A preparation method of an intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon

Abstract

The present invention belongs to the technical field of medical manufacturing, and particularly relates to a process preparation method of an intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon. The method comprises the following steps: (1) Co-extrusion molding of the tube body: Polyurethane particles containing an antistatic agent and a nano-antibacterial agent are melt-extruded by a twin-screw extruder, and are cooled and shaped by a four-stage temperature gradient after being molded by a multi-stage gradient temperature control mold; (2) Construction of a multi-cavity structure: 2-4 independent channels are formed through a rapid-switching mandrel system; (3) Balloon grafting: A pre-vulcanized silicone balloon is sleeved on the distal end of the catheter; (4) Functionalization treatment: A heparin-silicone oil composite coating loaded with nano-titanium dioxide modified by a silane coupling agent is plasma-sprayed on the surface of the catheter; (5) Tube body modification: Laser micro-machining of anti-slip patterns and setting of a platinum-iridium alloy imaging ring at the tip of the intestinal obstruction catheter. The synergistic antibacterial mechanism of the present invention significantly improves the anti-infection performance of the catheter, and the balloon can always be tightly combined with the catheter, being safe and durable.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical manufacturing, and particularly relates to a process preparation method for an intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon. Background Art

[0002] As a common disease of the digestive system, the intestinal obstruction catheter plays an indispensable role in its treatment process. However, current intestinal obstruction catheter products on the market have exposed many problems that urgently need to be solved, both in terms of performance and preparation process.

[0003] Most traditional intestinal obstruction catheters are made of a single material. Taking a polyvinyl chloride (PVC) catheter as an example, although it has the advantage of low cost, its flexibility is seriously insufficient, and it is extremely easy to fold when being pushed into the intestine, hindering its smooth passage. At the same time, the biocompatibility of this material is poor. If it is indwelled in the body for a long time, it is very easy to damage the intestinal mucosa, which will not only increase the pain of the patient, but also greatly increase the risk of infection. While a pure silicone catheter has excellent biocompatibility, its hardness is poor, and it is difficult to maintain a stable shape in a complex intestinal environment, which has a great impact on the accurate positioning of the catheter and effective drainage work. Thus, it can be seen that existing catheters fail to fully integrate the advantages of different materials, resulting in the key performance indicators of flexibility, strength, and biocompatibility not being able to reach an ideal balance state. In actual clinical applications, if the catheter is too soft, it is difficult to reach the obstruction site, and if it is too hard, it will damage the intestinal tissue, ultimately leading to a significant reduction in the treatment effect.

[0004] In addition, the existing connection methods between the balloon and the catheter generally have the problems of being simple and unreliable. When using a socket connection method, under the dual action of intestinal peristalsis and digestive juice, the balloon is extremely easy to separate from the catheter. Once this happens, it will not only delay the treatment time of the patient, but may even pose a threat to the patient's life safety. Even if some products use a glue bonding method, although the initial bonding strength is acceptable, as time goes by, the digestive juice will gradually weaken the bonding force, and ultimately the balloon will still fall off. Moreover, even if the initial connection is relatively firm, the connection part is still the weak link in the entire catheter structure. During the insertion and use of the catheter, this part bears a large stress and is prone to problems such as rupture and leakage, which will in turn affect the normal function of the balloon, such as difficult inflation or inability to maintain pressure, severely affecting the treatment effect.

[0005] From the perspective of the manufacturing process, there are many drawbacks in the current processes adopted to improve the performance of catheters. These processes often involve complex multi-layer structure designs or special chemical treatment methods, which not only require expensive professional equipment, but also have extremely complex operation procedures, with high requirements for the production environment and the technical level of operators. This not only significantly increases the production cost, but also makes large-scale production and clinical promotion face numerous difficulties. More critically, most of the existing processes only focus on solving a single problem, such as only paying attention to the connection strength between the balloon and the catheter, while ignoring the comprehensive improvement of the overall performance of the catheter. There is a lack of consideration for important aspects such as the long-term stability, biocompatibility of the catheter in the intestine, and its interaction with human tissues, thus unable to meet the diverse actual clinical needs.

