Synthetic graft for scleroplasty and method of its manufacture

 

(57) Abstract:

The invention relates to medicine, namely to ophthalmology, and is intended to modify the surface region and improved method of manufacturing synthetic grafts used for scleroplasty. When correction of progressive myopia invention is used to improve the mechanical strength of the connection of the graft with the sclera through the creation of favorable conditions for the germination of the connective tissue of the sclera in the transplant without significantly increasing the time of manufacture of the graft. The invention allows to significantly improve the biocompatibility of the graft. Synthetic graft for scleroplasty includes a base of desired shape from a synthetic polymeric material having a layer with pores opening on its surface facing the sclera, is different from the layer structure to improve the wettability of its surface and reduce output through the surface of the toxic compounds from the volume of the material layer. A method of manufacturing a synthetic graft for scleroplasty includes making the basis of the desired shape from a synthetic polymer macoga or other material, and surface cleaning, the base with applied layer was processed in the low-temperature discharge plasma generated in a gaseous environment to education in the surface region of the specified layer with pores other than the layer of the transition structure for improving the wettability of its surface and reduce output through the surface of the toxic compounds from the volume of the material layer. 2 S. and 9 C.p. f-crystals, 1 Il.

The invention relates to medicine, namely to ophthalmology, and is intended to modify the surface region and improved method of manufacturing synthetic grafts used for scleroplasty, in particular for the correction of progressive myopia, and can be used to improve the mechanical strength of the connection of the graft with the sclera through the creation of favorable conditions for the germination of the connective tissue of the sclera in the transplant without significantly increasing the time of manufacture of the graft. The invention allows to significantly improve the biocompatibility of the graft.

The most widely used material used currently for scleroplasty is cadaveric sclera. But the use of IRNA material is not always available;

- during the transplantation of cadaveric material tests should be performed for infections that can be transferred through the implanted material, which not only increases the cost of the material and increases the manufacturing time of transplant, but makes its use in cases of emergency;

- preservation and storage tissue of the sclera is problematic;

- implantable sclera corpses after operations scleroplasty may over time be established, which reduces the effect of the operation and makes it trudnoprohodimi.

So now develops self-direction on the use of synthetic materials.

It is known that one of the most effective methods of stopping the progression of myopia is to strengthen the sclera graft in the form of a bandage of a biological or synthetic materials, such as silicone rubber [1, 2]. To improve the operation efficiency you need robust splicing synthetic graft with the sclera of the patient. However, synthetic material requirements of low toxicity. In the case of use for a scleroplasty transplant from silicone, NDS it is characterized by an increased yield of oligomers and other toxic compounds from the volume of transplant outside. All this can lead to deterioration of the mechanical strength of the connection of the graft with the sclera and complications in the postoperative period.

More appropriate synthetic grafts for scleroplasty, selected as a prototype, are grafts of synthetic polymeric material having a layer with pores opening on its surface facing the sclera - silicone, PTFE, polyurethane, which in the manufacture impart the desired shape [3]. With proper selection of material and method of processing tissue elements in some cases get the opportunity to partially germinate in the pores of this layer and thus to provide an improved mechanical contact between the sclera and the transplant.

However, this is not always the result largely depends on the surface condition of the graft. The obstacle to this is the reduced hydrophilicity or even hydrophobicity (silicone and PTFE) is a synthetic polymeric materials, and the presence of toxic macromolecular compounds and their fragments of synthetic material. The latter causes postoperative complications worsen the STI for a new operation.

A known method of manufacturing a synthetic graft for scleroplasty [1, 2], including making the basis of the desired shape from a synthetic resin material, for example silicone, and its processing, which consists in cleaning the surface of the graft.

However, this method cannot provide a sufficiently strong mechanical connection of the synthetic graft with the sclera, because used in its manufacture surface treatment of transplant does not change its properties, while maintaining its hydrophilicity and permeability to toxic compounds that reduce the above effects, in terms of joint strength, and postoperative complications.

