CN102488578A - Quick blood flow reconstruction device and preparation method thereof - Google Patents
Quick blood flow reconstruction device and preparation method thereof Download PDFInfo
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- CN102488578A CN102488578A CN2011104167467A CN201110416746A CN102488578A CN 102488578 A CN102488578 A CN 102488578A CN 2011104167467 A CN2011104167467 A CN 2011104167467A CN 201110416746 A CN201110416746 A CN 201110416746A CN 102488578 A CN102488578 A CN 102488578A
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Abstract
The invention discloses a quick blood flow reconstruction device and a preparation method thereof, and aims to solve the technical problem to quickly realize blood vessel reperfusion and blood flow reconstruction. The quick blood flow reconstruction device is provided with a guide wire; the far end of the guide wire is provided with a meshy sacculus; the meshy sacculus is cylindrical in a release state; two ends of the meshy sacculus have constricted meshy structures; the axis of the meshy sacculus is in slide contact with the guide wire; and a stopper is arranged in the meshy sacculus and on a core wire at the far end. The preparation method for the quick blood flow reconstruction device comprises the following steps of: preparing the guide wire with the meshy sacculus; conveying an outer tube of a recovery conduit; and conveying an inner tube of the recovery conduit. Compared with the prior art, the invention has the advantages that: the quick blood flow reconstruction device is firmly arranged on a lesion part of a totally occluded blood vessel through the meshy sacculus, blood flow can be instantly restored in a small flow rate, the guide wire with the meshy sacculus is put on a thrombus part of the blood vessel for 45 to 120 minutes, and the blood vessel can be completely restored; and the two ends of the meshy sacculus have the enclosed meshy structures to protect the near end and the far end of the blood vessel, and new embolism at the near end or the far end is prevented.
Description
Technical field
The present invention relates to a kind of medical surgical instrument and preparation method thereof, particularly a kind of apparatus that is used for interventional therapy full cut-off plug angiopathy and preparation method thereof.
Background information
Blood of human body solidify or blood in the sticking mutually collection of some visible component, form solid matter piece vascular occlusion, be a kind of carry out slowly, mainly involve small artery and venous vascular lesion in the extremity.Pathological change is stage, the nonsuppurative inflammation companion intracavity thrombosis of blood vessel wall, and tube chamber blocks, and causes limb ischemia.
Generally adopt dual mode treatment vascular occlusion clinically: medicine thrombolytic and machinery are got bolt.Heparin is main anticoagulant, can effectively prevent and treat deep venous thrombosis of lower limbs, is widely used in unstable angina pectoris in recent years, acute myocardial infarction and the brain treatment of diseases of finally waiting indefinitely.But heparin has many shortcomings, and is hemorrhage as being prone to, and the chamber clotting mechanism monitoring that must experimentize is used inconvenience, and can be brought out thrombocytopenia and aleucia.Bolt device Concentric Retriever is got in only having just by what EV3 Company of the FDA of FDA (Food and Drug Adminstration) approval produced of can be applicable at present that thrombosis takes out in the blood vessel.The smooth rate of the revascularization of this utensil after clinical use is 55.6%～60%, is that the machinery that is applied at present to treat blood vessel embolism is in the world got pin device.The principle that this device uses is: at the lesion vessels near-end, utilize the blood supply of interim filling air bag blocking-up blood vessel, wrap up thrombosis with turn, and it is drawn in conduit cavity in blood vessel, eliminate the interim filling air bag of blood vessel, withdraw from conduit then.This utensil only is provided with nearly segment protect device, and its spiral spring circle is prone to cause thrombosis to be broken into fragment in the removal of thromboses process, causes the blood vessel far-end by thromboembolism, and operation process need blocking blood flow, possibly cause the distal vessels blood supply insufficiency.
Summary of the invention
The purpose of this invention is to provide a kind of quick blood flow reconstructing device and preparation method thereof, the technical problem that solve is a Rapid Realization revascularization, rebuilds blood flow.
