The invention is directed toward a sterile formable implant composition for application to a bone defect site comprising bioactive glass particles in an aqueous carrier solution, the bioactive glass particles being added to a viscous carrier at a concentration ranging from about 68% to about 76% (w/w), the carrier comprising a mixture of glycerol and polyethylene glycol ranging from 24% to 32% (w/w) with the ratio of glycerol to polyethylene glycol ranging from about 45:55 to about 65:35.
Allograft Tissue Purification Process For Cleaning Bone
Carl DePaula - Cranbury NJ, US Devin Mahony - Lodi NJ, US Moon Sunwoo - Old Tappan NJ, US Arthur Gertzman - Stony Point NY, US
International Classification:
A01N001/00 A61L002/025
US Classification:
422/020000, 422/028000, 435/001100
Abstract:
A method for producing a cleaned bone graft with osteoinductivity above 2.0 suitable for transplantation into a human. The first step is sonicating a bone graft in a nonionic detergent in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. and for a time period ranging from 15 minutes to 2 hours effective to produce a cleaned bone graft essentially free from bone marrow. The bone graft is sonicated in purified water in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. a plurality of times to remove the detergent producing a cleaned bone graft. The bone graft is then sonicated in hydrogen peroxide in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. for a time period ranging from 10 minutes to about 2 hours effective to retain osteoinductivity of the bone graft and again sonicated in purified water in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. a plurality of times to produce a cleaned bone graft. The final step is sonicating the bone graft in an alcohol at a temperature ranging from 33 C. to 37 C. for 30 minutes to 2 hours, all of the steps being effective to reduce any initially present viruses at least two logs and bacteria at least ten logs and the bone graft is finally sonicated in purified water to remove the alcohol.
The invention is directed toward a formable ceramic composition for application to a bone defect site which comprises a ceramic compound of beta tricalcium phosphate particles. The particle size ranges from about 40 microns to 500 microns and is mixed in a hydrogel carrier containing citric acid buffer, the hydrogel component of the carrier ranging from about 1.0 to 5.0% of the composition and the composition has a pH between 7.0 to 7.8.
Katherine Gomes - Hillsborough NJ, US Carl DePaula - Cranbury NJ, US Jeffrey Cartmell - Freehold NJ, US David Gocke - Skillman NJ, US Carina Syring - Basel, CH Rudiger Von Versen - Basdorf, DE
International Classification:
A61K 35/34
US Classification:
424569000
Abstract:
The present invention is a process for preparing soft tissue such as tendons, ligaments, cartilage, fascia, dermis, human valves and human veins for implant in a human and removes cellular components and forms an decellular matrix having as major components collagens and elastins while sterilizing the tissue. The process comprises the following steps: (1) isolating from a suitable donor a desired soft tissue sample of the biological material; (2) processing and decellularizing the soft tissue including inspection for visual defects, trimming and soaking the tissue in a detergent depending on whether the tissue is fascia or dermis and rinsing same with sterile water; (3) sterilizing the soft tissue in a vacuum and soaking the tissue in an antibiotic composition or peracetic acid depending on whether the soft tissue is fascia or dermis and rinsing same; (4) processing the tissue by cutting the tissue to size and perforating the tissue; and (5) dipping the tissue in 70% ethanol and packaging the tissue.
