A kind of manufacturing process of loach guide wire

Abstract

The present invention belongs to the technical field of medical devices, and discloses a manufacturing process of a loach guide wire, including some steps: taking a nickel-titanium alloy profile at one end, grinding the nickel-titanium alloy profile to form a continuous multi-segment core wire monomer; coating a polymer on the core wire monomer, cooling and shaping after coating, coating a hydrophilic layer on the surface of the polymer, and solidifying after coating to obtain a coated core wire; taking the connection position of two adjacent core wire monomers as the cutting position, cutting the coated core wire to obtain a multi-segment loach guide wire body; cutting the core wire monomers at the two ends of each loach guide wire body to a preset length; heating the end of the loach guide wire body to melt the polymer separated from the cut core wire monomer into a hemispherical structure coating the end of the core wire monomer, and then cooling and shaping the hemispherical polymer to obtain the loach guide wire. The manufacturing process of the loach guide wire provided by the present invention simplifies the process flow and effectively improves production efficiency.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a manufacturing process of a loach guide wire. Background Art

[0002] Interventional therapy is an emerging treatment method in recent years. It introduces special catheters, guidewires and other precision instruments into the human body, and uses medical imaging equipment to assist in observation to diagnose and locally treat lesions in the patient's body. Among the related instruments for interventional therapy, medical guidewires are the most common instruments, and loach guidewires are widely used as common medical guidewires. As a super-slippery guidewire for special treatment, loach guidewires undergo special surface treatment to reduce the friction between the guidewire and the microcatheter, improve the guiding and transmission capabilities of the guidewire, and thus reduce the risk of damage to the human body.

[0003] In the existing method for making loach guide wires, a whole roll of nickel-titanium alloy is usually coated with a polymer, which is then cut into sections of monomers after the coating is completed. The ends of each section of the monomers are then ground to remove the polymer coated on both ends of the monomers and grind the two ends of the monomers into sharp tips. A polymer sleeve is then put on the ground tip, and the polymer sleeve is melted and coated on the tip by hot melting. Finally, a hydrophilic layer is coated on the entirety to make the loach guide wire. This method requires grinding the exposed ends of each section of the monomers, has many process flows, a complicated production process, and low production efficiency. Summary of the invention

[0004] The purpose of the present invention is to provide a process for producing a loach guide wire, so as to solve the problem that the loach guide wire production process in the prior art has many steps and low output efficiency.

[0005] To achieve this object, the present invention adopts the following technical solutions:

[0006] A process for making a loach guide wire comprises the following steps:

[0007] S100, taking a section of nickel-titanium alloy profile, and grinding the nickel-titanium alloy profile to form a continuous multi-section core wire monomer;

[0008] S200, coating a molten polymer on a plurality of continuous core wire monomers, cooling and shaping the core wire after coating, and then coating a hydrophilic layer on the surface of the polymer, and solidifying the hydrophilic layer after coating to obtain a coated core wire;

[0009] S300, cutting the coated core wire at a connection position between two adjacent core wire monomers to obtain multiple segments of loach guide wire bodies;

[0010] S400, cutting off the core wire monomers at two ends of each segment of the loach guide wire body by a preset length;

[0011] S500, heating the end of the loach guide wire body to melt the polymer separated from the cut core wire monomer into a hemispherical structure covering the end of the core wire monomer, and then cooling the hemispherical polymer to shape it to obtain a loach guide wire.

[0012] Optionally, the core wire monomer includes a first end, a connecting part and a third end, the first end and the third end are connected by the connecting part, the connecting part is conical in shape, the diameter of the first end is equal to the minimum diameter of the connecting part, and the diameter of the third end is equal to the maximum diameter of the connecting part.

[0013] Optionally, in step S100, the first end of each core wire monomer is connected to the first end of the adjacent core wire monomer on the corresponding side, and the third end of each core wire monomer is connected to the third end of the adjacent core wire monomer on the corresponding side.

[0014] Optionally, in the step S100, the first end of each section of the core wire monomer is connected to the third end of the core wire monomer adjacent to the corresponding side.

[0015] Optionally, in step S200, the method for cooling and shaping the polymer is cooling and shaping in water.

