CN107362437A - A kind of predilation seal wire and preparation method thereof - Google Patents
A kind of predilation seal wire and preparation method thereof Download PDFInfo
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- CN107362437A CN107362437A CN201710657274.1A CN201710657274A CN107362437A CN 107362437 A CN107362437 A CN 107362437A CN 201710657274 A CN201710657274 A CN 201710657274A CN 107362437 A CN107362437 A CN 107362437A
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- seal wire
- core filaments
- safety net
- sheath
- coating
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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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- 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
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
-
- 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
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
-
- 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
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A61M2025/0046—Coatings for improving slidability
-
- 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
- A61M2025/09008—Guide wires having a balloon
-
- 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
- A61M2025/09058—Basic structures of guide wires
- A61M2025/09083—Basic structures of guide wires having a coil around a core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09108—Methods for making a guide wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
-
- 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
- A61M2025/09166—Guide wires having radio-opaque features
-
- 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
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
-
- 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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
This application discloses a kind of seal wire, including distal end, near-end, it is additionally provided with core filaments, the core filaments are in seal wire, and extend to the distal end from the near-end of seal wire, the core filaments are provided with expansion position, and the diameter at the expansion position is more than the diameter of the core filaments, and the head end that the core filaments are located at the distal end is provided with safety net and is fixedly connected with the safety net.The application also provides a kind of preparation method of seal wire.The present invention sets up safety net by being located at the head end of distal end in core filaments, reduces the loss of seal wire torsion/moment of torsion transmission, while " whipping " phenomenon is eliminated, ensures the flexibility and non-deformability of wire distal；Simultaneously as set expansion position on seal wire, narrow positions due to radial support acts on and by predilation, narrow positions inner chamber is become big, so as to facilitate sacculus to pass through narrow positions.And the expansion position transition of predilation seal wire is very round and smooth, soft, wound will not be caused to blood vessel.
Description
Technical field
The application is related to technical field of medical instruments, more particularly to a kind of predilation seal wire of intravascular Interventional Treatment
And preparation method thereof.
Background technology
Cardiovascular and cerebrovascular disease is the number one killer of modern society's health, and the number of cardiovascular and cerebrovascular disease is died from the whole world every year
Up to 15,000,000 people, it is the first to occupy the various causes of the death.PCI is current clinical treatment coronary atherosclerotic heart disease
Main Means, stenotic lesion can be effectively treated by intervening implantation foley's tube or support, recovers normal blood circulation, protects
Demonstrate,prove blood supply.
Seal wire be in interventional medical device in indispensable auxiliary products, be widely used in medical interventions
In, play guide rail and positioning action into human organ for various intervention catheters and implantation instrument.Implementing the mistake of operation
Cheng Zhong, the true chamber of seal wire intravasation is needed first, the sacculus for pre-installing support is then sent to vascular lesion position, such as fruit disease along seal wire
It is severely narrow to become position, sacculus possibly can not by narrow section, therefore, need to first with a Radical extensin seal wire pre-expansion narrow positions,
Sacculus is passed through again, so as to carry out subsequent procedures, can so be shortened operating time, be improved success rate of operation.
Existing seal wire is mainly made up of core filaments, sheath and coating, in order to ensure the rigidity of guidewire proximal, increase distal end (head
End) flexibility and conveniently by complications blood vessel, core filaments overall diameter proximally arrive interlude to distally be sequentially reduced, still
The reduction of core filaments diameter, though head end can be made more soft, also simultaneously the cross-sectional area of head end core filaments is substantially reduced, causes to lead
Torsion, the moment of torsion heavy losses of silk, when rotating guidewire proximal, moment of torsion can not 1:1 transmission.Moment of torsion is hoarded in distal end somewhere,
When continuing to rotate seal wire, moment of torsion discharges suddenly, causes wire distal that jump, the phenomenon of whipping occurs, influences wire distal and exist
The control in direction in blood vessel.Another important performance of seal wire is that the ability of integrality is remained during manipulation, and clinic should
Hemadostewnosis position or elsewhere is easily stuck in middle seal wire, at this moment generally require removes its safety by pullling guidewire proximal
Go out, if seal wire non-deformability is insufficient, easily lead to head end lengthening deformation or fracture, influence the safety progress of operation.
The content of the invention
In order to solve the above technical problems, first purpose of the present invention is provide a kind of predilation seal wire, of the invention the
Two purposes are to provide the preparation method of above-mentioned predilation seal wire.The present invention sets up safety by being located at the head end of distal end in core filaments
Net, increase the cross-sectional area of wire distal, reduce the loss of seal wire torsion/moment of torsion transmission, while " whipping " phenomenon is eliminated,
Ensure the flexibility and non-deformability of wire distal, simultaneously as setting expansion position on seal wire, possess tapering transition section,
Diameter becomes larger, narrow positions due to radial support acts on and by predilation, narrow positions inner chamber is become big, so as to facilitate ball
Capsule passes through narrow positions.And the expansion position transition of predilation seal wire is very round and smooth, soft, wound will not be caused to blood vessel.
