Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Polymer from ethylenic monomers only
Patent
1997-01-23
1998-08-25
Zitomer, Fred
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
Polymer from ethylenic monomers only
424 7831, 424422, 424423, 424487, 2523151, 5263031, A61F 202
Patent
active
057980969
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The invention relates to formulations of biocompatible hydrogels for medical applications which can be used: preferably those defects in humans which are due to traumatic, congenital or age distorsions of the shape and dimensions or due to loss of form stability of some organs consisting of soft tissues, e.g.: other parts of the body and, specifically, mammoplasty (preferably in the case of mammary aplasia or hypomastia), through injecting an elastic medium into spongy vascular tissue of the penis.
Demands for an improvement in bodily shape and functioning as mentioned above and other similar cases have become widespread and are frequently reasoned by the mere patient's desire.
That is why biocompatible materials for the above mentioned applications should satisfy some hardly consistent requirements. Among the most important requirements are: an organ, where an endoprosthesis has been placed, irrespective of the age when the patient was operated; biocompatible material, especially in large-dosage (up to 1000 ml) applications.
That is why to meet the above application requirements it is practical to use gelling biocompatible materials.
Actually, minimal trauma occurance and the shortest possible introduction of a biocompatible material, absence of carcinogenicity and minimal allergic reactions being the fact, are achieved by using a water solution of bovine collagen which, being a highly refined and partially depolymerized product, turns into an elastic and mechanically stable hydrogel at a temperature below 37 deg. C. following injection into the organ that has been treated as to shape and dimensions (see (Ford Ch., Martin D. M., Warner Th. F. Injectable collagen in laryngeal rehabilitation//LARYNGOSCOPE, 1984, 94, pp.513-518).
Being protein, collagen, however, would completely be resorbed in the patient's body in a considerably short period of time (less than half a year).
It is, therefore, suitable for use in endoprosthetic practice primarily in the cases when a complete substitution of an endoprosthesis for connective tissues is acceptable or when a patient, according to medical indications, needs a precisely temporary endoprosthesis.
It should be also noted that due to its resorption ability and to intra-tissue and inter-tissue migration, and whereas it is susceptible of an enzyme attack, the bovine collagen solution is practically unsuitable for application as a material for long-term endoprostheses.
Considering the above, the gelling biocompatible materials based on synthetic polymers are more preferable.
Thus, the biocompatible gelling material in the form of hydrophilic esters of polyglycols and of metacrylic acid is known to be applied in endoprosthetic practice (Kresa L., Rems T., Wichterle O. Hydrogel implant in vocal cord//Otolaryngol. Head Neck Surg.--1988, V. 98, No 3, pp. 242-245).
A required dose of such dry material is implanted via a section in the region of cosmetic or functional treatment and then the operative wound is satured. Thereafter, the material swells by absorbing water from adjacent tissues, to thereby provide for a local increase in the volume of the corrected organ.
This biocompatible material is characterized by a high biochemical stability.
In application, however, a durable therapeutic effect is achieved at the expense of traumatic surgical interventions associated with edemas and aseptic inflammations.
Therefore, the most promising for endoprosthetic practice and other applications are commercially available injectable liquid biocompatible gelling materials.
The biocompatible gelling material as a solution containing water-insoluble polymers, among them non-cross-linked acrylonitrile polymers or their copolymers, polyvinylacetate, a linear or low-branched polymer or copolymer of 2-hydroxyethyl-acrylate and methyl-acrylate, poly-n-vinyliminocarbonile and dimethylsulfoxide or other polar readily miscible with water organic solvents, may be exemplified (Stoy V., Chvapil M., U.S. Pat. No. 4,631,188; 1986). In obtaining copolymers, use may be made of addit
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Maloe Vnedrencheskoe Predpriyatie "Interfall"
Zborovsky Ilya
Zitomer Fred
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