阅读说明：本技术 医用导丝的制造方法 (Method for manufacturing medical guide wire ) 是由 涂坚慧 于 2021-10-12 设计创作，主要内容包括：本发明公开了一种医用导丝的制造方法,其中,医用导丝的制造方法包括：裁切镍钛芯丝中至少一端；将所述镍钛芯丝的裁切端连接不锈钢芯丝,并形成第一整体；将所述第一整体套入预绕制的弹簧中；所述不锈钢芯丝与所述弹簧直接焊接,并进行整体清洁。(The invention discloses a manufacturing method of a medical guide wire, wherein the manufacturing method of the medical guide wire comprises the following steps: cutting at least one end of the nickel-titanium core wire; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.)

1. A method of manufacturing a medical guidewire, comprising:

cutting at least one end of the nickel-titanium core wire;

connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole;

sleeving the first whole into a pre-wound spring;

the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.

2. The method for manufacturing a medical guide wire according to claim 1, wherein at least one end of the cut nitinol wire comprises:

horizontally placing the nickel-titanium core wire, and cutting at least one end of the nickel-titanium core wire;

flattening the cut end of the nickel-titanium core wire;

the flattened nickel-titanium core wire is butted with the stainless steel core wire.

3. The method of claim 1, wherein said nesting the first monolith into a pre-wound spring comprises:

the spring is correspondingly wound based on a preset diameter;

and sleeving the first whole body, which is connected with the cutting end of the nickel-titanium core wire and the stainless steel core wire, into the pre-wound spring.

4. The method of manufacturing a medical guidewire according to claim 1, wherein the stainless steel core wire is directly welded to the spring and is integrally cleaned, comprising:

horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively;

horizontally butting the stainless steel core wire with the spring;

carrying out laser welding on a butt joint between the stainless steel core wire and the spring, and heating to a molten state;

and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.

5. The method for manufacturing the medical guide wire according to claim 4, wherein the outer diameter of the welding part between the stainless steel core wire and the spring is 0.015-0.017 inches, and the tensile strength is more than or equal to 500 MPa.

6. The method of manufacturing a medical guidewire according to claim 1, wherein the stainless steel core wire is directly welded to the spring and is integrally cleaned, comprising:

horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively;

horizontally butting the stainless steel core wire with the spring;

carrying out high-frequency eddy melting on a butt joint between the stainless steel core wire and the spring, and heating to a molten state;

and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.

7. The method for manufacturing a medical guide wire according to claim 6, wherein the outer diameter of the welded portion between the stainless steel core wire and the spring is 0.013 to 0.016 inches, and the tensile strength is not less than 400 MPa.

8. The method of manufacturing a medical guidewire according to claim 1, wherein the stainless steel core wire is directly welded to the spring and is integrally cleaned, comprising:

horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively;

horizontally aligning the stainless steel core wire with the spring;

controlling the distance between the stainless steel core wire and the spring to be 1-10 mu m;

electrifying the two clamps, and pressurizing the two clamps to 10kV respectively to enable the butt joint between the stainless steel core wire and the spring to be in a molten state;

and filling nitrogen into the joint between the stainless steel core wire and the spring, and cooling and shaping.

9. The method for manufacturing a medical guide wire according to claim 8, wherein the outer diameter of the welded portion between the stainless steel core wire and the spring is 0.014 to 0.016 inches, and the tensile strength is not less than 500 MPa.

10. The method for manufacturing a medical guidewire according to any one of claims 1-9, further comprising:

and spraying hydrophilic coatings on the nickel-titanium core wire, the stainless steel core wire and the spring.

Technical Field

The invention relates to the technical field of medical guide wires, in particular to a medical guide wire and a manufacturing method thereof.

Background

With continuous exploration and pursuit of minimally invasive treatment, more and more self-expandable stents and release systems are applied to treatment of pathological changes in various human body lumens, such as bile ducts, esophagus, neurovascular and the like. Currently, in surgery, the delivery of self-expanding stents is typically accomplished using a delivery guidewire. The medical guide wire is a medical product, has the functions of guiding, positioning or puncturing and the like, and is a special metal wire widely applied in operations.

In the prior art, a main body of the medical guide wire is made of stainless steel, and a Sn ball is used as a solder, so that the stainless steel guide wire has poor wettability after the solder is melted by heat in a welding process, and the situations of insufficient soldering, false soldering and the like are easy to occur, so that the product yield is influenced.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a medical guide wire and a manufacturing method thereof, wherein at least one end of a nickel-titanium core wire is cut; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded and are integrally cleaned, welding auxiliary materials are not adopted, so that insufficient welding and false welding caused by welding auxiliary materials are avoided, the yield of the medical guide wire is improved, the repeatability and stability of manufacturing the medical guide wire are improved, and the quality of manufacturing the medical guide wire is ensured.

