Method for chemical treatment of xenopericardium

FIELD: medicine.

SUBSTANCE: there is offered method for chemical treatment of xenopericardium that involves chemical stabilisation of xenopericardium with 0.625% glutardialdehyde and following processing with 1% sodium dodecyl sulphate; chemically stabilised xenopericardium is additionally processed with 0.05÷0.25% aqueous solution of chitosan or metal-containing chitosan with deacetylation degree 50÷98% and molecular weight 4÷140·103 at pH 3÷5; upon termination of processing, xenopericardium is fixed in 70% aqueous solution of ethanol; then modified xenopericardium is kept in 0.10÷0.50% aqueous solution of chitosan N-sulphosuccinate with molecular weight 10÷166·103 or chitosan 3,6-O-disulphate with molecular weight 7÷180·103 at pH 4÷8 during 20÷60 mines at temperature 20÷30°C with following fixation in absolute ethanol.

EFFECT: improved durability and biocompatibility of bioprostheses.

3 ex, 7 tbl, 3 dwg

 

The invention relates to medicine, namely to cardiovascular surgery.

A method of processing biological prostheses from xenopericardial (RF Patent No. 2120212, 20.10.1998), including the processing of the tissue (kenopanishad calf) in a solution of 0.625% glutaraldehyde and surface-active substances (surfactants) in the mode of intense shaking during multiple shift working solution. As the surfactant used, for example, 1% sodium dodecylsulfate.

The disadvantage of this method is the fragility of biological prostheses from xenopericardial, namely calcification to 6-8 year after implantation. In addition, as a result of chemical processing xenopericardial glutaraldehyde and dodecyl sulfate reduced hydrophilicity and, therefore, the biocompatibility of xenopericardial and increases its cytotoxicity due to the content of the residual aldehyde groups, provoking the deposition of calcifications.

The technical result of the proposed method of chemical treatment of xenopericardial is to increase the durability and biocompatibility of bioprocesos made from such xenopericardial, by increasing their hydrophilicity, reduction of cytotoxicity and susceptibility to calcifications result is achieved by neutralizing the residual aldehyde groups CNS is Americana through education aldimine relations with the amine groups of chitosan and the formation on the surface of xenopericardial hydrophilic biologo coverage of oppositely charged derivatives of chitosan.

The method is as follows. Kenopanishad stabilize of 0.625% solution of glutaraldehyde followed by treatment with 1% sodium dodecylsulfate. Obtained chemically stable kenopanishad further treated 0,05÷0.25% aqueous solution of chitosan or metal-containing chitosan with deacetylation (DM) 50÷98% and a molecular mass (MM) 4÷140·103at pH 3÷5 within 20÷60 min at 20÷30°C. At the end of processing kenopanishad fixed in 70% aqueous ethanol and then kenopanishad fixed primary chitosan coating can withstand 0,10÷0,50% aqueous solution of N-sulfosuccinate chitosan with MM 10÷166·103or 3,6-O-disulfate chitosan with 7 MM÷180·103at pH 4÷8 within 20÷60 min at 20÷30°C With subsequent fixation of the coating in absolute ethanol. Modified kenopanishad stored in sterile saline solution at 6-8°C.

As a result of processing xenopericardial, stabilized with glutaraldehyde aqueous solution of chitosan or metal-containing chitosan, is linking the past with the biological tissue with the formation of aldimine relations due to the interaction of the amino groups of the polymer with residual aldehyde groups stabilized with glutaraldehyde xenopericardial. Selected for atagonia pH 3-5 chitosan solutions provides first, the protonation of the required number of amino groups of chitosan for its complete dissolution and, secondly, makes it possible to link them to their residual aldehyde groups xenopericardial. For the formation of a durable hydrophilic coating modified with chitosan kenopanishad further treated oppositely charged derivatives of chitosan, such as N-sulfosuccinimidyl (MHS) and 3,6-O-desulfation (OCX) with the formation of polyelectrolyte complex (PEC). Selected in the range of pH 4-8 solutions of sulphate of chitosan provides effective electrostatic interaction as carboxyl and sulfate groups used derivatives with amino groups of chitosan, covering the first layer kenopanishad. At the end of processing kenopanishad stand in absolute ethanol to transfer the formed coating in water-insoluble form, which allows long-term storage of the modified kenopanishad in sterile saline at a temperature of 6-8°C.

