A blood vessel puncture positioning film for DSA guidance and a preparation process thereof

Abstract

The application relates to a DSA-guided blood vessel puncture positioning film and a preparation process thereof, and belongs to the technical field of medical devices; the DSA-guided blood vessel puncture positioning film is prepared from medical back adhesive, polycaprolactone and self-made X-ray self-developing polyurethane as raw materials; the X-ray self-developing polyurethane is heated and melted first, then is printed into a developing dot matrix, the polycaprolactone is heated and melted, then is coated on the developing dot matrix to form a film, finally, the medical back adhesive is coated on the back of the polycaprolactone film and is solidified and sterilized to obtain the DSA-guided blood vessel puncture positioning film; the DSA-guided blood vessel puncture positioning film preparation method is simple, different numbers and shapes of dot matrices can be printed according to requirements to cope with different operations, the developing dot matrix has good X-ray absorption effect, clear imaging, is non-toxic and harmless, and has good biocompatibility.

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 digital subtraction angiography (DSA), computed tomography (CT), and magnetic resonance imaging (MRI). Through the use of puncture needles, guide wires, catheters, microcatheters, catheter sheaths, stents and other interventional therapy equipment, embolic microspheres and other implantable materials are introduced into the body's lesions through minimally invasive wounds through femoral artery puncture. With the development of interventional radiotherapy, the demand for related medical devices has increased. Medical devices also have more stringent requirements, and people increasingly hope to be able 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 emulsifiers such as heavy metal powders, heavy element inorganic salts or heavy atom organics, this method can easily lead to material deterioration and performance degradation, and may also 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 through the following technical solutions:

[0005] A DSA-guided vascular puncture positioning membrane comprises a medical adhesive layer and a polycaprolactone membrane that is transparent to X-rays. The polycaprolactone membrane is provided 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.

[0006] A process for preparing a vascular 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 a pre-designed development dot matrix in the mold;

[0008] Second step, after heating and melting the polycaprolactone, evenly spread it in the mold with developed dot array, after cooling and solidification, peel off to get polycaprolactone film with developed dot array on the surface;

[0009] Third step, coat medical back adhesive on the back of polycaprolactone film with developed dot array on the surface, after solidification, sterilization, get a vascular puncture positioning film for DSA guidance.

[0010] Further, the medical back adhesive is medical e cyanoacrylic acid 6B adhesive.

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

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

[0013] Preferably, the thickness of the developed dot array is 0.5-1mm.

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

[0015] Further, the temperature for heating and melting the X-ray self-developing polyurethane is 260-280℃, and the temperature for heating and melting the polycaprolactone is 70-80℃.

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

[0017] Step 1, mix 3,5-diiodo-4-hydroxybenzaldehyde, 2-amino-3,5-diiodopyridine, hydroxypropanone, L-proline, and cyclopentyl methyl ether in a three-necked flask, start magnetic stirring, react at room temperature for 2h, after the reaction is completed, add saturated ammonium chloride solution to the three-necked flask to quench the reaction, then separate the organic layer with a separatory funnel, after removing the solvent from the organic layer by rotary evaporation, chromatograph the organic layer on a silica gel column to get intermediate 1;

[0018]

[0019] Step 2, mix intermediate 1, dodecyl bromide, and acetonitrile in a three-necked flask, install a condenser and a thermometer, start magnetic stirring, react at a temperature of 80℃ for 36h, after the reaction is completed, spin dry the reaction liquid to get intermediate 2;

[0020]

[0021] Step 3, polytetrahydrofuran is added into a three-necked flask, a thermometer is installed, magnetic stirring is started, the temperature of the system is raised to 120℃, then the system is pumped to vacuum and stirred for 2h to remove water, then nitrogen is introduced into the three-necked flask and the temperature of the system is lowered to 70℃, after the temperature is lowered, diphenylmethane-4,4'-diisocyanate and dibutyltin dilaurate are added into the three-necked flask, and reaction is carried out at the temperature of 70℃ for 2h, then the N,N-dimethylacetamide solution of intermediate 2 is added into the three-necked flask, and reaction is continued at the temperature of 70℃ for 2h, finally 1,4-butanediol is added into the three-necked flask, and reaction is carried out at the temperature of 70℃ for 3h, after the reaction is completed, the product is poured into a four-fluoride mold and placed in an oven for drying, thus the X-ray autograph polyurethane is obtained.

