Method of antibiotics fixation within porous implants
SUBSTANCE: method of antibiotics fixation within porous implants is described. Result of method application lies in possibility of reliable fixation of antibiotic solution within porous implant and arrangement of favourable conditions for haemostasis in operative wound due to application of 10% gelatine solution as antibiotic carrier. Specified result is achieved by filling porous implants with antibiotic solution in liquid gel. For this purpose implant is dipped in solution by 3/4. Filling occurs under the influence of capillary forces. After solution cooled to form dense gel, antibiotic is fixed in implant pores and gradually released after installation to bone defect area.
EFFECT: reliable fixation of antibiotic solution within porous implant and arrangement of favourable conditions for haemostasis in operative wound.
3 cl, 1 ex
The invention relates to medicine, namely to traumatology, orthopedics and neurosurgery, is intended for the treatment of osteomyelitis of the spine and prevention of suppurative complications in reconstructive surgeries with the use of porous implants, such as titanium nickelide.
A known method of application of the antibiotic on nikeid-titanium wire elements, which for deposition of the drug on the surface of the substrate using electrochemical oxidation of nickeled-titanium samples, followed by "sewing" of the antibiotic due to chemical (hydrogen) relationships between functional groups of the substrate and drug, to do this before applying the antibiotic you need to activate the implant by forming on its surface active functional groups by increasing on the implant surface oxide layer (Biocompatible materials with shape memory and new technologies in medicine. / Under the editorship of Prof. Vaikunthera. - Tomsk: IAP Publishing NTL, 2004. - S-229).
However, in the known method using wire elements that are missing interconnected micropores, while the active substance is located only on the surface.
There is a method of soaking a porous implant Nickel-titanium in the solution of the antibiotic (isometimes materials with shape memory and new technologies in medicine / edited Professor Vaikunthera. - Tomsk: IAP Publishing NTL, 2004. - P.66-74).
However, the implant prepared in a known manner formed in the Lodge, accompanied by the generation between him and the implant layer of air and blood. In addition, further immersing the implant in a box accompanied by displacement solution of the antibiotic from the implant into the wound.
A known method of applying antibiotic coating of materials with interconnected micro-cavities, in which the micro-cavities injected aqueous solution 1 containing at least one soluble in water component from the groups of aminoglycoside antibiotics, tetracycline antibiotics, lincosamide antibiotics, 4-chinolin-antibiotics and chlorhexidine, and the aqueous solution 2 containing at least one water-soluble component from the group of alkyl sulphates, alkyl sulphonates, alkylarylsulphonates, dialkylanilines, alkylarylsulfonates, dialkylanilines, cycloalkylation, cycloalkylcarbonyl, alkylcyclohexanes, however, the introduction of solutions 1 and 2 water main remove and component solutions 1 and 2, the micro-cavities in the coating of which consists of poorly soluble in water sediment (patent 2236871 of the Russian Federation. Publ. 2004.03.20).
However, in the known method using the two solutions to obtain coverage in micropol the regions, while one pre-remove the water that leads to the formation of poorly soluble precipitate, which includes an antibiotic, the bioavailability of the latter is reduced due to poor solubility.
The present invention is to develop a method of fixation of antibiotics in porous implants.
The problem is solved in that in the method of fixation of antibiotics in porous implants, including the filling of micropores of the implant with a solution of the antibiotic, pre-prepared sterile solution of the antibiotic and liquid gel, then the resulting solution is placed a porous implant to 3/4 of its height, which is kept in the solution until the formation of a dense gel, with zero flow, the implant is extracted from it and used to replace bone defects.
In an embodiment of the invention as a liquid gel using high-molecular compounds (IUDs), capable at room temperature to form a thick gel, firmly fixed in the pores of the implant.
To reduce costs when performing the way it is expedient as a Navy to use a solution of gelatin.
Suitable for uniform dissolution of the antibiotic in the Navy to use pre-dissolving the antibiotic in sterile water for injection.
For formation of a strong nl is ka implant - bone - it is advisable to use a porous implant of titanium nickelide.
The present invention is explained detailed description, examples and tables.
The method is as follows.
For cooking liquid gel using high-molecular compounds (IUD)such as gelatin, collagen.
Under aseptic conditions to produce a portion of gelatin to produce a 12.5% solution, pour to swell in water for injections. Then in a water bath capacity with gelatin heated to 40°they reach complete dissolution, that is, a liquid gel. Sterilized by three heating to 105°C for 30 min for three consecutive days. One portion is poured into the bowl Petri for control of sterility. Second, after cooling to 35-40°poured a solution of the antibiotic Cefotaxime, achieving its maximum concentration. For this dose of antibiotic in the amount of 1 g was dissolved in 2 ml of water for injection in aseptic conditions and poured to 8 ml of a 12.5% solution of gelatin. After thorough mixing corked. In the following within 7 days of taking samples of a solution of the antibiotic to evaluate the activity of the drug, which assess the biological way, comparing the zone of growth inhibition of microorganisms.
