Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Patent
1996-12-17
1998-10-20
Milano, Michael J.
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
623 11, 606 70, 606 76, A61F 228
Patent
active
058240888
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The invention is directed to a cover device for temporarily covering bone voids, particularly a recess, filled with ossiferous material such as hydroxyl apatite granules, in the proper bone tissue of the body. The device comprises a perforated reinforcement element for covering the void in essentially shape-stable fashion that is composed of relatively stiff but flexible material such as a supporting grid of metal or the like, and a single-layer or multi-layer cover membrane carried by the reinforcement element.
A further subject matter of the invention is a method for manufacturing a cover device for temporarily covering bone voids, particularly a recess, filled with ossiferous material such as hydroxyl apatite granules, in the proper bone tissue of the body, whereby a perforated reinforcement element for covering the void in essentially shape-stable fashion is composed of relatively stiff but flexible material such as a supporting grid of metal or the like, is provided with a single-layer or multi-layer cover membrane and is brought into a use-specific shape.
It is standard in osteosurgery, for example in the reconstruction of bones in plastic surgery or in surgical operations of the jaw, to fill bone voids in the form of recesses or cavities in the proper bone tissue of the body with ossiferous material that is usually composed of a mixture of bone replacement material such as hydroxyl apatite granules and proper bone particles of the body. In order to assure that the ossiferous material is grown through with bone proceeding essentially only from the bone side but not by epithelium and sub-epithelial connective tissue in an undesirable way, the recess is closed with a cover membrane of the species initially cited. The bone void can be essentially completely eliminated, namely, only when it is assured that the ossiferous material is grown completely through in ossiferous fashion.
Up to now, polytetrafluorethylene films, for example, that must be removed after the healing of the bone void, have been employed as cover membranes. Films of resorbable material are also known.
As a consequence of the flexible plastic material employed for cover membranes, the membrane is not stiff but can change in position due to a mechanical stressing by the surrounding, soft body tissue, for example as a result of muscle movements or externally acting forces. Such micro-movements of the cover membrane, which can ensue in all spatial directions, have the disadvantage that the ossiferously predetermined granulation tissue situated under the cover membrane in the direct proximity thereof that replaces the primarily arising blood coagulate under the membrane and between the particles of the ossiferous material is dedifferentiated in such a way that sub-epithelial, fibrous connective tissue develops.
DE 91 15 341 U1 discloses a supporting lattice for the acceptance of particulate bone replacement agents that is composed of a biodegradable and thermoplastically shapable polymer. The supporting lattice serve the purpose of enabling a mechanical support of bone replacement material and, for example given complete partition of the lower jaw, fixing the two resection stumps to one another. A closing of a bone recess from the non-bone tissue upon simultaneous mechanical immobilization and stabilization both relative to the surrounding, soft body tissue as well as relative to the ossiferous material is not possible with this supporting lattice.
EP 0 504 103 A1 discloses a fastening means for a cover membrane composed of tissue-compatible film; however, the problems already initially described arise given such a movable cover membrane.
The subject matter of U.S. Pat. No. 5,591,234, which claims priority from German patent application P 43 02 709.1-35 is directed to a cover device of the species with which the undisturbed conversion of the ossiferously predetermined granulation tissue forming in the bone void into bone tissue is guaranteed in that movements on the part of the cover membrane are prevented by t
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Milano Michael J.
Nguyen Tram A.
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