Guide wire production method and guide wire

Abstract

The invention discloses a guide wire production method and a guide wire, and the guide wire production method comprises the steps: carrying out the surface processing of a nickel-titanium hypotube, and obtaining a first-form hypotube; performing heat treatment processing on the first-form hypotube to obtain a second-form hypotube; performing oxide layer cleaning on the second-form hypotube to obtain a third-form hypotube; the third-form hypotube, a core wire and a developing spring form a guide wire, and then a hydrophilic coating is formed on the outer surface of the third-form hypotube, so that the adhesion performance of the hydrophilic coating on the outer side of the nickel-titanium hypotube can be effectively improved, the phenomenon that the hydrophilic coating is easy to fall off during use is greatly reduced, and the service life of the nickel-titanium hypotube is prolonged. In addition, the elasticity and flexibility of the guide wire in use are improved, and the overall use performance is improved.

Description

Technical Field

[0001] The present invention relates to a surgical instrument, in particular to a guide wire production method and a guide wire. Background Art

[0002] The hydrophilic coating on the guidewire's surface plays multiple roles in interventional procedures. First, it becomes exceptionally smooth upon contact with water, forming a low-friction surface. This significantly reduces friction during guidewire passage through blood vessels, making it easier for the device to pass through narrow vascular lesions and reducing the risk of puncture and frictional damage. This not only improves the success rate of the procedure but also alleviates pain for the patient.

[0003] Current guidewires are typically made of stainless steel. While it's relatively easy to create a hydrophilic coating on the surface of stainless steel guidewires, stainless steel guidewires have low elasticity and flexibility. To improve the functionality of guidewires, some use nickel-titanium alloys for the hypotubes that connect their tips. This improves the overall elasticity and flexibility of the guidewires, but when the hydrophilic coating is formed on the hypotube's outer surface, the coating adheres poorly and easily falls off during use, reducing the safety of the guidewire. Therefore, a guidewire with a stable hydrophilic coating on the nickel-titanium hypotube is urgently needed. Summary of the Invention

[0004] The purpose of the present invention is to provide a guidewire production method and a guidewire to solve one or more technical problems existing in the prior art and at least provide a beneficial option or create conditions.

[0005] The solution of the present invention to solve its technical problems is:

[0006] A guide wire production method comprising:

[0007] Performing surface processing on the nickel-titanium hypotube to obtain a hypotube of a first form;

[0008] performing heat treatment on the first-form hypotube to obtain a second-form hypotube;

[0009] cleaning the oxide layer of the second-form hypotube to obtain a third-form hypotube;

[0010] The third-form sea wave tube is combined with a core wire and a developing spring to form a guide wire, and then a hydrophilic coating is formed on the surface of the third-form sea wave tube.

[0011] This technical solution has at least the following beneficial effects: the surface of the nickel-titanium sea wave tube is processed to obtain a suitable outer diameter size and improve the hardness of the nickel-titanium sea wave tube, at this time a first-form sea wave tube is obtained, and then the first-form sea wave tube is heat-treated, at this time the softness of the first-form sea wave tube can be improved, and its performance can be further enhanced. In this process, an oxide layer will be generated on the surface of the first-form sea wave tube, and it is difficult for the oxide layer to form a strong bond with the hydrophilic coating, making it difficult for the hydrophilic coating to adhere. At this time, the oxide layer on the surface of the second-form sea wave tube is cleaned to obtain a third-form sea wave tube with a clean surface, and the developing spring is sleeved and fixed on the end of the core wire, and then the third-form sea wave tube is sleeved and fixed on the outside of the developing spring to form a guide wire. At this time, a hydrophilic coating is formed on the surface of the third-form sea wave tube in the guide wire, which can make the hydrophilic coating firmly adhere to the surface of the third-form sea wave tube, thereby effectively improving the adhesion performance of the hydrophilic coating on the outside of the nickel-titanium sea wave tube, greatly reducing the phenomenon of the hydrophilic coating easily falling off during use, and improving the elasticity and flexibility of the guide wire during use, thereby improving the overall performance.

[0012] As a further improvement of the above technical solution, the cleaning of the oxide layer of the second-type hypotube includes:

[0013] The second-form hypotube is subjected to ultrasonic alkali treatment, sandblasting polishing, high-pressure water washing, plasma activation, ultrasonic cleaning and heating drying.

