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

By combining extrusion coating and ultrasonic spraying in the guide wire preparation process, the core wire and sensor are double-layeredly clad, solving the problem of poor uniformity of the cladding layer in the prior art, and significantly improving the durability and application effect of the guide wire.

CN119701163AActive Publication Date: 2025-03-28FOSHAN QIYOU MEDICAL TECH CO LTD
View PDF 5 Cites 0 Cited by

Patent Information

Application Number
CN202411893147.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-20
Publication Date
2025-03-28
Estimated Expiration
2044-12-20

AI Technical Summary

Technical Problem

In the extrusion coating process, the uniformity of the coating layer of the existing guide wire is poor, especially near the sensor head position, which often causes unevenness, resulting in reduced application effect and durability of the guide wire.

Method used

Two different coating processes are used: the extrusion coating process covers the core wire, and the connection between the sensor and the sensor and the core wire is covered by ultrasonic spraying process to form two cladding layers. The ultrasonic spraying process ensures high accuracy of the uniformity and thickness control of the coating layer by atomizing the polymer dispersion into fine particles and uniformly coating under the action of airflow.

Benefits of technology

The overall uniformity and bonding force of the guide wire cladding layer are improved, and the problem that the extrusion cladding process is difficult to make the cladding layer fully adhere to the core wire and the sensor is solved, which significantly improves the durability and application effect of the guide wire.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN119701163A_ABST
    Figure CN119701163A_ABST
Patent Text Reader

Abstract

The invention discloses a preparation process of a polymer coated guide wire of a pre-embedded sensor and the guide wire, and belongs to the field of production of medical apparatuses and instruments. The invention discloses a preparation process of a polymer coated guide wire of a pre-embedded sensor. The preparation process comprises the following steps: cleaning the surface of a core wire; melting the first polymer to form a polymer melt, extruding the polymer melt to coat the core wire, and cooling to form a first coating layer; and coating the sensor and the joint of the sensor and the core wire with the second polymer dispersion liquid through ultrasonic spraying, and drying to form a second coating layer, thereby obtaining the guide wire. The guide wire has the advantages that the uniformity of the coating layer is improved, and the application effect and durability of the guide wire are improved.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The present application relates to the field of medical device production, and in particular to a preparation process of a polymer-coated guidewire with a pre-embedded sensor and a guidewire. Background Art

[0002] Guidewires are important medical devices used in minimally invasive interventional treatments, which can accurately reach the lesion site for diagnosis and treatment without opening human tissue. During interventional treatment of organs such as fallopian tubes, the guidewire will continuously exert pressure on the organ. Therefore, there is a type of guidewire, including a core wire and a sensor. The sensor is set at the head of the core wire to continuously monitor the pressure parameters of the organ in real time, providing an important basis for precision medicine in order to improve the functionality and reliability of the guidewire.

[0003] Since the surface of the guide wire needs to have a certain degree of lubricity to reduce friction damage to organs, and the core wire of the guide wire is generally made of alloy, the surface of the guide wire needs to be coated with a layer of polymer to form a coating. The common way to coat the polymer is extrusion coating, where the extruder flows the molten polymer into the extrusion die, and the core wire passes through the extrusion die, so that the molten polymer wraps the surface of the core wire. After the core wire passes out of the die, it is cooled, thereby forming a coating on the surface of the core wire.

[0004] However, for guidewires with sensors on the head, it is often found that the coating layer is not uniform after extrusion coating, especially the coating layer near the head has many uneven spots, which reduces the application effect and durability of the guidewire. Summary of the invention

[0005] In order to improve the uniformity of the coating layer and improve the application effect and durability of the guide wire, the present application provides a polymer-coated guide wire preparation process and a guide wire for embedding a sensor.

[0006] In the first aspect, the present application provides a polymer-coated guide wire preparation process for a pre-embedded sensor using the following technical solution: A process for preparing a polymer-coated guide wire for pre-embedded sensors comprises the following steps: Clean the core wire surface; Melting a first polymer to form a polymer melt, extruding the polymer melt to coat the core wire, and cooling to form a first coating layer; The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying, and dried to form a second coating layer to obtain the guide wire.

