CN114504722B - Guide wire and guide wire forming method - Google Patents

Guide wire and guide wire forming method Download PDF

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Publication number
CN114504722B
CN114504722B CN202011286848.7A CN202011286848A CN114504722B CN 114504722 B CN114504722 B CN 114504722B CN 202011286848 A CN202011286848 A CN 202011286848A CN 114504722 B CN114504722 B CN 114504722B
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section
diameter section
polymer sheath
polymer
equal
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CN114504722A (en
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刘宇星
王美贤
祝学元
谭家宏
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Shanghai Microport Longmai Medical Equipment Co ltd
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Shanghai Microport Longmai Medical Equipment Co ltd
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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

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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 provides a guide wire and a guide wire forming method, comprising the following steps: providing a core wire, wherein the core wire comprises a first equal-diameter section, a cone section and a second equal-diameter section which are connected in turn in a transitional manner, and the cross section width of the cone section is gradually reduced from one end close to the first equal-diameter section to one end close to the second equal-diameter section; sleeving a polymer sheath on the cone section and the second equal diameter section, wherein the polymer sheath exposes the tail end of the second equal diameter section; sleeving a heat shrinkage tube on the polymer sheath, wherein the length of the heat shrinkage tube is not less than that of the polymer sheath; heating the polymer sheath until the polymer sheath tip melts around the exposed portion of the second constant diameter section; and removing the heat shrinkage tube. The guide wire and the guide wire forming method solve the problems that the traditional guide wire end is difficult to process when forming a polymer sheath, the equipment and the mould are complex, the purchase, use and maintenance cost is high, the guide wire end is too thin to form, the product cannot be processed and the like.