After sterility check and confirm the saving activity of Antibes is the material of the drug in the gel carry out the filling of porous implants with a solution of the antibiotic in liquid gel.
Then fill the porous implants obtained solution.
For this purpose, the implant is sterilized and aseptically submerged, leaving 1/4 of the height of the implant free of liquid in a vessel containing 10% solution of water-soluble antibiotic in 10% sterile solution of gelatin.
When this liquid gel antibiotic heated to a temperature 37,0-40,0°C. Filling of micropores occurs due to capillary forces of the implant. It is advisable not to immerse the implant in the solution, because, due to the high viscosity of the solution is not all the air is displaced. Maximum absorption is observed at the dive at 2/3 or 3/4 of horizontally oriented implant. After filling the pores of the implant (not less than 5 min) and subsequent cooling of the solution to form a tight gel implant is extracted from the tank with the solution.
In case of incomplete immersion of the implant in a solution of gelatin, the air is displaced from the implant gradually and completely replaced by the solution until it directly on the implant surface. The filling control implants is carried out by weighing.
The amount of antibiotic in the micropores of the implant depends on the active capacity of the pores, the size of the implant and the solubility of a particular antibiotic in the water.
Example 1. The mass of impl ntata of 9.55,
Aseptic conditions were hanging gelatin to produce a 12.5% solution, was poured to swell in water for injections. Then in a water bath capacity with gelatin was heated to 40° - complete dissolution. Sterilized by three heating to 105°C for 30 min for three consecutive days. One portion was decanted into bowls Petri for control of sterility. Second, after cooling to 35-40°C was added a solution of the antibiotic Cefotaxime in 2 ml of water for injection. The dose of antibiotic in the amount of 1 g was dissolved in 2 ml of water for injection in aseptic conditions and was added to 8 ml of a 12.5% solution of gelatin. After thorough mixing corked. In the subsequent interval in two days took a sample solution of the antibiotic in 10% gelatin gel to evaluate the activity of the drug, which was checked by the biological method, comparing the zone of growth inhibition of microorganisms. Within 1 week of significant differences was not.
After sterility check and confirm the saving activity of antibacterial drug in the gel were filling porous implants with a solution of the antibiotic in the solution of gelatin.
Filling of porous implants of this solution was carried out as follows.
The implant is sterilized and aseptically submerged, leaving 1/4 of the surface of the implant is free from the liquid in the vessel, containing 10% solution of water-soluble antibiotic in 10% sterile solution of gelatin. In the preparation of a solution of gelatin water take into account the water used to dissolve the antibiotic.
10% solution of the antibiotic in a 10% solution of gelatin was heated to a temperature close to body temperature, 37,0-40,0°C. Filling occurs due to capillary forces of the implant. It is advisable not to immerse the implant in the solution, because, due to the high viscosity of the solution is not all the air is displaced. Maximum absorption was observed when immersed 2/3 or 3/4 of horizontally oriented implant. After filling the pores of the implant (not less than 5 min) and subsequent cooling of the solution to form a tight gel implant was removed from the tank with the solution.
In case of incomplete immersion of the implant in a solution of gelatin, the air is displaced from the implant gradually and completely replaced by the solution until it directly on the implant surface. The filling control implants was carried out by weighing.
The proposed method of fixation of antibiotics is highly effective for use of porous implants for replacement of bone defects formed after removal of the affected bone tissue injuries and inflammatory diseases of bones against the background of radical sanac and the source of infection. Facilitates hemostasis in the operating wound and prolonged action of antibiotic at the site of infection.
|Data from experimental studies show that for the prevention of suppurative complications in the use of porous implants of titanium nickelide for replacement of bone defects, including osteomyelitis of the spine, it is advisable to fill the implant with a solution of the antibiotic gel. The implant has antibacterial activity, because the drug is released gradually, after go into the liquid phase of the gel solution. In addition, the gelatin solution has a haemostatic effect that facilitates hemostasis in the operating wound.|
The proposed method allows for prolonged action of the antibiotic. While the antibacterial activity of the drug lasts for seven days, then gradually decreased during the week.
This method of fixation of the antibiotics used in the clinic of the Department of traumatology, orthopedics and field surgery Tyumen state medical Academy. Prepared this way, implants, fixed them in antibiotic used in the treatment of osteomyelitis of the spine at eight p. the patients with good long-term results of treatment follow-up period more than two years).
1. The method of fixation of antibiotics in porous implants, including the filling of micropores of the implant with a solution of an antibiotic, wherein the pre-prepared sterile antibiotic solution in a liquid gel, representing a biocompatible macromolecular compounds, forming a gel, such as gelatin or collagen, in which is placed a porous implant to 3/4 of its height and incubated in the solution to form a tight gel related micro-cavities in the implant and use it to replace bone defects.