[0016] Optionally, in step S200, the method of solidifying the hydrophilic layer is high temperature heating solidification or ultraviolet light solidification.

[0017] Optionally, in step S400, the preset length of the core wire monomer removed at each end of the loach guide wire body is 2-3 mm.

[0018] Optionally, in step S500, the method for cooling and shaping the hemispherical polymer is cooling and shaping in water.

[0019] Optionally, the polymer is made of thermoplastic polyurethane or polyether block polyamide.

[0020] Optionally, the hydrophilic layer is made of polyvinyl pyrrolidone.

[0021] Beneficial effects:

[0022] The present invention provides a manufacturing process for a loach guide wire, which comprises grinding an entire nickel-titanium alloy profile to form a continuous multi-segment core wire monomer, then coating the continuous multi-segment core wire monomer with a polymer, and coating a hydrophilic layer, and then cutting the entire nickel-titanium alloy core wire with the connection position of two adjacent core wire monomers as the cutting position to obtain a loach guide wire body, then cutting the core wire monomers at both ends of each loach guide wire body by a preset length, and then heating the end of the loach guide wire body to melt the polymer separated from the core wire monomer with the preset length cut off into a hemispherical structure coating the end of the core wire monomer, and then cooling the polymer to obtain the loach guide wire, thereby eliminating the step of grinding each loach guide wire body, simplifying the process flow, effectively improving production efficiency, and also saving polymer consumption. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic flow chart of the manufacturing process of the loach guide wire of the present invention;

[0024] Figure 2 It is a schematic diagram of the first ends of two adjacent core wire monomers of the present invention being connected to each other;

[0025] Figure 3 It is a schematic diagram of the third ends of two adjacent core wire monomers of the present invention being connected to each other;

[0026] Figure 4 It is a schematic diagram of connecting the first end and the third end of two adjacent core wire monomers of the present invention;

[0027] Figure 5 It is a structural schematic diagram of a single loach guide wire body of the present invention;

[0028] Figure 6 It is a schematic diagram of the structure after the polymers at both ends of a single loach guide wire body are cut open and a length of the core wire monomer is cut off;

[0029] Figure 7 It is a structural schematic diagram of the loach guide wire of the present invention.

[0030] In the figure:

[0031] 100, core wire monomer; 110, first end portion; 120, connecting portion; 130, third end portion; 200, polymer; 300, hydrophilic layer. DETAILED DESCRIPTION

[0032] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0033] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0034] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0035] In the description of this embodiment, the terms "upper", "lower", "right", etc., directions or positional relationships are based on the directions or positional relationships shown in the drawings, and are only for the convenience of description and simplification of operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0036] This embodiment provides a process for making a loach guide wire, referring to Figure 1 As shown, the manufacturing process of loach guide wire includes the following steps:

[0037] S100, taking a section of nickel-titanium alloy profile, and grinding the nickel-titanium alloy profile to form a continuous multi-section core wire monomer 100;

[0038] S200, coating a molten polymer 200 on a continuous multi-segment core wire monomer 100, cooling and shaping the polymer 200 after coating, and then coating a hydrophilic layer 300 on the surface of the polymer 200, and solidifying the hydrophilic layer 300 after coating to obtain a coated core wire;

[0039] S300, cutting the coated core wire at the connection position between two adjacent core wire monomers 100 to obtain multiple sections of loach guide wire bodies;

[0040] S400, cutting off the core wire monomers 100 at two ends of each loach guide wire body by a preset length;

[0041] S500, heating the end of the loach guide wire body to melt the polymer 200 separated from the cut core wire monomer 100 into a hemispherical structure covering the end of the core wire monomer 100, and then cooling the hemispherical polymer 200 to shape it to obtain the loach guide wire.

[0042] The manufacturing process of a loach guide wire provided in the present embodiment can realize continuous production, eliminates the step of grinding each section of the loach guide wire body, simplifies the process flow, and effectively improves production efficiency. Moreover, after cutting off the core wire monomer 100 of a preset length at both ends of the loach guide wire body, the polymer 200 separated from the core wire monomer 100 with a preset length cut off at both ends of the loach guide wire body is directly used as the raw material for sealing the two ends of the loach guide wire body for hot melting, without the need for an external polymer sleeve, which further saves the consumption of the polymer 200.

