Inflatable balloon (versions)

FIELD: medical equipment.

SUBSTANCE: inflatable balloon can be used for making catheters which have carrier axial polymer tube with inflatable working medium through hole in wall of tube by balloon dispose at one end and with valve unit for keeping working medium, disposed at the other end. Device is intended for curing detachment of retina by means of blocking rupture of retina under effect of wave of impression generated by inflated balloon. Inflatable balloon has end tubular taps for fastening to carrier axial tube and central inflatable part, which can take shape of sphere, or ellipse either cylinder of the balloon. Walls of balloon are made of three layers of internal and external layers of silicon rubber to have intermediate layer of polyorganosiloxane. Walls are made of three layers of internal and external layers of silicon rubber to have intermediate layer of polyorganosiloxane. According to the second version, tubular sections of silicon rubber are disposed concentrically onto surface of ends of inflatable part; the sections are integrated with the surface of tube. The sections are made for widening at balloon's bulge.

EFFECT: improved mechanical strength; reduced gas permeability.

8 cl, 2 ex, 4 dwg

 

The invention relates to medical equipment and is intended for use, for example, when creating a catheter, containing the bearing axis of the polymeric tube to inflate the working environment (liquid or air) through the hole in the tube wall of the cylinder at one end and with the valve site to keep the working environment at the other end. The invention can be used for the treatment of detachment of the retina by blocking the retinal tear under the influence of shaft depressions created by the inflated balloon.

Famous balloon-catheter, inflate the fluid (RU # 2005451, 1994).

Known also inflate the balloon-catheter, having an oval body with a saddle-shaped recess in the end portion (RU # 2109497, 1998).

Known urology and ophthalmology catheters, in which the cylinders are made of latex (Prospect "COOK Products for urology", S. 22; N. Linkoff, I. Kreessig, Prospekt "The Scleral Buckling Ballon Catheter"; the Prospectus of the company Artek medical Various medical latex products").

The disadvantage of this solution is the possibility of allergic reactions in patients (in particular, the catheters described in the prospectus "COOK Products for urology", s), the unsuitability of latex balloons for dry-heat sterilization, and limited shelf life of products.

The next anal is regarded as one of the claimed invention are selected is described in the literature balloon-catheters, made in the form of single-channel catheter tube having a distal end extending cylinder and a closed tip, and the proximal - valve for fluid retention (Kreissing I. Two new applications of the balloon procedure: Different uses of its indentation of the globe. Klin Monatsbl Augennheilked, 1989, and Movshovich A.L., Saksonova E.O., Dzidziguri E.A., Ilinitskii V.V. Modification of an inflatable balloon catheter for the treatment of retinal detachment. Vestn. Oftalmol, 1990).

In these structures the thin-walled cylinder is also made of latex, which limits the shelf life of the product makes it suitable for dry-heat sterilization. In addition, in the described construction underrepresented different configurations of cylinders in the expanded condition, the necessity of which is dictated by a variety of possible shapes and sizes of retinal breaks.

The General problem to be solved variants of the invention is to improve the operational and functional qualities of the container by creating a virtually gas-tight products with high mechanical strength, long shelf life, and the tank should have a reliable fixation in the expanded state in the place of its location and allow to produce different configurations of the balloon in the expanded state.

The problem is solved due to the fact that according to the first embodiment of the invention, the inflatable balloon contains oncewe tubular taps for mounting to the bearing axial tube and the Central inflatable tubular section, receiving at the blowing ball, or ellipsometry, or cylindrical container, and the wall of the container is made of inner and outer layers of silicone rubber with an intermediate layer of polyorganosiloxane.

The intermediate layer of the wall of the container made by the method of dipping of the compound based on high-molecular polyorganosiloxane containing reinforcing fillers and agents, vulcanization reaction of hydrosilation.

In addition, the balloon may be made with ring sublayers for fastening tubular bends to the axial tube, with an annular sublayers made of devulcanizing silicone rubber.

For the second variant of the invention the problem is solved due to the fact that the inflatable balloon includes an end of the tubular taps for mounting to the bearing axial tube and the Central inflatable tubular section, when receiving the blow of the ball, or ellipsometry, or cylindrical container, and the wall of the container is made of inner and outer layers of silicone rubber with an intermediate layer of polyorganosiloxane, while on the surface of the ends of the inflatable section arranged concentrically integrally United with the surface of the tubular segments of silicone rubber made with the possibility to expand the rhenium in the blown container.

Integrally United with the surface of the ends of the inflatable section of the tubular sections are made of silicone rubber, similar elongation of the rubber layers of the walls of the container, while the solidity of the connection segments with the surface of the inflatable section is provided silicone adhesive sublayer.