The present invention adopts following technical scheme: a kind of quick blood flow reconstructing device, and said quick blood flow reconstructing device is provided with the tennis seal wire, and the tennis seal wire is provided with seal wire; The far-end of seal wire is provided with netted sacculus; Netted sacculus release conditions are cylindric, the RF of two ends for shrinking, and its axis is coaxial with seal wire; Netted sacculus and seal wire form sliding-contact, on the far-end core silk, the inside of netted sacculus is provided with stop.
Seal wire of the present invention is connected with the near-end core silk that is positioned at near-end by the far-end core silk that is positioned at far-end, is equipped with fixedly NiTi pipe in the junction, and the seal wire free state is that linearity is thread.
The distal end of seal wire of the present invention is connected with conductive filament head.
Conductive filament head of the present invention adopts platinum wire, tungsten alloy or billon silk, stainless steel silk to turn to coil spring shape.
Indicating is equipped with at the two ends of netted sacculus of the present invention.
Tennis seal wire of the present invention is arranged on to carry and reclaims in the conduit, forms sliding-contact with carrying the recovery conduit.
Outer tube and the interior pipe that conduit is provided with coaxial setting reclaimed in conveying of the present invention, and outer tube and interior pipe form and be slidingly connected.
The far-end outer rim of outer tube of the present invention is equipped with the outer tube indicating, and proximal outer tube is connected with outer tube joint, and proximal outer tube and outer tube joint junction are equipped with outer tube strain relief sleeve pipe; Said outer tube is a three-decker, and internal layer adopts politef, and the intermediate layer is steel wire, helical spring or steel wire+helical spring; Outer nylon, nylon elastomer or the polyurethane of adopting.
Pipe indicating in the far-end outer rim of the pipe dress in of the present invention; In the pipe near-end be connected with inner pipe joint, pipe strain relief sleeve pipe in interior pipe near-end and inner pipe joint junction are equipped with is managed in said inside and outside being two-layer; Internal layer adopts politef, outer nylon, nylon elastomer or the polyurethane of adopting.
A kind of method for preparing of quick blood flow reconstructing device; May further comprise the steps: one, preparation tennis seal wire, 1, the braiding webmaster, adopt nitinol alloy wire, titanium silk, platinum wire, platinumiridio silk, stainless steel silk; Diameter is 0.038mm～0.30mm; Quantity is 8～48, the braiding webmaster, and every foot node number that has of webmaster is 10～72; 2, the far-end of grinding far-end core silk and proximal end are the tapering transition section; Adopt nitinol alloy wire; External diameter is 0.25～0.97mm, and length is 500～3000mm, and being ground to distal length is that 90～140mm, proximal length are the taper of 20～30mm; Technological parameter is: 2000 rev/mins of rotating speeds, amount of feeding 3mm/s; Near-end core silk adopts and scribbles the politef stainless steel silk, and external diameter is 0.25～0.97mm, and length is 2500～0mm, grinding near-end core silk far-end and near-end, the long 20～30mm of its far-end grinding taper, the long 30～40mm of near-end grinding taper; 3, netted sacculus is made, and it is on the netted sacculus mould of taper that the webmaster that braiding is good is nested with at cylindric, two ends, in vacuum 10
-3Below the handkerchief, with 10～20min time, be warming up to 450～550 ℃, be incubated 30 minutes, naturally cool to room temperature in the stove from room temperature; Webmaster is taken off from netted sacculus mould, is platinum, platinum alloy, gold, Nitinol or the rustless steel indicating of 0.37～1.2mm with the braided wires overcoat top external diameter at webmaster two ends, adopts soldering to connect 230 ± 30 ℃ of welding temperatures; 4, make the conductive filament head spring: adopting diameter is platinum wire, tungsten alloy or billon silk, the stainless steel silk of 0.05～0.25mm, is 0.20～0.97mm around causing external diameter, long 7～150mm, and pitch is the conductive filament head spring of 0.06～0.26mm; 5, the assembling of tennis seal wire; Netted sacculus one end is enclosed within far-end core silk far-end; With material is that rustless steel, external diameter are that 0.33～1.16mm, internal diameter are that the stop of 0.2～1.0mm is nested with on far-end core silk; Then the netted sacculus other end is enclosed within on the far-end core silk, stop is weldingly fixed on the far-end