DSA-guided vascular puncture positioning membrane and preparation process thereof

Abstract

The invention relates to a DSA-guided vascular puncture positioning membrane and a preparation process thereof, and belongs to the technical field of medical instruments. Medical gum, polycaprolactone and self-made X-ray self-developing polyurethane serve as raw materials, the vascular puncture positioning film for DSA guiding is prepared, the X-ray self-developing polyurethane is heated to be molten and then printed into a developing dot matrix, then the polycaprolactone is heated to be molten and then smeared on the developing dot matrix to form the film, and the film is formed. Finally, the back face of the polycaprolactone film is coated with medical gum, curing and sterilization are carried out, and the vascular puncture positioning film for DSA guiding is obtained.The preparation method of the vascular puncture positioning film for DSA guiding is simple, dot matrixes of different numbers and shapes can be printed according to needs to cope with different operations, the X-ray absorption effect of the developing dot matrixes is good, and the film is suitable for being used in various operations. Imaging is clear, no toxicity or harm is caused, and good biocompatibility is achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to a blood vessel puncture positioning membrane for DSA guidance and a preparation process thereof. Background Art

[0002] Interventional radiotherapy, also known as interventional radiology or interventional therapy, is an emerging science that has been developing rapidly since the 20th century. It plays an increasingly important role in today's biomedical field and is widely used in the fields of vascular diseases and tumor diseases. Interventional therapy is usually assisted and monitored by imaging equipment such as electronic digital subtraction angiography DSA, electronic computer tomography CT and magnetic resonance imaging. Through the use of puncture needles, guide wires, catheters, microcatheters, catheter sheaths, stents and other interventional treatment equipment, embolic microspheres and other implant materials are introduced into the body's lesions through minimally invasive wounds through femoral artery puncture. With the development of interventional radiotherapy, related medical devices are being Medical devices also have more stringent requirements. People increasingly hope to evaluate the application of these implant materials in the human body in a non-invasive way. However, the polymer materials used in medical devices usually only contain elements with low electron cloud density such as carbon, hydrogen, oxygen, and nitrogen, which cannot be detected by X-rays. Although there are methods in the prior art to improve the radiation absorption effect of polymer materials, such as blending polymers with appropriate radiopaque emulsions such as heavy metal powders, heavy element inorganic salts or heavy atom organic matter, this method can easily lead to material deterioration and performance degradation, and may migrate into the human body and cause harm to the human body. Based on this, the present invention provides a DSA-guided vascular puncture positioning membrane and a preparation process thereof. Summary of the invention

[0003] The object of the present invention is to provide a DSA guided vascular puncture positioning membrane and a preparation process thereof, so as to solve the problems mentioned in the above background technology.

[0004] The purpose of the present invention can be achieved by the following technical solutions:

[0005] A DSA guided vascular puncture positioning membrane comprises a medical adhesive layer and a polycaprolactone membrane that can transmit X-rays, and a developing dot matrix with an X-ray absorbing effect is distributed on the surface of the polycaprolactone membrane, and the developing dot matrix is ​​a self-made X-ray self-developing polyurethane;

[0006] A preparation process of a blood vessel puncture positioning membrane for DSA guidance comprises the following steps:

[0007] The first step is to heat and melt the X-ray self-developing polyurethane and then use a 3D printer to print out the pre-designed development dot matrix in the mold;

[0008] The second step is to heat and melt the polycaprolactone and evenly apply it to a mold with a developing dot matrix, and then peel it off after cooling and solidification to obtain a polycaprolactone film with a developing dot matrix distributed on the surface;

[0009] The third step is to coat the back of the polycaprolactone film with the developing dots distributed on the surface with medical adhesive, and then sterilize it after curing to obtain a blood vessel puncture positioning membrane for DSA guidance.

[0010] Furthermore, the medical adhesive backing is medical e-cyanoacrylate 6B adhesive.

[0011] Furthermore, the thickness of the polycaprolactone film with the development dot array distributed on the surface is 1-2 mm.

