A controllable performance soft film coated guide wire device and method

Abstract

This invention discloses a device and method for a guidewire with controllable performance of a soft membrane. The method includes: preparing a coating solution comprising a thermosetting resin and a curing agent; the weight ratio of the thermosetting resin to the curing agent being 10:1; fixing the guidewire in a first moving assembly and placing it in the coating solution; fixing an acoustic wave actuator in a second moving assembly and placing the acoustic wave actuator in the coating solution; the first moving assembly and / or the second moving assembly moving according to a preset trajectory, causing the coating solution to cure on the outer wall of the guidewire. In this application, the performance of the soft membrane can be adjusted by modifying the composition of the coating solution and the acoustic wave processing parameters during the acoustic wave curing process. Simultaneously, by controlling the coating solution formulation and / or acoustic wave parameters in different regions during the curing process, the mechanical properties of different axial sections of the guidewire can be precisely controlled, achieving gradient control of guidewire performance while balancing clinical suitability and production efficiency.

Description

Technical Field

[0001] This invention relates to the technical field of guidewire coating, and more particularly to a device and method for coating guidewires with a controllable soft membrane. Background Technology

[0002] Medical guidewires are crucial instruments in interventional vascular surgery. An ideal guidewire needs to possess excellent delivery capability, maneuverability, support, and flexibility and safety when navigating tortuous blood vessels. However, current medical guidewire manufacturing technologies often struggle to balance these properties, resulting in numerous inherent drawbacks. Among these, the safety of guidewires navigating tortuous blood vessels has long been a concern in the industry. To address this challenge, it is necessary to cover the portion of the medical guidewire, except for the tip, with a soft membrane to prevent puncture or damage to blood vessels. Currently, the equipment available for soft membrane coating of medical guidewires mainly includes extrusion coating equipment, coating and curing equipment, and specialized processing equipment (such as using peelable heat-shrink tubing).

[0003] Extrusion coating equipment offers high production efficiency, is suitable for large-scale continuous production, and allows for real-time thickness monitoring. However, it suffers from high mold costs, material limitations, and difficulty in controlling the precision of ultra-fine guidewires. Coating and curing equipment can form extremely thin, uniform coatings that do not affect guidewire performance, cure quickly, and achieve special functions. However, it faces challenges in adhesion control, poses biocompatibility risks, and has stringent environmental requirements. Specialized process equipment (such as using peelable heat shrink tubing) can perfectly protect the guidewire substrate, especially suitable for ultra-fine diameter products. However, its reliance on specific auxiliary materials leads to high costs and increases process complexity.

[0004] In summary, existing manufacturing equipment suffers from limitations in processing materials, poor biocompatibility of coating materials, and cumbersome processing procedures. Currently, no existing technology can simultaneously overcome these multiple shortcomings to achieve efficient, safe, and adjustable performance in flexible film coating. Summary of the Invention

[0005] This invention aims to at least partially address one of the problems in related technologies. Therefore, one objective of this invention is to provide a method for coating guidewires with a controllable PVC membrane. The processing steps are simplified: a coating solution is cured on the outer surface of the guidewire using acoustic wave processing, thereby achieving PVC membrane coating. During the acoustic curing process, the performance of the PVC membrane can be adjusted by modifying the composition of the coating solution and the acoustic wave processing parameters. Simultaneously, by controlling the coating solution formulation and / or acoustic wave parameters in different regions during curing, the mechanical properties of different axial sections of the guidewire can be precisely controlled, achieving gradient control of guidewire performance while balancing clinical suitability and production efficiency.

[0006] A method for coating guidewires with a controllable performance membrane, comprising: A coating solution is prepared, the coating solution comprising a thermosetting resin and a curing agent; the weight ratio of the thermosetting resin to the curing agent is 10:1; The guidewire is secured in the first moving assembly and placed in the coating solution; The acoustic wave action head is fixed in the second moving component and placed in the coating liquid. The first moving component and / or the second moving component move according to a preset trajectory, so that the coating liquid solidifies on the outer wall of the guidewire.

