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AqualiftTM – is the most physiologic and safe among all existing implants, which can be used in any anatomic region. Nowadays AqualiftTM is the most perspective implant which soon can take the leadership and dominate in the medical market.
National Medical Technologies Center and SRMC Medicap are concerned in partnership and promotion of advanced technologies in the world market.
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Stages of development of synthetic hydrophilic gels.
In the late 80-s of the XX-th century the polyacrylamide gels came into medical practice as implants for filling of the body soft tissues. Their advantages are: simplicity of injection, possibility of sterilization by radiation, stability at storage, jelly-like consistence and very high water content. In the 90-s such gels as "Interfall", "Formacryl", "Esteform" were widely applied in Russia and other CIS countries for contour and augmentation plastics of soft tissues. But after their broad clinical application some reports about complications began to appear.
“Interfall Gel” – is the first thixotropic injection gel material meant for augmentation of the body soft tissues. It was produced in Ukraine (JSC “Kievmedpreparat”).
Hydrogel “Formacryl” – is analog of “Interfall”. It is a cross-linked polyacrylamide with a branched structure, transparent, colorless, homogeneous material of jelly-like consistence having 5 % of polymer and 95 % of apyrogenic water, it’s characteristics: refraction index 1.334 -1.338; pH = 7 - 8.5; content of non-polymerized acrylamide in the gel is not regulated. It is produced in Russia by the “Bioform” company.
“Bioformacryl” – is analog of the “Formacryl” gel, registered in Italy by the company PROGEN, contains 0.04 % of non-polymerized acrylamide.“Argiform” – antibacterial hydrophilic polyacrylamide gel with 0.03 % of arylamide (AA). Antibacterial effect is provided by the presence of silver.
“Amazing Gel” (PANG) – is produced by the company FUHUA in China, consists of polyacrylamide hydrogel and contains the biological growth factors “bTGF” and “EGF”.
Polyacrylamide hydrogels are created on the basis of polyacrylamide, which is received from acrylamide (ÀÀ). Acrylamide – is unsaturated compound with double bonds, easily polymerized. Insufficient polymerization of ÀÀ or week cross-linkage of PAA would result in leaving remains of reactive functional groups. Study of influence of residual monomers and side products in PAA is especially important during elaboration of implantation materials. The first generation of hydrogels for injections were jelly-like substances with thixotropic properties. Those first products were not soluble in water. When applying some pressure on such gels they are fragmentized into little pieces, and after lifting the pressure they re-unite again. This property of the gel allows injecting it into the organism by means of a usual syringe through the “camphor” needle. After injection, the gel fragments should again form the aggregates filling up the cavity.
Having analyzed the experience in application of polyacrylamide gels of the first generation, we can now conclude that possible complications caused by them can be referred to their physical and chemical properties:
- Thixotropy, insolubility in water - fragmentation, aseptic inflammative and tissue reactions, superfluous tissue damage by thick needles. All this is caused by the non-reacted residues of the synthesis components which are difficult to be removed from insoluble in water fragments of the gel.
- Alkalescent pH 7-8.5 - tissue reactions, high risk of infection, stiffness at the site of injection.
- Twice-distilled water as main component – reaction of the surrounding tissues to hypotonic aqueous medium, stiffness at the site of injection, lumpiness, pain, etc.
In 2001 the new polyacrylamide hydrogel Eutrophill (Outline) was produced by the ProCytech company (France). It has the properties of a unique biodegrading water-soluble filler. It consists of the cation copolymer poly(acrylamide-co-DADMA), phosphate buffer, water for injections. Beginning from 2004, the “National Medical Technologies Center” (Ukraine) began production of a new generation implant on the basis of the infusion line at the pharmaceutical plant in Lugansk City. From the beginning of 2007 the implant is produced under the trade mark “AqualiftTM” (registration certificate ¹5869/2006). AqualiftTM – is a filler for the soft tissues, which acts as depot for normal physiologic solution (0.9 % sodium chloride) locked in a matrix of three-dimensional frame of complex synthetic polymer with amide and carboxylic groups. Long chains of the high-molecular polymer are cross-linked together by peptide bonds and form a stable three-dimensional frame. Presence of multiple active carboxylic groups gives positive charge to the polymer molecule and provides high hydrophilicity and water solubility.
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