A kind of novel microtubularTechnical field
The present invention relates to a kind of microtubular more particularly to a kind of novel microtubulars.
Background technique
With the development of the social economy, deep variation, especially aging of population and city has occurred in national life modeThe acceleration of town process, Chinese cardiovascular risk factors fashion trend is obvious, and the number of the infected for resulting in cardiovascular disease continuesIncrease.China probably has 2,200,000 with the patient of chronic total occlusion of coronary artery at present.
Clinically, when carrying out Minimally Interventional Therapy for the blood vessel of Chronic total occlusion or vascular dissection, in order toImprove the success rate of seal wire passed through, it usually needs microtubular and seal wire are used cooperatively, and microtubular is seal wire small firstIt is intravascular that additional support force is provided, and the two alternately moves ahead, and substantially increases the ability that seal wire passes through Occlusion.
After lesion locations are passed through in seal wire completion, it is also necessary to confirm that seal wire is in the very intracavitary next step that can carry out of blood vessel and controlsTreat operation, such as the technological means such as balloon expandable, stenter to implant.Pass through imaging evaluation seal wire to blood vessel distal injection contrast agentWhether the true chamber of blood vessel is in.
In the course of surgery, it needs microtubular being pushed to lesion locations from vitro, this requires microtubulars to have very by forcePush performance, buckle resistance energy and tracking performance etc., it is ensured that microtubular accurately reaches disease in surgical procedure and becomes position simultaneouslyAcross lesion vessels, passes through and withdraw from without injuring healthy blood vessel, while convenient for seal wire.
Existing microtubular, it is small generally cannot all to meet pipe size simultaneously, but meet push performance, buckle resistance energy andTracking performance is excellent, increases seal wire in this way and passes through the difficulty of Occlusion, while increasing the operation requirement to doctor, extendsConduit increases the physical effects of patient in the internal time of patient.
CN 107376101A describes a kind of microtubular for Transcaheter cloure TACE, the microtubularIt include: tube socket, diffusion-induced stress pipe, pipe shaft and head end；Diffusion-induced stress pipe sleeve is covered in the outside of tube socket and pipe shaft junction, and is passed throughThe mode of back-off is fixed together with tube socket；Pipe shaft includes liner layer, enhancement layer and jacket layer；Enhancement layer includes braiding section, takesSection and spiral section are connect, wherein braiding section, close to tube socket, spiral section leans near head end, lap segment is located between braiding section and spiral section；The structure of helical spring is made of single taenidium for spiral section, and the microtubular head end of patent statement has good submissiveProperty, while head end has good shape retentivity, still, pushability performance is poor, because of one layer of braiding that proximal end only hasLayer is reinforced, if it is desired to the wall thickness of conduit must be increased by improving push performance, will increase the size of conduit in this way, increases pipe sizeIt will increase the difficulty by tortuous blood vessel, while increasing the risk and difficulty of operation.
US 7507229B2 describes a kind of for protruding into the multi-layer duct of the depths of human body, including liner layer, braiding layerAnd oversheath.Conduit is provided across height flexibility needed for vascular system and high intensity.External sheath layer is gradually hardened by 7 kindsPolymer material composition, the count of middle braid layer only has one-shot change, can not achieve the hardness of microtubular from distal endThe process being gradually hardened to proximal end.
To sum up, the generally existing following problems of existing microtubular: microtubular is difficult the size having had both and good physicalEnergy；Microtubular cannot be guaranteed gradually to be hardened from conduit pipe shaft is distal-to-proximal；Flexibility is good, but push performance is bad, is easyIt gives a discount；Head end shape retentivity is bad, can not be successfully into vascular bifurcation position.
Summary of the invention
The present invention is to solve above-mentioned technical problem present in existing microtubular, provides a kind of existing good size, and haveGood physical property, while head end has the novel microtubular of good shape retentivity again.
To achieve the above object, the invention adopts the following technical scheme:
Provide a kind of novel microtubular, be tubular structure, including set gradually from distal end to proximal end head end, pipe shaft,Diffusion-induced stress pipe and needle stand, in which:
Doped with developability material in the head end, developing ring is equipped between the head end and the pipe shaft；
The pipe shaft successively includes jacket layer, braiding enhancement layer, braiding layer and liner layer from outside to inside；And
The proximal end of the pipe shaft is fixedly connected with the needle stand, and the pipe shaft proximal end and the junction of the needle stand are arranged withThe diffusion-induced stress pipe.
Further, the outer diameter of the head end becomes larger from distal end to proximal end.
Further, the material of the head end is soft polyamide or flexibel polyurethane.
