Preparation process of polymer-coated guide wire with embedded sensor and guide wire

Abstract

This application discloses a process for preparing a polymer-coated guidewire for a pre-embedded sensor, and the guidewire itself, belonging to the field of medical device manufacturing. The process for preparing a polymer-coated guidewire for a pre-embedded sensor includes the following steps: cleaning the surface of a core wire; melting a first polymer to form a polymer melt, extruding the polymer melt to coat the core wire, cooling to form a first coating layer; ultrasonically spraying a second polymer dispersion onto the sensor and the connection between the sensor and the core wire, drying to form a second coating layer, thus obtaining the guidewire. This application has the advantages of improving the uniformity of the coating layer, enhancing the application effect and durability of the guidewire.

Description

Technical Field

[0001] This application relates to the field of medical device manufacturing, and in particular to a process for preparing a polymer-coated guidewire for a pre-embedded sensor and the guidewire itself. Background Technology

[0002] Guidewires are important medical devices used in minimally invasive interventional treatments, enabling accurate access to lesions for diagnosis and treatment without opening human tissue. During interventional treatments of organs such as the fallopian tubes, the guidewire continuously applies pressure to the organ. Therefore, one type of guidewire includes a core wire and a sensor. The sensor is located at the tip of the core wire to continuously monitor the organ's pressure parameters in real time, providing crucial data for precision medicine. To improve the functionality and reliability of guidewires...

[0003] Because the guidewire surface needs a certain degree of lubrication to reduce frictional damage to organs, and the core wire of the guidewire is generally made of alloy, the guidewire surface needs to be coated with a polymer to form a coating layer. The common method of polymer coating is extrusion coating. The extruder pours molten polymer into the extrusion die, the core wire passes through the extrusion die, and the molten polymer coats the surface of the core wire. After the core wire exits the die, it is cooled, thereby forming a coating layer on the surface of the core wire.

[0004] However, for guidewires with sensors at the head, the uniformity of the coating layer is often found to be poor after extrusion coating, especially the coating layer near the head, which has many unevenness problems, reducing the application effect and durability of the guidewire. Summary of the Invention

[0005] To improve the uniformity of the coating layer and enhance the application effect and durability of the guidewire, this application provides a process for preparing a polymer-coated guidewire for pre-embedded sensors and the guidewire itself.

[0006] Firstly, the polymer-coated guidewire fabrication process for a pre-embedded sensor provided in this application adopts the following technical solution:

[0007] A process for fabricating a polymer-coated guidewire for an embedded sensor includes the following steps:

[0008] Clean the surface of the core wire;

[0009] The first polymer is melted to form a polymer melt, the polymer melt is extruded and coated onto the core filament, and then cooled to form a first coating layer;

[0010] The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire, and then dried to form the second coating layer, thus obtaining the guide wire.

[0011] By adopting the above technical solution, the core wire and sensor are coated with two different coating processes respectively, which improves the flexibility of the guide wire preparation process. Among them, ultrasonic spraying atomizes the second polymer dispersion into fine particles and uniformly coats it on the sensor surface under the action of airflow, covering the originally irregular connection between the sensor and the core wire. The resulting second coating layer has high uniformity and high thickness control accuracy, and the first coating layer and the second coating layer have high bonding tightness. This solves the problem that the extrusion coating process is difficult to make the coating layer fully adhere to the core wire and the sensor, improves the overall bonding force between the coating layer and the core wire and the sensor surface, and also improves the durability.

[0012] Optionally, during the ultrasonic spraying process, the viscosity of the second polymer dispersion is 7–17 mPa·s, the flow rate is 0.001–0.002 mL / s, the ultrasonic frequency is 110–125 kHz, and the core wire rotation speed is 80–150 rpm.

[0013] By adopting the above technical solution, under the combination of specific viscosity, flow rate, ultrasonic frequency and core wire rotation speed, the amount of dispersion liquid falling on the core wire or sensor surface per unit time and the spray particle size are affected, thereby affecting the evaporation rate and leveling of the dispersion liquid, so as to obtain a second coating layer with good uniformity and bonding force.

[0014] Optionally, the thickness of the coating layer is designed according to the specific application scenario and functional requirements of the guidewire, and the spraying time of the second polymer dispersion is designed according to the thickness of the coating layer.