[0007] Furthermore, the thermosetting resin includes at least one of polydimethylsiloxane, epoxy resin, medical-grade silicone rubber, polyurethane, polyimide, cyanoacrylate, polyetheretherketone, thermoplastic polyurethane, polylactic acid-glycolic acid copolymer, polyethylene glycol derivative, and polycaprolactone.

[0008] Furthermore, the coating solution also includes at least one of the following: medical-grade silicone oil, phospholipid polymer, polyvinylpyrrolidone, medical-grade nano-silica, and diamond powder.

[0009] Furthermore, the coating liquid also includes at least one of the following: hydroxyapatite nanoparticles with a particle size of less than 100 nm, chitosan and its derivatives with a degree of deacetylation greater than 85%, magnetic nanoparticles, and vitamin E.

[0010] Furthermore, the coating solution also includes barium sulfate dispersed at the micron or nano level, or zirconium dioxide dispersed at the micron or nano level, or zirconium oxide dispersed at the micron or nano level.

[0011] Furthermore, the coating solution also includes medical-grade nano-silver.

[0012] Furthermore, during the guidewire coating process, the coating solution formulations for the proximal end, middle end, and distal end of the guidewire are different. Diamond powder is added to the coating solution for the proximal end of the guidewire, while medical-grade silicone oil is added to the coating solution for the distal end of the guidewire. The distal end of the guidewire refers to the end that first enters the blood vessel.

[0013] Furthermore, the acoustic wave action head has a ring-shaped structure.

[0014] Furthermore, the diameter of the guidewire before lamination is 1.0-1.5 mm, and the diameter of the guidewire after lamination is 3.0-3.5 mm.

[0015] The second objective of this application is to provide a controllable performance soft membrane coating guide wire device, including an acoustic wave action head, a coating liquid pool, a first moving component, and a second moving component; the guide wire is fixed in the first moving component; the acoustic wave action head is fixed in the second moving component; the coating liquid pool contains coating liquid, the acoustic wave action head is placed in the coating liquid, and the first moving component and / or the second moving component moves according to a preset trajectory, so that the coating liquid solidifies on the outer wall of the guide wire.

[0016] Compared with the prior art, the technical solution provided in this application has the following advantages: This application provides a method for coating guidewires with controllable performance using a soft membrane, comprising: preparing a coating solution, wherein the coating solution includes a thermosetting resin and a curing agent; the weight ratio of the thermosetting resin to the curing agent is 10:1; fixing the guidewire in a first moving assembly and placing it in the coating solution; fixing an acoustic wave action head in a second moving assembly and placing the acoustic wave action head in the coating solution; the first moving assembly and / or the second moving assembly moving according to a preset trajectory, thereby solidifying the coating solution on the outer wall of the guidewire. The processing steps of this application are concise. By using acoustic wave processing on the guidewire surface to solidify the coating solution on the outer surface of the guidewire, soft membrane coating is achieved. During the acoustic wave curing process, the performance of the soft membrane can be adjusted by adjusting the composition of the coating solution and the acoustic wave processing parameters. Simultaneously, by controlling the coating solution formulation and / or acoustic wave parameters in different areas during the curing process, the mechanical properties of different axial sections of the guidewire can be precisely controlled to achieve gradient control of guidewire performance, balancing clinical suitability and production efficiency.

[0017] This application also provides a performance-controllable flexible film coating guide wire device, including an acoustic wave action head, a coating liquid pool, a first moving component, and a second moving component; the guide wire is fixed in the first moving component; the acoustic wave action head is fixed in the second moving component; the coating liquid pool contains coating liquid, and the acoustic wave action head is placed in the coating liquid. Compared with traditional flexible film coating production equipment, such as extrusion coating equipment which requires high-precision molds and complex processing equipment, or special process equipment using peelable heat shrink tubing which relies on specific tooling and auxiliary materials, resulting in high production costs, the equipment in this application requires fewer components, has a simple structure, is relatively easy to maintain, and has lower requirements for the production environment. Attached Figure Description

[0018] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] In the attached image: Figure 1 This is a schematic diagram of the soft membrane-coated guidewire device in Embodiment 2 of this application; Figure 2 for Figure 1 A magnified view of the middle guidewire location; Figure 3 This is a schematic diagram of the preparation process of the soft membrane-coated guidewire in Embodiment 2 of this application; Figure 4 This is a schematic diagram of the preparation process of the soft membrane-coated guidewire in Embodiment 3 of this application; Figure 5 This is a photograph of the guidewire covered with a soft membrane in an embodiment of this application. Figure 6 This is a schematic diagram showing the relationship between the tensile strength of the soft membrane and the power of the acoustic wave generator in an embodiment of this application; Figure 7 This is a schematic diagram showing the relationship between the tensile strength of the diaphragm and the power of the acoustic wave generator in an embodiment of this application.

