Filling composition containing calcium sulfate and viscous biopolymers to stimulate bone forming and concretion

FIELD: medicine, gel composition.

SUBSTANCE: claimed composition contains calcium sulfate and viscous biopolymers and can be easily introduced into defect part of damaged bone. Composition of present invention is capable of penetration into adjacent organs and is useful as physiologically acceptable filling material for bone concretion.

EFFECT: composition to prevent growth of undesired conjunctive tissues and to induce blood vessel growth and bone osteoblast development in earlier stage.

7 ex, 9 dwg, 1 tbl, 6 cl

 

The technical FIELD TO WHICH the INVENTION RELATES.

The present invention relates to molding compositions for connecting bones, and more particularly to molding compositions containing calcium sulfate and viscous biopolymers for bone formation, and to use it to stimulate bone formation, and bone fusion.

BACKGROUND of INVENTION

Recently, bone loss is often caused by disease or a traffic accident, so replacing lost bone mass is very important. One of the ways to compensate loss of bone mass is a free bone grafting, and more preferably applies the priming composition for the connection of the bone. At the present time to enhance bone growth in length or for the correction of the size of the underdeveloped jaws used a technique of stretching the bones, which require a large number of molding compositions for connecting bones.

The technique of stretching the bones used to stimulate bone growth, particularly growth in length by stretching, on theory that "tensile forces stimulate the histogenesis". The technique of stretching the bones were primarily designed to stimulate bone growth and limb, but also widely used for stretching the jaw bone. Method of stretching h is lustnau bone represents one developed in the field of oral and maxillofacial surgery techniques which allows you to improve facial proportions not by dissection of the bone, and through the gradual displacement of the bones of the facial skull by overlaying the fixing device for a bone extension on the exposed treatment portion of the jaw bone and the Central part of the face.

After Ilizarov also been developed biomechanical elements for bone extension (Ilizarov G.A., J. Dis. Orthop. Inst., 48(1):1, 1988; Ilizarov G.A., Clin. Ortho., 239:263, 1989; Ilizarov G.A., Clin. Ortho., 238:249, 1989), methods of bone extension was successfully used to compensate loss of bone mass bone. For successful execution of the traction bones it is important to maintain the blood supply in the area stretching bones and securely attach an external latch on both sides of the joint part of the bone that leads to stimulation of bone fusion through its gradual stretching White S.H., J. Bone Join Surgery, 72-B:350, 1990; White S.H., Orthop. Clin. North. Amer., 22:569, 1991; Fischgrund J., Paley D., Sulter D., Clin. Orthop., 301:31, 1994).

The period of fusion of the bones depends on being an extension of part of the bone, such as bone facial skull or bones, blood, the patient's age and so on. After stretching the bones fusion of craniofacial bones takes 3-5 weeks in children and 6-12 weeks in adults, while the fusion of bones takes 3-6 months regardless of the age of the patient. Performing stretching cerebralized bones difficult, one of which is the high risk of complications, and the other in the long-term return to a normal life due to the length of the period of bone fusion. Namely treatment after bone extension takes 2-4 months and includes the latent phase, phase bone extension and phase of fusion of the bones.

In the message Carls and Sailer noted that with an increase of 1 mm per day biochemical and physiological indicators were better than the growth of 2-3 mm per day (Carls & Sailer, J. Craniomaxillofac. Surg., 94:152, 1994). Ilizarov also it was also noted that with an increase of 1 mm per day was observed the best results, while the growth of 0.5 mm per day was premature fusion of the bones and the growth of 2 mm per day has resulted in undesirable changes in exposed tissue traction (Ilizarov, J. Dis. Orthop. Inst., 48(1):1, 1988; Ilizarov, Clin. Ortho. 239:263, 1989). In addition it is also known that sequential growth causes the least damage in the tissues and the best development of capillary vessels and bone formation. Therefore, the reduction of duration of stretching of the bone and bone fusion can help prevent the development of complications and more rapid return of the patient to normal life. In order to reduce the duration of stretching of the bone and bone fusion to stimulate bone formation and ankylosis of the coast is, apply a priming composition for the connection of the bone.