[0014] As a further improvement of the above technical solution, the ultrasonic alkali treatment of the second-form hypotube includes:

[0015] The second-form hypotube is placed in an ultrasonic cleaning bath containing alkaline solution for cleaning at a frequency of 33 Hz and a temperature range of 60°C to 80°C for 10 to 15 minutes;

[0016] The second-form hypotube is placed in an ultrasonic cleaning bath filled with deionized water for cleaning at a frequency of 33 Hz and a temperature not higher than 60 degrees Celsius for 15 to 20 minutes.

[0017] As a further improvement of the above technical solution, the sandblasting and polishing of the second-form hypotube includes:

[0018] The second-form hypotube is sandblasted using 2000-mesh aluminum oxide at a distance of 50 to 150 mm, the sandblasting time lasting 15 to 20 seconds, and the sandblasting pressure being 0.2 MPa to 0.7 MPa.

[0019] As a further improvement of the above technical solution, the plasma activation of the second-form hypotube includes:

[0020] The second-type hypotube was plasma activated using oxygen gas at a pressure of 0.4 MPa and a charge / discharge power of 100 W for 5 minutes.

[0021] As a further improvement of the above technical solution, the heating and drying of the second-form hypotube includes:

[0022] The second-form hypotube was dried at a temperature range of 45 degrees Celsius to 55 degrees Celsius for 6 hours.

[0023] As a further improvement of the above technical solution, the surface processing of the nickel-titanium hypotube includes:

[0024] Grinding the outer diameter of the nickel-titanium hypotube by a centerless grinder so that the outer diameter of the nickel-titanium hypotube reaches a preset size;

[0025] The nickel-titanium hypotube is subjected to femtosecond laser cutting to form grooves on the surface of the nickel-titanium hypotube.

[0026] As a further improvement of the above technical solution, the heat treatment of the first-shaped hypotube includes:

[0027] Heating the first-form hypotube at 480 degrees Celsius for 15 to 20 minutes under vacuum, or heating the first-form hypotube at 500 degrees Celsius for 10 minutes under vacuum;

[0028] The first-type hypotube is cooled by water.

[0029] As a further improvement of the above technical solution, forming a hydrophilic coating on the surface of the third-form hypotube includes:

[0030] The surface of the third-form hypotube is coated with a silane-based hydrophilic coating, and then coated with a polyvinyl pyrrolidone hydrophilic coating.

[0031] A guide wire is produced by applying the above guide wire production method.

[0032] This technical solution has at least the following beneficial effects: since the guidewire has a nickel-titanium hypotube, and a hydrophilic coating is formed on the surface of the nickel-titanium hypotube using the above-mentioned guidewire production method, the adhesion performance of the hydrophilic coating on the outside of the nickel-titanium hypotube can be effectively improved, which greatly reduces the phenomenon that the hydrophilic coating is easy to fall off during use, and improves the elasticity and flexibility of the guidewire during use, thereby improving the overall performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] To more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly describes the drawings required for describing the embodiments. Obviously, the drawings described only illustrate some embodiments of the present invention, not all of them. Those skilled in the art can derive other design solutions and drawings based on these drawings without inventive effort.

[0034] Figure 1 The present invention is a flow chart of the nickel-titanium hypotube production method.

[0035] Figure 2 This is a flow chart of the present invention for cleaning the oxide layer of the second-type hypotube. DETAILED DESCRIPTION

[0036] The following describes embodiments of the present invention in detail. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0037] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present invention.

[0038] In the description of the present invention, "several" means one or more, "many" means more than two, "greater than," "less than," and "exceed" are understood to exclude the number itself, while "above," "below," and "within" are understood to include the number itself. The use of "first" and "second" in the description is solely for the purpose of distinguishing technical features and should not be construed as indicating or implying relative importance, implicitly specifying the number of the indicated technical features, or implicitly specifying the order of the indicated technical features.

[0039] In the description of the present invention, unless otherwise clearly defined, terms such as setting, installing, and connecting should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in the present invention based on the specific content of the technical solution.

[0040] Reference Figure 1 , a guidewire production method, including but not limited to the following steps:

[0041] Step S100: performing surface processing on the nickel-titanium hypotube to obtain a hypotube of a first form. During the surface processing of the nickel-titanium hypotube, the nickel-titanium hypotube may be physically modified to improve the performance of the nickel-titanium hypotube.

[0042] Step S200: heat-treating the first-shaped hypotube to obtain a second-shaped hypotube. During the heat-treating process, the first-shaped hypotube may be subjected to heat drawing or other operations to improve the straightness and softness of the first-shaped hypotube.