[0006] In summary, it is urgent to develop an innovative process preparation method. Through this new method, it is expected to comprehensively improve the comprehensive performance of the intestinal obstruction catheter, provide safer and more effective treatment devices for clinical applications, and effectively guarantee the treatment effect and health safety of patients. Summary of the Invention

[0007] The purpose of the present invention is to provide a process preparation method for an intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon.

[0008] To achieve the above purpose, the present invention provides the following technical solutions:

[0009] A process preparation method for an intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon, comprising the following steps:

[0010] (1) Tube body co-extrusion molding: Polyurethane particles containing antistatic agent and nano-antibacterial agent are melt-extruded through a twin-screw extruder, and are cooled and shaped by four-stage temperature gradient after being molded by a multi-stage gradient temperature control mold; the multi-stage gradient temperature control mold includes 3-5 independent pressure control sections. Between adjacent sections, the temperature of the previous section decreases by 20°C - 40°C and the temperature of the subsequent section is not lower than 120°C, and the pressure of the previous section decreases by 2MPa - 4MPa and the pressure of the subsequent section is not lower than 4MPa.

[0011] (2) Multi-cavity structure construction: 2-4 independent channels are formed through a rapid switching mandrel system, and the wall thickness tolerance of the channels is controlled within ±0.05mm;

[0012] (3) Balloon grafting: The pre-vulcanized silicone balloon is sleeved on the distal end of the catheter. At the joint between the balloon and the catheter, plasma treatment is carried out with argon and nitrogen with a volume ratio of 3:1, the treatment power is 200W - 300W, and the vacuum degree is controlled at 10 -2 Pa - 10 -3Pa, with a processing time of 30 seconds to 60 seconds; after processing, apply a medical adhesive containing boron nitride nanosheets with a mass fraction of 15% - 20%, an aspect ratio of ≥100:1, and a surface modified by an amino silane coupling agent.

[0013] (4) Functionalization treatment: Plasma spray a heparin-silicone oil composite coating on the surface of the catheter, and the coating is loaded with nano-titanium dioxide modified by a silane coupling agent.

[0014] (5) Tube body modification: Laser micro-machine anti-slip patterns and set a platinum-iridium alloy imaging ring at the tip of the intestinal obstruction catheter.

[0015] Further, the antistatic agent in step (1) is 1-ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide ionic liquid type, with a mass percentage of 0.8% - 1.0%; the nano-antibacterial agent is nanoparticles coated with polyvinylpyrrolidone on the surface, with a mass percentage of 0.8% - 1.2% and a particle size of 20nm - 50nm.

[0016] Further, in step (1), the melting temperature of the twin-screw extruder is 185°C - 200°C, the screw speed is 80rpm - 120rpm, the melt pressure is 2.5MPa - 3.5MPa, and the length-diameter ratio is 25:1 - 30:1.

[0017] Further, in step (1), the four-stage temperature gradient cooling and shaping is carried out, and the temperature gradient is 80°C → 50°C → 30°C → 15°C in sequence. The water cooling time for each stage is 3 minutes - 5 minutes, and the water cooling medium flow rate is 0.5m / s - 1.2m / s.

[0018] Further, the surface of the boron nitride nanosheets in step (3) is modified by an amino silane coupling agent, and the mass ratio of the modifier to boron nitride is 1:50 - 1:30. It is cured at a pressure of 0.5MPa - 1.0MPa for 90 seconds - 150 seconds, and the peel strength at the joint between the balloon and the catheter after curing is ≥1.5N / mm.

[0019] Further, the composite coating in step (4) contains 16.7% - 20% heparin, 79.3% - 82.8% silicone oil, and 0.5% - 1.0% nano-titanium dioxide modified by a silane coupling agent by total mass percentage; the plasma spraying distance is 80mm - 120mm, the powder feeding rate is 5g / min - 8g / min, and the coating thickness is 8μm - 15μm.

[0020] Further, the platinum-iridium alloy imaging ring in step (5) is set at 10cm - 15cm from the tip of the catheter, the mass ratio of platinum to iridium is 9:1, the wire diameter is 0.05mm - 0.08mm, and the winding density is 8 turns / cm - 12 turns / cm; the X-ray contrast is measured by the barium sulfate solution impregnation test method simulating the intestinal environment, the test voltage is 120kV, and the contrast is ≥300HU.

