Device for delivery of medicinal preparation, method of manufacture and application of the device

FIELD: medicine.

SUBSTANCE: method and device can be used for selective treatment of ill parts of tissue or organs of human bodies. Surface of medicinal devices being in contact with mentioned parts of body under pressure of medicinal devices are covered with lypophile, mainly water-insoluble medicinal aids being capable of connecting with any components of tissue, which medicinal preparations effect onto tissue immediately after contact and they effect for very short period of time without making dangerous effect onto adjacent healthy tissue. Device has balloon which surface is connected with lypophile, water-insoluble medicinal preparations being capable of binding with tissue. After contact with tissue is made, medicinal preparations are capable of instant release of biological active matters. Balloon is provided with preformed longitudinal folds. Biological active matter covers parts of balloon hidden by folds.

EFFECT: higher efficiency of treatment.

20 cl, 11 ex

 

The invention relates to a device for issuing medicines for selective treatment of certain sections of tissues or parts of bodies and method of making such coated drug devices, and also relates to a method of its manufacture and to its use.

Many diseases affect not the entire body simultaneously, and is limited to certain types of fabrics, often separate, very local areas of tissues or parts of bodies. Examples are tumors, diseases of the joints and blood vessels.

Medical treatment of these diseases is mainly due to oral or intravenous input medicines, which are distributed throughout the body and in many cases it is for serious diseases cause adverse effects in healthy tissues and organs, limiting their application. Selective treatment of the tissue was achieved through tied specifically to the diseased tissue of medicines (e.g., antibodies) with preservation of the application or by selectively introducing, for example, direct injection into the affected tissue or supply through the catheter to supply diseased tissue blood vessels. If the sampling rate from the greater part of the short duration of action of the drugs and invasive methods villas have problems, because arbitrarily repeatable cottage is prohibited. When sampling through the introduction of supplying the diseased tissue in the bloodstream have the additional problem of insufficient extraction of medicines with the rapid passage of blood or solution of biologically active substances through the blood vessels.

These problems are still solved by drugs with a slow release of biologically active substances which release drug implants or for a longer time through selective access paths, such as implanted catheters, etc.

We already know the coated surfaces are placed in the body of medical devices, including catheters, means for improving the slip or to prevent blood clotting, however, without remedial action.

In addition, catheters provide special devices for injection of drugs into the arterial wall, such as through a needle or through a high pressure adjacent to the vessel wall perforation of the wall of the catheter.

Other principles are based on the increased time of contact between the wall of the artery and applied through the catheter a composition of biologically active substances, when appropriate period of time to stop the blood flow, for example, using two who llandogo catheter located between the cylinders, filled with a solution of a medicinal product chamber or cavity provided between, for example, by thickening the outer wall of the cylinder, and the flow can, to a limited extent to support due to passing through the cylinder channel.

In the US 5102402 medicines in the form of microcapsules for the sustained release of biologically active substances is placed in a pre-made grooves balloon catheters. After the expansion of the container microcapsules must be embedded in the vessel wall, stay there and slowly release the biologically active substance. Numerous authors offer also apply to balloon catheters placed in the hydrogel medicines and function of the hydrogel as the adhesion means remains open to improve slip or slow release of drugs.

The disadvantage of these products in any case is a complex structure with relevant problems in the manufacture, quality control and cost, as well as additional burdening of the doctor-patient operations in the application. Part of these methods leads to very undesirable damage to the vessel beyond its deliberate expansion. On the other hand, any way provided to increase the contact time of the events which e has the additional consequence of insufficient supply of tissue with blood and oxygen.

Completeness sake, it should still refer to the one described in WO 01/24866 device for preventing restenosis, covered from natural cell membranes lipid ceramide. This substance is used because it is not found in common medications affinity with the cell walls of the arterial wall. In the literature, however, still dominates the view that drug prevention of restenosis requires release necessary biologically active substances within days.

The basis of the invention lies in the task of creating a device for a limited defined areas of tissue or parts of bodies of the issuing of a medicinal product which no harmful effects would be of a strong therapeutic effect on healthy tissue, little burdened be patient and could be applied and be manufactured with low cost.

According to the invention this problem is solved by a device made in accordance with the characteristics of items 1 and 15 formula. Dependent points, there are other signs and preferred improvements of the invention.