[0012] Preferably, the mold used is a polytetrafluoroethylene mold.

[0013] Preferably, the thickness of the development dot matrix is ​​0.5-1 mm.

[0014] Preferably, the thickness of the medical adhesive layer is 0.1-0.3 mm.

[0015] Furthermore, the temperature at which the X-ray self-developing polyurethane is heated and melted is 260-280°C, and the temperature at which the polycaprolactone is heated and melted is 70-80°C.

[0016] Furthermore, the X-ray self-developing polyurethane is prepared by the following steps:

[0017] Step 1, 3,5-diiodo-4-hydroxybenzaldehyde, 2-amino-3,5-diiodopyridine, hydroxyacetone, L-proline and cyclopentyl methyl ether were mixed in a three-necked flask, magnetic stirring was turned on, and the mixture was reacted at room temperature for 2 hours. After the reaction was completed, a saturated ammonium chloride solution was added to the three-necked flask to quench the reaction, and then an organic layer was separated with a separatory funnel. The organic layer was evaporated to remove the solvent, and then subjected to silica gel column chromatography to obtain intermediate 1;

[0018]

[0019] Step 2, the intermediate 1, dodecyl bromide and acetonitrile were mixed in a three-necked flask, a condenser and a thermometer were installed, magnetic stirring was turned on, and the reaction was carried out at a temperature of 80° C. for 36 hours. After the reaction was completed, the reaction solution was spin-dried to obtain the intermediate 2;

[0020]

[0021] Step 3, add polytetrahydrofuran to a three-necked flask, install a thermometer, turn on magnetic stirring, raise the system temperature to 120°C, evacuate the system and stir for 2 hours to remove water, then introduce nitrogen into the three-necked flask and lower the system temperature to 70°C, add diphenylmethane-4,4'-diisocyanate and dibutyltin dilaurate to the three-necked flask after cooling, and react at a temperature of 70°C for 2 hours, then add the N,N-dimethylacetamide solution of intermediate 2 to the three-necked flask, and continue to react at a temperature of 70°C for 2 hours, finally add 1,4-butanediol to the three-necked flask, and react at a temperature of 70°C for 3 hours, after the reaction is completed, pour the product into a polyfluoroethylene mold and put it into an oven for drying to obtain the X-ray self-developing polyurethane.

[0022]

[0023] Furthermore, the dosage ratio of 3,5-diiodo-4-hydroxybenzaldehyde, 2-amino-3,5-diiodopyridine, hydroxyacetone, L-proline and cyclopentyl methyl ether used in step 1 is 0.05 mol: 0.05-0.06 mol: 0.05-0.06 mol: 0.01 mol: 80-100 mL.

[0024] Furthermore, the amount ratio of the intermediate 1, dodecyl bromide and acetonitrile used in step 2 is 0.03 mol: 0.04-0.05 mol: 50-60 mL.

[0025] Furthermore, the molecular weight of the polytetrahydrofuran used in step 3 is 1000.

[0026] Furthermore, the N,N-dimethylacetamide solution of intermediate 2 used in step 3 is prepared from 0.02 mol intermediate 2 and 120 mL N,N-dimethylacetamide solution.

[0027] Furthermore, the amount ratio of polytetrahydrofuran, diphenylmethane-4,4'-diisocyanate, dibutyltin dilaurate, N,N-dimethylacetamide solution of intermediate 2, and 1,4-butanediol used in step 3 is 40g: 0.07-0.08mol: 0.1-0.11g: 120mL: 0.01-0.02mol.

[0028] Beneficial effects of the present invention:

[0029] 1) The present invention uses medical adhesive, polycaprolactone and a self-made X-ray self-developing polyurethane as raw materials to prepare a DSA-guided vascular puncture positioning membrane. The present invention heats and melts the X-ray self-developing polyurethane and prints it into a developing dot matrix, then heats and melts the polycaprolactone and applies it on the developing dot matrix to form a film, and finally coats the medical adhesive on the back of the polycaprolactone film and solidifies it to obtain a DSA-guided vascular puncture positioning membrane. The DSA-guided vascular puncture positioning membrane of the present invention has good biocompatibility, is non-toxic and harmless, and will not cause irritation to the human body.