2. The method according to claim 1, characterized in that use pre-dissolving the antibiotic in sterile water for injection.
3. The method according to claims 1 and 2, characterized in that use porous implant of titanium nickelide.
SUBSTANCE: ingredients are hardened in situ to produce solid biocompatible material capable of left in organism for a long time.
EFFECT: enhanced effectiveness in recovering mechanical strength of skeleton after cancer diseases; reduced risk of complications.
27 cl, 1 dwg
SUBSTANCE: method has stages for manufacturing medical device and introducing effective dose of Linezolid.
EFFECT: improved infection prophylaxis in medical purpose devices.
17 dwg, 11 dwg, 6 tbl
FIELD: medical equipment.
SUBSTANCE: when treating surface of implant intended for implantation into bone tissue, microscopic roughness is provided, which roughness has pores and peaks. Diameter of pores is smaller or equal to 1 micron, depth of pores equals to 500 nm maximum, width of peak at level of half of pores equals to 15-150% diameter of pores.
EFFECT: higher reliability of attachment of implant.
21 cl, 3 tbl, 10 dwg, 2 ex
SUBSTANCE: the present innovation deals with a medicinal prosthesis that contains metallic material, such as titanium or its alloy, in which surface parts of metallic material area covered with the layer of the corresponding hydroxide material, such as titanium hydroxide. Preferably, hydroxide layer contains one or more biomolecular substances being connected with it. Also, the innovation in question refers to electrolytic process for obtaining a medicinal prosthesis. Metallic prostheses are of improved biological compatibility.
EFFECT: higher efficiency.
24 cl, 8 ex, 3 tbl
SUBSTANCE: method involves introducing proper mesenchyme stem cells separated from marrow and cultivated in vitro. The cells are implanted on a carrier into cerebral cortex region planned in advance. To do it, the mesenchyme stem cells are preliminarily introduced into modified resorbable stent (carrier). The number of cells to be introduced is equal to 7-12 mln per one Brodman zone selected for transplanting autologic mesenchyme stem cells. Marked anatomical changes in brain regions being the case, the same quantity of cells are inravascularly (intravenously or intra-arterially) introduced. The treatment is carried out in particular cases in concurrently introducing the mesenchyme stem cells in intraperenchymatous or intravenous way.
EFFECT: enhanced effectiveness of treatment in cognitive-mnestic function disorder cases.
SUBSTANCE: transplant mixture has liophylized allogenic bone tissue and allogenic hydroxyapatite and patient autoblood platelets gel with Metronidazole, taken in the following components proportions (%): liophylized allogenic bone tissue - 65; allogenic hydroxyapatite - 10; patient autoblood platelets gel - 20; Metronidazole - 5.
EFFECT: enhanced effectiveness of treatment; no clamps required; reliably and tightly closed bone tissue defect; accelerated regenerate reorganization; improved antiseptic and immunomodulating action.
FIELD: medicine, in particular tubular polyurethane articles (guides, suction drainages, catheters) having aseptic coat.
SUBSTANCE: claimed articles are produced by providing of article elements followed by assembly thereof and application of aseptic coat by impregnation of catheter surface with chlorohexidine and/or salts thereof (e.g., dihydrochloride, or diacetate, or bigluconate, etc.), by article treatment for 14-180 min with aqueous-alcohol solutions of chlorohexidine and/or salts thereof at 20-60°C, containing (mass %): chlorohexidine and/or salts thereof 1-5; ethanol or methanol 75-85; water 15-25.
EFFECT: prolonged anti-microbial activity; protection against body contamination during catheterizing.
5 cl, 1 tbl
SUBSTANCE: bone-and-mineral product contains porous bone mineral particles produced from natural bone and having crystalline structure practically corresponding to natural bone structure and practically containing no endogenous organic material. The particles have fibers of physiologically compatible type II resorbable collagen at least on their surface. Mass proportion of type II collagen fibers and porous bone mineral is at least equal to approximately 1:40.
EFFECT: enhanced effectiveness in recovering combined injuries of cartilage and bone tissue in articulations having defects.
8 cl, 6 dwg
FIELD: medicine; therapeutic dentistry.
SUBSTANCE: new biological material for layer has low antigeny properties and keeps physical and mechanical properties of initial donor tissue. Biological laying has powder-like modified dentine with unblocked chemical bonds among collagen, chondrointin sulfates and mineral salts and Alloplant biological materials which have to be osteogeny stimulator, vasculogeny stimulator, phagocytosis stimulator at definite content of components. Laying for curing pulpitis has biological active matters to stimulate angiogenesis, dentinogenesis which matters activate phagocytosis.
EFFECT: improved efficiency of treatment.