Thanks to the invention easiest way for you to make superior, carrying medicine balloon catheter or similar medical device, with the possibility of multilateral application and ensure asiausa instant release of biologically active substances. Unexpectedly and contrary to popular belief, does not require any prolonged release of biologically active substances from an inert matrix (polymer, hydrogel microcapsules etc) or special chemical or physical conditions of biologically active substances. Therefore, do not require sophisticated technology to produce and control Depotformulierungen.

The coating on the catheter balloons drugs, according to the invention is of particular advantage, because after the expansion of blood vessels or other cavities in the body with the help of the cylinders there is often a need for therapeutic measures to prevent narrowing or blockage created by the container under pressure of the lumen, to limit tumor growth or to promote the healing process, including the establishment of collateral circulation. This can be achieved through drugs, showing their effects in the immediate vicinity of the surface of the cylinder. Drugs on the way to the goal - in most cases through intensively washed by the blood of the artery until inflating the balloon have a strong adhesion with him, then a short, often lasting only seconds contact time is pressurized cylinder with cloth issued in effective dose and absorbed it with the ability Ave is in preventing flushing flow, immediately recovering due to the blowing of the container.

For coverage provided according to the invention, the wire used for input of catheters, needles and catheters or part of the catheter, pressed against the diseased tissues, at least for a short time. Preferred materials catheters are polyamides, polyamide mixtures and copolymers, polyethylene terephthalate, polyethylene and copolymers, polyurethane, natural rubber and its derivatives. The length and diameter provided for medical treatment plots catheters or balloons is not critical for the application, because the dosage calculated as micrograms of biologically active substances 1 mm2surface. For example, expansion of coronary vessels distributed cylinders with a diameter of 2-4 mm and a length of 1.0 to 4.0 mm For other vessels can also be used cylinders with a diameter up to >20 mm and a length of >10 see Covered surface can be smooth (i.e. without a special structure for the absorption of biologically active substances), roughened or provided with structures in an arbitrary manner, and special surface structures are not a condition of adhesion of biologically active substances, however, and do not hinder adhesion. Adhesion of biologically active substances from the surfaces of the container caused solely by the choice of K is included solvents or affecting adhesion additives. She is unexpectedly strong even on perfectly smooth surfaces of the container.

All surfaces can additionally be covered or can be covered with substances which improve the sliding of the products, prevent blood clotting on the surface or improve other properties of medical devices without the need of issue in the surrounding area used to cover materials and without significant restrictions due to coverage of the impact of biologically active substances for the treatment of the target tissue and thereby efficiency.

Balloons catheters formed from very thin plastic tubes by expanding segment of length 1-10 see Enhanced, very thin-walled balloon membrane is folded in several located along the axis of the catheter folds and firmly wound around the axis of the catheter, so that the extended section is in the folded state of slightly larger diameter than the rest of the catheter. Tight folding of the balloon membrane is a prerequisite for the passage of the balloon catheter without problems through the introduction gateways, guiding catheters, and, for example, strongly narrowed segments of blood vessels.

The balloons of the catheters can be folded and unfolded States are covered, and in any case, achieving a solid, fairly uniform coverage of the surface, and biologically the active substances, even while covered folding of the folded balloon catheter have strong adhesion to the surface.

Manufacturer covered in the unfolded condition of the container is not breaking cover, for example, through the use of balloon membranes with pre-formed folds and bends, the structure in which the material is not lost under tension and which, after discharge pressure from the cylinder cause the balloon sheath again properly, at least freely formed without requiring external force as the root cause. Only after this pre-formed folds compress to the outside or through a vacuum. In any case, the folds do not require fixing a biologically active substance. In addition, the folding may be due to a slight mechanical effort by a very smooth material, and the tools can also be moistened, for example, slippery biocompatible fluids, in which biologically active substances do not dissolve or at least dissolve poorly.

According to another variant of the invention the cylinders finally folded balloon catheter cover by immersion in low viscosity solutions of active substances. Solvents and biologically active substance penetrates between the extremely narrow folds and form there unexpectedly uniform and reproducible dose coverage, not damaged in any other servant of the what stage. Stuck outside the solution or stuck outside after drying the solvent of the coating can be left there or on an additional working step, to remove, so it remains closed folds of the balloon biologically active substance.

After covering with the folded balloon to put on a balloon catheter stent and extrude it. After that you only need sterilization, for example, by ethylene oxide.

