CN114504722A - Guide wire and guide wire forming method - Google Patents
Guide wire and guide wire forming method Download PDFInfo
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- CN114504722A CN114504722A CN202011286848.7A CN202011286848A CN114504722A CN 114504722 A CN114504722 A CN 114504722A CN 202011286848 A CN202011286848 A CN 202011286848A CN 114504722 A CN114504722 A CN 114504722A
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- 238000000034 method Methods 0.000 title claims abstract description 52
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 241001484259 Lacuna Species 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
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- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
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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
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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)
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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 conical section and a second equal-diameter section which are sequentially connected in a transition mode, and the cross section of the conical 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 conical section and the second equal-diameter section, wherein the polymer sheath exposes the tail end of the second equal-diameter section; sleeving a heat shrinkable tube on the polymer sheath, wherein the length of the heat shrinkable tube is not less than that of the polymer sheath; heating the polymer jacket until the polymer jacket ends melt wrap around the exposed portion of the second radiused section; and removing the heat shrinkable tube. The guide wire and the guide wire forming method provided by the invention solve the problems that when the polymer sheath is formed at the head end of the traditional guide wire, the processing difficulty of a mould is high, the equipment and the mould are complex, the purchase, use and maintenance costs are high, the guide wire head end is too thin to form the guide wire, the product cannot be processed and the like.
Description
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 an emerging therapeutic approach that is intermediate between conventional therapies such as surgery, medicine, and include both intravascular and non-vascular interventions. After more than 30 years of development, the patient is called three-pillar department of surgery and medicine. In brief, the interventional therapy is a minimally invasive treatment method in which a small channel with a diameter of several millimeters is made on a blood vessel and skin or the local part of a lesion is treated under the guidance of an imaging device (an angiography machine, a fluoroscopy machine, a CT, an MR, a B-ultrasound) through an original pipeline of a human body such as a respiratory pipeline and a gastrointestinal pipeline without operating to expose the lesion. The interventional therapy is characterized by small trauma, simplicity, convenience, safety, effectiveness, few complications and obviously shortened hospitalization time.
The guide wire is an indispensable instrument in interventional operation, has the function of introducing a catheter into a blood vessel or other lumens of a body through the skin, and is an important tool for assisting the catheter to selectively enter a tiny blood vessel branch or other lesion lacuna and replacing the catheter in operation. Guidewires are typically composed of a core wire, a spring or polymer sheath, and a coating, among others. The polymer sheath tube is a common part of the guide wire, has the functions of transmitting torque, providing a soft head end under the condition of ensuring the support property and simultaneously having the developing property. The polymer sheath material is generally polyurethane, polyethylene, polypropylene, polyacrylate, aromatic polyester, polysiloxane, etc. The polymer sheath material can synthesize the medical polymer material with good physical and mechanical properties, blood compatibility and biocompatibility by selecting proper soft and hard chain segment structures and proportion thereof. The polymer sheath may be added with metal powders of tungsten, platinum and gold to enhance developability, which are formed by compounding and extrusion.
The polymer sheath tip at the guide wire head end is generally formed by direct extrusion molding through an insert die or heating, cooling and shaping through a die of a tip forming machine, but the two methods are only suitable for forming the tip of the guide wire head end with the diameter of more than 0.7mm, the processing difficulty of the tip forming die of the guide wire head end with the diameter of less than 0.7mm is very high, and the related technology is basically absent in China. In addition, the front end of the guide wire head end is of a gradually changing size, the minimum size reaches below 0.1mm, the tip forming stress is weak, and the forming difficulty is high.
Disclosure of Invention
It is an object of the present invention to provide a guidewire forming method to address one or more of the problems of the prior art.
In order to solve the above technical problem, the present invention provides a guide wire forming method, including:
providing a core wire, wherein the core wire comprises a first equal-diameter section, a conical section and a second equal-diameter section which are sequentially connected in a transition mode, and the cross section of the conical 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 conical section and the second equal-diameter section, wherein the polymer sheath exposes the tail end of the second equal-diameter section;
sleeving a heat shrinkable tube on the polymer sheath, wherein the length of the heat shrinkable tube is not less than that of the polymer sheath;
heating the polymer jacket until the polymer jacket forms a hemispherical end that wraps around the exposed portion of the second radiused section; and the number of the first and second groups,
and removing the heat shrinkable tube.