1 dwg, 2 ex
FIELD: medicine, pharmacy.
SUBSTANCE: invention proposes implant prepared by mixing a carrier material with components of the preparation antibiotic/antibiotics with delayed release of an active substance (aminoglycoside, lincosamide antibiotics, 4-quinolone antibiotics and tetracyclines), and a method for preparing the implant. Release of an active substance from implant during from some days to some weeks doesn't dependent from a carrier material and adsorption effects of a carrier-material surface.
EFFECT: improved and valuable properties of preparation.
13 cl, 1 tbl, 6 ex
FIELD: medicine-destination polymers.
SUBSTANCE: invention relates to biologically stable hydrogels to be employed as endoprosthesis consisting essentially of following components: polyacrylamide including acrylamide, crosslinked methylene-bis-acrylamide, wherein acrylamide and methylene-bis-acrylamide are linked at molar ratio from 150:1 to 1000:1. Hydrogel is rinsed with water or physiologic solution so that it contains about 0.5-3.5% polyacrylamide and less than 50 ppm acrylamide and methylene-bis-acrylamide monomers, while modulus of elasticity of hydrogel is approximately 10 to 700 Pa and its complex viscosity about 2 to 90 Pa*sec. Rinsing stage allows removal of nearly all amounts (even trace amounts) of above-indicated monomers resulting in lower toxicity and higher stability of hydrogel. Biologically stable hydrogel is used as injectable prosthesis to fill soft tissues and also to treat or prevent urinary incontinence or anal incontinence. Hydrogel, obtained in a few stages including combining acrylamide and methylene-bis-acrylamide, initiating radical polymerization, and rinsing with apyrogenic water or physiologic solution, is also useful in treatment or prevention of bladder-ureter reflux in mammalians. In all these cases biologically stable hydrogels contain between 0.5 and 25% polyacrylamide.
EFFECT: enlarged resource for manufacturing endoprostheses.
10 cl, 3 dwg, 7 tbl
- when the endoprosthesis through targeted injections hydrogel for plastics soft tissues of the face, breast, penis, calf muscles, vocal cords and other tissues, the density of which corresponds to the density of the hydrogel;
- as a filler in the manufacture of implants, including implants breast;
- as a depot for drugs with long-term medication, such as tumors or abscesses;
- as a carrier for culturing human cells and animals with subsequent implantation of hydrogel containing cells in the mammalian organism
SUBSTANCE: described method of implant material production on basis of pored polytetrafluorethylene includes processing of base surface which serves as a substrate, deposition of surface layer modified with alloying elements onto processed substrate by magnetron deposition of one of targets selected from the following metals: titanium, zirconium, hafnium, niobium, tantalum, mainly titanium, carbides of mentioned metals, mainly titanium carbide of TiC0.5; compound ceramic materials from the following group: TiC0.5+10 mass.% CaO; TiC0.5+10 mass.% CaO+2 mass.% KMnO4; TiC0.5+10 mass.% ZrO2; TiC0.5+10 mass.% hydroxyapatite (Ca10(PO4)6(OH)2, deposition of one of mention targets at that is carried out at pressure 1-2x10-1 Pa, at substrate temperature between 150-170°C, in argon or argon and nitrogen medium at nitrogen partial pressure 14%. Implant material includes base of polytetrafluorethylene of porosity 3.0-40.0%, and surface layer of thickness not less than 50 nm modified with alloying elements composing mentioned targets. Surface layer at deposition of metal target in argon medium contains mentioned metal as alloying element mainly titanium. Surface layer at deposition of metal carbide in argon and nitrogen medium contains Ti-C-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% CaO in argon and nitrogen medium contains Ti-Ca-C-O-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% CaO+2 mass.% KMpO4 in argon and nitrogen medium contains Ti-Ca-Mn-K-C-0-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% ZrO2 in argon and nitrogen medium contains Ti-Zr-C-O-N as alloying elements. Surface layer at deposition of ceramic target TiC0.5+10 mass.% (Ca10(PO4)6(OH)2, in argon and nitrogen medium contains Ti-Ca-P-C-O-N as alloying elements.
EFFECT: method of implant materials production as a substrate for hybrid implants characterized by improved physicochemical, biomechanical properties and enhanced biological activity to biotissues.
10 cl, 1 dwg
FIELD: medical engineering.
SUBSTANCE: method involves producing titanium dioxide coating. The coating is produced by thermal oxidizing of metal base in gas medium being mixture of inert (Ar, Ne, He) gases and oxidant (O2, CO2) gases. Oxidation process is run at 600-1000°C. Gas mixture is supplied into working space under pressure of 1.2-1.3 atm. Oxidized implant is cooled to 20-30°C in inert gas medium.
EFFECT: enhanced effectiveness in producing all-purpose single phase biological coating of high adaptation degree to surrounding tissues; low production costs; high engraftment ability.