[0022]

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

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

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

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

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

[0028] The beneficial effects of the present application are as follows:

[0029] 1) The present invention uses medical adhesive, polycaprolactone and a homemade X-ray self-developing polyurethane as raw materials to prepare a DSA-guided vascular puncture positioning membrane. The present invention first 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 react with dodecyl bromide to produce quaternary ammonium salt to obtain intermediate 2, finally uses intermediate 2 and 1,4-butanediol as chain extender, polytetrahydrofuran (PTF) is obtained. An X-ray self-developable polyurethane is prepared by using furan and diphenylmethane-4,4'-diisocyanate as polymerization monomers. The X-ray self-developable polyurethane material of the present invention contains a large number of iodine atoms, which have a high electron cloud density and a good absorption effect on X-rays. The iodine atoms can give the X-ray self-developable polyurethane material of the present invention a good X-ray development effect. The iodine atoms in the X-ray self-developable polyurethane material exist in the form of compounds and are non-toxic. In addition, the X-ray self-developable polyurethane material of the present 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 developed dot matrix has a good absorption effect on X-rays, provides 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 embodiments described 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 making any creative efforts shall fall 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 reaction was carried out at room temperature for 2 h. After the reaction was completed, 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 rotary 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, equipped with a condenser and a thermometer, and magnetic stirring was turned on. The reaction was carried out at 80°C for 36 hours. After the reaction was completed, the reaction solution was spin-dried to obtain intermediate 2;

[0037] Step 3, 40g of polytetrahydrofuran was added to a three-necked flask, a thermometer was installed, and magnetic stirring was turned on. After the system temperature was raised to 120°C, the system was evacuated to a vacuum and stirred for 2h to remove water. Then, nitrogen was introduced into the three-necked flask and the system temperature was lowered to 70°C. After cooling, 0.07mol diphenylmethane-4,4'-diisocyanate and 0.1g dibutyltin dilaurate were added to the three-necked flask, and the mixture was reacted at a temperature of 70°C for 2h. Then, 120mL of a solution prepared by 0.02mol intermediate 2 and 120mL N,N-dimethylacetamide was added to the three-necked flask, and the reaction was continued at a temperature of 70°C for 2h. Finally, 0.1mol 1,4-butanediol was added to the three-necked flask and the mixture was reacted at a temperature of 70°C for 3h. After the reaction was completed, the product was poured into a tetrafluoroethylene mold and placed in an oven to dry 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, 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 rotary 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, equipped with a condenser and a thermometer, and magnetic stirring was turned on. The reaction was carried out at 80°C for 36 hours. After the reaction was completed, the reaction solution was spin-dried to obtain intermediate 2;

