CN116617543B - Manufacturing method of micro-guide wire and micro-guide wire - Google Patents
Manufacturing method of micro-guide wire and micro-guide wire Download PDFInfo
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- CN116617543B CN116617543B CN202310685091.6A CN202310685091A CN116617543B CN 116617543 B CN116617543 B CN 116617543B CN 202310685091 A CN202310685091 A CN 202310685091A CN 116617543 B CN116617543 B CN 116617543B
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 24
- 229910052751 metal Inorganic materials 0.000 claims abstract description 42
- 239000002184 metal Substances 0.000 claims abstract description 42
- 238000005868 electrolysis reaction Methods 0.000 claims abstract description 31
- 238000000034 method Methods 0.000 claims abstract description 24
- 239000011248 coating agent Substances 0.000 claims abstract description 18
- 238000000576 coating method Methods 0.000 claims abstract description 18
- 238000012545 processing Methods 0.000 claims abstract description 13
- 230000008569 process Effects 0.000 claims abstract description 12
- 238000003466 welding Methods 0.000 claims abstract description 6
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 26
- 239000003792 electrolyte Substances 0.000 claims description 21
- 230000007797 corrosion Effects 0.000 claims description 16
- 238000005260 corrosion Methods 0.000 claims description 16
- 230000003247 decreasing effect Effects 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 3
- MYKHTOBDZZVWKK-UHFFFAOYSA-M lithium methanol chloride Chemical compound [Li+].[Cl-].CO MYKHTOBDZZVWKK-UHFFFAOYSA-M 0.000 claims description 3
- 229920002401 polyacrylamide Polymers 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 3
- 229910001220 stainless steel Inorganic materials 0.000 claims description 3
- UDEGSYXELBQAAG-UHFFFAOYSA-N azanium;methanol;chloride Chemical compound [NH4+].[Cl-].OC UDEGSYXELBQAAG-UHFFFAOYSA-N 0.000 claims description 2
- JNYIQRMXGCWKOU-UHFFFAOYSA-M sodium methanol chloride Chemical compound [Na+].[Cl-].OC JNYIQRMXGCWKOU-UHFFFAOYSA-M 0.000 claims description 2
- 208000010392 Bone Fractures Diseases 0.000 abstract description 8
- 206010017076 Fracture Diseases 0.000 abstract description 8
- 238000010791 quenching Methods 0.000 abstract description 4
- 230000000171 quenching effect Effects 0.000 abstract description 4
- 238000000227 grinding Methods 0.000 description 24
- 230000002792 vascular Effects 0.000 description 13
- 238000005554 pickling Methods 0.000 description 9
- 230000003902 lesion Effects 0.000 description 8
- 238000005482 strain hardening Methods 0.000 description 8
- 239000000463 material Substances 0.000 description 7
- 210000004204 blood vessel Anatomy 0.000 description 5
- 238000003754 machining Methods 0.000 description 4
- 239000002893 slag Substances 0.000 description 4
- 230000003628 erosive effect Effects 0.000 description 3
- 231100000216 vascular lesion Toxicity 0.000 description 3
- 230000009471 action Effects 0.000 description 2
- 238000003915 air pollution Methods 0.000 description 2
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- 230000001419 dependent effect Effects 0.000 description 2
- 238000005265 energy consumption Methods 0.000 description 2
- 230000007613 environmental effect Effects 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 238000005299 abrasion Methods 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
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- 238000005530 etching Methods 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09108—Methods for making a guide wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
- Y02E60/00—Enabling technologies; Technologies with a potential or indirect contribution to GHG emissions mitigation
- Y02E60/30—Hydrogen technology
- Y02E60/36—Hydrogen production from non-carbon containing sources, e.g. by water electrolysis
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
The application provides a manufacturing method of a micro-guide wire and the micro-guide wire, wherein the manufacturing method comprises the following steps: electrolysis, sleeve processing, welding and coating. Compared with the conventional micro-guide wire, the method adopts the electrolysis mode to process the strip-shaped opening on the metal tube, burrs and quenching cannot be generated on the metal tube, so that the risk of fracture caused by embrittlement of the tube body is avoided, the micro-guide wire manufactured by the method is better in operability and smoother in head end flexibility, a user can conveniently intervene a tortuous vessel in an operation through the vessel, the possibility of puncturing the vessel wall can be prevented, the driving force for operating the micro-guide wire is improved obviously, and the core wire structure in the micro-guide wire determines that the micro-guide wire has excellent supporting force in the vessel intervention operation. Can ensure the safe operation and improve the success rate of the operation.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to a manufacturing method of a micro-guide wire and the micro-guide wire.