Meanwhile, it is known that bone autograft-treated allograft, xenograft and substitute bone graft to stimulate bone formation. Bone autograft used for the treatment of articular agglutination or treatment of a fracture without stretching, or to prevent damage and voids caused by infection, tumor, or surgery, by filling the cavity of the bone and replacement of bone loss. Transplanted bone autograft has a high capacity for absorption, which leads to the restoration of blood circulation. At this time, the differentiation of precursor cells of bone tissue leading to bone formation of osteoblasts, the activation of which stimulates the restoration of the bone, and replenishes the loss of bone mass. However, the application of bone autograft is problematic because there is a limit on the number of aspirated bone material and high morbidity, which causes the auxiliary operation on the donor bone. Therefore, to stimulate bone repair in the areas of traction applied bone morphogenic protein, or other alternate bone graft. Bone morphogenic protein is considered the most the e effective material, inducing the restoration of the bone, but its application in clinical practice is limited due to its high cost and difficulties of its receipt.

Calcium sulfate is a type of casting material to connect the bones, which is suitable for use in humans and induces the growth of bone osteoblasts and blood vessels, and stimulates bone healing at an early stage. This material contributes to the normal structure of bone by stimulating the formation of new bone in proper condition, acts as a shield during the accretion of the fracture by preventing the growth of unwanted connective tissue and can be replaced with bone during the recovery process. In experiments on dogs Beeson proved that entered in the frontal sinus of dogs calcium sulfate induced bone regeneration within 4-6 weeks (Beeson W., Arch. Otolaryngol., 107:664, 1981), and publication Pecora al. also reported the effect of calcium sulfate, is introduced in section rarefaction of the bone in the jaw bone of a mouse, on the healing of the fracture, which is three weeks after injection was observed partially or throughout the site (Pecora g, Andreana S., Margarone III, J.E., Covani U., Sottosanti J.S., Oral Surg. Oral Med. Oral Pathol. Oral Radio Endod., 84:434, 1997). In accordance with the message Pelter calcium sulfate is suitable for the safe introduction of various the diversified types of patients with bone loss, stimulate bone regeneration, as absorbed in the body within a few weeks or a few months, and did not cause any complications or any threat (Pelter LF., Am. J. Surg., 97(3):311, 1959). However, traditionally used as a molding composition for the regeneration of bone calcium sulfate difficult to enter in the area of rarefaction of the bone, since the composition is in the form of tablets or powder. For the introduction of such compositions inevitably surgery scar that painful for patients.

Therefore, the authors of the present invention tried to improve the way the introduction of calcium sulphate. The authors of the present invention prepared gelatinous composition comprising calcium sulfate and viscous biopolymers, and proved they made the invention by the fact that the composition of the present invention can easily be introduced by injection into the site of bone rarefaction, does not penetrate into the surrounding organs and reduces the duration of fusion of the bones by stimulating bone formation and bone fusion.

SUMMARY of the INVENTION

The present invention relates to a gel-like molding compositions for connecting bones, stimulating bone formation and bone healing, which can be easily introduced in the missing part of the damage is given to the bones and a longer stay in this area.

BRIEF DESCRIPTION of DRAWINGS

Figure 1 is a picture showing a pill of calcium sulfate, which are used in the preparations of the composition of the present invention.

Figure 2 is a picture showing the overlay of the experimental animal of the outer clamp at the reaction of stretching the bone with the use of a composition according to the present invention.

Figa is a photograph showing the degree of fusion of the bones in the control group 1, which was evaluated by the method of x-ray examination 3 weeks after bone extension, particularly the animals of the control group 1 were injected with only carboxymethylcellulose and induced stretching of 1 mm per day for 10 days.

FIGU is a photograph showing the degree of fusion of the bones in the control group 1, which was evaluated by the method of x-ray examination 6 weeks after bone extension, particularly the animals of the control group 1 were injected with only carboxymethylcellulose and induced stretching of 1 mm per day for 10 days.

Figs is a photograph showing the degree of fusion of the bones in the control group 2, which was evaluated by the method of x-ray examination 3 weeks after the exhaust is Oia bones, specifically animals of the control group 2 were injected with only carboxymethylcellulose and induced stretching to 2 mm per day for 5 days.

Fig.3D is a photograph showing the degree of fusion of the bones in the control group 2, which was evaluated by the method of x-ray examination 6 weeks after bone extension, particularly the animals of the control group 2 were injected with only carboxymethylcellulose and induced stretching to 2 mm per day for 5 days.

Figa is a photograph showing the degree of fusion of the bones in receiving calcium sulfate group 1, which was evaluated by the method of x-ray examination 3 weeks after bone extension, particularly the animals treated with the calcium sulfate group 1 were injected with the composition of the present invention and induced stretching of 1 mm per day for 10 days.