[0043] Step 3, 40g of polytetrahydrofuran was added to a three-necked flask, a thermometer was installed, and magnetic stirring was turned on. After the system temperature was raised to 120°C, the system was evacuated to vacuum and stirred for 2h to remove water. Then, nitrogen was introduced into the three-necked flask and the system temperature was lowered to 70°C. After cooling, 0.075mol of diphenylmethane-4,4'-diisocyanate and 0.105g of dibutyltin dilaurate were added to the three-necked flask, and the mixture was reacted at a temperature of 70°C for 2h. Then, 120mL of a solution prepared by 0.02mol of intermediate 2 and 120mL of N,N-dimethylacetamide was added to the three-necked flask, and the reaction was continued at a temperature of 70°C for 2h. Finally, 0.15mol of 1,4-butanediol was added to the three-necked flask and the mixture was reacted at a temperature of 70°C for 3h. After the reaction was completed, the product was poured into a tetrafluoroethylene mold and placed in an oven to dry 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 reaction was carried out at room temperature for 2 h. After the reaction was completed, 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 rotary 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, equipped with a condenser and a thermometer, and magnetic stirring was turned on. 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, 40 g of polytetrahydrofuran is added to a three-necked flask, a thermometer is installed, magnetic stirring is started, the temperature of the system is raised to 120℃, then the system is pumped to vacuum and stirred for 2 h to remove water, then nitrogen is introduced into the three-necked flask and the temperature of the system is lowered to 70℃, after the temperature is lowered, 0.08 mol of diphenylmethane-4,4'-diisocyanate and 0.11 g of dibutyltin dilaurate are added to the three-necked flask, and the reaction is carried out at a temperature of 70℃ for 2 h, then 120 mL of a solution prepared from 0.02 mol of intermediate 2 and 120 mL of N,N-dimethylacetamide is added to the three-necked flask, and the reaction is continued at a temperature of 70℃ for 2 h, finally, 0.2 mol of 1,4-butanediol is added to the three-necked flask, and the reaction is carried out at a temperature of 70℃ for 3 h, after the reaction is completed, the product is poured into a four-fluorine mold and placed in an oven for drying, thereby obtaining the X-ray autographing polyurethane.

[0050] In this embodiment, the molecular weight of the polytetrahydrofuran used is 1000.

[0051] Experimental Example 1

[0052] The X-ray autographing polyurethane obtained in Examples 1-3 is respectively tested for antibacterial rate against Escherichia coli and Staphylococcus aureus according to the national standard GB / T 20944.3-2008, and 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] As can be seen from Table 1, the antibacterial rates of the X-ray autographing polyurethane of the present application against Escherichia coli and Staphylococcus aureus are both 99.9%, which indicates that the X-ray autographing polyurethane of the present application has good antibacterial effect.

[0056] Example 4

[0057] A blood vessel puncture positioning film for DSA guidance, comprising a medical e-cyanoacrylic acid 6B system adhesive layer and a polycaprolactone film which can transmit X-rays, the surface of the polycaprolactone film is distributed with a developing dot array having X-ray absorption effect, and the developing dot array is the X-ray autographing polyurethane obtained in Example 1;

[0058] A preparation process of a blood vessel puncture positioning film for DSA guidance, comprising the following steps:

[0059] First step, the X-ray autographing polyurethane obtained in Example 1 is heated to 260℃ to melt, then a 3D printer is used to print a pre-designed developing dot array in a four-fluorine mold, wherein the thickness of the developing dot array is 0.5 mm;

[0060] In the second step, the polycaprolactone is heated to 70°C and melted, and then evenly applied to a PTFE mold with a developing dot matrix distributed thereon. After cooling and solidification, the polycaprolactone film with a developing dot matrix distributed on the surface is peeled off to obtain a polycaprolactone film with a thickness of 1 mm.

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

[0062] Example 5

[0063] A DSA-guided vascular puncture positioning membrane comprises a medical e-cyanoacrylate 6B adhesive layer and an X-ray-transmissive polycaprolactone membrane, 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 process for preparing a vascular puncture positioning membrane for DSA guidance comprises the following steps:

[0065] The first step is to heat the X-ray self-developable 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 PTFE mold, wherein the thickness of the development dot matrix is ​​0.75 mm;

[0066] In the second step, the polycaprolactone is heated to 75°C and melted, and then evenly applied to a PTFE mold with a developing dot matrix distributed thereon. After cooling and solidification, the polycaprolactone film with a developing dot matrix distributed on the surface is peeled off to obtain a polycaprolactone film with a thickness of 1.5 mm.

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

[0068] Example 6

[0069] A DSA-guided vascular puncture positioning membrane comprises a medical e-cyanoacrylate 6B adhesive layer and an X-ray-transmissive polycaprolactone membrane, 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 process for preparing a vascular 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 PTFE mold, wherein the thickness of the development dot matrix is ​​1 mm;

[0072] In the second step, the polycaprolactone is heated to 80°C and melted, and then evenly applied to a PTFE mold with a developing dot matrix distributed thereon. After cooling and solidification, the polycaprolactone film with a developing dot matrix distributed on the surface is peeled off to obtain a polycaprolactone film with a thickness of 2 mm.