In order to solve the technical problem, an embodiment of the present invention provides a method for manufacturing a medical guidewire, including: cutting at least one end of the nickel-titanium core wire; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.

Optionally, at least one end of the cut nitinol wire comprises: horizontally placing the nickel-titanium core wire, and cutting at least one end of the nickel-titanium core wire; flattening the cut end of the nickel-titanium core wire; the flattened nickel-titanium core wire is butted with the stainless steel core wire.

Optionally, the step of sleeving the first whole into the pre-wound spring includes: the spring is correspondingly wound based on a preset diameter; and sleeving the first whole body, which is connected with the cutting end of the nickel-titanium core wire and the stainless steel core wire, into the pre-wound spring.

Optionally, the stainless steel core wire and the spring are directly welded, and the integral cleaning is performed, including: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out laser welding on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.

Optionally, the outer diameter of the welding position between the stainless steel core wire and the spring is 0.015-0.017 inch, and the tensile strength is larger than or equal to 500 MPa.

Optionally, the stainless steel core wire and the spring are directly welded, and the integral cleaning is performed, including: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out high-frequency eddy melting on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.

Optionally, the outer diameter of the welding position between the stainless steel core wire and the spring is 0.013-0.016 inches, and the tensile strength is larger than or equal to 400 MPa.

Optionally, the stainless steel core wire and the spring are directly welded, and the integral cleaning is performed, including: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally aligning the stainless steel core wire with the spring; controlling the distance between the stainless steel core wire and the spring to be 1-10 mu m; electrifying the two clamps, and pressurizing the two clamps to 10kV respectively to enable the butt joint between the stainless steel core wire and the spring to be in a molten state; and filling nitrogen into the joint between the stainless steel core wire and the spring, and cooling and shaping.

Optionally, the outer diameter of the welding position between the stainless steel core wire and the spring is 0.014-0.016 inches, and the tensile strength is more than or equal to 500 MPa.

Optionally, the method further includes: and spraying hydrophilic coatings on the nickel-titanium core wire, the stainless steel core wire and the spring.

In an embodiment of the invention, at least one end of the nitinol wire is cut by the method of an embodiment of the invention; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded and are integrally cleaned, welding auxiliary materials are not adopted, so that insufficient welding and false welding caused by welding auxiliary materials are avoided, the yield of the medical guide wire is improved, the repeatability and stability of manufacturing the medical guide wire are improved, and the quality of manufacturing the medical guide wire is ensured.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

Fig. 1 is a schematic flow chart of a method of manufacturing a medical guidewire in an embodiment of the invention;

fig. 2 is a schematic view of the docking of the medical guide wire according to the present invention;

fig. 3 is a schematic diagram of a docking of a medical guidewire according to an embodiment of the present invention;

fig. 4 is a schematic view of the docking of the medical guide wire according to the second embodiment of the present invention;

fig. 5 is a schematic view of the docking of the medical guide wire according to an embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Examples

As shown in fig. 1 and 2, a method for manufacturing a medical guidewire includes:

s11: cutting at least one end of the nickel-titanium core wire;

in the specific implementation process of the invention, the specific steps can be as follows: horizontally placing the nickel-titanium core wire, and cutting at least one end of the nickel-titanium core wire; flattening the cut end of the nickel-titanium core wire; the flattened nickel-titanium core wire is butted with the stainless steel core wire.

The cutting end of the nickel-titanium core wire is flattened, so that the nickel-titanium core wire is in butt joint with the stainless steel core wire, and the connectivity of the nickel-titanium core wire and the stainless steel core wire is improved.

S12: and connecting the cut end of the nickel-titanium core wire with the stainless steel core wire to form a first whole.

The cutting end of the nickel-titanium core wire and the stainless steel core wire are connected horizontally and form a first whole body, so that the connection of the spring is realized based on the first whole body.

S13: and sleeving the first whole body into the pre-wound spring.

In the specific implementation process of the invention, the specific steps can be as follows: the spring is correspondingly wound based on a preset diameter; and sleeving the first whole body, which is connected with the cutting end of the nickel-titanium core wire and the stainless steel core wire, into the pre-wound spring.

The springs are correspondingly wound based on preset diameters, and various springs with different diameters are formed, so that the springs with different diameters can be connected conveniently.

S14: the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.

The stainless steel core wire and the spring are clamped and fixed through a clamp, the stainless steel core wire and the spring are fixed through the clamp, the stainless steel core wire and the spring are butted, a certain local heating method is adopted, such as high-energy laser melting, high-frequency induction zone melting, high-voltage discharge melting and the like, so that the interface between the stainless steel core wire and the spring is locally melted, heating is stopped after a certain time, and the interface between the stainless steel core wire and the spring is automatically welded. The welding process can realize accurate regulation and control by adjusting the technical parameters of heating, has high production repeatability and stable performance, and can greatly improve the yield of the key process.

