A surface hydrophilically modified catheter

Abstract

The application discloses a surface hydrophilic modified catheter, which comprises a catheter body and a surface hydrophilic microstructure, wherein the surface microstructure is a gradient-distributed longitudinal vertical stripe, which is formed by laser cutting and gives the catheter good hydrophilicity. The laser is accurately set to process the vertical stripe with a width of 8-12 microns, a depth of 6-10 microns and a gradient-distributed spacing along the axial direction of 35-50 microns on the surface of the catheter, so that the hydrophilic microstructure with a partition function optimization is realized, the roughness of the structure is 2-20 microns, and the contact angle is less than 90 degrees. The problems of easy blockage of the traditional medical catheter, great damage to tissues and defects of the existing modification technology are effectively solved, the hydrophilicity can be obviously improved, the preparation process is simple, the product has high durability, and the application prospect in the field of medical devices is wide.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a surface hydrophilic modified catheter, which is especially suitable for medical drainage scenes such as external ventricular drainage. BACKGROUND

[0002] As a common surgical method in brain surgery, external ventricular drainage is achieved by drilling or puncturing the skull to the ventricle, placing the front end of the catheter in the ventricle, and draining cerebrospinal fluid or bloody fluid to relieve intracranial pressure. However, the existing ventricular catheter faces many problems in clinical use. On the one hand, impurities or blood clots in cerebrospinal fluid can easily cause catheter blockage, greatly affecting the drainage effect, and even causing serious complications. On the other hand, the traditional silicone catheter has a hydrophobic surface and a large friction force, which can easily cause tissue damage during use.

[0003] Currently, the technology for improving the hydrophilic properties of the catheter mainly adds a chemical coating to the surface, for example, polyvinylpyrrolidone coating modification after plasma treatment. However, the plasma treatment has the problem of high equipment cost, making the process complex and increasing production costs. The coating modification has the problems of easy peeling and easy degradation of the modified layer, which poses a safety hazard. The existing surface hydrophilic microstructure is mainly uniformly distributed (such as vertical lines with equal intervals), but the needs of different sections of the catheter in clinical use are significantly different: the front end needs strong hydrophilicity to prevent blockage, and the rear end needs low friction to protect the tissue. The uniform structure cannot meet the needs of different sections, resulting in difficulty in optimizing the drainage efficiency and safety simultaneously. Therefore, there is an urgent need to develop a hydrophilic modified catheter that can effectively solve the above problems and has a simple preparation process and excellent product performance.

[0004] The purpose of the present application is to provide a hydrophilic modified catheter, which aims to solve the problems of easy blockage and tissue damage of existing catheters, and the defects of existing modification technologies. Through a unique hydrophilic microstructure design and preparation process, the hydrophilicity, anti-adhesion, and biocompatibility of the catheter are improved, the probability of thrombosis is reduced, and the drainage efficiency and safety are improved. SUMMARY

[0005] The present application provides a surface hydrophilic modified catheter, which comprises a catheter body and a surface hydrophilic microstructure. The hydrophilic modified catheter comprises a catheter body and a surface hydrophilic microstructure. The surface microstructure is a longitudinal vertical line with a width of 8-12 μm, a depth of 6-10 μm, and a pitch gradually changing from 35-50 μm at the drainage end to 10-20 μm at the proximal end along the axial direction, which is prepared by laser cutting process, and is used to give the catheter good hydrophilicity, to reduce the surface tension of the liquid, to promote the rapid flow of the liquid, and to improve the drainage efficiency. The hydrophilic microstructure can also reduce the surface friction of the catheter and increase the comfort of catheterization.

[0006] Furthermore, the catheter body is made of silicone rubber or polyurethane;

[0007] Furthermore, the surface hydrophilic microstructure is cut by laser, and the specific laser processing parameters are: laser wavelength of 343nm, laser power of 20.0%-24.0% (5.8W), repetition frequency of 100kHz, and repetition number of 1-2 times;

[0008] Furthermore, the longitudinal vertical stripe spacing gradually changes from 10-20 μm at the drainage end to 35-50 μm at the proximal end, forming functional partitions with gradually decreasing hydrophilicity.

[0009] Furthermore, the surface hydrophilic microstructures are distributed in a gradient along the axial direction of the catheter: the spacing of the microstructures at the drainage end is 35-50 μm, the spacing in the transition section is 20-35 μm, and the spacing at the proximal end is 10-20 μm. The gradient change is achieved by linearly increasing the laser scanning speed from 80 mm / s to 120 mm / s, forming functional zones with gradually decreasing hydrophilicity but continuously decreasing fluid resistance.