FIGU is a photograph showing the degree of fusion of the bones in receiving calcium sulfate group 1, which was evaluated by the method of x-ray examination 6 weeks after bone extension, particularly the animals treated with the calcium sulfate group 1 were injected with the composition of the present invention and induced stretching of 1 mm per day for 10 days.

Figa is a fo is ografia, which shows the degree of fusion of the bones in receiving calcium sulfate group 2, which was evaluated by the method of x-ray examination 3 weeks after bone extension, particularly the animals treated with the calcium sulfate group 2 were injected with the composition of the present invention and induced stretching to 2 mm per day for 5 days.

FIGU is a photograph showing the degree of fusion of the bones in receiving calcium sulfate group 2, which was evaluated by the method of x-ray examination 6 weeks after bone extension, particularly the animals treated with the calcium sulfate group 2 were injected with the composition of the present invention and induced stretching to 2 mm per day for 5 days.

Figa is a picture showing made 3 weeks after bone extension histological slice in the control group 1, specific animal groups were injected with only carboxymethylcellulose and induced stretching of 1 mm per day for 10 days (arrows pointers: primary cut part of the bone).

FIGU is a picture showing is made 6 weeks after bone extension histological slice in the control group 1, specific animal groups were injected with only carboxymethylcellulose, induce is ovali traction at 1 mm per day for 10 days (arrows pointers: primary cut part of the bone).

Figs is a picture showing confirmed by staining hematoxylin-eosin formation of new bone along the edge of the area stretching bones in the control group 1, animals which were injected with only carboxymethylcellulose and induced stretching of 1 mm per day for 10 days (A: osteoblasts, B: fibrous tissue).

Figa is a picture showing made 3 weeks after bone extension histological slice in the control group 2, specific animal groups were injected with only carboxymethylcellulose and induced stretching to 2 mm per day for 5 days (arrows pointers: primary cut part of the bone).

FIGU is a picture showing is made 6 weeks after bone extension histological slice in the control group 2, specific animal groups were injected with only carboxymethylcellulose and induced stretching to 2 mm per day for 5 days (arrows pointers: primary cut part of the bone).

Figs is a picture showing confirmed by staining hematoxylin-eosin formation of new bone along the edge of the area stretching bones in the control group 2, animals which were injected with only carboxymethylcellulose and induced the traction to 2 mm per day for 5 days (A: osteoblasts, B: fibrous tissue).

Figa is a picture showing made 3 weeks after bone extension histological slice treated with calcium sulfate group 1, specific animal groups were injected with the composition of the present invention and induced stretching of 1 mm per day for 10 days (arrows pointers: primary cut part of the bone).

FIGU is a picture showing that the center of the territory stretching filled with osteoblasts and fibrous tissues, which was confirmed by staining hematoxylin-eosin histological slice presented on figa (A: osteoblasts, B: fibrous tissue).

Figs is a picture showing is made 6 weeks after bone extension histological slice treated with calcium sulfate group 1, specific animal groups were injected with the composition of the present invention and induced stretching of 1 mm per day for 10 days (arrows pointers: primary cut part of the bone).

Fig.8D is a picture showing the formation of new bone around the area stretching confirmed by staining hematoxylin-eosin presented on figs histological slice.

Figa is a picture showing a DM is taken 3 weeks after bone extension histological slice treated with calcium sulfate group 2, specifically animal groups were injected with the composition of the present invention and induced stretching to 2 mm per day for 5 days (arrows pointers: primary cut part of the bone).

FIGU is a picture showing the beginning of bone formation along the edge of the plot traction and United with the land stretching of the fibrous intermediate space, which was confirmed by staining hematoxylin-eosin histological slice presented on figa.

Figs is a picture showing is made 6 weeks after bone extension histological slice treated with calcium sulfate group 2, specific animal groups were injected with the composition of the present invention and induced stretching to 2 mm per day for 5 days (arrows pointers: primary cut part of the bone).

Fig.9D is a picture showing the formation of new bone in half of the area stretching confirmed by staining hematoxylin-eosin presented on figs histological slice (A: osteoblasts, B: fibrous tissue).

DETAILED description of the INVENTION

To achieve the above objectives the present invention relates to a gel-like molding compositions for connecting bones containing calcium sulfate and viscous biopolymer.