[0021] The beneficial effects of the present invention are as follows:

[0022] 1. Synergistic antibacterial: By adopting the combination of an ionic liquid antistatic agent and a polyvinylpyrrolidone-coated nano-antibacterial agent, the generation of static electricity on the catheter surface can be effectively reduced, making the surface resistivity ≤ 10 8 Ω·sq⁻¹. Meanwhile, the antibacterial rate against Staphylococcus aureus is ≥ 95% (action time 24 h). This synergistic antibacterial mechanism not only inhibits the adsorption of bacteria but also effectively kills bacteria, significantly improving the anti-infection performance of the catheter.

[0023] 2. High interfacial strength: By using plasma treatment technology in combination with an adhesive containing boron nitride nanosheets, the peel strength at the joint between the balloon and the catheter is greatly improved, reaching 1.8 N / mm - 2.2 N / mm, while it is only 0.9 N / mm in the comparative example. This improvement greatly enhances the stability of the connection between the balloon and the catheter, ensuring that the balloon can always be tightly combined with the catheter in a complex in-vivo environment, being safe and durable.

[0024] 3. Process stability: By using a four-stage gradient cooling process, the crystallinity of the tube body can be made more uniform. As shown by XRD testing, the difference in the full width at half maximum < 0.5°. At the same time, the wall thickness tolerance of the tube body can be controlled within ±0.03 mm, which is better than the industry's general standard of ±0.05 mm. This not only improves the dimensional accuracy of the catheter but also enhances the structural stability of the tube body, reducing product quality problems caused by process instability. Brief Description of the Drawings

[0025] Figure 1 It is a basic flowchart of the process for preparing an intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon.

[0026] Figure 2 It is a line graph comparing the antistatic agent content and antibacterial agent content of Examples 1 - 3 and Comparative Examples 1 - 3.

[0027] Figure 3 It is a line graph comparing the balloon glass strength (N / mm) of Examples 1 - 3 and Comparative Examples 1 - 3.

[0028] Figure 4 It is a line graph comparing the X-ray contrast (HU) of Examples 1 - 3 and Comparative Examples 1 - 3.

[0029] Figure 5 It is a line graph comparing the antibacterial rate (%) of Examples 1 - 3 and Comparative Examples 1 - 3. Detailed Embodiments

[0030] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention; obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention. A basic flowchart of the process for preparing an intestinal obstruction catheter by grafting a silicone balloon onto a polyurethane catheter is shown in the appendix Figure 1 . Example 1

[0031] 1. Co-extrusion molding of the tube body: The antistatic agent uses an ionic liquid type antistatic agent of 1-ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide with a mass percentage of 0.8%. The nano antibacterial agent selects nanoparticles with a mass percentage of 0.8%, a particle size of 20 nm, and a surface coated with polyvinylpyrrolidone. The melting temperature of the twin-screw extruder is 185 °C, the screw speed is 80 rpm, the melt pressure is 2.5 MPa, and the length-diameter ratio is 25:1. The multi-stage gradient temperature control mold has 3 independent pressure control sections. The temperature of the first section is 200 °C and the pressure is 6 MPa; the temperature of the second section is reduced by 20 °C to 180 °C and the pressure is reduced by 2 MPa to 4 MPa; the temperature of the third section is further reduced by 20 °C to 160 °C and the pressure is maintained at 4 MPa. Four-stage temperature gradient cooling and shaping, the temperature gradients are 80 °C (water cooling time 3 minutes) → 50 °C (water cooling time 3 minutes) → 30 °C (water cooling time 3 minutes) → 15 °C (water cooling time 3 minutes) in sequence, and the flow rate of the water cooling medium is 0.5 m / s.

[0032] 2. Construction of the multi-cavity structure: Two independent channels are formed by quickly switching the core mold system, and the wall thickness tolerance of the cavity is controlled within ±0.05 mm.

[0033] 3. Balloon grafting: At the joint of the balloon and the catheter, plasma treatment is carried out with argon and nitrogen in a volume ratio of 3:1, the treatment power is 200 W, the vacuum degree is controlled at 10 -2 Pa, and the treatment time is 30 seconds. After treatment, a medical adhesive containing boron nitride nanosheets with a mass fraction of 15%, an aspect ratio of 100:1, and a surface modified with an amino silane coupling agent is coated, and the mass ratio of the modifier to boron nitride is 1:50. It is cured at a pressure of 0.5 MPa for 90 seconds, and the peel strength at the joint of the balloon and the catheter after curing is 1.52 N / mm.