Background
The micro-guide wire is widely applied to vascular interventional operations and is an indispensable medical instrument for interventional operations. Microcatheters typically consist of a core wire, a sleeve, a sheath, and a coating, the core wire being a metal wire for providing support for the guidewire; the sleeve is a nickel-titanium alloy pipe with a plurality of strip-shaped openings on the surface, and is connected to the head end of the core wire to play roles in supporting, transmitting, controlling and guiding; the sheath is generally made of PU material and is attached to the surface of the core wire for protecting the core wire; the coating is coated on the surfaces of the sheath and the sleeve, so that friction on the surface of the guide wire is reduced, and the guide wire can slide conveniently.
In the related art, an opening on a sleeve is usually formed by cutting a nickel-titanium alloy pipe by adopting laser, burrs are easily generated in the processing mode, and the high temperature generated by the laser can cause local quenching on the nickel-titanium alloy pipe, so that the sleeve becomes fragile, the risk of pipe body fracture is increased, the normal operation is influenced, and meanwhile, the core wire is mechanically impacted by grinding, metal fatigue and cold work hardening can be generated, the delivery performance of the core wire is reduced, the performance of the guide wire in various aspects such as regulating force, flexibility and pushing force is reduced, the fracture risk of the core wire is increased, the normal operation of the operation is influenced, and the success rate of the operation is reduced.
Disclosure of Invention
The embodiment of the application provides a manufacturing method of a micro-guide wire, which comprises the following steps:
and (3) electrolysis: electrolyzing at the head end of the core wire to form a taper section;
and (3) sleeve processing: immersing a metal tube in electrolyte, immersing a needle electrode in the electrolyte and approaching one end of the metal tube, and performing the following operations from one end of the metal tube to the other end of the metal tube at intervals to obtain a sleeve;
respectively connecting the electrolyte and the needle-shaped electrode with the positive electrode and the negative electrode of the current, rotating the metal tube, and alternately opening and closing the current in the rotating process of the metal tube until a plurality of strip-shaped openings distributed at intervals are formed in the axial direction of the metal tube by electrolysis;
welding: sleeving the sleeve on the taper section of the core wire, and welding two ends of the sleeve with two ends of the taper section;
and (3) coating: a hydrophilic coating is coated on the surface of the sleeve.
According to the manufacturing method of the micro-guide wire, provided by the embodiment of the application, the strip-shaped opening is processed on the metal tube in an electrolysis mode, burrs are not generated on the metal tube, and the metal tube is quenched, so that the risk of fracture caused by embrittlement of the tube body is avoided, the safety of an operation is improved, normal operation is guaranteed, and the success rate of the operation is improved.
And the taper section is molded at the head end of the core wire in an electrolysis mode, so that mechanical impact on the core wire caused by grinding is avoided, the delivery performance of the core wire can be kept as much as possible, and compared with a conventional guide wire, the micro guide wire has better operability and smoother head end flexibility; the micro-guide wire has the capability of easily passing through lesions under the natural state of the blood vessel, has obvious flexibility, is convenient for an operator to pass through the tortuous blood vessel in the vascular intervention operation, is not easy to cause vascular perforation, and the breaking force of the micro-guide wire is obviously improved, and the core wire structure in the micro-guide wire determines that the micro-guide wire has excellent supporting force in the vascular intervention operation, can help the operator to break through difficult pain points in the operation, can ensure safe, smooth and efficient operation process, and can effectively improve the success rate of the operation.