There is also known a method of manufacturing a synthetic graft for scleroplasty [3] was chosen as the prototype, including making the basis of the desired shape from a synthetic resin material, application of a layer with pores opening on its surface facing the sclera, is made of the same or of a different material and its processing, which consists in cleaning the surface. At the same time as the base material layer and use tetrafluoroethylene and polyurethane, and tons of opportunity for improved mechanical contact between the sclera and synthetic graft due to partial germination of connective tissue elements of the sclera into the pores.

However, this is not always the result strongly depends on the surface condition of the graft. Used in [3] treatment of transplant does not increase hydrophilicity of such material that does not create the necessary conditions for more substantial germination of connective tissue elements of the sclera into the pores and does not provide thereby a sufficient mechanical strength of the contact sclera with a synthetic graft material. In addition, this treatment does not reduce the excretion of high-molecular compounds and their fragments in the connective-tissue elements of the sclera, which also prevents the creation of the above mentioned conditions and does not improve the biocompatibility of the graft, leading to the above consequences.

The analysis allows us to formulate a specific task, aimed at the elimination of these disadvantages of the known solutions. It consists in such modifications of the transplant and how it is processed, which would increase the mechanical strength of the connection of the graft with the sclera through the creation of favorable conditions for more substantial germination of connective tissue elements of the sclera into the pores of the graft.

the Tata for scleroplasty, including the basis of the desired shape from a synthetic polymeric material having a layer with pores opening on its surface facing the sclera, according to the invention the layer with pores in the surface region is different from that of a layer of transitional framework for improving the wettability of its surface and reduce output through the surface of the toxic compounds from the volume of the material layer.

The solution of the stated problem and the achievement of a specified result is that in the method of manufacturing a synthetic graft for scleroplasty, including making the basis of the desired shape from a synthetic resin material, application of a layer with pores opening on its surface facing the sclera, is made of the same or other material, and surface cleaning according to the invention the base with a layer processed in the low-temperature discharge plasma generated in a gaseous environment, to education in the surface region of the specified layer with pores other than the layer of the transition structure for improving the wettability of its surface and reduce output through the surface of the toxic compounds from the volume is to scleroplasty (transitional structure in the surface region), and its method of preparation (type and processing conditions, transplant) demonstrate compliance of both objects of the claimed group of inventions to the patentability requirements of novelty.

The invention is made by the authors of the idea of creating favorable conditions for the germination of living tissue into the pores to increase thereby the mechanical strength of the connection of the graft with the sclera. Its implementation was possible due to the transition patterns between living tissue and the graft is located in the surface region. Mentioned transitional structure provides an implementation of this idea by giving the transplant better wettability and lower toxicity. Transitional structure improves the biological compatibility of the graft.

This structure created by the method comprising processing layer with pores of the graft in the low-temperature discharge plasma. This allows us to improve the wettability of the entire surface region of the layer, including its outer surface and the surface of the pores, and reduce output through these surfaces toxic compounds from the volume of the layer. This processing is shown in the figure, where 1 - base, 2 - layer with pores, 3 - time, 4 - transitional structure (shown conventionally by the lines thicker surface layer 2, including the surface of pores in the entire surface region, which separately in the figure is not marked).

It should be noted that to obtain a graft mentioned properties could not be used known recommendations regarding hydrophilization surface using plasma without significant modification. This is due to the lack of data on the effect on these properties of the complex form of the surface layer with pores (see Fig.), and the lack thereof, concerning the influence of pore size, degree of porosity and the material layer with pores. The very absence in the prior art mentions the possibility to transplant the above properties, by introducing mentioned transition patterns in the layer with the pores demonstrate compliance of the claimed invention, the patentability requirements for inventive step, both the device and the method of its implementation.

Thus, the implementation of the invention entails changes as constructive (non-layer structure in the surface region of the specified layer with pores), t is of such structure), who are interdependent because they are manifestations of a single inventive concept set forth in the essence of the claimed group of inventions.

The advantages proposed by the authors ideas about the need to use transition patterns is the possibility of implementing such a structure different from a structural material using the polymer chain and fragments of a material layer with pores and typed fragments of the polymer chains. This allows you to use different private decisions regarding the choice of the material layer with the pores and the basis for the preservation of the properties, provide the specified transition structure.