core silk welding temperature: 230 ± 30 ℃; With the distal end of conductive filament head spring housing at far-end core silk, conductive filament head spring, rustless steel flat filament and far-end core silk 5 are welded to connect, technological parameter is: electric current 80～100A, pulsewidth 4.0～6.0ms, frequency, 6～8HZ, weld interval 1～3s; Far-end core silk near-end and near-end core silk far-end are put in fixedly NiTi pipe, connect or soldering is fixedly connected the three with medical AB is gluing; Two, carry to reclaim the making of conduit outer tube, 1, outer pipe shaft makes, with inner layer material; Wire of intermediate layer net, helical spring or steel wire+helical spring, cladding material are nested with in proper order on the plug of Nitinol, rustless steel or politef, near distal end, are nested with the upper exterior tube indicating; Be nested with the fluorinated ethylene propylene (FEP) heat shrink films again; Technological parameter is: 380～450 ° of F of rheology temperature, and rheology speed 0.08～0.16cm/s takes out plug and processes outer pipe shaft; 2, joint is bonding, on the far-end contact surface of proximal outer tube outer rim and joint, smears ultraviolet cured adhesive, the near-end of the outer tube remote stomidium from joint is put in to rigging position, with the irradiation of purple light machine with its curing; Outside outer tube pipe shaft, be nested with the strain relief sleeve pipe, the strain relief sleeve pipe tightened up the remote location at joint with hot-air blower near joint; Three, carry to reclaim the making of pipe in the conduit, interior pipe two-layerly is made up of inside and outside, with inner layer material; Cladding material is nested with on the plug of Nitinol, rustless steel or politef; The pipe indicating is nested with the fluorinated ethylene propylene (FEP) heat shrink films again near distal end, being nested with, and technological parameter is: 380～450 ° of F of rheology temperature; Rheology speed 0.08～0.16cm/s takes out plug and processes interior pipe shaft.
The present invention compared with prior art utilizes netted sacculus firmly to place full cut-off plug vascular lesion position, and blood flow can recover at the moment low discharge; The tennis seal wire was continued to be placed on the vascular thrombosis place after 45～120 minutes; Blood flow can recover fully, and netted sacculus two ends are the RF of sealing, to the near-end and the far-end of blood vessel protection is provided; The issuable thrombosis fragment of operation process is fallen in the netted sacculus and is hunted down, and avoids forming near-end or the new thromboembolism of distal site.
Description of drawings
Fig. 1 is the tennis guide wire sketch map of the embodiment of the invention.
Fig. 2 is the outer tube structure figure that conduit is reclaimed in the conveying of the embodiment of the invention.
Fig. 3 is the inner tube structure figure that conduit is reclaimed in the conveying of the embodiment of the invention.
Fig. 4 is a lesion vessels sketch map before the treatment.
Fig. 5 is a quick blood flow reconstructing device course of conveying sketch map of the present invention ().
Fig. 6 is a quick blood flow reconstructing device course of conveying sketch map of the present invention (two).
Fig. 7 is a quick blood flow reconstructing device course of conveying sketch map of the present invention (three).
Fig. 8 is a quick blood flow reconstructing device course of conveying sketch map of the present invention (four).
Fig. 9 is that quick blood flow reconstructing device of the present invention discharges complete sketch map.
Figure 10 is a quick blood flow reconstructing device therapeutic process sketch map of the present invention.
Figure 11 is that sketch map is accomplished in quick blood flow reconstructing device treatment of the present invention.
Figure 12 is a webmaster sketch map of the present invention.
Figure 13 is a sketch map after the netted sacculus molding of the present invention.
Figure 14 is a netted sacculus mould sketch map of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing and embodiment the present invention is explained further details.Each sequence number is expressed as in the accompanying drawings: 1 is conductive filament head, and 2 is stop, and 3 is netted sacculus, and 4 are indicating; 5 is far-end core silk, and 6 are fixing NiTi pipe, and 7 is near-end core silk, and 8 is the outer tube indicating; 9 is outer tube, and 10 is interior pipe indicating, and 11 is interior pipe, and 12 is outer tube joint; 13 is outer tube strain relief sleeve pipe, and 14 is inner pipe joint, and 15 is interior pipe strain relief sleeve pipe.
