Biomaterials for tissue repair

Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Processes of preparing a desired or intentional composition...

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604 51, 604 56, 523115, 523116, 128898, 524531, 424422, 424 7832, A61L 2500, A61K 3736, C08L 3314

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054687870

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BRIEF SUMMARY
BACKGROUND OF THE INVENTION

This invention relates to the use of biomaterials for tissue repair and is particularly concerned with the use of physiologically acceptable polymeric materials in such tissue repair, especially cartilage repair.
The use of physiologically acceptable polymeric materials in the preparation of biomedical appliances such as hearing aids, artificial eyes and dentures is well Known, as is the use of polymeric materials as bone cements in the field of orthopaedics. Such polymeric materials are often used in the form of a curable composition which is initially in a fluid, semi-liquid, dough-like or other mouldable form, but which cures or hardens at the temperature of use to form a strong solid of physical properties dependent on the use to which it is being put. Examples of such curable compositions are to be found in International Patent Application No. WO89/03695 and GB Patent 2 107 341 which disclose the use of curable compositions comprising a powdered methacrylate polymer mixed with a methacrylate monomer. For such applications as the preparation of hearing aids, artificial eyes and dentures which require dimensional accuracy, it is important to provide compositions of low linear curing shrinkage and GB Patent 2 107 341 is directed to such an aim. For use as bone cement it is important to prevent subsequent failure at the bone-cement interface and, to this end, WO89/03695 discloses the inclusion of a cell growth stimulant such as human growth hormone so as to increase the rate of healing of, for example, a bone fracture and give a joint of increased strength. The emphasis in the previous use of these curable compositions has therefore been directed to attaining bonding strength and/or material strength and dimensional stability dependent on the intended use.


DESCRIPTION OF THE INVENTION

Surprisingly, it has been found that certain curable compositions comprising a methacrylate polymer mixed with a suitable unsaturated monomer can be employed to promote tissue repair, with or without the addition of cell growth stimulants such as human growth hormone. Even more surprisingly, it has been found that such compositions can be employed to promote cartilage repair.
Cartilage, which differs from bone in construction, has previously been considered substantially non-repairable. Attempts to repair cartilage currently include the introduction of carbon fibres behind the cartilage; however such carbon fibres are brittle and, while a fibrous tissue forms in the implanted area, the resulting growth is not that of true cartilage composed of chondrocytes expressing their normal phenotype and producing their own matrix components. Implantation of cartilage components and hydrogel compositions have also been tried with limited success. There is therefore a great need for a breakthrough in the treatment of cartilage defects.
The present invention comprises the use of a moromet/polymer mixture in the preparation of a curable composition for introduction to a site requiring tissue repair in a human or animal body in order to promote said tissue repair, the monomer component being selected from monomeric esters of general formula I ##STR1##
wherein R is a hydrogen atom or a methyl group, m is 0, 1 or 2, and X is a 3 to 6 membered heterocyclic ring and the polymer component is selected from acrylate and methacrylate polymers and copolymers thereof. Preferably X is an oxygen containing heterocycle.
According to a further aspect of the invention there is provided a process for the promotion of tissue repair comprising introducing to a site requiring tissue repair in a human or animal body, a curable composition comprising a monomer component selected from monomeric esters of general formula I above and a polymer component selected from acrylate and methacrylate polymers and copolymers thereof and causing or allowing the composition to cure in contact with the site.
The monomeric ester component is preferably selected from methacrylates where X is a heterocyclic group of formula ##STR2## where n is 1,

REFERENCES:
patent: 4820744 (1989-04-01), Kubota et al.
Patel, M. P. et al "Heterocyclic methacrylates . . . " Chemical Abstracts, vol. 116, No. 24, 27 Jan. 1992.

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