[0043] Specifically, in S100, a grinding device is used to grind the nickel-titanium alloy profile, so that the nickel-titanium alloy profile is ground as a whole into a continuous multi-segment core wire monomer 100, and the multi-segment core wire monomer 100 is connected in sequence.

[0044] Further, refer to Figures 2 to 4 As shown, the core wire monomer 100 includes a first end 110, a connecting portion 120 and a third end 130. The first end 110 and the third end 130 are connected by the connecting portion 120. The connecting portion 120 is tapered. The diameter of the first end 110 is equal to the minimum diameter of the connecting portion 120, and the diameter of the third end 130 is equal to the maximum diameter of the connecting portion 120. In this embodiment, the third end 130 does not need to be ground, but the first end 110 and the connecting portion 120 both need to be ground. The tapered connecting portion 120 is a transition section 130 between the first end 110 and the third end, thereby coherently connecting the first end 110 and the third end 130. It is worth mentioning that Figures 2 to 4 Only a part of the continuous structure of multiple sections of core wire monomers 100 connected in sequence is schematically shown. In this embodiment, the length of the connecting portion 120 is preferably set to 150 mm, the total length of the first end portion 110 and the connecting portion 120 is preferably not more than 400 mm, the minimum diameter of the connecting portion 120, that is, the diameter of the first end portion 110 is processed according to actual needs, and its minimum size can be processed to 0.2 mm, and the maximum diameter of the connecting portion 120, that is, the diameter of the third end portion 130 is processed according to actual needs, and no excessive restrictions are made here.

[0045] In step S100, the multi-segment core wire monomer 100 formed after grinding is specifically referred to Figures 2 to 3As shown, the first end 110 of each core wire monomer 100 is connected to the first end 110 of the core wire monomer 100 adjacent to the corresponding side, and the third end 130 of each core wire monomer 100 is connected to the third end 130 of the core wire monomer 100 adjacent to the corresponding side, that is, the adjacent core wire monomers 100 are connected relative to each other in pairs. In this embodiment, this connection method can enable the grinding equipment to achieve continuous grinding on the entire nickel-titanium alloy profile, effectively ensuring production efficiency. In this embodiment, the grinding equipment is preferably configured as a CNC grinder. After the feed amount data, feed angle and other data are set in the CNC grinder, the CNC grinder can automatically perform continuous grinding on the entire nickel-titanium alloy profile.

[0046] Further, refer to Figure 4 As shown, in step S100, in addition to the above-mentioned method of connecting two adjacent core wire monomers 100, the first end 110 of each core wire monomer 100 is connected to the third end 130 of the core wire monomer 100 adjacent to the corresponding side, that is, the adjacent core wire monomers 100 are connected end to end. In this embodiment, with this connection method, the grinding equipment can also achieve continuous grinding on the entire nickel-titanium alloy profile, and when cutting multiple coated core wires in the subsequent step S300, there is no need to swap the positions of two adjacent coated core wires, which makes it easier to collect the coated core wires. It is worth mentioning that under this connection method, a retraction distance needs to be reserved in advance at the connection position between the third end 130 of one core wire monomer 100 and the first end 110 of the core wire monomer 100 adjacent to the corresponding side, so that the CNC grinder can retract the tool during operation.

[0047] In step S200, specifically, the continuous multi-segment core wire monomer 100 structure formed after grinding is fed into the extrusion die, and the polymer 200 in a molten state is preferably fed into the extrusion die through an extruder, so that the polymer 200 in a molten state is coated on the surface of the continuous multi-segment core wire monomer 100 structure. The material of the polymer 200 is preferably set to thermoplastic polyurethane (TPU) or polyether block polyamide (PEBAX). Thermoplastic polyurethane is an elastomer that can be plasticized by heating and dissolved by solvents. It has high strength, high toughness and high wear resistance, while polyether block polyamide has good thermoplastic elastomer properties, good elasticity, toughness and fatigue resistance. This embodiment is not limited to this, and the material of the polymer 200 can also be other thermoplastic elastomers, which are not too limited here. Further, after the coating work is completed, the polymer 200 needs to be cooled and shaped. The method for cooling and shaping the polymer 200 in this embodiment is preferably cooling and shaping in water, and the water temperature of the cooling water is preferably but not limited to 10°C.