In one possible implementation manner, the method for manufacturing the micro-guide wire provided in the embodiment of the application includes the steps of: the method comprises the steps of starting from the head end of a core wire, setting a part, close to the head end, of the core wire as an electrolysis area, immersing the electrolysis area on the core wire in electrolyte, immersing a corrosion electrode in the electrolyte and close to the head end of the core wire, and respectively connecting the electrolyte and the corrosion electrode with a positive electrode and a negative electrode of current;
moving the corrosion electrode from its initial position to the other end of the electrolytic region along the length direction of the electrolytic region by a distance D 1 Then return to the distance D along the original path 1 To the initial position of the corrosion electrode; distance of movement D toward the other end of the electrolysis zone 2 Back edge original path return distance D 2 To the initial position … of the corrosion electrode toward the other end of the electrolytic zone by a distance D N Back edge original path return distance D N To the initial position of the corrosion electrode until a taper section is formed on the head end of the core wire, the distance D 1 Distance D 2 … distance D N Sequentially decreasing in length.
In one possible implementation manner, the method for manufacturing the micro-guide wire provided in the embodiment of the application is that the electrolyte in the electrolysis step is one of lithium chloride methanol solution, sodium chloride methanol solution and ammonium chloride methanol solution.
In one possible implementation manner, the hydrophilic coating in the coating step is made of one of polyvinylpyrrolidone, polyacrylamide, polyethylene glycol and polyvinyl alcohol.
In one possible implementation manner, the manufacturing method of the micro-guide wire provided in the embodiment of the application is that the core wire in the electrolysis step is a nickel-titanium alloy wire or a stainless steel wire.
In one possible implementation manner, the manufacturing method of the micro-guide wire provided in the embodiment of the present application, the metal tube in the sleeve processing step is a nickel-titanium alloy tube.
The embodiment of the application also provides the micro-guide wire manufactured by the manufacturing method of the micro-guide wire. Compared with a conventional guide wire, the micro-guide wire provided by the embodiment of the application has better operability and smoother head end flexibility, is convenient for a surgeon to pass through a tortuous blood vessel in a vascular intervention operation, can also prevent the possibility of puncturing the blood vessel wall, is beneficial to remarkably improving the driving force of the micro-guide wire, and has an excellent supporting force in the vascular intervention operation due to the core wire structure in the micro-guide wire. Can ensure the safe operation and improve the success rate of the operation.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, a brief description will be given below of the drawings that are needed in the embodiments or the prior art descriptions, it being obvious that the drawings in the following description are some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort to a person skilled in the art.
FIG. 1 is a schematic illustration of a core wire;
FIG. 2 is a schematic view of a metal tube;
FIG. 3 is a schematic illustration of a casing process;
FIG. 4 is a schematic view of a sleeve;
FIG. 5 is a schematic view of a microcatheter;
FIG. 6 is a detailed schematic of the electrolysis step.
Reference numerals illustrate:
100-micro-guide wires;
10-core wire;
10 a-electrolysis zone;
11-taper section;
20-metal tube;
30-sleeve;
31-a bar-shaped opening;
40-hydrophilic coating;
50-etching the electrode;
60-needle electrode.
Detailed Description
The micro-guide wire is widely applied to the neuro-interventional operation and is an indispensable medical instrument in the neuro-interventional operation. Microcatheters typically consist of a core wire, a sleeve, a sheath, and a coating, the core wire being a metal wire for providing support for the guidewire; the sleeve is a nickel-titanium alloy pipe with a plurality of strip-shaped openings on the surface, and is connected to the head end of the core wire to play roles in supporting, transmitting, controlling and guiding; the sheath is generally made of PU material and is attached to the surface of the core wire for protecting the core wire; the coating is coated on the surfaces of the sheath and the sleeve, so that friction on the surface of the guide wire is reduced, and the guide wire can slide conveniently.
The superiority of the guide wire function is mainly evaluated by the following aspects:
the adjusting force of the guide wire, namely the operability of the guide wire, refers to the capability of rotating and twisting the tip of the guide wire along with the operator when the operator rotates the proximal section (the external metal pushing rod section) of the guide wire, and reflects the flexibility of the tip of the guide wire under manual operation, and the stronger the adjusting capability is, the stronger the guide wire reaches and spans lesions.