[0021] Reference numerals: 1. Acoustic wave generator; 2. Acoustic wave action head; 3. First clamp; 4. Medical guidewire; 5. Covering fluid pool; 6. Fluid pool fixing assembly; 7. Second moving assembly; 8. First moving assembly. Detailed Implementation

[0022] To provide a clearer understanding of the technical features, objectives, and effects of this invention, specific embodiments are now described in detail with reference to the accompanying drawings. In the following description, it should be understood that the orientations or positional relationships indicated by terms such as "front," "rear," "upper," "lower," "left," "right," "longitudinal," "horizontal," "vertical," "horizontal," "top," "bottom," "inner," "outer," "head," and "tail" are based on the orientations or positional relationships shown in the accompanying drawings, and are constructed and operated in a specific orientation. They are only for the convenience of describing this technical solution and do not indicate that the referred mechanism or element must have a specific orientation; therefore, they should not be construed as limitations on this invention.

[0023] It should also be noted that, unless otherwise explicitly specified and limited, terms such as "installation," "connection," "linking," "fixing," and "setting" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. When an component is referred to as being "on" or "below" another component, the component can be located "directly" or "indirectly" on the other component, or there may be one or more intermediary components. The terms "first," "second," "third," etc., are only for the convenience of describing this technical solution and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, features defined with "first," "second," "third," etc., may explicitly or implicitly include one or more of that feature. For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances.

[0024] In the following description, specific details such as particular system structures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of the invention. However, those skilled in the art will understand that the invention can be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, mechanisms, circuits, and methods are omitted so as not to obscure the description of the invention with unnecessary detail.

[0025] Example 1

[0026] This application provides a method for coating guidewires with a controllable performance membrane, comprising: S1: Prepare a coating solution, which includes a thermosetting resin and a curing agent; the weight ratio of the thermosetting resin to the curing agent is 10:1.

[0027] The thermosetting resin in this application includes at least one of polydimethylsiloxane, epoxy resin, medical-grade silicone rubber, polyurethane, polyimide, cyanoacrylate, polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), polylactic acid-glycolic acid copolymer (PLGA), polyethylene glycol derivative (PEG), and polycaprolactone (PCL).

[0028] In this application, the curing agent refers to a crosslinking agent that can promote the curing of thermosetting resin to form a tough, transparent elastomer. For example, Dow Corning Sylgard 184 can be selected as a dedicated curing agent.

[0029] The formulation of the coating solution in this application can be adjusted according to its application scenario. To improve the lubricity of the soft membrane, the coating solution also includes at least one of medical-grade silicone oil, phospholipid polymer, and polyvinylpyrrolidone. Specifically, the medical-grade silicone oil accounts for 2-5 wt% of the coating solution and can act as a lubricant to improve the sliding performance of the soft membrane surface. The phospholipid polymer accounts for 1-3 wt% of the coating solution and can improve the biocompatibility and surface lubricity of the soft membrane surface; the polyvinylpyrrolidone (PVP) accounts for 5-10 wt% of the coating solution and can enhance the hydrophilicity and lubricity of the soft membrane surface.

[0030] To improve the mechanical strength and wear resistance of the PVC membrane, the coating solution also includes at least one of medical-grade nano-silica and diamond powder. Specifically, the medical-grade nano-silica accounts for 3-8 wt% of the coating solution, which can improve mechanical strength and wear resistance. The diamond powder accounts for 1-3 wt% of the coating solution, and can significantly enhance hardness and wear resistance.

[0031] Hydroxyapatite nanoparticles with a particle size of less than 100 nm can also be added to the coating solution to enhance bioactivity and reduce foreign body reactions. The mass percentage of hydroxyapatite nanoparticles in the coating solution is 3-8 wt%.