[0015] Optionally, during ultrasonic spraying, the flow rate at the ultrasonic spraying sensor location is 0.0016–0.0020 mL / s, the ultrasonic frequency is 120–125 kHz, and the core wire rotation speed is 120–150 rpm; the flow rate at the connection between the ultrasonic spraying sensor and the core wire is 0.001–0.0015 mL / s, the ultrasonic frequency is 110–115 kHz, and the core wire rotation speed is 80–100 rpm.

[0016] By adopting the above technical solution, different spraying parameters are used for the sensor and the connection between the sensor and the core wire to adapt to the irregular structure of the connection between the sensor and the core wire, promote the entry of some of the second polymer liquid into and bond the gap at the connection, improve the bonding force between the first coating layer and the second coating layer, and improve the overall uniformity of the coating layer.

[0017] Optionally, a position range of 30-40% of the sensor length is left on the surface of the core wire for the second covering layer to cover. The connection between the sensor and the core wire includes a position range of 30-40% of the sensor length in the sensor and a position range of 30-40% of the sensor length in the core wire.

[0018] By adopting the above technical solution, the range of the connection between the core wire and the sensor is determined according to the length of the sensor, thereby refining the corresponding ultrasonic spraying parameters. This can strengthen the connection between the core wire and the sensor and significantly improve the uniformity and thickness control accuracy of the second coating layer at the connection.

[0019] Optionally, the second polymer dispersion is a polyurethane dispersion, wherein the polyurethane dispersion is an MDI / PCD type aqueous polyurethane dispersion.

[0020] By adopting the above technical solution, the MDI / PCD type waterborne polyurethane dispersion refers to a waterborne polyurethane prepared from diphenylmethane diisocyanate as isocyanate and polycarbonate diol as polyether polyol. The polyurethane has a good film-forming effect and forms an effective second coating layer.

[0021] Optionally, the first polymer is selected as thermoplastic polyurethane, wherein the thermoplastic polyurethane is an MDI / PPG type thermoplastic polyurethane.

[0022] By adopting the above technical solution, the MDI / PPG type waterborne polyurethane dispersion refers to a thermoplastic polyurethane prepared from diphenylmethane diisocyanate as isocyanate and polypropylene glycol as polyether polyol. Thermoplastic polyurethane has good processing performance and can reduce friction when the guide wire moves after being coated on the surface of the core wire.

[0023] The first coating layer is formed by MDI / PPG type thermoplastic polyurethane and the second coating layer is formed by MDI / PCD type waterborne polyurethane dispersion. This improves the interfacial compatibility between the first and second coating layers, allowing the second coating layer to more uniformly coat the connection between the core wire and the sensor, thereby improving the bonding force.

[0024] Optionally, after cleaning the core wire surface, the core wire surface is subjected to sandblasting and plasma surface treatment.

[0025] By adopting the above technical solutions, the surface roughness and surface activity of the core wire are improved, thereby enhancing the overall bonding force between the coating layer and the core wire.

[0026] Optionally, the surface of the core wire can be cleaned using ultrasonic cleaning.

[0027] Secondly, the guidewire provided in this application adopts the following technical solution:

[0028] A guidewire includes a core wire, the surface of which is covered with a first coating layer, a sensor is connected to the head of the core wire, and the surface of the sensor and the connection between the sensor and the core wire are covered with a second coating layer.

[0029] In summary, this application has the following beneficial effects:

[0030] 1. The core wire and sensor are coated using extrusion coating and ultrasonic spray coating processes, respectively, which improves the flexibility of the guide wire preparation process. Ultrasonic spray coating atomizes the second polymer dispersion into fine particles and uniformly coats the sensor surface under the action of airflow, covering the originally irregular connection between the sensor and the core wire. The resulting second coating layer has high uniformity and high thickness control accuracy, and the first coating layer and the second coating layer have high bonding tightness. This solves the problem that the extrusion coating process is difficult to make the coating layer fully adhere to the core wire and the sensor, improves the overall bonding force between the coating layer and the core wire and the sensor surface, and also improves durability.