Quick blood flow reconstructing device of the present invention is provided with the tennis seal wire, and the tennis seal wire is arranged on to carry and reclaims in the conduit, and can in carrying the recovery conduit, slide, and reclaims conduit with conveying and forms sliding-contact.
As shown in Figure 1; The tennis seal wire is provided with thread far-end core silk that is positioned at far-end 5 and the near-end core silk 7 that is positioned at near-end; The near-end of far-end core silk 5 is connected with the far-end of near-end core silk 7; The junction is equipped with fixedly NiTi pipe 6, far-end core silk 5, near-end core silk 7 and fixedly NiTi pipe 6 to constitute free states be the seal wire of linearity.The distal end of far-end core silk 5 is connected with softish conductive filament head 1, and near-end one side of conductive filament head 1 is provided with netted sacculus 3.Netted sacculus 3 release conditions are cylindric, the RF of two ends for shrinking, and its axis is coaxial with seal wire, and netted sacculus 3 can radially shrink, and with the far-end core silk 5 formation sliding-contacts of seal wire, can on far-end core silk 5, slide.On the far-end core silk 5, the inside of netted sacculus 3 is provided with stop 2, is used to limit netted sacculus 3 along position that far-end core silk 5 slides.Indicating 4 is equipped with at the two ends of netted sacculus 3, is used for X ray and keeps watch on the position that shows woven mesh sacculus 3 down.
It is that the braided wires braiding forms that netted sacculus 3 adopts memory alloy wire nitinol alloy wire, titanium silk, platinum wire, platinumiridio silk, stainless steel silk; The braided wires diameter is 0.038～0.30mm; Quantity is 8～48, and it is 10-72 that every foot node that has is counted PPI (Point per inch).Netted sacculus 3 is assemblied on the far-end core silk 5, and the maximum outside diameter after netted sacculus 3 discharges fully is 3～30mm.For ease of under X-ray, seeing open netted sacculus 3, can be on netted sacculus 3 gold-plated or platinum alloy, also can when establishment, enroll composite or the NITI and the golden composite of two above platinum wires, spun gold, tungsten filament, tantalum wire, NITI silk and platinum.
Indicating 4 external diameters at netted sacculus 3 two ends are 0.37～1.2mm, adopt platinum, platinum alloy, gold, Nitinol or rustless steel, are connected with netted sacculus 3 through welding.
Far-end core silk 5 adopts nitinol alloy wire, and the silk footpath is 0.25～0.97mm, and length is 500～3000mm.Far-end core silk 5 distal ends are the tapering transition section, are used for being connected with conductive filament head 1.
Near-end core silk 7 adopts the stainless steel silk that scribbles polytetrafluoroethylene PTFE, and the silk footpath is 0.25～0.97mm, and length is 2500～0mm, and the seal wire length overall is 3000mm, if far-end core silk is 3000mm, then near-end core silk is 0.
Fixedly NiTi pipe 6 external diameters are 0.33～0.97mm, and internal diameter is 0.25～0.89mm, and length is 40mm.Far-end core silk 5 adopts the fixedly NiTi pipe 6 of Nitinol to be nested with near-end core silk 7 junctions and connects as one.
Can be arranged on after netted sacculus 3 is retracted to carry and reclaim in the conduit, can in carrying the recovery conduit, slide.Carry and reclaim the outer tube 9 and interior pipe 11 that conduit is provided with coaxial setting, outer tube 9 forms with interior pipe 11 and is slidingly connected.In being contracted in, netted sacculus 3 slides in the pipe 11.
As shown in Figure 2, outer tube 9 is used for the tennis seal wire is transported to the target location, and operation withdraws from it after finishing externally, and its internal diameter is 0.61～2.1mm, and external diameter is 0.81～2.5mm, long 140～150mm.The far-end outer rim of outer tube 9 is equipped with the outer tube indicating 8 that can develop under the X ray, and outer tube indicating 8 external diameters are 0.71～2.2mm, adopts platinum, platinum alloy, gold, Nitinol or rustless steel, is connected with outer tube 9 through the mode of welding.Outer tube 9 near-ends are connected with outer tube joint 12, and outer tube 9 near-ends and outer tube joint 12 junctions are equipped with outer tube strain relief sleeve pipe 13.
