Balloon catheter

FIELD: medicine.

SUBSTANCE: given invention refers to balloon for medicinal equipment, specifically for catheter used within angioplasty containing polyamide copolymer material, characterised by the fact that specified polyamide copolymer material is presented with general formula (I), HO-(PF-OOC-PA-COO-PF-COO-PA)n-COOH, where PA is polyamide segment, PF is diol segment containing dimeric diol and/or corresponding diol polyester with end OH groups and n is number within 5 to 20.

EFFECT: improved plasticity performance.

25 cl, 1 dwg, 3 tbl, 2 ex

 

The present invention relates to cylinders for medical devices, in particular for a cylinder placed in the distal end of the catheter for use in angioplasty.

The use of catheters in angioplasty is widely known. A catheter having at the distal end of the balloon, pushed for conducting the string up until it reaches the entrance to a narrowed artery. As soon as the container arrives in the narrowed area of the artery, it is repeatedly subjected to inflation and deflation (inflation and deflation). Inflation of the balloon and its subsequent deflation inside the arteries reduce the amount of narrowing in the arterial system and restore adequate blood flow in the affected stenosis cardiac region.

Chemical/physical and mechanical characteristics of polymeric material, which consists of the cylinder, and determine its plasticity, i.e. the adaptability of the container to the arterial system and its resistance to stretching, which is the main characteristics of the optimal cylinder. Requirements for ductility and strength and size of the container can vary depending on the type of use and size of the vessel into which the catheter. The benefits of various polymers, consistent with specific mechanical applications of cylinders.

The problem posed in the present is sobienie, is to create a balloon catheter capable of improving characteristics of plasticity compared to the cylinders of the prior art.

The object of the present invention, therefore, is the use of the material from which the balloon catheter for use in angioplasty, balloon, made from this material as outlined in the attached claims.

Other characteristics and advantages of the container, which are the object of the present invention will become clearer from the following detailed description of the present invention and from the following figure 1, which shows a graph showing the ultimate tensile strength of cylinders made of polymer material according to the present invention.

Cylinders for use in medical devices according to the present invention is formed by block copolymers with polyetherimide blocks. Mentioned polyetherimide polymers are usually referred to in abbreviated form REA.

Particularly suitable polymeric material for receiving a container such as the container of the present invention, composed of monomers forming the polyamide blocks, modified dimeric dialami and/or the corresponding complex polyesters with terminal Oh groups containing Dima is nye diols.

Mainly, the most common use of lactams, aminocarbonyl acids and diamines for the formation of a polyamide segment. However, the polyamide segment preferably is selected from PA 6, PA 6/6, PA 6/9, PA 6/10, PA 6/12, PA 6/36, PA 11, PA 12, PA 12/12. In addition, it is preferable to use copolyamids or multiplemodel obtained from C2-C36dicarboxylic acid, and C2-C12diamines, and also from 6-lactam, 12-lactam, isophthalic, terephthalic and naphthalene dicarboxylic acids.

More preferably, the polyamide segments are derived from monomers C6-C12the lactam or of the monomers C6-C12aminocarbonyl acid. Polyamide component can also be obtained by polycondensation of the corresponding above-described salts of diamines and carboxylic acids.

Dimer diols, usually used to obtain polyetherimide polymer are aliphatic dimeric dialami with molecular weight in the range from 400 to 2000, preferably in the range from 400 to 1000. These dimeric diols get known industrial methods, including, for example, the recovery of both carboxyl groups of the hydrated dimer fatty acid to alcohol groups, or by dimerization of unsaturated alcohols. Diols obtained by using these technologies, it is the amount of by-products always have a changing number of trimeric triolo and monofunctional alcohols. Preferably used in the present invention diol components are C36and/or C44dimer diols with the content of dimer diol and at least 90%, with the content mendiola less than 1% and with a content of Tirol less than 5% and have a hydroxyl number between 195 and 225 mg KOH/g more preferred are dimeric diols with the content of dimer diol more than 94% and a content of the monofunctional alcohol and substance of the trimeric Tirol less than 0.5%.