Table 1 lists used in the proposed method, chemical processing xenopericardial derivatives of chitosan with the most significant characteristics such as the degree of deacetylation (DM), molecular mass (MM) and sulfur content.

Table 1
Physico-chemical characterization of chitosan and its derivatives
№ p/pThe connection nameCipherDM, %MM, 10-3g/molSulfur, %
1ChitosanHit 198140-
2-//-Hit 27660-
3-//-Hit 3504-
4Cu-chitosanHit-Cu85100-
5Ag-chitosanHit-Ag9820 -
6N-sulfosuccinate chitosanMHS-1-1666,5
7-//-MHS-2-108,5
8-//-MHS-3-1284,0
9-//-MHS-4-705,5
10-//-The MHS-5-377,0
113,6-O-disulfate chitosanAn .ocx 1-18014,3
12-//-An .ocx 2-21 15,0
13-//-An .ocx 3-9715,3
14-//-An .ocx 4-4015,7
15-//-An .ocx 5-714,8

The following are specific examples of the proposed method.

Example 1

Kenopanishad calf is subjected to stabilization of 0.625% solution of glutaraldehyde followed by treatment with 1% sodium dodecylsulfate and made him bioproces in the form of plates.

Kenopanishad in the form of plates with a size of 30 cm2and a thickness of 0.4-0.5 mm thoroughly washed several times with sterile saline with 6-fold change of the solution at a rate of 500 ml per 100 g of tissue, washed kenopanishad placed in 50 ml (10 g/50 ml) of 0.05% aqueous solution of Hit-1 with 140 MM·103g/mol and pH 3, intensively stirred on a shaker for 30 min at 20°C. At the end of processing kenopanishad immersed in 70% aqueous ethanol and then xenotar the card with a fixed primary chitosan coating is placed in 50 ml of 0.10% aqueous solution of the MHS-3 MM 128·10 3g/mol and pH 8, intensively mixed in a shaker throughout 30 min at 20°C. At the end of processing dual polymer layer on the surface of xenopericardial fixed with absolute ethanol, after which the modified kenopanishad placed in sterile saline and stored at a temperature of 6-8°C. the Achievement of the technical result is confirmed by preclinical biomedical research, the results of which are compared with the method of the prototype are given in tables 2-5.

Example 2

Kenopanishad calf is subjected to stabilization of 0.625% solution of glutaraldehyde followed by treatment with 1% sodium dodecylsulfate and made him bioproces in the form of plates.

Kenopanishad in the form of plates with a size of 30 cm2and a thickness of 0.4-0.5 mm thoroughly washed several times with sterile saline with 6-fold change of the solution at a rate of 500 ml per 100 g of tissue, washed kenopanishad placed in 50 ml (10 g/50 ml) of a 0.25% aqueous solution of Hit-Cu with 100 MM·103g/mol with a pH of 4 for 60 min at 30°C. At the end of processing kenopanishad immersed in 70% aqueous ethanol and then kenopanishad fixed primary chitosan coating is placed in 50 ml of 0.25% aqueous solution of the MHS-5 with 37 MM·103g/mol and pH 5 for 60 min at 30°C. At the end of processing double p the polymer layer on the surface of xenopericardial fixed with absolute ethanol, then the modified kenopanishad placed in sterile saline and stored at a temperature of 6-8°C. the Achievement of the technical result is confirmed by preclinical biomedical research, the results of which are compared with the method of the prototype are given in tables 2-5.

Example 3

Kenopanishad calf is subjected to stabilization of 0.625% solution of glutaraldehyde followed by treatment with 1% sodium dodecylsulfate and made him bioproces in the form of plates.