[0030] 2) The present invention uses 3,5-diiodo-4-hydroxybenzaldehyde, 2-amino-3,5-diiodopyridine and hydroxyacetone as raw materials, utilizes the aldehyde group of 3,5-diiodo-4-hydroxybenzaldehyde, the amino group of 2-amino-3,5-diiodopyridine and the α-hydrogen of hydroxyacetone to undergo Mannich reaction under the catalysis of L-proline to obtain intermediate 1, then uses intermediate 1 and dodecyl bromide as raw materials, utilizes the pyridine nitrogen atom of intermediate 1 to undergo quaternary ammonium salt reaction with dodecyl bromide to obtain intermediate 2, finally uses intermediate 2 and 1,4-butanediol as chain extender, polytetrahydrofuran An X-ray self-developing polyurethane is prepared by using furan and diphenylmethane-4,4'-diisocyanate as polymerization monomers; the X-ray self-developing polyurethane material of the invention contains a large amount of iodine atoms, the iodine atoms have a high electron cloud density and have a good absorption effect on X-rays, the iodine atoms can give the X-ray self-developing polyurethane material of the invention a good X-ray development effect, and the iodine atoms in the X-ray self-developing polyurethane material exist in the form of compounds and are non-toxic. In addition, the X-ray self-developing polyurethane material of the invention also has a pyridyl quaternary ammonium salt structure and has good antibacterial properties.

[0031] 3) The preparation method of the DSA-guided vascular puncture positioning membrane of the present invention is simple, and different numbers and shapes of dot matrixes can be printed as needed to cope with different surgeries. The developing dot matrix has a good absorption effect on X-rays, clear imaging, is non-toxic and harmless, and has good biocompatibility. DETAILED DESCRIPTION

[0032] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. 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.

[0033] Example 1

[0034] An X-ray self-developing polyurethane is prepared by the following steps:

[0035] Step 1, 0.05 mol 3,5-diiodo-4-hydroxybenzaldehyde, 0.05 mol 2-amino-3,5-diiodopyridine, 0.05 mol hydroxyacetone, 0.01 mol L-proline, and 80 mL cyclopentyl methyl ether were mixed in a three-necked flask, magnetic stirring was turned on, and the mixture was reacted at room temperature for 2 h. After the reaction was completed, a saturated ammonium chloride solution was added to the three-necked flask to quench the reaction, and then the organic layer was separated with a separatory funnel. The organic layer was evaporated to remove the solvent and then subjected to silica gel column chromatography to obtain intermediate 1;

[0036] Step 2, 0.03 mol intermediate 1, 0.04 mol dodecyl bromide, and 50 mL acetonitrile were mixed in a three-necked flask, a condenser and a thermometer were installed, magnetic stirring was turned on, and the reaction was carried out at a temperature of 80° C. for 36 hours. After the reaction was completed, the reaction solution was spin-dried to obtain intermediate 2;

[0037] Step 3, add 40g of polytetrahydrofuran to a three-necked flask, install a thermometer, turn on magnetic stirring, raise the system temperature to 120°C, evacuate the system and stir for 2h to remove water, then introduce nitrogen into the three-necked flask and lower the system temperature to 70°C, add 0.07mol diphenylmethane-4,4'-diisocyanate and 0.1g dibutyltin dilaurate to the three-necked flask after cooling, and react at a temperature of 70°C for 2h, then add 120mL of a solution prepared by 0.02mol intermediate 2 and 120mL N,N-dimethylacetamide to the three-necked flask, and continue to react at a temperature of 70°C for 2h, finally add 0.1mol 1,4-butanediol to the three-necked flask, and react at a temperature of 70°C for 3h, after the reaction is completed, pour the product into a polyfluoroethylene mold and put it into an oven for drying to obtain the X-ray self-developing polyurethane.