Diol polyesters with terminal Oh groups constituting the polyamide polymer obtained by condensation of the above-described diol dimers with aliphatic and/or aromatic C4-C44dicarboxylic acids. Preferred is the use of hydrated C36dimer fatty acids. Preferred diol polyesters are hydroxyl number between 28 and 90 mg KOH/g, preferably between 50 and 80 mg KOH/g

Polyamidoamine the polymer used for the formation of cylinders according to the present invention, can be produced using one way or two-stage method. In the first case, the monomers forming the polyamide blocks are placed in one of the reaction the reactor with the above-described diol components together and condense first under normal pressure and then under bonigen the m pressure, obtaining high molecular polyetherimide polymer. The method of synthesizing polyetherimide polymer contains two stages: in the first stage, the polyamide segment is formed of the above polyamide monomers, and in the second stage thus obtained polyamide segment is connected with diol components when carrying out the esterification reaction in the conditions, typically known to specialists in this field of technology.

The General chemical formula thus obtained polyetheramine polymers may be represented as follows (formula (I):

H-(O-PF-OOC-PA-COO-PF-OOC-PA-CO)n-OH, (I)

where PA represents a polyamide block, while PF is a diol unit containing dimeric diols, and/or diol polyesters c terminal Oh groups, and n is an integer between 5 and 20.

The content of the diol component in polyetherimide copolymer is 5-50 wt%. Preferably the concentration of the diol component is supported in the interval from 10 to 30 wt%, more preferably between 10 and 20% weight. by weight of the total composition.

These above-described polymers used in the present invention for receiving cylinders for medical devices are commercially available, for example, under the trade name Grilamid®from Ems-Chemie AG, Switzerland. Especially suitable is asimi examples of commercially available polymers are Grilamid ®FE7303 and Grilamid®FE7372. In particular, the polymer Grilamid®FE7303 formed from a polyamide segments that are derived from laurolactam with molecular weight equal to 197 g/mol, and polyester segments derived from a dimer diol components, commercially available under the trademark Pripol®2033 and Priplast®3197, molecular weight, respectively 550 g/mol and 1980 g/mol, commercially available from Unichema North America, Chicago, Ill., USA. Weight present laurinlactam component relative to the total weight of the final composition of the copolymer is an 80.2%, while the weight ratio of diol segments in the final composition of the copolymer, respectively 12,0% Pripol®2033 and 3.7% Priplast®3197. In particular, Pripol®2033 is a diol dimer derived dimer C36fatty alcohol with a molecular weight of 550, diol component more of 94.5% and a hydroxyl number equal to 200-215 mg KOH/g

Priplast®3197 is a diol aliphatic polyester formed from C36components dimer acid obtained by the dimerization of unsaturated C18a fatty acid and a diol component, obtained by hydrogenation of C36dimer acid. This particular polyester diol has a molecular the popular weight 200 and a hydroxyl value of between 52 and 60 mg KOH/g

The polyamide polymer having the General formula (I), characterized by high flexibility and toughness, high strength and good resistance to hydrolysis. In particular PF units derived from diol components are responsible for the flexibility and softness of the copolymer, while PA polyamide blocks give the copolymer hardness, rigidity and crystallinity.

In particular, consideration of the properties of the above copolymer material gives underlying the present invention understanding about how to use these properties, as they provide high benefits in the specific application of these polyetheramine copolymers used in medical devices, and the greatest benefits in particular the use of balloons used in angioplasty.

In the following Table 1 shows the data obtained in the test for flexibility polyetherimide material according to the present invention, carried out on extruded tubes, of which subsequently received the cylinders. This test confirms the characteristics of high flexibility of the material described above. In particular, the measured shock flexible tubes for cylinders Grilamid®FE7303. The test was performed in accordance with the description provided by the International organization for standardization (the International Standards Organisation (ISO) and describes the output in ISO 14630: 1997. The tube is a cylinder with an outer diameter of 0.9 mm is fixed clamping device so that its effective length amounted to 0.15 mm Spot sensor associated with the power gauge feature so that it only lightly touches the surface of the specified tube is a cylinder. The sensor in contact with the tube is moved below and measured the force required to achieve a certain downward movement of the sensor. The speed of downward movement of the sensor was 20 mm/min. In the following Table 1 shows the size of the load (in Newtons, N), obtained with pre-defined values for the downward movement of the sensor (from 1 to 8 mm).