Description

Guide wire and guide wire forming method
Technical Field
The invention relates to the technical field of medical instruments, in particular to a guide wire and a guide wire forming method.
Background
Interventional procedures are emerging therapeutic approaches intermediate to conventional therapies such as surgery, internal medicine, including endovascular and non-vascular interventional procedures. Over 30 years of development, it has now been known as the three major supportive disciplines along with surgery and internal medicine. In short, the interventional therapy is a minimally invasive treatment method for locally treating the focus under the guidance of image equipment (angiography machine, fluoroscopy machine, CT, MR, B ultrasonic) by making a micro-channel with a diameter of a few millimeters on blood vessels and skin or by using the original pipelines of a human body such as respiratory pipelines, gastrointestinal pipelines and the like under the condition of exposing the focus without opening the operation. The interventional therapy is characterized by small trauma, simplicity, safety, effectiveness, less complications and obviously shortened hospitalization time.
A guidewire is an indispensable instrument in interventional procedures, has the effect of introducing a catheter percutaneously into a blood vessel or other lumen of the body, and is an important tool to assist the catheter in selectively accessing small vessel branches or other diseased lumens, and to replace the catheter during procedures. The guidewire is typically comprised of a core wire, a spring or polymer sheath, a coating, and the like. The polymer sheath is a common component of a guide wire, has torque transmission, provides a soft head end under the condition of ensuring support, and has development. The polymer sheath material is generally polyurethane, polyethylene, polypropylene, polyacrylate, aromatic polyester, polysiloxane, etc. The polymer sheath material can be synthesized into medical polymer materials with good physical and mechanical properties, blood compatibility and biocompatibility by selecting proper soft and hard chain segment structures and proportions thereof. The polymer sheath can be added with metal powder such as tungsten, platinum, gold and the like to enhance developability, and the polymer sheath is formed by extrusion of a mixture.
The shaping of the tip end of the polymer sheath of the spinneret end is generally carried out by direct extrusion molding through an insert die or die heating, cooling and shaping of a tip shaping machine, but the two methods are only suitable for shaping the tip end of the spinneret end with the diameter of more than 0.7mm, and the processing difficulty of the shaping die of the tip end of the spinneret end with the diameter of less than 0.7mm is very high, so that no related technology exists in China basically. In addition, the front end of the thread guiding end is gradually changed in size, the minimum size is less than 0.1mm, the forming stress of the tip is weak, and the forming difficulty is high.
Disclosure of Invention
The present invention is directed to a method of forming a guidewire that overcomes one or more of the problems of the prior art.
In order to solve the above technical problems, the present invention provides a method for forming a guide wire, comprising:
providing a core wire, wherein the core wire comprises a first equal-diameter section, a cone section and a second equal-diameter section which are connected in turn in a transitional manner, and the cross section width of the cone section is gradually reduced from one end close to the first equal-diameter section to one end close to the second equal-diameter section;
sleeving a polymer sheath on the cone section and the second equal diameter section, wherein the polymer sheath exposes the tail end of the second equal diameter section;
sleeving a heat shrinkage tube on the polymer sheath, wherein the length of the heat shrinkage tube is not less than that of the polymer sheath;
heating the polymer sheath until the polymer sheath forms a hemispherical tip surrounding an exposed portion of the second constant diameter section; the method comprises the steps of,
and removing the heat shrinkage tube.
Optionally, in the method for forming a guide wire, the method for heating the polymer sheath includes:
tilting the core wire to a preset angle, wherein the second constant diameter section faces downwards;
and heating the polymer sheath from the conical section to the second constant diameter section in sequence.
Optionally, in the method for forming a guide wire, before sequentially heating the polymer sheath from the taper section to the second constant diameter section, the method for forming a guide wire further includes:
heating the cone section until the polymer sheath and the heat shrinkage tube are thermally attached to the cone section; the method comprises the steps of,
and stretching the heat-shrinkable tube along the length direction of the cone section.
Optionally, in the method for forming a guide wire, the preset angle is an acute angle.
Optionally, in the method for forming a guide wire, the preset angle is in a range of 30 ° to 45 °.
Optionally, in the method for forming a guide wire, the length of the heat-shrinkable tube is greater than the length of the polymer sheath, and two ends of the heat-shrinkable tube respectively exceed two ends of the polymer sheath by 5mm to 7mm.
Optionally, in the guidewire forming method, the exposed portion of the second constant diameter section has a length of 6mm to 8mm.
Optionally, in the method of forming a guide wire, the outer diameter of the polymer sheath is 1.5-2 times the outer diameter of the first constant diameter section.
Optionally, in the method for forming a guide wire, after removing the heat shrinkable tube, the method further includes:
grinding the reshaped polymeric sheath such that the outer diameter dimension of the polymeric sheath is consistent with the outer diameter of the first constant diameter section.
The invention also provides a guide wire which is manufactured by adopting the guide wire forming method.