Optionally, in the method for forming a guidewire, the method for heating the polymer sheath includes:
inclining the core wire to a preset angle, wherein the second equal-diameter section faces downwards;
sequentially heating the polymer jacket from the conical section to the second radiused section.
Optionally, in the method for forming the guide wire, before the polymer sheath is sequentially heated from the conical section to the second equal-diameter section, the method for forming the guide wire further includes:
heating the cone section until the polymer jacket and the heat shrink tube are heat-adhered to the cone section; and the number of the first and second groups,
and stretching the heat shrinkable tube along the length direction of the conical section.
Optionally, in the guide wire forming method, the preset angle is an acute angle.
Optionally, in the guide wire forming method, the preset angle ranges from 30 ° to 45 °.
Optionally, in the guide wire forming method, the length of the heat shrink tube is greater than the length of the polymer sheath, and two ends of the heat shrink tube respectively exceed two ends of the polymer sheath by 5mm to 7 mm.
Optionally, in the guide wire forming method, the length of the exposed portion of the second equal-diameter section is 6mm to 8 mm.
Optionally, in the guide wire forming method, an outer diameter of the polymer sheath is 1.5 to 2 times an outer diameter of the first equal-diameter section.
Optionally, in the guide wire forming method, after removing the heat shrinkable tube, the guide wire forming method further includes:
grinding the reshaped polymer jacket such that an outer diameter dimension of the polymer jacket conforms to an outer diameter of the first radius segment.
The invention also provides a guide wire which is manufactured by adopting the guide wire forming method.
In summary, the guide wire forming method provided by the present invention includes: providing a core wire, wherein the core wire comprises a first equal-diameter section, a conical section and a second equal-diameter section which are sequentially connected in a transition mode, and the cross section of the conical 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 conical section and the second equal-diameter section, wherein the polymer sheath exposes the tail end of the second equal-diameter section; sleeving a heat shrinkable tube on the polymer sheath, wherein the length of the heat shrinkable tube is not less than that of the polymer sheath; heating the polymer jacket until the polymer jacket ends melt wrap around the exposed portion of the second radiused section; and removing the heat shrinkable tube. The guide wire forming method provided by the invention is simple and feasible, and solves the problems that when a polymer sheath is formed at the head end of the traditional guide wire, the processing difficulty of a mould is high, the equipment and the mould are complex, the purchase, use and maintenance costs are high, the guide wire head end is too thin to form the guide wire, the product cannot be processed, and the like.
Drawings
FIG. 1 is a flow chart of a method of forming a guidewire according to an embodiment of the present invention;
FIGS. 2 to 5 are schematic structural views corresponding to steps in the forming process of the guide wire in this embodiment;
wherein the reference numerals are as follows:
100-core filament; 11-a first diameter section; 12-a cone section; 13-a second equal-diameter section; 200-a polymer jacket; 300-heat shrinkable tube; 200' -final polymer jacket.
Detailed Description
The guide wire and the guide wire forming method according to the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.
As shown in fig. 1, the present embodiment provides a guide wire forming method including the steps of:
s11, providing a core wire, wherein the core wire comprises a first constant diameter section, a conical section and a second constant diameter section which are connected in a transition mode in sequence, and the cross section of the conical section is gradually reduced from one end close to the first constant diameter section to one end close to the second constant diameter section;
s12, sleeving a polymer sheath on the conical 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 shrinkable tube on the polymer sheath, wherein the length of the heat shrinkable tube is not less than that of the polymer sheath;
s14, heating the polymer sheath until the tail end of the polymer sheath is fused and wrapped on the exposed part S15 of the second equal-diameter section, and removing the heat shrinkable tube.
The above steps are described in detail below.