[0034] 4. Functionalization treatment: The composite coating contains 16.7% heparin, 82.8% silicone oil, and 0.5% nano titanium dioxide modified with a silane coupling agent by total mass percentage. The plasma spraying distance is 80 mm, the powder feeding rate is 5 g / min, and the coating thickness is 8 μm.

[0035] 5. Tube modification: Laser micro-machining anti-slip lines. A platinum-iridium alloy developing ring is set 10 cm away from the tip of the catheter, with a platinum-iridium mass ratio of 9:1, a wire diameter of 0.05 mm, and a winding density of 8 turns / cm. It is measured by the barium sulfate solution immersion test method that simulates the intestinal environment, with a test voltage of 120 kV and an X-ray contrast of 302 HU. Example 2

[0036] 1. Co-extrusion of tube body: the mass percentage of antistatic agent is 0.9%, the mass percentage of nano antibacterial agent is 1.0%, and the particle size is 35nm. The melt temperature of the twin-screw extruder is 193℃, the screw speed is 100rpm, the melt pressure is 3.0MPa, and the aspect ratio is 27:1. The multi-stage gradient temperature control mold is equipped with 4 independent pressure control sections. The temperature of the first section is 205℃ and the pressure is 6MPa; the temperature of the second section is reduced by 30℃ to 175℃, and the pressure is reduced by 2MPa to 4MPa; the temperature of the third section is further reduced by 30℃ to 145℃, and the pressure is maintained at 4MPa; the temperature of the fourth section is further reduced by 30℃ to 115℃, and the pressure is maintained at 4MPa. Four-stage temperature gradient cooling, the temperature gradient is 80℃ (water cooling time 4 minutes) → 50℃ (water cooling time 4 minutes) → 30℃ (water cooling time 4 minutes) → 15℃ (water cooling time 4 minutes), and the flow rate of the water cooling medium is 0.8m / s.

[0037] 2. Multi-cavity structure construction: three independent cavities are formed, and the cavity wall thickness tolerance is ±0.05mm.

[0038] 3. Balloon grafting: plasma treatment power 250W, vacuum degree 5×10 -3 Pa, processing time 45 seconds. The adhesive contains boron nitride nanosheets with a mass fraction of 17.5% and a diameter-to-thickness ratio of 120:1, and the mass ratio of the modifier to boron nitride is 1:40. Curing at a pressure of 0.75MPa for 120 seconds, the peel strength after curing is 1.85N / mm.

[0039] 4. Functional treatment: Composite coating: heparin 18.5%, silicone oil 81%, silane coupling agent modified nano titanium dioxide 0.5%. Plasma spraying distance 100mm, powder feeding rate 6.5g / min, coating thickness 12μm.

[0040] 5. Tube modification: Laser micro-machining anti-slip lines. A developing ring is set at 12.5cm from the tip of the catheter, with a platinum-iridium alloy mass ratio of 9:1, a wire diameter of 0.065mm, and a winding density of 10 turns / cm. The X-ray contrast is 320HU. Example 3

[0041] 1. Tube body co-extrusion molding: The mass percentage of the antistatic agent is 1.0%, the mass percentage of the nano-antibacterial agent is 1.2%, and the particle size is 50 nm. The melting temperature of the twin-screw extruder is 200 °C, the screw speed is 120 rpm, the melt pressure is 3.5 MPa, and the length-diameter ratio is 30:1. The multi-stage gradient temperature control die is set with 5 independent pressure control sections. The temperature of the first section is 210 °C and the pressure is 6 MPa; the temperature of the second section is reduced by 40 °C to 170 °C, and the pressure is reduced by 2 MPa to 4 MPa; the temperature of the third section is further reduced by 40 °C to 130 °C, and the pressure remains 4 MPa; the temperature of the fourth section is further reduced by 40 °C to 90 °C and adjusted to 120 °C, and the pressure remains 4 MPa; the temperature of the fifth section is further reduced by 40 °C to 80 °C and adjusted to 120 °C, and the pressure remains 4 MPa. Four-stage temperature gradient cooling, the temperature gradients are 80 °C (water cooling time 5 minutes) → 50 °C (water cooling time 5 minutes) → 30 °C (water cooling time 5 minutes) → 15 °C (water cooling time 5 minutes) in sequence, and the flow rate of the water cooling medium is 1.2 m / s.