The technical result from the use of the above-described two embodiments of the invention is the improvement of the functional properties of the container due to the possibility of obtaining various forms of the balloon in an inflated condition due to the proposed construction of the wall of the cylinder and of the materials used, as well as the fixation of the advanced tank in the place of its location. This provides increased mechanical strength of the container and reducing the permeability of the walls. The design and material of the wall of the cylinder allow you to get the product during storage which its technical properties are not significantly changed, there is achieved an increase in shelf life of the product. In addition, there is a physiological inertness of the product even with long-term presence of the balloon in the patient's body, in particular, in the membranes of the eyes when using the invention in cylinders-catheters used in the treatment of retinal detachment.

Additional technical result from ispolzovanpokoleniya is the possibility of obtaining such a shape of an inflated balloon, in which the container size in the transverse direction relative to the longitudinal axis of the catheter tube is greater than its dimension in the longitudinal direction. This form of container is required, for example, to extend the possibilities of block breaks in the retina of different configurations. Having on diametrically opposite surfaces of the inflatable balloon integrally United with these surfaces of the tubular segments complicates blowing cylinder along the axial tube and directs this blowing in the transverse direction.

It is known that silicone rubber causes physiological inertness of the product and long term storage, but due to the low mechanical strength of silicone rubber made from it, the balloon may break down under the blow. One reason for this may be the microdefects in the thickness of the wall of the container, if you make it a single layer of silicone rubber.

In addition, it is known that a thin silicon films (membranes) have a high permeability (see encyclopedia of polymer. M: Soviet encyclopedia, 1972, vol. 1, s-590), resulting in a relatively rapid decrease in the volume of the inflatable single layer balloon made of silicone rubber due to the diffusion of the internal volume of the container.

Medico-technical result from the use stated in the ways of the invention based on the implementation of the walls of the container three-layer, which greatly increases its strength when blown in comparison with a single-layer design with equal wall thickness. theory of the mechanical strength of rubber is known that with increasing thickness of the layer of rubber increases the risk of defects in the thickness of the layer and, accordingly, the risk of reduction in the tensile deformation, for example, when the blowing of the container. In this regard, even two-layer wall structure of the container substantially increases its strength compared to the single layer design with an equal thickness. In the claimed invention further increase the mechanical strength provides an intermediate layer of polyorganosiloxane. The influence of the intermediate layer to increase the mechanical strength of the whole structure is in the "healing" of possible micro defects on the surfaces of the layers of the walls of the container and also as a result of their adhesive connection (bonding). Thus it can be assumed that due to the presence of the two boundary surfaces in the wall thickness of the container provides a significant reduction in gas permeability. The introduction of an intermediate layer of polyorganosiloxane enables to preserve the useful properties of silicone rubber, to significantly increase the mechanical strength, reduce permeability, to ensure that the manufacture of the cylinder roseiformis in an inflated condition and to improve its functional and performance properties.

The invention is illustrated by drawings, which depict:

figure 1 is a first embodiment of the invention with the balloon in naraguta state;

figure 2 - the same with the balloon in an inflated state;

figure 3 is a second embodiment of the invention with the balloon in naraguta state;

figure 4 - same with the balloon in an inflated condition.

Balloon inflatable silicone attached to the bearing axial tube 1, made of silicone rubber or other materials and having a hole 2 for feeding the working environment. The wall of the cylinder formed by the inner 3 and outer 4 layers of silicone rubber, between which there is an intermediate layer 5 of polyorganosiloxane. This intermediate layer 5 is formed when polyorganosiloxane in liquid initial state or in the form of a solution in a volatile solvent is applied to the surface of the inner layer 3 of the wall of the cylinder, then after removal of the solvent is installed from above the outer layer 4. The intermediate layer can be formed, in particular, by dipping method of the compound based on high-molecular polyorganosiloxane containing reinforcing fillers and agents, vulcanization reaction of hydrosilation.

As polyorganosiloxane can be used low molecular weight (liquid) or high molecular weight (plastic) polymer material and the compound containing in addition to polyorganosiloxane known ingredients, including vulcanizing agents. In the latter case, the heat treatment of the resulting construction is curing the intermediate layer.

End of the tubular branches 6 are intended for fastening to the bearing axial tube 1. Central inflatable section 7 of the container having naraguta state a tubular shape, when blown accepts spherical, or ellipsoidal, or cylindrical shape defining the shape of the container in working condition.