Further, the developability material is in tungsten powder or barium sulfate or bismuth oxide or bismuth subcarbonate or artificial schelliteOne or more of combinations.
Further, the proximal face joint welding of the head end is in braiding layer, and the braiding layer of the pipe shaft distal endThe pipe shaft is stretched out with liner layer.
Further, the developing ring is embedded in the head end, and the developing ring coats the braiding layer completelyDistal end end face.
Further, the material of the developing ring is platinumiridio or gold or platinum.
Further, the liner layer with a thickness of 0.008-0.02mm.
Further, the material of the liner layer is high density polyethylene (HDPE) or polytetrafluoroethylene (PTFE).
Further, the internal diameter of the liner layer becomes larger from distal end to proximal end, and the internal diameter of the liner layer distal end is0.41-0.45mm, the internal diameter of the liner layer proximal end are 0.48-0.53mm.
Further, the braiding layer is woven by stainless steel braided wires or NiTi braided wires mariages, the braided wiresFor circle silk or flat filament or elliptical filaments.
Further, the braiding line number of the braiding layer is 16-32 strands, and the count PPI of the braiding layer is from distallyIt is gradually become smaller to proximal end, the count PPI of the braiding layer distal end is 220-280, the count of the braiding layer proximal endPPI is 50-100.
Further, the braiding enhancement layer is set to the proximal end of the pipe shaft, and the length of the braiding enhancement layer is 800-1100mm。
Further, the braiding enhancement layer is woven by stainless steel braided wires or NiTi braided wires mariages, the volumeThe braiding line number for knitting enhancement layer is 20-36 strands, and being horizontally disposed in the braiding enhancement layer has several braiding reinforced wires 10.
Further, the proximal end face of the diffusion-induced stress pipe is fixedly connected by buckling with the distal face of the needle stand.
Further, the hardness of the jacket layer becomes larger from distal end to proximal end, the variation of the hardness of the jacket layerRange is 30-71D.
Further, the jacket layer is made of the different polyamide of a variety of hardness, polyurethane and polyolefine material；
Further, the outer diameter of the jacket layer becomes larger from distal end to proximal end, and the outer diameter of the jacket layer distal end is0.05-0.066mm, the internal diameter of 4 proximal end of jacket layer are 0.81-0.92mm.
Further, hydrophilic coating is coated on the outer surface of the jacket layer.
The present invention by adopting the above technical scheme, compared with prior art, has the following technical effect that
Novel microtubular of the invention, have very strong push performance, buckle resistance energy and tracking performance, while conduit fromIt is distal-to-proximal to be gradually hardened, it can guarantee the flexibility and shape retention of distal end, it is ensured that microtubular is accurate in surgical procedureIt reaches patient's diseased region and passes through tortuous lesion vessels.
Detailed description of the invention
Fig. 1 is the overall structure diagram of novel microtubular；
Fig. 2 is the braiding structure schematic diagram of novel microtubular；
Fig. 3 is novel microtubular pipe shaft and head end the schematic diagram of the section structure；
Fig. 4 is the braiding layer braiding structure schematic diagram of novel microtubular；
Fig. 5 is the sectional view of Section A-A in novel microtubular；
Fig. 6 is the braiding structure schematic diagram of braiding layer in novel microtubular；
Fig. 7 is the braiding structure schematic diagram that enhancement layer is woven in novel microtubular；
Fig. 8 is the sectional view of section B-B in novel microtubular；
Fig. 9 is the structural schematic diagram of jacket layer in novel microtubular；
Figure 10 is the structural schematic diagram of head end in novel microtubular
Figure 11 is the status diagram that novel microtubular enters blood vessel；
Wherein, each appended drawing reference are as follows:
1- head end, 2- pipe shaft, 3- needle stand, 4- jacket layer, 5- liner layer, 6- braiding layer, 7- weave enhancement layer, and 8- diffusion is answeredSolenoid, 9- developing ring, 10- weave reinforced wire, 11 control towers protrusion, 12- control tower groove.
Specific embodiment
The present invention is described in more detail below by specific embodiment, for a better understanding of the present invention,But following embodiments are not intended to limit the scope of the invention.
As shown in figs. 1-11, be tubular structure the embodiment of the invention provides a kind of novel microtubular, including from distal end toHead end 1, pipe shaft 2, diffusion-induced stress pipe 8 and the needle stand 3 that proximal end is set gradually, in which: doped with developability material in head end 1,Developing ring 9 is equipped between head end 1 and pipe shaft 2；Pipe shaft 2 successively includes jacket layer 4, braiding enhancement layer 7, braiding layer 6 from outside to insideAnd liner layer 5；And the proximal end of pipe shaft 2 is fixedly connected with needle stand 3, the junction of 2 proximal end of pipe shaft and needle stand 3 is arranged with diffusionStress tube 8.