[0073] The third step is to coat the back of the polycaprolactone film with the developed dot matrix distributed on the surface with medical e-cyanoacrylate 6B adhesive, and then 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 with a thickness of 2 mm.

[0076] Experimental Example 2

[0077] The imaging performance of the imaging dot array distributed on the DSA-guided vascular puncture positioning membrane obtained in Examples 4-6 was tested using a standard clinical X-ray apparatus to test the imaging effect of X-rays, with a 2 mm aluminum plate as the control. The X-ray conditions were 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] As can be seen from Table 2, 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 a 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 DSA guiding blood vessel puncture positioning film and the preparation process thereof are described in detail above, the principles and implementation manners of the present application are described by using specific examples in this paper, the above examples are only used for helping to understand the method and the core idea of the present application, including the best mode, and also enable any person skilled in the art to practice the present application, including manufacturing and using any device or system, and implementing any combined method. It should be pointed out that, for those skilled in the art, some improvements and modifications can be made to the present application without departing from the principles of the present application. In particular, as long as there is no structural conflict, each feature in the disclosed embodiments of the present application can be combined with each other in any way, and the description of these combinations is not exhaustive in this specification, which is only for the purpose of omitting the length and saving resources. Therefore, the present application is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A process for preparing a vascular puncture positioning membrane for DSA guidance, 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 a pre-designed development dot matrix in the mold; The second step is to heat and melt the polycaprolactone and evenly apply it to the mold with the developer dot matrix distributed on it, and then peel it off after cooling and solidification to obtain a polycaprolactone film with the developer dot matrix distributed on the surface; The third step is to coat the back of the polycaprolactone film with the developed dot array on the surface with medical adhesive, and then sterilize it after curing to obtain a DSA guided vascular puncture positioning membrane; The X-ray self-imaging polyurethane in the DSA guided vascular puncture positioning membrane is prepared by the following steps: Step 1: Mix 3,5-diiodo-4-hydroxybenzaldehyde, 2-amino-3,5-diiodopyridine, hydroxyacetone, L-proline, and cyclopentyl methyl ether in a container, stir evenly, and react at room temperature for 2 hours to obtain intermediate 1; Step 2: Mix the intermediate 1, dodecyl bromide and acetonitrile in a container, stir evenly, and react at 80° C. for 36 hours to obtain the intermediate 2; Step 3: Add polytetrahydrofuran to the container, raise the system temperature to 120°C, evacuate the system to vacuum and stir for 2 hours to remove water, then introduce nitrogen into the container and lower the system temperature to 70°C. After cooling, add diphenylmethane-4,4'-diisocyanate and dibutyltin dilaurate to the container, and react at a temperature of 70°C for 2 hours. Then, add the N,N-dimethylacetamide solution of intermediate 2 to the container, and continue to react at a temperature of 70°C for 2 hours. Finally, add 1,4-butanediol to the container and react at a temperature of 70°C for 3 hours. After the reaction is completed, pour the product into a mold and place it in an oven to dry to obtain the X-ray self-developing polyurethane.

2. The process for preparing a DSA guided vascular puncture positioning membrane according to claim 1, characterized in that: The amount 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 process for preparing a 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 process for preparing a 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 by mixing 0.02 mol of intermediate 2 with 120 mL of N,N-dimethylacetamide solution.

5. The process for preparing a 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. The process for preparing a DSA guided vascular puncture positioning membrane according to claim 1, characterized in that: The medical adhesive backing is medical e-cyanoacrylate 6B adhesive.

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

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

9. The process for preparing a vascular puncture positioning membrane for DSA guidance according to claim 1, characterized in that: The heating and melting temperature of X-ray self-developable polyurethane is 260-280℃, and the heating and melting temperature of polycaprolactone is 70-80℃.

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