Technical scheme provided by the invention is as follows：
A kind of seal wire, including distal end, near-end, are additionally provided with core filaments, and the core filaments are in seal wire, and from the described near of seal wire
End extends to the distal end, and the core filaments are provided with expansion position, and the diameter at the expansion position is more than the diameter of the core filaments,
The head end that the core filaments are located at the distal end is provided with safety net and is fixedly connected with the safety net.
Preferably, the core filaments or safety net are closed by Nitinol, stainless steel, cobalt-base alloys, Fe-Mn alloys, Cu-Zn
One or more materials in gold, Fe-Ni alloy/C are made.
Preferably, the safety net is 50- by the braiding preparation of 6-20 one metal wires, or by cuts in metallic pipe to void density
It is prepared by 300PPI.
Preferably, the distal end of the safety net is located at the head end of the distal end with the core filaments with near-end and passes through resistance respectively
Welding, soldering, ultrasonic bonding, laser welding, any of it is bonded, is clasped mode and connect.
Preferably, sheath is additionally provided with, for the sheath on the outside of the safety net, the core filaments are located at the head of the distal end
End is coaxially disposed with the safety net, sheath.
Preferably, the sheath is in the mixing sheath of turn sheath, polymer jacket, or turn and polymer
It is any.
Preferably, development spring is provided with the safety net or sheath, or provided with one or more developing marks, it is described
Development spring or developing mark are prepared using any of platinum-tungsten alloys, platinum-nickel alloy, platinumiridio, gold material.
Preferably, the expansion position is proximally and distally provided with tapering transition section with the joining place of the core filaments, described
Position is expanded apart from the core sheath proximal end 1-20mm, a diameter of 0.35-0.80mm at the expansion position, the expansion position
A diameter of 0.35-0.80mm partial-length is 5-20mm, and the expansion position is proximally and distally connected with the core filaments
The tapering transition segment length that place is set is respectively 10-30mm.
Preferably, the seal wire is additionally provided with coating, and the coating covers the part surface or all surfaces of the seal wire, institute
It is hydrophilic coating or hydrophobic coating to state coating, and the hydrophilic coating is polyvinylpyrrolidone coating, polyoxyethylene ene coatings, thoroughly
Any of bright acid esters acrylic acid coatings or polymethyl vinyl ether-maleic anhydride coating；The hydrophobic coating is polytetrafluoro
Any of vinyl coating, silicone coating.
The present invention also provides the method for preparing above-mentioned predilation seal wire, comprises the following steps：
1) core filaments are made：Grinding prepares core filaments, keeps the diameter at expansion position to be more than the diameter of the core filaments；
2) make and assemble safety net：Metal wire knitted or cuts in metallic pipe prepare safety net；Safety net is sleeved on core
On silk, keep core filaments to be coaxially disposed with safety net, pass through resistance welding, soldering, ultrasonic bonding, laser welding, bonding, buckle
Core filaments are connected by any of cooperation method with safety net；
3 make and assemble sheath：Turn sheath in sheath is prepared by filament winding device, and/or, the polymer in sheath
Sheath is prepared by melt process；By sheath on safety net, keep core filaments, safety net, sheath to be coaxially disposed, pass through resistance
Welding, soldering, ultrasonic bonding, laser welding, any of it is bonded, is clasped method and connect core filaments, safety net, sheath
Connect；
4) applying coating：Using spraying or semar technique in seal wire surface coatings.
Predilation seal wire includes distal end, near-end, is distally part of the seal wire away from operator, typically refers to seal wire and enter blood
Part in pipe；Near-end be seal wire close to the part of operator, the part for being often referred to not intravasation and being operated by operator.Lead
Silk an important performance be moment of torsion transmission ability, most preferably 1:1 torque responsive ability, i.e., when operator's operation seal wire is near
When end rotation is turned around, wire distal is driven also to have an identical to rotate.And when wire distal head end (i.e. core filaments positioned at distally
Head end) when being gradually reduced, the transmission of moment of torsion is affected diameter, easily there is " whipping " phenomenon.
" whipping " phenomenon refers to when rotating guidewire proximal, and moment of torsion can not 1:1 transmission and hoard in distal end somewhere, suddenly
Discharge and cause head end jump or the phenomenon of whipping of distal end.In order to prevent " whipping " phenomenon from occurring, cause surgical procedure not smooth
Or influence patient health, the present invention provides a kind of new technical scheme and eliminates " whipping " phenomenon, including in seal wire, from seal wire
Near-end extends to the core filaments of wire distal, and is located at the safety net that the head end of the distal end sets in core filaments.The core of the present invention
Silk runs through whole seal wire, and the head of through wire distal, and the head end that the distal end is then located in core filaments sets safety net, kept away
Exempt from core filaments and do not reach the deficiency that seal wire caused by head end turns round control property.And safety net is coaxially disposed with core filaments, is deposited inside safety net
In part core filaments, seal wire intensity is enhanced, improves reliability, the danger for effectively avoiding safety net from being broken or come off.Safety net
The head end of fixed core filaments distal end can be played a part of by setting, and is made head end easily moulding and kept energy with good plastotype
Power, safety net make seal wire have excellent torsion control, eliminate " wagging the tail " effect.