[0031] 2. Under specific conditions of viscosity, flow rate, ultrasonic frequency and core wire rotation speed, and with different spraying parameters applied to the sensor and the connection between the sensor and the core wire, the irregular structure at the connection between the sensor and the core wire is adapted to promote the entry of some of the second polymer liquid into and bond the gap at the connection, and improve the bonding force between the first coating layer and the second coating layer interface, thereby improving the overall uniformity of the coating layer. Attached Figure Description

[0032] Figure 1 This is a cross-sectional view of the guidewire in Embodiment 1 of this application.

[0033] Explanation of reference numerals in the attached figures:

[0034] 1. Core wire; 2. Sensor; 3. Lead wire; 4. First coating layer; 5. Second coating layer. Detailed Implementation

[0035] The following is in conjunction with the appendix Figure 1 This application will be described in further detail.

[0036] This application discloses a guidewire, such as Figure 1 As shown, a guide wire includes a core wire 1 and a sensor 2. The core wire 1 is made of nickel-titanium alloy. The outer diameter of the straight section of the core wire 1 is 0.45 mm. The surface of the core wire 1 is covered with a first coating layer 4. The sensor 2 is connected to the head of the core wire 1. The outer diameter of the head end of the core wire 1 is 0.18 mm. The surface of the sensor 2 and the connection between the sensor 2 and the core wire 1 are covered with a second coating layer 5. The overall outer diameter of the guide wire is 0.89 mm.

[0037] Specifically, the lead wire 3 of sensor 2 is axially inserted into the core wire 1, and the lead wire 3 is electrically connected to the medical monitoring equipment to realize the transmission of sensing signals.

[0038] Example 1

[0039] This application also discloses a process for preparing a polymer-coated guidewire for a pre-embedded sensor, comprising the following steps:

[0040] S1. Clean the surface of the core wire.

[0041] The core wire surface is cleaned using ultrasonic cleaning. Specifically, the core wire is placed in an ultrasonic cleaner containing a cleaning agent, which can be water or a surfactant cleaning agent; in this embodiment, water is used. The core wire is immersed and cleaned at an ultrasonic frequency of 30 kHz for 10 minutes. After cleaning, it is dried to complete the cleaning process.

[0042] The core wire was sandblasted using liquid blasting. Specifically, the core wire was placed in a wet blasting machine, with a shot-to-water mass ratio of 1:5.6 in the slurry, a blasting time of 2 seconds, a blasting pressure of 0.35 MPa, and a blasting distance of 90 mm. The shot used was white corundum, sieved between 500 and 600 mesh.

[0043] Plasma surface treatment is performed on the sanded surface of the core wire. The core wire is placed in a plasma surface treatment machine, and after evacuation, gas is introduced. The output power of the plasma surface treatment is 1500W, the treatment time is 40s, the gas flow rate is 500sccm, and the gas used for plasma surface treatment is a mixture of argon and oxygen, with oxygen accounting for 7% of the flow rate.

[0044] S2. The first polymer is melted to form a polymer melt, the polymer melt is extruded to coat the core filament, and cooled to form a first coating layer.

[0045] Specifically, the polymer used is thermoplastic polyurethane, specifically MDI / PPG type thermoplastic polyurethane, which is commercially available. The core filament is inserted into an extrusion die, and the polymer is melted at 170°C using an extruder to form a polymer melt. The polymer melt flows into the extrusion die, coating the core filament. A 30% portion of the sensor length near the head of the core filament remains uncoated for the second coating layer. After exiting the extrusion die, the core filament is cooled in a cooling medium to form the first coating layer, and then dried to obtain the guide wire.

[0046] S3. The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire for 480 seconds, then dried to form the second coating layer, thus obtaining the guide wire.

[0047] Specifically, the second polymer dispersion is a polyurethane dispersion, specifically an MDI / PCD type waterborne polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic spraying machine is used to coat the sensor and the connection point between the sensor and the core wire. The connection point includes a 30% range within the sensor and a 30% range within the core wire.

[0048] During the ultrasonic spraying process, the flow rate at the ultrasonic spraying sensor location is 0.0016 mL / s, the ultrasonic frequency is 120 kHz, and the core wire rotation speed is 150 rpm; the flow rate at the connection between the ultrasonic spraying sensor and the core wire is 0.001 mL / s, the ultrasonic frequency is 110 kHz, and the core wire rotation speed is 100 rpm.