In summary, the method for forming a guide wire provided by the invention comprises the following steps: providing a core wire, wherein the core wire comprises a first equal-diameter section, a cone section and a second equal-diameter section which are connected in turn in a transitional manner, and the cross section width of the cone section is gradually reduced from one end close to the first equal-diameter section to one end close to the second equal-diameter section; sleeving a polymer sheath on the cone section and the second equal diameter section, wherein the polymer sheath exposes the tail end of the second equal diameter section; sleeving a heat shrinkage tube on the polymer sheath, wherein the length of the heat shrinkage tube is not less than that of the polymer sheath; heating the polymer sheath until the polymer sheath tip melts around the exposed portion of the second constant diameter section; and removing the heat shrinkage tube. The guide wire forming method provided by the invention is simple and feasible, and solves the problems that the traditional guide wire end is difficult to process when forming a polymer sheath, the equipment and the mould are complex, the purchase, use and maintenance cost is high, the guide wire end is too thin to form, the product cannot be processed and the like.
Drawings
FIG. 1 is a flow chart of a method of forming a guidewire in this embodiment;
FIGS. 2 to 5 are schematic views of the structures corresponding to the steps in the process of forming the guide wire in the present embodiment;
wherein, each reference sign is explained as follows:
100-core wire; 11-a first constant diameter section; 12-cone section; 13-a second constant diameter section; 200-a polymer sheath; 300-heat shrinkage tube; 200' -final polymer sheath.
Detailed Description
The guide wire and the method of forming the guide wire according to the present invention will be described in further detail with reference to the accompanying drawings and examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.
As shown in fig. 1, the present embodiment provides a guide wire forming method, which includes the steps of:
s11, providing a core wire, wherein the core wire comprises a first equal-diameter section, a cone section and a second equal-diameter section which are sequentially connected in a transitional manner, and the cross section width of the cone section is gradually reduced from one end close to the first equal-diameter section to one end close to the second equal-diameter section;
s12, sleeving a polymer sheath on the cone section and the second equal diameter section, wherein the polymer sheath exposes the tail end of the second equal diameter section;
s13, sleeving a heat shrinkage tube on the polymer sheath, wherein the length of the heat shrinkage tube is not less than that of the polymer sheath;
and S14, heating the polymer sheath until the tail end of the polymer sheath is melted to wrap the exposed part S15 of the second constant diameter section, and removing the heat shrinkage tube.
The above steps are described in detail below.
First, step S11 is performed, as shown in fig. 2, a core wire 100 is provided, where the core wire 100 includes a first constant diameter section 11, a taper section 12 and a second constant diameter section 13 that are sequentially connected in transition, and the taper section 12 gradually decreases in cross-sectional width from one end near the first constant diameter section 11 to one end near the second constant diameter section 13. Because the first constant diameter section 11, the conical section 12 and the second constant diameter section 13 are in transitional connection, the diameter of the first constant diameter section 11 is equal to the maximum outer diameter of the conical section 12, and the diameter of the second constant diameter section 13 is equal to the minimum outer diameter of the conical section 12.
Generally, because the diameter of the second constant diameter section 13 is small, even less than 0.1mm, the second constant diameter section 13 is made to be weak, and thus the polymer jacket is difficult to form in the second constant diameter section 13.
Next, step S12 is performed, as shown in fig. 3, a polymer sheath 200 is sleeved on the taper section 12 and the second constant diameter section 13, where a portion of the end of the second constant diameter section 13 is exposed by the polymer sheath 200, and the end of the second constant diameter section 13 is the head end of the core wire 100, so that when the polymer sheath 200 is heated subsequently, the exposed portion of the second constant diameter section 13 is melt-wrapped by the end of the polymer sheath 200 to form a head end hemispherical ball. Preferably, the exposed portion of the second constant diameter section 13 has a length of 6mm to 8mm, for example, 6mm, 7mm, 8mm, etc.
Preferably, the outer diameter of the polymer sheath 200 is 1.5-2 times that of the first constant diameter section 11, for example, may be 1.5, 1.8, 2 times that of the first constant diameter section 11, and the wall thickness of the polymer sheath 200 may be enough to allow the polymer sheath 200 to be sleeved on the taper section 12, so that the outer diameter of the polymer sheath 200 after being heated and reformed is only slightly larger than that of the first constant diameter section 11, so that the time for grinding the reformed polymer sheath 200 can be shortened when the outer diameter of the reformed polymer sheath 200 is equal to that of the first constant diameter section 11.
Next, step S13 is performed, as shown in fig. 4, to sleeve a heat shrinkage tube 300 on the polymer sheath 200, where the length of the heat shrinkage tube 300 is not less than the length of the polymer sheath 200, so that the heat shrinkage tube 300 can bind all the polymer sheaths 200, thereby defining the shape of the reshaped polymer sheath 200.
Preferably, the length of the heat shrinkable tube 300 is greater than the length of the polymer jacket 200, and the two ends of the heat shrinkable tube 300 respectively exceed the two ends of the polymer jacket 200 by 5 mm-7 mm, for example, may respectively exceed the two ends of the polymer jacket 200 by 5mm, 6mm, 7mm, etc., so as to facilitate the removal of the heat shrinkable tube 300 after the polymer jacket 200 is reformed.
Then, step S14 is performed to heat the polymer sheath 200 until the exposed portion of the second constant diameter section 13 is wrapped by the polymer sheath 200, and the heating is stopped. The melted polymer jacket 200 forms a rounded hemispherical bulb at the exposed portion of the second constant diameter section 13 due to the spatial confinement of the heat shrink tube 300 and the surface attraction of the polymer.