[0038] The molecular weight of the polytetrahydrofuran used in this embodiment is 1000.

[0039] Example 2

[0040] An X-ray self-developing polyurethane is prepared by the following steps:

[0041] Step 1, 0.05 mol 3,5-diiodo-4-hydroxybenzaldehyde, 0.055 mol 2-amino-3,5-diiodopyridine, 0.055 mol hydroxyacetone, 0.01 mol L-proline, and 90 mL cyclopentyl methyl ether were mixed in a three-necked flask, magnetic stirring was turned on, and the mixture was reacted at room temperature for 2 h. After the reaction was completed, a saturated ammonium chloride solution was added to the three-necked flask to quench the reaction, and then the organic layer was separated with a separatory funnel. The organic layer was evaporated to remove the solvent and then subjected to silica gel column chromatography to obtain intermediate 1;

[0042] Step 2, 0.03 mol intermediate 1, 0.045 mol dodecyl bromide, and 55 mL acetonitrile were mixed in a three-necked flask, a condenser and a thermometer were installed, magnetic stirring was turned on, and the reaction was carried out at a temperature of 80° C. for 36 hours. After the reaction was completed, the reaction solution was spin-dried to obtain intermediate 2;

[0043] Step 3, add 40g of polytetrahydrofuran to a three-necked flask, install a thermometer, turn on magnetic stirring, raise the system temperature to 120°C, evacuate the system and stir for 2h to remove water, then introduce nitrogen into the three-necked flask and lower the system temperature to 70°C, add 0.075mol of diphenylmethane-4,4'-diisocyanate and 0.105g of dibutyltin dilaurate to the three-necked flask after cooling, and react at a temperature of 70°C for 2h, then add 120mL of a solution prepared by 0.02mol of intermediate 2 and 120mL of N,N-dimethylacetamide to the three-necked flask, and continue to react at a temperature of 70°C for 2h, finally add 0.15mol of 1,4-butanediol to the three-necked flask, and react at a temperature of 70°C for 3h, after the reaction is completed, pour the product into a polyfluoroethylene mold and put it into an oven for drying to obtain the X-ray self-developing polyurethane.

[0044] The molecular weight of the polytetrahydrofuran used in this embodiment is 1000.

[0045] Example 3

[0046] An X-ray self-developing polyurethane is prepared by the following steps:

[0047] Step 1, 0.05 mol 3,5-diiodo-4-hydroxybenzaldehyde, 0.06 mol 2-amino-3,5-diiodopyridine, 0.06 mol hydroxyacetone, 0.01 mol L-proline, and 100 mL cyclopentyl methyl ether were mixed in a three-necked flask, magnetic stirring was turned on, and the mixture was reacted at room temperature for 2 h. After the reaction was completed, a saturated ammonium chloride solution was added to the three-necked flask to quench the reaction, and then the organic layer was separated with a separatory funnel. The organic layer was evaporated to remove the solvent and then subjected to silica gel column chromatography to obtain intermediate 1;

[0048] Step 2, 0.03 mol intermediate 1, 0.05 mol dodecyl bromide, and 60 mL acetonitrile were mixed in a three-necked flask, a condenser and a thermometer were installed, magnetic stirring was turned on, and the reaction was carried out at a temperature of 80° C. for 36 hours. After the reaction was completed, the reaction solution was spin-dried to obtain intermediate 2;

[0049] Step 3, add 40g of polytetrahydrofuran to a three-necked flask, install a thermometer, turn on magnetic stirring, raise the system temperature to 120°C, evacuate the system and stir for 2h to remove water, then introduce nitrogen into the three-necked flask and lower the system temperature to 70°C, add 0.08mol diphenylmethane-4,4'-diisocyanate and 0.11g dibutyltin dilaurate to the three-necked flask after cooling, and react at a temperature of 70°C for 2h, then add 120mL of a solution prepared by 0.02mol intermediate 2 and 120mL N,N-dimethylacetamide to the three-necked flask, and continue to react at a temperature of 70°C for 2h, finally add 0.2mol 1,4-butanediol to the three-necked flask, and react at a temperature of 70°C for 3h, after the reaction is completed, pour the product into a tetrafluoroethylene mold and put it into an oven for drying to obtain the X-ray self-developing polyurethane.