[0032] Chitosan and its derivatives with a degree of deacetylation greater than 85% can also be added to the coating solution as natural antibacterial agents to enhance biocompatibility. The mass percentage of chitosan and its derivatives in the coating solution is 1-3 wt%.

[0033] High-purity (Fe-free) solvents can also be added to the coating solution. 2+ Magnetic nanoparticles (Fe3O4) containing impurities are used to impart magnetic response properties, which can be applied to magnetic navigation guide wires. The mass percentage of magnetic nanoparticles in the coating solution is 0.5-2 wt%.

[0034] Low to medium doses of vitamin E can also be added to the coating solution as an antioxidant to extend the lifespan of the guidewire. The mass percentage of vitamin E in the coating solution is 0.5-1 wt%.

[0035] The coating solution also includes medical-grade nano-silver, which accounts for 0.5-2 wt% of the coating solution. It can serve as a broad-spectrum and potent antibacterial agent and can also effectively reduce the risk of catheter-related infections.

[0036] To achieve the development function of the coated guidewire, this application may further add micron- or nano-sized dispersed barium sulfate, or micron- or nano-sized dispersed zirconium dioxide, or micron- or nano-sized dispersed zirconium oxide to the coating solution. Specifically, the mass percentage of micron- or nano-sized dispersed barium sulfate in the coating solution is 10-20 wt%, and the mass percentage of micron- or nano-sized dispersed zirconium dioxide / zirconia in the coating solution is 5-15 wt%.

[0037] When performing subsequent acoustic curing coating, it is necessary to ensure that the viscosity of the coating solution is kept within a certain range so that it can be easily adhered to the outer periphery of the guide wire by acoustic curing. If the viscosity of the coating solution is too high, a diluent can be used to adjust its viscosity. The diluent can be low molecular weight PDMS silicone oil.

[0038] In this application, the coating liquid can be mixed evenly using methods such as mechanical stirring, magnetic stirring, or homogenizing. After even mixing, the coating liquid needs to be subjected to vacuum treatment to effectively remove air trapped within it, thereby improving its curing effect and performance.

[0039] S2: Fix the guidewire in the first moving assembly 8 and place it in the coating solution.

[0040] The guide wire can be fixed to the first moving component 8 by the first clamp 3. The clamp structure facilitates the installation and removal of the guide wire and can ensure the connection strength between the guide wire and the first moving component 8.

[0041] In this application, the first moving component 8 can drive the guidewire to achieve three degrees of freedom of movement: two-dimensional translation in a plane parallel to the coating liquid surface, and rotational movement around the guidewire axis; thereby ensuring uniform coating on the outer wall of the guidewire. In this application, the first moving component 8 can be a simple three-axis motion device, or it can be a CNC machine tool, a robotic arm, or other motion control mechanism.

[0042] S3: Fix the acoustic wave action head 2 in the second moving component 7, and place the acoustic wave action head 2 in the coating liquid. The first moving component 8 and / or the second moving component 7 move according to a preset trajectory, so that the coating liquid solidifies on the outer wall of the guide wire.

[0043] In this application, the acoustic wave actuating head 2 is fixed in the second moving assembly 7 by a second clamp. The clamp structure facilitates the installation and disassembly of the acoustic wave actuating head 2 and ensures the connection strength between the acoustic wave actuating head 2 and the second moving assembly 7. The shape of the second clamp can be adapted and replaced according to the shape of the working end of the acoustic wave actuating head 2, and the size of the coating liquid pool 5 can also be adapted and replaced according to the size of the guide wire. The second moving assembly 7 is used to drive the acoustic wave actuating head 2 to move in three-dimensional space to achieve position adjustment of the acoustic wave actuating head 2.

[0044] The working end of the acoustic wave actuating head 2 has shapes including, but not limited to: pointed, flat, concave, convex, and irregularly shaped heads designed and manufactured for specific purposes. The working end of the acoustic wave actuating head 2 also varies in size to meet the manufacturing requirements of the target continuum. The overall shape of the acoustic wave actuating head 2 includes, but is not limited to: planar, cylindrical, curved (focusing), annular, or dynamically changeable biomimetic shapes with flexible sound field control.