The flexibility of the guidewire, which guides the ability of the guidewire to conform to the natural state of the vessel through the lesion, is primarily dependent on the stiffness and diameter of the core wire. The greater the core wire hardness, the thicker the diameter and the less compliant the guidewire. The guide wire with high flexibility has soft tip, is not easy to cause vascular perforation, and is safe to operate. The tip of the guide wire with small flexibility is harder, and vascular perforation is easy to cause.
Push force of the guidewire, push force of the guidewire directs the ability of the guidewire to pass through the lesion under the action of the surgeon's manipulation of the external push rod. The pushing force of the guide wire is mainly dependent on the diameter of the core wire. The thicker the core wire, the more uniform the push force is conducted, and the easier it is to pass through twisted and angled vascular lesions.
The supporting force of the guide wire, which guides the guide wire to serve as a conveying guide rail of a balloon and a stent in vascular intervention, and the stability degree of the guide wire in a lesion vessel, particularly a complex lesion vessel, is related to the diameter of the core wire. The thicker the core wire, the better and more stable the supporting force of the guide wire.
In the related art, an opening on the sleeve is usually formed by cutting a nickel-titanium alloy pipe by laser, burrs are easy to generate in the processing mode, and the high temperature generated by the laser can cause local quenching on the nickel-titanium alloy pipe, so that the sleeve becomes brittle, the risk of pipe body fracture is increased, the normal operation is influenced, and the success rate of the operation is reduced.
In addition, slag can adhere to the nickel-titanium alloy pipe through laser cutting, the slag needs to be removed through further pickling, when different nickel-titanium alloy pipes are pickled, the concentration of acidic substances in the pickling solution can change due to the amount of chemical reaction with the nickel-titanium alloy pipe, and the pickling reaction is difficult to control, so that the pickling degree of different nickel-titanium alloy pipes is different, the pickling effect of different nickel-titanium alloy pipes is different, and the quality of the sleeve is uneven.
In addition, when the core wire leaves the factory, the factory performance of the core wire is the best state for manufacturing the guide wire, mechanical impact can be caused to the core wire during grinding, metal fatigue and cold work hardening can be generated, so that the factory performance of the core wire is reduced, and the performance of the guide wire in various aspects such as adjusting force, flexibility, pushing force and the like is reduced. And because the core wire is hardened by cold working, the core wire becomes hard and brittle, the fracture risk of the core wire is increased, the normal operation of the operation is affected, and the success rate of the operation is reduced.
Moreover, due to abrasion loss, the consistency of the grinding precision is difficult to ensure, so that the reject ratio of the guide wire production is increased.
Cold work hardening: the cold deformation strength and hardness index of the metal material are improved along with the increase of the cold deformation degree, but the plasticity and toughness are reduced, which is also called cold hardening.
Metal fatigue: when materials and structures are subjected to repeated loads, the stress value does not exceed the strength limit of the materials all the time, and even is lower than the elastic limit, the materials and structures can be damaged, and the phenomena of damage to the materials and structures under the repeated action of alternating loads are called fatigue damage of metals.
Based on this, the manufacturing method of the micro-guide wire and the micro-guide wire provided by the embodiment of the application adopt an electrolysis mode to process the strip-shaped opening on the nickel-titanium alloy tube, and burrs and quenching can not be generated on the nickel-titanium alloy tube, so that the risk of fracture caused by embrittlement of the tube body is avoided, the safety of the operation is improved, the normal operation of the operation is ensured, and the success rate of the operation is improved.
In addition, slag is not adhered to the nickel-titanium alloy pipe, so that the nickel-titanium alloy pipe is not required to be pickled, the pickling step can be omitted, and the problem of uneven quality of the sleeve caused by pickling can be avoided.
Moreover, the taper section is molded at the head end of the core wire in an electrolysis mode, so that the mechanical impact of traditional grinding to the core wire is avoided, the prepared guide wire can keep the delivery performance of the core wire to the greatest extent, the adjustment force, the flexibility, the pushing force, the breaking force and the like are remarkably improved, the risk of breakage of the core wire can be reduced, the safe, smooth and efficient operation process is ensured, and the success rate of the operation can be effectively improved.
