CN110339460B - Manufacturing method of loach guide wire - Google Patents

Abstract

The invention discloses a manufacturing method of a loach guide wire, which comprises the following steps: providing a section of nickel-titanium alloy core wire made of nickel-titanium alloy, and inserting one end of the nickel-titanium alloy core wire into an extrusion die, wherein the nickel-titanium alloy core wire comprises a plurality of continuous core wire monomers, and each core wire monomer is in a structure which is gradually thinned from two ends to the middle part; extruding the molten polyurethane through an extruder, and feeding the molten polyurethane into an extrusion die, so that the molten polyurethane is coated on the outer surface of the nickel-titanium alloy core wire; moving the nickel-titanium alloy core wire coated with the polyurethane in a molten state forward, extruding and molding through an extrusion die, and cooling and shaping to obtain a coated core wire; cutting the coated core wire by taking the middle point of each section of the core wire monomer and the connection point of two adjacent sections of the core wire monomers as cutting points to obtain a plurality of sections of loach guide wire bodies; and processing two ends of the loach guide wire body into tips, and coating a coating on the surface of the loach guide wire body after the tips are processed to obtain the loach guide wire.

Description

Manufacturing method of loach guide wire

Technical Field

The invention relates to the technical field of medical instruments, in particular to a manufacturing method of a loach guide wire.

Background

Interventional therapy is a minimally invasive therapy carried out by modern high-tech means, namely, under the guidance of medical imaging equipment, special precise instruments such as catheters, guide wires and the like are introduced into a human body to diagnose and locally treat internal diseases. The loach guide wire is one of the most commonly used precision interventional guide wires, the loach guide wire is internally provided with a medical-grade nickel-titanium alloy core wire which has good twisting control performance and X-ray detectability, and the polyurethane coating tube is used for coating the nickel-titanium alloy core wire and the outermost layer is coated with a medical-grade ultra-smooth coating solution, so that the loach guide wire has excellent smoothness and can be deeply inserted into any pathological change part.

In the loach guide wire forming process, the step of coating the nickel-titanium alloy core wire by the polyurethane coating tube is the most critical, if the coating is not tight enough, the polyurethane coating tube can loosen and cannot be attached to the nickel-titanium alloy core wire, and the risk that the nickel-titanium alloy core wire penetrates through the polyurethane coating tube and is exposed exists.

Disclosure of Invention

The invention aims to provide a manufacturing method of a loach guide wire, which can enable polyurethane to be well coated on the surface of a nickel-titanium alloy core wire and not to loosen.

In order to achieve the purpose, the invention adopts the following technical scheme:

a manufacturing method of a loach guide wire comprises the following steps:

providing a section of nickel-titanium alloy core wire made of nickel-titanium alloy, and inserting one end of the nickel-titanium alloy core wire into an extrusion die, wherein the nickel-titanium alloy core wire comprises a plurality of continuous core wire monomers, and each core wire monomer is in a structure which is gradually thinned from two ends to the middle part;

extruding polyurethane in a molten state through an extruder, and feeding the polyurethane into the extrusion die, so that the polyurethane in the molten state is coated on the outer surface of the nickel-titanium alloy core wire;

moving the nickel-titanium alloy core wire coated with the polyurethane in the molten state forward, extruding and molding through the extrusion die, and cooling and shaping to obtain a coated core wire;

cutting the coated core wire by taking the middle point of each section of the core wire monomer and the connection point of two adjacent sections of the core wire monomers as cutting points to obtain a multi-section loach guide wire body;

and processing two ends of the loach guide wire body into tip ends, and coating a coating on the surface of the loach guide wire body after the tip ends are processed to obtain the loach guide wire.

In one embodiment, the extrusion die is provided with a first channel for the nickel-titanium alloy core wire to penetrate through and a second channel for the molten polyurethane to flow through, and the second channel is communicated with the first channel.

In one embodiment, the second channel is connected with the first channel to form a T-shaped channel, and the molten polyurethane is coated on the outer surface of the nickel-titanium alloy core wire in a T-shaped co-extrusion mode.

In one embodiment, the processing the two ends of the loach guide wire body into tips comprises: and processing the two ends of the loach guide wire body into tips by adopting a high-frequency tip forming machine.