First, step S11 is executed, as shown in fig. 2, providing a core wire 100, where the core wire 100 includes a first constant diameter section 11, a conical section 12 and a second constant diameter section 13, which are connected in sequence, and the cross-sectional width of the conical section 12 gradually decreases from an end near the first constant diameter section 11 to an end near the second constant diameter section 13. Since the first equal diameter section 11, the conical section 12 and the second equal diameter section 13 are connected in transition, the diameter of the first equal diameter section 11 is equal to the maximum outer diameter of the conical section 12, and the diameter of the second equal diameter section 13 is equal to the minimum outer diameter of the conical section 12.
Generally, the diameter of the second equal-diameter section 13 is small, even less than 0.1mm, so that the second equal-diameter section 13 can bear weak force, and the polymer sheath is difficult to form on the second equal-diameter section 13.
Next, step S12 is executed, as shown in fig. 3, a polymer sheath 200 is sleeved on the conical section 12 and the second equal-diameter section 13, the polymer sheath 200 exposes a portion of the end of the second equal-diameter section 13, where the end of the second equal-diameter section 13 is the head end of the core wire 100, so that when the polymer sheath 200 is heated subsequently, the end of the polymer sheath 200 is melted and wraps the exposed portion of the second equal-diameter section 13 to form a head end hemispherical ball head. Preferably, the length of the exposed portion of the second equal-diameter section 13 is 6mm to 8mm, for example, 6mm, 7mm, 8mm, etc.
Preferably, the outer diameter of the polymer sheath 200 is 1.5 times to 2 times, for example, 1.5 times, 1.8 times, 2 times, etc. of the outer diameter of the first equal-diameter section 11, and the wall thickness of the polymer sheath 200 is enough to allow the polymer sheath 200 to be sleeved on the tapered section 12, so that the outer diameter of the polymer sheath 200 reshaped after heating is only slightly larger than the outer diameter of the first equal-diameter section 11, and thus, the time for grinding the reshaped polymer sheath 200 can be shortened when the reshaped polymer sheath 200 is ground to have the same outer diameter as the outer diameter of the first equal-diameter section 11.
Next, step S13 is executed, as shown in fig. 4, a heat shrinkable tube 300 is sleeved on the polymer sheath 200, and the length of the heat shrinkable tube 300 is not less than the length of the polymer sheath 200, so that the heat shrinkable tube 300 can bind all the polymer sheath 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 sheath 200, and both ends of the heat shrinkable tube 300 respectively exceed both ends of the polymer sheath 200 by 5mm to 7mm, for example, respectively exceed 5mm, 6mm, 7mm, etc., so as to facilitate the removal of the heat shrinkable tube 300 after the polymer sheath 200 is reshaped.
Next, step S14 is executed to heat the polymer sheath 200 until the exposed portion of the second equal-diameter section 13 is wrapped by the polymer sheath 200, and the heating is stopped. The melted polymer jacket 200 forms a rounded hemispherical ball head at the exposed portion of the second radiused section 13 due to the space constraint of the heat shrink tube 300 and the surface attraction of the polymer.
In step S14, the method for heating the polymer sheath 200 may specifically include: inclining the core wire 100 to a preset angle with the second equal-diameter section 13 facing downwards; the polymer jacket 200 is heated sequentially from the conical section 12 to the second radiused section 13. Preferably, the preset angle is an acute angle, and preferably, the preset angle ranges from 30 ° to 45 °, for example, 30 °, 40 °, 45 °, and the like.
In this embodiment, a heat gun may be used to heat the polymer sheath 200. In other embodiments, other heating methods, such as high temperature baking, may be used. The manner in which the polymer jacket 200 is heated is not a limitation of the present application.
When the polymer sheath 200 is heated, there is an inevitable uneven heating of the polymer sheath 200, so that the polymer sheath 200 melts slowly at some positions and the polymer sheath 200 melts rapidly at some positions, and thus the polymer sheath 200 has unevenness in the same circumferential direction after the polymer sheath 200 is reshaped. In this embodiment, the core wire 100 is inclined to a preset angle, the second equal-diameter section 13 faces downward, so that the polymer sheath 200 flows downward after being melted, and the polymer sheath 200 is heated by sequentially heating the second equal-diameter section 13 from the tapered section 12, and the heat shrinkable tube 300 is heated to shrink so as to accelerate the flow of the polymer sheath 200, so that the condition that the polymer sheath 200 after being reshaped has unevenness in the same circumferential direction can be effectively improved.