In step S14, the method for heating the polymer jacket 200 may specifically include: tilting the core wire 100 to a preset angle, the second constant diameter section 13 facing downward; the polymer jacket 200 is heated sequentially from the cone segment 12 to the second constant diameter segment 13. Preferably, the preset angle is an acute angle, and preferably, the range of the preset angle is 30 ° to 45 °, for example, 30 °, 40 °, 45 °, and the like.
In this embodiment, a heat gun may be used to heat the polymer jacket 200. In other embodiments, other heating means, such as high temperature baking, etc., may be used. The manner in which the polymer jacket 200 is heated is not limiting of the present application.
When the polymer sheath 200 is heated, the polymer sheath 200 inevitably has uneven heating, so that some positions of the polymer sheath 200 melt slowly, and some positions of the polymer sheath 200 melt faster, so that after the polymer sheath 200 is reformed, the polymer sheath 200 has unevenness in the same circumferential direction. In this embodiment, by tilting the core wire 100 to a preset angle, the second constant diameter section 13 is downward, so that the polymer sheath 200 can flow downward after melting, and the polymer sheath 200 is heated from the taper section 12 to the second constant diameter section 13 in sequence, so that the heat shrinkage tube 300 is heated to shrink and accelerate the flow of the polymer sheath 200, and the situation that the polymer sheath 200 after being reformed has roughness in the same circumferential direction can be effectively improved.
In addition, in the present embodiment, preferably, before the polymer sheath 200 is heated sequentially from the tapered section 12 to the second constant diameter section 13, the method for forming a guide wire further includes: heating the cone segment 12 until the polymer jacket 200 and the heat shrink tubing 300 are thermally attached to the cone segment 12; and stretching the heat shrinkable tube 300 along the length direction of the cone section 12. The taper section 12 is heated to fix one end of the polymer sheath 200 and one end of the heat shrinkage tube 300 on the taper section 12, and then the other end of the heat shrinkage tube 300 is stretched to prevent the polymer sheath 200 from deforming, so that the operation process is simple and feasible.
After the polymer jacket 200 is reformed, step S15 is performed to remove the heat shrink tubing 300.
In addition, after the heat shrinkable tube 300 is removed, the method for forming a guide wire according to the present embodiment further includes: the reshaped polymer sheath 200 is ground so that the outer diameter dimension of the final polymer sheath 200' corresponds to the diameter of the first constant diameter section 11.
In order to make the final polymer jacket 200 'have a size that meets the specification, it is generally necessary that the outer diameter of the polymer jacket 200 reformed by heating is not smaller than the diameter of the first constant diameter section 11, for example, when the diameter of the first constant diameter section 11 is 0.44mm, the outer diameter of the polymer jacket 200 reformed by heating may be 0.5mm to 0.7mm, and then the reformed polymer jacket 200 is ground by a grinding tool so that the outer diameter size of the final polymer jacket 200' coincides with the diameter of the first constant diameter section 11.
Preferably, when the reformed polymer jacket 200 is ground, the grinding tool has a machining length corresponding to the length of the reformed polymer jacket 200. The length of the polymer sheath 200 is generally 8cm and 12cm, and the common grinding wheel, the guide wheel and the workpiece support are all combinations with processing lengths of more than 15cm, so that the positions of the core wire 100 which do not need to be processed can be damaged if the combination is not replaced; if the machining length of the grinding tool such as a grinding wheel, a guide wheel and a workpiece support is shorter than 8cm, the ground head end stretches out of the grinding constraint part too much in the grinding process, so that the guide head end is easy to bend and damage in the grinding rotation process. Therefore, grinding wheels, guide wheels and workpiece supports with machining lengths equal to 8cm and 12cm are selected.
Further preferably, in the embodiment, a grinding wheel with good heat conductivity, difficult adhesion of the surface and fine and difficult falling off of sand grains is selected, such as a CBN grinding wheel, a diamond grinding wheel, a SiC grinding wheel and the like, and the grinding wheel can rapidly transfer grinding heat in the grinding process, so that the grinding material is not adhered to the grinding particles, the grinding material is discharged conveniently, and the grinding loss of the grinding particles of the grinding wheel is reduced; in addition, the fully-synthetic water-soluble cutting fluid is selected, so that the grinding area can be rapidly cooled, cleaned and protected, meanwhile, the cutting fluid is guaranteed to be fully poured in the grinding process, generated heat is taken away, and the temperature of the grinding area is kept at a lower level to the greatest extent; in the grinding process, the rotation speed of the grinding machine guide wheel is properly selected, so that the grinding rotation speed and the feeding speed of the core wire 100 are controlled to be matched with the grinding wheel speed, the heat generation in the grinding process is reduced, and the best grinding effect is achieved. The guide wire after grinding is shown in fig. 5.
In summary, according to the guide wire forming method provided by the invention, the polymer sheath tube is wrapped on the core wire by adopting the thermal shrinkage process, so that the processing and maintenance cost of a sheath type guide wire tip forming die and equipment below 0.7mm is saved; the method has the advantages that the proper polymer sheath and the heat shrinkage tube size and the heat shrinkage position are selected, the flowing direction of the polymer sheath is controlled, the polymer sheath has better forming effect, the whole operation is simple and feasible, and the problems that the die processing difficulty is high, the equipment and the die are complex, the purchase, use and maintenance cost are high, the spinneret end is too thin to form, the product cannot be processed and the like in the traditional spinneret end polymer sheath tip forming method are solved.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.