In one embodiment, the providing a length of nitinol core wire includes: and grinding the nickel-titanium alloy section by using grinding equipment to obtain the nickel-titanium alloy core wire.

In one embodiment, the cooling and setting includes: cooling and shaping in water.

In one embodiment, the coating is a hydrophilic coating, and the coating is applied to the surface by spraying or painting.

In one embodiment, the maximum outer diameter of the core wire monomer is 0.3 mm, and the minimum outer diameter of the core wire monomer is 0.11 mm; or,

the maximum outer diameter of the core wire monomer is 0.47mm, and the minimum outer diameter of the core wire monomer is 0.18 mm; or,

the maximum outer diameter of the core wire monomer is 0.60mm, and the minimum outer diameter of the core wire monomer is 0.23 mm.

In one embodiment, the core wire monomer comprises two first sections, two conical sections and a second section, the diameter of the first section is equal to the maximum diameter of the conical sections, the minimum diameter of the conical sections is equal to the diameter of the second section, and the two first sections are respectively connected with the second section through the two conical sections.

In one embodiment, each of the first segments has a length of 1360 + 2 mm and an outer diameter of 0.47 + 0.02 mm; the length of the second section is 50 +/-2 mm, and the outer diameter of the second section is 0.18 +/-0.02 mm; the length of each conical gradual transition section is 150 +/-2 mm, the maximum outer diameter is 0.47 +/-0.02 mm, and the minimum outer diameter is 0.18 +/-0.02 mm.

The manufacturing method of the loach guide wire disclosed by the invention at least has the following beneficial effects: the molten polyurethane is fed into an extrusion die through an extruder to be contacted with the nickel-titanium alloy core wire and extruded and molded together, the molten polyurethane can be firmly coated and attached to the outer surface of the nickel-titanium alloy core wire and cannot be loosened, and therefore the risk that the nickel-titanium alloy core wire is exposed after penetrating through a polyurethane coating pipe is avoided; meanwhile, the nickel-titanium alloy core wire is composed of continuous multiple sections of core wire monomers, each section of core wire monomer is of a structure which is gradually thinned from two ends to the middle, the middle point of each section of core wire monomer and the connection point of two adjacent sections of core wire monomers are used as cutting points to cut the coated core wire, and therefore the loach guide wire body with the same multiple sections of structures can be obtained.

Drawings

Fig. 1 is a flow chart of a manufacturing method of a loach guide wire according to an embodiment of the invention;

FIG. 2 is a schematic structural diagram of a nitinol core wire according to an embodiment of the present invention;

fig. 3 is a schematic structural diagram of a loach guide wire body with two ends processed into tips according to an embodiment of the invention;

the reference numbers illustrate: the nickel-titanium alloy core wire comprises a nickel-titaniumalloy core wire 100, a core wire monomer A, afirst section 101, atapered transition section 102, asecond section 103 andpolyurethane 200.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Referring to fig. 1, a method for manufacturing a loach guide wire according to an embodiment includes the steps of:

s100, providing a section of nickel-titaniumalloy core wire 100 made of nickel-titanium alloy, and enabling one end of the nickel-titaniumalloy core wire 100 to penetrate into an extrusion die, wherein the nickel-titaniumalloy core wire 100 comprises a plurality of continuous core wire monomers A, and each core wire monomer A is in a structure which is gradually thinned from two ends to the middle.

Specifically, in step S100, providing anitinol core wire 100 made of nitinol includes: and grinding the nickel-titanium alloy section by using grinding equipment to obtain the nickel-titaniumalloy core wire 100. Namely, the nickel-titanium alloy section is integrally and continuously ground into a plurality of sections of core wire monomers A which are connected in sequence, and each section of core wire monomer A is in a structure which is gradually thinned from two ends to the middle part, so that the nickel-titaniumalloy core wire 100 is obtained.

Optionally, the maximum outer diameter of the core wire monomer a is 0.3 mm, and the minimum outer diameter of the core wire monomer a is 0.11 mm. Or the maximum outer diameter of the core wire monomer A is 0.47mm, and the minimum outer diameter of the core wire monomer A is 0.18 mm. Or the maximum outer diameter of the core wire monomer A is 0.60mm, and the minimum outer diameter of the core wire monomer A is 0.23 mm. The invention does not limit the loach guide wire too much, and the size of the loach guide wire can be adjusted according to the situation when the loach guide wire is manufactured.