In the solution of the present invention, head end direction of the diameter of core filaments from the near-end towards the distal end can be set gradual
Reduce, make the head end of wire distal there is good flexibility, be more easy to through vessel branch.The core filaments are located at the distal end
Head end can be arranged to tapered, parabolic type, streamlined, or any of homalocephalus shape such as ellipse, class ellipse, be easy to
The movement of seal wire in the blood vessel, reduce the possibility of loss blood vessel, good compliance and push performance are provided for seal wire.
Meanwhile the present invention expands position by being set on predilation seal wire, seal wire is previously threaded through narrow positions, so as to
Reach the purpose of predilation, solve the problems, such as that other apparatuses such as sacculus, support are difficult to by excessive stenotic lesion position, so as to contract
Short operating time, improve success rate of operation.When predilation seal wire reaches stenotic lesion position, wire distal because diameter is small and
Narrow positions is passed through, but the expansion position of seal wire possesses tapering transition section, and diameter becomes larger, and narrow positions is due to radially
Supporting role and by predilation, narrow positions inner chamber is become big, so as to facilitate sacculus to pass through narrow positions.And predilation seal wire
The transition of expansion position it is very round and smooth, soft, wound will not be caused to blood vessel.
The head end of wire distal can set linear pattern, may also set up in certain Prebending type, to adapt to clinical different diseases
Become the operation requirement in area.
Technical scheme compared with prior art, has advantages below：
1st, in the present invention, the head end of the through wire distal of core filaments, and safety net is arranged, increase the head end of wire distal
Cross-sectional area, reduce torsion, the loss of machine of torque of seal wire, so as to eliminate " whipping " phenomenon；
2nd, safety net both ends are fixedly connected with core filaments, the ability for enhance seal wire head end Resisting fractre, coming off；
3rd, the head end of predilation wire distal sets core filaments size smaller, therefore has head end flexibility concurrently.
4th, predilation seal wire can be with predilation narrow positions, and soft not blood trouble pipe.
5th, predilation seal wire preparation method is simple, easily realize, can change as needed expansion position diameter and
Seal wire global design is not influenceed.
In the present invention, safety net is more soft for the internal solid cylinder compared to same diameter using latticed, and
With the resistance to deformation intensity close to internal solid cylinder structure.The head end of core filaments distal end sets safety net, can lead whole predilation
Silk has flexibility, non-deformability and good moment of torsion transitivity concurrently.Coordinate sheath, coating simultaneously, seal wire has been taken into account head
Hold flexibility, remarkable handling and resistance to deformation characteristic, it is suppressed that the jump that predilation seal wire head end occurs when moment of torsion transmits
Or " whipping " phenomenon, the head end of predilation wire distal are easy to repeatedly moulding and have good plastotype confining force, the parent on surface
Water coating causes seal wire to have good lubricity and tracking performance again.The predilation seal wire surface of the present invention is smooth, and head end is soft
It is soft easily it is moulding, and can pre-expansion hemadostewnosis position, be easy to other intervention apparatus pass through diseased region, predilation seal wire expansion
Position transition is round and smooth, soft, hurtless measure.In addition, the preparation method is simple, easily realize and cost is relatively low.
Brief description of the drawings
, below will be to embodiment or existing in order to illustrate more clearly of the embodiment of the present application or technical scheme of the prior art
There is the required accompanying drawing used in technology description to be briefly described, it should be apparent that, drawings in the following description are only this
Some embodiments described in application, for those of ordinary skill in the art, on the premise of not paying creative work,
Other accompanying drawings can also be obtained according to these accompanying drawings.
Fig. 1 is a kind of structural representation (linear pattern head end) of predilation seal wire in the embodiment of the present invention；
Fig. 2 is another structural representation (Prebending type head end) of predilation seal wire in the embodiment of the present invention；
Fig. 3 is the schematic cross-section of predilation wire distal in the embodiment of the present invention；
Fig. 4 is the use state diagram of predilation seal wire in the embodiment of the present invention；
Reference：1- distal ends；2- near-ends；3- core filaments；301- expands position；4- safety nets；5- sheaths；6- coatings.
Embodiment
In order that those skilled in the art more fully understand the technical scheme in the application, it is real below in conjunction with the application
The accompanying drawing in example is applied, the technical scheme in the embodiment of the present application is clearly and completely described, it is clear that described implementation
Example only some embodiments of the present application, rather than whole embodiments.It is common based on the embodiment in the application, this area
The every other embodiment that technical staff is obtained under the premise of creative work is not made, it should all belong to the application protection
Scope.