[0043] Step S300 involves cleaning the oxide layer on the second-form hypotube to obtain a third-form hypotube. While heat treatment is used to improve the performance of the first-form hypotube, oxides form on its surface during this process. Multiple tests have shown that these oxides hinder the formation of a strong bond with the hydrophilic polymer coating. Therefore, in this step, the oxide layer formed on the surface of the second-form hypotube is cleaned.

[0044] In step S400, the third-type hypotube is assembled with a core wire and a developing spring to form a guidewire, and a hydrophilic coating is then applied to the surface of the third-type hypotube. After the third-type hypotube, core wire, and developing spring are assembled to form the guidewire, the surface of the third-type hypotube is coated to prevent the hydrophilic coating applied directly to the third-type hypotube from interfering with the overall assembly.

[0045] From the above, it can be seen that the surface of the nickel-titanium sea wave tube is processed to obtain a suitable outer diameter size and improve the hardness of the nickel-titanium sea wave tube. At this time, a first-form sea wave tube is obtained, and then the first-form sea wave tube is heat-treated. At this time, the softness of the first-form sea wave tube can be improved, and its performance can be further enhanced. In this process, an oxide layer will be generated on the surface of the first-form sea wave tube. It is difficult for the oxide layer to form a strong bond with the hydrophilic coating, making it difficult for the hydrophilic coating to adhere. At this time, the oxide layer on the surface of the second-form sea wave tube is cleaned to obtain a third-form sea wave tube with a clean surface. The developing spring is sleeved and fixed on the end of the core wire, and then the third-form sea wave tube is sleeved and fixed on the outside of the developing spring to form a guide wire. At this time, a hydrophilic coating is formed on the surface of the third-form sea wave tube in the guide wire, which can make the hydrophilic coating firmly adhere to the surface of the third-form sea wave tube. This can effectively improve the adhesion performance of the hydrophilic coating on the outside of the nickel-titanium sea wave tube, greatly reducing the phenomenon that the hydrophilic coating is easy to fall off during use, and improving the elasticity and flexibility of the guide wire during use, thereby improving the overall performance.

[0046] In step S300, the oxide layer of the second-type hypotube is cleaned, including but not limited to the following steps:

[0047] Step S310 , performing ultrasonic alkali treatment on the second-type hypotube.

[0048] Step S320: sandblasting and polishing the second-type hypotube.

[0049] Step S330: flushing the second-type hypotube with high-pressure water.

[0050] Step S340 , performing plasma activation on the second-type hypotube.

[0051] Step S350: ultrasonically clean the second-type hypotube.

[0052] Step S360: heating and drying the second-form hypotube.

[0053] In step S300, the oxide layer on the surface of the second-form hypotube is preliminarily removed by alkali washing the second-form hypotube, and then the oxide layer on the surface of the second-form hypotube is further removed by sandblasting and polishing. At this time, the surface roughness of the second-form hypotube is changed, thereby improving the adhesion of the hydrophilic coating to the surface of the second-form hypotube in physical form. Then, the surface of the second-form hypotube is plasma activated to enhance the adhesion effect of the hydrophilic coating, thereby improving the adhesion of the hydrophilic coating to the surface of the second-form hypotube in chemical form, and greatly improving the problem of the hydrophilic coating easily falling off after coating.

[0054] In step S310, the second-form hypotube is subjected to ultrasonic alkali treatment, including but not limited to the following steps:

[0055] In step S311, the second-form hypotube is cleaned in an ultrasonic cleaning bath containing alkaline solution at a frequency of 33 Hz and a temperature range of 60°C to 80°C for 10 to 15 minutes. Sodium hydroxide is mixed with water at a ratio of 1:10 and added to the ultrasonic cleaning bath to change the roughness of the second-form hypotube and remove the oxide layer on the nickel-titanium hypotube.

[0056] In step S312, the second-form hypotube is placed in an ultrasonic cleaning bath filled with deionized water for cleaning at a frequency of 33 Hz and a temperature not exceeding 60 degrees Celsius for 15 to 20 minutes. Deionized water is used to clean the alkaline-treated second-form hypotube to prevent the alkaline liquid from accumulating on the surface of the second-form hypotube and forming yellow spots.

[0057] Since a yellow or blue oxide layer is generated on the surface of the first-form hypotube in step S200, in order to further remove it, step S320 can be performed to sandblast the second-form hypotube, including: using 2000-mesh aluminum oxide to sandblast the second-form hypotube at a distance of 50 to 150 mm, the sandblasting time lasting 15 to 20 seconds, and the sandblasting pressure being 0.2 MPa to 0.7 MPa.