[0049] Example 2

[0050] This application also discloses a process for preparing a polymer-coated guidewire for a pre-embedded sensor, comprising the following steps:

[0051] S1. Clean the surface of the core wire.

[0052] The core wire surface is cleaned using ultrasonic cleaning. Specifically, the core wire is placed in an ultrasonic cleaner containing a cleaning agent, which can be water or a surfactant cleaning agent; in this embodiment, water is used. The core wire is immersed and cleaned at an ultrasonic frequency of 30 kHz for 10 minutes. After cleaning, it is dried to complete the cleaning process.

[0053] The sandblasting and plasma treatment of the core wire surface are the same as in Example 1.

[0054] S2. The first polymer is melted to form a polymer melt, the polymer melt is extruded to coat the core filament, and cooled to form a first coating layer.

[0055] Specifically, the polymer used is thermoplastic polyurethane, specifically MDI / PPG type thermoplastic polyurethane, which is commercially available. The core filament is inserted into an extrusion die, and the polymer is melted at 170°C using an extruder to form a polymer melt. The polymer melt flows into the extrusion die, coating the core filament. A 40% portion of the sensor length near the head of the core filament remains uncoated for the second coating layer. After exiting the extrusion die, the core filament is cooled in a cooling medium to form the first coating layer, and then dried to obtain the guide wire.

[0056] S3. The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire for 480 seconds, then dried to form the second coating layer, thus obtaining the guide wire.

[0057] Specifically, the second polymer dispersion is a polyurethane dispersion, specifically an MDI / PCD type waterborne polyurethane dispersion with a viscosity of 17 mPa·s. An ultrasonic spraying machine is used to coat the sensor and the connection point between the sensor and the core wire. The connection point includes a 40% range within the sensor and a 40% range within the core wire.

[0058] During the ultrasonic spraying process, the flow rate at the ultrasonic spraying sensor location is 0.0020 mL / s, the ultrasonic frequency is 125 kHz, and the core wire rotation speed is 120 rpm; the flow rate at the connection between the ultrasonic spraying sensor and the core wire is 0.0015 mL / s, the ultrasonic frequency is 115 kHz, and the core wire rotation speed is 80 rpm.

[0059] Example 3

[0060] The difference between this embodiment and Embodiment 1 lies in S3.

[0061] S3. The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire for 480 seconds, then dried to form the second coating layer, thus obtaining the guide wire.

[0062] Specifically, the second polymer dispersion is a polyurethane dispersion, specifically an MDI / PCD type waterborne polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic spraying machine is used to coat the sensor and the connection point between the sensor and the core wire. The connection point includes a 30% range within the sensor and a 30% range within the core wire.

[0063] During the ultrasonic spraying process, the flow rate at both the ultrasonic spraying sensor position and the connection point between the ultrasonic spraying sensor and the core wire is 0.0016 mL / s, the ultrasonic frequency is 120 kHz, and the core wire rotation speed is 150 rpm.

[0064] Example 4

[0065] The difference between this embodiment and Embodiment 1 lies in S3.

[0066] S3. The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire for 480 seconds, then dried to form the second coating layer, thus obtaining the guide wire.

[0067] Specifically, the second polymer dispersion is a polyurethane dispersion, specifically an MDI / PCD type waterborne polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic spraying machine is used to coat the sensor and the connection point between the sensor and the core wire. The connection point includes a 30% range within the sensor and a 30% range within the core wire.

[0068] During the ultrasonic spraying process, the flow rate at both the ultrasonic spraying sensor position and the connection point between the ultrasonic spraying sensor and the core wire is 0.001 mL / s, the ultrasonic frequency is 110 kHz, and the core wire rotation speed is 100 rpm.

[0069] Example 5

[0070] The difference between this embodiment and Embodiment 1 is that the core wire surface is subjected to sandblasting and plasma surface treatment between S1 and S2.

[0071] Comparative Example 1

[0072] A process for fabricating a polymer-coated guidewire for an embedded sensor includes the following steps:

[0073] S1. Clean the surface of the core wire.

