CN103861195A - Super-smooth guide wire for use in transradial coronary intervention - Google Patents

Super-smooth guide wire for use in transradial coronary intervention Download PDF

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Publication number
CN103861195A
CN103861195A CN201210570427.6A CN201210570427A CN103861195A CN 103861195 A CN103861195 A CN 103861195A CN 201210570427 A CN201210570427 A CN 201210570427A CN 103861195 A CN103861195 A CN 103861195A
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CN
China
Prior art keywords
wire
seal wire
core
seal
wrapping
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Granted
Application number
CN201210570427.6A
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Chinese (zh)
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CN103861195B (en
Inventor
窦克非
仪克晶
刘智勇
张久礼
吕冬
沈辉
郝升旗
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Shanghai dragon minimally invasive medical equipment Co. Ltd.
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Shanghai Microport Medical Group Co Ltd
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Application filed by Shanghai Microport Medical Group Co Ltd filed Critical Shanghai Microport Medical Group Co Ltd
Priority to CN201210570427.6A priority Critical patent/CN103861195B/en
Priority to PCT/CN2013/087684 priority patent/WO2014090077A1/en
Publication of CN103861195A publication Critical patent/CN103861195A/en
Application granted granted Critical
Publication of CN103861195B publication Critical patent/CN103861195B/en
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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
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core
    • A61M2025/09091Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • 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

Abstract

The invention discloses a super-smooth guide wire for use in transradial coronary intervention. The guide wire comprises a core wire, a winding wire and a jacket, wherein the core wire is positioned on the inner layer of the guide wire; the winding wire is positioned on the middle layer of the guide wire and covers the entire core wire; the near end of the core wire is connected with the near end of the winding wire; the far end of the core wire is in a free state; the jacket is positioned on the outer layer of the guide wire and covers most of the winding wire. Compared with the prior art, the super-smooth guide wire has the advantages that the problems of poor supporting property, poor touch feel feedback, easiness in causing vascular injury and incapability of conveniently and repeatedly entering a catheter and the like of the super-smooth guide wire during transradial coronary intervention diagnosis and treatment are solved, and the comprehensive performance of a radiography guide wire is improved comprehensively.