Kenopanishad in the form of plates with a size of 30 cm2and a thickness of 0.4-0.5 mm thoroughly washed several times with sterile saline with 6-fold change of the solution at a rate of 500 ml per 100 g of tissue, washed kenopanishad placed in 50 ml (10 g/50 ml) of a 0.25% aqueous solution Hit with 3 MM 4·103g/mol and pH 5 for 20 min at 25°C. At the end of processing kenopanishad immersed in 70% aqueous ethanol and then kenopanishad fixed primary chitosan coating is placed in 50 ml of 0.30% aqueous solution of an .ocx 2 MM 21·103g/mol and pH 7 for 60 min at 25°C. Upon completion of the processing of dual polymer layer on the surface of xenopericardial fixed with absolute ethanol, after which the modified kenopanishad placed in sterile saline and stored at ambient temperature the re 6-8°C. The achievement of the technical result is confirmed by preclinical biomedical research, the results of which are shown in tables 2-5, which shows the advantages of the proposed method in comparison with the method of the prototype.

Table 2
Toxicological studies. Cytotoxicity on short-term suspension culture of motile cells
Valid value: the number of surviving cells, %The placeholderExample 1Example 2Example 3
70-12050±5%106±4%95±6%101±4%

Table 3
The study of calcification in vivo in rats
The method of chemical stabilization of biological tissuesThe number of samplesThe content of CA, mg/g dry cloth
FR is type 53by 8.22±0,42
The proposed methodExample 1410,51±0,1
Example 2380,22±0,03
Example 3440,35±0,07

Table 4
Microbiological studies. The formation of biofilms of S. Epidermidis
The method of chemical stabilization of biological tissuesThe test result
The placeholder100%
The proposed methodExample 1≤1%
Example 2≤1%
Example 3≤1%

37,16±1,44
Table 5
Uprugoopticheskii properties is as chemically stable xenopericardial
The method of chemical stabilization of biological tissuesσ, MPa tensile strength (in two directions)E, MPa Modulus of elasticity (in two directions)εmax, % Maximum strain to the discontinuity (in two directions)
The placeholder15,08±0,7171,40±1,3441,43±1,62
7,32±0,4337,21±1,1041,30±1,43
Discov-
by the way
Example 1of 12.33±0,7768,51±2,1536,98±1,57
7,21±0,5738,08±1,8938,12±1,19
Example 213,77±0,1874,77±0,8842,01±1,53
6,98±0,5735,99±1,6538,08±1,28
Example 314,43±0,1169,76±1,84
7,45±0,2637,38±1,4743,07±1,87

The data presented indicate that the modification of xenopericardial Hit 1 and then the MHS-3 as described in example 1, or Hit-Cu and then the MHS-5 as described in example 2, or Hit 3 and then an .ocx 2, as described in example 3 significantly reduces the cytotoxicity of biological prostheses made from modified xenopericardial.

The data presented indicate that the modification of xenopericardial Hit 1 and then the MHS-3 as described in example 1, or Hit-Cu and then the MHS-5 as described in example 2, or Hit 3 and then OCX-2 as described in example 3, can significantly reduce the calcification of biological prostheses made from modified xenopericardial, on the model of subcutaneous implantation in rats.

The data presented indicate that the modification of xenopericardial Hit 1 and then the MHS-3 as described in example 1, or Hit-Cu and then the MHS-5 as described in example 2, or Hit 3 and then an .ocx 2, as described in example 3, gives biological prostheses made from modified xenopericardial, antimicrobial properties.

The data presented indicate that the modification of xenopericardial Hit 1 and then the MHS-3 as described in example 1, or Hit-Cu and then With The X-5, as described in example 2, or Hit 3 and then OCX-2 as described in example 3 does not reduce the mechanical strength of xenopericardial.

Other specific examples that reveal the essence of the present invention are shown in table 6.

In the examples described in table 6, the amount of coating substance (immobilized PEK) on the surface of xenopericardial was determined by color reaction with the phenol-sulfuric acid spectrophotometrically at a wavelength of 492 nm.

The thickness of the film to be formed on xenopeltidae was determined on the basis of the amount of coating substance (m)determined from the sulfur x-ray fluorescence method, according to the formula:

h=m/r·S

where: h is the film thickness (cm); m is the mass of the film (g); r is the density of polymer (g/cm3); S is the sample area (cm2).

