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CN111012998A - Interventional therapy medical micro-guide wire and manufacturing method thereof - Google Patents

Interventional therapy medical micro-guide wire and manufacturing method thereof Download PDF

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Publication number
CN111012998A
CN111012998A CN202010114610.XA CN202010114610A CN111012998A CN 111012998 A CN111012998 A CN 111012998A CN 202010114610 A CN202010114610 A CN 202010114610A CN 111012998 A CN111012998 A CN 111012998A
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CN
China
Prior art keywords
wire
section
micro
gold
head end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202010114610.XA
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Chinese (zh)
Inventor
付学森
许佳润
赵善铭
付钰锟
刘杰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Maipuqi Medical Technology Co ltd
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Shenzhen Maipuqi Medical Technology Co ltd
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Publication date
Application filed by Shenzhen Maipuqi Medical Technology Co ltd filed Critical Shenzhen Maipuqi Medical Technology Co ltd
Priority to CN202010114610.XA priority Critical patent/CN111012998A/en
Publication of CN111012998A publication Critical patent/CN111012998A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09108Methods for making a guide wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09133Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09166Guide wires having radio-opaque features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09175Guide wires having specific characteristics at the distal tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09191Guide wires made of twisted wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production

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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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention relates to the technical field of medical instruments and discloses a medical micro-guide wire for interventional therapy and a manufacturing method thereof, wherein the micro-guide wire comprises an inner core, the inner core comprises a conveying section, a gradually-changed diameter section and a head end gentle section which are integrally formed and sequentially arranged, a developing gold wire is tightly wound on the head end gentle section, the outer layers of the inner core and the developing gold wire are wrapped with TPU layers, hydrophilic coatings are coated on the surfaces of the TPU layers, and the micro-guide wire is manufactured through the following steps: preparing materials, winding gold wires, fixing the gold wires, wrapping outer skins, and coating hydrophilic coatings; the surface of this little seal wire is smooth, the head end is soft, and the head end is the section closely around there is the development gold wire, and the shadow demonstration is more concentrated to the shadow intensity in certain area has been strengthened, has promoted the development effect greatly.

