A material and method for preparing a transcatheter aortic valve

By using modified polyacrylate and rare earth metal oxide modified polytetrafluoroethylene in the heart valve material for cross-linking reaction, the problem of insufficient anticoagulation and anti-calcification performance of valve materials in the prior art is solved, efficient anti-thrombosis and anti-coagulation performance is achieved, and the biocompatibility and durability of valve materials are improved.

CN116440324BActive Publication Date: 2025-05-09NANJING SAINT MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202310386269.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-04-12
Publication Date
2025-05-09
Estimated Expiration
2043-04-12

AI Technical Summary

Technical Problem

In the prior art, the anticoagulation and anti-calcification properties of heart valve materials are insufficient, resulting in the valve being prone to thrombosis and calcification problems during long-term use, affecting its service life and safety.

Method used

Using polyacrylate as raw material, by adding tetradecylallyl ammonium bromide to the polyol solution for grafting reaction, a modified polyacrylate was obtained and cross-linked with polytetrafluoroethylene modified with rare earth metal oxide to prepare a valve material with excellent anticoagulation and calcification resistance.

Benefits of technology

The valve material has good antithrombotic and anticoagulant properties, reduces platelet adhesion and activation, avoids thrombosis, and has good biocompatibility and durability, and does not require long-term anticoagulant treatment.

✦ Generated by Eureka AI based on patent content.
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Abstract

The invention discloses a method for preparing a material for a transcatheter aortic valve, comprising: dispersing polyacrylate in a polyol solution, then adding tetradecyl allyl ammonium bromide to the mixed solution and carrying out a grafting reaction in the presence of an initiator to obtain a modified polyacrylate; mixing polytetrafluoroethylene and a rare earth metal oxide, then stirring at an ambient temperature below 10°C to uniformly mix the raw materials while avoiding polytetrafluoroethylene agglomeration, then pressing and sintering the raw materials to obtain rare earth metal modified polytetrafluoroethylene; mixing the modified polyacrylate, rare earth metal modified polytetrafluoroethylene and a crosslinking agent obtained above and carrying out a crosslinking reaction, heat treating the product after the reaction, washing the product after the reaction with water, and drying the product to obtain the material for a transcatheter aortic valve. The valve material obtained according to the invention has more excellent mechanical properties, blood compatibility and biocompatibility.
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Description

Technical Field

[0001] The present invention belongs to the field of biomedical technology, and in particular, relates to a material and a method for preparing a transcatheter aortic valve. Background Art

[0002] Around 300,000 people worldwide are affected by heart valve diseases each year. These diseases involve abnormal valve leaflet tissue, such as excessive tissue growth, tissue degradation or rupture, tissue stiffening or calcification, or abnormal tissue ectopic placement throughout the cardiac cycle, i.e. annular dilatation, ventricular remodeling, leading to decreased valve function, such as leakage or blood backflow (i.e. valvular insufficiency) or resistance to positive blood flow (i.e. valvular stenosis).

[0003] Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive valve replacement surgery, which refers to the placement of an assembled aortic valve into the aortic root via catheter to replace the original aortic valve and functionally complete the aortic valve replacement. The specific implantation process of TAVR is: first compress the artificial valve into a transcatheter delivery system, and then use the delivery system to deliver the valve to the aortic root through the artery (such as the femoral artery, subclavian artery, active abdominal aorta, etc.) or the apex of the heart and release it, fix it in the valve ring, and replace the human aortic valve with an artificial valve. TAVR has become the main treatment for patients with aortic stenosis who cannot tolerate surgery or are at high risk of surgery.

[0004] Artificial valve replacements are one of the most widely used cardiovascular devices, and the demand for them is increasing. Currently, the available clinical devices are limited to mechanical and biological valves. However, the long-term clinical application of such valves is very problematic, given some persistent critical issues such as thrombogenicity and service life.

[0005] In fact, mechanical valves have a life span and do not require repeated surgery because they do not experience structural failure, but because they cause thromboembolic complications, patients must take anticoagulant therapy throughout their lives. Bioprosthetic valves made from porcine, bovine or equine pericardium, modeled and sutured to a support structure (stent) reproduce the functional biomechanical characteristics of the native valve, causing fewer thromboembolic complications, but in many cases must be replaced after 10-15 years of implantation due to the occurrence of calcification problems and damage caused by the decellularization treatments undergone to reduce problems related to immune responses.