Description

Trans-radial is got involved superslide seal wire
Technical field
The present invention relates to disposable use medical instruments field, specifically, relate to a kind ofly for coronary artery intervention diagnosis and treatment operation, particularly when trans-radial approach, realize diagnosis and the treatment guiding of conduit in human body and the superslide seal wire of positioning action.
Background technology
Percutaneous coronary is got involved and is referred to through conduit diagnosis degree of stenosis and carry out diagnosis and the Therapeutic Method of respective handling.At present, femoral artery and radial artery are mainly divided in the intervention path of coronary artery intervention diagnosis and treatment operation.1989, the pioneering Experience of Transradial of Canadian doctor Campeau carried out coronarography, and within 1992, Dutch doctor Kiemenij has reported the result that adopts this approach to treat.Along with coronary artery intervention diagnosis and treatment operation popularizing in the world, trans-radial carries out coronary artery intervention and has been widely used in clinical crown cardiopathia intervention diagnosis and treatment, and little with its damage, Local Complications is few, the advantage of perioperatively to anticoagulant, antiplatelet drug little, the postoperative tube drawing immediately of restriction and needn't force to lie in bed 24 hours etc. more " Wicresoft " and patient and get involved doctor's favor extremely.China is carried out coronary artery intervention diagnosis and is treated operation by radial artery path having exceeded 500,000 examples every year at present.
In percutaneous coronary intervention diagnosis and treatment operation, radiography seal wire is a kind of important apparatus, for angiography catheter being imported in blood vessel and resting on the position of appointment.The properties (as: the propelling movement power of the holding power of seal wire, the compliance of seal wire, seal wire etc.) of seal wire is the key factor that whole intervene operation carries out smoothly.
Modal radiography seal wire has traditional stainless steel silk to be wound around seal wire and superslide seal wire (being commonly called as Misgurni anguillicaudati seal wire) in the market.Stainless steel silk is wound around seal wire and adopts helical spring to be wound around the form of core silk, its head end without reducing, hardness are large, compliance is poor, be difficult for by the larger blood vessel of flexibility.In addition, traditional seal wire head end, without reducing, also makes its head end diameter larger, and seal wire is large with blood vessel wall frictional force in intervention procedure, push difficulty, be easy to cause vasospasm.Superslide seal wire has good smoothness because of it, has greatly reduced the propelling movement power of seal wire and has had very strong handling capacity, has obtained more and more doctors' accreditation.But, in superslide seal wire physical arrangement, do not adopt or the local spring wrapping wire design that adopts traditional seal wire, the structure that surface adopts polymer jacket to add hydrophilic coating all covers, its surface is too smooth, operator's feel is not good enough, high smoothness has caused the loss of tactile feedback, easily causes blood vessel injury in the time of intervention diagnosis and treatment.The lighter causes the hemorrhage complications such as local hematoma, and severe one causes osteofascial compartment syndrome to jeopardize patient's life.According to statistics, have at present 5%~8% trans-radial diagnosis and treat operative hemorrhage complication directly or indirectly to be caused by superslide seal wire, the use of superslide seal wire has increased operation risk, for patient has caused unnecessary misery.
At present, on market, in common superslide seal wire, can be divided into the common superslide seal wire of straight type and J type elbow superslide seal wire by head end shape.The former has the remarkable performance of passing through, but its surface is too smooth, in the process pushing, easily causes blood vessel injury.The latter, due to its head end bending, has increased buffering, effectively reduces the damage to blood vessel in propelling movement process.But J type seal wire is after use, and owing to can not head end being straightened by the mode of push-and-pull, inconvenience enters conduit again, increase the fussy degree of operation.In sum, the performance of superslide seal wire remains in open defect at present, possesses very large room for improvement.
Get involved the present situation of the performance of class superslide seal wire according to above-mentioned heart, the main deficiency existing is: when 1) improving smoothness with polymer jacket, other performances of product are reduced, mainly to have reduced seal wire supportive and safety, affect operator's feel, increased the risk of blood vessel injury; 2), although J type elbow superslide seal wire can reduce the risk of blood vessel injury, and inconvenience enters conduit again, increased the fussy degree of operation.
Summary of the invention
The present invention is intended to solve above-mentioned one or more problems of mentioning, and a kind of superslide seal wire that can have good combination property in trans-radial intervention diagnosis and treatment operation process and can repeatedly enter conduit is provided.
According to an aspect of the present invention, provide a kind of seal wire, comprising: core core silk, this core core silk is positioned at the internal layer of seal wire; Wrapping wire, this wrapping wire is positioned at the intermediate layer of seal wire and covers whole core core silk, and wherein, the near-end of core core silk is connected with the near-end of wrapping wire, and the far-end of core core silk is in free state; And sheath, this sheath is positioned at the outer of seal wire and covers the major part of wrapping wire.
Preferably, seal wire also comprises safe core silk, and this safe core silk is between core core silk and wrapping wire, and the near-end of safe core silk is connected with near-end and the far-end of wrapping wire respectively with far-end.
Preferably, seal wire also comprises coating, and this coating is applied on the surface of sheath.
Preferably, the far-end of core core silk is tapered.
Preferably, wrapping wire is helical spring wrapping wire.
Preferably, the part not covered by sheath of wrapping wire is positioned at the subregion at seal wire middle part, can manipulate the camber in wire distal region by this part wrapping wire of push-and-pull.
Preferably, the part not covered by sheath of wrapping wire is positioned at the proximal end region of seal wire, can manipulate the camber in wire distal region by this part wrapping wire of push-and-pull.
Preferably, safe core silk is flat and a side that is positioned at core core silk.
Preferably, core core silk adopts the manufactures of Nitinol, rustless steel, Ti-Nb alloy, Ti-Ni-X alloy, Cu-Zn alloy, Cu-Zn-Ni alloy, Fe-Ni alloy or Fe-Mn alloy.
Preferably, safe core silk is stainless steel silk.
Preferably, sheath is polymer jacket.
Preferably, coating is Teflon, PVP, polyethylene, polypropylene, polrvinyl chloride, polyester, polyamide, polyimides, polyurethanes, polystyrene, Merlon, silicones, fluor resin coating or the composite coating that comprises described any combination thereof.
Preferably, the near-end of core core silk and the near-end of wrapping wire weld together.