The first embodiment is as follows:

in the specific implementation process of the invention, the specific steps can be as follows: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out laser welding on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping. The outer diameter of the welding position between the stainless steel core wire and the spring is 0.015-0.017 inch, and the tensile strength is larger than or equal to 500 MPa.

Referring to fig. 3, a stainless steel core wire with an outer diameter of 0.014 inches was fixed using a jig, a spring with an outer diameter of 0.018 was fixed using a jig, the stainless steel core wire was butted against the spring, the butted portion of the stainless steel core wire and the spring was irradiated with a high-energy laser with a power of 10kW, so that the butted portion of the stainless steel core wire and the spring was in a molten state, the irradiation was stopped after 100ms, and the temperature was rapidly reduced and cooled in a nitrogen atmosphere, and then the butted portion of the stainless steel core wire and the spring was automatically welded. The outer diameter of the joint of the stainless steel core wire and the spring is 0.015-0.017 inch, and the tensile strength is more than or equal to 500 MPa.

The second embodiment is as follows:

in the specific implementation process of the invention, the specific steps can be as follows: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out high-frequency eddy melting on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping. The outer diameter of the welding part between the stainless steel core wire and the spring is 0.013-0.016 inches, and the tensile strength is larger than or equal to 400 MPa.

Referring to fig. 4, the stainless steel core wire with an outer diameter of 0.012 inches is fixed by a clamp, the spring with an outer diameter of 0.016 is fixed by a clamp, the stainless steel core wire and the spring are butted, the butted part of the stainless steel core wire and the spring is heated by a high-frequency eddy current melting device with a power of 1kW, so that the guide wire at the butted part of the stainless steel core wire and the spring is in a molten state, power supply is stopped after 1s, the temperature is rapidly reduced and the guide wire is cooled in a nitrogen atmosphere, and then the interfaces of the two guide wires are automatically welded. The outer diameter of the joint of the stainless steel core wire and the spring is 0.013-0.016 inches, and the tensile strength is larger than or equal to 400 MPa.

The third concrete embodiment:

in the specific implementation process of the invention, the specific steps can be as follows: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally aligning the stainless steel core wire with the spring; controlling the distance between the stainless steel core wire and the spring to be 1-10 mu m; electrifying the two clamps, and pressurizing the two clamps to 10kV respectively to enable the butt joint between the stainless steel core wire and the spring to be in a molten state; and filling nitrogen into the joint between the stainless steel core wire and the spring, and cooling and shaping. The outer diameter of the welding position between the stainless steel core wire and the spring is 0.014-0.016 inches, and the tensile strength is more than or equal to 500 MPa.

Referring to fig. 5, the stainless steel core wire with an outer diameter of 0.014 inches was fixed using a jig, the spring with an outer diameter of 0.016 was fixed using a jig 33, the stainless steel core wire and the spring were aligned, the distance between the stainless steel core wire and the spring was controlled to be 1 to 10 μm, a voltage of 10kV was applied between the two jigs, a current was 50mA, the power was turned off after 100ms, the butt joint of the stainless steel core wire and the spring was in a molten state, the butt joint of the stainless steel core wire and the spring was rapidly cooled down in a nitrogen atmosphere, and then the butt joint of the stainless steel core wire and the spring was automatically welded. The outer diameter of the joint of the stainless steel core wire and the spring is 0.014-0.016 inches, and the tensile strength is more than or equal to 500 MPa.

In addition, the embodiment lists three methods of high-energy laser melting, high-frequency induction zone melting and high-voltage discharge melting for local hot melting of the welding port to realize the welding of the medical guide wire. Other situations which conform to the automatic welding mode of no welding flux and local high-temperature hot melting of the welding port to prepare the medical guide wire are all within the protection scope of the invention.

S15: and spraying hydrophilic coatings on the nickel-titanium core wire, the stainless steel core wire and the spring.

And cleaning and drying the nickel-titanium core wire, the stainless steel core wire and the spring, performing surface treatment on the nickel-titanium core wire, the stainless steel core wire and the spring, coating a hydrophilic coating, and then performing further subsequent processes to finally manufacture a finished product.

In an embodiment of the invention, at least one end of the nitinol wire is cut by the method of an embodiment of the invention; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded and are integrally cleaned, welding auxiliary materials are not adopted, so that insufficient welding and false welding caused by welding auxiliary materials are avoided, the yield of the medical guide wire is improved, the repeatability and stability of manufacturing the medical guide wire are improved, and the quality of manufacturing the medical guide wire is ensured.

The principle and embodiments of the present invention should be explained by using specific examples, and the above descriptions of the examples are only used to help understanding the method and the core idea of the present invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present invention.