CN114159629A - High-speed preparation method of blood vessel covered stent for emergency treatment of sudden coronary perforation in operation - Google Patents
High-speed preparation method of blood vessel covered stent for emergency treatment of sudden coronary perforation in operation Download PDFInfo
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Abstract
The invention discloses a high-speed preparation method of a blood vessel covered stent for emergent coronary perforation emergency in operation, relates to the field of preparation of blood vessel covered stents, and aims to solve the technical problems of easy unloading, frangibility, poor stability and large outer diameter of the existing covered stent. The method comprises the following steps: firstly, preparing a basement membrane material, then preparing a membrane casting solution, then putting the tube-mesh vascular stent with the saccule into the membrane casting solution for soaking, taking out the stent and putting the stent into a coagulating bath to obtain a layer of tightly-coated and completely-cured film on the surface of the stent, thus finishing the preparation of the vascular covered stent. The self-made blood vessel covered stent has the advantages of high preparation speed, capability of being prepared within 11-105 s, good tensile property, good stability, thin film thickness, little influence on the outer diameter of the blood vessel stent, difficulty in load shedding and capability of being used in the field of medical treatment.
Description
Technical Field
The invention relates to a preparation method of a blood vessel covered stent.
Background
The incidence of various cardiovascular diseases is increasing year by year, and Percutaneous Coronary Intervention (PCI) has become an important treatment method for cardiovascular diseases. Percutaneous transluminal angioplasty is characterized in that a puncture needle, a guide wire and a guide sheath are utilized to insert a balloon catheter sleeved with a contracted stent into a human blood vessel and deliver the balloon catheter to a narrow part of the blood vessel, the stent is also expanded along with the expansion of the balloon, and after the balloon is contracted and withdrawn, a deformed metal stent is left in place to play a role in expanding the blood vessel.
Although percutaneous transluminal angioplasty is a well-established technique, vessel rupture due to misoperation and other reasons, particularly due to faulty operation of a puncture needle or the like, cannot be avoided. Coronary Artery Perforation (CAP) is one of the rare but life-threatening complications of percutaneous coronary intervention, accounting for 0.1% -3.0% of PCI. Coronary perforation can lead to a sharp increase in pericardial pressure, causing cardiac tamponade, impairment of hemodynamics, and long-term coronary pseudo-aneurysms and coronary ventricular fistulas, which can die in a short time if the patient does not manage it in time.
The covered stent has become a main treatment means for coronary perforation, in particular to patients with poor hemostatic effect of balloon low-pressure dilatation and coronary perforation. The covered stent is not only a treatment means with special structure and function in the coronary artery field, but also a supplement to the traditional treatment means (medicine, embolism, operation and the like). At present, the commonly used covered stents for coronary perforation mainly comprise two types, namely a coronary covered stent made of Polytetrafluoroethylene (PTFE) and the like and a PTFE covered stent with a sandwich structure which is temporarily made in a catheter chamber.
The clinical manifestations of the current covered stents are not satisfactory, and the main reasons are considered as follows: the whole external diameter of the 'sandwich' structure stent is larger, the texture hardness is overlarge, the delivery performance and the trafficability of the stent system are poor, the stent is not easy to be delivered to a required position in twisted and calcified lesions, and the cost of the stent is overhigh, which causes overlarge economic burden of a patient. The model of the covered stent is not fully prepared due to rare occurrence of coronary perforation and cost consideration in each hospital catheter room, so the covered stent commonly used at present is mostly self-made, and a closed stent is formed by a method of wrapping the stent by using sterile application, polytetrafluoroethylene and other membranes. This kind of interim self-control coronary artery tectorial membrane support, membrane and support laminating are inseparable enough, and the membrane drops easily at vascular transportation in-process, and this kind of tectorial membrane mode can make the support external diameter too big, is difficult for carrying the affected part, and the support sacculus is stuck and is difficult to the withdrawal, and self-control tectorial membrane support is breakable, lacks stability.
Disclosure of Invention
The invention provides a high-speed preparation method of a blood vessel covered stent for emergency treatment of sudden coronary perforation in an operation, aiming at solving the technical problems of easy unloading, fragility, poor stability and large outer diameter of the existing self-made covered stent.