The present invention also relates to the use of specified composition for the stimulation of bone formation and bone fusion.

Additional features of the present invention will be discussed later in this document.

The present invention relates to a gel-like molding compositions containing calcium sulfate and viscous biopolymer.

The composition according to the present invention comprises (a) a mixture of (20-80 wt.%), consisting of CaSO4(90˜99 wt.%) and CaCO3, MgCO3and CaCO3.MgCO3(1˜10 wt.%) and (b) viscous biopolymer (80-20 wt.%).

CaSO4is a main ingredient of the composition of the present invention, and the composition may be added one or more of inorganic salts selected from the group consisting of CaCO3, MgCO3, CaCO3.MgCO3and mixtures thereof. In preferred embodiments of implementing the present invention, the content CaSO490˜99 wt.% of the total content of inorganic salts, and the content of CaCO3, MgCO3, CaCO3·MgCO3is 1˜10 wt.%. More preferably, when the content in the composition CaSO4is 98˜99 wt.%, the content of CaCO30.3˜1 wt.%, the content of MgCO30.3˜1 wt.%, and the content of CaCO3.MgCO3 0.5˜1 wt.%. Calcium sulfate is an inexpensive filling material for bone joints and usually comes in the form of high-purity powder or pills (see figure 1). When the absorption of calcium sulphate bone newly formed bone is restored to its anatomical and structural characteristics, which leads to accelerated growth of newly formed bone. In addition, the calcium sulfate is an intake and a relatively safe material, which does not cause the development of inflammatory responses.

In the present invention, the gel composition is prepared by mixing powdered calcium sulphate and viscous biopolymer. The viscous polymer may be selected from the group consisting of carboxymethyl cellulose, hyaluronic acid, chitosan, polyacrylic acids, simple, polyvinyl esters, polystyrenes, ethers of cellulose, cellulose ethers, starches and polysaccharides. In a preferred embodiment of the present invention as a viscous polymer used carboxymethylcellulose.

For the composition of the present invention the preferred content of powdered calcium sulphate content of viscous biopolymer is 20:80˜80:20, and more preferred is a ratio of 50:50.

Pre is respectful embodiment, to obtain the composition of the present invention carboxymethylcellulose, used as viscous biopolymer, can be used in the form of sodium salt polycarboxylates cellulose ether. Sodium carboxymethyl cellulose is an odorless hygroscopic powder, with different coloring, such as white, cream, and so forth, and is used as the base material. This material is used for obtaining the suspension or turbid fluid.

It is also known that the carboxymethyl cellulose is a harmless protective material used for ileostomy or colostomy (Raynolds JEF., Martindale., The Extra Pharmacopoeia, 29:1433, 1989).

The authors of the present invention is injected with a mixture of calcium sulphate and viscous biopolymer in being an extension of the parcel using needles No. 18, which was the easiest and fastest way of introduction, it does not require auxiliary operations. 3 weeks after the injection, the composition of the present invention has stimulated the formation of new bone through powerful mineralization, and 6 weeks after injection was widely observed formation of new bone. In addition, the composition of the present invention slowly absorbed into the body, and at the end of the suction remained only calcium sulfate, which had no effect on the regeneration of bone and did not cause the development of inflammatory reactions. Therefore, it was Doc who cut the composition of the present invention is a safe material.

The present invention also relates to the use of a composition for the stimulation of bone formation and bone fusion.

To test whether the priming composition for connecting bone to stimulate bone formation and bone healing, the authors of the present invention carried out the operation of stretching the jaw bone dog 2 mm or 1 mm per day, and then introduced into it by the injection of a composition of the present invention, and investigated the effect of composition on bone healing at an early stage.

As a result, in each group, which was conducted traction bone 2 mm per day, with the exception of the control group, was observed calcification around the site of stretching the jaw bone, which was confirmed by radiographs obtained at week 3 and week 6 after stretching. Between the slit parts of the bone was also observed radiolucent area, and adjacent on both sides to cut the parts of the bone parts of the connection varied from group to group. At 3 weeks after bone extension in the control group, which was conducted traction bone 1 mm or 2 mm per day without injection of the composition of the present invention, as in the other group, which was conducted traction bones 2 Iim day with the injection of the composition, radiolucent area was barely visible, whereas in the group, which was conducted traction bone 1 mm per day by injection of the composition was observed massive radiopaque area. At 6 weeks after bone extension radiopaque area has significantly extended towards the centre of the land, stretching as in the control group, which was conducted traction bone 1 mm per day without injection of the composition of the present invention, and in the group, which was conducted traction bone 1 mm or 2 mm per day by injection of the composition. Most radiopaque area was observed in the group, which was conducted traction bone 1 mm per day by injection of the composition of the present invention, whereas in the control group, which was conducted traction bone 2 mm per day without injection of the composition of the present invention, the radiopaque area was barely visible (see figure 3-5).