Done this way the operation is extremely simple, little prone to failure and may also be provided with a mechanically, chemically and physically receptive coating materials. It turned out that the floor in this way does not lead to undesirable weakening or bonding folds and that caused by biologically active substance is firmly sticks, not Sivas the path of blood, and, on the other hand, when the inflation of the balloon at the target tissue substantially releases the biologically active substance.

As medicines are considered lipophilic, substantially water-insoluble, communicating with any components of the fabric, very effective drugs. Lipophilic called medicinal product, the distribution coefficient which butanol: water buffer pH=0.5, and preferably = 1 and particularly p is edocfile = 5 or octanol: water buffer pH=7=1, preferably = 10 and particularly preferably >50. Alternatively or additionally medicinal >10%, preferably >50% and particularly preferably >80% should reversibly or irreversibly to contact the component parts of the cell. Preferably the substances to suppress cell proliferation or inflammatory processes are antioxidants, such as paclitaxel and other taxanes, paromycin and related substances, tacrolimus and related substances, corticoid, sex hormones (estrogen, estradiol, anti-androgens) and related compounds, statins, epothilone, probucol, prostacyclins, inducers of angiogenesis, etc.

Substances are found on the surfaces of various medical devices preferably in the form of dry solids or in the form of oil. It is preferable that particles of a minimum size (for the most part <5 μm, preferably <5 μm, particularly preferably <0.1 ám), particularly preferably amorphous, non-crystalline structure of the particles of a minimum size, which upon contact with the tissue because of its large surface, despite the fundamentally low solubility drugs quickly into solution and does not act as microcapsules, i.e. dissolve spontaneously and quickly. Enough that the effective dose of them is for the smallest form or amorphous particles; large particles, however, almost do not contribute to the concentration of biologically active substances in the tissue, however, not prevent it. The dosage depends on the desired action, and the effectiveness of the drug. It can reach up to 5 μg/mm2and this is not the upper limit. Smaller dosing easier to implement.

Good adhesion to the surfaces of catheters, needles or wires in the absorption in the tissue is achieved by placing highly lipophilic, poorly water-soluble biologically active substances in a readily water-soluble matrix material. As a matrix substances suitable low molecular weight (molecular weight <5000 D, preferably <2000 D) a hydrophilic substance, such as used in vivo contrast agents and dyes for different diagnostic methods in medicine, sugar and related substances such as sugar alcohols, low molecular weight glycols, biocompatible organic and inorganic salts, for example benzoate, salts and other derivatives of salicylic acid, etc. as contrast agents should indicate iodinated x-ray contrast media and paramagnetic chelates, and examples of the dyes are indocyanine green, fluorescein and methylene blue. Excipients can serve also for str is Ksenia food storage, to call a special additional pharmacological effects or to serve for quality control.

In another implementation of pharmaceutical bioactive substances can adsorb on the particles or with a low molecular weight matrix is applied on the surface of suitable medical devices. As particles suitable known as biocompatible diagnostic tools, such as ferrites, and various contrast agents for sonography.

Excipients of all types can be applied to a greater or lesser dose than the biologically active substance.

The coating of medical devices is done through a solvent, suspendida or emulsifying environments named drugs and auxiliary substances. Suitable solvent, suspendresume or emulsifying environments are, for example, ethanol, isopropanol, ethyl acetate, diethyl ether, acetone, dimethyl sulfoxide, dimethyl formamide, glycerol, water or mixtures thereof. The choice of solvents depends respectively on the solubility of the biologically active substances and additives, as well as from wetting the coated surfaces and the impact on the structure remaining after evaporation of the solvent of the coating and the particles, their adhesion to the surface and transfer of biologically active substances in the tissue within a very short in which the time of contact.

The application can be carried out, for example, by dipping, smearing, devices for measuring the volume or sputtering, respectively, at different temperatures and, if necessary, saturated solvent vapour in the atmosphere. The process can be repeated many times, if necessary, also with the use of different solvents and auxiliaries.

Cylinders folded balloon catheters may be coated by dipping in containing the biologically active substance solution or other measures surprisingly evenly, with playback capability, regulation on the dose and without compromising the function of the catheter. When you dive in unsaturated solutions of biologically active substances does not occur, contrary to expectation, the total separation of pre-printed biologically active substances, and is reproducible increase in its content in the cylinders.