When using an .ocx 4 for obtaining the sulfur on the surface of xenopericardial accounting for 0.25%. Based on these data, the calculation of the thickness (h) of the film formed in example 9 (table 6), is:

Wetting angle, and the rate of sorption of water droplets xenopericardium (table 7), reflecting the degree of hydrophilicity of the surface of xenopericardial, was evaluated using a standardized procedure of registration of the dynamics of form adsorbed drops and fixing geometry for n is the period of time using a digital camera installation FemtoScan Radian (CCM, Russia).

The residual aldehyde groups after treatment xenopericardial chitosan was determined by color reaction with 2,4-dinitrophenylhydrazine spectrophotometrically at wavelengths of 460 nm and 525 nm. Measurements showed almost complete absence of free aldehyde groups after treatment xenopericardial solutions of chitosan.

Table 6
Specific examples of chemical processing xenopericardial chitosan and its sulfadiazine
№ p/pSample (code)Primary processingSample (code)Secondary processingThe amount of coating substance, mg/g and/or g/cmWetting angle, degreesToxicity index, %
pHS with %t minT, °CpHS with %t minT, °the
1Hit 130,053020MHS-380,1030203/3950106±2
2Hit-Cu40,256030The MHS-550,2560308/901385±6
3Hit 350,252025OCX-270,3060256/8225101±4
4Hit 2 40,154025MHS-270,3040254/6335100±3
5Hit 250,154025OCX-270,3020255/743599±5
6Hit 140,206030OCX-140,4050306/803595±4
7Hit-Ag50,2550 25CCX-460,2050254/555090±5
8Hit 350,103020OCX-360,20602012/1502099±5
9Hit-Cu40,052020OCX-450,10302015/1311083±7
10Hit-Ag30,255025OCX-5740258/1074092±3

Figure 1 shows the dependence of the contact angle of wetting of the substrate xenopericardial for water drops from time with a single layer (samples 01A and A) and double layer (samples 02A and 04A) coatings. Legend:

1. conta - uncoated (prototype);

2. 01A - single-layer coating of the Hit-3;

3. 02A - two-layer coating Hit 3 + MHS-1;

4. A mono - layer coverage of the Hit-Cu;

5. 04A - two-layer coating of the Hit-Cu + MHS-5.

Presented in figure 1 suggest that the increase in hydrophilicity of the surface of xenopericardial in the primary processing (01A and A), which additionally increases after secondary treatment sulfopropyl chitosan (MHS-1 and the MHS-5). In this case, as can be seen from table 7, the rate of absorption drops for samples covered OCX, with a high content of sulfate groups is considerably higher (examples 6-8)than for samples coated with the MHS, as control samples plate, obtained by the method specified in the prototype.

Table 7
The initial contact angle and speed of absorption of water in some samples modificarea the tion xenopericardial
Samples from table 6The initial contact angle, degreesSorption stream is absorbed into the sample through the contact area, g/(cm2×from)
The placeholder703×10-5
Example 1502×10-5
Example 4354×10-5
Example 5354×10-5
Example 10358×10-5
The placeholder802×10-5
Example 7507×10-5
Example 64019×10-5
Example 82017×10-5
Example 91040×10-5

the La characteristics degree of molecular dispersion of the studied solutions used the method of dynamic light scattering. Measurement of particle sizes of these solutions showed that aqueous solutions of the sulfated derivatives of chitosan containing mainly particles of two types of radius R1(0)=3,5±1 nm and R2(0)=123,6±8 nm for the MHS and R1(0)=5,5±1 nm and R2(0)=175,4±7,4 nm for the OCX. Meanwhile, weakly acidic aqueous solutions of chitosan contain small amounts of supramolecular particles, the size of which in some cases exceed the limit exceptions used for sterilizing membranes (0.22 μm). Obviously, this is due to the different form of aggregated macromolecules in the used solvents. When processing xenopericardial according to the proposed method original chitosan solutions (see paragraph 1-5, table 1), fixation in 70% aqueous ethanol, and then the solutions of the MHS or OCX, followed by precipitation with absolute ethanol, obviously, can be formed of a larger comprehensive supramolecular particles. Figure 2 and 3 presents the results of the study by the method of scanning electron microscopy surface morphology of chemically stable xenopericardial before processing solutions derivative of chitosan (figure 2) and xenopericardial modified chitosan (p/p 1-5, table 1) and 3,6-O-disulfate chitosan (figure 3). Thus, the invention presents a combination of traits obviously ensures achievement of the technical result, and it reduces the degree of calcification and cytotoxicity of bioprocesos imparts antimicrobial properties, which certainly increases their durability and reduces the risk of re-operations.