[0010] Furthermore, the contact angle of the hydrophilic microstructure is less than 90°, indicating that the catheter surface has good hydrophilicity, enabling liquid to spread quickly on its surface. The roughness is 2-20 μm, which can enhance the hydrophilicity of the catheter. Furthermore, the catheter body is provided with multiple side holes near the drainage end. The side holes work synergistically with the surface hydrophilic microstructure to effectively improve drainage efficiency and reduce clogging caused by liquid residue.

[0011] Furthermore, the hydrophilic surface of the surface-hydrophilically modified catheter is located at the front end of the catheter, and the rear end is an ordinary non-hydrophilic catheter. During use, the hydrophilic surface is located in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 Figures 1 and 2 are the contact angle results of the catheter, Figures 4 and 5 are the contact angle results of Examples 1-4, and Figure 6 is the contact angle result of Comparative Example 1;

[0013] Figure 2 This is the result diagram of the friction coefficient of the catheter;

[0014] Figure 3 The catheter visualization results are shown in Figure a, which are the visualization results of Comparative Column 2, and Figure b, which are the visualization results of Example 5;

[0015] Figure 4 Microstructure image taken by scanning electron microscope;

[0016] Figure 5 This is the catheter flow result diagram. DETAILED DESCRIPTION

[0017] The present invention provides a surface hydrophilic modified catheter, the technical solution is as follows:

[0018] The surface-hydrophilic modified catheter includes a catheter body and a surface hydrophilic microstructure. The surface microstructure consists of longitudinal stripes with a width of 8-12 μm and a depth of 6-10 μm, with a spacing gradually varying from 35-50 μm at the drainage end to 10-20 μm at the proximal end. These stripes are produced using a laser cutting process and are used to impart hydrophilicity to the catheter, thereby reducing liquid surface tension, promoting rapid liquid flow, and improving drainage efficiency. The hydrophilic microstructure also reduces catheter surface friction, increasing catheter placement comfort.

[0019] Furthermore, the catheter body is made of silicone rubber or polyurethane;

[0020] Furthermore, the surface hydrophilic microstructure is cut by laser, and the specific laser processing parameters are: laser wavelength of 343nm, laser power of 20.0%-24.0% (5.8W), repetition frequency of 100kHz, and repetition number of 1-2 times;

[0021] Furthermore, the longitudinal vertical stripe spacing gradually changes from 10-20 μm at the drainage end to 35-50 μm at the proximal end, forming functional partitions with gradually decreasing hydrophilicity.

[0022] Furthermore, the surface hydrophilic microstructures are distributed in a gradient along the axial direction of the catheter: the spacing of the microstructures at the drainage end is 35-50 μm, the spacing in the transition section is 20-35 μm, and the spacing at the proximal end is 10-20 μm. The gradient change is achieved by linearly increasing the laser scanning speed from 80 mm / s to 120 mm / s, forming functional zones with gradually decreasing hydrophilicity but continuously decreasing fluid resistance.

[0023] Furthermore, the contact angle of the hydrophilic microstructure is less than 90°, indicating that the catheter surface has good hydrophilicity, enabling liquid to spread quickly on its surface. The roughness is 2-20 μm, which can enhance the hydrophilicity of the catheter. Furthermore, the catheter body is provided with multiple side holes near the drainage end. The side holes work synergistically with the surface hydrophilic microstructure to effectively improve drainage efficiency and reduce clogging caused by liquid residue.

[0024] Furthermore, the hydrophilic surface of the surface-hydrophilically modified catheter is located at the front end of the catheter, and the rear end is an ordinary non-hydrophilic catheter. During use, the hydrophilic surface is located in the body.

[0025] Beneficial effects

[0026] Through the unique micron-scale longitudinal vertical ridge surface hydrophilic microstructure design, the catheter surface contact angle is reduced to less than 90°. This microstructure can effectively reduce the surface tension of the liquid, allowing the liquid to spread and flow rapidly on the catheter surface, and has excellent hydrophilicity. The hydrophilic microstructure and the catheter body are integrally formed through laser cutting without additional coating, eliminating the risk of the modified layer falling off, degrading and entering the human body. The gradient microstructure gives the front end of the catheter more excellent hydrophilicity, significantly improving the adsorption capacity of high-viscosity liquids. The proximal friction coefficient is 35% lower than that of the uniform structure, reducing the risk of catheter injury. The gradient design reduces vortex formation and improves drainage efficiency by 25%. The surface microstructure reduces the friction of the catheter surface by approximately 28%, significantly reducing friction and pulling on surrounding tissues such as brain tissue and blood vessels during catheterization, effectively avoiding tissue tearing and mechanical damage.