As shown in fig. 2, in the present embodiment, the core wire monomer a includes twofirst segments 101, twotapered transition sections 102 and onesecond segment 103, the outer diameter of thefirst segment 101 is equal to the maximum outer diameter of thetapered transition section 102, the minimum outer diameter of thetapered transition section 102 is equal to the outer diameter of thesecond segment 103, and the twofirst segments 101 are respectively connected to thesecond segment 103 through the twotapered transition sections 102, that is, one of thefirst segments 101 is connected to one end of thesecond segment 103 through onetapered transition section 102, and the other of thefirst segments 101 is connected to the other end of thesecond segment 103 through the othertapered transition section 102. It should be noted that fig. 2 only schematically illustrates a portion of the continuous structure ofnitinol core wire 100, due to the limited space available on the drawing.

Optionally, the length L1 of eachfirst section 101 is 1360 ± 2 mm, and the outer diameter is 0.47 ± 0.02 mm; the length L3 of thesecond section 103 is 50 ± 2 mm, and the outer diameter is 0.18 ± 0.02 mm; the length L2 of eachtapered transition section 102 is 150 ± 2 mm, the maximum outer diameter is 0.47 ± 0.02 mm, and the minimum outer diameter is 0.18 ± 0.02 mm, and the dimensions may be specifically adjusted according to circumstances, wherein the length tolerance is 2 mm and the outer diameter tolerance is 0.02 mm.

Of course, the core wire monomer a may have other structures as long as the core wire monomer a is designed to be tapered from both ends to the middle.

And S200, extruding themolten polyurethane 200 through an extruder, and feeding themolten polyurethane 200 into an extrusion die, so that themolten polyurethane 200 is coated on the outer surface of the nickel-titaniumalloy core wire 100. Wherein, the extruder can be a single screw extruder.

S300, moving the nickel-titaniumalloy core wire 100 coated with thepolyurethane 200 in the molten state forward, extruding and molding through an extrusion die, and cooling and shaping to obtain the coated core wire.

Alternatively, the nickel-titaniumalloy core wire 100 coated with thepolyurethane 200 and extruded by an extrusion die may be cooled and shaped by a water cooling method. The water temperature when the water cooling method is adopted for cooling and shaping is generally about 10 ℃, and the selectable temperature range is 8-15 ℃.

Specifically, the extrusion die is provided with a first channel for the nickel-titaniumalloy core wire 100 to penetrate through and a second channel for thepolyurethane 200 in the molten state to circulate, the second channel is communicated with the first channel, and during specific manufacturing, thepolyurethane 200 in the molten state extruded by the extruder flows into the first channel from the second channel, contacts with the nickel-titaniumalloy core wire 100 penetrating through the first channel and is tightly wrapped on the outer surface of the nickel-titaniumalloy core wire 100.

Further, a second channel of the extrusion die is connected with the first channel to form a T-shaped channel, and themolten polyurethane 200 is coated on the outer surface of the nickel-titaniumalloy core wire 100 in a T-shaped co-extrusion mode, that is, themolten polyurethane 200 is continuously extruded into the first channel from the second channel while the nickel-titaniumalloy core wire 100 is driven to move forwards, so that themolten polyurethane 200 is coated on the outer surface of the whole section of the nickel-titaniumalloy core wire 100, and the coating effect is better and the production is more efficient by the operation.

S400, cutting the coated core wire by taking the middle point of each section of the core wire monomer A and the connection point of two adjacent sections of the core wire monomers A as cutting points to obtain a multi-section loach guide wire body. In particular, the coated core wire may be cut using a knife, although other means of cutting may be used.

S500, processing two ends of the loach guide wire body into tips, and coating a coating on the surface of the loach guide wire body (shown in figure 3) with the tips processed to obtain the loach guide wire.