Description

Interventional therapy medical micro-guide wire and manufacturing method thereof
Technical Field
The invention relates to the technical field of medical instruments, in particular to a medical micro-guide wire for interventional therapy and a manufacturing method thereof.
Background
In the clinical operation process of the cardiac-cerebral surgery, because the blood vessel at the pathological change position is complicated, the surgical instrument and the like can be guided to the pathological change position by using the precise nerve micro-guide wire with smaller diameter frequently, so that the medical care personnel can adopt a more effective treatment operation scheme. The farther the micro-guidewire can be placed into the vessel, the higher the support that can be provided, and the better the possibility and effectiveness of treatment. However, the diameter of the micro guide wire is very small, often 0.014 ″, even smaller, the developing position of the front end needs to be clear, so that the operator can be ensured to be accurately positioned, and therefore the requirement of the micro guide wire with clear front end developing, soft head end and good supporting force on clinic is very large.
The current micro guide wire is mostly developed by adopting a spring sleeve or a point-shaped development or strip-shaped development belt, the current micro guide wire is poor in development effect, if the spring sleeve is used for developing under X-ray tracking, light and shadow are not concentrated, the brightness is not obvious, the point-shaped development or strip-shaped development belt cannot be used for developing at 360 degrees, the development effect is worse, and certain limitation is realized.
Therefore, there is a need for a micro-guidewire with smooth surface, soft tip and sharp tip development.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a medical micro guide wire for interventional therapy and a manufacturing method thereof.
In order to solve the technical problem, the invention is realized by the following scheme: the utility model provides a medical little seal wire of interventional therapy, includes the inner core, the inner core includes transport section, gradual change diameter section and the head end flattish section that integrated into one piece arranged in proper order, it has the development gold wire to closely wind on the head end flattish section, the outer parcel of inner core and development gold wire has the TPU layer, the coating of TPU layer surface has hydrophilic coating.
Further, the inner core is a nickel-titanium alloy wire, and the length of the inner core is 1800-2500 mm.
Further, the diameter of the conveying section is 0.2-0.25 mm, the length of the gradual change diameter section is 150-200 mm, the length of the head end gentle section is 20-50 mm, and the diameter of the head end gentle section is 0.08-0.12 mm.
Furthermore, the winding length of the developing gold wire is 20-50 mm, the diameter of the developing gold wire is 0.03-0.05 mm, and the gold content of the developing gold wire is 99.99%.
Further, the TPU layer is a thermoplastic elastic layer which is extruded and molded through an extruder die, the front end of the micro guide wire is of a spheroid structure, and the diameter of the micro guide wire is 0.3mm or 0.36mm or 0.41mm or 0.48 mm.
Further, the hydrophilic coating is a VEMA hydrophilic coating.
In order to solve the technical defect of poor developing effect in the prior art, the invention provides a method for manufacturing a medical micro guide wire for interventional therapy, which comprises the following steps:
(1) preparing materials:
the length is 1800-2500 mm, and 1 nickel-titanium alloy wire formed in an integrated mode is cast;
1 gold wire with the length of 300mm and the diameter of 0.03-0.05 mm;
(2) and (3) winding a gold wire:
fixing one end of a gold wire at one end of the head end gentle section in a welding or glue fixing mode, and then uniformly and tightly winding the gold wire on the head end gentle section in a winding or manual winding mode through an automatic winding machine, wherein the winding length is controlled within the range of 20-50 mm;
(3) fixing a gold wire:
after the winding is finished, cutting off redundant gold wires, and fixing the other end of the gold wires in the same fixing mode in the step 2;
(4) wrapping with outer skin:
extruding the inner core assembly in the step 3 through an extruder die to coat a TPU outer skin;
(5) coating a hydrophilic coating:
naturally cooling the guide wire in the step 4 to room temperature, and coating the VEMA hydrophilic coating in a dip coating or spray coating mode.
Compared with the prior art, the invention has the beneficial effects that:
(1) the nickel-titanium alloy inner core of the micro guide wire comprises a conveying section, a gradual change diameter section and a head end flat section which are integrally formed and sequentially arranged, wherein the diameter of the conveying section is 0.2-0.25 mm, so that the guide wire has excellent pushing performance and supporting performance.
(2) The developing gold wire is tightly wound on the inner core head end gentle section of the micro-guide wire, the developing gold wire is tightly wound on the head end gentle section in an automatic or manual mode, and due to the tight arrangement of the gold wire, the light and shadow display of the micro-guide wire is concentrated under the tracking of X-rays, so that the light and shadow intensity in a certain area is enhanced, and the developing effect is greatly improved.
Drawings
FIG. 1 is a schematic structural diagram of a medical micro-guide wire for interventional therapy according to the present invention;
FIG. 2 is a schematic view of a gold wire winding of the interventional therapy medical micro-guide wire of the present invention;
FIG. 3 is a schematic view showing the fixed state of the gold wire of the interventional therapy medical micro-guide wire of the present invention;
FIG. 4 is a schematic view of the wrapping and coating of the interventional medical micro-guidewire;
in the drawings: 1. the inner core, 2, the development gold wire, 3, the TPU layer, 4, the hydrophilic coating, 11, the conveying section, 12, the gradual change diameter section, 13, the head end gentle section.
Detailed Description
The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings so that the advantages and features of the invention can be more readily understood by those skilled in the art, and the scope of the invention will be more clearly and clearly defined.
Referring to the attached drawing 1, the interventional therapy medical micro guide wire comprises an inner core 1, wherein the inner core 1 comprises a conveying section 11, a gradually-changed diameter section 12 and a head end gentle section 13 which are integrally formed and sequentially arranged, a developing gold wire 2 is tightly wound on the head end gentle section 13, the outer layers of the inner core 1 and the developing gold wire 2 are wrapped with a TPU layer 3, and the surface of the TPU layer 3 is coated with a hydrophilic coating 4.
The invention has a preferable technical scheme that: the inner core 1 is a nickel-titanium alloy wire, the length of the nickel-titanium alloy wire is 1800-2500 mm, the nickel-titanium alloy wire not only has a unique shape memory function, but also has the excellent characteristics of wear resistance, corrosion resistance, high damping, superelasticity and the like, the characteristics provide excellent pushing performance, supporting performance and bending performance for the micro guide wire, and the micro guide wire can be penetrated into various blood vessels with complex structures.
The invention has a preferable technical scheme that: the diameter of the conveying section 11 is 0.2-0.25 mm, the length of the gradual change diameter section 12 is 150-200 mm, the length of the head end gentle section 13 is 20-50 mm, and the diameter of the head end gentle section 13 is 0.08-0.12 mm.
The invention has a preferable technical scheme that: the winding length of the developing gold wire 2 is 20-50 mm, the diameter of the developing gold wire 2 is 0.03-0.05 mm, the gold content of the developing gold wire 2 is 99.99%, and the higher the gold content of the gold wire is, the better the developing performance is.
The invention has a preferable technical scheme that: the TPU layer 3 is a thermoplastic elastic layer and is formed by extrusion through an extruder die, the front end of the micro guide wire is of a spheroid structure, the diameter of the micro guide wire is 0.3mm or 0.36mm or 0.41mm or 0.48mm, and the smooth guiding performance of the micro guide wire is improved by the front end of the spheroid.
The invention has a preferable technical scheme that: the hydrophilic coating 4 is a VEMA hydrophilic coating, and the VEMA hydrophilic coating improves the biocompatibility of blood and the micro-guide wire and improves the smoothness of the micro-guide wire in the blood.
To make the micro-guidewire of the present invention, and with reference to fig. 2, the present invention is made by a method comprising the steps of:
(1) preparing materials:
1 fusion-casting integrally-formed nickel-titanium alloy wire: the length of the nickel-titanium alloy wire in the preferred embodiment of the invention is 2500mm, the diameter of the conveying section 11 is 0.25mm, the diameter of the head end flat section 13 is 0.1mm, the length of the gradual change diameter section 12 is 180mm, and the length of the head end flat section 13 is 40 mm;
1 gold wire: the length of the gold wire of the preferred embodiment of the invention is 300mm, and the diameter is 0.05 mm;
(2) and (3) winding a gold wire:
one end of the gold wire is fixed at one end of the head end gentle section (13) in a spot welding mode, then the gold wire is uniformly and tightly wound on the head end gentle section (13) in a manual winding mode, the winding length is 30mm, and the distance between the two ends of the gold wire and the two ends of the head end gentle section (13) is ensured to be the same during winding;
(3) fixing a gold wire:
after the gold wire winding is finished, cutting off redundant gold wires, and fixing the other end of the gold wire in a spot welding fixing mode;
(4) wrapping with outer skin:
extruding the inner core assembly in the step 3 through an extruder die to coat the TPU outer skin, wherein the outlet diameter of the extruder is 0.3mm or 0.36mm or 0.41mm or 0.48mm, so as to obtain micro guide wires with different specifications such as 0.3mm/0.36mm/0.41mm/0.48mm, the outlet diameter of the extruder in the preferred embodiment is 0.3mm, and the diameter of the prepared micro guide wire is 0.3 mm.
(5) Coating a hydrophilic coating:
and (4) naturally cooling the micro-guide wire in the step (4) to room temperature, coating a VEMA hydrophilic coating in a dip coating mode, taking out and air-drying to obtain the complete micro-guide wire.
The micro-guide wire of the present invention was compared to the micro-guide wire of the prior art by the following experiment:
animal in vivo experiments: the short sheath with the hemostatic valve is placed in the femoral artery through the femoral artery cannula, and is sent into the micro-guide wire of the invention through the short sheath with the hemostatic valve and the patent application number of the invention: 201510759045.1, in the experimental process, the two types of micro guide wires are pushed, pulled back and guided into the bent blood vessel respectively, and finally, the X-ray tracing is carried out simultaneously, so that the micro guide wires are more labor-saving to push and obviously brighter in developing brightness.
The diameter of the head end gentle section of the micro guide wire is reduced to 0.08-0.12 mm through the gradual-change diameter section, so that the head end of the guide wire is softer, the bending and twisting flexibility of the micro guide wire is enhanced, and the developing gold wires are tightly wound on the head end gentle section.
The above description is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by using the contents of the present specification and the accompanying drawings, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (7)