[0027] Example 1

[0028] A silicone catheter body was prepared, and a hydrophilic surface microstructure was created using laser cutting equipment. The laser wavelength was set at 343 nm, the laser power was 22.5% (5.8 W), the repetition rate was 100 kHz, the scanning speed was 100 mm / s, and the number of repetitions was 1. Scanning electron microscopy of the processed catheter revealed that the longitudinal vertical lines of the surface microstructure were 10 μm wide, 8 μm deep, and 30 μm apart.

[0029] Example 2

[0030] A silicone catheter body was prepared and laser cutting parameters were adjusted: a 343nm laser wavelength, 20.0% laser power (5.8W), a 100kHz repetition rate, a scan speed of 80mm / s, and two repetitions. Inspection of the processed catheter revealed vertical ridges on its surface with a microstructure measuring 8μm in width, 6μm in depth, and 10μm in pitch.

[0031] Example 3

[0032] A silicone catheter body was prepared, and laser cutting parameters were set: a laser wavelength of 343 nm, a laser power of 24.0% (5.8 W), a repetition rate of 100 kHz, a scanning speed of 80 mm / s, and a repetition rate of 1. Testing revealed that the microstructure on the surface of the processed catheter had vertical lines with a width of 12 μm, a depth of 10 μm, and a spacing of 50 μm.

[0033] Example 4

[0034] Prepare the polyurethane catheter body, and use a laser cutting device to prepare the surface hydrophilic microstructure. Set the laser wavelength to 343 nm, the laser power to 22.5% (5.8 W), the repetition frequency to 100 kHz, the scanning speed to 100 mm / s, and the repetition number to 1. After processing the catheter, scanning electron microscope detection is performed. It is measured that the longitudinal vertical stripe width of the surface microstructure is 10 μm, the depth is 8 μm, and the pitch is 30 μm.

[0035] Example 5

[0036] Take a silica gel catheter, use a wavelength of 343 nm laser, power of 22.5% (5.8 W), repetition frequency of 100 kHz; drainage end (0-10 cm): scanning speed of 90 mm / s, repetition of 1, vertical stripes with width of 10 μm, depth of 8 μm, and pitch of 40 μm are obtained; transition section (10-15 cm): scanning speed is linearly increased from 90 mm / s to 100 mm / s, and the pitch is gradually changed to 15 μm; proximal end (15-20 cm): scanning speed is increased to 110 mm / s, repetition of 1, vertical stripes with pitch of 15 μm and depth of 10 μm are obtained.

[0037] Example 6

[0038] Take a silica gel catheter, use a wavelength of 343 nm laser, power of 20.0% (5.8 W), repetition frequency of 100 kHz; drainage end (0-10 cm): scanning speed of 80 mm / s, repetition of 1, vertical stripes with width of 10 μm, depth of 8 μm, and pitch of 50 μm are obtained; transition section (10-15 cm): scanning speed is linearly increased from 80 mm / s to 110 mm / s, and the pitch is gradually changed to 20 μm; proximal end (15-20 cm): scanning speed is increased to 120 mm / s, repetition of 1, vertical stripes with pitch of 20 μm and depth of 10 μm are obtained.

[0039] Example 7

[0040] Take a silica gel catheter, use a wavelength of 343 nm laser, power of 24.0% (5.8 W), repetition frequency of 100 kHz; drainage end (0-10 cm): scanning speed of 90 mm / s, repetition of 1, vertical stripes with width of 10 μm, depth of 8 μm, and pitch of 30 μm are obtained; transition section (10-15 cm): scanning speed is linearly increased from 90 mm / s to 120 mm / s, and the pitch is gradually changed to 10 μm; proximal end (15-20 cm): scanning speed is increased to 120 mm / s, repetition of 1, vertical stripes with pitch of 10 μm and depth of 10 μm are obtained.

[0041] Comparative Example 1

[0042] A silicone catheter body was prepared, and a hydrophilic surface microstructure was created using laser cutting equipment. The laser wavelength was set at 343 nm, the laser power was 25% (5.8 W), the repetition rate was 100 kHz, the scanning speed was 130 mm / s, and the number of repetitions was 1. Scanning electron microscopy of the processed catheter revealed that the longitudinal vertical lines of the surface microstructure were 14 μm wide, 12 μm deep, and 60 μm apart.

[0043] Comparative Example 2

[0044] Prepare the silicone catheter body without any treatment.

[0045] Verification Example

[0046] In order to illustrate the technical solution and effects of a surface hydrophilic modified catheter, the above embodiments and comparative examples were tested and verified.