Table 1
The rolling movement transversely-positioned element
Sample1mm2 mm3 mm4 mm5 mm6 mm7 mm8 mm
10,080,150,240,250,250,230,210,15
Naked-20,090,190,250,250,26 0,210,16
Ruska30,090,190,260,260,260,240,20,15
(H)40,080,20,260,280,270,240,220,17
50,070,170,250,260,250,240,230,17
Average

value
0,080,180,250,260,260,240,210,16

The table shows the maximum applied point load equal 0,26 N corresponding to the movement of the transducer at a distance of 4-5 mm, This value determines the point of maximum ductility of the material. This result is particularly important because it clearly shows the excellent properties of flexibility of the material of the present invention, as expressed in the elastic elongation of the material.

In addition, the tube polyetherimide material having the General formula (I)has a shore hardness D (Shore D) more than 60, the modulus of elasticity in tension between 400 and 800 MPa, rustagi the surrounding load on the gap between 35 and 55 MPa and elongation at break of about 300%. In particular, preferably used tube Grilamid®FE7303 has a hardness of shore D 66, the modulus of elasticity tensile strength 500 MPa, tensile strain at break of 40 MPa and elongation at break 300%.

Thus, the distinctive properties superior flexibility above polyetherimide material are of particular interest for the application of the above material in balloons angioplasty. In fact, together with the other above-described characteristics of the relationship of hardness and elasticity of the resulting cylinders differ in the combination of properties of strength, ductility and softness, which is the characteristics of the cylinders of the present invention.

Cylinders obtained with the polymer material described in the present invention have excellent characteristics of high plasticity and elasticity. In fact, due to the fact that the plasticity of the material means the ability of a material to recover its original shape after temporary changes this initial shape deformation, it becomes apparent that the cylinder formed by flexible material that can easily withstand the mechanical stresses caused by repeated impact of inflation and deflation, when necessary angioplasticheskih interventions.

In addition, it has been unexpectedly found that the cylinder and polyetherimide material, which is the object of the present invention, in addition to the excellent characteristics of adaptability to the arteries and resistance to stretching has excellent characteristics of plasticity, understood as the percentage increase in diameter of cylinder pressure rise.

This combination of properties, good flexibility, on the one hand, and excellent ductility and strength, on the other hand, distinguishes the cylinders of the present invention and, in addition, is a combination of properties, the main cylinder, injected into the arterial system of the patient during angioplasticheskih operations.

To test the plasticity and flexibility at a nominal pressure of 7 bar was tested 31 sample cylinders with an outer diameter of 3 mm, with double wall thickness, part of 0.04 mm, and the obtained polymer Grilamid®FE7303.

Tests for flexibility was carried out on the tank, suspended by their ends to the supports. The sensor was placed in the middle, slightly touching the surface of the cylinder. Then the probe was moved down and measured load required to achieve a certain downward movement of the sensor. The value of the bending load measured for the promotion of the sensor at a distance of 4 mm, accounting for 0.25 H. This value confirms the excellent flexibility of the tested cylinders, obtained with the use of new materials according to this is the overarching invention.

Tests for plasticity was performed by measuring the increase in the diameter (in mm) cylinders depending on the boost pressure (in bars) to achieve the burst pressure. Table 2 shows the most important data obtained in this test. This table shows data relating to the middle of the registered values of the burst pressure, the standard deviations of the measurements and calculated RBP (rated burst pressure).The value ofrated burst pressureit was inferred from probabilistic calculations, in which the standard deviation three times subtracted from the value of the average burst pressure measured in the tests with the container.

Table 2
Diameter of cylinder (mm)3,00
Average wall thickness (mm)0,041
The average burst pressure (bar)22,36
The standard deviation0,89
Estimated RBP (bar)19,67

Specialist in the art it is obvious that the values given in this table are important for determining the properties of good plasticity cylinders according to the present invention. In particular, the above data burst pressure are the two who are important in combination with the properties of good flexibility cylinders. In fact, it can be noted that the cylinders, which is the object of the present invention possess the properties of plasticity, usually available at much less flexible materials. In addition, as described in the present invention the new cylinders have a significant advantage in a higher burst pressure and, consequently, a higher RBP in addition to a smaller percentage increase in the diameter between the nominal pressure and the specified RBP compared with the properties of cylinders in the art that have comparable characteristics of flexibility.

