least a part of the nucleus of a intravertebral disc. The prosthetic device is composed of at least two essentially parallel soft layers of an elastically deformable hydrogel and at least one rigid layer, the rigid layer having less compressibility than the soft layers, being adjacent to the soft layers, parallel to them, and firmly attached to them. In some embodiments, the soft layers have the same thickness and composition. Typically, the prosthesis has more than one rigid layer and these rigid layers have the same thickness and composition. The number of soft layers is usually one more than the number of rigid layers, with, e.g., at least three soft layers.

Hydrogel-based prosthetic device for replaceing at least a part of the nucleus of a spinal disc

The present invention is a spinal nucleus implant for replacement of at least a portion of nucleus pulposus tissue removed from a spinal disc of a living vertebrate to restore function of the spinal disc and related vertebral joint. The implant is an anisotropically swellable, biomimetic xerogel plastic, having a two phase structure with a hydrophobic phase having high crystallinity and low water content and with hydrophilic phase having low crystallinity and high water content and having a negatively charged lubricious surface. The xerogel plastic is capable of rehydration and of osmotic movement of liquid therethrough in response to osmotic pressure change to thereby increase and decrease liquid content in its hydrated state. The present invention also relates to surgical implant procedures utilizing this spinal nucleus implant.

Spinal nucleus implant

The present invention is a method of making acrylonitrile copolymers having multi block structure comprising acrylic acid, acryl amids and acrylamidine hydrophilic groups in hydrophilic blocks and residual nitrile groups in hydrophobic blocks, by partial hydrolysis of polyacrylonitrile to a predetermined hydrolysis conversion at which the hydrolysis is self terminating by a process that improves quality and reduces product heterogeneity. It includes forming a first reaction mixture which includes polyacrylonitrile dissolved in an aqueous reactive solvent containing sodium thiocyanate; forming a second reaction mixture comprising a reaction catalyst of the general formula MY dissolved in an aqueous reactive solvent containing sodium thiocyanate; mixing the reaction mixtures of steps (a) and (b) above to form a master reaction mix; dividing the reaction mix into a plurality of physical reaction compartments so as to increase outer surface area relative to volume as compared to outer surface area of a single reaction compartment to enhance cooling efficiency and to reduce undesirable center core thermal effects; and, heating the divided master reaction mix to a predetermined reaction temperature range and maintaining the temperature range for a predetermined time sufficient for completion of a predetermined level of hydrolysis at which the resulting copolymer solution is substantially stable at ambient temperature. The invention also includes hydrogel products resulting from the method.

Hydrogel and method of making

The present invention is a bioreactor wound dressing which includes a first layer, being a transport layer, in direct contact with a wound. It includes at least one layer of a permeable polymeric media containing, in equilibrium with body fluids, at least 40% by weight of liquid, and is impermeable for infectious agents of any kind and being permeable to water soluble substances having molecular weight up to at least 1000 Daltons. There is a second layer, being a fluid reservoir layer that is adjacent to the transport layer and is capable of containing between 40% and 100% of its volume of an aqueous liquid, wherein the transport layer and reservoir layer are permeably interconnected for aqueous solutions and are in a substantial osmotic equilibrium. The invention also includes a method of wound treatment utilizing the bioreactor wound dressing.

Bioreactor wound dressing

The present invention is directed to a coating composition which includes a component A and component B. Component A is either an emulsion or dispersion having a hydrophobic elastomer stabilized with at lease one emulsifier. Component B is a dispersion or solution of a hydrophilic polymer which is insoluble in water, swellable in water and soluble in one or more water-miscible solvents. The hydrophobic elastomers may be polymers or copolymers of butadiene, isoprene, chloroprene, styrene, acrylonitrile, ethylene, propylene, isobutylene, alkylacrylates and alkylmethacrylates; polyrethanes, polyureas, polysiloxanes, elastomeric polyamides and polyesters. The hydrophilic polymers may be segmented polyurethanes, segmented polyures, segmented polyesters, partially hydrolyzed poly(vinyl acetate), partially hydrolyzed polyacrylonitrile, partially aminolyzed polyacrylonitrile, and ethylene glycol monomethacrylate. An optional Component C may be included which could be organic diluents and plasticizers; surfactants; water-soluble polymeric additives; inorganic or organic salts; pigments; fillers; biocides; UV-absorbers; preservatives; and particulate covalently cross-linked hydrogels.

Flexible hydrophilic composite coatings

The present invention is directed to a composition comprising a nitrogen-containig drug-polymer salt and a method for making said composition. The drug-polymer salt is comprised of one or more drugs having basic groups as part of their chemical structure which are capable of forming salts with acids and one or more hydrophilic polymers containing carboxylate groups and amidine groups as pendant groups. Such polymeric salts of drugs have been found to have excellent bio-availability and advantageous release profiles in various forms (gels, ointments, pills, etc.). Particularly advantageous polymers contain pendant nitrile groups in addition to carboxyls and amidines which provide the polymer with hydrogel characteristics.