[0048] Further, in step S200, after the cooling of the polymer 200 is completed, the surface of the polymer 200 is coated with a hydrophilic layer 300. The material of the hydrophilic layer 300 is preferably set to polyvinyl pyrrolidone (PVP). Polyvinyl pyrrolidone has excellent biocompatibility and good flow-aiding effect, and will not cause irritation to the vascular mucosa. In addition, the method of coating the hydrophilic layer 300 is preferably but not limited to the spraying method. After the hydrophilic layer 300 is coated, the hydrophilic layer 300 needs to be solidified. The method of solidifying the hydrophilic layer 300 is preferably high-temperature heating solidification or ultraviolet light solidification. Both high-temperature heating and ultraviolet light use the principle of temperature rise to heat and solidify the hydrophilic layer 300 coated on the surface of the polymer 200, thereby obtaining a coated core wire. The solidification method of the hydrophilic layer 300 is not limited to this, and can also be other methods that apply the principle of temperature rise to heat the hydrophilic layer 300, which is not limited too much here.

[0049] In step S300, specifically, when the first end 110 of the core wire monomer 100 is connected to the first end 110 of the core wire monomer 100 adjacent to the corresponding side, the third end 130 of each section of the core wire monomer 100 is connected to the third end 130 of the core wire monomer 100 adjacent to the corresponding side, that is, the adjacent core wire monomers 100 are connected in pairs, the cutting position includes a first cutting position and a second cutting position, wherein the first cutting position is located at the midpoint of the two first ends 110 connected to the two adjacent core wire monomers 100, and the second cutting position is located at the midpoint of the two third ends 130 connected to the two adjacent core wire monomers 100; when the first end 110 of each section of the core wire monomer 100 is connected to the third end 130 of the core wire monomer 100 adjacent to the corresponding side, that is, the adjacent core wire monomers 100 are connected end to end, the cutting position is located at the connection position of the first end 110 and the third end 130 connected to the two adjacent core wire monomers 100.

[0050] In step S400, specifically, refer to Figures 5 to 7As shown, the core wire monomer 100 at the two ends of the loach guide wire body is cut off by a preset length, that is, after an incision is made at the two ends of the loach guide wire body at a preset position, the core wire monomer 100 exposed from the incision to the end of each end is cut off. After the cutting is completed, the polymer 200 originally coated on the core wire monomer 100 of the cut section is not cut off, and will be used as a material for re-coating the two exposed ends of the loach guide wire body. Furthermore, the preset length of the core wire monomer 100 cut off at each end of the loach guide wire body is 2-3mm, that is, the cutting position of the polymer 200 at each end of the loach guide wire body is 2-3mm inward from the end of the core wire monomer 100. If the cutting distance is too small, after the core wire monomer 100 is cut off at both ends of the loach guide wire body, the amount of polymer 200 that is not cut off at the two corresponding ends will be relatively small, and after the cut polymer 200 is melted in the subsequent step S500, the problem of not being able to completely cover the end of the core wire monomer 100 will arise; if the cutting distance is too large, after the core wire monomer 100 is cut off at both ends of the loach guide wire body, the amount of polymer 200 that is not cut off at the two corresponding ends will also be relatively large, exceeding the amount of polymer used for re-coating 200 at the two ends of the loach guide wire body in the subsequent step S500, and will also cause a waste of excess polymer 200.