[0006] At present, there are also descriptions about new mechanical valve materials in the prior art. For example, the Chinese invention patent with application number CN202011135753.5 discloses an artificial heart valve material and its preparation method, first preparing a curcumin block-modified polyurethane with a mass content of 4%-10% of curcumin; then mixing the curcumin block-modified polyurethane with a metal salt solution, using the ketone group on the curcumin molecular chain to coordinate with the metal ion to obtain a curcumin-modified polyurethane complex; finally, solution spinning is performed to obtain curcumin-modified polyurethane complex fibers. For another example, the Chinese invention patent with application number CN201811112705.7 discloses a method for preparing a polymer material for a heart valve, comprising the following steps: (i) preparation of a double-terminal hydroxybenzophenone condensation monomer, (ii) preparation of a chlorocitric acid derivative, (iii) ionized condensation polymer, and (iv) ion exchange.

[0007] Although valve materials have been improved in the prior art, their anticoagulation and anticalcification properties still have deficiencies that need to be improved.

[0008] Polyacrylate is a homopolymer or copolymer with acrylic acid ester as monomer. It is a colorless or slightly yellow transparent viscous liquid at room temperature. Polyacrylate is a non-toxic material that is flexible and elastic at room temperature and has good weather resistance, but low tensile strength. At present, there is no report on its application in the preparation of valve materials. Summary of the invention

[0009] The purpose of the present invention is to overcome the problems existing in the prior art and provide a material and method for preparing a transcatheter aortic valve. The valve material of the present invention has excellent anticoagulant and anticalcification properties.

[0010] The purpose of the present invention and the solution to the technical problem are achieved by adopting the following technical solutions.

[0011] One aspect of the present invention provides a method for preparing a material for a transcatheter aortic valve, characterized in that the method comprises the following steps:

[0012] Dispersing polyacrylate in a polyol solution with a concentration of 10-20wt%, then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of an initiator to obtain a modified polyacrylate; the mass ratio of the polyacrylate, tetradecyl allyl ammonium bromide and the initiator is 1:0.3-0.6:0.05-0.1;

[0013] The polytetrafluoroethylene and the rare earth metal oxide are mixed in a mass ratio of 1:0.1-0.3, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to mix the raw materials evenly while preventing the polytetrafluoroethylene from agglomerating, and then the raw materials are compression molded and sintered to obtain rare earth metal modified polytetrafluoroethylene;

[0014] The modified polyacrylate, rare earth metal-modified polytetrafluoroethylene and cross-linking agent obtained above are mixed in a mass ratio of 1:1-3:0.3-0.5 and subjected to a cross-linking reaction. After the reaction, the product is treated at 60-80°C for 1-3h, and the product after the reaction is washed with water and dried to obtain the material of the transcatheter aortic valve.

[0015] Preferably, the polyacrylate comprises polymethyl acrylate and polyethyl acrylate, and the molecular weight thereof is in the range of 1×10 6 -1×10 8 between.

[0016] Preferably, the polyol is selected from any one of ethylene glycol, 1,2-propylene glycol, 1,4-butanediol, 1,6-hexanediol and glycerol.

[0017] Preferably, the initiator is one or any combination of ammonium persulfate, sodium persulfate, vitamin C-sodium persulfate redox system, vitamin C and sodium metabisulfite mixture-sodium persulfate redox system.

[0018] Preferably, the compression molding conditions are: room temperature, pressure 25-30 MPa, and holding time 3-5 min.

[0019] Preferably, the sintering conditions are: temperature 300-400° C., time 6-8 h.

[0020] Preferably, the molecular weight of the polytetrafluoroethylene is 1×10 6 -1×10 8 between.

[0021] Preferably, the rare earth metal oxide is selected from any one of the following groups: La, Ce, Pr, Nd, Pm, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb, Lu.

[0022] Preferably, the crosslinking agent is selected from any one of di-tert-butyl peroxide, diethylenetriamine, 2,5-dimethyl-2,5 di-tert-butyl peroxide hexane, diisopropyl hydroperoxide, 2-ethyl-4-methylimidazole, 2-phenylimidazole, 2-isopropylimidazole, tetrahydrophthalic anhydride, hexahydrophthalic anhydride, triethylenetetramine, dimethylaminopropylamine, and diethylaminopropylamine.