Meanwhile, the problems that grinding wheel loss is caused by grinding processing, grinding accuracy is difficult to keep consistent and the like are avoided, and the yield of guide wire production is improved. Meanwhile, the problems of high energy consumption, high environmental noise, air pollution caused by grinding fluid atomization, high maintenance cost and high skill requirement on workers in grinding processing are solved.
For the purpose of making the objects, technical solutions and advantages of the present application more apparent, the technical solutions in the embodiments of the present application will be described in more detail below with reference to the accompanying drawings in the preferred embodiments of the present application. In the drawings, the same or similar reference numerals refer to the same or similar components or components having the same or similar functions throughout. The described embodiments are some, but not all, of the embodiments of the present application. The embodiments described below by referring to the drawings are exemplary and intended for the purpose of explaining the present application and are not to be construed as limiting the present application. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without making any inventive effort, are intended to be within the scope of the present application.
FIG. 1 is a schematic illustration of a core wire; FIG. 2 is a schematic view of a metal tube; FIG. 3 is a schematic illustration of a casing process; FIG. 4 is a schematic view of a sleeve; FIG. 5 is a schematic view of a microcatheter; FIG. 6 is a detailed schematic of the electrolysis step.
Referring to fig. 1-5, an embodiment of the present application provides a method for manufacturing a micro-guide wire, including the following steps:
and (3) electrolysis: the taper section 11 is electrolytically formed at the head end of the core wire 10.
And (3) sleeve processing: the metal tube 20 is immersed in the electrolyte, the needle electrode 60 is immersed in the electrolyte and is close to one end of the metal tube 20, and the following operations are performed at intervals from one end of the metal tube 20 to the other end thereof, respectively, to obtain the bushing 30.
The electrolyte and the needle electrode 60 are respectively turned on the positive and negative electrodes of the current and the metal tube 20 is rotated, and the current is turned on and off in turn during the rotation of the metal tube 20 until a plurality of bar-shaped openings 31 (see fig. 2 to 4) are electrolytically formed in the axial direction of the metal tube 20 at intervals.
Specifically, the metal tube 20 in the sleeve processing step is a nickel-titanium alloy tube.
Welding: the sleeve 30 is sleeved on the taper section 11 of the core wire 10, and two ends of the sleeve 30 are welded with two ends of the taper section 11.
And (3) coating: the surface of the sleeve 30 is coated with a hydrophilic coating 40 to obtain a micro-guide wire 100 (see fig. 5).
Specifically, the material of the hydrophilic coating 40 in the coating step is one of polyvinylpyrrolidone, polyacrylamide, polyethylene glycol, and polyvinyl alcohol.
According to the manufacturing method of the micro-guide wire, the strip-shaped opening is processed on the nickel-titanium alloy tube in an electrolysis mode, burrs are not generated on the nickel-titanium alloy tube, and the nickel-titanium alloy tube is quenched, so that the risk of fracture caused by embrittlement of the tube body is avoided, the safety of an operation is improved, normal operation is guaranteed, and the success rate of the operation is improved.
In addition, slag is not adhered to the nickel-titanium alloy pipe, so that the nickel-titanium alloy pipe is not required to be pickled, the pickling step can be omitted, and the problem of uneven quality of the sleeve caused by pickling can be avoided.
Referring to fig. 1 and fig. 6, in the embodiment of the present application, the electrolysis step in the above method is specifically: from the head end of the core wire 10, the portion of the core wire 10 near the head end is set as an electrolysis region 10a, the electrolysis region 10a on the core wire 10 is immersed in the electrolyte, the corrosion electrode 50 is immersed in the electrolyte and near the head end of the core wire 10, and the electrolyte and the corrosion electrode 50 are respectively connected with the positive electrode and the negative electrode of the current.
The corrosion electrode 50 is moved from its initial position to the other end of the electrolytic region 10a along the length direction of the electrolytic region 10a by a distance D 1 Then return to the distance D along the original path 1 To the initial position of the erosion electrode 50; distance D toward the other end of electrolytic area 10a 2 Back edge original path return distance D 2 To the initial position … of the corrosion electrode 50 toward the other end of the electrolytic region 10a by a distance D N Back edge original path return distance D N To the initial position of the erosion electrode 50 until a taper segment 11 is formed on the tip of the core wire 10, distance D 1 Distance D 2 … distance D N Sequentially decreasing in length.