Preferably, the near-end of safe core silk and far-end weld together with near-end and the far-end of wrapping wire respectively.
According to a further aspect in the invention, provide a kind of use can repeatedly enter the method for the seal wire of conduit, comprising:
Above-mentioned seal wire is provided;
Make the far-end of seal wire enter in conduit and push seal wire;
When needed, by pulling the part not covered by sheath of described wrapping wire, make the bending of wire distal region, to pass through bending channel;
In the time that operation completes, extract seal wire out;
By promoting the part not covered by sheath of described wrapping wire, wire distal region is straightened, thereby make the far-end of seal wire can again enter conduit.
Compared with prior art, the invention solves trans-radial intervention diagnosis and treatment operation process in superslide seal wire supportive poor, tactile feedback is not good enough, easily cause blood vessel injury, cannot repeatedly enter easily the problems such as conduit, has improved the combination property of radiography seal wire comprehensively.
Brief description of the drawings
Fig. 1 is the longitudinal section schematic diagram according to the seal wire of one embodiment of the present invention;
Fig. 2 is the process schematic diagram that the remote area of seal wire straightens from bending;
Fig. 3 is that after seal wire is drawn out of, its remote area straightens process schematic diagram; And
Fig. 4 is the longitudinal section schematic diagram according to the seal wire of another embodiment of the invention.
Detailed description of the invention
In this manual, same Reference numeral is used for representing same ingredient.
Fig. 1 is the longitudinal section schematic diagram according to the seal wire of one embodiment of the present invention.With reference to Fig. 1, seal wire mainly comprises core core silk 1, wrapping wire 2 and sheath 3.To be elaborated for each in these three parts below.
Core core silk 1 is positioned at the internal layer of seal wire, rounded or any other the suitable shape of its cross section.The far-end of core core silk 1 adopts reducing processing, is preferably and is tapered, and can make like this far-end of seal wire have better compliance, reduces far-end hardness and improve the propelling movement performance of seal wire.The material that core core silk 1 can adopt Nitinol, rustless steel, Ti-Nb alloy, Ti-Ni-X alloy, Cu-Zn alloy, Cu-Zn-Ni alloy, Fe-Ni alloy or Fe-Mn alloy etc. to have excellent in shape memory ability is made, thereby provides good holding power for seal wire.
Wrapping wire 2 is positioned at the intermediate layer of seal wire, and is preferably helical spring wrapping wire.Wrapping wire 2 covers whole core core silk 1, and the near-end of core core silk 1 and the near-end of wrapping wire 2 link together, and the far-end of core core silk 1 is in free state, is coated but does not link together by wrapping wire 2.Preferably, the near-end of core core silk 1 and the near-end of wrapping wire 2 are welded to connect, can certainly adopt such as bonding, other material connected mode such as be clasped.
Sheath 3 is positioned at the outer of seal wire and covers equably the major part of wrapping wire 2.According to the embodiment shown in Fig. 1, except the subregion at seal wire middle part, other region, by sheath 3 uniform folds, that is to say, the part not covered by sheath of wrapping wire 2 is positioned at the subregion at seal wire middle part, can manipulate the camber in wire distal region by this part wrapping wire of push-and-pull.According to the embodiment shown in Fig. 4, except the proximal end region of seal wire, other region, by sheath 3 uniform folds, that is to say, the part not covered by sheath of wrapping wire 2 is positioned at the proximal end region of seal wire, can manipulate the camber in wire distal region by this part wrapping wire of push-and-pull.Those skilled in the art it is also understood that the exposed part of wrapping wire 2 can select according to doctor's different operating custom, and are not limited to above-mentioned two kinds of embodiments.Sheath 3 is preferably polymer jacket, can certainly adopt other suitable material.
According to the structure of above-mentioned seal wire, compared with traditional superslide seal wire, the wrapping wire of seal wire of the present invention has covered whole seal wire, and polymer jacket does not cover completely.Wrapping wire covers whole seal wire and transmits performance in order to handling, the supportive and the moment of torsion that improve seal wire, and can provide good tactile feedback to make feel better.Polymer jacket does not cover completely, that is to say, part wrapping wire is outside exposed, and this makes to pull this part wrapping wire to manipulate the camber in wire distal plastotype region by push-and-pull.In Fig. 2 and Fig. 3, having clearly illustrated by push-and-pull pulls exposed wrapping wire part to adjust the degree of crook in wire distal plastotype region, facilitate seal wire repeatedly to enter conduit, so just solve elbow superslide wire distal well and be difficult for being straightened, increased the problem of operation fussy degree.
Next continue with reference to Fig. 1, except above mentioned three parts, seal wire can also comprise safe core silk 5, and it is covered completely by wrapping wire 2 between core core silk 1 and wrapping wire 2.According to the embodiment shown in Fig. 1, safe core silk 5 is flat and a side that is positioned at core core silk 1, the two ends of safe core silk 5 are connected with near-end and the far-end of wrapping wire 2 respectively, are preferably and weld together, can certainly adopt bonding, other material connected mode such as be clasped.In addition, it may occur to persons skilled in the art that, safe core silk 5 around core core silk 1 ringwise between core core silk 1 and wrapping wire 2.Safe core silk 5 can provide duplicate protection, avoids wrapping wire 2 to rupture and is retained in blood vessel, can also conduct axial tensile force, adjusts the camber in seal wire head end plastotype region.Safe core silk 5 is preferably stainless steel silk, can certainly adopt other suitable material.
Seal wire can also comprise the lip-deep coating 4 that is coated in sheath 3.Coating 4 can be Teflon, PVP, polyethylene, polypropylene, polrvinyl chloride, polyester, polyamide, polyimides, polyurethanes, polystyrene, Merlon, silicones, fluor resin coating or the composite coating that comprises described any combination thereof.
Mention above according to seal wire of the present invention and can repeatedly enter in use conduit, next will be explained.First, make the far-end of seal wire enter in conduit and push seal wire; Then, when needed, by pulling the part not covered by sheath of wrapping wire, make the bending of wire distal region, to pass through smoothly bending channel; In the time that operation completes, extract seal wire out; Then, by promoting the part not covered by sheath of wrapping wire, wire distal region is straightened, thereby the far-end that is conducive to seal wire enter in conduit again.
It will be apparent to those skilled in the art that, can disclosed embodiment be made various modifications and variations and do not departed from the scope of the present invention.Based on this description and the practice to content disclosed herein, those skilled in the art it will also be appreciated that other embodiment.It is only exemplary that this description and example should be counted as, and true scope of the present invention is indicated by claims and equivalent thereof.