The specified layer with pores can be made of the substrate material along with it (i.e. made with it in a single technological process), and the aforementioned structure is formed from polymer chains of this layer and their fragments, modified with the formation of additional cross-linking between the chains. Examples of this variant is used as the base material and a layer of porous silicone or silicone, the pores of which are made in this layer in the form of a perpendicular or inclined to the surface of t is y (i.e. on the surface of the graft) regular way (for example, in a checkerboard pattern) and obtained, in particular, by acting on the surface of the laser radiation in the desired direction. Possible, of course, and a different order then chosen from considerations of ease of manufacture and provide the required mechanical strength of the connection of the graft with the sclera. In each case, use this option to create the above-mentioned structure, designed to delay the penetration of toxic macromolecular compounds and their fragments of the volume of the layer with pores in the surrounding connective tissue elements of the sclera, are used as "building material" non-toxic, chemically inert polymer chain bases, as well as parts and components of these circuits are formed when exposed to low-temperature plasma discharge directly to the outer surface of the layer with the pores and on the surface of the pores. When creating a structure of this type, it is expedient processing of the substrate with a layer of low-temperature plasma discharge to be executed in the inert gas or inert gas with a small (a few percent) the addition of oxygen to weggoro option is a transplant, where as base material used non-woven material, and a specified layer of a different polymer material, for example PTFE filter, applied on a basis. The above structure may be formed from fragments of polymer chains as the material of this layer and other material, is introduced in the surface area of this layer in the plasma polymerization with the formation of additional cross-linking between the thus formed polymer chains. To create a structure of this type, it is expedient processing of the substrate with a layer of low-temperature plasma discharge to be executed in the environment of inert gas with additives vapor of monomers, which are transformed into plasma radicals, which are deposited in the surface region mentioned layer and then forming on the outer surface of the layer and on the surfaces of the pores of the fragments of the polymer chains, other than fragments of the polymer chains of the material layer. The emergence of a large number of radicals in the process of low-temperature plasma discharge leads to the formation of additional cross-linking between the thus formed polymer chains. However, in this waialua and their fragments, modified with the formation of additional cross-linking between the chains.

It is preferable that the surface layer with pores after the formation of the above-mentioned structure is additionally covered, and the pores filled with a composition designed to improve germination tissue of the sclera. The graft remain in this form prior to its use. Due to the fact that formed in the surface region of the specified layer of synthetic graft transitional structure has the property improved wettability mentioned composition is much more uniformly spreads over the surfaces of the layer with pores and fills the pores in the entire surface region of the layer.

It should be emphasized that for forming the above-mentioned structure in the surface region of the specified layer with pores can be used in low-temperature plasma of different types of discharge generated in the gas - glow, high frequency or microwave discharge.

Unlike plasma glow discharge in the plasma of high-frequency discharge has the ability to snap conduction currents in the plasma, the bias currents in the treated graft. which of conduct in the form of such discharge and the area of flow of electric current. Compared with the microwave plasma discharge in the proposed version can be accommodated in the discharge zone, at the same time a larger number of grafts or transplants large sizes. This is due to the scalability of high-frequency capacitive discharge type, which is very essential for the organization of serial production of transplants.

Generated method proposed transition structure in the surface region of the specified layer with pores to reduce the release of toxic compounds from the volume of material has the property of long-term hydrophilicity. However, it should be noted that the processing in the low-temperature plasma, capable of improving the wettability of the outer surface layer (the surface of the graft) may not be sufficient for the formation of the above-mentioned structure in the entire surface region of the specified layer with pores. On the other hand, the effects of plasma on the outer surface layer and the surface of the pore (see drawing) can lead to the creation of the structures mentioned above, and its destruction due to degradation of the material layer by the plasma. Therefore, the influence of the plasma on these surfaces produce over time, its in the material layer 2, but not exceeding the characteristic time of development of process of destruction of the plasma surface region layer at a given gas pressure and discharge power. The process of destruction of the surface region layer in the plasma associated with the ongoing processes of plasma-chemical etching. Due to the complexity of the shape of the surface layer with pores of desired values of the plasma parameters affecting the properties of the above-mentioned structure, may vary in each case and therefore established experimentally by varying the time of exposure to low temperature plasma under specified pressure and discharge power. This varies as the thickness of the structure, and the size of the surface region. Experiments authors showed that the exposure time of low-temperature plasma layer with pores to create the mentioned transition structure varies within a wide range (from tens of seconds to tens of minutes), depending on the pore size, degree of porosity and the material layer with pores.

