Method of antibiotics fixation within porous implants

FIELD: medicine.

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.



 

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