Please as shown in Figures 1 to 4, the embodiment of the present invention provides a kind of seal wire, including distal end 1, near-end 2, is additionally provided with core filaments
3, the core filaments 3 extend to the distal end 1 in seal wire, and from the near-end 2 of seal wire, and the core filaments 3 are provided with expansion
Position 301, the diameter at the expansion position 301 are more than the diameter of the core filaments 3, and the core filaments 3 are located at the head end of the distal end 1
It is fixedly connected provided with safety net 4 and with the safety net 4.
Predilation seal wire includes distal end 1, near-end 2, and distal end 1 is part of the seal wire away from operator, typically refers to seal wire and enters
Enter the part in blood vessel；Near-end 2 be seal wire close to the part of operator, the portion for being often referred to not intravasation and being operated by operator
Point.One important performance of seal wire is the ability of moment of torsion transmission, most preferably 1:1 torque responsive ability, i.e., when operator operates
When guidewire proximal rotation is turned around, wire distal is driven also to have an identical to rotate.And when head end (the i.e. core filaments 3 of wire distal
Positioned at distal end 1 head end) diameter be gradually reduced when, the transmission of moment of torsion receives influences, easily appearance " whipping " phenomenon.
" whipping " phenomenon refers to when rotating guidewire proximal, and moment of torsion can not 1:1 transmission and hoard in distal end somewhere, suddenly
Discharge and cause head end jump or the phenomenon of whipping of distal end.In order to prevent " whipping " phenomenon from occurring, cause surgical procedure not smooth
Or influence patient health, the present invention provides a kind of new technical scheme and eliminates " whipping " phenomenon, including in seal wire, from seal wire
Near-end extends to the core filaments 3 of wire distal, and is located at the safety net 4 that the head end of the distal end 1 sets in core filaments 3.The present invention
Core filaments 3 run through whole seal wire, and the head of through wire distal, the head end that the distal end 1 then be located in core filaments 3 sets and pacified
The whole network 4, avoid core filaments 3 and do not reach the deficiency that seal wire caused by head end turns round control property.And safety net 4 is coaxially disposed with core filaments 3, peace
Part core filaments 3 inside the whole network 4 be present, enhance seal wire intensity, improve reliability, effectively avoid safety net 4 from being broken or come off
It is dangerous.The setting of safety net 4 can play a part of the head end of fixed core filaments distal end, and make head end easily moulding and have good
Plastotype holding capacity, safety net 4 makes seal wire have excellent torsion control, eliminates " wagging the tail " effect.
In the solution of the present invention, the diameter of core filaments 3 can be set from the near-end 2 towards the head end direction of the distal end 1
It is gradually reduced, makes the head end of wire distal there is good flexibility, is more easy to through vessel branch.The core filaments 3 are positioned at described
Distally 1 head end can be arranged to tapered, parabolic type, streamlined, or any in the homalocephalus shape such as ellipse, class ellipse
Kind, it is easy to the movement of seal wire in the blood vessel, reduces the possibility of loss blood vessel, good compliance and pushability are provided for seal wire
Energy.
Meanwhile the present invention expands position 301 by being set on predilation seal wire, seal wire is previously threaded through narrow positions,
So as to reach the purpose of predilation, solve the problems, such as that other apparatuses such as sacculus, support are difficult to by excessive stenotic lesion position, from
And shorten operating time, improve success rate of operation.When predilation seal wire reaches stenotic lesion position, wire distal is due to diameter
It is small and pass through narrow positions, but the expansion position 301 of seal wire possesses tapering transition section, and diameter becomes larger, narrow positions
Due to radial support effect by predilation, narrow positions inner chamber is set to become big, so as to facilitate sacculus to pass through narrow positions.It is and pre-
It is very round and smooth, soft to expand the transition of expansion position 301 of seal wire, wound will not be caused to blood vessel.
The head end of wire distal can set linear pattern, may also set up in certain Prebending type, to adapt to clinical different diseases
Become the operation requirement in area.
Preferably, the core filaments 3 or safety net 4 are closed by Nitinol, stainless steel, cobalt-base alloys, Fe-Mn alloys, Cu-Zn
One or more materials in gold, Fe-Ni alloy/C are made.
The core filaments 3 and safety net 4 of predilation seal wire can by Nitinol, stainless steel, cobalt-base alloys, Fe-Mn alloys,
One or more materials in Cu-Zn alloys, Fe-Ni alloy/C are made, it is possible to use other suitably prepare the material of seal wire.Prepare
The material of seal wire should have outstanding durability, reverse the performance such as controlling and tracing property, and good support is provided for seal wire
Power and push power.And material surface should it is smooth, clean, without scab, crackle, scuffing etc. are harmful to patient the defects of.High intensity
Core filaments 3 can be provided for seal wire good holding power and push power.The making of core filaments 3 can use physics grinding or chemistry to carve
The methods of erosion or technology.In actual applications, the length of core filaments 3 can be 1000-4000mm.