Excess solution or excess, loosely adhering on the outside of a substance from a solution of the coating can be removed by simple methods without compromising the effectiveness of the coating.

Performed, according to the invention, and manufactured medical devices of all kinds come into contact with the tissue of short-term, i.e. within seconds, minutes or hours. In some cases it is desirable medical treatment of tissue in eposredstvennoe proximity to medical devices for example, the prevention of excessive growth as a reaction to trauma, reduction of tumor growth, facilitating the penetration of blood vessels or reduce inflammatory reactions. In all these cases described above it is possible to achieve a high local concentration of the drug in a long, surprisingly, time. A significant advantage is the extreme diversity of the possible applications of the described products and methods.

One preferred application is the reduction of hyperproliferative blood vessels caused by vasodilatation balloon catheters. This is achieved in the implanted area, if necessary, support vessels (stents) also due to their coverage of drugs, however, only directly closed by the stent portion of the vessel. Coated balloon catheters process, besides requiring treatment sites before and after stent, they can handle without re-implantation of the stent of land within existing stents or vessels, which should not or cannot be implanted stent. Compared with stents, releasing the drug over a long period of time is the best healing with good braking hyperproliferative, and decreases the risk trom the oz.

Below are described several forms of execution of the invention on the example coating balloon catheters, and for coating adhesion in blood, inhibition of restenosis and content of biologically active substances in the catheter.

Example 1. Floor pressurized balloon catheter paclitaxel in ethyl acetate Balloon catheters company BMT, Oberpfaffenhofen/Munich, Germany type of Joker Lite, the container size is 2.5×20 mm, after the maximum inflation dipped for 1 min in the entire length of the cylinder in ethyl acetate, 18,8 mg paclitaxel/ml +1% medicinal olive oil and dried: the content of paclitaxel 39 µg (after extraction with ethanol, HPLC-method).

Example 2. The floor of the deflated balloon catheter paclitaxel in ethyl acetate Balloon catheters company BMT, Oberpfaffenhofen/Munich, Germany type of Joker Lite, the container size is 2.5×20 mm, folded immersed for 1 min. across the length of the cylinder in ethyl acetate, 18,8 mg paclitaxel/ml +1% medicinal olive oil and dried: the content of paclitaxel 69 mcg.

Example 3. The floor of the deflated balloon catheter paclitaxel in ethyl acetate

a) Balloon catheters company BMT, Oberpfaffenhofen/Munich, Germany type of Joker Lite, the container size is 2.5×20 mm, folded dipped for 1 min over the entire length of the container ethyl acetate, 18,8 mg paclitaxel/ml +1% medicinal olive mA is La and dried 4 h: contents of paclitaxel 54 mcg.

b) Exactly the same, but 2 times for 5 seconds and dried for 1 h after each immersion in a solution (=to 3.33 ml ethyl acetate +100,0 ml paclitaxel): the content of paclitaxel 126 mcg.

C) Exactly the same, but 4 times in 5 seconds with drying for 1 h after each immersion in the same solution: the content of paclitaxel 158 mcg.

Example 4. The coated balloon catheter paclitaxel in acetone 350 ml paclitaxel dissolved in 9.0 ml of acetone. Balloon catheters company BMT, Oberpfaffenhofen/Munich, Germany type of Joker Lite, the container size is 2.5×20 mm in maximum pressurized state is dipped for 1 min for the entire length of the cylinder is recovered and the solvent is dried at room temperature for 12 hours Then the balloon and blow off with PTFE coated tool is folded in the usual way. As an option on the cylinder can be clamped stent appropriate size: 29 mcg paclitaxel on the container.

Example 5. The coated balloon catheter paclitaxel in acetone

a) Folded balloon catheters company BMT type Allegro, the container size is 2.5×20 mm, immersed in a mixture of 0.15 ml of ethanol +4,5 ál Ultravist 300 (x-ray contrast agent of the company Schering AG, Berlin, Germany) +1,35 ml acetone +0.8 mg Sudan red +30.0 mg of paclitaxel.

The folded segments of the balloon catheter is dipped 5 times: 1 time for 1 minute, then drying for 3 h, then 4 times 5 cut the d with an interval of 1 h; then clamp the stent and the catheter with the stent in the usual manner sterilized with ethylene oxide, the content of paclitaxel 172 mcg, the absence of detectable HPLC-method decomposition products of biologically active substances.

b) Instead of Ultravist 300 add saturated aqueous solution of mannitol.

