Collagen Corporation

Thomas L Smestad

George H Chu

Diana M Hendricks

Karl A Piez

Bruce B Pharriss

Woonza M Rhee

Richard A Berg

Joel S Rosenblatt

Larry J Braga

Frank A DeLustro

Donald G Wallace

Louis Fries

John M McPherson

Ann B Brannan

Daniel R Prows

Roseann Burhenne

Rees M Orland

Jacqueline A Tefft

Abigail Freeman

Jacqueline Anne Schroeder

Rosa Armstrong

Saeid Seyedin

Diana M Hendericks

Debera Brown

Daniel Prowse

The present invention discloses a novel method for preparing crosslinked biomaterial compositions for use in the augmentation of soft or hard tissue. In general, the method comprises mixing a biocompatible polymer, which is preferably collagen, with a sterile, dry crosslinking agent, which is preferably a synthetic hydrophilic polymer such as a functionally activated polyethylene glycol. Also provided are preferred processes for preparing sterile, dry crosslinking agents contained within syringes for use in the method of the invention. Methods for sterilization of the crosslinking agent include, but are not limited to, sterile filtration, aseptic processing, and e-beam or gamma irradiation. Methods for providing augmentation of soft or hard tissue using crosslinked biomaterial compositions prepared according to the method of the invention are also disclosed.

Process for preparing a sterile, dry crosslinking agent

Method of preparing crosslinked biomaterial compositions for use in

The present invention discloses a novel method for preparing crosslinked biomaterial compositions for use in the augmentation of soft or hard tissue. In general, the method comprises mixing a biocompatible polymer, which is preferably collagen, with a sterile, dry crosslinking agent, which is preferably a synthetic hydrophilic polymer such as a functionally activated polyethylene glycol. Also provided are preferred processes for preparing sterile, dry crosslinking agents contained within syringes for use in the method of the invention. Methods for sterilization of the crosslinking agent include, but are not limited to, sterile filtration, aseptic processing, and e-beam or gamma irradiation. Methods for providing augmentation of soft or hard tissue using crosslinked biomaterial compositions prepared according to the method of the invention am also disclosed.

Processes for the preparation of compositions used in conductive bone repair are disclosed. The compositions contain a mixture consisting essentially of either a calcium phosphate particulate mineral component or particulate hydroxyapatite in admixture with atelopeptide reconstituted fibrillar collagen. The method is comprised of mixing a dispersion of the collagen and mineral, the latter which is present in dry particulate form, followed by molding and drying the composition in a mold to obtain a dried composition.

Calcium phosphate/atelopeptide collagen compositions for bone repair

A device for correcting fine superficial facial lines which comprises a syringe fitted with a 31-33 gauge needle and an aqueous suspension of noncrosslinked fibrillar atelopeptide collagen contained within the syringe barrel, the concentration of collagen in the suspension being in the range of 10 to 50 mg/ml and the suspension exhibiting an extrusion plot in which there is a smooth substantially linear increase in force up to a substantially constant force in the range of 5 to 30 newtons.

Method for treating fine superficial facial lines

Device for treating fine superficial facial lines

A composition for use in bone repair, in particular, in only procedures, which comprises calcium phosphate mineral particles in admixture with atelopeptide reconstituted fibrillar collagen preparations is disclosed. This composition is non-immunogenic and encourages the fusion of host bone with new bone growth through the implant. Additional processes for curing the implant to improve its compressive strength include heat curing, maturation, and cross-linking.

Xenogeneic collagen/mineral preparations in bone repair

The present invention is a method for treating bony defects. The method involves contacting the bony defect with a formable composition and allowing the formable composition to solidify. The formable composition is comprised of 2-40% of reconstituted fibrillar atelopeptide collagen and 60-98% calcium phosphate mineral by weight exclusive of moisture. After the formable composition is placed in intimate contact with the bony defect, it is allowed to solidify until it acquires an additional characteristic selected from the group consisting of a compressive modulus of at 10 N/cm.sup.2 or a tensile strength of at least 1 N/cm.sup.2. The method can be used to repair a variety of bony defects such as bone non-union, fresh fractures, periodontal bony pockets, tooth extraction sockets and jaw cysts. Further, the composition can be used to augment an alveolar ridge.

Gamma irradiation of collagen/mineral mixtures

A biocompatible collagen/mineral composition which comprises a mixture of 2-40% reconstituted fibrillar atelopeptide collagen and 60-98% calcium phosphate mineral by weight, exclusive of water, is disclosed. The composition has a sterility assurance factor of at least as low as 10.sup.-6 and either a compressive modulus of at least 10 N/cm.sup.-2 or a tensile strength of about 3-12 N/cm.sup.-2.

A process for coating the pores of a mineral matrix with collagen by pumping collagen through the molded matrix is disclosed. The resulting coated matrix can be used as a prosthesis in bone repair.

Method of making molds with xenogeneic collagen/mineral preparations for

A process for sterilization of collagen/mineral compositions using .gamma. radiation is conducted under conditions which produce a product of desired handling and biocompatibility properties.

A composition for use in bone repair, in particular, in onlay procedures, which comprises calcium phosphate mineral particles in admixture with atelopeptide reconstituted fibrillar collagen preparations is disclosed. This composition is non-immunogenic and encourages the fusion of host bone with new bone growth through the implant. Additional processes for curing the implant to improve its compressive strength include heat curing, maturation, and cross-linking.

A method of repairing bone defects by use of suspensions containing purified atelopeptide, reconstituted, fibrillar skin collagen or bone collagen powder or mixtures thereof is disclosed. The suspensions provide matrices for conductive growth of bone into the defect. The skin collagen may also be lyophilized and used in the form of mats.

Methods of bone repair using collagen

Cross-linked atelopeptide collagen that is substantially free of residual cross-linking agent is prepared by: reconstituting atelopeptide collagen from solution by neutralizing the solution at a reduced temperature and a hypotonic ionic strength; cross-linking the reconstituted fibers in an aqueous medium at a concentration of 0.1 to 10 mg/ml with glutaraldehyde under conditions that produce cross-linked collagen that when in suspension in physiological saline at a concentration of 35 mg/ml exhibits a shear viscosity whose log varies linearly with the log of the shear rate and is approximated by the formula

Injectable cross-linked collagen implant material

A flexible, nonstress-bearing bone prosthesis is disclosed that comprises demineralized bone powder contained within a medical grade porous flexible casing made from polymeric fibers or a micro-porous membrane. The pores of the casing are smaller than the particle size of the bone powder but large enough to permit ingress of body cells associated with bone formation.

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Palo Alto, CA, United States of America

Thomas L Smestad