Also performed histological examination. In the 3 week after stretching in the control group, which was conducted traction bone 1 mm per day without injection of the composition of the present invention, the edges of the area stretching was observed forming osteoid osteoblasts, and in the center section of traction has also been observed a large number of fibrous tissue (see figa). Formation is the development of new bone was more noticeable in this group at 6 week after stretching, although the Central plot of traction was filled with fibrous tissues (see figv and 6C). In another control group, which was conducted traction bone 2 mm per day without injection of the composition of the present invention, in the area stretching was observed partial formation of new bone, and a large part of the plot traction was filled with fibrous tissues (see Fig.7).

Meanwhile, on the 3rd week after stretching in the group, which was conducted traction bone 1 mm per day by injection of the composition of the present invention, in the direction from the edge toward the center of the plot stretching was observed set of active osteoblasts and newly formed bone and fibrous tissue were predominant (see figa and 8B). 6 week after stretching in this group the newly formed new bone was distributed throughout the area of traction, which is similar to normal bone (see figs and 8D). On the 3rd week after stretching in the group, which was conducted traction bone 2 mm per day by injection of the composition of the present invention, the area stretching was connected with the fibrous intermediate space, and the edges were observed bone formation (see figa and 9B). 6 week after stretching, bone formation in this group was observed in half of the area of the extension (see figs and 9D).

As described here and earlier in this to umenta in the group, being traction bone 2 mm per day by injection of the composition of the present invention, the observed bone formation were worse than in the group that was conducted traction bone 1 mm per day by injection of the composition. Therefore, it is believed that the stretching of the bone 1 mm per day is clinically more effective.

In the control group, which was conducted traction bone 1 mm per day without injection of the composition of the present invention, the area stretching was not replaced by newly formed bone to 6 weeks after stretching and a large part of the plot traction was filled with fibrous tissues, except the edges of the plot, partially began the formation of new bone. Taking into account these results and the results obtained Califano and Komuro (Califano L., Cortese, A., Zupi A, Tajana G., J. Oral Maxillofac. Surg., 1994, 52, 1179; Komuro Y., Takato T., Harii K., Yonemara Y., Plast. Reconstr. Surg., 1994, 94, 152), it is concluded that the bone healing takes at least 6 weeks, and the faster the speed of traction, the shorter the duration of stretching of the bone. Thus, rapid stretching is preferred, because it prevents the formation of bone, as it can alleviate the suffering of patients and to prevent the occurrence of postoperative complications by reducing the duration of fusion of the bones.

As ravelo, the bone is subjected to traction, has a tendency to break down, so it is preferable to excessive traction on 10-20%, although the exact values for excess traction was not reported. Therefore, the degree of excessive traction is determined by the surgeon based on their own experience. It is believed that the resorption subjected to stretching of the bone depends on its salinity. For the adult or elderly patient to complete the process of fusion of the bones required after bone extension to wait 6-10 weeks. However, the authors of the present invention believe that in the case of use of the compositions of the present invention excessive traction is not required because the composition stimulates the regeneration of bone.

The above results proved that the composition of the present invention can effectively be used as safe for the body cheap priming compositions for connection, as the composition stimulates bone formation and bone healing at an early stage after bone extension, which leads to reduce the duration of fusion of the bones.

EXAMPLES

Practical and preferred in the present embodiments of the present invention is shown for illustrative purposes, as shown in the following examples.

However, it should be taken into consideration is s, on the basis of the disclosure of the present invention is a specialist in the art may make changes and improvements without going beyond being and scope of the present invention.

Example 1: Obtaining and casting compositions for connecting bones

The authors of the present invention received the priming composition for connecting the bones by mixing carboxymethyl cellulose (referred to as "CMC") with calcium sulfate. Specifically mixed together 98.9 g CaSO4.H2O, 0.3 g CaCO3, 0.3 g MgCO3and 0.5 g CaCO3.MgCO3, were added to 100 g of CMC, and then received the suspension that resulted in the receipt of a jelly-like composition of the present invention.