[0042] 2. Multi-cavity structure construction: Four independent channels are formed, and the wall thickness tolerance of the cavity is ±0.05 mm.

[0043] 3. Balloon grafting: The plasma treatment power is 300 W, the vacuum degree is 10 -3 Pa, and the treatment time is 60 seconds. The adhesive contains boron nitride nanosheets with a mass fraction of 20% and an aspect ratio of 150:1, and the mass ratio of the modifier to boron nitride is 1:30. It is cured at a pressure of 1.0 MPa for 150 seconds, and the peel strength after curing is 2.05 N / mm.

[0044] 4. Functionalization treatment: Composite coating: Heparin 20%, silicone oil 79.3%, silane coupling agent modified nano-titanium dioxide 0.7%. The plasma spraying distance is 120 mm, the powder feeding rate is 8 g / min, and the coating thickness is 15 μm.

[0045] 5. Tube body modification: Laser micro-machined anti-slip patterns. A radiopaque ring is set at 15 cm from the catheter tip, the mass ratio of platinum-iridium alloy is 9:1, the wire diameter is 0.08 mm, and the winding density is 12 turns / cm. The X-ray contrast is 330 HU.

[0046] Comparative Example 1

[0047] 1. Tube body co-extrusion molding: Without antistatic agent, the mass percentage of the nano-antibacterial agent is 1.0% and the particle size is 30 nm. The parameters of the twin-screw extruder and other conditions such as cooling are the same as in Example 2.

[0048] 2. Multi-cavity structure construction: The same as in Example 2.

[0049] 3. Balloon grafting: The same as in Example 2.

[0050] 4. Functionalization treatment: The same as in Example 2.

[0051] 5. Tube body modification: same as in Example 2.

[0052] Test results: The peel strength of the junction between the balloon and the catheter is 1.3N / mm, the X-ray contrast is 310HU, and because there is no antistatic agent, the surface resistivity is relatively high, and the antibacterial rate is 90%.

[0053] Comparative Example 2

[0054] 1. Co-extrusion of tube body: same as in Example 2.

[0055] 2. Construction of multi-cavity structure: same as Example 2.

[0056] 3. Balloon grafting: The plasma treatment is the same as in Example 2, but the coated medical adhesive does not contain boron nitride nanosheets. Curing is carried out under the same pressure and time, and the peel strength of the joint between the balloon and the catheter after curing is only 0.8 N / mm.

[0057] 4. Functionalization treatment: same as Example 2.

[0058] 5. Tube body modification: same as in Example 2.

[0059] Comparative Example 3

[0060] 1. Co-extrusion of tube body: same as in Example 2.

[0061] 2. Construction of multi-cavity structure: same as Example 2.

[0062] 3. Balloon grafting: same as in Example 2.

[0063] 4. Functionalization treatment: same as Example 2.

[0064] 5. Tube modification: Laser micro-machining anti-slip lines. A developing ring is set at 12.5cm from the tip of the catheter, with a platinum to iridium mass ratio of 8:2, a wire diameter of 0.04mm, and a winding density of 6 turns / cm. It is measured by the barium sulfate solution immersion test method that simulates the intestinal environment, with a test voltage of 120kV and an X-ray contrast of 250HU.

[0065] The comparison line graph of the antistatic agent content, balloon glass strength (N / mm), X-ray contrast (HU) and antibacterial rate (%) of Examples 1-3 and Comparative Examples 1-3 is shown in the attached figure. Figures 2 - 5 .