[0023] Preferably, the drying process is: drying in a vacuum drying oven at 60-80° C. to constant weight.

[0024] By means of the above technical scheme, the present invention has at least the following advantages: the present invention uses polyacrylate as one of the raw materials, which is a preferred raw material due to its abundant source and non-toxicity, and carries out grafting reaction between hydrophobic tetradecyl allyl ammonium bromide and polyacrylate in the presence of an initiator, so that the obtained modified polyacrylate has good hydrophobic properties and improves its tensile strength, and before the reaction, the polyacrylate is dispersed in a polyol alkaline solution to provide abundant OH for the entire reaction. - Microenvironment, which can avoid the formation of impurities during the reaction and ensure the stability of the product structure. Rare earth metal oxides and polytetrafluoroethylene are both chemically stable substances. After the two substances are mixed, they are compression molded and sintered, and the rare earth metal oxides can be loaded on the polytetrafluoroethylene molecular chain. The sintering effect can increase the van der Waals force between polytetrafluoroethylene and rare earth metal oxides, and improve the stability of the combination between polytetrafluoroethylene and rare earth metal oxides. The modified polyacrylate and rare earth metal modified polytetrafluoroethylene are subjected to polymer cross-linking reaction in the presence of a cross-linking agent, so that the cross-linked product has good biocompatibility, and the rare earth metal oxides contained in the copolymer obtained in the presence of a cross-linking agent can also act as an anti-calcification agent, so that the valve material obtained has good anti-calcification performance. The copolymer produced by cross-linking modified polyacrylate and rare earth metal modified polytetrafluoroethylene contains multiple groups on its molecular chain, such as tetradecyl allyl ammonium bromide, rare earth metal oxide and other groups, which are firmly bound to the polymer molecular chain, reducing the adsorption performance of the valve material, and avoiding the adhesion, aggregation and activation of platelets on the surface of the material to cause thrombosis. Therefore, the valve material obtained according to the method of the present invention has anti-thrombotic and anti-coagulation properties, has very good blood compatibility, does not require long-term anticoagulant treatment, has good durability and reliability, and avoids the pain caused by long-term surgery of the transplant recipient.

[0025] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention and implement it according to the contents of the specification, the preferred embodiments of the present invention are described in detail as follows. Implementation

[0026] In order to make the technical means, creative features, objectives and effects of the present invention easy to understand, the technical solutions in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example 1

[0027] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0028] Polymethyl acrylate (molecular weight 1×10 6 -1×10 8 The modified polymethyl acrylate is prepared by dispersing tetradecyl allyl ammonium bromide (TABA) in a 15 wt% ethylene glycol solution, and then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of ammonium persulfate to obtain the modified polymethyl acrylate. The mass ratio of polymethyl acrylate, tetradecyl allyl ammonium bromide and ammonium persulfate is 1:0.5:0.08.

[0029] Polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8 The raw materials were mixed with lanthanum oxide at a mass ratio of 1:0.2, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to make the raw materials uniformly mixed and avoid polytetrafluoroethylene agglomeration, and then the raw materials were compression molded and sintered to obtain lanthanum oxide modified polytetrafluoroethylene. The compression molding conditions were: room temperature, pressure 25 MPa, and holding time 4 minutes. The sintering conditions were: temperature 350°C, time 7 hours.

[0030] The modified polymethyl acrylate, lanthanum oxide-modified polytetrafluoroethylene and triethylenetetramine obtained above were mixed in a mass ratio of 1:2:0.4 and subjected to a cross-linking reaction. After the reaction, the product was treated at 70°C for 2h, and the product after the reaction was washed with water 3 times and dried in an empty drying oven at 70°C to constant weight, thereby obtaining the material for the transcatheter aortic valve. Example 2

[0031] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0032] Polymethyl acrylate (molecular weight 1×10 6 -1×10 8The modified polymethyl acrylate is prepared by dispersing tetradecyl allyl ammonium bromide (TDA) in a 10 wt% 1,2-propylene glycol solution, and then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of ammonium persulfate to obtain the modified polymethyl acrylate. The mass ratio of polymethyl acrylate, tetradecyl allyl ammonium bromide and ammonium persulfate is 1:0.6:0.05.