The invention relates to a high-speed preparation method of a blood vessel covered stent for emergent coronary perforation emergency in operation, which comprises the following steps:
firstly, taking 1-25 parts of thermoplastic resin, 2-50 parts of first graft, 5-100 parts of second graft, 0.5-10 parts of catalyst and 0.5-10 parts of ligand according to the mass parts;
secondly, dissolving the thermoplastic resin weighed in the step one in an organic solvent, heating and stirring the mixture until the thermoplastic resin is completely dissolved, and cooling the mixture to room temperature to obtain a thermoplastic resin solution;
thirdly, adding the first graft obtained in the first step into the thermoplastic resin solution, and stirring at room temperature under the protection of nitrogen for reaction; uniformly mixing the catalyst and the ligand weighed in the step one, adding the mixture into a thermoplastic resin solution, carrying out oil bath heating under the protection of nitrogen for reaction, and cooling to room temperature after the reaction is finished;
fourthly, adding the second graft weighed in the first step into the thermoplastic resin solution, continuing to perform oil bath heating reaction under the protection of nitrogen, cooling to room temperature after the reaction is completed, precipitating, filtering, washing and drying to obtain a base membrane material;
fifthly, mixing the base film material, the plasticizer and the organic solvent, and heating for reaction to obtain a membrane casting solution; wherein the mass ratio of the base film material to the plasticizer is (100-1): 1, and the mass ratio of the base film material to the organic solvent is 1: (4-20);
sixthly, putting the tube-mesh intravascular stent with the saccule into the membrane casting solution to be soaked for 1-5 s;
and seventhly, taking out the stent, placing the stent into a coagulating bath for 10-100 s to obtain a layer of tightly-coated and completely-cured film on the surface of the stent, and thus completing the preparation of the blood vessel covered stent.
Further, the thermoplastic resin in the first step is polyvinylidene fluoride (PVDF), polypropylene, cellulose acetate, polyvinyl chloride, polyethylene, carboxymethyl cellulose, chitosan or polyvinyl alcohol.
Further, the first graft in step one is butadiene, 1, 3-pentadiene, isoprene, 2, 4-hexadiene, 1, 5-hexadiene-3, 4-diol, trans-2, 4-decadienal, diallylamine, dicyclopentadiene, 2, 4-hexadienoic acid or 1, 8-nonadiene.
Further, the second graft in the first step is acrylic acid, butenoic acid, 4-pentenoic acid, N-isopropylacrylamide, styrene, methacrylic acid, butyl acrylate, 2-vinylacetamidoacrylic acid, ethyl acrylate, 3-indoleacrylic acid, ethyl methacrylate or alpha-bromoacrylic acid.
Further, the catalyst in the first step is cuprous chloride (CuCl), cuprous bromide (CuBr), cuprous iodide (CuI), ferrous chloride (FeCl)2) Ferrous bromide (FeBr)2) Iron iodide (FeI)2) Nickel chloride (NiCl)2) Nickel bromide (NiBr)2) Nickel iodide (NiI)2) Or tris (triphenylphosphine) ruthenium dichloride (RuCl2 (PPh)3)3)。
Further, the ligand in the first step is Pentamethyldiethylenetriamine (PMDETA), Hexamethyltriethylenetetramine (HMTETA), ligand tris- (N, N-dimethylaminoethyl) amine (Me6-TREN), decabromodiphenyl ether (BDE) or bis (2-picolyl) octadecylamine (BPMODA).
Further, the organic solvent in the second step is N, N-dimethylformamide, N-dimethylacetamide, N-methylpyrrolidone, dimethylsulfoxide, methanol, ethanol, acetone, ethylene glycol, acetic acid, glycerol or dimethylsulfoxide.
Furthermore, the heating temperature in the second step is 40-80 ℃.
Furthermore, the stirring time in the third step is 6-24 hours, and the oil bath reaction time is 8-20 hours.
Furthermore, the reaction time of the oil bath in the fourth step is 3-15 h.
Furthermore, the heating reaction in the fifth step is carried out for 4-12 hours at the temperature of 40-80 ℃.
Still further, the plasticizer in the fifth step is dibutyl phthalate, dioctyl phthalate, dipentyl phthalate, tributyl citrate, trioctyl citrate, epoxidized soybean oil, epoxy acetyl linoleic acid methyl ester, glycerin, sorbitol, polyethylene glycol or chlorinated paraffin.
Further, the tubular mesh-shaped blood vessel stent in the sixth step is a cobalt-based alloy mesh, a stainless steel fiber mesh, a copper fiber mesh, an iron fiber mesh, a titanium fiber mesh or an aluminum fiber mesh.