[0074] The core wire surface is cleaned using ultrasonic cleaning. Specifically, the core wire is placed in an ultrasonic cleaner containing a cleaning agent, which can be water or a surfactant cleaning agent; in this embodiment, water is used. The core wire is immersed and cleaned at an ultrasonic frequency of 30 kHz for 10 minutes. After cleaning, it is dried to complete the cleaning process.

[0075] The sandblasting and plasma treatment of the core wire surface are the same as in Example 1.

[0076] S2. The first polymer is melted to form a polymer melt, the polymer melt is extruded to coat the core filament, and cooled to form a coating layer.

[0077] Specifically, the polymer used is thermoplastic polyurethane, specifically MDI / PPG type thermoplastic polyurethane, which is commercially available. The core filament is inserted into the extrusion die, and the polymer is melted at 170°C through the extruder to form a polymer melt. The polymer melt flows into the extrusion die, where it coats the core filament and the sensor. After exiting the extrusion die, it enters a cooling medium for cooling, forming a coating layer, and is then dried to obtain the guide wire.

[0078] Comparative Example 2

[0079] The difference between this comparative example and Example 1 lies in S3.

[0080] S3. The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire for 480 seconds, then dried to form the second coating layer, thus obtaining the guide wire.

[0081] Specifically, the second polymer dispersion is a polyurethane dispersion, specifically an MDI / PCD type waterborne polyurethane dispersion with a viscosity of 30 mPa·s. An ultrasonic spraying machine is used to coat the sensor and the connection point between the sensor and the core wire. The connection point includes a 30% range within the sensor and a 30% range within the core wire.

[0082] During the ultrasonic spraying process, the flow rate at the ultrasonic spraying sensor location is 0.0016 mL / s, the ultrasonic frequency is 120 kHz, and the core wire rotation speed is 150 rpm; the flow rate at the connection between the ultrasonic spraying sensor and the core wire is 0.001 mL / s, the ultrasonic frequency is 110 kHz, and the core wire rotation speed is 100 rpm.

[0083] Comparative Example 3

[0084] The difference between this comparative example and Example 1 lies in S3.

[0085] S3. The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire for 480 seconds, then dried to form the second coating layer, thus obtaining the guide wire.

[0086] Specifically, the second polymer dispersion is a polyurethane dispersion, specifically an MDI / PCD type waterborne polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic spraying machine is used to coat the sensor and the connection point between the sensor and the core wire. The connection point includes a 30% range within the sensor and a 30% range within the core wire.

[0087] During the ultrasonic spraying process, the flow rate at the ultrasonic spraying sensor location is 0.0030 mL / s, the ultrasonic frequency is 100 kHz, and the core wire rotation speed is 150 rpm; the flow rate at the connection between the ultrasonic spraying sensor and the core wire is 0.0025 mL / s, the ultrasonic frequency is 90 kHz, and the core wire rotation speed is 100 rpm.

[0088] Comparative Example 4

[0089] The difference between this comparative example and Example 1 lies in S3.

[0090] S3. The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire for 480 seconds, then dried to form the second coating layer, thus obtaining the guide wire.

[0091] Specifically, the second polymer dispersion is a polyurethane dispersion, specifically an MDI / PCD type waterborne polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic spraying machine is used to coat the sensor and the connection point between the sensor and the core wire. The connection point includes a 30% range within the sensor and a 30% range within the core wire.

[0092] During the ultrasonic spraying process, the flow rate at the ultrasonic spraying sensor location is 0.0016 mL / s, the ultrasonic frequency is 150 kHz, and the core wire rotation speed is 180 rpm; the flow rate at the connection between the ultrasonic spraying sensor and the core wire is 0.001 mL / s, the ultrasonic frequency is 130 kHz, and the core wire rotation speed is 160 rpm.

[0093] Effect test

[0094] Uniformity test: Use a biaxial laser diameter gauge to test the outer diameter of the guide wire tip. Clamp the tail end of the guide wire, place the guide wire tip above the guide wheel, and test and record the outer diameter of the guide wire tip at a stroke speed of 10-20 mm / s. The outer diameter tolerance is not greater than ±0.03 mm to be considered qualified.