In addition, in this embodiment, preferably, before the polymer sheath 200 is sequentially heated from the conical section 12 to the second equal-diameter section 13, the method for forming the guide wire further includes: heating said conical section 12 until said polymer jacket 200 and said heat shrink tubing 300 are heat attached to said conical section 12; and stretching the heat shrinkable tube 300 in a length direction of the tapered section 12. The conical section 12 is heated to fix one ends of the polymer sheath 200 and the heat shrinkable tube 300 on the conical section 12, and then the other end of the heat shrinkable tube 300 is only required to be stretched to prevent the polymer sheath 200 from deforming, so that the operation process is simple and feasible.
After the polymer jacket 200 is reshaped, step S15 is performed to remove the heat shrinkable tube 300.
In addition, after removing the heat shrinkable tube 300, the method for forming a guide wire according to the present embodiment further includes: the reshaped polymer jacket 200 is ground such that the final outer diameter dimension of the polymer jacket 200' corresponds to the diameter of the first radius segment 11.
In order to meet the size of the final polymer sheath 200', it is generally required that the outer diameter of the polymer sheath 200 reshaped by heating is not smaller than the diameter of the first diameter section 11, for example, when the diameter of the first diameter section 11 is 0.44mm, the outer diameter of the polymer sheath 200 reshaped by heating may be 0.5mm to 0.7mm, and then the reshaped polymer sheath 200 is ground by using a grinding tool so that the outer diameter of the final polymer sheath 200' is consistent with the diameter of the first diameter section 11.
Preferably, when the reshaped polymer sheath 200 is ground, the processing length of the grinding tool is identical to the length of the reshaped polymer sheath 200. The polymer sheath 200 is generally 8cm and 12cm long, and the common grinding wheel, guide wheel and workpiece support are all combinations with processing length larger than 15cm, so that the part of the core wire 100 which does not need to be processed can be damaged if the core wire is not replaced; if the processing length of the grinding tool such as the grinding wheel, the guide wheel and the workpiece support is shorter than 8cm, the ground head end can extend out of the grinding constraint part too long in the grinding process, and the guide wire head end is easy to bend and damage in the grinding and rotating process. Therefore, grinding wheels, guide wheels and workpiece supports with machining lengths equal to 8cm and 12cm are selected.
Preferably, in the embodiment, a grinding wheel with good thermal conductivity, a surface which is not easy to adhere, and fine sand which is not easy to fall off is selected, such as a CBN grinding wheel, a diamond grinding wheel, a SiC grinding wheel and the like, and the grinding wheel can quickly transmit grinding heat in the grinding process, so that the grinding material is not adhered to the abrasive particles, the unloading is convenient, and the grinding loss of the abrasive 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 fully poured in the grinding process, the generated heat is taken away, and the temperature of the grinding area is kept at a lower level to the maximum extent; in the grinding process, the rotating speed of the guide wheel of the grinding machine is selected to control the grinding rotating speed and the feed speed of the core wire 100, the rotating speed is matched with the speed of the grinding wheel, heat generation in the grinding process is reduced, and the best grinding effect is achieved. The milled guidewire is shown in fig. 5.
In conclusion, the guide wire forming method provided by the invention adopts the thermal shrinkage process to wrap the polymer protective sleeve on the core wire, so that the processing and maintenance costs of a protective sleeve type guide wire tip forming die and equipment which are less than 0.7mm are saved; the method has the advantages that the proper sizes of the polymer sheath and the heat shrinkable tube and the heat shrinkable position are selected, the flow direction of the polymer sheath is controlled, the polymer sheath has a better forming effect, the whole operation is simple and feasible, and the problems that the mold processing difficulty is large, the equipment and the mold are complex, the purchasing and using cost and the maintenance cost are high, the guide wire head end is too thin to form, the product cannot be processed and the like in the traditional guide wire head end polymer sheath tip forming method are solved.