Examples 2-7

The authors of the present invention was obtained gel-like composition according to the above example 1 method on the basis presented in table 1 ratios of components.

td align="center"> 98 g
Table 1
The ratio of the components of the composition
CaSO4CaCO3MgCO3CaCO3Correlation with CMC
H2OMgCO3
Example 20.5 g0.5 g1 g20:80
Example 398 g0.4 g0.4 g1.2 g30:70
Example 4to 98.5 g0.3 g0.2 g1 g40:60
Example 5to 98.5 g0.5 g0.5 g0.5 g60:40
Example 699 g0.3 g0.2 g0.5 g70:30
Example 799 g0.2 g0.5 g0.3 g80:20

Experimental example 1: Operation traction bones

To test whether the composition of the present invention to stimulate bone formation and bone healing in the early phase, the authors of the present invention conducted an operation to traction bone in the jaw bones of dogs. After surgery, the authors present invention was administered to dogs composition of the present invention and watched for any changes.

Specifically for experiments used 8 dogs aged 5 months and were grouped them by 4 dogs in the control group and treated group composition. These groups were divided into subgroups, such as the control of the GRU is PA 1, being traction bone 1 mm per day, control group 2, which was conducted traction bone 2 mm per day, treated with the composition of the group 1, which was conducted traction bone 1 mm per day, treated with the composition of group 2, which was conducted traction bone 2 mm per day.

After General anesthesia and vybivanija the surgical field with subsequent disinfection breathing dog supported using introduced into the lungs of the tubes. Made the skin incision with a length of 3-4 cm along the bottom edge of the bone, raised masticatory muscle and allocated the lower part of the jaw bone. Then was carried out using the saws vertical osteotomy in the Central part of the lower jaw and completely cut the jawbone. Inside the cut side of 1 cm to the right and to the left of the area of the incision reinforcing pins of the external fixator. In the process of fixing pins on the jaw bone using a drill site mounting washed with saline to avoid burn plots fastening. The pins were introduced to the depth at which they barely passed through the jaw bone, and then they were firmly fixed. After fixing all the two pins were connected to the apparatus for stretching the bones (Molina Distractors, Wells Johnson Company) (figure 2).

On the area of the incision had stitches a 5-0 vicryl and 5-0 nylon layer surface the layer and bred dog from a state of anesthesia. Every 12 hours for 7 days after surgery was administered penicillin by intramuscular injection (100000 µg/kg), and for pain relief every 4 to 6 hours oral introduced anodin. Within two days after surgery, the dog was fed soft food, and on the third day provided regular meals. The fifth day after the operation began to perform traction bone 1 mm / day for 10 days (control group 1 and treated with the composition of the group 1) or 2 mm a day for 5 days (up to 10 mm; control group 2 and treated with the composition of the group 2).

On the day of the end of a bone extension in the area stretching with a needle of No. 18 introduced by injection of 1 ml priming compositions for connecting bones obtained in the above-described example 1 (pigv). Meanwhile, in the control group in the area of traction was introduced only 1 ml of carboxymethylcellulose.

After the introduction of dogs compositions of the present invention apparatus for stretching the bones were kept on the dog for 6 weeks to heal and restore bone. 3 weeks after bone extension, 1 dog from each group were killed by injection of overdose phenobarbital (40-50 mg/kg), and the remaining 4 dogs were killed after 6 weeks (Fig 3).

<1-1> x-Ray study

X-ray study of each group of animals with provideno the operation of stretching the bones are held weekly, and after 3 weeks and 6 weeks on radiographs was marked bone formation and bone healing, respectively.

As a result, in each group, except the control group 2, in the area stretching the jaw bone calcification was observed (Fig.3-5). Confirmed education radiolucent area between the slit parts of the bone and adjacent to the cut portions of the jaw bone on both sides of the connection sections. At 3 weeks after bone extension in the control groups and treated with the composition according to the present invention group 2 radiolucent area was barely visible, whereas in the treated composition according to the present invention group 1 was observed massive radiopaque area. At 6 weeks after bone extension in each group, except the control group 2, the radiopaque area has significantly extended towards the centre of the land, stretching, and most radiopaque area was observed in the treated composition according to the present invention group 1.