[0095] Peeling force test: The two ends of the guide wire are pulled by a universal tensile testing machine and the force value is observed until the force value rises and then stabilizes. At this time, the polymer coating layer peels off from the surface of the core wire. The maximum force value when it stabilizes is recorded as the peeling force.

[0096] Table 1

[0097] Uniformity (mm) Peeling force (N) Example 1 0.36±0.01 82.4 Example 2 0.36±0.02 83.2 Example 3 0.36±0.03 78.3 Example 4 0.36±0.03 77.4 Comparative Example 1 0.36±0.09 58.7 Comparative Example 2 0.36±0.07 65.8 Comparative Example 3 0.36±0.05 70.7 Comparative Example 4 0.36±0.07 66.6

[0098] Referring to Table 1, the guidewire in Comparative Example 1 is entirely covered by extrusion coating, resulting in significantly poor surface uniformity. Compared to Example 1, where the first and second coating layers are formed by extrusion coating and ultrasonic spraying respectively, the guidewire exhibits higher surface uniformity. Furthermore, the bonding force between the second coating layer and the sensor, as well as the bonding force between the first and second coating layers, indirectly affects the peeling force between the coating layer and the core wire. Example 1 shows a significantly enhanced peeling force, improving the guidewire's application performance and durability.

[0099] The test results from Example 1 and Comparative Examples 2-4 show that, with the combination of specific viscosity, flow rate, ultrasonic frequency and core wire rotation speed, a second coating layer with good uniformity and bonding force can be obtained, making the pre-embedded sensor position more smoothly covered, so as to meet the needs of guide wire movement in organs.

[0100] The test results from Examples 1 and 3-4 show that using different spraying parameters for the sensor and the connection between the sensor and the core wire helps to improve the bonding force between the first coating layer and the second coating layer, and improves the overall uniformity of the coating layer.

[0101] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this specific embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A process for preparing a pre-embedded sensor polymeric coated guidewire, characterized by: Includes the following steps: Clean the surface of the core wire; The first polymer is melted to form a polymer melt, the polymer melt is extruded and coated onto the core filament, and then cooled to form a first coating layer; The second polymer dispersion is ultrasonically sprayed onto the sensor and the connection between the sensor and the core wire. Ultrasonic spraying atomizes the second polymer dispersion into fine particles, which are then uniformly coated onto the sensor surface under the action of airflow and cover the connection between the sensor and the core wire. After drying, a second coating layer is formed, and a guide wire is obtained. During ultrasonic spraying, the flow rate at the ultrasonic spraying sensor location is 0.0016~0.0020 mL / s, the ultrasonic frequency is 120~125 kHz, and the core wire rotation speed is 120~150 rpm; the flow rate at the connection between the ultrasonic spraying sensor and the core wire is 0.001~0.0015 mL / s, the ultrasonic frequency is 110~115 kHz, and the core wire rotation speed is 80~100 rpm. The surface of the core wire leaves a position range of 30-40% of the sensor length for the second covering layer to cover. The connection between the sensor and the core wire includes a position range of 30-40% of the sensor length in the sensor and a position range of 30-40% of the sensor length in the core wire. The first polymer is thermoplastic polyurethane, and the second polymer dispersion is a polyurethane dispersion.

2. The process for preparing a polymer coated guidewire with embedded sensors as claimed in claim 1, wherein: The polyurethane dispersion is an MDI / PCD type aqueous polyurethane dispersion.

3. The process for preparing a polymer-coated guidewire for a pre-embedded sensor according to claim 1, characterized in that: The thermoplastic polyurethane is an MDI / PPG type thermoplastic polyurethane.

4. The process for preparing a polymer-coated guidewire for a pre-embedded sensor according to any one of claims 1-3, characterized in that: After cleaning the core wire surface, the core wire surface is subjected to sandblasting and plasma surface treatment.

5. The process for fabricating a polymer-coated guidewire for an embedded sensor according to claim 1, characterized in that: The surface of the core wire is cleaned using ultrasonic cleaning.

6. A guidewire, prepared based on the polymer-coated guidewire preparation process for pre-embedded sensors according to any one of claims 1-5, comprising a core wire, the surface of the core wire being coated with a first coating layer, the head of the core wire being connected to a sensor, and the surface of the sensor and the connection between the sensor and the core wire being coated with a second coating layer.

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