[0058] In this step S320, aluminum oxide is used for sandblasting and polishing to remove the oxide layer and reduce the roughness of the surface of the hypotube. When sandblasting, the sandblasting mesh number can be adjusted to improve the sandblasting effect. When the sandblasting mesh number is too small, the surface of the hypotube will be too smooth, resulting in poor adhesion of the hydrophilic coating. When the mesh number is too large, the hydrophilic coating will become uneven and agglomerated. Therefore, adjusting the mesh number of aluminum oxide to 2000 can make the surface of the hypotube better bonded with the hydrophilic coating.

[0059] In step S330, the second-form hypotube is flushed with high-pressure water, including: fixing the two ends of the second-form hypotube on the tooling respectively, using a nozzle with a water outlet diameter of 3 mm, and flushing the second-form hypotube with a water pressure of 2 MPa to 3.5 MPa, the water temperature is 60 degrees Celsius, the working distance from the nozzle to the second-form hypotube is between 10 mm and 18 mm, the nozzle moves from one end to the other end along the second-form hypotube, and the moving speed is 1 mm per second. After completing one cleaning, the second-form hypotube is rotated 180° and cleaned again.

[0060] By flushing the second-form hypotube, sandblasting particles can be removed and laser cutting residues can be removed again.

[0061] In step S340 , plasma activation is performed on the second-type hypotube, including: maintaining a pressure of 0.4 MPa using oxygen and performing plasma activation on the second-type hypotube at a charge and discharge power of 100 W for 5 minutes.

[0062] During the plasma activation process of the second-form hypotube, hydrophobic groups, such as hydroxyl or carboxyl groups, can be introduced onto the metal surface. These hydrophobic groups have adsorbed hydrophilic properties, enhancing the bonding reaction with the subsequent hydrophilic coating.

[0063] In step S350, the second-type hypotube undergoes ultrasonic cleaning. This is the second ultrasonic cleaning of the second-type hypotube. Similarly, the second-type hypotube is placed in an ultrasonic cleaning bath filled with deionized water at a frequency of 33 Hz and a temperature no higher than 60 degrees Celsius for 15 to 20 minutes. This ultrasonic cleaning is primarily used to ensure that no residue remains from the previous process.

[0064] In step S360, the second-form hypotube is heated and dried, including drying the second-form hypotube at a temperature between 45°C and 55°C for 6 hours. Drying the second-form hypotube for a long time within this temperature range ensures that the surface of the second-form hypotube is dry while preventing the re-generation of an oxide layer on the surface of the second-form hypotube due to the high temperature, thereby ensuring the quality of the oxide layer cleaning of the second-form hypotube.

[0065] In step S100, the nickel-titanium hypotube is subjected to surface processing, including but not limited to the following steps:

[0066] Step S110: Grinding the outer diameter of the nickel-titanium hypotube with a centerless grinder to achieve a predetermined outer diameter. Grinding the outer diameter of the nickel-titanium hypotube with a centerless grinder to achieve a smooth surface and a desired size.

[0067] In step S120, the nickel-titanium hypotube is subjected to femtosecond laser cutting, forming grooves on its surface. Femtosecond laser cutting is a material removal process. By cutting grooves on the nickel-titanium hypotube surface, the overall hardness of the nickel-titanium hypotube can be changed. For example, the more grooves cut into the nickel-titanium hypotube, the softer it is, and vice versa. In addition, the cutting spacing can be controlled to produce asymmetric hardness and softness of the nickel-titanium hypotube.

[0068] In step S200, the first-type hypotube is subjected to heat treatment, including but not limited to the following steps:

[0069] Step S210: heating the first-type hypotube at 480 degrees Celsius for 15 to 20 minutes under a vacuum state, or heating the first-type hypotube at 500 degrees Celsius for 10 minutes under a vacuum state.

[0070] Step S220: Cooling the first-type hypotube with water.

[0071] By heat treating the first-form hypotube, the softness of the first-form hypotube can be further improved and the fatigue resistance of the first-form hypotube can be increased. In addition, by controlling the heating temperature range and time range under these two conditions, the first-form hypotube can be heated evenly, which can better offset the stress caused by uneven heating in the previous process.

