Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1999-06-16
2001-09-18
Azpuru, Carlos A. (Department: 2165)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C514S772300
Reexamination Certificate
active
06290982
ABSTRACT:
BACKGROUND OF THE INVENTION
During the last years in the biomedical applications synthetic implant materials have been taken into use to an ever-increasing degree. Biomaterial is defined to be a synthetic structural material whose aim is to interact with the biological system, and to replace, to treat, promote healing and renewal of and to join tissue, organs or some function of the body. Applications of these materials are reviewed in a publication edited by Höcker et al. (Macromolecular Symposia, vol. 103, January 1996, Klee, D., Severich, B., Höcker, H., pp. 19-29). Among the most important present and future applications are fixation materials of different types for bone fracture treatment which can be used for manufacturing screws, nails or rods for the above mentioned application, just to mention an example. These materials can be either non-biodegradable ones, e.g., metals or metal alloys, or polymeric materials degradable at a controlled rate in the body.
The most widely used biodegradable materials are high molecular weight lactide homopolymers, and lactide copolymers with, for example, glycolide. Useful parts or products are processed from these materials with processing methods for thermoplastics known in polymer technology, such as injection molding, hot pressing or extrusion.
Dentistry is well familiar with polymeric materials, too. Typical polymeric dental filling materials are chemically (for example, photochemically) curable plastics based on methyl methacrylate, dimethyl acrylate and their derivatives.
Fixation bone cements for orthopedic hip prostheses are also based on monomer combinations methacrylate type. In these applications the curing is based on redox initiated free radical polymerization, and on thus accomplished cross-linking and network formation.
The methacrylate based implant materials are, however, neither biodegradable nor biocompatible to any particular extent, as Dr. Heikkilä reports in his dissertation (Annales Universitatis Turkuensis Ser. D: Medica-Odontologica, tom. 240, 23.8. 1996, Turku/Finland, Heikkilä, J., Bioactive glass as a bone substitute in experimental and clinical bone defects, pp. 1-97, especially on p. 30).
In the use of methacrylate based implant materials further problems are caused by the exposition of personnel to volatile compounds, and the heat released during the reaction which may lead to an excessive local temperature increase, and to tissue damages as a consequence.
Another application for synthetic implant materials is controlled release of drugs or other bioactive substances when the idea is that the potent agent is released at a controlled rate from the polymeric matrix. As an example of this kind of application one can mention Norplant, a product brand and a trade mark of Leiras Co., which is based on a non-degradable polymeric material. A definitely formed device is implanted into the body by a surgical operation, and it is removed therefrom in a similar manner after a defined time when the active component has been released and diffused to the body.
Specific needs for development in the present state of the art are connected to the following areas:
Biocompatibility
If the material is not biocompatible it may induce tissue inflammation, unwanted cell growth, or rejection. Biocompatibilities of the presently used bone cements based for the most part on poly(methyl methacrylate) are unsatisfactory. This causes a certain risk of loosening of the hip prosthesis even in the case that there exists connective tissue formation between the polymeric material and bone tissue. A better biocompatibility would be a significant benefit for these materials.
Bioactivity
A bioactive implant material makes possible an active interaction between the tissue and the implant. As an example can be taken a mechanism by which the tissue is enabled to reconstruct into the implanted material while the implanted material itself is gradually removed due to biodegradation. Heimke, G. and Griss, P. have in their publication (Tissue interactions to bone replacement materials, in Bioceramics of calcium phosphate, de Groot, K. (ed.), 1983, CRC Press, Boca Raton Fla., pp. 79-97) characterized the concept of bioactivity, and have been cited by Heikkilä in his publication (
FIG. 1
in the publication cited on page 1 where a) bioincompatible materials, b) bioinert but by the interface biocompatible materials, and c) bioactive and biocompatible materials are presented schematically. In the case a) the implant is tolerated but no connection with bone is formed, in the case b) intimate contact without bone bonding occurs at the interface whereas in the case c) both intimate contact with chemical bone bonding and gradual transformation between bone and implant material will result).
Bioactive materials have scarcely been reported in the literature. Especially in the case of bone cements bioactivity would be desirable and a significant benefit.
Controlled Biodegradation
Depending on the application and purpose of implant materials, they are expected to have either long lasting durability or controlled degradability in the body at a predetermined rate to harmless degradation products. The wanted degradation rate is depending substantially on the renewal rate of the tissue. In the case of bone tissue, it may be case of several months, or even of a time span in the range of half an year to one year.
In the case of controlled drug delivery it is crucial what is the desired rate of release of the active ingredient from the biodegradable matrix. When the potent ingredient release is based on matrix degradation the rate of matrix degradation determines the release rate of the drug. When active agent is released from the matrix through diffusion, degradation of the matrix shall happen mainly only after the release of the active agent.
Industrial Hygienic Aspects
The materials in continuous clinical use have to be safe to the users in a sense of work safety and hygiene. This is a severe drawback with the present bone cements and dental filling materials which are based on methacrylates.
Controlled Mechanical Properties
The mechanical properties required from implant materials are depending on the application. With bone implants usually a compression strength of at least 50 Mpa is necessary, as well as bending strength and tensile strength values which are at the level of those of bone. On the other hand, even in the bone applications , in case of bone grafting by filling of fractures and cavities, one can fairly well apply implant materials of lower strength if only the use properties, mouldability, biocompatibility, and possible biodegradability are at an optimum level.
In connection with soft tissue the requirements, on the other hand, are elasticity, flexibility and softness.
Plasticizability and Hardening Thereafter
The today used polymeric implant materials are either pieces of definite shape, i.e., processed before implanting to the final form using methods known in the plastics technology (as an example one can mention biodegradable bone nails based on polylactide, e.g., trade name Biofix), or bone cements based on methacrylate which typically have no biodergradability and lack bioactivity but as monomers, or as a blend of monomers, can be shaped in the target according to the needs, and can be hardened thereafter.
In surgery there would be plenty of applications for plasticizable, and afterwards to solid curable biodegradable polymeric materials. Then the idea is, that the material is plastic in connection to the surgical operation , and can be shaped according to the target's shapes or can be forced to penetrate even into small cavities, fractures and pores. Thereafter it again reversibly becomes solid, mechanically tough material which, however, has the property of controlled degradation. Thus plasticizable material can then be of the type of wax, plastic or rubber.
Better biocompatibility, bioactivity and wished mechanical properties as combined to the mouldability in the target and hardening occurring thereafter are properties which before the
Orava Petri
Seppala Jukka
Azpuru Carlos A.
JVS-Polymers Oy
Kubovcik & Kubovcik
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