In addition, the low value of standard deviation, calculated for the investigated samples of the cylinder indicates high uniformity of properties and characteristics of the cylinders obtained with the use of new materials according to the present invention. In addition, this statistic indicate a high level of reproducibility distinctive preferred characteristics of the cylinders, which is the object of the present invention.

Due to its good flexibility, the container according to the present invention also has better maneuverability. In fact, the container of polyetherimide material shows a good ability to follow the string and has a good adaptation to the location of the vessel. Therefore, this feature is istica also improves the ability of the catheter, in the distal end of which is placed a cylinder, for the better advancement through the vasculature to reach affected by the stenosis site. In addition, good flexibility of the container when it reaches the narrowing of the arteries also guarantees a great opportunity to put nonduty the container in the locked stenosis site. Best adaptability of the material allows the passage of nenadoelo cylinder through the narrowed area of the artery. Finally, it's easy to get the tank on the venous bed through the affected stenosis plot means reducing the risk of additional damage to the involved venous system and directly affected by the stenosis site.

Good plasticity characteristics of the container obtained from polyetherimide material described in the present invention, mean that these cylinders are suitable for use in the treatment of coronary arteries, as limited to the risk of rupture of the vessel due to excessive expansion of the container.

Good characteristics of flexibility and elasticity of the balloon of the present invention also provide an opportunity to get the cylinders, which have the primary differences in improved properties, which consists in returning to its original diameter after each successive inflation. This allows one cylinder-rayed the change of inflation more times and for longer time. In addition, the consequence of this are also good characteristics of resistance to wear of the cylinder. In fact, under normal use balloon angioplasty reduces the burst pressure of the balloon during the second consecutive inflations. Despite this, good flexibility of the container from polyetherimide material of the present invention enhances the ability to maintain a burst pressure that is set for a new cylinder. This feature also allows the use of the container according to the present invention for more inflation, and over a longer time.

An additional advantage of the cylinders obtained from polyetheramine materials of the present invention, is that they are well manifest themselves in a test of strength.

In fact, with the cylinders of the present invention conducted a test to assess the force required to rupture the container under load elongation. This test was performed in accordance with the description provided by the International organization for standardization and are described in standards ISO 14630:1997. Thus, with the aim of testing of cylinders, such as cylinders according to the present invention, load at break, used cylinders, made of Grilamid®FE7303 with an external diameter 3 mm, length 20 mm and a thickness of 0.04 MMDS test cylinders with one end attached to the fixed clamp and the opposite end to movable transversely positioned element, which is moved with a speed of 50 mm/min, stretching the balloon to rupture. Then the expected elongation of the balloon as a relative maximum load to the peak load, which indicates the point of rupture of the container and therefore corresponds to the load of the gap.

The results obtained in the specified test tensile cylinder according to the present invention, shown in the drawing, which represents a graph of the force-motion.

In this test revealed that the cylinders of polyetherimides the material load value gap constituting a 32,5 N, which corresponds to the percentage elongation equal to about 123 %. When comparing these data with data obtained from cylinders normally used for angioplasty, there are a great strength, and great ability to lengthen the cylinders according to the present invention.

The property is a high viscosity of the material described above and the ability to maintain a high degree of viscosity even a long time to give an additional advantage in the use of this material is used in balloons for angioplasty. In particular, this advantage is reflected in a good slip properties of the material in the extrusion process with the formation of the tube, which then receive the container. Therefore, the copolymer is a material, described in this invention does not require adding to the polyamide composition of plasticizing agents that facilitate the method.

An additional advantage of the above polyetherimide material is low water absorption in aqueous solutions. In fact, it is known that polymeric substances absorb water and therefore tend to swell. However, due to the low water absorption polyetherimide polymers of the present invention have no tendency to swell and therefore in aqueous solutions have a very small increase in weight and volume, while maintaining their inherent shape, size and fixed in size.