Claims (15)

1. a seal wire, comprising:
Core core silk, described core core silk is positioned at the internal layer of seal wire;
Wrapping wire, described wrapping wire is positioned at the intermediate layer of seal wire and covers whole core core silk, and wherein, the near-end of described core core silk is connected with the near-end of wrapping wire, and the far-end of described core core silk is in free state; And
Sheath, described sheath is positioned at the outer of seal wire and covers the major part of described wrapping wire.
2. seal wire according to claim 1, also comprises safe core silk, and described safe core silk is between described core core silk and wrapping wire, and the near-end of described safe core silk is connected with near-end and the far-end of described wrapping wire respectively with far-end.
3. seal wire according to claim 1 and 2, also comprises coating, and described coating is applied on the surface of described sheath.
4. seal wire according to claim 1, wherein, the far-end of described core core silk is tapered.
5. seal wire according to claim 1, wherein, described wrapping wire is helical spring wrapping wire.
6. seal wire according to claim 1, wherein, the part not covered by sheath of described wrapping wire is positioned at the subregion at seal wire middle part, can manipulate the camber in wire distal region by this part wrapping wire of push-and-pull.
7. seal wire according to claim 1, wherein, the part not covered by sheath of described wrapping wire is positioned at the proximal end region of seal wire, can manipulate the camber in wire distal region by this part wrapping wire of push-and-pull.
8. seal wire according to claim 2, wherein, described safe core silk is flat and a side that is positioned at core core silk.
9. seal wire according to claim 1, wherein, described core core silk adopts the manufactures of Nitinol, rustless steel, Ti-Nb alloy, Ti-Ni-X alloy, Cu-Zn alloy, Cu-Zn-Ni alloy, Fe-Ni alloy or Fe-Mn alloy.
10. seal wire according to claim 2, wherein, described safe core silk is stainless steel silk.
11. seal wires according to claim 1, wherein, described sheath is polymer jacket.
12. seal wires according to claim 3, wherein, described coating is Teflon, PVP, polyethylene, polypropylene, polrvinyl chloride, polyester, polyamide, polyimides, polyurethanes, polystyrene, Merlon, silicones, fluor resin coating or the composite coating that comprises described any combination thereof.
13. seal wires according to claim 1, wherein, the near-end of described core core silk and the near-end of wrapping wire weld together.
14. seal wires according to claim 2, wherein, the near-end of described safe core silk and far-end weld together with near-end and the far-end of described wrapping wire respectively.
15. 1 kinds of uses can enter the method for the seal wire of conduit repeatedly, comprising:
Provide according to the seal wire described in independent claims 1;
Make the far-end of seal wire enter in conduit and push seal wire;
When needed, by pulling the part not covered by sheath of described wrapping wire, make the bending of wire distal region, to pass through bending channel;
In the time that operation completes, extract seal wire out;
By promoting the part not covered by sheath of described wrapping wire, wire distal region is straightened, thereby make the far-end of seal wire can again enter conduit.
CN201210570427.6A 2012-12-14 2012-12-14 Trans-radial gets involved superslide seal wire Active CN103861195B (en)

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PCT/CN2013/087684 WO2014090077A1 (en) 2012-12-14 2013-11-22 Transradial intervention super-smooth guidewire