[0045] The acoustic wave amplification head 2 can be fixed at one or more resonant frequencies between 20-100 kHz according to design parameters. The single-sided amplitude of the acoustic wave amplification head 2 is any value between 3-50 μm.

[0046] In actual operation, this application can control the second moving component 7 to move the acoustic wave action head 2 to a position at a specific distance from the guide wire and keep it stationary, while the first moving component 8 drives the guide wire to rotate and move, so as to ensure that a soft film is solidified on the outer periphery of the guide wire.

[0047] This application also provides a performance-controllable flexible film coating guide wire device, including an acoustic wave actuating head 2, a coating liquid pool 5, a first moving component 8, and a second moving component 7; the guide wire is fixed in the first moving component 8; the acoustic wave actuating head 2 is fixed in the second moving component 7; the coating liquid pool 5 contains coating liquid, and the acoustic wave actuating head 2 is placed in the coating liquid. Compared with traditional flexible film coating production equipment, such as extrusion coating equipment which requires high-precision molds and complex processing equipment, or special process equipment using peelable heat shrink tubing which relies on specific tooling and auxiliary materials, resulting in high production costs, the equipment in this application requires fewer components, has a simple structure, is relatively easy to maintain, and has lower requirements for the production environment.

[0048] This application achieves soft film coating by using acoustic wave processing to solidify a composite liquid on the outer surface of the guide wire. The performance can be adjusted by modifying the composition of the composite liquid (including thermosetting resin, diamond powder, etc.) and the acoustic wave processing parameters (such as ultrasonic frequency, amplitude, power, etc.).

[0049] This application has the following beneficial effects: 1. By adjusting the acoustic parameters, the comprehensive performance of the coated diaphragm can be adjusted without changing the composition of the coating solution. For example, controlling the acoustic parameters can achieve extremely low surface friction, anti-kink and anti-collapse capabilities, flexibility, and tracking ability. This application can precisely control the mechanical performance gradient of different segments of the guidewire axis according to the differences in vascular anatomy: increasing stiffness at the proximal end to ensure pushability and anti-kink, and enhancing flexibility at the distal end to adapt to tortuous or narrow vascular paths; at the same time, it eliminates the need to change materials, simplifies the process, reduces debugging costs, and can achieve gradient performance through a single coating, taking into account both clinical adaptability and production efficiency.

[0050] 2. This application can obtain soft films with different properties suitable for different scenarios by adding different components to the coating solution, and the variety of coating solutions can better meet the needs of future processing and production.

[0051] 3. Compared to traditional flexible film coating production equipment, such as extrusion coating equipment which requires high-precision molds and complex processing equipment, or special process equipment using peelable heat shrink tubing which relies on specific tooling and auxiliary materials, resulting in higher production costs, the equipment in this application requires fewer components, has a simpler structure, is relatively easy to maintain, and has lower requirements for the production environment. Furthermore, unlike the complex processing flow of traditional coating equipment, the processing steps of the equipment in this invention mainly include the following: guide wire preparation, coating solution preparation, and coating application, making the process convenient and efficient.

[0052] Example 2

[0053] like Figures 1-3 As shown, this application provides a controllable performance soft membrane coating guide wire device, including an acoustic wave action head 2, an acoustic wave generator 1, a coating liquid pool 5, a first moving component 8, and a second moving component 7. The coating liquid pool 5 is provided with graduation lines. The prepared coating liquid is added into the coating liquid pool 5, and it needs to be above the graduation line position. The coating liquid pool 5 is fixed at a certain height by the liquid pool fixing component 6 to facilitate the guide wire to be immersed in it. At the same time, the coating liquid pool 5 can be detachably fixed to the top of the liquid pool fixing component 6 to facilitate the replacement of the coating liquid pool 5, so as to realize the curing of different coating liquid components in the same guide wire.