This property is also an advantage primarily at the stage of extrusion of the tube, which then receive the container. In fact, prior to the extrusion of all materials should be placed in a drying oven to remove residual moisture present in the granules. Therefore, the polymer material having a lower water absorption, first of all requires more than a short preliminary time drying. In addition, during the extrusion of the tube emerging from the mold is passed through the calibration and cooling tanks containing water. The greater the amount of water, which polymer tube tends to absorb the occurs greater risk education Micropilot the th inside of the tube wall and, therefore, micro-cavities inside walls of the container. These micro-cavities indicate abrupt changes in wall thickness of the container and therefore represent a potential weak point of rupture of the container.

In addition, it should be noted that polyetheramines material described in this invention has a high chemical resistance to hydrolysis in an aqueous environment. This chemical stability towards hydrolytic destruction increases the shelf life of the container obtained from this material, as distinctive mechanical properties of the container are guaranteed to stay within the time.

The cylinders according to the present invention fabricated using known for producing balloon catheter techniques, such as, for example, the technique of extrusion of the polymer material known to specialists in this field of technology.

The present invention is additionally described through the following examples to illustrate and not limit the present invention, of which the characteristics and advantages of the present invention will become more apparent.

Examples

The conditions of extrusion tubes for cylinders made of materials according to the present invention

In Examples 1 and 2 described tubes for cylinders manufactured by extrusion of Polym REGO material Grilamid ®FE7303. Before extrusion, the balls of this polymer was dried until the moisture content below 0.10%. The tube was extrudible under controlled temperature melting point of from 210°C and up to 240°C by hot extrusion through five extrusion zones respectively with adjustable temperatures. The basis for the parameters of the method of extrusion was the processing conditions of the polymer, recommended by the manufacturer of the polymer. After the polymeric material has extrudible of the mold tube, it was passed through a small aeration zone in which it is cooled in a bath of deionized water, with temperatures around 20°C. Then transfer tube through a water bath used manual lift. After this, the tube is cut into segments 260 mm

Using this method produced tubes of various sizes.

Example 1

In this example produced the cylinders obtained from Grilamid®FE7303, the size of 3.00 mm, This polymer has a hardness on a scale of shore D 66, the modulus of elasticity tensile strength 500 MPa, tensile strain at break of 40 MPa and elongation at break 300 %. Segments of the tube had the value of the outer diameter OD of 0.85 mm and 0.55 mm For receiving the container size 3.00 mm with the length of the main part 20 mm, used shape with dimensions suitable to allow and osnovnosti tube and the inner diameter of the Central part of the tube to expand and inflate to the desired final dimensions. These cylinders size 3.00 mm was obtained by way of with temperatures in the 90°C and domestic inflationary pressure 28 bar.

The cylinders, thus obtained, were subjected to the standard test gap. In particular, we measured the double wall thickness nenadoelo cylinder. In addition, the container was subjected to inflation consistent with increasing pressure, in order to measure the external diameter of each time increasing the pressure to rupture the container. The final results obtained in this test are listed below in table 3.

Example 2

In this example produced the cylinders obtained from Grilamid®FE7303 size 3,50 mm This polymer has a hardness on a scale of shore D 66, the modulus of elasticity tensile strength 500 MPa, tensile strain at break of 40 MPa and elongation at break 300%. Segments of the tube had the value of the outer diameter OD of 0.85 mm and 0.55 mm For receiving the container size 3,50 mm with the length of the main part of 20 mm was used the same way as described in example 1, except for different temperature conditions and domestic inflationary pressure. In particular, we used the temperature of the process 100°C and the internal inflation pressure of 26 atmospheres. The final results obtained in the test of these tanks to rupture, are provided below in table 3

Example
Table 3
Size

cylinder (mm)
Thickness

double

wall (mm)
Average

pressure

break

(ATM)
RBP

(ATM)
13,00to 0.0322118
23,50being 0.0362016

1. A balloon for a medical device, in particular for catheters used in angioplasty containing polyamide copolymer material, characterized in that the copolymer polyamide material represented by the General formula (I)

H-(O-PF-OOC-PA-COO-PF-COO-PA-CO)n-OH,

where PA is a polyamide segment, PF is a diol segment containing polyesters, dimer diols with integral HE-groups, and n is a number from 5 to 20.

2. The container according to claim 1, wherein said diol segment has a molecular weight of from 400 to 2000.

3. The container according to claim 2, wherein said diol segment has a molecular weight of from 400 to 1000.

4. The container according to claims 1, 2 or 3, in which these dimeric diols are36and/or C44dimer diols with the diol dimer content of at least 90%.

