A catheter material for varicose vein closure procedures and a method of making the same

Abstract

The application discloses a catheter material for varicose vein closure surgery and a preparation method thereof, and raw materials at least include 100-150 parts of a polymer base material, 10-15 parts of a lubricant and 3-8 parts of a coupling agent in terms of weight. The catheter material is corrosion resistant and has high compatibility with human bodies, can effectively prevent human body fluids and tissue fragments from adhering and immersing into the catheter material, thereby improving the use effect of the catheter material, can prevent the catheter from being touched with human tissues to cause damage, avoids damage to human tissues, can reduce discomfort and inflammatory reactions during use, and can meet the use requirements of clinical surgery.

Description

Technical Field

[0001] This invention relates to the field of medical catheter materials, particularly to the field of IPC A61, and more specifically, to a catheter material for varicose vein closure surgery and its preparation method. Background Technology

[0002] Varicose veins are irregular dilation and deformation caused by the inability of veins to completely close, leading to blood pooling and varicose veins. The affected veins are very fragile, and even slight injury can easily cause them to rupture, resulting in massive venous bleeding. If this bleeding occurs during rest, it may go unnoticed due to the lack of pain, leading to serious consequences. Untreated varicose veins can even cause venous thrombosis, which can travel through the bloodstream and pose a life-threatening risk.

[0003] There are various surgical treatments for varicose veins. When catheters are used during surgery, the veins are small and fragile, and the catheters may damage tissues, arteries, or even nerves. Therefore, the quality requirements for catheters are extremely strict.

[0004] CN111281447A discloses an endovenous closure system for varicose veins of the lower extremities. It includes a connector between a self-locking injector and a catheter, and uses a light-based positioning device to accurately position the catheter entering the vein. The system is simple and convenient to operate. This technical solution features a hydrophilic coating on both the outer wall and inner lumen of the catheter, facilitating the catheter's entry and exit from the vein and the movement of the guidewire within the catheter. However, the hydrophilic coating increases the catheter's thickness, making it more susceptible to damage to other tissues. Furthermore, the coating carries the risk of detachment, which could harm the patient. Summary of the Invention

[0005] To address the aforementioned problems, a first aspect of the present invention provides a catheter material for varicose vein closure surgery, comprising, by weight, at least: 100-150 parts of polymer substrate, 10-15 parts of lubricant, and 3-8 parts of coupling agent.

[0006] Preferably, the polymer substrate is at least one of polytetrafluoroethylene, polyethylene, polyvinyl chloride, and polyvinylpyrrolidone.

[0007] Preferably, the polymer substrate is a mixture of polyvinyl chloride and polyvinylpyrrolidone, wherein the mass ratio of polyvinyl chloride to polyvinylpyrrolidone is (3-5):(1.5-4).

[0008] Preferably, the mass ratio of polyvinyl chloride to polyvinylpyrrolidone is 3.5:3.

[0009] Preferably, the lubricating oil is at least one of silicone oil, low-density polyethylene, and aliphatic amide.

[0010] Preferably, the lubricating oil is silicone oil.

[0011] Preferably, the raw material also includes an acrylic acid derivative.

[0012] Preferably, the mass ratio of the polymer substrate to the acrylic derivative is (10-15):(5-9).

[0013] Preferably, the mass ratio of the polymer substrate to the acrylic derivative is 12:7.

[0014] Preferably, the acrylic derivative is at least one of polymethyl methacrylate, polyacrylamide, and polymethyl methacrylate.

[0015] Preferably, the acrylic derivative is a mixture of polymethyl methacrylate and polyacrylamide, wherein the mass ratio of polymethyl methacrylate to polyacrylamide is (0.75-1.25):1.

[0016] Preferably, the mass ratio of methyl methacrylate to polyacrylamide is 1:1.

[0017] The second aspect of the present invention provides a method for preparing a catheter material for varicose vein closure surgery, comprising at least the following steps: (1) placing a polymer substrate and an acrylic derivative in a container, heating and stirring to mix evenly; (2) adding a lubricant and a coupling agent to the mixture obtained in (1), stirring evenly, and then performing twin-screw extrusion granulation to obtain the material.

[0018] Preferably, the heating and stirring temperature in step (1) is 150-200℃, and the stirring time is 30-60 min.

[0019] Preferably, the heating and stirring temperature in step (1) is 170°C and the stirring time is 45 min.

[0020] Preferably, the extrusion granulation temperature in step (2) is 160-180℃.

[0021] Preferably, the extrusion granulation temperature in step (2) is 165°C.

[0022] This application uses a blend of polyvinyl chloride (PVC) and polyvinylpyrrolidone (PVP) as the polymer base material for preparing catheter materials. This effectively reduces the surface energy of the catheter, preventing the adhesion and infiltration of bodily fluids and tissue debris, thus improving the corrosion resistance of the catheter material. Furthermore, when the mass ratio of the acrylic acid derivative methyl methacrylate (MMA) to polyacrylamide is 1:1, PMA can react with silicone oil to form an elastomer structure. The multiple groups in MMA can form hydrogen bonds with the amide groups within the system, thereby increasing the hydrophilicity of the catheter material surface. MMA can increase molecular rigidity through hydrogen bonding between methyl groups and other molecular structures, resulting in a catheter material that possesses both hydrophilicity and structural rigidity. This prevents catheter corrosion and avoids damage from contact with bodily tissue, thereby improving the catheter's performance.

[0023] Beneficial effects:

[0024] 1. This invention provides a catheter material for varicose vein closure surgery, which is corrosion-resistant and highly biocompatible, effectively preventing the adhesion and infiltration of bodily fluids and tissue debris into the catheter material, thereby improving the effectiveness of the catheter material.