Thus, the electrolysis region 10a of the core wire 10 is moved by the distance D 1 Covered and not moved by distance D 2 The covered area is electrolyzed twice (each time the erosion electrode 50 moves back and forth), moved by a distance D 2 Covered and not moved by distance D 3 The covered area is electrolyzed four times and so on, and finally moved by the distance D N The covered area was electrolyzed 2N times, and thus the diameter of the core wire 10 was gradually decreased from one end to the other end thereof, thereby forming a taper section 11.
Specifically, the electrolyte in the electrolysis step is 1mol/L lithium chloride methanol solution, and the core wire 10 in the electrolysis step is nickel titanium alloy wire or stainless steel wire.
The taper section 11 is molded at the head end of the core wire 10 in an electrolysis mode, so that mechanical impact on the core wire 10 caused by grinding can be avoided, the performance of the core wire 10 can be maintained, the risk of breakage of the core wire 10 is reduced, normal operation is ensured, and the success rate of the operation is improved. The problems that grinding wheel loss is caused by grinding processing, grinding accuracy is difficult to keep consistent and the like are avoided, and the yield of guide wire production is improved. Meanwhile, the problems of high energy consumption, high environmental noise, air pollution caused by grinding fluid atomization, high maintenance cost and high skill requirement on workers in grinding processing are solved.
The embodiment of the application provides a micro-guide wire, by the preparation method of above-mentioned micro-guide wire, compare in conventional guide wire, the micro-guide wire that this application embodiment provided is controlled better, the head end compliance is more smooth, make things convenient for the operator to pass through the tortuous blood vessel in the vascular intervention operation, can also prevent the possibility of puncture the vascular wall, the driving force of operating micro-guide wire is showing and is promoting, the core silk structure in this micro-guide wire has decided that it possesses outstanding holding power at vascular intervention operation, can guarantee the safety of operation and go on, improve the success rate of operation. Compared with the conventional guide wire processed by grinding on the market:
if the core wire is subjected to grinding, mechanical impact on the core wire during the grinding process may cause a decrease in the adjusting force of the core wire. However, the micro-guide wire provided by the embodiment of the application adopts an electrolytic machining mode to machine the taper section on the core wire, so that mechanical impact on the core wire can be avoided, metal fatigue and cold work hardening of the core wire are avoided, the adjusting force of the core wire is enabled to be close to the level of the core wire when leaving the factory as much as possible, the operability of the guide wire is enabled to be better, and the guide wire has stronger capability of reaching and crossing lesions.
After the core wire is ground, mechanical impact on the core wire in the grinding process can cool and harden the core wire, so that the hardness of the core wire is increased, and the flexibility of the guide wire is reduced. If compliance of the guide wire is to be ensured, then it is necessary to grind a part of the core wire more, so that the diameter of the core wire becomes smaller. However, this treatment results in a decrease in the pushing force and the supporting force of the guide wire. The guide wire provided by the embodiment of the application adopts an electrolytic machining mode to machine the taper section on the core wire, so that the mechanical impact on the core wire can be avoided, the metal fatigue and cold work hardening of the core wire are avoided, and the hardness of the core wire cannot be increased. Therefore, compared with the grinding method, the core wire can have larger diameter under the condition of ensuring the same flexibility, thereby ensuring the pushing force and supporting force of the guide wire, ensuring that the transmission of the pushing force is more uniform and easier to pass through twisted and angled vascular lesions, and improving the stability of the guide wire in complex lesion vessels when the guide wire is used as a conveying guide rail of a balloon and a bracket in vascular intervention. The operation is safer and smoother, and the success rate of the operation can be improved.