1. The utility model provides a medical little guide wire of intervention treatment, includes inner core (1), its characterized in that: the inner core (1) includes conveying section (11), gradual change diameter section (12) and head end flattish section (13) that integrated into one piece arranged in proper order, it has development gold wire (2) to closely wind on head end flattish section (13), the outer parcel of inner core (1) and development gold wire (2) has TPU layer (3), TPU layer (3) surface coating has hydrophilic coating (4).
2. The interventional procedure medical micro-guidewire of claim 1, wherein: the inner core (1) is a nickel-titanium alloy wire, and the length of the nickel-titanium alloy wire is 1800-2500 mm.
3. The interventional procedure medical micro-guidewire of claim 1, wherein: the diameter of carrying section (11) is 0.2 ~ 0.25mm, the length of gradual change diameter section (12) is 150mm ~ 200mm, the length of head end gentleness section (13) is 20 ~ 50mm, the diameter of head end gentleness section (13) is 0.08 ~ 0.12 mm.
4. The interventional procedure medical micro-guidewire of claim 1, wherein: the winding length of the developing gold wire (2) is 20-50 mm, the diameter of the developing gold wire is 0.03-0.05 mm, and the gold content of the developing gold wire (2) is 99.99%.
5. The interventional procedure medical micro-guidewire of claim 1, wherein: the TPU layer (3) is a thermoplastic elastic layer and is extruded and molded through an extruder die, the front end of the micro guide wire is of a spheroid structure, and the diameter of the micro guide wire is 0.3mm or 0.36mm or 0.41mm or 0.48 mm.
6. The interventional procedure medical micro-guidewire of claim 1, wherein: the hydrophilic coating (4) is a VEMA hydrophilic coating.
7. A method for manufacturing the interventional therapy medical micro-guide wire according to claims 1 to 6, which comprises the following steps:
(1) preparing materials:
the length is 1800-2500 mm, and 1 nickel-titanium alloy wire formed in an integrated mode is cast;
1 gold wire with the length of 300mm and the diameter of 0.03-0.05 mm;
(2) and (3) winding a gold wire:
one end of a gold wire is fixed at one end of the head end gentle section (13) in a welding or glue fixing mode, then the gold wire is uniformly and tightly wound on the head end gentle section (13) in a winding or manual winding mode through an automatic winding machine, and the winding length is controlled within the range of 20-50 mm;
(3) fixing a gold wire:
after the winding is finished, cutting off redundant gold wires, and fixing the other end of the gold wires in the same fixing mode in the step 2;
(4) wrapping with outer skin:
extruding the inner core assembly in the step 3 through an extruder die to coat a TPU outer skin;
(5) coating a hydrophilic coating:
naturally cooling the guide wire in the step 4 to room temperature, and coating the VEMA hydrophilic coating in a dip coating or spray coating mode.
CN202010114610.XA 2020-02-25 2020-02-25 Interventional therapy medical micro-guide wire and manufacturing method thereof Pending CN111012998A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202010114610.XA CN111012998A (en) 2020-02-25 2020-02-25 Interventional therapy medical micro-guide wire and manufacturing method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202010114610.XA CN111012998A (en) 2020-02-25 2020-02-25 Interventional therapy medical micro-guide wire and manufacturing method thereof