[0025] 2. This invention uses an acrylic acid derivative, methyl methacrylate, and polyacrylamide in a mass ratio of 1:1, along with silicone oil, which effectively enhances the hydrophilicity of the catheter material.

[0026] 3. The polymethyl methacrylate used in this invention can form hydrogen bonds with other molecules in the system, thereby improving the hydrophilicity of the catheter material while also increasing its rigidity.

[0027] 4. The catheter material for varicose vein closure surgery prepared by this invention has excellent performance, can prevent the catheter from contacting and damaging human tissue, avoid damage to human tissue, and reduce discomfort and inflammatory response during use.

[0028] 5. The catheter material for varicose vein closure surgery provided by this invention does not use a coating, so there is no risk of the coating falling off in the human body, and it will not cause harm to patients, thus meeting the needs of clinical use. Detailed Implementation

[0029] Example

[0030] Example 1:

[0031] Example 1 provides a catheter material for varicose vein closure surgery, which, by weight, comprises: 120 parts polymer base material, 12 parts lubricant, 5 parts coupling agent, and 70 parts acrylic acid derivative.

[0032] The polymer base material is a mixture of polyvinyl chloride and polyvinylpyrrolidone, with a mass ratio of polyvinyl chloride to polyvinylpyrrolidone of 3.5:3;

[0033] Polyvinylpyrrolidone was purchased from Shanghai E. En Chemical Technology Co., Ltd., model number R018592; polyvinyl chloride was purchased from Polyton Technologies, Inc., USA, grade XV3905.

[0034] The lubricating oil is silicone oil;

[0035] The acrylic acid derivative is a mixture of polymethyl methacrylate and polyacrylamide, with a mass ratio of polymethyl methacrylate to polyacrylamide of 1:1.

[0036] Polymethyl methacrylate (PMMA) was purchased from Jiuding Chemical (Shanghai) Technology Co., Ltd., model number PH082; polyacrylamide was purchased from Shanghai Aladdin Biochemical Technology Co., Ltd., model number P108471.

[0037] The coupling agent was isobutyltriethoxysilane purchased from Shanghai E. En Chemical Technology Co., Ltd., model number R050500;

[0038] The preparation method of the catheter material for varicose vein closure surgery as described above includes the following steps: (1) placing the polymer substrate and acrylic derivative in a container, heating and stirring to mix evenly; (2) adding lubricant and coupling agent to the mixture obtained in (1), stirring evenly, and then performing twin-screw extrusion granulation to obtain the final product.

[0039] In step (1), the heating and stirring temperature is 170℃ and the stirring time is 45 min;

[0040] The extrusion granulation temperature in step (2) is 165℃.

[0041] Example 2

[0042] Example 2 provides a catheter material for varicose vein closure surgery. The specific implementation method is the same as that of Example 1, except that, by weight, the raw materials include: 132 parts of polymer base material, 10 parts of lubricant, 5 parts of coupling agent, and 77 parts of acrylic acid derivative.

[0043] Comparative Example 1

[0044] Comparative Example 1 provides a catheter material for varicose vein closure surgery, which is implemented in the same way as Example 1, except that the acrylic derivative is polymethyl methacrylate.

[0045] Comparative Example 2

[0046] Comparative Example 2 provides a catheter material for varicose vein closure surgery, the specific implementation of which is the same as that of Example 1, except that the polymer substrate is 120 parts by weight of polyvinyl chloride.

[0047] Performance testing:

[0048] 1. Corrosion resistance test: The corrosion resistance of different catheter materials for varicose vein closure surgery in Examples 1-2 and Comparative Examples 1-2 was tested according to GB / T 11547-2008 "Determination of resistance of plastics to liquid chemical reagents". The average value of the test results is recorded in Table 1.

[0049] 2. Elongation at break test: The elongation at break of different catheter materials for varicose vein closure surgery in Examples 1-2 and Comparative Examples 1-2 was tested according to GB / T 1040-92 "Test Method for Tensile Properties of Plastics". The average value of the measured results is recorded in Table 1.

[0050] Table 1

[0051] Quality loss due to corrosion (%) Appearance change level Elongation at break (%) Example 1 0.011 No change 182 Example 2 0.013 No change 178 Comparative Example 1 0.036 No change 154 Comparative Example 2 0.042 No change 143

Claims

1. A catheter material for varicose vein closure surgery, characterized in that, By weight, the raw materials include at least: 100-150 parts polymer base material, 10-15 parts lubricant, and 3-8 parts coupling agent; The polymer substrate is a mixture of polyvinyl chloride and polyvinylpyrrolidone, wherein the mass ratio of polyvinyl chloride to polyvinylpyrrolidone is (3-5):(1.5-4). The lubricant is silicone oil; The raw materials also include acrylic acid derivatives, which are a mixture of polymethyl methacrylate and polyacrylamide in a mass ratio of 1:

1. The mass ratio of the polymer substrate to the acrylic derivative is (10-15):(5-9); the coupling agent is isobutyltriethoxysilane.

2. A method for preparing a catheter material for varicose vein closure surgery according to claim 1, characterized in that, The process includes at least the following steps: (1) placing the polymer substrate and acrylic derivative in a container, heating and stirring to mix them evenly; (2) adding lubricant and coupling agent to the mixture obtained in (1), stirring evenly, and then performing twin-screw extrusion granulation to obtain the final product.

3. The method for preparing catheter material for varicose vein closure surgery according to claim 2, characterized in that, The heating and stirring temperature in step (1) is 150-200℃, and the stirring time is 30-60min.