An example of a specific embodiment of the invention.

The invention is used for the basis of the synthetic polymeric material is silicone, PTFE, polyurethane or other materials and PCA form may be different depending on the destination. Is applied to the substrate (for example, by means of surface polymerization) layer with pores extending to the surface of the graft, addressed to the sclera, is made of the same or of a different material. Next, produce a surface cleaning as outlined, for example, in [3], and put the graft in plasma-chemical reactor directly into the area of the discharge. For this transplant is hung, for example, using molybdenum wire so that it is located between the flat electrodes. The inner space of the reactor was pumped to a pressure of less than 0.1 Top, then fill the working gas (argon) to a pressure of 0.2-2 Top. Then in a gaseous environment excite high-frequency capacitive discharge type at a frequency of 13.56 MHz, in which the graft is exposed to low-temperature argon plasma for a time sufficient for formation in the surface region of the specified layer with pores other than the layer of the transition structure for improving the wettability of its surface and reduce output through the surface of the toxic compounds from the volume of the material layer. When used as the base material and the specified layer with pores of porous silicon for forming the above-mentioned structure, the education is the development of more than 15 minutes begins the development process of destruction of the surface layer. When the exposure time to less than 12 minutes products the impact of the plasma does not have time to process the surface of pores in the surface region layer basis. The graft is created with a transition structure has the property of long-term hydrophilicity (wettability) and has low toxicity. Transition structure contributes to the compatibility of live tissue (connective tissue elements of the sclera) with a layer with pores all very complex internal surfaces of the layer surfaces of the pores). The adequacy of the processing time of low-temperature plasma of transplant to create favorable conditions for the germination of living tissue in the pores is controlled in each case as follows. Handle in fixed experimental conditions, several (5-10) of the samples at different duration (from 1 to 30 minutes) the impact of the plasma on the graft. Then for each sample, after it is put to the test medium (distilled water or a composition for filling cavities in the body), measure the concentration of a toxic component in the aqueous extract by one of known methods, for example using liquid chromatography. For the specified base material and a layer with pores (porous silicon) SNIM for the above optimal processing time (12-15 minutes). This time corresponds to the beginning of the stabilization of the dependence of the reduced output of toxic compounds from the time of processing and 3-5 times longer than the time required for hydrophilization surface region layer with pores. Time hydrophilization determined for the same samples on the saturation dependence of gain mass grafts from the processing time after removing them from the specified control environment. In the following the necessary processing time for this material was determined by time hydrophilization, increased 3-5 times. For other material layer with pores determine the optimal processing time to produce a similar way.

After processing by plasma graft is taken out of the reactor and introduced into the atmosphere (atmospheric air), after which it is ready for further use. For better conservation properties of hydrophilicity in the surface layer, it is preferable to place the graft in the vessel with distilled water or saline solution. Processed by plasma graft after filling the atmosphere of air may be placed in a vessel with a composition designed to improve the germination of sclera tissues for storage and dalneyshnie cavities in the body, and industrial produced according to TU 64-2-309-80. This polymer composition is applied when conducting scleroplastic operations and promotes the regeneration of tissues of the eye after surgery [4]. Can be used and any other composition similar purpose.

Operations for the manufacture of synthetic graft for scleroplasty described, in particular, in the specific example, may be summarized as follows:

- made the basis of desired shape from a synthetic resin material and applied to it a layer with pores opening on its surface facing the sclera, is made of the same or other material;

- carry out the cleaning of the surface of the obtained graft;

- have the transplant directly into the area of the discharge in the gas in the interelectrode gap of the plasma-chemical reactor, preferably in the middle part;

- vacuum plasma-chemical reactor and fill it with an inert gas (argon) to a pressure of 0.2-2 Top;