Preferably, the safety net 4 is woven by 6-20 one metal wires and prepared, or is by cuts in metallic pipe to void density
It is prepared by 50-300PPI.,
Safety net 4 can weave or cut into different mesh-densities according to the demand of the head end different soft and hard degree of wire distal
(PPI), in the present invention, safety net 4 can be woven by 6-20 one metal wires and be prepared, or be by cuts in metallic pipe to void density
It is prepared by 50-300PPI.When need seal wire head end it is harder when, the twine head number (wire used of safety net 4 can be increased
Number), or increase twine sectional dimension；Conversely, when need seal wire head end it is softer when, it is possible to reduce the net of safety net 4
Silk head number, or reduce the sectional dimension of twine 4.
Preferably, the distal end of the safety net 4 is located at the head end of the distal end 1 with the core filaments 3 with near-end and passed through respectively
Resistance welding, soldering, ultrasonic bonding, laser welding, any of it is bonded, is clasped mode and connect.
Safety net 4 is located at the head end of the distal end 1 located at core filaments 3, and safety net 4 is fixedly connected with core filaments 3.Generally, pacify
After the whole network 4 is prepared by metal wire knitted or cuts in metallic pipe, it is arranged with core filaments 3, and passing through resistance welding, soldering, ultrasonic wave
Welding, laser welding, any of it is bonded, is clasped mode and be fixedly connected with core filaments 3.Safety net 4 can be connected to and lead
The head end optional position of silk distal end.And the distal end of safety net is fixedly connected with near-end both ends with core filaments, seal wire head end is enhanced
Resisting fractre, the ability to come off.Avoid the core filaments 3 of seal wire insufficient without the torsion control of head end therefore is reached, or seal wire head end is compiled
The risk that knitmesh is easily broken off, come off with the welding of the tip of core filaments 3.In the present embodiment, the distal end of safety net 4 and near-end respectively with core
The distal end of silk 3 is welded together in parallel.In the present embodiment, the mesh-density of safety net 4 is uniformly distributed.
In the present invention, the twine cross section of the safety net 4 can be circular or square, generally set the net of safety net 4
Silk circular cross section a diameter of 0.01-0.06mm, square cross-sectional dimension 0.01*0.01-0.01*0.06mm.The safety
The length of net 4 can be 10-50mm.And safety net 4, the cross section of its each twine is circular or square, or other
Irregular shape.
Material, head number, size and the position of safety net 4 can according to seal wire flexibility, non-deformability, moment of torsion transmission with
And moulding ability of head end etc. is required and customized.The head end of wire distal sets safety net 4, enhances moment of torsion transfer performance, eliminates
The possibility of " whipping " phenomenon occurs for the head end of wire distal when moment of torsion transmits.
Preferably, sheath 5 is additionally provided with, the sheath 5 is located at the distal end located at the outside of safety net 4, the core filaments 3
1 head end is coaxially disposed with the safety net 4, sheath 5.
The present invention sets up sheath 5 in the outside of safety net 4, can avoid the structure of safety net 4 to blood vessel or lesion
The stimulation or harmful effect in region.Core filaments 3, safety net 4 and sheath 5 are coaxially disposed, and are mutually connected to each other so that core
Silk 3 and safety net 4 have the stability that rotates in a circumferential direction, and the seal wire of the present invention is placed in the blood vessel of distortion, when rotating guidewire proximal,
Distal end will be had equal or close to 1:1 torque feedback, eliminate moment of torsion transmit when wire distal head end occur jump or
" whipping " phenomenon.
Preferably, the sheath 5 is in turn sheath, polymer jacket, or the mixing sheath of turn and polymer
It is any.
Sheath 5 can use any in turn sheath, polymer jacket, or the mixing sheath of turn and polymer
Kind, it can also use other suitable materials.Turn sheath can improve tactile feedback capability, but frictional force is larger；And polymer
Jacket surface is smooth, improves the handling capacity of seal wire, but tactile feedback capability is low compared with turn sheath.Using turn with polymerizeing
The mixing sheath of thing can improve the support force and traceability of seal wire with volume.Which kind of material sheath is specifically prepared using, can be according to institute
For focus difference selected.Polymer jacket can be used in polyurethane, PLA, nylon elastomer, polyether-ether-ketone
Any material.
Preferably, development spring is provided with the safety net 4 or sheath 5, or provided with one or more developing marks, institute
Development spring or developing mark is stated to prepare using any of platinum-tungsten alloys, platinum-nickel alloy, platinumiridio, gold material.