[0007] By adopting the above technical scheme, the core wire and the sensor are coated respectively with two different coating processes, thereby improving the flexibility of the guide wire preparation process. Ultrasonic spraying is to atomize the second polymer dispersion into fine particles, which are evenly coated on the sensor surface under the action of airflow, and cover the originally irregular connection between the sensor and the core wire. The second coating layer thus formed has high uniformity and high thickness control accuracy, and the first coating layer and the second coating layer are tightly connected, which solves the problem that it is difficult to make the coating layer fully fit the core wire and the sensor in the extrusion coating process, improves the bonding strength of the overall coating layer with the core wire and the sensor surface, and also improves durability.

[0008] Optionally, during the ultrasonic spraying process, the viscosity of the second polymer dispersion is 7 to 17 mPa·s, the flow rate is 0.001 to 0.002 mL / s, the ultrasonic frequency is 110 to 125 KHz, and the core wire rotation speed is 80 to 150 rpm.

[0009] By adopting the above technical solution, under the coordination of specific viscosity, flow rate, ultrasonic frequency and core wire rotation speed, the amount of dispersion liquid and the spray particle size falling on the core wire or sensor surface per unit time are affected, thereby affecting the volatilization rate and leveling properties of the dispersion liquid, so as to obtain a second coating layer with good uniformity and bonding strength.

[0010] 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.

[0011] Optionally, during the ultrasonic spraying process, the flow rate at the ultrasonic spray sensor position is 0.0016~0.0020mL / s, the ultrasonic frequency is 120~125KHz, and the core wire rotation speed is 120~150rpm; the flow rate at the connection between the ultrasonic spray sensor and the core wire is 0.001~0.0015mL / s, the ultrasonic frequency is 110~115KHz, and the core wire rotation speed is 80~100rpm.

[0012] By adopting the above technical scheme, different spraying parameters are used for the sensor and the connection between the sensor and the core wire, respectively, to adapt to the irregular structure of the connection between the sensor and the core wire, promote part of the second polymer liquid to enter and bond the gap at the connection, and improve the bonding strength of the interface between the first coating layer and the second coating layer, thereby improving the overall uniformity of the coating layer.

[0013] Optionally, a position range of 30 to 40% of the sensor length is reserved on the surface of the core wire for coating by the second coating layer, and the connection between the sensor and the core wire includes a position range of 30 to 40% of the sensor length in the sensor and a position range of 30 to 40% of the sensor length in the core wire.

[0014] 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, which can strengthen the connection between the core wire and the sensor and fully improve the uniformity and thickness control accuracy of the second coating layer at the connection.

[0015] Optionally, the second polymer dispersion is a polyurethane dispersion, and the polyurethane dispersion is an MDI / PCD type water-based polyurethane dispersion.

[0016] By adopting the above technical scheme, 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.

[0017] Optionally, the first polymer is thermoplastic polyurethane, and the thermoplastic polyurethane is MDI / PPG type thermoplastic polyurethane.

[0018] By adopting the above technical scheme, the MDI / PPG type water-based polyurethane dispersion refers to a thermoplastic polyurethane prepared from diphenylmethane diisocyanate as isocyanate and polypropylene glycol as polyether polyol. The thermoplastic polyurethane has good processing properties and can reduce the friction when the guide wire moves after being coated on the surface of the core wire.

[0019] 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, so as to improve the interface compatibility between the first coating layer and the second coating layer, so that the second coating layer can be more evenly coated on the connection between the core wire and the sensor, thereby improving the bonding force.

[0020] Optionally, after cleaning the surface of the core wire, sandblasting and plasma surface treatment are performed on the surface of the core wire.

[0021] By adopting the above technical solution, the surface roughness and surface activity of the core wire are improved, and the bonding strength between the entire coating layer and the core wire is improved.

[0022] Optionally, the core wire surface is cleaned by ultrasonic cleaning.

[0023] In the second aspect, the present application provides a guidewire adopting the following technical solution: A guide wire comprises a core wire, the surface of the core wire is coated with a first coating layer, the head of the core wire is connected with a sensor, and the surface of the sensor and the connection between the sensor and the core wire are coated with a second coating layer.