- stir in the inert gas in the interelectrode gap of the high-frequency capacitive discharge type;

is subjected to graft the impact of low-temperature plasma discharge in an inert gas (argon); the aqueous layer with pores other than the layer of the transition structure for improving the wettability of its surface and reduce output through the surface of the toxic compounds from the volume of the material layer with pores;

the time of exposure to plasma set experimentally for a given material, the pressure and discharge power; completion of the formation of the mentioned transition patterns in the surface region layer with pores is determined by the dependence of the reduced output of toxic compounds from the time of processing and judging by the start of the stabilization and this dependence, and subsequently this moment control based on the time to achieve steady weight gain of mass of the graft after it is put in distilled water or in a composition for filling cavities in the body;

- upon completion of the processing of the graft plasma extracted from the reactor and introduced into the ambient air, and then placed in distilled water, saline solution or composition for filling cavities in the body for preoperative storage than completing the manufacture of synthetic graft for scleroplasty.

From the above examples of embodiment of the invention, it follows that for the manufacture of graft use commercially available materials (silicone, Teflon, and others) and industrial machinery and tools for manufacturing transplant, giving it healthful on the compliance of the claimed invention, the conditions of patentability of industrial applicability.

On the other hand, the above examples are only illustrative of some forms of the invention and may not be considered as limiting of its essence, which is most fully reflected in the claims.

Literature.

1. Utkin C. F. Strengthening the sclera silicone rubber with progressive myopia. - In the book: Fifth all-Union Congress of ophthalmologists. M, 1979, T. 1, S. 157-158.

2. Ilnitsky centuries Temporary and permanent episcleral sealing in surgery for retinal detachment, its prevention. - Dis. Prof. the honey. Sciences. M., 1995.

3. J. T. Jacob-LaBarre, M. Assouline, T. Byrd, M. McDonald Synthetic scleral reinforcement materials: 1. Development and in vivo tissue biocompatibility response. Jour. of Biomedical Materials Reseach, V. 28, 699-712 (1994).

4. Composition for the treatment of progressive myopia. RF patent N 2012336 from 15.05.1994 (Authors: E. S. Avetisov, M. I. Vinetsky, E. N. It was demonstrated, and others).

1. Synthetic graft for scleroplasty, including the basis of the desired shape from a synthetic polymeric material and the polymeric layer with the pores extending to the surface of the graft, addressed to the sclera, characterized in that the layer with pores in the surface region has a transitional structure containing polymer chain and their fragmentsize transplant for scleroplasty under item 1, characterized in that the layer with pores made of the same material and at the same time with the base.

3. Synthetic graft for scleroplasty under item 2, characterized in that the graft is made of a porous silicone.

4. Synthetic graft for scleroplasty in PP.1 and 2, characterized in that the graft is made of silicone, and the pores are made in the form of a perpendicular or inclined to the surface of the graft channels.

5. Synthetic graft for scleroplasty under item 1, characterized in that the layer is then deposited on the base and is made of other than at the base polymer material, and a transition structure formed of the fragments of the polymer chains as the material of this layer and additional material, is introduced in the surface area of this layer by plasma polymerization with the formation of additional cross-linking between the thus formed polymer chains.

6. Synthetic graft for scleroplasty under item 1, characterized in that the base is made of non-woven material, and a layer with pores from PTFE microfilter, marked on base, transitional structure formed from polymer chains chains and hydrophilic groups.

7. Synthetic graft for scleroplasty under item 2, characterized in that the pores are located on the outer surface of the specified layer regularly.

8. A method of manufacturing a synthetic graft for scleroplasty, including making the basis of the desired shape from a synthetic polymeric material layer with pores opening on its surface facing the sclera, is made of the same or other material, and the cleaning of the surface, characterized in that the layer is then subjected to processing in the low-temperature discharge plasma generated in an inert gas environment, the capacity of the discharge and the duration of treatment with it mentioned layer set depending on the type of gas and pressure to education in the surface region of the mentioned transition layer structure comprising the polymer chains and fragments thereof, modified by the formation of additional cross-linking between the chains.

9. A method of manufacturing a synthetic graft under item 8, characterized in that the layer with the pores are produced by drawing it on the canvas or manufacture from base material at the same time with her in a single technological process.

11. A method of manufacturing a synthetic graft under item 8, characterized in that the discharge is a high-frequency capacitive discharge type.

 

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