Claims (8)

1. A method of forming a guidewire, comprising:
providing a core wire, wherein the core wire comprises a first equal-diameter section, a cone section and a second equal-diameter section which are connected in turn in a transitional manner, and the cross section width of the cone section is gradually reduced from one end close to the first equal-diameter section to one end close to the second equal-diameter section;
sleeving a polymer sheath on the cone section and the second equal diameter section, wherein the polymer sheath exposes the tail end of the second equal diameter section;
sleeving a heat shrinkage tube on the polymer sheath, wherein the length of the heat shrinkage tube is not less than that of the polymer sheath;
heating the polymer sheath until the polymer sheath tip melts around the exposed portion of the second constant diameter section;
removing the heat shrinkage tube;
wherein the method of heating the polymer jacket comprises:
tilting the core wire to a preset angle, wherein the second constant diameter section faces downwards;
and heating the polymer sheath from the conical section to the second constant diameter section in sequence.
2. The guidewire forming method of claim 1, wherein prior to sequentially heating the polymer jacket from the tapered section to the second constant diameter section, the guidewire forming method further comprises:
heating the cone section until the polymer sheath and the heat shrinkage tube are thermally attached to the cone section; the method comprises the steps of,
and stretching the heat-shrinkable tube along the length direction of the cone section.
3. The guidewire forming method of claim 1, wherein the predetermined angle is an acute angle.
4. The guidewire forming method of claim 1, wherein the predetermined angle is in the range of 30 ° to 45 °.
5. The guidewire forming method of claim 1, wherein the heat shrink tube has a length greater than the length of the polymer jacket and two ends of the heat shrink tube extend 5mm to 7mm beyond the two ends of the polymer jacket, respectively.
6. The guidewire forming method of claim 1, wherein the exposed portion of the second constant diameter section has a length of 6mm to 8mm.
7. The guidewire forming method of claim 1, wherein the outer diameter of the polymer jacket is 1.5-2 times the outer diameter of the first constant diameter section.
8. The guidewire forming method of claim 1, wherein after removing the heat shrink tube, the guidewire forming method further comprises:
grinding the reshaped polymeric sheath such that the outer diameter of the polymeric sheath is consistent with the outer diameter of the first constant diameter section.
CN202011286848.7A 2020-11-17 2020-11-17 Guide wire and guide wire forming method Active CN114504722B (en)

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CN114504722B true CN114504722B (en) 2024-01-23

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR844723A (en) * 1937-10-14 1939-07-31 Ici Ltd Improvements in the manufacture of electric cables
CN107320838A (en) * 2017-07-17 2017-11-07 佛山市迪华科技有限公司 The forming method and equipment of a kind of PCI seal wire
CN109173012A (en) * 2018-11-14 2019-01-11 苏州海维尔医疗器械有限公司 Anti-scratch superslide seal wire, its method for coating and coating equipment

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7553287B2 (en) * 2003-10-30 2009-06-30 Boston Scientific Scimed, Inc. Guidewire having an embedded matrix polymer
US7651578B2 (en) * 2006-06-08 2010-01-26 Boston Scientific Scimed, Inc. Guidewire with polymer jacket and method of making
US20200306509A1 (en) * 2019-03-28 2020-10-01 Lake Region Medical, Inc. Guidewire and method therefor

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR844723A (en) * 1937-10-14 1939-07-31 Ici Ltd Improvements in the manufacture of electric cables
CN107320838A (en) * 2017-07-17 2017-11-07 佛山市迪华科技有限公司 The forming method and equipment of a kind of PCI seal wire
CN109173012A (en) * 2018-11-14 2019-01-11 苏州海维尔医疗器械有限公司 Anti-scratch superslide seal wire, its method for coating and coating equipment

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