<1-2> Histology

The bone samples were taken using an electric saw from the subjected to stretching of the jaw bones, including adjacent normal bone tissue. The obtained cut part of the bone was subjected to fixation with 10% neutral formalin for 1 not the eat, and then decalzinirute in 10% nitric acid and 10% sodium citrate for 2 days. Samples weighing 4-6 g was obtained by dehydration and fixation, paraffin, using conventional techniques. Samples were stained with hematoxylin-eosin for observation of histological changes using a light microscope.

In the 3 week after stretching in the control group 1 at the edges of the plot traction partially observed forming osteoid osteoblasts, and in the center of the plot stretching was observed a large number of fibrous tissue (figa). 6 week after stretching the formation of new bone was more than 3 a week, and the center of the territory stretching was filled with fibrous tissues (figv and 6C). In the control group 2 in the area stretching was observed partial formation of new bone, and a large part of the plot traction was filled with fibrous tissues (7). On the 3rd week after stretching in the treated composition according to the present invention group 1 at the edges and in the center section of traction there were also a number of active osteoblasts, and the sites were filled by newly formed bone and fibrous tissues (figa and 8B). 6 week after stretching the newly formed new bone was distributed over the whole area stretching that was similar to normal bone (figs and 8D). On the 3rd week after stretching in the floor is of awsa composition of the present invention the group 2 area stretching was connected with the fibrous intermediate space, and the edges were observed bone formation (figa and 9B). 6 week after stretching, bone formation was observed in half of the area stretching figs and 9D).

INDUSTRIAL APPLICABILITY

The jelly composition of the present invention induces the formation of new bone, provides the normal structure of bones, prevents the growth of undesirable connective tissue, and sufficiently suitable for replacing bone in humans in the recovery process, and induces blood vessel growth and development of bone osteoblasts at an early stage. Therefore, the composition of the present invention can effectively be used as safe for the body casting material to connect the bones.

1. Gel, stimulating bone formation and bone healing and casting composition, including

1) 20-80 wt.% mixtures containing calcium sulfate and one or more inorganic salts selected from the group consisting of caso3, MgCO3, CaCO3·MgCO3and mixtures thereof, where the content of calcium sulphate is 90-99 wt.% from the total mass of the mixture and the content of inorganic salts comprising 1-10 wt.%, and

2) 80-20 wt.% viscous biopolymer.

2. Gel, stimulating bone formation and bone healing molding composition for the connection of a bone according to claim 1, to the which includes 98-99 wt.% CaSO 4, 0.3 to 1 wt.% Caso3, 0.3 to 1 wt.% MgCO3and 0.5-1 wt.% CaCO3·MgCO3.

3. Gel, stimulating bone formation and bone healing and casting composition according to claim 1, in which viscous biopolymer selected from the group consisting of carboxymethylcellulose, hyaluronic acid, chitosan, polyacrylic acids, simple, polyvinyl esters, polystyrenes, ethers of cellulose, cellulose ethers, starches and polysaccharides.

4. Gel, stimulating bone formation and bone healing and casting composition according to claim 3, in which viscous biopolymer is a carboxymethyl cellulose.

5. Gel, stimulating bone formation and bone healing and casting composition according to claim 1, in which the ratio of calcium sulfate and viscous biopolymer is 50:50.

6. Gel, stimulating bone formation and bone healing and casting the composition of any of claim 1 or 2, in which the calcium sulfate is CaSO4or CaSO4·H2O.



 

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7 cl, 7 dwg, 1 tbl, 6 ex

The invention relates to medicine and medical technology, maxillo-facial, cranial or aesthetic surgery, dentistry, oncologically, traumatology
The invention relates to a multilayer membrane containing matrix layer consisting predominantly of collagen II and having a loose spongy structure, and at least one barrier layer having a dense, relatively impermeable structure

The invention relates to medicine, namely to arthrology, and can be used for the treatment of degenerative and post-traumatic deforming arthritis and other crippling damage to the joints

The invention relates to medicine, namely to orthopedics and traumatology, and can be used for bone grafting

The invention relates to medicine, in particular to the field of traumatology and orthopedics in the treatment of false joints and unjoining fractures of long bones
The invention relates to medicine, namely to traumatology in the treatment of hip fractures
The invention relates to medicine, namely to eteorology and orthopedics

FIELD: stomatologic techniques and materials.