C) Instead of Ultravist 300 add saturated aqueous solution of sodium salicylate, pH 7.5.

g) In a ready solution after 5A add 5 mg of acetylsalicylic acid.

d) In a ready solution after 5A add 5 mg of glycerin.

Example 6. Adhesion of biologically active substances in the blood

Used 12 balloon catheters company BMT type Allegro, the container size is 2.5×20 mm Every 6 pieces of folded segments of cylinders catheters were immersed either in 0.15 ml of ethanol +4,5 ál Ultravist 300+1,35 ml acetone +0.8 mg Sudan red +30.0 mg of paclitaxel or 1.5 ml ethyl acetate +0.8 mg Sudan red +31,0 mg paclitaxel 5 times: 1 times for 1 min, then dried for 3 h, then 4 times in 5 seconds with an interval of 1 h: then 3 folded balloon each the series is slightly moved in 50 ml of human blood for 5 min at 37°S, and then removed for analysis of the content of paclitaxel: decrease of average values (n=3 for each method of coating due to the 5-minute moving in the blood compared to every three control catheters, is not administered in the blood).

Aceto is: 12%

The ethyl acetate: 10%

Example 7. The study of inhibition of restenosis after angioplasty and stent implantation in coronary vessels pigs

Folded balloon catheters company BMT type Joker Lite, the container size is 2.5×20 mm or 3.0×20 mm was immersed for 1 minute or in a solution of 3.33 ml of ethyl acetate (EA)+100.0 mg of paclitaxel, or in solution In 0.45 mg ethanol +100 ál of Ultravist 300+4,5 ml of acetone (Ac)+150,0 mg paclitaxel and dried overnight at room temperature. Another (small dose = L) or 4 (high dose =N) of the immersion process was carried out only for 5 seconds, the next day, with a break of 1 hour

The content of biologically active substances after two immersion in the solution In an average of 250 mcg, when five-time immersion in a solution of 500 mg, and in a solution of 400 mcg.

A total of 22 pigs with covered paclitaxel catheters or uncoated catheters into the left coronary artery anterior or right side were implanted stents, and for stimulation of restenosis vessels slightly stretched by the hyperplasia tissue. After 5 weeks, the animals were subjected to reinvigorate and measured the degree of narrowing of the vessel on angiograms using an automatic computer program.

GroupStenosis (%)
Without coating50,49
AcL20,22
EAN36,01
ASN0,86
P0,004

Quantitative coronary angiography after 5 weeks after implantation of the stent with uncoated and coated catheters; stenosis = percentage reduction in lumen diameter in the zone of the stent compared to the lumen diameter immediately after stent implantation: mean value and statistical significance of the treatment effect.

Example 8. The content of biologically active substances after the expansion vessel and stent implantation.

Cylinders of example 7 after stent implantation and extraction of the animals were separated for a length of about 3 cm from the balloon catheter was immersed in 1.5 ml of ethanol. The content of paclitaxel was determined by HPLC method. Have studied all available covered cylinders and selection of uncovered struts.

Coronary vessel:

- 3,0×20 mm plating: AU high 38±4 μg (n=4), As low 22±5 mcg (n=2), EEE high 41 µg (n=1);

to 3.5×20 mm, floor: Ac high 37±10 μg (n=8), Ac low 26±b ág (n=8), EEE high 53±9 μg (n=9);

- uncoated (regardless of size and area of the vessel) of 0.9±1,0 µg (n=7). Example 6 shows that a maximum of 10% of the dose is lost before the balloon Boo is no inflated, and about 10% of the dose remains in the container.

Example 9

Probucol enter in acetone at a concentration of 100 mg/ml; the solution is used for coating balloon catheters, as described in the previous examples.

Example 10

Rapamycin is dissolved in diethylether at a concentration of 10 mg/ml of Coating parts of balloons catheters carried out as described in the previous examples; after removing from the solution coating cylinders should be as soon as possible horizontally oriented, and always turn around their longitudinal axis.

Example 11

Epothilone In dissolved in ethyl acetate at a concentration of 2 mg/ml; the solution is used for coating balloon catheters, as described in the previous examples.