[0024] In summary, this application has the following beneficial effects: 1. The core wire and the sensor are coated respectively by the extrusion coating process and the ultrasonic spray coating process to improve the flexibility of the guide wire preparation process. The ultrasonic spraying is to atomize the second polymer dispersion into fine particles, which are evenly coated on the sensor surface under the action of airflow, and cover the originally irregular connection between the sensor and the core wire. The second coating layer thus formed has high uniformity and high thickness control accuracy, and the first coating layer and the second coating layer are tightly connected, which solves the problem that it is difficult for the extrusion coating process to make the coating layer fully fit the core wire and the sensor, improves the bonding strength of the coating as a whole with the core wire and the sensor surface, and also improves durability.

[0025] 2. Under the coordination of specific viscosity, flow rate, ultrasonic frequency and core wire rotation speed, 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 part of the second polymer liquid to enter and bond the gap at the connection, and improve the bonding force at the interface between the first coating layer and the second coating layer, thereby improving the overall uniformity of the coating layer. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a cross-sectional structural diagram of the guidewire of Example 1 of the present application.

[0027] Description of reference numerals: 1. Core wire; 2. Sensor; 3. Lead wire; 4. First coating layer; 5. Second coating layer. DETAILED DESCRIPTION

[0028] The following is combined with Figure 1 This application is described in further detail.

[0029] The present application discloses a guide wire, 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 straight section outer diameter of the core wire 1 is 0.45 mm, the surface of the core wire 1 is coated 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 coated with a second coating layer 5, and the overall design outer diameter of the guide wire is 0.89 mm.

[0030] Specifically, the lead wire 3 of the sensor 2 is axially inserted into the core wire 1 , and the lead wire 3 is electrically connected to the medical monitoring device to achieve the transmission of the sensing signal.

[0031] Example 1 The present application also discloses a process for preparing a polymer-coated guide wire for pre-embedded sensors, comprising the following steps: S1. Clean the core wire surface.

[0032] The surface of the core wire is cleaned by ultrasonic cleaning. Specifically, the core wire is placed in an ultrasonic cleaning machine filled with a cleaning agent, which may be water or a surfactant cleaning agent, specifically water in this embodiment, and the core wire is soaked and cleaned at an ultrasonic frequency of 30kHz for 10 minutes, and dried after cleaning to complete the cleaning.

[0033] The core wire is sandblasted by liquid sandblasting. Specifically, the core wire is placed in a wet sandblasting machine, the mass ratio of shot blasting to water in the abrasive liquid is 1:5.6, the sandblasting time is 2s, the sandblasting pressure is 0.35MPa, and the sandblasting distance is 90mm. The shot blasting uses a size of 500-600 mesh, and the material of the shot blasting is white corundum.

[0034] Plasma surface treatment is performed on the sand surface of the core wire. The core wire is placed in a plasma surface treatment machine, and gas is introduced after vacuuming. 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 mixed gas composed of argon and oxygen, in which the oxygen flow rate accounts for 7%.

[0035] S2. Melting the first polymer to form a polymer melt, extruding the polymer melt to coat the core wire, and cooling to form a first coating layer.

[0036] Specifically, the polymer is thermoplastic polyurethane, which is MDI / PPG type thermoplastic polyurethane, which can be obtained commercially. The core wire is passed into the extrusion die, and the polymer is melted at 170°C by an extruder to form a polymer melt, and the polymer melt flows into the extrusion die, so that the polymer melt coats the core wire in the extrusion die, wherein the surface of the core wire close to the head is left uncoated at a position range of 30% of the sensor length, so as to be coated by the second coating layer; after passing through the extrusion die, the core wire enters the cooling medium for cooling to form a first coating layer, and is dried to obtain a guide wire.

[0037] S3. The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying for 480 seconds. The coating is dried to form a second coating layer to obtain a guide wire.