The one side of the present embodiment, such as Fig. 1-3, shown in 9-11, the outer diameter of head end 1 becomes larger from distal end to proximal end, headEnd 1 uses airflow design, and it is smooth to guarantee that the head end of microtubular protrudes into human vas.
The one side of the present embodiment, the material of head end 1 are soft polyamide or flexibel polyurethane, and preferably polyether block is poly-Amide, polyether-block-polyamide have the performance of thermoplastic elastomer (TPE), polyether-block-polyamide due to its unique chemical structureFor most light engineering thermoplastic elastomer, there is no the loss of mechanical performance under repeated deformation, and antifatigue, while polyethers is embeddingSection polyamide is to guarantee that microtubular keeps size constancy, polyethers under different environmental conditions with accurate dimensional stabilityThe good rebound of block polyamide and elasticity are restored, when microtubular is extracted out from human vas, it is ensured that microtubular is indeformable.
The one side of the present embodiment, such as Fig. 1-3, shown in 9-11, developability material is tungsten powder or barium sulfate or three oxidations twoBismuth or one or more of bismuth subcarbonate or artificial schellite, head end add simultaneously using soft polyether-block-polyamide material as base-materialEnter that the extruding pipe that the auxiliary material of development is formed is logical, by welding procedure by head end with pipe shaft being combined together tightly.
The one side of the present embodiment, as shown in Figure 10, the proximal face joint welding of head end 1 is in braiding layer 6, and pipe shaft 2 is remoteThe braiding layer 6 and liner layer 5 at end stretch out pipe shaft 2, and the proximal face of head end 1 is equipped with protrusion 11 of setting up the stage, the distal end of pipe shaft 2 be equipped with byThe groove 12 of setting up the stage that the upper surface of braiding layer 6 and 4 side end face of jacket layer are constituted, control tower protrusion 11 and 12 company of matching of control tower grooveIt connects, control tower protrusion 11 passes through welded connecting with control tower groove 12.
The one side of the present embodiment, such as Fig. 1-2, shown in 10-11, developing ring 9 is embedded in head end 1, and developing ring 9 is completeThe distal end end face of braiding layer 6 is coated, one end of developing ring 9 is located at the junction of control tower protrusion 11 with control tower groove 12, developing ring 9By braiding layer 6 tightly be strapped in internal layer, while providing the effect of development, then the extruded tube sleeve of the tube head 1 with developabilityOnto developing ring 9, the inside is wrapped in by welding, the dual development effect of head end may be implemented in this way, provided for patientOne good development effect.
The one side of the present embodiment, such as Fig. 3, shown in 5,8,10, liner layer 5 with a thickness of 0.008-0.02mm, guaranteeingWhile 5 mechanical strength of liner layer, the thickness control of liner layer 5 is ensured that microtubular protrudes into people within 0.008-0.02mmBody blood vessel it is smooth, the mechanical strength of liner layer 5 will not be enhanced and sacrifice the integral thickness of microtubular.
The one side of the present embodiment, the material of developing ring 9 are platinumiridio or gold or platinum, platinumiridio, gold andPlatinum develops clearly under X-ray, and medical personnel can be helped to position the position of microtubular in the blood vessel.
The one side of the present embodiment, the material of liner layer 5 are high density polyethylene (HDPE) or polytetrafluoroethylene (PTFE), highdensity poly- secondAlkene and the equal part packet postal small volume of highdensity polytetrafluoroethylene (PTFE), the preferable feature of mechanical strength, liner layer select high density poly-While ethylene and high density polytetrafluoroethylene (PTFE) improve the mechanical strength of microtubular entirety, guarantee the diameter of microtubular it is smaller withJust microtubular is smooth enters human vas.
The one side of the present embodiment, such as Fig. 3, shown in 5,8,10, the internal diameter of liner layer 5 becomes larger from distal end to proximal end,The internal diameter of 5 distal end of liner layer is 0.41-0.45mm, and the internal diameter of 5 proximal end of liner layer is 0.48-0.53mm, and liner layer 5 can be to leadSilk, which provides, stablizes support.
The one side of the present embodiment, such as Fig. 2-6, shown in 10, braiding layer 6 is by stainless steel braided wires or NiTi braided wires mariagesIt weaves, braided wires are circle silk or flat filament or elliptical filaments, and the flexibility of microtubular can be enhanced using mariages braiding and prevent beatingFolding ability.