1. A device for issuing medicines for the treatment of patients tissue sections or parts of organs, including the bladder, the surface of which is linked lipophilic, water-insoluble, communicating with the tissues of drugs with opportunity after contact with the tissue instantaneous release of biologically active substances, characterized in that the container has a pre-molded, longitudinal folds, and the biologically active substance covers closed folds the sections of the container.

2. The device according to claim 1, characterized in that the container is made of a smooth material, which linked Lech is only means.

3. The device according to claim 1, characterized in that the balloon is covered in the folded state by dipping, spreading, spraying or applying through the device volume measurements in low-viscosity solution of biologically active substances.

4. The device according to claim 1, characterized in that the lipophilic drugs are substances for inhibition of cell proliferation or inflammatory processes or antioxidative.

5. The device according to claim 4, characterized in that the drugs are paclitaxel and other taxanes, rapamycin and related compounds, tacrolimus and related substances, corticoid, sex hormones and related compounds, statins, epothilone, probucol, prostacyclins, or inducers of angiogenesis.

6. The device according to claim 4 or 5, characterized in that the lipophilic drugs are on the surface of the cylinder in the form of dry solids or oils.

7. The device according to claim 6, characterized in that the effective dose of drugs includes a structure with a particle size of <0.1 to 5 microns.

8. The device according to claim 1, characterized in that the medicinal product is placed in an easily water-soluble matrix material.

9. The device according to claim 8, characterized in that the matrix substance consists of low molecular weight hydrophilic substances with molecules of the nuclear biological chemical (NBC weight< 5000 D.

10. The device according to claim 1, characterized in that the lipophilic drug absorbed on the particles or deposited on the surface of the cylinder with low-molecular matrix.

11. The device according to claim 1, characterized in that the cylinder is additionally coated with substances to impact on the ability to slide or to reduce blood clotting.

12. A method of manufacturing a device according to claims 1-11, which consists in the fact that lipophilic drugs and excipients in a solvent, suspendida or emulsifying medium applied to the surface of the balloon in the expanded state by dipping, spreading or spraying, noise free environment coupled with the surface of the substance is removed and the folding cylinder is performed by the tool, with the ability to slide.

13. The method according to item 12, characterized in that the coating process carried out repeatedly.

14. The method according to item 13, wherein as solvent, suspendida or emulsifying environments used ethanol, isopropanol, ethyl acetate, diethyl ether, acetone, dimethyl sulfoxide, dimethyl formamide, glycerol, water, or mixtures thereof.

15. The method according to one of PP-14, characterized in that the coating on the cylinder is applied before or after sterilization without stent or placed stent.

16. The method according to item 12 characterized in that what tool for folding cylinder moisten biocompatible lubricants.

17. The method according to item 12, wherein the stent is mounted on the device before or after the coating process.

18. The method according to item 12, wherein the device is coated sterilized by ethylene oxide.

19. The application is made and manufactured by p devices for treatment of vascular diseases or disorders of the blood supply.



 

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14 cl, 4 ex

FIELD: medicine.

SUBSTANCE: endovascular bifurcation implanted prosthetic appliance can be used in X-ray-endovascular surgery for restoration of changed parts of clearings of blood vessels, for example, of aneurysm of thoracic part of aorta or abdominal aneurysm. Prosthetic appliance has main case provided with bifurcation in distal part and two legs form of extended polytetrafluoroethylene and strengthened from outside by self-widened metal stenter made of zigzag-curved wire, which form cylindrical surfaces. Prosthetic appliance is made integral and it is provided with envelope of extended polytetrafluoroethylene, which covers metal stenter by two guiding branches - shorter and longer ones, as well as fixing threads for shorter and longer branches. Shorter branch has ring at its proximal end to let longer branch go. There is thread-extender onto distal end. Shorter and longer branches are attached to prosthetic appliance by fixing threads for shorter and longer branches correspondingly by means of loop-shaped easily loosing seam. Fixing thread for longer branch has one its end attached to distal end of leg and it reaches proximal end of main case. Fixing thread of shorter branch is attached close to distal end of leg and it attaches shorter branch until point of bifurcation. Branches are connected higher than point of bifurcation of main case.

EFFECT: prevention of replacement of prosthetic appliance due to complications; simplicity and high comfort of implantation operation.

8 cl, 10 dwg

FIELD: medical engineering.