Outer tube 9 is a three-decker, and internal layer adopts polytetrafluoroethylene PTFE, and endoporus can obtain less frictional resistance during use, and the intermediate layer is steel wire, helical spring or steel wire+helical spring.Steel wire is with rustless steel, tungsten or the NITI silk of diameter 0.01～0.06mm, and PPI is 30～120.Steel wire is in order to guarantee to carry the thrust that reclaims conduit outer tube 9; Helical spring is processed with rustless steel, tungsten filament or the NITI filament winding of diameter 0.01～0.07mm; Pitch is 0.012～0.1mm; External diameter is 0.71～2.2mm, and helical spring guarantees to carry the fracture resistance that reclaims conduit outer tube 9, also can increase the X-ray visuality.Nylon elastomer or the polyurethane PU of outer employing nylon, U.S. pebax are material.
As shown in Figure 3, interior pipe 11 places in the outer tube, strengthens the outer tube enabling capabilities, is used to help the outer tube intravasation to reach smooth and easy delivery guidewire in blood vessel, and its internal diameter is 0.43～1.82mm, and external diameter is 0.60～2.0mm, and length is 160～170mm.The far-end outer rim of interior pipe 11 is equipped with the interior pipe indicating 10 that can develop under the X ray, and platinum, platinum alloy, gold, Nitinol or rustless steel are adopted in interior pipe indicating 10, are connected with interior pipe 11 through welding.Interior pipe 11 near-ends are connected with inner pipe joint 14, pipe strain relief sleeve pipe 15 in interior pipe 11 near-ends and inner pipe joint 14 junctions are equipped with.
The polymeric material of different hardness is adopted in the outer segmentation of the skin of outer tube 9 and interior pipe 11; Make and carry the hardness that reclaims conduit vertically by near-end to far-end classification deliquescing gradually; Near-end has good propelling movement and twisting property, and far-end is softer, and pliability is good; Can in the cardiovascular and cerebrovascular vessel of complicacy, freely carry, avoid injured blood vessel.
As shown in Figure 4, the thrombi 17 in the blood vessel 16 causes inaccessible section at the thromboembolism position, and occluding vascular 16 is obstructed the blood flow 18 in the blood vessel 16.
As shown in Figure 5, when using quick blood flow reconstructing device of the present invention, carry the outer tube 9 that reclaims conduit to be sent the inaccessible section that causes through thrombi 17 along the guiding seal wire of operation usefulness with the interior pipe 11 in it, surpass inaccessible section far-end 4mm to outer tube indicating 8.Withdraw from guiding seal wire and interior pipe 11, through loading bin the tennis seal wire is sent into and carried in the outer tube 9 that reclaims conduit, under X ray is kept watch on, slowly push to far-end; As shown in Figure 6; Near indicating 8, netted sacculus 3 far-ends pass inaccessible section, and are as shown in Figure 7 until the conductive filament head 1 of tennis seal wire; Outer tube and tennis seal wire are adjusted its position as a whole, and extremely netted sacculus 3 far-end indicatings 4 surpass plug segment 10～15mm.As shown in Figure 8, keep tennis seal wire invariant position, return and remove outer tube 9, all be released until netted sacculus 3 from outer tube 9 far-ends.As shown in Figure 9, this moment, netted sacculus 3 was opened naturally, from thrombi 17, ran through whole thrombi 17 positions; Netted sacculus 3 two ends are released and are filled to blood vessel 16 tube walls; Blood vessel 16 to thrombi 17 near-ends and far-end forms protection, and blood flow part is at once rebuild, but flow is very little.The conveying of tennis seal wire and dispose procedure are accomplished.