After the core wire is ground, mechanical impact on the core wire in the grinding process can cool and harden the core wire, so that the hardness of the core wire is increased, and the flexibility of the guide wire is reduced. If compliance of the guide wire is to be ensured, then it is necessary to grind a part of the core wire more, so that the diameter of the core wire becomes smaller. However, this treatment results in a reduced pushing force of the guide wire. The micro-guide wire provided by the embodiment of the application adopts an electrolytic machining mode to machine the taper section on the core wire, so that the mechanical impact on the core wire can be avoided, the metal fatigue and cold work hardening of the core wire are avoided, and the hardness of the core wire cannot be increased. Therefore, compared with the grinding method, the core wire can have larger diameter under the condition of ensuring the same flexibility, thereby ensuring the pushing force of the guide wire, ensuring that the transmission of the pushing force is more uniform and easier to pass through twisted and angled vascular lesions, ensuring that the operation is safer and smoother, and improving the success rate of the operation.
After the core wire is ground, mechanical impact on the core wire in the grinding process can cool and harden the core wire, so that the core wire becomes hard and brittle, and the breaking risk of the core wire can be increased. The micro-guide wire provided by the embodiment of the application adopts an electrolytic machining mode to machine the taper section on the core wire, so that the mechanical impact on the core wire can be avoided, the core wire is prevented from generating metal fatigue and cold work hardening, and the core wire is prevented from being broken easily.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present application, and not for limiting the same; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present application.
Claims (7)
1. The manufacturing method of the micro-guide wire is characterized by comprising the following steps of:
and (3) electrolysis: electrolyzing at the head end of the core wire to form a taper section;
and (3) sleeve processing: immersing a metal tube in electrolyte, immersing a needle electrode in the electrolyte and approaching one end of the metal tube, and performing the following operations from one end of the metal tube to the other end of the metal tube at intervals to obtain a sleeve;
respectively connecting the electrolyte and the needle-shaped electrode with the positive electrode and the negative electrode of the current, rotating the metal tube, and alternately opening and closing the current in the rotating process of the metal tube until a plurality of strip-shaped openings distributed at intervals are formed in the axial direction of the metal tube by electrolysis;
welding: sleeving the sleeve on the taper section of the core wire, and welding two ends of the sleeve with two ends of the taper section;
and (3) coating: a hydrophilic coating is coated on the surface of the sleeve.
2. The method of manufacturing a microcatheter as in claim 1, wherein the step of electrolyzing comprises: the method comprises the steps of starting from the head end of a core wire, setting a part, close to the head end, of the core wire as an electrolysis area, immersing the electrolysis area on the core wire in electrolyte, immersing a corrosion electrode in the electrolyte and close to the head end of the core wire, and respectively connecting the electrolyte and the corrosion electrode with a positive electrode and a negative electrode of current;
moving the corrosion electrode from its initial position to the other end of the electrolytic region along the length direction of the electrolytic region by a distance D 1 Then return to the distance D along the original path 1 To the initial position of the corrosion electrode; distance of movement D toward the other end of the electrolysis zone 2 Back edge original path return distance D 2 To the initial position … of the corrosion electrode toward the other end of the electrolytic zone by a distance D N Back edge original path return distance D N To the initial position of the corrosion electrode until a taper section is formed on the head end of the core wire, the distance D 1 Distance D 2 … distance D N Sequentially decreasing in length.
3. The method of claim 2, wherein the electrolyte in the step of electrolyzing is one of lithium chloride methanol solution, sodium chloride methanol solution and ammonium chloride methanol solution.
4. The method of claim 2, wherein the hydrophilic coating in the coating step is one of polyvinylpyrrolidone, polyacrylamide, polyethylene glycol and polyvinyl alcohol.
5. The method of manufacturing a micro-wire according to claim 2, wherein the core wire in the electrolysis step is a nickel-titanium alloy wire or a stainless steel wire.
6. The method of manufacturing a micro-wire according to claim 2, wherein the metal tube in the sleeve processing step is a nickel-titanium alloy tube.
7. A microcatheter made by the method of making a microcatheter of any of claims 1-6.
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| CN202310685091.6A CN116617543B (en) | 2023-06-09 | 2023-06-09 | Manufacturing method of micro-guide wire and micro-guide wire |
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| CN116617543A (en) | 2023-08-22 |
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