[0050] The molecular weight of the polytetrahydrofuran used in this embodiment is 1000.

[0051] Experimental Example 1

[0052] The X-ray self-developing polyurethane obtained in Examples 1-3 was tested for the antibacterial rates against Escherichia coli and Staphylococcus aureus according to the national standard GB / T20944.3-2008. The test results are shown in Table 1:

[0053] Table 1

[0054] project Escherichia coli inhibition rate (%) Staphylococcus aureus inhibition rate (%) Example 1 99.9 99.9 Example 2 99.9 99.9 Example 3 99.9 99.9

[0055] It can be seen from Table 1 that the antibacterial rates of the X-ray self-developable polyurethane of the present invention against Escherichia coli and Staphylococcus aureus are both 99.9%, indicating that the X-ray self-developable polyurethane of the present invention has a good antibacterial effect.

[0056] Example 4

[0057] A DSA guided vascular puncture positioning membrane, comprising a medical e-cyanoacrylate 6B adhesive layer and a polycaprolactone membrane that can transmit X-rays, wherein a developing dot matrix having an X-ray absorbing effect is distributed on the surface of the polycaprolactone membrane, and the developing dot matrix is ​​the X-ray self-developing polyurethane obtained in Example 1;

[0058] A preparation process of a blood vessel puncture positioning membrane for DSA guidance comprises the following steps:

[0059] The first step is to heat the X-ray self-developing polyurethane obtained in Example 1 to 260° C. and melt it, and then use a 3D printer to print a pre-designed development dot matrix in a polytetrafluoroethylene mold, wherein the thickness of the development dot matrix is ​​0.5 mm;

[0060] Step 2: Heat the polycaprolactone to 70°C and melt it, then evenly apply it to a PTFE mold with a developing dot matrix, and then cool and solidify it and peel it off to obtain a polycaprolactone film with a developing dot matrix distributed on the surface, wherein the thickness of the polycaprolactone film is 1 mm;

[0061] The third step is to coat the back of the polycaprolactone film with the developing dots distributed on the surface with medical e-cyanoacrylate 6B adhesive, and sterilize it after curing to obtain a DSA guided vascular puncture positioning film, wherein the thickness of the medical back adhesive layer is 0.1 mm.

[0062] Example 5

[0063] A DSA guided vascular puncture positioning membrane, comprising a medical e-cyanoacrylate 6B adhesive layer and a polycaprolactone membrane that can transmit X-rays, wherein a developing dot matrix having an X-ray absorbing effect is distributed on the surface of the polycaprolactone membrane, and the developing dot matrix is ​​the X-ray self-developing polyurethane obtained in Example 2;

[0064] A preparation process of a blood vessel puncture positioning membrane for DSA guidance comprises the following steps:

[0065] The first step is to heat the X-ray self-developing polyurethane obtained in Example 2 to 270°C for melting, and then use a 3D printer to print a pre-designed development dot matrix in a polytetrafluoroethylene mold, wherein the thickness of the development dot matrix is ​​0.75 mm;

[0066] Step 2: Heat the polycaprolactone to 75°C and melt it, then evenly apply it to a PTFE mold with a developing dot matrix distributed on it. After cooling and solidification, peel it off to obtain a polycaprolactone film with a developing dot matrix distributed on the surface, wherein the thickness of the polycaprolactone film is 1.5 mm.

