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.