The one side of the present embodiment, such as Fig. 2-6, shown in 10, the braiding line number of braiding layer 6 is 16-32 strands, braiding layer 6Count PPI gradually becomes smaller from distal end to proximal end, and the count PPI of 6 distal end of braiding layer is 220-280,6 proximal end of braiding layerCount PPI be 50-100, in addition gradual change when the firmness change of conduit is woven using mariages, microtubular can be enhancedFlexibility and anti-discounting ability.
The one side of the present embodiment, as shown in Fig. 2-3,7-8,11, braiding enhancement layer 7 is set to the proximal end of pipe shaft 2, and braiding addsThe length of strong layer 7 is 800-1100mm, and braiding enhancement layer 7 is not arranged in reason in braiding layer 6 comprehensively and is: due to microtubularHead end be introduced into human vas, therefore need preferable submissive performance, and part can be reduced to a certain extent by weaving enhancement layer 7The flexibility of conduit is difficult to enter human vas, braiding enhancement layer 7 to the proximal end for being arranged in pipe shaft 2 to avoid the occurrence of microtubular.
The one side of the present embodiment, as shown in Fig. 2-3,7-8,11, braiding enhancement layer 7 is compiled by stainless steel braided wires or NiTiIt knits a mariages to weave, the braiding line number of braiding enhancement layer 7 is 20-36 strands, and weaving to be horizontally disposed in enhancement layer 7 has several volumesReinforced wire 10 is knitted, the push performance and twisting property of pipe shaft 2 can be enhanced by increasing braiding enhancement layer 7, while microtubular possessesLesser size improves the passability of blood vessel, and especially when the collateral position tortuous in height occurs for lesion, the micro- of this design is ledThe advantage of pipe clinically is fairly obvious.
The one side of the present embodiment, as shown in Figure 1, left side of the right side of diffusion-induced stress pipe 8 by buckle and needle stand 3It is fixedly connected, 2 proximal connecting end of microtubular pipe shaft is expanded into horn mouth, then inserted with the PC material of hard transparent by needle stand 3Enter needle stand 3, then connect it with pipe shaft 2 with UV uv-curable glue, goes diffusion-induced stress pipe 8 with soft elastomer TPE material,Diffusion-induced stress pipe 8 is connect by back-off with needle stand 3.
The one side of the present embodiment, as shown in figure 9, the hardness of jacket layer 4 becomes larger from distal end to proximal end, jacket layer 4The variation range of hardness is 30-71D, the gradual change when firmness change of conduit, can promoted it is micro- lead anti-discounting ability whileHave both certain flexibility.
The one side of the present embodiment, as shown in figure 9, jacket layer 4 is by the different polyamide of a variety of hardness, polyurethane and gathersOlefin material is constituted, and in these three high molecular materials of polyamide, polyurethane and polyolefin, the hardness of polyamide is minimum, andThe hardness highest of polyolefin, by unlike material, its own hardness performance realizes the hardness gradient effect of jacket layer 4.
The one side of the present embodiment, as shown in figure 9, the outer diameter of jacket layer 4 becomes larger from distal end to proximal end, jacket layer 4The outer diameter of distal end is 0.05-0.066mm, and the internal diameter of 4 proximal end of jacket layer is 0.81-0.92mm, and jacket layer 4 sets for streamlined structureMeter, it is smooth into human vas that such structure design is conducive to microtubular.
The one side of the present embodiment is coated with hydrophilic coating on the outer surface of jacket layer 4, significantly reduces entire micro- leadThe coefficient of friction of pipe further enhances his passage capacity.
The present invention is difficult the size having had both and good physical property for existing microtubular, it cannot be guaranteed that from catheter tubeBody is distal-to-proximal to be gradually hardened, flexibility is good, but it is bad to push performance, be easy to give a discount and head end shape retentivity notGood, the problems such as can not be successfully into vascular bifurcation position, the present invention has very strong push performance, buckle resistance energy and tracing propertyCan, while conduit is gradually hardened from distal end to proximal end, can guarantee the flexibility and shape retention of distal end in this way, it is ensured that micro- to leadPipe accurately reaches disease in surgical procedure and becomes position and across tortuous lesion vessels.
The specific embodiment of microtubular of the present invention is described in detail above, but it is merely an example, the present inventionIt is not restricted to particular embodiments described above.To those skilled in the art, what any couple of present invention carried out is equalModifications and substitutions are also all among scope of the invention.Therefore, made impartial without departing from the spirit and scope of the inventionTransformation and modification, all should be contained within the scope of the invention.