Prospects for clinical application of biological prostheses from xenopericardial processed by the proposed method by preimplantation genetic modification derivatives of chitosan, involve the creation of a new generation of biological prostheses with high biological compatibility, resistance to infection, calcification and, consequently, greater safety and efficiency in the body.

Developing new biological prostheses from xenopericardial with high biological compatibility, can be widely used in cardiac clinics of the Russian Federation and abroad.

Implementation of the proposed method of processing xenopericardial derivatives of chitosan in the production of bioprocesos will have positive socio-economic effect when using this type of prostheses in clinical practice by reducing the number of costly duplication of cardiosurgical interventions for replacing biological prosthetic heart valves.

The method of chemical treatment of xenopericardial, including chemical stabilization is the situation of xenopericardial of 0.625%solution of glutaraldehyde and subsequent treatment with 1%solution of sodium dodecyl sulfate, characterized in that the chemically stable kenopanishad further treated 0,05÷0.25%aqueous solution of chitosan or metal-containing chitosan with deacetylation 50÷98% and with a molecular mass of 4÷140·103at pH 3÷5, at the end of processing kenopanishad fixed in 70%aqueous solution of ethanol, then the modified kenopanishad withstand 0,10÷0,50%aqueous solution of N-sulfosuccinate chitosan with molecular weight of 10÷166·103or 3,6-O-disulfate chitosan with a molecular mass of 7÷180·103at pH 4÷8 within 20÷60 min at a temperature of 20÷30°C followed by fixation in absolute ethanol.



 

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6 cl, 5 dwg

FIELD: medical engineering.

SUBSTANCE: device has cylindrical body and locking disk member mounted therein with rotation about axis displaced relative to diameter being in parallel to it. Disk member center of gravity is deviated relative to its geometrical center and set so that its rotation axis passes through the center of gravity and the member itself is engageable with opposite device body ends in closed state. The device body has locking disk member stroke stopper manufactured as prominence located between the locking disk member rotation axis and device body diameter arranged in parallel to the rotation axis.

EFFECT: enhanced effectiveness of operation; reduced force magnitude needed for opening the locking member; maximum effective cross-section in open position.

6 cl, 1 dwg

FIELD: medical engineering.

SUBSTANCE: device has connection member manufactured from absorbable material connected to thread on one of its ends. The thread transmits longitudinal pulling force for introducing the connection member into valve ring tissue to set up it therein. The second device embodiment has different needle design. The needle is introduced into endomyocardium of valve ring and brought through a part of the opening perimeter. The needle is brought out and the connection member is introduced into endomyocardium by means of the thread in a way that free end of the connection member is to be at introduction point. The connection member is fixed in the endomyocardium and brought through the ring to the position characterized in that the other end is located in removal point and exits in this way from the endomyocardium. The second end is fixed.

EFFECT: normalized valve ring growth in children.

29 cl, 9 dwg

FIELD: medicine.

SUBSTANCE: method involves arranging testee and additional valves in system circulation canal with parameters of working liquid flow having physiological values. The working liquid has blood viscosity. Hemolysis degree is determined from changed elastic stress relaxation time in working liquid samples taken in course of the experiment. Preliminary tests are carried out with several additional valves of different hemolytic properties under working liquid flow parameters being fixed. Total hemolysis degree is measured in various combinations of mounted additional valves in circulation system canal. After having solved a linear equations system, hemolysis degree values as contributions caused by circulation system and additional valves. Hemolysis degree of a valve under test tested in combination with one of additional valves is calculated from a formula ΓNΣ0add, where ΓΣ is the total hemolysis degree, Γ0 is the hemolysis degree contributed by circulation system, Γadd is the hemolysis degree of additional valve used.

EFFECT: high accuracy in determining hemolysis degree.

1 dwg

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