[0054] The guide wire is fixed in the first moving assembly 8 by a first clamping member; the first moving assembly 8 can drive the guide wire to achieve three degrees of freedom of movement: two-dimensional translation in a plane parallel to the liquid surface, and rotational movement about the guide wire axis. The acoustic wave action head 2 is fixed in the second moving assembly 7 by a second clamp. The second moving assembly 7 drives the acoustic wave action head 2 to move to the initial height, and the position of the acoustic wave action head 2 remains fixed during processing to ensure the stability of the sound field.

[0055] This embodiment provides a method for coating guidewires with a controllable performance membrane, comprising: Step 1: Prepare the first coating solution, the second coating solution, and the third coating solution respectively. The first coating solution comprises the following components: 89.1 wt% PDMS, 8.9 wt% curing agent, and 2.0 wt% diamond powder. The second coating solution comprises the following components: 90.9 wt% PDMS and 9.1 wt% curing agent. The third coating solution comprises the following components: 87.3 wt% PDMS, 8.7 wt% curing agent, and 4.1 wt% medical-grade silicone oil.

[0056] After thoroughly mixing the first, second, and third coating solutions, a vacuum pump is used to evacuate the system for 600 seconds. The prepared first, second, and third coating solutions are then placed in separate coating solution tanks 5, ensuring the liquid levels reach the graduation marks.

[0057] Step 2: Connect the acoustic wave action head 2 to the acoustic wave generator 1, turn on the power, and fix the acoustic wave action head 2 in the second moving component 7.

[0058] Step 3: Fix the coating liquid pool 5 corresponding to the first coating liquid to the liquid pool fixing component 6 below the acoustic wave action head 2, and the second moving component 7 drives the acoustic wave action head 2 to descend until the lower surface of the acoustic wave action head 2 is immersed in the liquid surface by at least 1 mm.

[0059] Step 4: The medical guidewire 4 to be coated is fixed in the first moving assembly 8 by the first clamp 3. The first moving assembly 8 drives the medical guidewire 4 to move horizontally into the coating solution pool 5. The length of the area to be coated on the medical guidewire 4 is 20mm. Specifically, the proximal end of the guidewire requires 8mm of coating, which is covered with a soft membrane using the first coating solution; the middle end of the guidewire requires 4mm of coating, which is covered with a soft membrane using the second coating solution; and the proximal end of the guidewire requires 8mm of coating, which is covered with a soft membrane using the third coating solution. The distal end of the guidewire refers to the end of the medical guidewire 4 that first enters the blood vessel during use. For the proximal end of the guidewire, its rigidity needs to be improved to ensure pushability and anti-kink properties; for the distal end of the guidewire, its flexibility needs to be enhanced to adapt to curved or narrow blood vessel paths; and for the middle end of the guidewire, a transition between the performance of the proximal and distal ends is required.

[0060] Step 5: Apply the first coating solution, the second coating solution, and the third coating solution to the guidewire sequentially. When changing the coating solution, the corresponding coating solution tank 5 needs to be changed simultaneously. For the first coating solution, set the frequency of the acoustic wave generator 1 to 100kHz, the amplitude to 40µm, and the output power to 70%, i.e., 1400W. For the second coating solution, set the frequency of the acoustic wave generator 1 to 100kHz, the amplitude to 40µm, and the output power to 70%, i.e., 1400W. For the third coating solution, set the frequency of the acoustic wave generator 1 to 100kHz, the amplitude to 40µm, and the output power to 60%, i.e., 1200W.

[0061] For each stage of membrane coating, turn on sound wave generator 1; wait for the output sound wave to stabilize, such as... Figure 3 As shown, the stepper motor in the first moving assembly 8 is activated, causing the medical guidewire 4 to rotate unidirectionally at a low angular velocity. Simultaneously, the motor connected to the lead screw in the first moving assembly 8 is activated, causing the medical guidewire 4 to be fed at a low and constant speed.

[0062] Step 6: Once the medical guidewire 4 has completed the three stages of coating as observed by the naked eye, the processing can be completed. First, turn off the acoustic generator 1, then stop the operation of the first moving component 8. Control the second moving component 7 to first raise the acoustic action head 2, then control the first clamp 3 and the medical guidewire 4 to move horizontally away from the coating liquid pool 5. First, disassemble the coating liquid pool 5, then disassemble the medical guidewire 4; forming a soft membrane with different properties located on the outer wall of the medical guidewire 4.