SUBSTANCE: proposed membrane comprises at least two porous polytetrafluoroethylene layers: one adjusting parodentium tissues and the other being outside layer, the two having different porous structure. Layer adjusting parodentium tissues is characterized by volume portion of hollow space equal to 78-94%, specific surface of hollow space 0.5-0.9 mcm2/mcm3, average distance between hollows 20.0-50.0 mcm, and average volumetric chord 20.0-30.0 mcm. Outside layer is characterized by volume portion of hollow space equal to 30-60%, specific surface of hollow space 0.1-0.5 mcm2/mcm3, average distance between hollows 1.8-15.0 mcm, and average volumetric chord 1.0-15.0 mcm.

EFFECT: increased regenerative activity and simplified use.

7 cl, 7 dwg, 1 tbl, 6 ex

FIELD: medicine, gel composition.

SUBSTANCE: claimed composition contains calcium sulfate and viscous biopolymers and can be easily introduced into defect part of damaged bone. Composition of present invention is capable of penetration into adjacent organs and is useful as physiologically acceptable filling material for bone concretion.

EFFECT: composition to prevent growth of undesired conjunctive tissues and to induce blood vessel growth and bone osteoblast development in earlier stage.

7 ex, 9 dwg, 1 tbl, 6 cl

FIELD: medical engineering.

SUBSTANCE: method involves boiling reinforcing fabric in mixture of 10% aqueous solution of detergent powder Lotus or others, 5% aqueous solution of KOH or NaOH alkali during 45-60 min with following neutralization, removing saponated fats, activating superficial threads with 10% aqueous solution of oxalic acid, washing in running water and drying the reinforcing fabric at 25-60°C to reach humidity of 1.5-2.5%.

EFFECT: improved adhesive-cohesive reinforcing fabric properties; avoided delamination; high strength; reduced article weight.

1 tbl

FIELD: medicine.

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

FIELD: medicine.

SUBSTANCE: there is described method of obtaining of calcium phosphate nanoparticles, stabilised by salt matrix by interaction of components, first of which contains metal cation, and second contains anion. According to invention as the first component applied is water-soluble calcium salt, and as the second component, soluble orthophosphate, nanoparticles of water non-soluble calcium phosphate being formed, and salt matrix being formed from soluble by-product. Content of calcium phosphate nanoparticles in powder composite "oxide nanoparticles/salt matrix" constitutes 65-82 wt %.

EFFECT: method is aimed at creation of effective nanotechnologies, in order to prevent degradation, that is, aggregations of oxide nanoparticles of calcium phosphates.

5 tbl, 4 ex

Polymer composite // 2477627

FIELD: medicine.

SUBSTANCE: invention refers to polymer composites with the special characteristics used as medical implants, transformed structures, thermal activators and the other commercial structures. The composite comprises a polymer matrix with working temperatures exceeding fibre configuration recovery temperature, and tensile extension min. 2%, reinforced with the elements presented in the form of fibres extended in one or more directions with the fibre length min. 3 times more than the in-between distance, made of a thermal shape memory alloy.

EFFECT: invention enables producing the composite with the polymer matrix wherein high deformation cycle stability, superelasticity or shape-memory effect succeed to be brought together depending on fibre configuration recovery temperatures of the thermal shape memory alloys.

4 cl, 3 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and pharmacology, and represents a bioengineered collagen construct for reconstruction or replacement of damaged tissue, characterised by the fact that it comprises a layer of a purified collagen tissue matrix taken from the small intestinal submucosa, wherein said purified collagen tissue matrix is processed by a pharmaceutically acceptable antimicrobial agent and has the anti-microbial properties.

EFFECT: invention provides the bioengineered collagen construct with the improved antimicrobial properties.

17 cl, 11 ex, 2 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention aims at improved cement flour effective as a bone cement containing an organic ingredient consisting of one or more biologically acceptable and bioresorptive polymers, and an inorganic ingredient consisting of one or more calcium-phosphate compounds wherein the above calcium-phosphate compounds contains at least approximately 70% α-TCP. The biologically acceptable and bioresorptive polymers are specified in a group consisting of polysaccharides and salts thereof in the form of microparticles. The invention is related to the apatite calcium-phosphate cement (CPC) prepared by mixing the above cement flour with a liquid phase and curing. The invention also refers to using the injectable CPC for preparing the medical agent for treating bone defects as a tissue engineering frame, for making dental or bone implants consisting of a CPC cast.

EFFECT: preparing the improved cement flour.

19 cl, 6 tbl, 11 ex, 6 dwg

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