5. The container according to any one of claims 1 to 3, in which the hydroxyl number of these dimeric diols is from 195 to 225 mg KOH/g

6. The container according to any one of claims 1 to 3, in which the above diol polyesters with terminal HE-groups obtained by condensation with aliphatic and/or aromatic4-C44dicarboxylic acids.

7. The container according to claim 6, in which a hydroxyl number of specified diol polyesters ranges from 28 to 90 mg KOH/g

8. The container according to any one of claims 1, 3 or 7, in which the concentration of the specified diol segment is from 5 to 50% by weight of the total composition.

9. The container of claim 8, in which the concentration of the specified diol segment is from 10 to 30% by weight of the total composition.

10. The container according to claim 9, in which the concentration of the specified diol segment is from 10 to 20% by weight of the total composition.

11. The container according to any one of claims 1 to 3, 9 and 10, wherein said polyamide segment selected from RA 6, PA 6/6, PA 6/9, PA 6/10, PA 6/12, PA 6/36, PA 11, PA 12, PA 12/12.

12. The container according to any one of claims 1 to 3, 9 and 10, wherein said polyamide segment is obtained from linear or cyclic, aliphatic or aromatic With2-C36dicarboxylic acids and from aliphatic or aromatic C2-C12diamines.

13. The container according to any one of claims 1 to 3, 9 and 10, wherein said polyamide segment represents a C6-C12lactam.

14. The container according to any one of claims 1 to 3, 9 and 10, wherein said polyamide segment represents a C6-C 12aminocarbonyl acid.

15. The container according to any one of claims 1 to 3, 9 and 10, wherein said polyamide segment represents a lauryl lactam.

16. The container according to any one of claims 1 to 3, 9 and 10, wherein said diol segment represents a complex of the polyester of dimeric diols Pripol®2033 and/or Priplast®3197.

17. The container according to any one of claims 1 to 3, 9 and 10, in which the polyamide copolymer material is Grilamid®FE7303.

18. The cylinder 17, characterized in that it has a diameter of 3 mm at a nominal pressure of 7 bar and a wall thickness of 0.04 mm

19. The cylinder p, characterized in that it has a bending load equal to 0,25N, when moving the sensor of 4 mm.

20. The cylinder p, characterized in that it has estimated the average burst pressure equal to 22,36 bar.

21. The cylinder p, characterized in that it has a rated burst pressure equal to 19,67 bar.

22. The cylinder p, characterized in that it has a tensile strain at break of 32.5 MPa and a percentage elongation at break of about 123%.

23. The container according to any one of claims 1 to 3, 9, 10, 18-22, characterized in that it polyamide copolymer material has a hardness of shore D 66, the modulus of elasticity tensile strength 500 MPa, tensile strain at break of 40 MPa and elongation at break 300%.

24. The use of polyamide copolymer material on Liu the WMD one of claims 1 to 17 for the manufacture of cylinders for medical devices in particular, to catheters used in angioplasty.

25. The use of polyamide copolymer material according to paragraph 24, wherein the material has a hardness of shore D 66, the modulus of elasticity tensile strength 500 MPa, tensile strain at break of 40 MPa and elongation at break 300%.



 

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21 cl, 4 dwg, 2 tbl, 12 ex

FIELD: medicine.

SUBSTANCE: method involves producing and transplanting and implantable segment containing mature cartilage tissue cells fixed on absorbable supporting matrix for repairing animal cartilage. The implantable segment has absorbable elastic supporting matrix for culturing and fixing living cells thereon. Instrument for introducing the implantable segment, having mature cartilage tissue cells on supporting matrix, into defective animal cartilage area, has clamps and external tubular envelope. The envelope has an end holdable by user and an end for making introduction into defective cartilage area. Holder and telescopic member are available in the envelope end holdable by user. Injection canal is partially embedded into the holder and projects beyond the holdable envelope end towards the end for making introduction. The clamps are attached to the telescopic member. They are well adapted for catching and releasing the implantable segment when telescopically moving the holder in the envelope.

EFFECT: enhanced effectiveness in arranging and fixing implantable segment in the implantation place.