Development spring can be set in sheath 5, development spring is fixedly connected with the turn of sheath 5, or by the bullet that develops
Spring is fixed on safety net 4.Connected mode can match somebody with somebody for resistance welding, soldering, ultrasonic bonding, laser welding, bonding, buckle
Any of conjunction, bolt connection.In the present embodiment, using laser welding, laser energy 0.2-30J.
Development spring is generally arranged at the end of wire distal, visuality of the increase seal wire under X-ray, increases successful surgery
Rate.Turn in sheath 5, and development spring can be formed using coiling machine coiling.For example, wrapping wire diameter 0.02-
0.15mm, coiling machine rotating speed are about 1-10n/s, and pitch 0.01-0.05mm, spring overall length is 10-30mm.
Developing mark can be separately provided, and can also coordinate development spring to set.One or more developing marks are generally set,
Such as 1-3 developing mark.When developing mark coordinates development spring to set, developing mark can be arranged on to sheath 5 close to seal wire
One end of near-end.Developing mark can develop under X-ray, and increase is visual.Coordinate development spring can be by one section of wire distal
Development comes out, and is easy to operation to carry out.In the present embodiment, sheath 5 is encircled for protection for development spring and stainless steel spring and covers both connections
Composition, wherein, development spring is close to the end of wire distal.
Preferably, the joining place proximally and distally with the core filaments 3 at the expansion position 301 is provided with tapering transition section,
The expansion position 301 apart from the core sheath 5 near-end 1-20mm, a diameter of 0.35-0.80mm at the expansion position 301,
The partial-length of expansion 301 a diameter of 0.35-0.80mm of position is 5-20mm, the distal end at the expansion position 301 and near
The tapering transition segment length that the joining place of end and the core filaments 3 is set is respectively 10-30mm.
The expansion diameter of position 301 of the seal wire is more than the diameter at other positions of seal wire, and expansion position 301 is apart from the core
The near-end 1-20mm of sheath 5, and tapering transition section is provided with, to ensure that the distal end of seal wire first passes through lesion narrow zone, then pass through
Tapering transition section slowly expands lesion narrow zone.The needs performed the operation according to lesion region, can change desired seal wire enlarged portion
The diameter of position.
Preferably, the seal wire is additionally provided with coating 6, and the coating 6 covers the part surface or all surfaces of the seal wire,
The coating 6 is hydrophilic coating or hydrophobic coating, and the hydrophilic coating is polyvinylpyrrolidone coating, polyethylene glycol oxide painting
Any of layer, transparent acid esters acrylic acid coatings or polymethyl vinyl ether-maleic anhydride coating；The hydrophobic coating is poly-
Any of tetrafluoroethene coating, silicone coating.
Seal wire sets coating 6, and coating covers the part surface or all surfaces of the seal wire.Coating 6 is arranged on sheath 5
Outer layer, and extend to the near-end of seal wire.Coating 6 can cover all surfaces of seal wire, can also be located at seal wire from sheath 5 to
The part surface of guidewire proximal.When coating 6 is hydrophilic coating, such as polyvinylpyrrolidone coating, polyoxyethylene ene coatings, transparent
When any of acid esters acrylic acid coatings or polymethyl vinyl ether-maleic anhydride coating, hydrone can be attracted in its table
Face forms gelatinous surface, and reduce seal wire passes through resistance so that and seal wire has extraordinary lubricity and tracking performance, so as to
Reduce the passage resistance of seal wire in the blood vessels, make seal wire be easy to push.Seal wire is hydrophobic coating, such as polytetrafluorethylecoatings coatings, silicon
During any of oil coating, hydrone can be resisted, forms " wax-like " surface, reduces friction, increases the tracking performance of seal wire.
The present invention also provides the method for preparing above-mentioned predilation seal wire, comprises the following steps：
1) core filaments are made：Grinding prepares core filaments 3, keeps the diameter at expansion position 301 to be more than the diameter of the core filaments 3；
2) make and assemble safety net：Metal wire knitted or cuts in metallic pipe prepare safety net 4；Safety net 4 is sleeved on
In core filaments 3, keep core filaments 3 be coaxially disposed with safety net 4, by resistance welding, soldering, ultrasonic bonding, laser welding, glue
Method any of is connect, is clasped to be connected core filaments 3 with safety net 4；
3 make and assemble sheath：Turn sheath in sheath 5 is prepared by filament winding device, and/or, it is poly- in sheath (5)
Compound sheath is prepared by melt process；By sheath 5 on safety net 4, core filaments 3, safety net 4, sheath 5 is kept coaxially to set
Put, by resistance welding, soldering, ultrasonic bonding, laser welding, be bonded, the method that any of is clasped by core filaments 3,
Safety net 4, sheath 5 connect；
4) applying coating：Using spraying or semar technique in seal wire surface coatings 6.