[0033] Polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8 The raw materials were mixed with cerium trioxide at a mass ratio of 1:0.3, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to make the raw materials uniformly mixed and avoid polytetrafluoroethylene agglomeration, and then the raw materials were pressed and sintered to obtain polytetrafluoroethylene modified with cerium trioxide. The pressing conditions were: room temperature, pressure 30 MPa, and holding time 4 minutes. The sintering conditions were: temperature 350°C, time 7 hours.

[0034] The modified polymethyl acrylate, cerium trioxide-modified polytetrafluoroethylene and dimethylaminopropylamine obtained above were mixed in a mass ratio of 1:1:0.3 and subjected to a cross-linking reaction. After the reaction, the product was treated at 80°C for 1h, and the product after the reaction was washed with water 3 times and dried in an empty drying oven at 70°C to constant weight to obtain the material for the transcatheter aortic valve. Example 3

[0035] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0036] Polymethyl acrylate (molecular weight 1×10 6 -1×10 8 The modified polymethyl acrylate is prepared by dispersing tetradecyl allyl ammonium bromide (TABA) in a 20 wt% 1,6-hexanediol solution, and then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of sodium persulfate to obtain the modified polymethyl acrylate. The mass ratio of polymethyl acrylate, tetradecyl allyl ammonium bromide and sodium persulfate is 1:0.3:0.1.

[0037] Polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8 The raw materials were mixed with lanthanum oxide at a mass ratio of 1:0.1, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to make the raw materials uniformly mixed and avoid polytetrafluoroethylene agglomeration, and then the raw materials were compression molded and sintered to obtain lanthanum oxide modified polytetrafluoroethylene. The compression molding conditions were: room temperature, pressure 30 MPa, and holding time 4 minutes. The sintering conditions were: temperature 350°C, time 7 hours.

[0038] The modified polymethyl acrylate, lanthanum oxide-modified polytetrafluoroethylene and diethylaminopropylamine obtained above were mixed in a mass ratio of 1:3:0.5 and subjected to a cross-linking reaction. After the reaction, the product was treated at 80°C for 2h, and the product after the reaction was washed with water three times and dried in an empty drying oven at 70°C to constant weight, thereby obtaining the material for the transcatheter aortic valve. Example 4

[0039] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0040] Polyethyl acrylate (molecular weight 1×10 6 -1×10 8 The modified polyethyl acrylate was prepared by dispersing tetradecyl allyl ammonium bromide (TABA) in a 15 wt% 1,4-butanediol solution, and then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of sodium persulfate to obtain the modified polyethyl acrylate. The mass ratio of the polyethyl acrylate, tetradecyl allyl ammonium bromide and sodium persulfate was 1:0.4:0.06.

[0041] Polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8 The raw materials were mixed with cerium dioxide at a mass ratio of 1:0.2, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to make the raw materials uniformly mixed and avoid polytetrafluoroethylene agglomeration, and then the raw materials were pressed and sintered to obtain polytetrafluoroethylene modified with cerium dioxide. The pressing conditions were: room temperature, pressure 30 MPa, and holding time 5 minutes. The sintering conditions were: temperature 300°C, time 8 hours.

[0042] The modified polyethyl acrylate, cerium dioxide-modified polytetrafluoroethylene and di-tert-butyl peroxide obtained above were mixed in a mass ratio of 1:2:0.5 and subjected to a cross-linking reaction. After the reaction, the product was treated at 70°C for 3 hours. The product after the reaction was washed with water three times and dried in an empty drying oven at 70°C to constant weight, thereby obtaining the material for the transcatheter aortic valve. Example 5

[0043] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0044] Polyethyl acrylate (molecular weight 1×10 6 -1×10 8The modified polyethyl acrylate was prepared by dispersing tetradecyl allyl ammonium bromide (TDA) in a 15 wt% 1,2-propylene glycol solution, and then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of ammonium sulfate to obtain the modified polyethyl acrylate. The mass ratio of the polyethyl acrylate, tetradecyl allyl ammonium bromide and ammonium sulfate was 1:0.6:0.07.