SUBSTANCE: device has extracardial ventricular meshed envelope of anatomical shape manufactured from biocompatible flexible material. Titanium nickelide-based alloy is selected as the biocompatible flexible material. The meshed envelope structure is formed with jersey fabric texture from titanium nickelide fiber of 15-150 mcm diameter with mean mesh size of 4.5-5.5 mm. Meshed envelope volume is 8-12% as small as the volume of hear covered over myocardium surface in diastolic ventricle cycle phase.

EFFECT: prolonged service life; enhanced effectiveness in holding heart dilatation.

4 dwg, 1 tbl

FIELD: medicine; medical equipment.

SUBSTANCE: method and device can be used in small-invasive operative gastroenterology when curing morbid obesity. At least two deflated balloons of device are introduced into stomach. Balloons are introduced one after another with time interval of 7-10 days. Any balloon is inflated just after it is introduced. At bad endurance, at least one balloon is removed from stomach. Hypersthenic patients are capable of keeping in stomach at least three balloons of 150 ml each. Asthenic patients are capable of holding two balloons of 150 ml each. Device has excess pressure source provided with aid to make dismountable joint with working balloon. Balloon has volume of 150-250 ml and its walls have thickness of 0,9 mm max. Balloons are inflated just after they are introduced. Any working balloon is made of elastic material on base of silicon; balloon is disposed in retaining envelope and it is provided with back valve. Maximal size of back valve does not exceed 2/3 diameter of balloon.

EFFECT: reduced traumatism of treatment; simplified procedure.

7 cl, 2 dwg, 2 ex

FIELD: urology.

SUBSTANCE: drainage can be used for draining different (pyeloureteral, uretero-ureteral and uretero-vesical) anastomosis as well as anamostosis at urine derivation after cystectomy into continuous abdominal tube, suspending uro-ostomy, and orthopedic intestinal conduct. Urinary tracts drainage is made of elastic biological inert polymer material; it has diameter of 5-10 Ch and it can be installed by means of conductor. Drainage is made in form of spiral with length of 7-10 cm and with pitch of 5-7 turns per 1 cm; spiral is made of inert elastic organic polymer thread with diameter of 0,2-0,4 mm. Spiral turns on to non-spiral part made of same material to have length of 40 cm. Bigger relation of diameter-length and absence of continuous wall provide adequate drainage which helps to prevent atony of ureter and reduces chance of periureteritis due to limiting contact between drainage and ureter and due to higher elasticity of drainage.

EFFECT: improved efficiency oft treatment.

7 dwg

FIELD: urology.

SUBSTANCE: drainage can be used for draining different (pyeloureteral, uretero-ureteral and uretero-vesical) anastomosis as well as anamostosis at urine derivation after cystectomy into continuous abdominal tube, suspending uro-ostomy, and orthopedic intestinal conduct. Urinary tracts drainage is made of elastic biological inert polymer material; it has diameter of 5-10 Ch and it can be installed by means of conductor. Drainage is made in form of spiral with length of 7-10 cm and with pitch of 5-7 turns per 1 cm; spiral is made of inert elastic organic polymer thread with diameter of 0,2-0,4 mm. Spiral turns on to non-spiral part made of same material to have length of 40 cm. Bigger relation of diameter-length and absence of continuous wall provide adequate drainage which helps to prevent atony of ureter and reduces chance of periureteritis due to limiting contact between drainage and ureter and due to higher elasticity of drainage.

EFFECT: improved efficiency oft treatment.

7 dwg

FIELD: medicine; cardiac surgery.

SUBSTANCE: device can be used when doing low-invasion operations at vessels, which operations relate to rejection of intravenous filters together with thrombi and stints of vessels with bigger diameters without opening thorax under control of X-ray spectroscopy and echocardiography. Device for protection of big-diameter blood vessels during operation is made in from of two-channeled catheter onto which the soft container is placed for catching thrombi and fractures of torn-off tissue. Container has variable lateral size. Container has its wider side fastened to loop, which is connected with control handle by means of draught. Narrower side of container is connected with catheter. Loop is able of opening and to open container till complete overlap of gap in vessel. Openings are made in narrower part of container to keep blood current permanent. Working tool for controlling implant is disposed in one channel of catheter; working tool is capable of protrusion and independent manipulation. Filter of stint can be removed from big-diameter vessel safe and possible migration of torn-away fragment of vessel tissue or thrombus during manipulation is eliminated.

EFFECT: improved safe; higher reliability.

5 cl, 3 dwg

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