Further, the coagulation bath in the seventh step is deionized water, methanol, an aqueous methanol solution, ethanol, an aqueous ethanol solution, an aqueous N, N-Dimethylformamide (DMF) solution, an aqueous dimethylacetamide (DMAc) solution, an aqueous acetone solution, an aqueous Dimethylsulfoxide (DMSO) solution, or an aqueous glycerol solution.
The surface of the coronary artery covered stent prepared by the invention is covered with the corrosion-resistant film, the surface of the stent with proper size can be quickly covered with the film after the coronary artery of a patient is ruptured, and the coronary artery covered stent is conveyed to the position of the ruptured blood vessel through the minimally invasive percutaneous coronary intervention, so that the blood can be prevented from flowing out of an affected part in time. The preparation method can be completed within 11 s-105 s, has high film forming speed and low cost, can be suitable for all types of intravascular stents, and wins precious time for subsequent rescue work.
The invention relates to a blood vessel covered stent for emergent coronary perforation in operation, which consists of a tube mesh blood vessel stent and a corrosion-resistant surface layer attached to the outer layer of the tube mesh stent, wherein the thickness of the film is 30-150 micrometers, the implantation method of the stent has no difference with that of a common stent, and the blood vessel covered stent is characterized in that in percutaneous coronary artery intervention, when coronary perforation occurs, a proper stent can be selected according to the characteristics of a blood vessel, membrane casting liquid is dipped on the stent and put into a coagulation bath for rapid coagulation to form a membrane, and the membrane is conveyed to a required position in a body to achieve the effect of high-speed hemostasis.
Drawings
FIG. 1 is a graph showing the mechanical properties of the coating material prepared in example 1.
Detailed Description
The following examples are used to demonstrate the beneficial effects of the present invention.
Example 1: the high-speed preparation method of the blood vessel covered stent for the emergency treatment of the sudden coronary perforation in the operation comprises the following steps:
firstly, weighing 3g of cellulose acetate, 8g of isoprene, 20g of crotonic acid, 1g of CuI and 1.5g of bipyridine;
secondly, dissolving the cellulose acetate weighed in the step one in 20mL of N, N-dimethylformamide, heating and stirring at 70 ℃ until the cellulose acetate is completely dissolved, and cooling to room temperature to obtain a cellulose acetate solution;
thirdly, adding the isoprene weighed in the first step into the cellulose acetate solution, and stirring for 20 hours at room temperature under the protection of nitrogen; fully mixing the CuI and the bipyridyl weighed in the step one, adding the mixture into a cellulose acetate solution, carrying out oil bath reaction for 8 hours at 100 ℃ under the protection of nitrogen, and cooling to room temperature after the reaction is finished;
fourthly, adding the crotonic acid weighed in the first step into the cellulose acetate solution, continuing oil bath reaction for 10 hours under the protection of nitrogen, cooling to room temperature after the oil bath reaction is finished, precipitating by using ethanol, filtering, repeatedly washing by using a large amount of deionized water, and finally drying to obtain a multi-branch structure base membrane material CA-g-PB-g-butenoic acid;
fifthly, stirring 5g of the base membrane material prepared in the fourth step, 5g of dibutyl phthalate and 90g of N, N-dimethylacetamide (DMAc) for 8h at 60 ℃, and cooling to room temperature to obtain a casting solution;
sixthly, putting the cobalt-based alloy tube mesh intravascular stent with the saccule into the membrane casting solution to be soaked for 5 s;
and seventhly, taking out the stent, placing the stent into a deionized water coagulation bath for 60s to obtain a layer of tightly-coated and completely-cured film on the surface of the stent, and thus finishing the preparation of the blood vessel covered stent.
The structural formula of the multi-branch structure basement membrane material CA-g-PB-g-butenoic acid obtained in the fourth step of this embodiment is as follows:
the first graft isoprene is grafted on the main chain of cellulose acetate, and the second graft crotonic acid is grafted on isoprene, so that the grafting amount of crotonic acid is increased, and crotonic acid has a bactericidal effect.
And scraping a film with the thickness of 0.12mm on a glass plate by using the casting solution obtained in the fifth step, placing the glass plate in a coagulating bath for 30 seconds to solidify and form a film, cutting the film into strips of 4cm x 1cm after being taken off, clamping the strips on a universal testing machine for tensile test, and obtaining a tensile property test result as shown in figure 1, wherein the elongation at break can reach more than 260% as shown in figure 1, and the film material has good tensile property, can be kept complete and not broken in the expansion process of all common types of stents, has good stability, and thus has the effect of timely stopping bleeding.