Polymeric nitrogen-containing drug salt forms for controlled release

A hydrophilic coating composition used to impart increased lubricity and wettability to the surface of a hydrophobic substrate which is comprised of three essential components:

Thin film hydrophilic coatings

An implantable ophthalmic lens manufactured at least partly out of soft, elastic and pliable material substantially in the shape of a saucer is described. It includes an outer optical face forming one side of the lens, and an inner optical face forming the other side of the lens. A center portion of the inner optical face of the lens as well as the lens rim each have the shape of meniscus derived from the corresponding meniscus of a liquid precursor prior to solidification, the center portion meniscus and the rim meniscus being connected by an annular ring, all surfaces of the lens except the center portion of the inner optical face and the lens rim being replicas of a solid mold from which it is formed. The inner optical face center portion and the lens rim have the shape of a liquid precursor solidified in contact with an inert fluid. The method of manufacturing an ophthalmic lens involves solidification of a liquid precursor in an at least bipartite mold with a dished base and a tubular top member which is extendable under the surface of a liquid precursor. The annular ring is preferably a conically ground face.

Implantable ophthalmic lens, a method of manufacturing same and a mold

This application describes devices which have a first softer formable state, and the second stiffer shape-retaining shape and which are capable of repeatable transition from the first state to the second state (or vice versa) on demand. The device comprises:

Structural devices with changing mechanical properties responsive to

Novel amphoteric acrylic and methacrylic copolymers are described comprising cationic units of pendant N-substituted amidine and anionic units of acrylic or methacrylic acid and/or acidic groups carried by substituents of N-acrylamide, N-methacrylamide, N-acrylamidine or N-methacrylamidine. One preferred embodiment is a copolymer in which at least some types of functional groups are organized in blocks. Particularly preferred are blocks of pendant nitrile groups. Preferred compositions have the said N-substituents of the amides and/or amidines containing polar groups other than primary amines. Particularly preferred polar groups are tertiary amines, quaternary ammonium salts, hydroxyls and sulfonic acid. These copolymers may optionally be convalently or physically crosslinked and swellable rather than soluble in water. A method of preparing said amphoteric acrylic and methacrylic copolymers is described comprising the reaction of selected polymers with a multitude of pendant CN groups in mutual 1,3 positions with a primary amine in presence of water. One preferred method is the reaction of CN groups with the primary amine and water in the presence of a solvent of the said polymer and/or in the presence of a basic catalyst. The particularly preferred embodiment is a reaction of CN groups containing polymer dissolved in a mixture of the polymer solvent, a primary amine, water and an optional basic catalyst.

Hydrophilic acrylic copolymers and method of preparation

The present invention guidewire involves an elongated, non-hydrogel core element forming an inner part of the device, and an integral outside tubular layer of elastomeric hydrogel ('hydrogel sleeve'). This outer hydrogel layer has unique physical characteristics. They are (a) Gradient of chemical composition with increasing concentration of polar groups in the outward direction away from the core element; (b) Gradient of swelling in contact with water with water content increasing in the outward direction away from the core element; (c) Compressive stress in the outer hydrophilic layer causing the hydrogel in that layer to swell to a water content lower than its equilibrium value in a free-swelling state; and, optionally, (d) Inward-directed radial stress pushing the outside hydrogel layer constantly against the inner core element. The present invention also involves the methods of making these guidewires, including melt extrusion directly onto the core element, coagulation from solution, in situ hydrogel polymer formation, and tubing extrusion followed by consequent shrink-fit over the core.

Guidewires with lubricious surface and method of their production

Stable emulsions and dispersions of both the water-in-oil and oil-in-water types are prepared by subjecting mixtures of the two phases to shear stress in the presence of nitrile group-containing copolymers capable of forming hydrogels containing at least 90% by weight of water at room temperature.

Pan emulsion

The present invention contact lens is a soft, disposable lens which, under eye wearer conditions, changes one or more characteristics essential for comfortable use, at a predetermined time to initiate disposal thereof by the user. This lens, under wear conditions, changes, for example, at least its base curve redius and its deformability as a consequence of a change in hydrophilicity of at least a portion of the contact lens material. This hydrophilicity change may be achieved by various means, e.g. degradation of crosslinking bridges or conversion of less hydrophilic groups to groups having greater hydrophilicity. In one preferred embodiment, the conversion is achieved by hydrolysis of selected functional (hydrophobic) groups into hydrophilic groups.

Contact lens with pre-determined useful life

A method and apparatus for precision molding soluable polymers is disclosed, in order to form an exact and precisely shaped product, such as contact lenses and surgical implants. A preferred mold for forming contact lenses includes a female part having an indentation and a sharp circumferential edge surrounding the indentation. The mold also includes a male part which is adapted to contact the sharp circumferential edge of the female part to form the molding cavity between the indentation of the female part and the male part. A semi-permeable gate is formed between the female part and the male part for introducing coagulating fluid into the molding cavity while preventing the escape of the polymer solution from the molding cavity. The semi-permeable gate allows the diffusion of the coagulating fluid into the molding cavity at a faster rate than the rate of diffusion of solvent out of the molding cavity. The polymer solution is coagulated by the influx of the coagulating fluid into the polymer solution which causes both the coagulation and swelling of the polymer solution. Swelling of the polymer solution coagulates the solution under pressure within the molding cavity to form a precisely shaped product. Coagulation proceeds under pressure since the solvent diffuses out of the semi-permeable gate at a slower rate than the diffusion of the coagulating fluid into the molding cavity.

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Princeton, NJ, United States of America

Vladimir A Stoy