Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis
Patent
1990-08-06
1994-09-06
Isabella, David
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
623 4, 623 14, A61F 202
Patent
active
053444523
DESCRIPTION:
BRIEF SUMMARY
DESCRIPTION
1. Technical Field
The invention relates to an alloplastic implant on the basis of a histocompatible solid. The implant is particularly used in to even out skin irregularities. It can, however, be used for any other purpose in plastic surgery.
2. Background Art
It has been tried to "restore" elements of the human body which are pathologically changed or accidentally destroyed. Where necessary, such elements are replaced by foreign bodies. In particular, in the area of the plastic surgery and cosmetic surgery, implants are used more and more.
It is very often desired to even out irregularities of the skin of any origin permanently and without side effects. Using different materials such as collagen for this purpose and of course also for other purposes in plastic surgery is known.
Collagen is a xenogeneic protein product which is degraded in the body. In case an irregularity of the skin has been evened out with collagen, for instance by an injection under the skin (intracutanously or subcutaneously) then it is normally necessary to have further injections in order to restore the results originally obtained after the first injection.
Furthermore collagen causes allergies so that allergic reactions can be observed in at least 3% of the cases. The likelihood of allergic reaction increases with multiple injections which is normally required to obtain the desired result.
It is furthermore known to use gelatine for the above given purpose. However, gelatine has similar drawbacks as collagen. In addition it is much more difficult to inject gelatine.
Also, silicone or silicone oils, respectively, have been used. However, silicone oils cause a severe reaction of the tissue at the site of the injection (siliconome). In addition, the silicone oils are rather badly kept in place by the tissue at the injection site so that, as a consequence, the silicone oils are transmitted to more or less distant parts of the body, for instance lymphatic nodules and liver.
It is also known to perform an injection of fat by using endogenous fat for the purposes mentioned above. It has been observed, however, that such a measure frequently causes infection. Furthermore the endogenous fat is rapidly and strongly absorbed by the body so that normally only 10% of the injected fat remain immobilised at the desired site.
DISCLOSURE OF INVENTION
It is therefore an object of the present invention to provide an alloplastic implant which can easily be injected, remains immobilised at the site where it has been injected and is tolerated by the tissue so that no side effects are caused.
According to the present invention a histocompatible solid in the form of a powder is used as an implant. The solid particles forming the solid, which may be incorporated into a suspending agent, are injected for instance with an injection needle at the desired site.
The solid particles used according to the present invention have a smooth surface and are free from corners, edges and so on. In other words, the particles are not allowed to have sharp transitions at their surface. Said transitions are for instance found at such corners and edges. In addition they are not allowed to have peaks of any kind or tapered projections. Furthermore the surface should not have pores.
Consequently the transition from one outer surface to the other outer surface of the solid particles as used according to the present invention has to take place in a continuous manner. If such transitions are present, as it is the case for the edges of a cube, they have to be smoothed off.
According to the present invention it is therefore not possible to use solid particles which are crystallitres (for instance needle-shaped) or particles which have been obtained by mechanically breaking up greater units into small pieces since said particles possess the above mentioned sharp edges and corners.
Due to the smooth and smoothed off surface structure no cells and other tissue structures are damaged. In addition the danger of causing reactions of the tissue, which are followed by infe
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Krukowski, et al "Charged Beads Stimulate Bone Formation" 34th Annual Meeting Orth. Res. Soc. Feb. 1988.
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