The thickness of the film on the surface of the blood vessel covered stent prepared by the embodiment is 100 microns, and the influence on the outer diameter of the blood vessel covered stent is very small.
The blood vessel covered stent prepared by the embodiment has the advantages of tight coating of the film on the surface on the matrix, good binding force and difficult shedding.
The blood vessel covered stent prepared by the embodiment can be completed within 65s, the preparation speed is high, and precious time can be won for rescue in operation.
Example 2: the high-speed preparation method of the blood vessel covered stent for the emergency treatment of the sudden coronary perforation in the operation comprises the following steps:
firstly, weighing 5.0g of polyvinylidene fluoride, 30g of acrylic acid, 1.5g of CuBr and 2.0g of HMTETA;
secondly, dissolving the polyvinylidene fluoride weighed in the step one in N-methyl pyrrolidone, heating and stirring at 80 ℃ until the polyvinylidene fluoride is completely dissolved, and cooling to room temperature to obtain a polyvinylidene fluoride solution;
and thirdly, introducing butadiene into the polyvinylidene fluoride solution, and stirring for 20 hours at room temperature under the protection of nitrogen. Fully mixing the CuBr and the HMTETA weighed in the step one, adding the mixture into a polyvinylidene fluoride solution, carrying out oil bath reaction for 8 hours at 50 ℃ under the protection of nitrogen, and cooling to room temperature after the reaction is finished;
fourthly, adding the acrylic acid weighed in the step one into the polyvinylidene fluoride solution, continuing oil bath reaction for 10 hours under the protection of nitrogen, cooling to room temperature after the oil bath reaction is finished, precipitating by using ethanol, filtering, repeatedly washing by using a large amount of deionized water, and finally drying to obtain a base membrane material PVDF-g-BD-g-AA with a multi-branch structure;
fifthly, stirring 10g of the base membrane material prepared in the fourth step, 5g of dioctyl phthalate and 85g of N-methylpyrrolidone at 60 ℃ for 8h, and cooling to room temperature to obtain a membrane casting solution;
sixthly, putting the stainless steel fiber mesh pipe network intravascular stent with the saccule into the membrane casting solution to be soaked for 3 s;
and seventhly, taking out the stent, placing the stent into a methanol water solution coagulating bath for 50s to obtain a layer of tightly-coated and completely-cured film on the surface of the stent, thus finishing the preparation of the blood vessel covered stent.
The blood vessel covered stent prepared by the embodiment can be completed within 53s, the preparation speed is high, precious time can be gained for intraoperative rescue, and the surface film is tightly coated on a substrate, the binding force is good, and the shedding is not easy.
Claims (10)
1. A high-speed preparation method of a blood vessel covered stent for emergent coronary perforation in operation is characterized by comprising the following steps:
firstly, taking 1-25 parts of thermoplastic resin, 2-50 parts of first graft, 5-100 parts of second graft, 0.5-10 parts of catalyst and 0.5-10 parts of ligand according to the mass parts;
secondly, dissolving the thermoplastic resin weighed in the step one in an organic solvent, heating and stirring the mixture until the thermoplastic resin is completely dissolved, and cooling the mixture to room temperature to obtain a thermoplastic resin solution;
thirdly, adding the first graft obtained in the first step into the thermoplastic resin solution, and stirring at room temperature under the protection of nitrogen for reaction; uniformly mixing the catalyst and the ligand weighed in the step one, adding the mixture into a thermoplastic resin solution, carrying out oil bath heating under the protection of nitrogen for reaction, and cooling to room temperature after the reaction is finished;
fourthly, adding the second graft obtained in the first step into the thermoplastic resin solution, continuously carrying out oil bath heating reaction under the protection of nitrogen, cooling to room temperature after the reaction is finished, precipitating, filtering, washing and drying to obtain a base membrane material;
fifthly, mixing the base film material, the plasticizer and the organic solvent, and heating for reaction to obtain a membrane casting solution; wherein the mass ratio of the base film material to the plasticizer is (100-1): 1, and the mass ratio of the base film material to the organic solvent is 1: (4-20);
sixthly, putting the tube-mesh intravascular stent with the saccule into the membrane casting solution to be soaked for 1-5 s;
and seventhly, taking out the stent, placing the stent into a coagulating bath for 10-100 s to obtain a layer of tightly-coated and completely-cured film on the surface of the stent, and thus completing the preparation of the blood vessel covered stent.
