Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis
Patent
1995-09-15
1998-05-26
Weiss, John G.
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
623 16, A61F 202
Patent
active
057557870
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a semi-synthetic product obtained after a specific mechanical, thermal and chemical treatment of mother of pearl intended to modify the structure and the properties in such a manner that it may be used for the manufacture of shaped parts for the orthopaedic, craniofacial surgery, for the preparation of biological cements for the sealing of prostheses, of a bone regenerating material and of a stabilizing material in carcinology and in intervening imagery.
2. Description of the Related Art
The basic material, mother of pearl, originates from the nacreous test of aquatic mollusca, the physical-chemical structure of which comprises in addition to a mineral fraction representing 90% to 98% of the total mass in the shape of biocrystals, an organic fraction composed of fibers and non fibers, soluble or non-soluble proteins having a genic specificity making its use unsuitable in the actual state on the animal and on the man.
In effect, the biomaterial used as such would behave as a xenograft and would exhibit within a variable time its antigenic character with an unfavourable immunological reaction which could cause the rejection thereof.
SUMMARY OF THE INVENTION
One has found a mechanical, thermal and chemical process which permits to render insoluble the soluble fraction of the proteins, to tan the superficial portion and to prevent the tissual rejection phenomena.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Preferably the mother of pearl originates from the nacreous test of aquatic mollusca, bivalves, cephalopods and gasteropoda such as the Pinctada (Maxima, Margaritifera), the Concha, the Whelk, the Nautilus, the Ormer Tricdane, Triton Shell or any other mollusca the test of which contains the mother of pearl.
The specific treatment of the product according to the invention is composed in the following manner: obtain the nacreous portion alone, the latter is caused to be dipped for 24 hours in a bath of demineralized water containing 20% of hypochlorite. After washing under a water stream for 48 hours, the mother of pearl is caused to boil in a bath of demineralized water containing 20% of sodium hypochlorite for two 2 hours after change of the bath at each operation. At the end of these two steps, the material is rinsed with boiling water and placed in a drying oven where it undergoes a treatment with demineralized steam under a pressure of 2 bars for two 2 hour periods in the presence of chemical agents, the action of which is intended to fix and to tan the organic fraction and to cause a chemical surface reaction not only with the organic fraction but also with the mineral fraction. The agents for example are, without the list being limiting: sodium hypochlorite, acetic acid, glutaraldehyde, benzalkonium chloride, formaldehyde, diluted to 20%.
At the end of these steps, the product according to the invention is processed with demineralized steam under a pressure of 2 bars for one hour without any addition of chemical products. The product according to the invention is dried under vacuum by thermal stages up to 100.degree..
From now on the material according to the invention may be sterilized by gamma radiation at 2.5 megarads and is ready for use.
In order to modify the functional properties of the material in the powdery or plastic shape, one may add thereto mineral compounds such as: calcium hydroxide, calcium phosphate, calcium chloride or any other calcium salt, the product according to the invention in its powdery or plastic form then possesses adhesive properties which make it apt to be associated with other materials, such as, for instance, metals, and plastics materials.
The product according to the invention may also be associated with monomers or polymers as well as with methylic or acrylic derivatives.
The product according to the invention in its compact as well as powdery form may be impregnated under pressure with medicinal products which fix themselves upon the organic fraction of the mother of pearl an
REFERENCES:
Comptes Rendus De L'Academie des Sciences, vol. 309, No. 6, 27 Jul. 1989, pp. 203-210, Evelyne Lopez et al.
Camprasse Georges
Camprasse Serge
Black John M.
Pearl Ventures, Inc.
Weiss John G.
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