[0045] Polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8 The raw materials were mixed with praseodymium oxide at a mass ratio of 1:0.3, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to make the raw materials uniformly mixed and avoid polytetrafluoroethylene agglomeration, and then the raw materials were die-formed and sintered to obtain praseodymium oxide-modified polytetrafluoroethylene. The die-formed conditions were: room temperature, pressure 25 MPa, and holding time 5 minutes. The sintering conditions were: temperature 400°C, time 6 hours.

[0046] The modified polyethyl acrylate, praseodymium oxide-modified polytetrafluoroethylene and 2-ethyl-4-methylimidazole obtained above were mixed in a mass ratio of 1:3:0.4 and subjected to a cross-linking reaction. After the reaction, the product was treated at 60°C for 3 hours, and the product after the reaction was washed with water 3 times and dried in an empty drying oven at 70°C to constant weight, thereby obtaining the material for the transcatheter aortic valve. Example 6

[0047] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0048] Polyethyl acrylate (molecular weight 1×10 6 -1×10 8 The modified polyethyl acrylate is prepared by dispersing tetradecyl allyl ammonium bromide (TETRADECYL AMMONIUM BROMIDE) in a 10 wt% ethylene glycol solution, and then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of sodium persulfate to obtain the modified polyethyl acrylate. The mass ratio of polyethyl acrylate, tetradecyl allyl ammonium bromide and sodium persulfate is 1:0.5:0.09.

[0049] Polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8 The raw materials were mixed with lutetium oxide at a mass ratio of 1:0.1, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to make the raw materials uniformly mixed and avoid polytetrafluoroethylene agglomeration, and then the raw materials were pressed and sintered to obtain polytetrafluoroethylene modified with lutetium oxide. The pressing conditions were: room temperature, pressure 25 MPa, and holding time 3 minutes. The sintering conditions were: temperature 400°C, time 7 hours.

[0050] The modified polyethyl acrylate, lutetium oxide-modified polytetrafluoroethylene and diethylenetriamine obtained above were mixed in a mass ratio of 1:2:0.5 and subjected to a cross-linking reaction. After the reaction, the product was treated at 80°C for 1h, and the product after the reaction was washed with water 3 times and dried in an empty drying oven at 70°C to constant weight to obtain the material of the transcatheter aortic valve.

[0051] Comparative Example 1

[0052] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0053] Polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8 The raw materials were mixed with lanthanum oxide at a mass ratio of 1:0.2, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to make the raw materials uniformly mixed and avoid polytetrafluoroethylene agglomeration, and then the raw materials were compression molded and sintered to obtain lanthanum oxide modified polytetrafluoroethylene. The compression molding conditions were: room temperature, pressure 25 MPa, and holding time 4 minutes. The sintering conditions were: temperature 350°C, time 7 hours.

[0054] Polymethyl acrylate (molecular weight 1×10 6 -1×10 8 ), lanthanum oxide-modified polytetrafluoroethylene and triethylenetetramine are mixed in a mass ratio of 1:2:0.4 and subjected to a cross-linking reaction. After the reaction, the product is treated at 70°C for 2h, and the product after the reaction is washed with water 3 times and dried in an empty drying oven at 70°C to constant weight, thereby obtaining a transcatheter aortic valve material.

[0055] Comparative Example 2

[0056] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0057] Polymethyl acrylate (molecular weight 1×10 6 -1×10 8 The modified polymethyl acrylate is prepared by dispersing tetradecyl allyl ammonium bromide (TABA) in a 15 wt% ethylene glycol solution, and then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of ammonium persulfate to obtain the modified polymethyl acrylate. The mass ratio of polymethyl acrylate, tetradecyl allyl ammonium bromide and ammonium persulfate is 1:0.5:0.08.

[0058] The modified polymethyl acrylate and polytetrafluoroethylene (molecular weight 1×10 6 -1×10 8The mixture was mixed with triethylenetetramine in a mass ratio of 1:2:0.4 and subjected to a cross-linking reaction. After the reaction, the product was treated at 70°C for 2h. The product after the reaction was washed with water 3 times and dried in an empty drying oven at 70°C to constant weight, thereby obtaining a transcatheter aortic valve material.