Allograft Tissue Purification Process For Cleaning Bone
Carl Alexander DePaula - Cranbury NJ, US Devin Joshua Mahony - Lodi NJ, US Moon Hae Sunwoo - Old Tappan NJ, US Arthur A. Gertzman - Stony Point NY, US
International Classification:
A61F 2/28 A61L 2/025
US Classification:
623 1611, 422 20
Abstract:
A method for producing a cleaned bone graft with osteoinductivity above 2.0 suitable for transplantation into a human. The first step is sonicating a bone graft in a nonionic detergent in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. and for a time period ranging from 15 minutes to 2 hours effective to produce a cleaned bone graft essentially free from bone marrow. The bone graft is sonicated in purified water in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. a plurality of times to remove the detergent producing a cleaned bone graft. The bone graft is then sonicated in hydrogen peroxide in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. for a time period ranging from 10 minutes to about 2 hours effective to retain osteoinductivity of the bone graft and again sonicated in purified water in an ultrasonic cleaner at a temperature ranging from about 33 C. to about 37 C. a plurality of times to produce a cleaned bone graft. The final step is sonicating the bone graft in an alcohol at a temperature ranging from 33 C. to 37 C. for 30 minutes to 2 hours, all of the steps being effective to reduce any initially present viruses at least two logs and bacteria at least ten logs and the bone graft is finally sonicated in purified water to remove the alcohol.
Processing Soft Tissue, Methods And Compositions Related Thereto
Arthur Gertzman - Flemington NJ, US Michael Kawas - Freehold NJ, US Katherine G. Truncale - Hillborough NJ, US Moon Hae Sunwoo - Old Tappan NJ, US Alison Lee - Piscataway NJ, US Richard Seeman - South Bound Brook NJ, US Carl Alexander DePaula - Malvern PA, US Jeffrey S. Cartmell - Freehold NJ, US David J. Gocke - Princeton NJ, US Carina Syring - Biel-Benken, CH Rudiger von Versen - Wanditz, DE
International Classification:
A01N 1/02 C12N 5/071 A01N 1/00
US Classification:
435 13, 435325, 435 11
Abstract:
In certain embodiments, the present invention relates to a process for preparing skin removed from a human donor, including a living human donor, and removing cellular components and forming a decellular matrix having as major components collagens and elastins while disinfecting the tissue. In other embodiments, the present invention relates to a process for treating a decellularized soft tissue by freezing the same at a plurality of decreasing temperatures at atmosphere or higher such that there is formation of ice crystals having a size greater than 2.0 and lyophilizing the soft tissue under vacuum to remove the water to less than 6% forming a porous matrix.
Katherine GOMES TRUNCALE - Hillsborough NJ, US Carl Alexander DePaula - Cranbury NJ, US Jeffrey Stuart Cartmell - Freehold NJ, US David J. Gocke - Skillman NJ, US Carina Syring - Basel, CH Rudiger Von Versen - Basdorf, DE
Assignee:
Musculoskeletal Transplant Foundation - Edison NJ
International Classification:
C12N 5/00
US Classification:
435378
Abstract:
The present invention is a process for preparing soft tissue such as tendons, ligaments, cartilage, fascia, dermis, human valves and human veins for implant in a human and removes cellular components and forms an decellular matrix having as major components collagens and elastins while sterilizing the tissue. The process comprises the following steps:(1) isolating from a suitable donor a desired soft tissue sample of the biological material;(2) processing and decellularizing the soft tissue including inspection for visual defects, trimming and soaking the tissue in a detergent depending on whether the tissue is fascia or dermis and rinsing same with sterile water;(3) sterilizing the soft tissue in a vacuum and soaking the tissue in an antibiotic composition or peracetic acid depending on whether the soft tissue is fascia or dermis and rinsing same;(4) processing the tissue by cutting the tissue to size and perforating the tissue; and(5) dipping the tissue in 70% ethanol and packaging the tissue.
Biologic Matrices Comprising Anti-Infective Methods And Compositions Related Thereto
Described herein are methods and compositions related to biologic matrices comprising at least one anti-infective. In certain embodiments, the invention relates to a biologic matrix comprising a slowed release anti-infective agent. In a particular embodiment, the invention relates to an acellular dermal matrix comprising a slowed release antiinfective agent, wherein the anti-infective agent is triclosan. In further embodiments, the the biologic matrix is suitable for use in surgical procedures, such as, for example, for the replacement of damaged or inadequate integumental tissue or for the repair, reinforcement or supplemental support of soft tissue defects.