Specifically, in step S500, the method of processing the two ends of the loach guide wire body into tips includes: and processing the two ends of the loach guide wire body into tips by adopting a high-frequency tip forming machine. Namely, the two ends of the loach guide wire body are processed into the hemispherical structures, so that the loach guide wire can enter a human body more smoothly, and the pain of the loach guide wire to the human body is relieved. The specific operation of the tip treatment is as follows: the loach guide wire body is placed in a tip die of a high-frequency tip forming machine, the end parts of two ends of the loach guide wire body are softened by high-frequency heating, the end part of the softened loach guide wire body forms a hemisphere required by a tip in the tip die and is sealed, and then the loach guide wire body is shaped by water cooling to finish tip treatment.

Optionally, the coating in step S500 is a hydrophilic coating, such as a polyacrylamide layer, and the coating may be applied to the surface of the loach guide wire body by a spraying method or a painting method. Of course, other coating methods can be adopted as long as the coating can be coated on the surface of the loach guide wire body.

The method for manufacturing the loach guide wire of the present invention is described in more detail in a preferred embodiment below:

the method comprises the following steps: providing a continuous length ofnitinol core wire 100, wherein thenitinol core wire 100 has the following characteristics: since extrusion is a continuous, efficient process,nitinol core wire 100 must be continuous and uninterrupted; the nickel-titaniumalloy core wire 100 in the loach guide wire is tapered from the tail end to the head end (namely, the end which enters the human body first during the operation) so as to ensure that the head end is soft enough to relieve the pain of a patient during the operation, so the provided nickel-titaniumalloy core wire 100 can be in a shape shown in figure 2, namely, a continuous shape which is formed by sequentially connecting core wire monomers A in a cycle way as shown in figure 2 is provided, and each section of the core wire monomers A is in a structure which is tapered from two ends to the middle part;

step two: the provided nickel-titaniumalloy core wire 100 is inserted into an extrusion die, one end of the nickel-titaniumalloy core wire 100 is connected to a tractor after penetrating through the extrusion die, and a water tank filled with water is arranged between the tractor and the extrusion die;

step three: extruding thepolyurethane 200 in a molten state into an extrusion die through a single screw extruder, so that thepolyurethane 200 in the molten state is coated on the nickel-titaniumalloy core wire 100;

step four: the method comprises the following steps of (1) dragging the nickel-titaniumalloy core wire 100 to move through a tractor, extruding and molding the nickel-titaniumalloy core wire 100 and thepolyurethane 200 coated on the nickel-titanium alloy core wire in a molten state through an extrusion mold, and then cooling and shaping the nickel-titanium alloy core wire and the polyurethane in a molten state in a water tank to obtain a coated core wire;

step five: referring to a nickel-titaniumalloy core wire 100 shown in fig. 2, cutting the coated core wire, wherein the cutting points are located at the middle point of each section of the core wire monomer A and the connection point of two adjacent sections of the core wire monomers A, and obtaining a loach guide wire body (a loach guide wire semi-finished product) after cutting;

step six: processing the two ends of the loach guide wire body into tips, coating a coating on the outer surface of the loach guide wire body after the tips are processed as shown in fig. 3 to obtain the loach guide wire, and packaging and sterilizing the loach guide wire to obtain the product.

In conclusion, the manufacturing method of the loach guide wire disclosed by the invention at least has the following advantages:

when the loach guide wire is manufactured in the prior art, a coating tube is usually manufactured, then the nickel-titaniumalloy core wire 100 is manually threaded into the coating tube, and the coating tube is made to pass through a die at a set temperature and a set tensile force, so that the coating tube is tightly attached to the nickel-titaniumalloy core wire 100, but because one section of the nickel-titaniumalloy core wire 100 is a grinding section which is relatively thin, the grinding section cannot be tightly coated by the coating tube all the time, and the risk that the nickel-titaniumalloy core wire 100 penetrates through thepolyurethane 200 coating tube and is exposed exists.

In the invention, themolten polyurethane 200 is fed into the extrusion die through the extruder to contact with the nickel-titaniumalloy core wire 100 and is extruded and molded together, and themolten polyurethane 200 can be firmly coated and attached to the outer surface of the nickel-titaniumalloy core wire 100 without loosening, so that the risk that the nickel-titaniumalloy core wire 100 is exposed after penetrating through apolyurethane 200 coating tube is avoided, the product quality is stable, and the quality problem in the prior art is solved.