[0051] Further, in step S500, the two ends of the loach guide wire body are coated and sealed by using an arc-shaped hot melt mold. Specifically, the two ends of the loach guide wire body are placed in the arc-shaped hot melt mold, and the polymer 200 separated from the core wire monomer 100 with a preset length cut off at the two corresponding ends will also be placed in the hot melt mold, and then the hot melt mold is heated, so that the polymer 200 at the end of the loach guide wire body is reheated into a molten state to coat the exposed core wire monomer 100 at both ends of the loach guide wire body again, and under the shaping action of the arc-shaped hot melt mold, it becomes a rounded hemispherical structure, thereby completing the rounded end sealing treatment of the two ends of the loach guide wire body. Further, the hemispherical polymer 200 at both ends of the coated loach guide wire body is then cooled again, and the cooling method is preferably also selected to cool and shape in water, so that the hemispherical polymer 200 at both ends is fully cooled and shaped, and then the monomer finished product of the loach guide wire is obtained.

[0052] In this embodiment, the diameter of the loach guide wire can preferably be 0.26 mm (0.014 inches), 0.46 mm (0.018 inches), 0.89 mm (0.035 inches) or 0.97 mm (0.038 inches). Loach guide wires of other diameters can also be manufactured according to actual production requirements, and no further restrictions are made here.

[0053] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, various obvious changes, readjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A process for producing a loach guide wire, characterized in that: The steps include: S100, taking a section of nickel-titanium alloy profile, and grinding the nickel-titanium alloy profile to form a continuous multi-section core wire monomer (100); S200, coating a molten polymer (200) on a plurality of continuous core wire monomers (100), cooling and shaping the polymer after coating, and then coating a hydrophilic layer (300) on the surface of the polymer (200), and solidifying the hydrophilic layer (300) after coating to obtain a coated core wire; S300, cutting the coated core wire using the connection position of two adjacent core wire monomers (100) as the cutting position to obtain multiple segments of loach guide wire bodies; S400, cutting off the core wire monomer (100) at two ends of each section of the loach guide wire body by a preset length; After a cut is made at the two ends of the loach guide wire body at a preset position, the core wire monomer (100) exposed from the cut to the end of each end is cut off; after the cutting is completed, the polymer (200) originally covering the cut core wire monomer (100) is not cut off, and is used as a material for covering the two exposed ends of the loach guide wire body again; S500, heating the end of the loach guide wire body to melt the polymer (200) separated from the cut core wire monomer (100) into a hemispherical structure covering the end of the core wire monomer (100), and then cooling the hemispherical polymer (200) to shape it, thereby obtaining a loach guide wire.

2. The process for making loach guide wire according to claim 1, characterized in that: The core wire monomer (100) comprises a first end portion (110), a connecting portion (120) and a third end portion (130); the first end portion (110) and the third end portion (130) are connected via the connecting portion (120); the connecting portion (120) is conical in shape; the diameter of the first end portion (110) is equal to the minimum diameter of the connecting portion (120); and the diameter of the third end portion (130) is equal to the maximum diameter of the connecting portion (120).

3. The process for making loach guide wire according to claim 2, characterized in that: In step S100, the first end (110) of each section of the core wire monomer (100) is connected to the first end (110) of the core wire monomer (100) adjacent to the corresponding side, and the third end (130) of each section of the core wire monomer (100) is connected to the third end (130) of the core wire monomer (100) adjacent to the corresponding side.

4. The process for making loach guide wire according to claim 2, characterized in that: In the step S100, the first end (110) of each section of the core wire monomer (100) is connected to the third end (130) of the core wire monomer (100) adjacent to the corresponding side.

5. The process for making loach guide wire according to claim 1, characterized in that: In step S200, the method for cooling and shaping the polymer (200) is cooling and shaping in water.

6. The process for making loach guide wire according to claim 1, characterized in that: In step S200, the hydrophilic layer (300) is solidified by high temperature heating solidification or ultraviolet light solidification.

7. The process for making loach guide wire according to claim 1, characterized in that: In step S400, the core wire monomer (100) at each end of the loach guide wire body is cut off to a preset length of 2-3 mm.

8. The process for making loach guide wire according to claim 1, characterized in that: In step S500, the method for cooling and shaping the hemispherical polymer (200) is cooling and shaping in water.

9. The process for making loach guide wire according to any one of claims 1 to 8, characterized in that: The material of the polymer (200) is thermoplastic polyurethane or polyether block polyamide.

10. The process for producing loach guide wire according to any one of claims 1 to 8, characterized in that: The material of the hydrophilic layer (300) is polyvinyl pyrrolidone.

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