In preparation method in the present invention, the size of core filaments 3 prepared by step 1) can be：It is a diameter of to expand position 301
0.35-0.80mm, expansion 301 a diameter of 0.35-0.80mm of position partial-length is 5-20mm, the expansion position 301
The tapering transition segment length proximally and distally set with the joining place of the core filaments 3 is respectively 10-30mm, and the length of core filaments 3 is
1000-4000mm, a diameter of 0.15-0.4mm.In step 3), when sheath 5 is using turn sheath, the parameter of wrapping wire preparation
Can be：Wrapping wire diameter 0.02-0.12mm, wrapping wire rotating speed 1-50n/s, pitch 0.01-0.05mm, the long 10- of turn sheath
30mm。
Preparation method provided by the invention, it is simple to operate, be easily achieved, and the diameter at expansion position can be changed as needed
Size is without influenceing seal wire global design.The predilation seal wire completed is prepared, should check whether each part connection fastens, if
There is the position for coming off, being broken.Such as check coating 6 outward appearance have it is without exception.
The seal wire of the present invention, the section of head end, is core filaments 3, safety net 4, sheath 5, coating 6 successively from inside to outside.Core filaments 3
Positioned at seal wire innermost layer；Safety net 4 is located at seal wire intermediate layer and the head end of covering part core filaments 3；Sheath 5 is located at seal wire outer layer, covers
Cover whole safety net 4 and part core filaments 3；Coating 6 is located at seal wire outermost layer, covers whole sheath 5 and most of core filaments 3.This hair
It is bright to increase the cross-sectional area of wire distal by setting up safety net 4 in the head end of core filaments 3, reduce seal wire torsion/moment of torsion transmission
Loss, while " whipping " phenomenon is eliminated, ensures the flexibility and non-deformability of wire distal.
In the present invention, the use of safety net 4 is latticed, more soft compared to for the filled circles system of same diameter, and
And with the resistance to deformation intensity close to internal solid cylinder structure.The head end of the distal end of core filaments 3 sets safety net 4, can make whole pre-expansion
Open seal wire and have flexibility, non-deformability and good moment of torsion transitivity concurrently.Coordinate sheath 5, coating 6 simultaneously, make seal wire simultaneous
Head end flexibility, remarkable handling and resistance to deformation characteristic are cared for, it is suppressed that predilation seal wire head end occurs when moment of torsion transmits
Jump or " whipping " phenomenon, the head end of predilation wire distal be easy to repeatedly moulding and there is good plastotype confining force, table
The hydrophilic coating in face causes seal wire to have good lubricity and tracking performance again.The predilation seal wire surface of the present invention is smooth,
Head end is soft easily moulding, and can pre-expansion hemadostewnosis position, be easy to other intervention apparatus to be led by diseased region, predilation
The silk expansion transition of position 301 is round and smooth, soft, hurtless measure.In addition, the preparation method is simple, easily realize and cost is relatively low.
The foregoing description of the disclosed embodiments, professional and technical personnel in the field are enable to realize or using the present invention.
A variety of modifications to these embodiments will be apparent for those skilled in the art, as defined herein
General Principle can be realized in other embodiments without departing from the spirit or scope of the present invention.Therefore, it is of the invention
The embodiments shown herein is not intended to be limited to, and is to fit to and principles disclosed herein and features of novelty phase one
The most wide scope caused.
Claims (10)
1. a kind of seal wire, including distal end (1), near-end (2), it is characterised in that be additionally provided with core filaments (3), the core filaments (3) are located at and led
In silk, and the distal end (1) is extended to from the near-end (2) of seal wire, the core filaments (3) are provided with expansion position (301), institute
The diameter for stating expansion position (301) is more than the diameter of the core filaments (3), and the head end that the core filaments (3) are located at the distal end (1) is set
There is safety net (4) and be fixedly connected with the safety net (4).
2. seal wire according to claim 1, it is characterised in that the core filaments (3) or safety net (4) by Nitinol, no
One or more materials in rust steel, cobalt-base alloys, Fe-Mn alloys, Cu-Zn alloys, Fe-Ni alloy/C are made.
3. seal wire according to claim 1, it is characterised in that the safety net (4) is woven by 6-20 one metal wires and prepared,
Or prepared by cuts in metallic pipe to void density for 50-300PPI.
4. according to the seal wire any one of claim 1-3, it is characterised in that the distal end of the safety net (4) and near-end
Be located at respectively with the core filaments (3) head end of the distal end (1) by resistance welding, soldering, ultrasonic bonding, laser welding,
Mode any of is bonded, is clasped to connect.
5. seal wire according to claim 1, it is characterised in that be additionally provided with sheath (5), the sheath (5) is located at the peace
On the outside of the whole network (4), the core filaments (3) are located at the head end of the distal end (1) and the safety net (4), sheath (5) are coaxially disposed.
6. seal wire according to claim 5, it is characterised in that the sheath (5) is turn sheath, polymer jacket,
Or any of mixing sheath of turn and polymer.
