Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Processes of preparing a desired or intentional composition...
Patent
1998-06-05
1999-06-22
Merriam, Andrew E. C.
Synthetic resins or natural rubbers -- part of the class 520 ser
Synthetic resins
Processes of preparing a desired or intentional composition...
523113, 523115, 524414, 524456, 106 35, 106634, 106691, 501 72, 501 73, 65 331, 623 16D, A61K 606, C08K 340
Patent
active
059143568
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention provides novel, bioactive, load bearing, hardenable compositions, especially bone bonding compositions. In accordance with preferred embodiments, glass-ceramic reinforced resin matrix composites are provided which are, at once, deliverable, shapable, and able to adhere to metal, ceramic, and natural bone tissue. Preferred composites of the present invention are capable of bearing significant loads while remaining highly compatible with natural bone tissue. The compositions of the present invention are amenable to orthopaedic and dental uses in a number of contexts. Novel filled composites are employed comprised of novel inorganic fillers. Such fillers comprise combeite. Hard, shaped bodies are also provided.
BACKGROUND OF THE INVENTION
The need for biomaterials in orthopaedic and dental applications has increased as the world population ages. A significant amount of research into biomaterials for orthopaedic and dental uses has attempted to address the functional criteria for orthopaedic and denial reconstruction within the human body. The materials which have become available for such uses have improved in recent years. All such materials must be biocompatible, however, and the degree of biocompatibility exhibited by materials which are candidates for such use is always a major concern. Biomaterials useful for orthopaedic and dental reconstructions must have high strength, must be able to be immediately affixed to the situs for reconstruction, must bond strongly to bone, and must give rise to strong, highly resilient restorations.
Among the materials which have been used for orthopaedic and dental restorative purposes are bone cements based upon acrylic species such as polymethyl methacrylate (PMMA) and related compositions. Such materials usually are capable of convenient delivery to the site of restoration and can be formed as to be moldable and to have reasonable degrees of affinity for bony tissue. PMMA cements, however, lack bioactivity and the ability to generate a chemical bond to bone and new bone tissue formation. The inertness of such restoratives leads to micromotion and fatigue over time with attendant aseptic loosening. Additionally, the polymerization of PMMA-based materials can give rise to significant exothermicity which can lead to localized tissue necrosis and inflammation. Moreover, residual methyl methacrylate monomer can leech into surrounding tissue leading to site inflammation and implant failure. Implants formed from PMMA-based materials can also give rise to particulate debris, inflammation, and failure. PMMA polymeric structures are generally two-dimensional and limited as to strength.
Bone grafts using bioactive glasses and calcium phosphates, collagen, mixtures and the like nave good biocompatibility and give rise to bone tissue formation and incorporation in some cases. However, prior graft materials lack the desired load bearing strength and are generally technique sensitive.
Prior attempts to improve such bone grafting material through the development of self-setting calcium phosphate cements as well as glass ionomer bone cements have shown promise. Both materials can be bioactive in some cases and both can exhibit considerable strength. Glass ionomers, in particular, have enjoyed success in dental applications. However, most of the strengths of glass ionomer composites is achieved by reacting a fluoro-aluminosilicate glass with a polyalkenoic polymer matrix. Carboxyl functionalities exist on the polymer backbone, which functionalities chelate with ions in the surface bone material. The usual time for a surface active biomaterial to form an inner active layer with inner tissue is from six to eight weeks. If the material's function relies upon this interactive biolayer rather than its inherent strength, the required reaction time can lead to premature failure of the material.
A number of different glasses, glass-ceramics, and crystalline phase materials have been used, either alone or in combination with acrylic polymerizable species,
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Merriam Andrew E. C.
Orthovita, Inc.
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