The cylinder is made with a ring sublayers 8 of devulcanizing silicone rubber for mounting tubular branches 6 to the axial tube 1.

Figure 3 and 4 shows the container with the surface of the ends of the inflatable section 7 concentrically arranged integrally United with the surface of the tubular segments 9 of silicone rubber made with the possibility of expansion in the blow tank. Tubular segments 9 are made of silicone rubber, similar elongation of the rubber layers of the walls of the container, while the solidity of the connection segments with the surface of the inflatable section is provided silicone adhesive sublayer.

Examples of implementation of the invention.

Example 1. Using known techniques, as well as the data above were made about azzy catheters (series a), equipped stated inflatable cylinders in the first embodiment of the invention.

Bearing axial tube 1 made of medical silicone rubber and had an inner diameter of 1 mm, outer diameter 2 mm, length - 100-120 mm

The inner 3 and outer 4 tubular layers of the wall of the container has a thickness of 0.3 mm, a length of 18-20 mm and was made of medical silicone rubber of high elasticity. The intermediate layer 5 is made by dipping method of the compound based on high-molecular polyorganosiloxane. The compound contained reinforcing fillers and agents, vulcanization reaction of hydrosilation. Ring sublayers 8 made of devulcanizing silicone rubber and had a width of 3-4 mm, a thickness of 0.3-0.5 mm After installation of the tip carrier tube (from the cylinder) was produced by heat treatment of the obtained billet catheter within 2-4 hours at a temperature of 180°C. Then on the opposite end of the carrier tube installed valve node.

On the similar technology has made reference samples (series b), in which the container is made in the form of single-layer structures with a wall thickness of 0.6 mm At a statistically significant tests was determined by the strength of the cylinders when they are filling the working environment (saline) up to a volume of 2.5 ml

It was found that in Seri is destroyed In up to 35-40% of the samples, in series And destruction were not found.

It was also noted that when filling cylinders working environment in a quantity of 2 ml and the extract within 24 hours the samples of the series And better preserved dimensions of the container than the samples of series C.

Example 2. On part of the samples of the series And on the surface of the ends of the inflatable section 7 were installed concentrically integrally United with the surface of the tubular segments 9 of silicone rubber, similar to its elasticity rubber inner 3 and outer 4 layers of the wall of the cylinder. The wall thickness of the tubular segments 9 - 0.3 mm, length 6-8 mm Monolithic connection of the segments with the surface of the inflatable section 7 provided silicone adhesive sublayer 8. When filling cylinders series of samples and new samples (series C) the working environment in the amount of 1.5 ml was established that the tubular segments 9 are expanded together with the cylinder. The values of the ratios of the length of the cylinder in the longitudinal direction to the length of the cylinder in the transverse direction:

Series aSeries
1,20,85

It is seen that the tubular segments (series C) provides a greater expansion of the cylinder in the transverse direction.

1. The inflatable balloon containing end of the tubular taps for mounting to the bearing axially the tube and the Central inflatable section, host when blown spherical, or ellipsoidal, or cylindrical shape of the container, characterized in that the wall of the container is made of three-layer of the inner and outer layers of silicone rubber with an intermediate layer of polyorganosiloxane.

2. The container according to claim 1, characterized in that an intermediate layer of polyorganosiloxane deposited on the inner layer and the intermediate layer has an outer layer of silicone rubber.

3. The container according to claim 2, characterized in that for obtaining the intermediate layer used polyorganosiloxane in liquid initial state or in the form of a solution in a volatile solvent.

4. The container according to claim 2, characterized in that the intermediate layer is made by dipping method of the compound based on high-molecular polyorganosiloxane containing reinforcing fillers and agents, vulcanization reaction of hydrosilation.

5. The container according to claim 1, characterized in that it is made with a ring sublayers for fastening tubular bends to the axial tube, with an annular sublayers made of devulcanizing silicone rubber.

6. Balloon inflatable silicone containing end of the tubular taps for mounting to the bearing axial tube and the Central inflatable tubular section, when receiving the blown spherical, or ellipsoidal, or cylindrical shape of the container, the tives such as those the walls of the container are composed of inner and outer layers of silicone rubber with an intermediate layer of polyorganosiloxane, while on the surface of the ends of the inflatable section arranged concentrically integrally United with the surface of the tubular segments of silicone rubber made with the possibility of extension at the blowing of the container.

7. The container according to claim 6, characterized in that the integrally United with the surface of the ends of the inflatable section of the tubular sections made of silicone rubber, similar elongation of the rubber layers of the walls of the container, while the solidity of the connection segments with the surface of the inflatable section is provided silicone adhesive sublayer.



 

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