[0072] In step S400, a hydrophilic coating is formed on the surface of the third-form hypotube, including applying a silane-based hydrophilic coating to the surface of the third-form hypotube, followed by applying a polyvinyl pyrrolidone hydrophilic coating. The silane-based hydrophilic coating forms a base coat on the outside of the third-form hypotube, while the polyvinyl pyrrolidone forms a top coat. The silane-based hydrophilic coating forms a covalent bond with the outer surface of the third-form hypotube and chemically bonds with the outer polyvinyl pyrrolidone hydrophilic coating, enhancing adhesion strength. In practical applications, polyacrylamide, polyethylene glycol, or polyvinyl alcohol can also be used as the hydrophilic coating to form the top coat of the third-form hypotube.

[0073] After completing step S400, the guide wire also needs to be inspected for size, appearance, coating friction and anti-falling ability to ensure the production quality of the guide wire.

[0074] A guide wire is produced by applying the above guide wire production method.

[0075] In this guidewire, since it has a nickel-titanium hypotube and a hydrophilic coating is formed on the surface of the nickel-titanium hypotube using the above-mentioned guidewire production method, the adhesion performance of the hydrophilic coating on the outside of the nickel-titanium hypotube can be effectively improved, which greatly reduces the phenomenon of the hydrophilic coating easily falling off during use, and improves the elasticity and flexibility of the guidewire during use, thereby improving the overall performance.

[0076] The above specifically describes the preferred embodiments of the present invention, but the invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A guide wire production method, characterized in that: include: Performing surface processing on the nickel-titanium hypotube to obtain a hypotube of a first form; performing heat treatment on the first-form hypotube to obtain a second-form hypotube; cleaning the oxide layer of the second-form hypotube to obtain a third-form hypotube; The third-form sea wave tube is combined with a core wire and a developing spring to form a guide wire, and then a hydrophilic coating is formed on the surface of the third-form sea wave tube.

2. A guide wire production method according to claim 1, characterized in that: The step of cleaning the oxide layer of the second-type hypotube includes: The second-form hypotube is subjected to ultrasonic alkali treatment, sandblasting polishing, high-pressure water washing, plasma activation, ultrasonic cleaning and heating drying.

3. A guide wire production method according to claim 2, characterized in that: The ultrasonic alkali treatment of the second-form hypotube comprises: The second-form hypotube is placed in an ultrasonic cleaning bath containing alkaline solution for cleaning at a frequency of 33 Hz and a temperature range of 60°C to 80°C for 10 to 15 minutes; The second-form hypotube is placed in an ultrasonic cleaning bath filled with deionized water for cleaning at a frequency of 33 Hz and a temperature not higher than 60 degrees Celsius for 15 to 20 minutes.

4. A guide wire production method according to claim 2, characterized in that: The sandblasting and polishing of the second-form hypotube comprises: The second-form hypotube is sandblasted using 2000-mesh aluminum oxide at a distance of 50 to 150 mm, the sandblasting time lasting 15 to 20 seconds, and the sandblasting pressure being 0.2 MPa to 0.7 MPa.

5. A guide wire production method according to claim 2, characterized in that: The plasma activation of the second-form hypotube includes: The second-type hypotube was plasma activated using oxygen gas at a pressure of 0.4 MPa and a charge / discharge power of 100 W for 5 minutes.

6. A guide wire production method according to claim 2, characterized in that: The heating and drying of the second-form hypotube includes: The second-form hypotube was dried at a temperature range of 45 degrees Celsius to 55 degrees Celsius for 6 hours.

7. A guide wire production method according to claim 1, characterized in that: The surface processing of the nickel-titanium hypotube comprises: Grinding the outer diameter of the nickel-titanium hypotube by a centerless grinder so that the outer diameter of the nickel-titanium hypotube reaches a preset size; The nickel-titanium hypotube is subjected to femtosecond laser cutting to form grooves on the surface of the nickel-titanium hypotube.

8. A guide wire production method according to claim 1, characterized in that: The heat treatment of the first-shaped hypotube includes: Heating the first-form hypotube at 480 degrees Celsius for 15 to 20 minutes under vacuum, or heating the first-form hypotube at 500 degrees Celsius for 10 minutes under vacuum; The first-type hypotube is cooled by water.

9. A guide wire production method according to claim 1, characterized in that: The step of forming a hydrophilic coating on the surface of the third-form hypotube comprises: The surface of the third-form hypotube is coated with a silane-based hydrophilic coating, and then coated with a polyvinyl pyrrolidone hydrophilic coating.

10. A guide wire, characterized in that: The guidewire is produced by the guidewire production method according to any one of claims 1 to 9.

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