47 cl, 11 dwg

The invention relates to the field of medicine and related material for medical purposes, in particular the drive for human and animal cells, implanted in the body of a mammal, or depot for drugs, representing multifunctional biocompatible hydrogel containing cross-linked copolymer of acrylamide, methacrylamide, and a cross-linking agent is 2-hydroxyethyl methacrylate and N,N'-methylene-bis-acrylamide and water, and method of its production by copolymerize these monomers in three stages

The invention relates to a biodegradable and biocompatible polymer compositions with a memory of its own form, which can find application in medical devices and as carriers of therapeutic or diagnostic agents

Medical device // 2213582
The invention relates to medicine, in particular to neurosurgery and traumatology, and can be used to replace bone defects of the skull vault in patients after resection of crepancy

FIELD: medicine, in particular tubular polyurethane articles (guides, suction drainages, catheters) having aseptic coat.

SUBSTANCE: claimed articles are produced by providing of article elements followed by assembly thereof and application of aseptic coat by impregnation of catheter surface with chlorohexidine and/or salts thereof (e.g., dihydrochloride, or diacetate, or bigluconate, etc.), by article treatment for 14-180 min with aqueous-alcohol solutions of chlorohexidine and/or salts thereof at 20-60°C, containing (mass %): chlorohexidine and/or salts thereof 1-5; ethanol or methanol 75-85; water 15-25.

EFFECT: prolonged anti-microbial activity; protection against body contamination during catheterizing.

5 cl, 1 tbl

FIELD: medicine, in particular tubular polyurethane articles (guides, suction drainages, catheters) having aseptic coat.

SUBSTANCE: claimed articles are produced by providing of article elements followed by assembly thereof and application of aseptic coat by impregnation of catheter surface with chlorohexidine and/or salts thereof (e.g., dihydrochloride, or diacetate, or bigluconate, etc.), by article treatment for 14-180 min with aqueous-alcohol solutions of chlorohexidine and/or salts thereof at 20-60°C, containing (mass %): chlorohexidine and/or salts thereof 1-5; ethanol or methanol 75-85; water 15-25.

EFFECT: prolonged anti-microbial activity; protection against body contamination during catheterizing.

5 cl, 1 tbl

Balloon catheter // 2327489

FIELD: medicine.

SUBSTANCE: given invention refers to balloon for medicinal equipment, specifically for catheter used within angioplasty containing polyamide copolymer material, characterised by the fact that specified polyamide copolymer material is presented with general formula (I), HO-(PF-OOC-PA-COO-PF-COO-PA)n-COOH, where PA is polyamide segment, PF is diol segment containing dimeric diol and/or corresponding diol polyester with end OH groups and n is number within 5 to 20.

EFFECT: improved plasticity performance.

25 cl, 1 dwg, 3 tbl, 2 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine. High antimicrobial activity and desired smoothness providing high thromboresistance are ensured by modifying a product surface, e.g. a polyurethane polyurethane with chlorhexidine and/or its salts with the modification procedure ensured by applying 0.5-4% polyurethane of molecular weight 10000 to 40000 units. in tetrahydrofurane containing chlorhexidine and/or its salts in the amount 0.25-5% (wt) in relation to polyurethane weight that is followed by tetrahydrofurane evaporation.

EFFECT: what is described is a polyurethane catheter with antimicrobial coating, the method for preparing the antimicrobial coating on polyurethane products and the method for producing the polyurethane catheters with the antimicrobial coating.

3 cl, 1 tbl

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is a method for measuring antimicrobial-coated tubular polyurethane products, including multiple-lumen polyurethane catheters consisting in the three-staged chlorhexidine and/or its salts modification. Chlorhexidine and/or its salts are impregnated on the product surface by processing the products in aqueous-alcohol solutions of chlorhexidine and/or its salts, removing excessive chlorhexidine and/or its salts from the product surface, applying a solution of polyurethane in tetrahydrofurane containing chlorhexidine and/or its salts, and evaporating tetrahydrofurane.

EFFECT: preparing the polyurethane products, eg catheters possessing the prolonged antimicrobial activity being in full accord with the multifunctionality of the multiple-lumen catheters.

9 cl, 1 tbl

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