[0066] The above is only a preferred specific implementation of the present invention; however, the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical solution and its improved conception within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A preparation method of an intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon, characterized in that: It includes the following steps: (1) Co-extrusion molding of the tube body: Polyurethane particles containing antistatic agent and nano-antibacterial agent are melt-extruded by a twin-screw extruder, and are cooled and shaped by four-stage temperature gradient after being molded by a multi-stage gradient temperature control mold; the multi-stage gradient temperature control mold includes 3-5 independent pressure control sections. Between adjacent sections, the temperature of the previous section is reduced by 20°C - 40°C and the temperature of the subsequent section is not lower than 120°C, the pressure of the previous section is reduced by 2MPa - 4MPa and the pressure of the subsequent section is not lower than 4MPa; (2) Construction of the multi-cavity structure: 2-4 independent channels are formed by a rapid-switching core mold system, and the wall thickness tolerance of the cavity is controlled within ±0.05mm; (3) Balloon grafting: A pre-cured silicone balloon is attached to the distal end of the catheter. At the junction of the balloon and the catheter, a plasma treatment is performed using argon and nitrogen with a volume ratio of 3:

1. The treatment power is 200W-300W and the vacuum degree is controlled at 10 -2 Pa-10 -3 Pa, the treatment time is 30 seconds to 60 seconds; after the treatment, a medical adhesive containing boron nitride nanosheets with a mass fraction of 15% to 20%, a diameter-to-thickness ratio of ≥100:1 and a surface modified by an aminosilane coupling agent is coated; (4) Functionalization treatment: A heparin-silicone oil composite coating is plasma-sprayed on the surface of the catheter, and nano-titanium dioxide modified by silane coupling agent is loaded in the coating; (5) Modification of the tube body: Laser micro-machining of anti-slip patterns and setting a platinum-iridium alloy imaging ring at the tip of the intestinal obstruction catheter.

2. The preparation method of the intestinal obstruction catheter by grafting a silicone balloon to a polyurethane catheter according to claim 1, characterized in that: In step (1), the antistatic agent is 1-ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide salt ionic liquid type, with a mass percentage of 0.8% - 1.0%; the nano-antibacterial agent is nano-particles coated with polyvinylpyrrolidone on the surface, with a mass percentage of 0.8% - 1.2% and a particle size of 20nm - 50nm.

3. The preparation method of the intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon according to claim 1, wherein: In step (1), the melting temperature of the twin-screw extruder is 185°C - 200°C, the screw speed is 80rpm - 120rpm, the melt pressure is 2.5MPa - 3.5MPa, and the length-diameter ratio is 25:1 - 30:

1.

4. The preparation method of the intestinal obstruction catheter by grafting a silicone balloon onto a polyurethane catheter according to claim 1, wherein: In step (1), for the four-stage temperature gradient cooling and shaping, the temperature gradient is 80°C → 50°C → 30°C → 15°C in sequence, the water cooling time for each stage is 3 minutes - 5 minutes, and the water cooling medium flow rate is 0.5m / s - 1.2m / s.

5. The preparation method of the intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon according to claim 1, wherein: The surface of the boron nitride nanosheet in step (3) is modified by an amino silane coupling agent, the mass ratio of the modifier to boron nitride is 1:50 - 1:30, and it is cured at a pressure of 0.5MPa - 1.0MPa for 90 seconds - 150 seconds. After curing, the peel strength at the joint of the balloon and the catheter is ≥1.5N / mm.

6. The preparation method of the intestinal obstruction catheter by grafting a silicone balloon onto a polyurethane catheter according to claim 1, characterized in that: In step (4), the composite coating contains heparin 16.7% - 20%, silicone oil 79.3% - 82.8%, and silane coupling agent-modified nano-titanium dioxide 0.5% - 1.0% by total mass percentage; the plasma spraying distance is 80mm - 120mm, the powder feeding rate is 5g / min - 8g / min, and the coating thickness is 8μm - 15μm.

7. The preparation method of the intestinal obstruction catheter with a polyurethane catheter grafted with a silicone balloon according to claim 1, characterized in that: In step (5), the platinum-iridium alloy imaging ring is set at 10cm - 15cm from the tip of the catheter, the mass ratio of platinum to iridium is 9:1, the wire diameter is 0.05mm - 0.08mm, and the winding density is 8 turns / cm - 12 turns / cm; the X-ray contrast is measured by the barium sulfate solution impregnation test method simulating the intestinal environment, the test voltage is 120kV, and the contrast is ≥300HU.

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