By Baltazar Gomez --
On June 14, 2007, CryoLife, Inc. of Kennesaw, Georgia announced the grant of U.S. Patent No. 7,226,615 directed to BioFoam®, a protein hydrogel foam for rapidly filling and sealing open wounds. CyroLife's BioFoam® can be used in sports medicine for rapidly closing open wounds and allowing athletes to continue playing almost immediately after injury. BioFoam® may also be applicable in many life-saving situations where sealing wounds to prevent bleeding and infection is critical. In fact, CryoLife has received funds from the U.S. Department of Defense, as part of its battlefield trauma program, for the development of protein hydrogels to limit blood loss in injured soldiers.
CryoLife invented and developed BioFoam® as a hemostatic agent and tissue and organ sealant. CryoLife is exploring the use of BioFoam® for vascular sealing and tissue augmentation. BioFoam® contains an expansion agent to rapidly fill wounds when dispensed. It is easily applied and could potentially be used intraoperatively to control internal organ hemorrhage, limit blood loss, reduce the need for future operations, as well as to seal open wounds to improve outcomes in penetrating abdominal and chest injury. BioFoam® is based on the same technology platform of CryoLife's BioGlue® Surgical Adhesive approved by the FDA to control bleeding as an adjunct to sutures and staples in open surgical repair of large vessels. BioGlue® is also CE marked in the European Community and approved in Canada and Australia.
CryoLife and Endologix, Inc. signed a development and marketing agreement for the percutaneous or endovascular delivery of BioFoam® as a self-expanding sealant for endovascular aortic aneurysm grafts. Under the agreement, Endologix will be responsible for preclinical, clinical, and regulatory activities and costs, and CryoLife will manufacture BioFoam® for clinical use and commercial sale and receive a royalty on potential future product sales.
The '615 patent, entitled "Expandable Foam-Like Biomaterials and Methods," issued from U.S. Application No. 09/986,124, filed on November 7, 2001, and claims the benefit of U.S. Provisional Application No. 60/246,063, filed on November 7, 2000. The '615 patent covers liquid, injectable, aqueous solutions that are transformed in situ to an expandable foam-like, space filling, and adherent biomaterials. In particular, the foam-like biomaterial is the reaction product of a two-part liquid system that comprises a protein solution and a cross-linker solution. For example, the expandable foam-like biomaterial comprises a reaction product of human or animal-derived protein and a di- or polyaldehyde in the presence of a bicarbonate and an acidic titrant to impart a cellular foam structure to the material. Representative independent claims 1 and 12 of the '615 patent are listed below.
Claim 1. A kit for forming a solid cellular foam proteinaceous biopolymeric material comprising separate reactable aliquot portions consisting of a first aqueous solution containing a proteinaceous material, and a second aqueous solution which is reactable with, the proteinaceous component of the first aqueous solution to form a solid proteinaceous biopolymeric material in response to mixing of said first and second aqueous solutions, wherein the first aqueous solution includes a blowing agent, and wherein said second aqueous solution includes an acidic titrant reactable on contact with the blowing agent sufficient to evolve a gas to impart a cellular foam structure to the proteinaceous biopolymeric material concurrently while said proteinaceous material of said first aqueous solution reacts with said second aqueous solution to form said solid proteinaceous biopolymeric material.
Claim 12. A kit for forming a solid cellular foam proteinaceous biopolymeric material comprising separate reactable aliquot portions consisting of a first aqueous solution containing bovine or human serum albumin, and a second aqueous solution containing a di- or polyaldehyde which is reactable with the bovine or human serum albumin of the first aqueous solution to form a solid proteinaceous biopolymeric material in response to mixing of said first and second aqueous solutions, wherein one of the first and second aqueous solutions includes a blowing agent, and wherein the other of said first and second aqueous solutions includes an acidic titrant reactable on contact with the blowing agent sufficient to evolve a gas to impart a cellular foam structure to the proteinaceous biopolymeric material concurrently while said bovine or human serum albumin of said first aqueous solution reacts with said di- or polyaldehyde of said second aqueous solution to form said solid proteinaceous biopolymeric material.
Comments