7. the seal wire according to claim 5 or 6, it is characterised in that be provided with the safety net (4) or sheath (5) aobvious
Shadow spring, or provided with one or more developing marks, the development spring or developing mark using platinum-tungsten alloys, platinum-nickel alloy,
It is prepared by any of platinumiridio, gold material.
8. seal wire according to claim 5, it is characterised in that it is described expansion position (301) proximally and distally with it is described
The joining place of core filaments (3) is provided with tapering transition section, and expansion position (301) is apart from core sheath (5) the near-end 1-20mm, institute
State a diameter of 0.35-0.80mm of expansion position (301), described expansion position (301) a diameter of 0.35-0.80mm part length
Spend for 5-20mm, the tapering transition section proximally and distally set with the joining place of the core filaments (3) of expansion position (301)
Length is respectively 10-30mm.
9. seal wire according to claim 1, it is characterised in that the seal wire is additionally provided with coating (6), and the coating (6) is covered
The part surface or all surfaces of the seal wire are covered, the coating (6) is hydrophilic coating or hydrophobic coating, and the hydrophilic coating is
Polyvinylpyrrolidone coating, polyoxyethylene ene coatings, transparent acid esters acrylic acid coatings or polymethyl vinyl ether-maleic anhydride
Any of coating；The hydrophobic coating is any of polytetrafluorethylecoatings coatings, silicone coating.
10. prepare the method for the seal wire any one of claim 1-9, it is characterised in that comprise the following steps：
1) core filaments are made：Grinding prepares core filaments (3), keeps the diameter of expansion position (301) to be more than the diameter of the core filaments (3)；
2) make and assemble safety net：Metal wire knitted or cuts in metallic pipe prepare safety net (4)；Safety net (4) is sleeved on
In core filaments (3), keep core filaments (3) to be coaxially disposed with safety net (4), pass through resistance welding, soldering, ultrasonic bonding, Laser Welding
Method any of is connect, is bonded, being clasped to be connected core filaments (3) with safety net (4)；
3) make and assemble sheath：Turn sheath in sheath (5) is prepared by filament winding device, and/or, it is poly- in sheath (5)
Compound sheath is prepared by melt process；By sheath (5) on safety net (4), core filaments (3), safety net (4), sheath are kept
(5) be coaxially disposed, by resistance welding, soldering, ultrasonic bonding, laser welding, be bonded, any of be clasped method
By core filaments (3), safety net (4), sheath (5) connection；
4) applying coating：Using spraying or semar technique in seal wire surface coatings (6).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710657274.1A CN107362437A (en) | 2017-08-03 | 2017-08-03 | A kind of predilation seal wire and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710657274.1A CN107362437A (en) | 2017-08-03 | 2017-08-03 | A kind of predilation seal wire and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN107362437A true CN107362437A (en) | 2017-11-21 |
Family
ID=60310341
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710657274.1A Pending CN107362437A (en) | 2017-08-03 | 2017-08-03 | A kind of predilation seal wire and preparation method thereof |
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| CN111020274A (en) * | 2019-12-20 | 2020-04-17 | 有研亿金新材料有限公司 | Platinum-nickel alloy superfine wire and preparation method and application thereof |
| CN113041480A (en) * | 2021-04-22 | 2021-06-29 | 深圳麦普奇医疗科技有限公司 | Guide wire for coronary intervention |
| CN113797424A (en) * | 2021-11-01 | 2021-12-17 | 深圳麦普奇医疗科技有限公司 | Be used for CTO to intervene treatment seal wire |
| CN113827846A (en) * | 2021-11-09 | 2021-12-24 | 深圳麦普奇医疗科技有限公司 | TAVR seal wire |
| CN114618070A (en) * | 2022-01-27 | 2022-06-14 | 聚辉医疗科技(深圳)有限公司 | Micro-guide wire |
| EP4151265A1 (en) * | 2021-09-08 | 2023-03-22 | Neuravi Limited | Neuro access guide wire |
| CN116617543A (en) * | 2023-06-09 | 2023-08-22 | 株洲茂物医疗科技有限公司 | Manufacturing method of micro-guide wire and micro-guide wire |
| CN116617544A (en) * | 2023-06-09 | 2023-08-22 | 株洲茂物医疗科技有限公司 | Method for manufacturing guide wire and guide wire |
| CN116617544B (en) * | 2023-06-09 | 2024-04-26 | 株洲茂物医疗科技有限公司 | Method for manufacturing guide wire and guide wire |
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| CN116617543A (en) * | 2023-06-09 | 2023-08-22 | 株洲茂物医疗科技有限公司 | Manufacturing method of micro-guide wire and micro-guide wire |
| CN116617544A (en) * | 2023-06-09 | 2023-08-22 | 株洲茂物医疗科技有限公司 | Method for manufacturing guide wire and guide wire |
| CN116617543B (en) * | 2023-06-09 | 2024-03-08 | 株洲茂物医疗科技有限公司 | Manufacturing method of micro-guide wire and micro-guide wire |
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Application publication date: 20171121 |