[0067] The third step is to coat the back of the polycaprolactone film with the developing dots distributed on the surface with medical e-cyanoacrylate 6B adhesive, and sterilize it after curing to obtain a DSA guided vascular puncture positioning film, wherein the thickness of the medical back adhesive layer is 0.2 mm.

[0068] Example 6

[0069] A DSA guided vascular puncture positioning membrane, comprising a medical e-cyanoacrylate 6B adhesive layer and a polycaprolactone membrane that can transmit X-rays, wherein a developing dot matrix having an X-ray absorbing effect is distributed on the surface of the polycaprolactone membrane, and the developing dot matrix is ​​the X-ray self-developing polyurethane obtained in Example 3;

[0070] A preparation process of a blood vessel puncture positioning membrane for DSA guidance comprises the following steps:

[0071] The first step is to heat the X-ray self-developing polyurethane obtained in Example 3 to 280° C. and melt it, and then use a 3D printer to print a pre-designed development dot matrix in a polytetrafluoroethylene mold, wherein the thickness of the development dot matrix is ​​1 mm;

[0072] Step 2: Heat the polycaprolactone to 80°C and melt it, then evenly apply it to a PTFE mold with a developing dot matrix distributed on it. After cooling and solidification, peel it off to obtain a polycaprolactone film with a developing dot matrix distributed on the surface, wherein the thickness of the polycaprolactone film is 2 mm.

[0073] The third step is to coat the back of the polycaprolactone film with the developing dots distributed on the surface with medical e-cyanoacrylate 6B adhesive, and sterilize it after curing to obtain a DSA guided vascular puncture positioning membrane, wherein the thickness of the medical back adhesive layer is 0.3 mm.

[0074] Comparative Example 1

[0075] The comparative example is an aluminum plate, and the thickness of the aluminum plate is 2 mm.

[0076] Experimental Example 2

[0077] The developing performance test was conducted on the developing dot matrix distributed on the DSA guided vascular puncture positioning membrane obtained in Example 4-6. The developing effect of X-ray was tested using a standard clinical X-ray instrument, with a 2 mm aluminum plate as the control. The X-ray condition was 45 kW × 10 mA × 0.2 s. The test results are shown in Table 2:

[0078] Table 2

[0079] project Hounsfield Value Example 4 3412±163 Example 5 5264±194 Example 6 6938±214 Comparative Example 1 3122±45

[0080] It can be seen from Table 2 that the Hounsfield values ​​of the developing dot matrix on the DSA-guided vascular puncture positioning membrane in Examples 4-6 of the present invention are all higher than that of the 2 mm thick aluminum plate, indicating that the developing dot matrix on the DSA-guided vascular puncture positioning membrane of the present invention has a good developing effect.

[0081] The above is a detailed introduction to a DSA guided vascular puncture positioning membrane and its preparation process provided by the present invention. The principle and implementation method of the present invention are described in detail using specific examples. The description of the above embodiments is only used to help understand the method of the present invention and its core ideas, including the best mode, and also enables any technician in the field to practice the present invention, including the manufacture and use of any device or system, and the implementation of any combination method. It should be pointed out that for ordinary technicians in this technical field, the present invention can also be improved and modified without departing from the principle of the present invention. In particular, as long as there is no structural conflict, the various features in the embodiments disclosed in the present invention can be combined with each other in any way. The fact that these combinations are not exhaustively described in this specification is only for the purpose of omitting space and saving resources. Therefore, the present invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions that fall within the scope of the claims.