[0063] like Figure 2 As shown in the enlarged schematic diagram, the color of the membrane changes from dark to light, indicating that the stiffness of the membrane gradually decreases, reflecting its adjustable performance characteristics.

[0064] Example 3

[0065] like Figure 4 As shown, this application provides a performance-controllable soft membrane coating guide wire device, including an acoustic wave action head 2, an acoustic wave generator 1, a coating liquid pool 5, a first moving component 8, and a second moving component 7. The coating liquid pool 5 has graduated lines. The prepared coating liquid is added into the coating liquid pool 5, ensuring it covers the graduated lines. The coating liquid pool 5 is fixed at a certain height by the pool fixing component 6 to facilitate guide wire insertion. Simultaneously, the coating liquid pool 5 is detachably fixed to the top of the pool fixing component 6. In this embodiment, both the pool fixing component 6 and the coating liquid pool 5 are cylindrical structures.

[0066] The guide wire is fixed in the first moving assembly 8 by a first clamping member; the first moving assembly 8 can drive the guide wire to move up and down. The acoustic wave actuation head 2 has a cylindrical structure and is fixed in the second moving assembly 7 by a second clamp. During the coating process, the second moving assembly 7 drives the acoustic wave actuation head 2 to a position where its axis coincides with the axis of the coating liquid pool 5, and in the vertical direction, the acoustic wave actuation head 2 is located below the liquid surface of the coating liquid pool 5. The second moving assembly 7 drives the acoustic wave actuation head 2 to move to the initial height, and during the processing, the position of the acoustic wave actuation head 2 remains fixed to ensure the stability of the sound field.

[0067] This embodiment provides a method for coating guidewires with a controllable performance membrane, comprising: Step 1: Mix the PDMS and curing agent that meet the performance requirements at a mass ratio of 10:1, stir thoroughly until homogeneous, and then evacuate the vacuum for 600 seconds using a vacuum pump.

[0068] Step 2: Connect the acoustic wave action head 2 to the acoustic wave generator 1, turn on the power, adjust the acoustic wave parameters to the preset values, that is, the acoustic wave frequency is 100kHz and the acoustic wave amplitude is 40µm, and fix the acoustic wave action head 2 in the second moving component 7.

[0069] Step 3: Pour the prepared coating solution into the coating solution tank 5 until the liquid level reaches the graduation mark. Fix the coating solution tank 5 in the liquid tank fixing assembly 6 below the acoustic wave actuating head 2, and operate the second moving assembly 7 to lower the acoustic wave actuating head 2 until it naturally falls onto the neck of the cylindrical coating solution tank 5.

[0070] Step 4: The medical guidewire 4 to be coated is held by the first clamp 3 and moves vertically into the coating liquid pool 5 under the drive of the first moving component 8. It is then inserted into the round hole of the cylindrical acoustic wave head 2, ensuring that the lower end of the medical guidewire 4 does not exceed the end face of the cylindrical acoustic wave head 2.

[0071] Step 5: Adjust the output power of the acoustic wave generator 1 to 60%, i.e., 1200W, and turn on the acoustic wave generator 1. Wait for the output acoustic wave to stabilize, and then the first moving component 8 drives the medical guidewire 4 to descend at a low and uniform speed.

[0072] Step 6: Once the guidewire is visually observed to have completed the coating process, the procedure can be completed. First, turn off the acoustic generator 1, then stop the operation of the first moving component 8. Operate the second moving component 7 to raise the acoustic head 2, then control the first clamp 3 and the medical guidewire 4 to move horizontally away from the coating solution pool 5. First, disassemble the coating solution pool 5, then disassemble the medical guidewire 4.

[0073] The coated guidewire prepared in this embodiment is as follows: Figure 5 As shown, the diameter of medical guidewire 4 is 1.3 mm, and the diameter of the diaphragm is 3.1 mm. The thicker diaphragm demonstrated in this example has unique advantages: a thicker diaphragm can more effectively form a hydrogel lubricating layer, providing better lubrication and a significantly reduced coefficient of friction, allowing the guidewire to glide more smoothly within the blood vessel. The thicker coating provides more durable lubrication and reduces pushing resistance. Furthermore, the thicker diaphragm makes it easier for the guidewire to pass through narrow and tortuous blood vessel paths, especially suitable for complex cases. The thicker diaphragm is less prone to wear and failure when passing through complex blood vessel paths, extending its service life, improving the overall durability of the guidewire, and maintaining good lubrication performance during multiple operations.

