Material for osteoplasty

 

(57) Abstract:

The invention relates to medicine, namely to materials for reconstructive bone-reconstructive surgery in traumatology-orthopedics. The material consists of processed, degreased and dried cancellous bone tissue with a pore size of 0.05 to 5 mm, on the surface of which is applied a composition of biocompatible copolymer and physiologically active substances in the following ratio of components in the composition, wt.%: biocompatible copolymer of vinylpyrrolidone with acrylates 50-99, physiologically active substances 1-50, the ratio of the porous bone tissue and physiologically active polymeric composition is, wt.%: bone 60-99,3, physiologically active polymer composition of 0.7-40. The material has a high mechanical strength, provides long-term local antimicrobial and stimulating bone regeneration effect.

The invention relates to medicine, namely reconstructive bone-reconstructive surgery in traumatology-orthopedics.

The aim of the invention is to improve the treatment results of patients with disorders of the musculoskeletal system through the use of new to the stew, antimicrobial properties, stimulation of osteogenic effect.

Know the use of freeze-dried cadaver bone for filling bone defects (Kuzmenko C. A., A. Rezvan,, Gulyaev, S. C., Lifanova N. In. Our experience of the plastic closure of bone defects of the skull liofilizirovannami the allografts. Sat. abstracts. Bioinventory on the threshold of XXI century. S. 82-83).

However, the disadvantages of this material are:

the monolithic implant and the duration of its biodegradable, which, as is well known, it is difficult for education's own bone, which occurs only in the process of resorption of the graft;

the absence of physiological activity and antimicrobial properties.

Such materials can serve as a basis for the development of inflammatory complications in the postoperative period. Also known “Method of obtaining bone implants” (A. C. No. 990193, publ. 23.01.83, bull. No. 3). Such implants to ensure organic growing in him bone tissue was obtained by calcination of a fragment of the diaphysis of tubular bones with further filling of the channels and moves bioinert, biodegradable cyanoacrylate glue. However, these implants have a low mechanical the Nations, the duration of resorption as bone matrix, and cyanocrylate, and the absence of bioactive components in the implant significantly delaying the processes of revascularization and substitute my own actual bone tissue.

Also known Composition to stimulate the regeneration of bone tissue” (patent RF №2146928, publ. 27.03.00, bull. No. 9). The application of this composite material provides a faster regeneration of bone tissue due to the content in the polymeric matrix lyophilised fetal tissues, drugs, promoting regeneration of tissues and substances containing bound calcium. Received a good therapeutic effect when filling small bone cavities, stimulation distraction regenerates. However, the amount of bound calcium in the composition is insufficient for the treatment of extensive bone defects. The proposed material, practically, has no form, has a low strength characteristics and cannot, if necessary, to fix the position of the bone fragments during surgical correction.

The invention is as follows. Made the bone graft (matrix), which produce a thorough mechanical cleansing pelaut in 3% hydrogen peroxide solution. Then immersed in a solution of a mixture of chloroform with 96% ethanol (1:1) to remove the fat component for 3-5 days depending on the size of the sample. Activity solution to support its daily shift. Then carry out the drying in the air, freezing to -30 and lyophilization for 24 hours. On the resulting matrix after treatment with a porous structure with a pore size of 0.05-5 mm, are physiologically active composition of the biocompatible polymer and a physiologically active substances so that the composition of the material had a ratio of components, wt.%: bone 60-99,3; physiologically active polymer filler 0,7-40,0.

Physiologically active polymer filler consists of the following component ratio, wt.%: biocompatible copolymer (polyvinylpyrrolidone with acrylate) 50-99; physiologically active substances (antimicrobial drugs: gentamicin dioxidine, cefamezin); stimulants regeneration: orotic acid, calcium gluconate, lyophilized powder fetal tissue 1-50. The production of the material for osteoplasty finish packing implants in plastic bags and sterilized by a stream of fast electrons dose poperechnyy, dense filling of virtually any bone defects when performing reconstructive surgeries musculoskeletal and long-term, local, stimulating bone regeneration and antimicrobial effect. Below are examples of the implementation of the proposed technical solutions.

Example 1

On fat-free, porous bone implant with a pore size of 0.05-3 mm weight 1.5 g of the suspension of physiologically active substances in 25% ethanol solution of a copolymer of vinylpyrrolidone with methylmethacrylate applied composition containing after drying 0,99 g copolymer of vinylpyrrolidone with methylmethacrylate brand MRP-1; 0.002 g of cefamezin; 0.003 g orotovoy acid; 0.005 g of lyophilised fetal tissues. The implant used in the treatment of the patient K., aged 15, suffering from disease Osgood-Shlatter left. Pain in the tuberosity of left tibia appeared about 1.5 years ago. At the same time diagnosed. Prolonged conservative treatment effect is not given. Upon receipt marked phenomena of bursitis in the area of the insertion own the patellar tendon, the absence of ossification of Apophis. Made tunnelization the tibial tuberosity. In prosvetlenny the ü in 5 days. However, the merger of Apophis and clinical recovery occurred only after 14 months. Thus, the intensity of the stimulation process of ossification of Apophis was relatively low. At the same time showed a good antimicrobial effect of the implant.