Publications (1)

Publication Number Publication Date
CN111012998A true CN111012998A (en) 2020-04-17

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112972781A (en) * 2021-04-17 2021-06-18 深圳麦普奇医疗科技有限公司 Peripheral blood vessel interventional therapy guide wire
CN114748700A (en) * 2022-04-22 2022-07-15 华南理工大学 Super-hydrophilic coating for TPU coated guide wire and preparation method thereof

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10146390A (en) * 1997-12-05 1998-06-02 Terumo Corp Guide wire
US6019736A (en) * 1995-11-06 2000-02-01 Francisco J. Avellanet Guidewire for catheter
JP2004216130A (en) * 2002-12-27 2004-08-05 Toray Ind Inc Medical guide wire
US20070255217A1 (en) * 2003-09-16 2007-11-01 Abbott Cardiovascular Systems Inc. Textured polymer coated guide wire and method of manufacture
CN105268085A (en) * 2015-11-10 2016-01-27 深圳麦普奇医疗科技有限公司 Hydrophilic micro-guide wire for minimally-invasive intervention and manufacturing method of hydrophilic micro-guide wire
CN205198664U (en) * 2015-12-09 2016-05-04 仇汉诚 Medical equipment and little seal wire thereof
CN107456647A (en) * 2017-08-03 2017-12-12 湖南埃普特医疗器械有限公司 A kind of seal wire and preparation method thereof
CN211935131U (en) * 2020-02-25 2020-11-17 深圳麦普奇医疗科技有限公司 Medical micro guide wire for interventional therapy

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6019736A (en) * 1995-11-06 2000-02-01 Francisco J. Avellanet Guidewire for catheter
JPH10146390A (en) * 1997-12-05 1998-06-02 Terumo Corp Guide wire
JP2004216130A (en) * 2002-12-27 2004-08-05 Toray Ind Inc Medical guide wire
US20070255217A1 (en) * 2003-09-16 2007-11-01 Abbott Cardiovascular Systems Inc. Textured polymer coated guide wire and method of manufacture
CN105268085A (en) * 2015-11-10 2016-01-27 深圳麦普奇医疗科技有限公司 Hydrophilic micro-guide wire for minimally-invasive intervention and manufacturing method of hydrophilic micro-guide wire
CN205198664U (en) * 2015-12-09 2016-05-04 仇汉诚 Medical equipment and little seal wire thereof
CN107456647A (en) * 2017-08-03 2017-12-12 湖南埃普特医疗器械有限公司 A kind of seal wire and preparation method thereof
CN211935131U (en) * 2020-02-25 2020-11-17 深圳麦普奇医疗科技有限公司 Medical micro guide wire for interventional therapy

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112972781A (en) * 2021-04-17 2021-06-18 深圳麦普奇医疗科技有限公司 Peripheral blood vessel interventional therapy guide wire
CN114748700A (en) * 2022-04-22 2022-07-15 华南理工大学 Super-hydrophilic coating for TPU coated guide wire and preparation method thereof

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