[0038] Specifically, the second polymer dispersion is a polyurethane dispersion, which is an MDI / PCD type water-based polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic sprayer is used to spray and coat the sensor and the connection between the sensor and the core wire, and the connection between the sensor and the core wire includes a position range in the sensor that accounts for 30% of the sensor length, and a position range in the core wire that accounts for 30% of the sensor length.

[0039] During the ultrasonic spraying process, the flow rate at the ultrasonic spray sensor position 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 spray 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.

[0040] Example 2 The present application also discloses a process for preparing a polymer-coated guide wire for pre-embedded sensors, comprising the following steps: S1. Clean the core wire surface.

[0041] The surface of the core wire is cleaned by ultrasonic cleaning. Specifically, the core wire is placed in an ultrasonic cleaning machine filled with a cleaning agent, which may be water or a surfactant cleaning agent, specifically water in this embodiment, and the core wire is soaked and cleaned at an ultrasonic frequency of 30kHz for 10 minutes, and dried after cleaning to complete the cleaning.

[0042] The sandblasting and plasma treatment of the core wire surface are the same as in Example 1.

[0043] S2. Melting the first polymer to form a polymer melt, extruding the polymer melt to coat the core wire, and cooling to form a first coating layer.

[0044] Specifically, the polymer is thermoplastic polyurethane, which is MDI / PPG type thermoplastic polyurethane, which can be obtained commercially. The core wire is passed into the extrusion die, and the polymer is melted at 170°C by an extruder to form a polymer melt, and the polymer melt flows into the extrusion die, so that the polymer melt coats the core wire in the extrusion die, wherein the surface of the core wire close to the head is left uncoated at a position range of 40% of the sensor length, so as to be coated by the second coating layer; after passing through the extrusion die, the core wire enters the cooling medium for cooling to form a first coating layer, and is dried to obtain a guide wire.

[0045] S3. The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying for 480 seconds. The coating is dried to form a second coating layer to obtain a guide wire.

[0046] Specifically, the second polymer dispersion is a polyurethane dispersion, which is an MDI / PCD type water-based polyurethane dispersion with a viscosity of 17 mPa·s. An ultrasonic sprayer is used to spray and coat the sensor and the connection between the sensor and the core wire, and the connection between the sensor and the core wire includes a position range in the sensor that accounts for 40% of the sensor length, and a position range in the core wire that accounts for 40% of the sensor length.

[0047] During the ultrasonic spraying process, the flow rate at the ultrasonic spray sensor position 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 spray 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.

[0048] Example 3 The difference between this embodiment and embodiment 1 lies in S3.

[0049] S3. The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying for 480 seconds. The coating is dried to form a second coating layer to obtain a guide wire.

[0050] Specifically, the second polymer dispersion is a polyurethane dispersion, which is an MDI / PCD type water-based polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic sprayer is used to spray and coat the sensor and the connection between the sensor and the core wire, and the connection between the sensor and the core wire includes a position range in the sensor that accounts for 30% of the sensor length, and a position range in the core wire that accounts for 30% of the sensor length.

[0051] During the ultrasonic spraying process, the flow rate at the ultrasonic spraying sensor position and the connection between the ultrasonic spraying sensor and the core wire was 0.0016 mL / s, the ultrasonic frequency was 120 KHz, and the core wire rotation speed was 150 rpm.

[0052] Example 4 The difference between this embodiment and embodiment 1 lies in S3.

[0053] S3. The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying for 480 seconds. The coating is dried to form a second coating layer to obtain a guide wire.

[0054] Specifically, the second polymer dispersion is a polyurethane dispersion, which is an MDI / PCD type water-based polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic sprayer is used to spray and coat the sensor and the connection between the sensor and the core wire, and the connection between the sensor and the core wire includes a position range in the sensor that accounts for 30% of the sensor length, and a position range in the core wire that accounts for 30% of the sensor length.

[0055] During the ultrasonic spraying process, the flow rate at the ultrasonic spraying sensor position and the connection between the ultrasonic spraying sensor and the core wire was 0.001 mL / s, the ultrasonic frequency was 110 KHz, and the core wire rotation speed was 100 rpm.