Example 2

On fat-free porous bone implant with a pore size of 0.07 to 4 mm, a weight of 1.1 g of the suspension of physiologically active substances in 10% ethanol solution of a copolymer of vinylpyrrolidone with acrylate (ratio 2:1) applied a composition containing 0.04 g of copolymer; 0.0015 g dioksidina; 0.0011 g orotata potassium; 0,0014 g of lyophilised fetal tissues.

The implant used in the treatment of the patient C., age 12, about disease Haglund-Shintsa left. Effect from conservative treatment within 1 year was observed. Continued to disturb pains in the calcaneus, limp. In this regard, performed tunnelization Apophis calcaneus with the introduction into the bone defect of the above-mentioned composition. There were no complications. Pain disappeared after 1.5 months, although the fusion of bone fragments came only after 9 months. Thus, it is possible to talk on the stimulating effect of the implant on reparative regeneration in zone pathologizes bone implant with a pore size of 0.05 to 5 mm, weighing 0.8 g of the suspension of physiologically active substances in 20% ethanol solution of a copolymer of vinylpyrrolidone with butylmethacrylate brand of SPD-1 is applied a composition containing after drying 0,237 g of copolymer PPB-1; 0.035 g of gentamicin sulfate; 0,017 g orotata potassium; 0,018 g of calcium gluconate; 0.035 g of lyophilised fetal tissues. The implant used in the treatment of the patient Was, 10 years old, who was diagnosed with a disease Keller 1 from both sides. Before entering the VCO cyto was treated conservatively for 2 years by place of residence. The effect was not, therefore, been tunnelization zone osteochondropathy with the introduction of the channels and the bone defect of the above material. Full reliance on the feet is permitted within 10 days after the operation. There were no complications. After 6 months showed complete recovery of the scaphoid bone. Thus, increasing the proportion of bioactive components in the implant has enabled us to achieve a very fast and good result of the treatment of such a complex pathology of the musculoskeletal system.

Example 4

Fat-free porous bone implant with a pore size of 0.05 to 5 mm and a weight of 5.2 g, on which is applied a composition containing after drying, the copolymer of vinyl pyrrolidone is ASS="ptx2">

The implant used in the treatment of disease Keller 2 on the right of the patient 8 years. First felt pain in the right foot during a ballroom dancing lessons for 2 months in tsito. Upon receipt found in almost complete destruction of the head 2 of the metatarsal bone to the right. In the area of bone defect puncture and aspiration introduced fragments of this implant. There were no complications. After 1.5 months recovered contours of the bone, and three and a normal bone structure. The child is again started training at the ballet school. In comparison with literature data the treatment time is reduced by 3-4 times. Clearly proven powerful osteoinductive effect of the implant.

Example 5.

Fat-free porous bone implant with a pore size of 0.05 to 5 mm, a weight of 15.2 g, on which is applied a composition containing after drying, 3.6 g of a copolymer of vinylpyrrolidone with methylmethacrylate brand MRP-1, cefamezin 0.1 g, orotovoy acid and 0.09 g

The implant used in patients 3 years of age with congenital dislocation of left hip. For 4 months before going to cyto was operated by place of residence - produced operation of Saltaire, with fixation of the fragments of the pelvis with the allograft. The intervention was complicated nageen the shown components.

The wound healed primarily. Doppler ultrasound showed the rapid development of microvascular network in the area of the osteotomy of the pelvis. To 4 months after surgery, x-ray analysis revealed the substitution of the implant's own bone tissue. Resolved full bearing on the affected leg. Marked high antimicrobial and osteoreparative effect.

Material for osteoplasty on the basis of the processed low-fat cadaveric human bones, characterized in that the material consists of freeze-dried cancellous bone tissue with a pore size of from 0.05 to 5 mm, on the surface of which is applied a composition of biocompatible copolymer and physiologically active substances in the following ratio of components in the composition, wt.%:

Biocompatible copolymer of vinylpyrrolidone with acrylates 50-99

Physiologically active substances 1-50

the ratio of the porous bone tissue and physiologically active polymeric composition is, wt.%:

Bone 60-99,3

Physiologically active polymer composition of 0.7-40

 

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