[0047] Contact angle measurement: Soak the sample in ultrapure water for 60 seconds and then place it on the contact angle instrument's sample stage, ensuring it lies flat and free of wrinkles and distortion. Suspend a 5μL droplet of water on the tip of the needle and raise the stage so the sample surface contacts the suspended droplet. When the droplet is suspended on the sample surface, take a picture and record it.

[0048] Friction test: Clamp one end of the sample to be tested with a clamp, keep the sample in a vertical direction, and pass the other end through the middle of two silicone sheets. Set the clamping force to 2N, the lifting speed to 200mm / min, the test length to 100mm, and the immersion time to 60s to test the friction and friction coefficient.

[0049] X-ray development and shooting: Place the catheter on the examination bed of the X-ray machine, adjust the position and angle of the catheter, and take X-rays.

[0050] Scanning electron microscope photography: Use a scanning electron microscope to photograph the local microstructure of the surface.

[0051] The specific contact angle test results are as follows: Figure 1 As shown, due to the laser engraving of hydrophilic microstructures on the catheter surface, Examples 1, 2, 3, and 4 all spread out immediately after a drop of water landed on the surface, demonstrating excellent hydrophilicity, and this was not affected by the catheter material. However, due to significant changes in laser power and scanning speed, the microstructure dimensions of Comparative Example 1 significantly changed, rendering its surface hydrophobic and failing to achieve a hydrophilic effect.

[0052] The specific friction test results are as follows: Figure 2As shown, after engraving the hydrophilic microstructure, the friction coefficients of Examples 1, 2, and 3 decreased compared with the catheter of Comparative Example 2 without any treatment, among which the friction coefficient of Example 1 decreased by about 45%, but the friction coefficient of the hydrophobic microstructure in Comparative Example 1 increased.

[0053] Specific X-ray results such as Figure 3 As shown, there is no significant difference in developability between Comparative Example 2 and Example 1, indicating that the developability of the laser-engraved catheter is not affected by the laser engraving.

[0054] The specific SEM results are as follows: Figure 4 As shown, after the local part is magnified by scanning electron microscopy, it can be clearly seen that the structure is vertical lines.

[0055] Specific flow test results are as follows Figure 5 As shown, the flow rate of the catheter was tested, and the results showed that the flow rate of the gradient hydrophilic structure was greater than the flow rate of the uniform hydrophilic structure and the flow rate of the ordinary catheter.

Claims

1. A surface hydrophilic modified catheter, characterized in that: The hydrophilic modified catheter includes a catheter body and a surface hydrophilic microstructure. The surface hydrophilic microstructure is a longitudinal vertical stripe with a width of 8-12 μm, a depth of 6-10 μm, and a spacing gradually changing from 35-50 μm at the drainage end to 10-20 μm at the proximal end along the axial direction. The spacing of the microstructures at the drainage end is 35-50 μm, the spacing in the transition section is 20-35 μm, and the spacing at the proximal end is 10-20 μm, and is distributed in a gradient along the axial direction of the catheter. The surface hydrophilic microstructure is prepared by a laser cutting process, and the gradient distribution is achieved by linearly increasing the laser scanning speed from 80 mm / s to 120 mm / s. The surface hydrophilic microstructure gives the catheter good hydrophilicity, which can reduce the surface tension of the liquid, promote rapid flow of the liquid, and improve drainage efficiency. The surface hydrophilic microstructure can also reduce the surface friction of the catheter and increase the comfort of catheterization.

2. The surface hydrophilic modified catheter according to claim 1, characterized in that: The catheter body is made of silicone rubber or polyurethane.

3. The surface hydrophilic modified catheter according to claim 1, characterized in that: The surface hydrophilic microstructure is cut using a laser cutting process with a laser wavelength of 343 nm, a laser power of 5.8 W, a repetition frequency of 100 kHz, and a repetition frequency of 1 to 2 times.

4. The surface hydrophilic modified catheter according to claim 1, characterized in that: The hydrophilic microstructure has a contact angle of less than 90° and a roughness of 2-20 μm, thereby enhancing the hydrophilicity of the catheter.

5. The surface hydrophilic modified catheter according to claim 1, characterized in that The catheter body is provided with a plurality of side holes near the drainage end, and the side holes cooperate with the surface hydrophilic microstructure to further improve the drainage efficiency and prevent the side holes from being blocked.

6. The surface hydrophilic modified catheter according to claim 1, characterized in that: The hydrophilic surface of the surface-hydrophilic modified catheter is located at the front end of the catheter, and the rear end is an ordinary non-hydrophilic catheter. During use, the hydrophilic surface is located in the body.

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