[0074] According to the coating solution formulation in this embodiment, when the acoustic wave frequency is controlled at 100kHz and the acoustic wave amplitude at 40µm, the tensile strength and tensile strength of the formed soft membrane deteriorate depending on the power of the acoustic wave generator 1. Figure 6 and Figure 7 As shown, this demonstrates that with a fixed composition of the coating solution, there is no need to change materials, simplifying the process, reducing debugging costs, and achieving gradient performance through a single coating, thus balancing clinical suitability and production efficiency.

[0075] It is understood that the above embodiments only illustrate preferred embodiments of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can freely combine the above technical features without departing from the concept of the present invention, and can also make several modifications and improvements, all of which fall within the protection scope of the present invention. Therefore, all equivalent transformations and modifications made with respect to the scope of the claims of the present invention should fall within the scope of the claims of the present invention.

Claims

1. A method of performance-controllable soft film-coated guide wire, characterized by, include: A coating solution is prepared, the coating solution comprising a thermosetting resin and a curing agent; the weight ratio of the thermosetting resin to the curing agent is 10:1; The guidewire is secured in the first moving assembly and placed in the coating solution; The acoustic wave action head is fixed in the second moving component and placed in the coating liquid. The first moving component and / or the second moving component move according to a preset trajectory, so that the coating liquid solidifies on the outer wall of the guidewire.

2. The method of claim 1, wherein the soft film coating guide wire has a controllable performance. The thermosetting resin includes at least one of polydimethylsiloxane, epoxy resin, medical-grade silicone rubber, polyurethane, polyimide, cyanoacrylate, polyetheretherketone, thermoplastic polyurethane, polylactic acid-glycolic acid copolymer, polyethylene glycol derivative, and polycaprolactone.

3. The method of claim 1, wherein the soft film coating guide wire has a controllable performance. The coating solution also includes at least one of the following: medical-grade silicone oil, phospholipid polymer, polyvinylpyrrolidone, medical-grade nano-silica, and diamond powder.

4. The method of claim 1, wherein the soft film coating guide wire has a controllable performance. The coating solution also includes at least one of the following: hydroxyapatite nanoparticles with a particle size of less than 100 nm, chitosan and its derivatives with a degree of deacetylation greater than 85%, magnetic nanoparticles, and vitamin E.

5. The method of claim 1, wherein the soft film coating guide wire is characterized by, The coating solution also includes barium sulfate dispersed at the micron or nano level, or zirconium dioxide dispersed at the micron or nano level, or zirconium oxide dispersed at the micron or nano level.

6. The method of claim 1, wherein the soft film coating process is controllable. The coating solution also includes medical-grade nano-silver.

7. The method of claim 1, wherein the soft film coating process is controllable. During the guidewire coating process, the coating solution formulations for the proximal end, middle end, and distal end of the guidewire are different. Diamond powder is added to the coating solution for the proximal end of the guidewire, while medical-grade silicone oil is added to the coating solution for the distal end. The distal end of the guidewire refers to the end that first enters the blood vessel.

8. The method of claim 1, wherein the soft film coating process is controllable. The acoustic wave action head has a circular ring structure.

9. The method of claim 1, wherein the soft film coating process is controllable. The diameter of the guidewire before lamination is 1.0-1.5 mm, and the diameter of the guidewire after lamination is 3.0-3.5 mm.

10. A controllable performance soft film-coated guide wire device, characterized by, It includes an acoustic wave action head, a coating liquid pool, a first moving component, and a second moving component; the guide wire is fixed in the first moving component; the acoustic wave action head is fixed in the second moving component; the coating liquid pool contains coating liquid, the acoustic wave action head is placed in the coating liquid, and the first moving component and / or the second moving component moves according to a preset trajectory, so that the coating liquid solidifies on the outer wall of the guide wire.

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