Claims

1. A DSA guided vascular puncture positioning membrane, characterized in that: It comprises a medical adhesive layer and a polycaprolactone film that can transmit X-rays, and the surface of the polycaprolactone film is distributed with a developing dot matrix that has an X-ray absorbing effect, and the developing dot matrix is ​​a self-made X-ray self-developing polyurethane; Wherein, the medical adhesive is medical e-cyanoacrylate 6B adhesive, and the X-ray self-developing polyurethane is made by the following steps: Step 1, 3,5-diiodo-4-hydroxybenzaldehyde, 2-amino-3,5-diiodopyridine, hydroxyacetone, L-proline and cyclopentyl methyl ether are mixed in a container, stirred evenly, and reacted at room temperature for 2 hours to obtain intermediate 1; Step 2, mixing intermediate 1, dodecyl bromide and acetonitrile in a container, stirring evenly, and reacting at 80° C. for 36 hours to obtain intermediate 2; Step 3, add polytetrahydrofuran to the container, raise the system temperature to 120°C, evacuate the system and stir for 2 hours to remove water, then introduce nitrogen into the container and lower the system temperature to 70°C, add diphenylmethane-4,4'-diisocyanate and dibutyltin dilaurate to the container after cooling, and react at 70°C for 2 hours, then add the N,N-dimethylacetamide solution of intermediate 2 to the container, and continue to react at 70°C for 2 hours, finally add 1,4-butanediol to the container, and react at 70°C for 3 hours, after the reaction is completed, pour the product into a mold and put it into an oven to dry, so as to obtain the X-ray self-developing polyurethane.

2. The DSA guided vascular puncture positioning membrane according to claim 1, characterized in that: The dosage ratio of 3,5-diiodo-4-hydroxybenzaldehyde, 2-amino-3,5-diiodopyridine, hydroxyacetone, L-proline and cyclopentyl methyl ether used in step 1 is 0.05 mol: 0.05-0.06 mol: 0.05-0.06 mol: 0.01 mol: 80-100 mL.

3. The DSA guided vascular puncture positioning membrane according to claim 1, characterized in that: The amount ratio of intermediate 1, dodecyl bromide and acetonitrile used in step 2 is 0.03 mol: 0.04-0.05 mol: 50-60 mL.

4. The DSA guided vascular puncture positioning membrane according to claim 1, characterized in that: The molecular weight of the polytetrahydrofuran used in step 3 is 1000, and the N,N-dimethylacetamide solution of intermediate 2 used is prepared from 0.02 mol intermediate 2 and 120 mL N,N-dimethylacetamide solution.

5. The DSA guided vascular puncture positioning membrane according to claim 1, characterized in that: The amount ratio of polytetrahydrofuran, diphenylmethane-4,4'-diisocyanate, dibutyltin dilaurate, N,N-dimethylacetamide solution of intermediate 2, and 1,4-butanediol used in step 3 is 40g: 0.07-0.08mol: 0.1-0.11g: 120mL: 0.01-0.02mol.

6. A process for preparing a DSA guided vascular puncture positioning membrane according to any one of claims 1 to 5, characterized in that: The following steps are involved: The first step is to heat and melt the X-ray self-developing polyurethane and then use a 3D printer to print out the pre-designed development dot matrix in the mold; The second step is to heat and melt the polycaprolactone and evenly apply it to a mold with a developing dot matrix, and then cool and solidify it and peel it off to obtain a polycaprolactone film with a developing dot matrix distributed on the surface; The third step is to coat the back of the polycaprolactone film with the developing dots distributed on the surface with medical adhesive, and then sterilize it after curing to obtain a blood vessel puncture positioning membrane for DSA guidance.

7. The process for preparing a DSA guided vascular puncture positioning membrane according to claim 5, characterized in that: The medical backing adhesive is medical e-cyanoacrylate 6B series adhesive.

8. The process for preparing a DSA guided vascular puncture positioning membrane according to claim 5, characterized in that: The thickness of the polycaprolactone film with the development dot matrix distributed on the surface is 1-2 mm, and the thickness of the medical back adhesive layer is 0.1-0.3 mm.

9. The process for preparing a DSA guided vascular puncture positioning membrane according to claim 5, characterized in that: The thickness of the developed dot matrix is ​​0.5-1 mm.

10. The process for preparing a DSA guided vascular puncture positioning membrane according to claim 5, characterized in that: The heating and melting temperature of X-ray self-developing polyurethane is 260-280°C, and the heating and melting temperature of polycaprolactone is 70-80°C.

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