Warsaw Orthopedic Gains Patent for Bone Regeneration Technology

Warsaw, Ind.-based Warsaw Orthopedic Inc., which is now owned by Medtronic, has earned a patent for a new bone regeneration device. According to the patent document filed with the U.S. Patent and Trademark Office, the bone regeneration device including fascia and demineralized bone matrix mixed at a temperature not exceeding about 40 degree Centigrade and freeze-dried into the bone regeneration device. The patent also covers methods of preparing such a bone regeneration device and methods of treating bone defects using such a bone regeneration device.

The patent request was filed in Nov. 2008, and was granted this month.

Bone grafts, which are performed surgically, are procedures by which new bone or a replacement material is placed into spaces between or around fractures or holes in bone (bone defects) to aid in healing. Bone grafting is used to repair bone fractures that are extremely complex, pose a significant risk to the patient or fail to heal properly. They are also used to help fusion between vertebrae, correct deformities or provide structural support for fractures of the spine. In addition to fracture repair, bone graft is used to repair defects in bone caused by birth defects, traumatic injury, or surgery for bone cancer.

Traditional bone grafting has included the use of autograft bone, tissue from the patient, or allograft bone, tissue from a donor. In addition to traditional bone grafting, a number of synthetic bone graft substitutes have been used or explored, including some materials that contain ceramics, calcium phosphates or demineralized bone matrix (DBM). DBM is demineralized allograft bone with osteoinductive activity. Demineralized bone matrices are prepared by acid extraction of allograft bone, resulting in the loss of most of the mineralized component but retention of collagen and noncollagenous proteins including growth factors. The efficacy of a demineralized bone matrix as a bone-graft substitute or extender is due to the presence of bone morphogenetic protein (BMP) as well as the ratios of the different BMPs present. BMPs belong to the transforming growth factor superfamily of proteins. DBM has been shown to exhibit the ability to induce and/or conduct the formation of bone. So, it is typically desirable to implant and maintain demineralized bone matrix at a site at which bone growth is desired.

On the other hand, demineralized bone matrix is susceptible to corruption during manufacture when it is incorporated into a medical device. A material that can withstand manufacture at a reasonable cost, and perform well in the operating room and during the implantation procedure, has significant commercial potential, Warsaw noted in the patent document.

Warsaw’s new material reportedly fulfills these needs.