The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.
Claims (10)
1. A method of forming a guidewire, comprising:
providing a core wire, wherein the core wire comprises a first equal-diameter section, a conical section and a second equal-diameter section which are sequentially connected in a transition mode, and the cross section of the conical 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 conical section and the second equal-diameter section, wherein the polymer sheath exposes the tail end of the second equal-diameter section;
sleeving a heat shrinkable tube on the polymer sheath, wherein the length of the heat shrinkable tube is not less than that of the polymer sheath;
heating the polymer jacket until the polymer jacket ends melt wrap around the exposed portion of the second radiused section;
and removing the heat shrinkable tube.
2. The method of forming a guidewire as in claim 1, wherein heating the polymer jacket comprises:
inclining the core wire to a preset angle, wherein the second equal-diameter section faces downwards;
sequentially heating the polymer jacket from the conical section to the second radiused section.
3. The method of forming a guidewire as in claim 2, further comprising, prior to sequentially heating the polymer jacket from the conical section to the second radiused section:
heating the cone section until the polymer jacket and the heat shrink tube are heat-adhered to the cone section; and the number of the first and second groups,
and stretching the heat shrinkable tube along the length direction of the conical section.
4. The method of forming a guidewire as in claim 2, wherein the predetermined angle is an acute angle.
5. The method of forming a guidewire as in claim 2, wherein the predetermined angle is in a range of 30 ° to 45 °.
6. The method of forming a guidewire as in claim 1, wherein the heat shrinkable tube has a length greater than a length of the polymer jacket and wherein ends of the heat shrinkable tube extend 5mm to 7mm beyond the ends of the polymer jacket.
7. The method of forming a guidewire as in claim 1, wherein the exposed portion of the second radiused segment has a length between 6mm and 8 mm.
8. The method of forming a guidewire as in claim 1, wherein the polymer jacket has an outer diameter that is between 1.5 and 2 times an outer diameter of the first diameter segment.
9. The method of forming a guidewire as in claim 1, further comprising, after removing the heat shrink tubing:
grinding the reshaped polymer jacket such that an outer diameter of the polymer jacket coincides with an outer diameter of the first radius section.
10. A guide wire produced by the guide wire forming method according to any one of claims 1 to 9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011286848.7A CN114504722B (en) | 2020-11-17 | 2020-11-17 | Guide wire and guide wire forming method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011286848.7A CN114504722B (en) | 2020-11-17 | 2020-11-17 | Guide wire and guide wire forming method |
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| CN114504722A true CN114504722A (en) | 2022-05-17 |
| CN114504722B CN114504722B (en) | 2024-01-23 |
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Citations (6)
| 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 |
| US20050096567A1 (en) * | 2003-10-30 | 2005-05-05 | Scimed Life Systems, Inc. | Guidewire having an embedded matrix polymer |
| US20070299366A1 (en) * | 2006-06-08 | 2007-12-27 | Sharrow James S | Guidewire with polymer jacket and method of making |
| 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 |
| US20200306509A1 (en) * | 2019-03-28 | 2020-10-01 | Lake Region Medical, Inc. | Guidewire and method therefor |
-
2020
- 2020-11-17 CN CN202011286848.7A patent/CN114504722B/en active Active
Patent Citations (6)
| 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 |
| US20050096567A1 (en) * | 2003-10-30 | 2005-05-05 | Scimed Life Systems, Inc. | Guidewire having an embedded matrix polymer |
| US20070299366A1 (en) * | 2006-06-08 | 2007-12-27 | Sharrow James S | Guidewire with polymer jacket and method of making |
| 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 |
| US20200306509A1 (en) * | 2019-03-28 | 2020-10-01 | Lake Region Medical, Inc. | Guidewire and method therefor |
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| Publication number | Publication date |
|---|---|
| CN114504722B (en) | 2024-01-23 |
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