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Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104383632A (en) * 2014-11-28 2015-03-04 中山市普利斯微创介入医械有限公司 Anti-folding central venous catheter
CN104399175A (en) * 2014-11-28 2015-03-11 中山市普利斯微创介入医械有限公司 Anti-folding guide wire
CN104436409A (en) * 2014-11-28 2015-03-25 中山市普利斯微创介入医械有限公司 Anti-folding pigtail catheter
CN106955423A (en) * 2017-03-22 2017-07-18 尚华 A kind of blood vessel fibre-optic catheter
CN106963992A (en) * 2017-03-22 2017-07-21 尚华 A kind of marmem hypotube and its application in blood vessel optical fiber seal wire
CN107362437A (en) * 2017-08-03 2017-11-21 湖南埃普特医疗器械有限公司 A kind of predilation seal wire and preparation method 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
US9869826B1 (en) 2017-03-22 2018-01-16 Hua Shang Magnetic optical fiber coupling device
US9925389B1 (en) 2017-03-22 2018-03-27 Hua Shang Shape memory alloy hypotube and use thereof in a blood vessel optical fiber guide wire
WO2018120451A1 (en) * 2016-12-28 2018-07-05 尚华 Vascular fiber optic guide wire
WO2018170789A1 (en) * 2017-03-22 2018-09-27 尚华 Blood vessel optical fiber catheter
CN110013596A (en) * 2019-04-24 2019-07-16 广州启骏生物科技有限公司 A kind of seal wire for conduit percutaneous puncture
CN110312542A (en) * 2017-03-10 2019-10-08 朝日英达科株式会社 Probe
US10639496B2 (en) 2016-12-28 2020-05-05 Hua Shang Blood vessel optical fiber guide wire
WO2021121293A1 (en) * 2019-12-19 2021-06-24 先健科技(深圳)有限公司 Guide wire, welding device and welding method
CN114618070A (en) * 2022-01-27 2022-06-14 聚辉医疗科技(深圳)有限公司 Micro-guide wire
CN114711955A (en) * 2022-05-11 2022-07-08 上海安通医疗科技有限公司 Electric control ablation catheter for radial artery

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Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104383632A (en) * 2014-11-28 2015-03-04 中山市普利斯微创介入医械有限公司 Anti-folding central venous catheter
CN104399175A (en) * 2014-11-28 2015-03-11 中山市普利斯微创介入医械有限公司 Anti-folding guide wire
CN104436409A (en) * 2014-11-28 2015-03-25 中山市普利斯微创介入医械有限公司 Anti-folding pigtail catheter
US10639496B2 (en) 2016-12-28 2020-05-05 Hua Shang Blood vessel optical fiber guide wire
WO2018120451A1 (en) * 2016-12-28 2018-07-05 尚华 Vascular fiber optic guide wire
CN110312542A (en) * 2017-03-10 2019-10-08 朝日英达科株式会社 Probe
US9925389B1 (en) 2017-03-22 2018-03-27 Hua Shang Shape memory alloy hypotube and use thereof in a blood vessel optical fiber guide wire
US9869826B1 (en) 2017-03-22 2018-01-16 Hua Shang Magnetic optical fiber coupling device
WO2018170787A1 (en) * 2017-03-22 2018-09-27 尚华 Shape memory alloy hypotube and application thereof in blood vessel optical fiber guide wire
WO2018170789A1 (en) * 2017-03-22 2018-09-27 尚华 Blood vessel optical fiber catheter
CN106963992A (en) * 2017-03-22 2017-07-21 尚华 A kind of marmem hypotube and its application in blood vessel optical fiber seal wire
CN106955423B (en) * 2017-03-22 2020-02-04 尚华 Blood vessel optical fiber catheter
CN106955423A (en) * 2017-03-22 2017-07-18 尚华 A kind of blood vessel fibre-optic catheter
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
CN107362437A (en) * 2017-08-03 2017-11-21 湖南埃普特医疗器械有限公司 A kind of predilation seal wire and preparation method thereof
CN110013596A (en) * 2019-04-24 2019-07-16 广州启骏生物科技有限公司 A kind of seal wire for conduit percutaneous puncture
WO2021121293A1 (en) * 2019-12-19 2021-06-24 先健科技(深圳)有限公司 Guide wire, welding device and welding method
CN114618070A (en) * 2022-01-27 2022-06-14 聚辉医疗科技(深圳)有限公司 Micro-guide wire
CN114711955A (en) * 2022-05-11 2022-07-08 上海安通医疗科技有限公司 Electric control ablation catheter for radial artery

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