The patent's assignee for patent number 8529933 is
News editors obtained the following quote from the background information supplied by the inventors: "Orthopedic procedures involving the directed formation of new bone tissue benefit from implantation of biomaterials that stimulate and guide the repair process. The physical properties of the biomaterials in terms of composition and architecture influence the early integration of new bone tissue and ideally enable progressive replacement with natural bone without biological or structural incompatibilities at the implant site. Furthermore, the parallel delivery of therapeutic agents in conjunction with the biomaterials provide for improved clinical outcomes through the acceleration of the bone formation process, the improvement of bone quality, the concomitant reduction of pain, the prophylactic control of infection and other clinical benefits.
"Orthopedic surgeons have historically used autograft (bone removed from the patient) as the biomaterial of choice to repair areas of the skeleton damaged by trauma or disease. Discussion on Dental Structure and Dental Caries, Proc R Soc Med. 1946 August; 39(10): 637-645. However, high incidences of donor site morbidity, the necessity of a painful second `harvesting` surgical procedure, and the absence of large quantities of bone available for grafting compromises patient outcomes. Alternate natural sources of bone tissue have also been utilized in the form of allografts (bone taken from a cadaver) and xenografts (bone obtained from animals). However, these are not ideal options due to significant concerns related to: (1) transmission of disease, (2) difficulty of procurement and processing, (3) uncertain immune response, and (4) premature resorption.
"In recognition of the limitations of natural bone tissue sources, significant innovation has occurred in the development of synthetic substitutes that attempt to mimic the beneficial features of natural bone while precluding the negative effects. Duplicating the performance advantages of natural bone tissue is challenging as the chemistry, biology and structure of the tissue are all influential in promoting successful orthopedic repair.
"The clinical performance of biomineral-based implants has shown that the chemistry of the implant-bone interface is improved through the use of materials that employ calcium phosphate or similar inorganic compositions. As the main inorganic component of bone consists of a highly substituted calcium phosphate apatite, researchers concerned with developing synthetic bone substitutes have concentrated on the various forms of calcium phosphate. These include hydroxyapatite, carbonated apatite, fluoroapatite, .alpha. and .beta. tricalcium phosphate, tetracalcium phosphate, octacalcium phosphate, and combinations thereof. In general, these materials have proven to be both biocompatible and osteoconductive and are well tolerated by host tissues. Anna Rita Calafiori et al., Low Temperature Method for the Production of Calcium Phosphate Fillers, BioMedical Engineering OnLine, 3:8 (2004); and
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