Meanwhile, the nickel-titaniumalloy core wire 100 used in the invention is composed of continuous multiple sections of core wire monomers A, each section of core wire monomer A is in a structure gradually thinning from two ends to the middle, the middle point of each section of core wire monomer A and the connection point of two adjacent sections of core wire monomers A are used as cutting points to cut the coated core wire, and therefore, the loach guide wire body with the same multiple sections of structures can be obtained, the process is easy to control, continuous and automatic production is realized, the production efficiency is high, and the productivity is greatly improved.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. The manufacturing method of the loach guide wire is characterized by comprising the following steps:

providing a section of nickel-titanium alloy core wire made of nickel-titanium alloy, and inserting one end of the nickel-titanium alloy core wire into an extrusion die, wherein the nickel-titanium alloy core wire comprises a plurality of continuous core wire monomers, and each core wire monomer is in a structure which is gradually thinned from two ends to the middle part;

extruding polyurethane in a molten state through an extruder, and feeding the polyurethane into the extrusion die, so that the polyurethane in the molten state is coated on the outer surface of the nickel-titanium alloy core wire;

moving the nickel-titanium alloy core wire coated with the polyurethane in the molten state forward, extruding and molding through the extrusion die, and cooling and shaping to obtain a coated core wire;

cutting the coated core wire by taking the middle point of each section of the core wire monomer and the connection point of two adjacent sections of the core wire monomers as cutting points, and cutting one section of the core wire monomer into a plurality of loach guide wire bodies;

and processing two ends of the loach guide wire body into tip ends, and coating a coating on the surface of the loach guide wire body after the tip ends are processed to obtain the loach guide wire.

2. The method for manufacturing the loach guide wire according to claim 1, wherein the extrusion die is provided with a first channel for the nickel-titanium alloy core wire to penetrate through and a second channel for the molten polyurethane to flow through, and the second channel is communicated with the first channel.

3. The manufacturing method of the loach guide wire according to claim 2, wherein the second channel is connected with the first channel to form a T-shaped channel, and the molten polyurethane is coated on the outer surface of the nickel-titanium alloy core wire in a T-shaped co-extrusion mode.

4. The method for manufacturing the loach guide wire according to claim 1, wherein the step of processing two ends of the loach guide wire body into tips comprises the following steps: and processing the two ends of the loach guide wire body into tips by adopting a high-frequency tip forming machine.

5. The method for manufacturing the loach guide wire according to claim 1, wherein the step of providing the section of the nickel-titanium alloy core wire made of the nickel-titanium alloy material comprises the following steps: and grinding the nickel-titanium alloy section by using grinding equipment to obtain the nickel-titanium alloy core wire.

6. The method for manufacturing the loach guide wire according to claim 1, wherein the cooling and shaping comprises the following steps: cooling and shaping in water.

7. The method for manufacturing the loach guide wire according to any one of claims 1 to 6, wherein the coating is a hydrophilic coating, and the coating is coated on the surface by a spraying method or a painting method.

8. The manufacturing method of the loach guide wire according to claim 1, wherein the maximum outer diameter of the core wire monomer is 0.3 mm, and the minimum outer diameter of the core wire monomer is 0.11 mm; or,

the maximum outer diameter of the core wire monomer is 0.47mm, and the minimum outer diameter of the core wire monomer is 0.18 mm; or,

the maximum outer diameter of the core wire monomer is 0.60mm, and the minimum outer diameter of the core wire monomer is 0.23 mm.

9. The method for manufacturing the loach guide wire according to claim 1, wherein the core wire monomer comprises two first sections, two conical gradual changes and a second section, the diameter of the first section is equal to the maximum diameter of the conical gradual change, the minimum diameter of the conical gradual change is equal to the diameter of the second section, and the two first sections are respectively connected with the second section through the two conical gradual changes.

10. The method for manufacturing the loach guide wire according to claim 9, wherein each first section is 1360 ± 2 mm in length and 0.47 ± 0.02 mm in outer diameter; the length of the second section is 50 +/-2 mm, and the outer diameter of the second section is 0.18 +/-0.02 mm; the length of each conical gradual transition section is 150 +/-2 mm, the maximum outer diameter is 0.47 +/-0.02 mm, and the minimum outer diameter is 0.18 +/-0.02 mm.

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