[0059] Comparative Example 3

[0060] A material for a transcatheter aortic valve, the preparation method of which comprises the following steps:

[0061] Polymethyl acrylate (molecular weight 1×10 6 -1×10 8 between 1×10 6 -1×10 8 The mixture was mixed with triethylenetetramine in a mass ratio of 1:2:0.4 and subjected to a cross-linking reaction. After the reaction, the product was treated at 70°C for 2h. The product after the reaction was washed with water 3 times and dried in an empty drying oven at 70°C to constant weight, thereby obtaining a transcatheter aortic valve material.

[0062] Comparative Example 4

[0063] Commercially available polytetrafluoroethylene valve materials.

[0064] Test example: Performance testing of valve materials

[0065] The properties of the valve materials prepared in Examples 1-6 and Comparative Examples 1-4 were tested. The test methods and results are shown in Table 1.

[0066] Table 1 Comparison of performance of different valve materials

[0067] It can be seen from Table 1 that, compared with Comparative Examples 1-4, the valve materials obtained according to Examples 1-6 of the present invention have more excellent mechanical properties, blood compatibility and biocompatibility.

[0068] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment as above, it is not used to limit the present invention. Any technician familiar with this profession can make some changes or modifications to equivalent embodiments of equivalent changes by using the methods and technical contents disclosed above without departing from the scope of the technical solution of the present invention. However, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A method for preparing a material for a transcatheter aortic valve, characterized in that: The method comprises the following steps Dispersing polyacrylate in a polyol solution with a concentration of 10-20wt%, then adding tetradecyl allyl ammonium bromide to the mixed solution and performing a grafting reaction in the presence of an initiator to obtain a modified polyacrylate; the mass ratio of the polyacrylate, tetradecyl allyl ammonium bromide and the initiator is 1:0.3-0.6:0.05-0.1; The polytetrafluoroethylene and the rare earth metal oxide are mixed in a mass ratio of 1:0.1-0.3, and then stirred at a speed of 30 rpm for 5 minutes and then at a speed of 200 rpm for 10 minutes at an ambient temperature below 10°C to mix the raw materials evenly while preventing the polytetrafluoroethylene from agglomerating, and then the raw materials are compression molded and sintered to obtain rare earth metal modified polytetrafluoroethylene; The modified polyacrylate, rare earth metal-modified polytetrafluoroethylene and cross-linking agent obtained above are mixed in a mass ratio of 1:1-3:0.3-0.5 and subjected to a cross-linking reaction. After the reaction, the product is treated at 60-80°C for 1-3h, and the product after the reaction is washed with water and dried to obtain the material of the transcatheter aortic valve.

2. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The polyacrylate includes polymethyl acrylate and polyethyl acrylate, and its molecular weight is 1×10 6 -1×10 8 between.

3. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The polyol is selected from any one of ethylene glycol, 1,2-propylene glycol, 1,4-butanediol, 1,6-hexanediol and glycerol.

4. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The initiator is one or any combination of ammonium persulfate, sodium persulfate, vitamin C-sodium persulfate redox system, vitamin C and sodium pyrosulfite mixture-sodium persulfate redox system.

5. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The compression molding conditions are: room temperature, pressure 25-30 MPa, and holding time 3-5 min.

6. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The sintering conditions are: temperature 300-400° C., time 6-8 h.

7. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The molecular weight of polytetrafluoroethylene is 1×10 6 -1×10 8 between.

8. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The rare earth metal oxide is selected from any one of the following groups of oxides: La, Ce, Pr, Nd, Pm, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb, and Lu.

9. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The crosslinking agent is selected from any one of di-tert-butyl peroxide, diethylenetriamine, 2,5-dimethyl-2,5 di-tert-butyl peroxide hexane, diisopropyl hydroperoxide, 2-ethyl-4-methylimidazole, 2-phenylimidazole, 2-isopropylimidazole, tetrahydrophthalic anhydride, hexahydrophthalic anhydride, triethylenetetramine, dimethylaminopropylamine, and diethylaminopropylamine.

10. The method for preparing a material for a transcatheter aortic valve according to claim 1, characterized in that: The drying process is: drying in a vacuum drying oven at 60-80° C. to a constant weight.

Citation Information

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