2. The method for preparing a vascular stent graft for emergency treatment of intraoperative emergent coronary perforation according to claim 1, wherein the thermoplastic resin in the first step is polyvinylidene fluoride, polypropylene, cellulose acetate, polyvinyl chloride, polyethylene, carboxymethyl cellulose, chitosan or polyvinyl alcohol.
3. The high-speed preparation method of the vascular stent graft for emergency treatment of sudden coronary perforation in operation according to claim 1 or 2, wherein the first graft in the first step is butadiene, 1, 3-pentadiene, isoprene, 2, 4-hexadiene, 1, 5-hexadiene-3, 4-diol, trans-2, 4-decadienal, diallylamine, dicyclopentadiene, 2, 4-hexadienoic acid or 1, 8-nonadiene.
4. The method for preparing a vascular covered stent for emergency treatment of sudden coronary artery perforation in operation according to claim 1 or 2, wherein the second graft in the first step is acrylic acid, butenoic acid, 4-pentenoic acid, N-isopropylacrylamide, styrene, methacrylic acid, butyl acrylate, 2-aminoacrylic acid acetate, ethyl acrylate, 3-indoleacrylic acid, ethyl methacrylate or alpha-bromoacrylic acid.
5. The method for preparing a vascular stent graft for emergency treatment of intraoperative emergent coronary perforation according to claim 1 or 2, wherein the catalyst in the step one is cuprous chloride, cuprous bromide, cuprous iodide, ferrous chloride, ferrous bromide, ferrous iodide, nickel chloride, nickel bromide, nickel iodide or tris (triphenylphosphine) ruthenium dichloride.
6. The method for preparing a vascular covered stent for emergency treatment of sudden coronary artery perforation in operation according to claim 1 or 2, wherein the ligand in the first step is pentamethyldiethylenetriamine, hexamethyltriethylenetetramine, ligand tri- (N, N-dimethylaminoethyl) amine, decabromodiphenyl ether or bis (2-picolyl) octadecylamine.
7. The method for preparing a vascular stent graft for emergency treatment of sudden coronary artery perforation in operation according to claim 1 or 2, wherein the organic solvent in the second step is N, N-dimethylformamide, N-dimethylacetamide, N-methylpyrrolidone, dimethyl sulfoxide, methanol, ethanol, acetone, ethylene glycol, acetic acid, glycerol or dimethyl sulfoxide.
8. The method for preparing a vascular stent graft for emergency treatment of sudden coronary artery perforation in operation according to claim 1 or 2, wherein the plasticizer in the fifth step is dibutyl phthalate, dioctyl phthalate, diamyl phthalate, tributyl citrate, trioctyl citrate, epoxidized soybean oil, epoxy acetyl methyl linoleate, glycerin, sorbitol, polyethylene glycol or chlorinated paraffin.
9. The high-speed preparation method of the vascular stent graft for the emergency treatment of the sudden coronary perforation in the operation according to claim 1 or 2, wherein the vascular stent graft in the sixth step is a cobalt-based alloy mesh, a stainless steel mesh, a copper mesh, an iron mesh, a titanium mesh or an aluminum mesh.
10. The high-speed preparation method of the vascular stent graft for the emergency treatment of the intraoperative sudden coronary perforation according to claim 1 or 2, wherein the coagulation bath in the seventh step is deionized water, methanol, an aqueous methanol solution, ethanol, an aqueous ethanol solution, an aqueous N, N-dimethylformamide solution, an aqueous dimethylacetamide solution, an aqueous acetone solution, an aqueous dimethyl sulfoxide solution or an aqueous glycerol solution.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117653434A (en) * | 2023-12-12 | 2024-03-08 | 上海交通大学医学院附属瑞金医院卢湾分院 | Y-shaped tectorial membrane tracheal stent, imbedding device and manufacturing method |
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|---|---|---|---|---|
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| CN117653434A (en) * | 2023-12-12 | 2024-03-08 | 上海交通大学医学院附属瑞金医院卢湾分院 | Y-shaped tectorial membrane tracheal stent, imbedding device and manufacturing method |
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| CN114159629B (en) | 2023-03-24 |
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