[0056] Example 5 The difference between this embodiment and embodiment 1 is that the surface of the core wire is subjected to sandblasting and plasma surface treatment between S1 and S2.

[0057] Comparative Example 1 A process for preparing a polymer-coated guide wire for pre-embedded sensors comprises the following steps: S1. Clean the core wire surface.

[0058] The surface of the core wire is cleaned by ultrasonic cleaning. Specifically, the core wire is placed in an ultrasonic cleaning machine filled with a cleaning agent, which may be water or a surfactant cleaning agent, specifically water in this embodiment, and the core wire is soaked and cleaned at an ultrasonic frequency of 30kHz for 10 minutes, and dried after cleaning to complete the cleaning.

[0059] The sandblasting and plasma treatment of the core wire surface are the same as in Example 1.

[0060] S2. Melting the first polymer to form a polymer melt, extruding the polymer melt to coat the core wire, and cooling to form a coating layer.

[0061] Specifically, the polymer is thermoplastic polyurethane, which is MDI / PPG type thermoplastic polyurethane, which can be obtained commercially. The core wire is inserted into the extrusion die, and the polymer is melted at 170° C. by the extruder to form a polymer melt, which flows into the extrusion die, so that the polymer melt coats the core wire and the sensor in the extrusion die, passes out of the extrusion die, and enters the cooling medium for cooling to form a coating layer, which is dried to obtain the guide wire.

[0062] Comparative Example 2 The difference between this comparative example and Example 1 is S3.

[0063] S3. The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying for 480 seconds. The coating is dried to form a second coating layer to obtain a guide wire.

[0064] Specifically, the second polymer dispersion is a polyurethane dispersion, which is an MDI / PCD type water-based polyurethane dispersion with a viscosity of 30 mPa·s. An ultrasonic sprayer is used to spray and coat the sensor and the connection between the sensor and the core wire, and the connection between the sensor and the core wire includes a position range in the sensor that accounts for 30% of the sensor length, and a position range in the core wire that accounts for 30% of the sensor length.

[0065] During the ultrasonic spraying process, the flow rate at the ultrasonic spray sensor position 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 spray 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.

[0066] Comparative Example 3 The difference between this comparative example and Example 1 is S3.

[0067] S3. The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying for 480 seconds. The coating is dried to form a second coating layer to obtain a guide wire.

[0068] Specifically, the second polymer dispersion is a polyurethane dispersion, which is an MDI / PCD type water-based polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic sprayer is used to spray and coat the sensor and the connection between the sensor and the core wire, and the connection between the sensor and the core wire includes a position range in the sensor that accounts for 30% of the sensor length, and a position range in the core wire that accounts for 30% of the sensor length.

[0069] During the ultrasonic spraying process, the flow rate at the ultrasonic spray sensor position 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 spray 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.

[0070] Comparative Example 4 The difference between this comparative example and Example 1 is S3.

[0071] S3. The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying for 480 seconds. The coating is dried to form a second coating layer to obtain a guide wire.

[0072] Specifically, the second polymer dispersion is a polyurethane dispersion, which is an MDI / PCD type water-based polyurethane dispersion with a viscosity of 7 mPa·s. An ultrasonic sprayer is used to spray and coat the sensor and the connection between the sensor and the core wire, and the connection between the sensor and the core wire includes a position range in the sensor that accounts for 30% of the sensor length, and a position range in the core wire that accounts for 30% of the sensor length.

[0073] During the ultrasonic spraying process, the flow rate at the ultrasonic spray sensor position 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 spray 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.

[0074] Effect test Uniformity test: Use a dual-axis laser diameter gauge to detect the outer diameter of the guide wire tip. Clamp the tail end of the guide wire, place the guide wire tip on the guide wheel, and detect and record the outer diameter of the guide wire tip at a travel speed of 10-20mm / s. The outer diameter tolerance is not greater than ±0.03mm, which is qualified.

[0075] Peeling force test: Use a universal tensile testing machine to pull up both ends of the guide wire respectively, and observe the change in force value until the force value tends to stabilize from an upward trend. At this time, the polymer coating peels off from the surface of the core wire, and the maximum force value when it is stable is recorded as the peeling force.

[0076] Table 1 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 Combined with Table 1, the guide wire of Comparative Example 1 is covered with a coating layer by extrusion coating, and the surface uniformity is significantly poor. Compared with the method of forming the first coating layer and the second coating layer by extrusion coating and ultrasonic spraying respectively in Example 1, it can be seen that the uniformity of the surface of the guide wire is higher. In addition, the binding force between the second coating layer and the sensor and the binding force between the first coating layer and the second coating layer will indirectly affect the peeling force of the coating layer and the core wire as a whole. The peeling force of Example 1 is significantly enhanced, which improves the application effect and durability of the guide wire.

[0077] It can be seen from the test results of Example 1 and Comparative Examples 2-4 that under the coordination of specific viscosity, flow rate, ultrasonic frequency and core wire rotation speed, a second coating layer with good uniformity and bonding strength can be obtained, so that the position of the embedded sensor can be coated more smoothly to meet the movement needs of the guide wire in the organ.

[0078] It can be seen from the test results of Example 1 and Examples 3-4 that using different spraying parameters for the sensor and the connection between the sensor and the core wire can help improve the bonding strength at the interface between the first coating layer and the second coating layer and improve the overall uniformity of the coating layer.

[0079] This specific implementation manner is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make non-creative modifications to the specific implementation manner as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A process for preparing a polymer-coated guide wire for pre-embedded sensors, characterized in that: The following steps are involved: Clean the core wire surface; Melting a first polymer to form a polymer melt, extruding the polymer melt to coat the core wire, and cooling to form a first coating layer; The second polymer dispersion is coated on the sensor and the connection between the sensor and the core wire by ultrasonic spraying, and dried to form a second coating layer to obtain the guide wire.

2. The process for preparing a polymer-coated guide wire for a pre-embedded sensor according to claim 1, characterized in that: 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.

3. The process for preparing a polymer-coated guide wire for a pre-embedded sensor according to claim 2, characterized in that: During the ultrasonic spraying process, the flow rate at the ultrasonic spray sensor position is 0.0016~0.0020mL / s, the ultrasonic frequency is 120~125KHz, and the core wire speed is 120~150rpm; the flow rate at the connection between the ultrasonic spray sensor and the core wire is 0.001~0.0015mL / s, the ultrasonic frequency is 110~115KHz, and the core wire speed is 80~100rpm.

4. The process for preparing a polymer-coated guide wire for a pre-embedded sensor according to claim 1, characterized in that: A position range of 30-40% of the sensor length is reserved on the surface of the core wire for coating by the second coating layer, and 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.

5. The process for preparing a polymer-coated guide wire for a pre-embedded sensor according to claim 1, characterized in that: The second polymer dispersion is a polyurethane dispersion, and the polyurethane dispersion is an MDI / PCD type waterborne polyurethane dispersion.

6. The process for preparing a polymer-coated guide wire for a pre-embedded sensor according to claim 1, characterized in that: The first polymer is thermoplastic polyurethane, and the thermoplastic polyurethane is MDI / PPG type thermoplastic polyurethane.

7. A process for preparing a polymer-coated guide wire for a pre-embedded sensor according to any one of claims 1 to 6, characterized in that: After the core wire surface is cleaned, sandblasting and plasma surface treatment are performed on the core wire surface.

8. The process for preparing a polymer-coated guide wire for a pre-embedded sensor according to claim 1, characterized in that: The surface of the core wire is cleaned by ultrasonic cleaning.

9. A guidewire, prepared based on the polymer-coated guidewire preparation process for embedded sensors according to any one of claims 1 to 8, 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, the surface of the sensor and the connection between the sensor and the core wire being coated with a second coating layer.

Citation Information

Patent Citations

  • Guide wire, super-smooth guide wire forming method, single core wire coating extrusion system and application

    CN114559627A

  • Endoluminal physiological sensing device with embedded conformal conductors

    CN116322499A

  • Non - vascular chamber way seal wire

    CN206688006U

  • Sensor and guidewire assembly

    EP1849409A1

  • Medical guide wire

    JP2016101311A