Shown in figure 10; Continue to place the tennis seal wire in blood vessel 45～120 minutes; In the blood circulation process, through autolysis, thrombi is slowly dissolved; Recover blood flow fully until blood vessel, during issuable thrombosis fragment fall in the netted sacculus 3 and via netted sacculus mesh and catch by it.Shown in figure 11, keep the invariant position of tennis seal wire, advance outer tube 9 toward far-end, all get in the outer tubes 9 until netted sacculus 3, outer tube 9 and interior tennis seal wire thereof are withdrawn from as a whole external, accomplish the whole surgery process.
The method for preparing of quick blood flow reconstructing device of the present invention may further comprise the steps:
One, preparation tennis seal wire
1, the braiding webmaster adopts nitinol alloy wire, titanium silk, platinum wire, platinumiridio silk, stainless steel silk, and diameter is 0.038mm～0.30mm, and quantity is 8～48, the braiding webmaster, and it is 10～72 that every foot node that has of webmaster is counted PPI.Shown in figure 12, best is with 16 diameter 0.071mm nitinol alloy wires, on the HTBZ-40 type braider of Shenzhen Huitai Medical Instrument Co., Ltd manufacturing, weaves webmaster, and PPI is 16.
2, the far-end of grinding far-end core silk and proximal end are the tapering transition section, adopt nitinol alloy wire, and external diameter is 0.25～0.97mm, and length is 500～3000mm.Best for adopting the nitinol alloy wire of diameter 0.36mm; After the blanking; With the far-end of silk and near-end on the TG12X4 type cylindrical grinder of U.S. ROYAL MASTER GEINDERS.INC manufactured; Being ground to distal length is that 90～140mm, proximal length are the taper of 20～30mm, and technological parameter is: 2000 rev/mins of rotating speeds, amount of feeding 3mm/s.Near-end core silk adopts and scribbles the polytetrafluoroethylene PTFE stainless steel silk, and external diameter is 0.25～0.97mm, and length is 2500～0mm; The seal wire length overall is 3000mm, if far-end core silk is 3000mm, then near-end core silk is 0; Grinding near-end core silk far-end and near-end; Processing method is identical with grinding far-end core silk with parameter, the long 20～30mm of its far-end grinding taper, the long 30～40mm of near-end grinding taper.
3, netted sacculus is made, and the webmaster that braiding is good is nested with on netted sacculus mould, and shown in figure 14, netted sacculus mould is cylindric, and two ends are taper.Webmaster behind the dress mould is put into the ZSK2-12-6 type vacuum heat treatment furnace heat treatment typing that Wuhan industrial furnace factory makes, in vacuum 10
-3Below the handkerchief, with 10～20min time, be warming up to 450～550 ℃, be incubated 30 minutes, naturally cool to room temperature in the stove from room temperature.After the thermoforming webmaster is taken off from netted sacculus mould; With the braided wires overcoat top external diameter at webmaster two ends is platinum, platinum alloy, gold, Nitinol or the rustless steel indicating of 0.37～1.2mm; The best is the platinum indicating, adopts soldering to connect 230 ± 30 ℃ of welding temperatures; Shown in figure 13, process complete netted sacculus.
4, make the conductive filament head spring: adopting diameter is platinum wire, tungsten alloy or billon silk, the stainless steel silk of 0.05～0.25mm; On the L80 type precision spring coiling machine that U.S. Roth Greaves & Associates.Inc company produces, be 0.20～0.97mm around causing external diameter; Long 7～150mm, pitch is the conductive filament head spring of 0.06～0.26mm.
5, the assembling of tennis seal wire; Netted sacculus 3 one ends are enclosed within far-end core silk 5 far-ends; Be that medical grade rustless steel, external diameter are that 0.33～1.16mm, internal diameter are that the opening stop 2 of 0.2～1.0mm is nested with on far-end core silk 5 from this position with material again; (far-end core silk 5 is nested with the position of stop 5 earlier through partly processing, and size is less than the raw material diameter) is enclosed within netted sacculus 3 other ends on the far-end core silk 5 then; Adopt soldering stop 2 to be weldingly fixed on the far-end core silk 5 welding temperature: 230 ± 30 ℃.Behind the welded limiting device 2, in the conductive filament head spring, insert the rustless steel flat filament of one 0.002 " * 0.006 ", be used to increase conductive filament head tensile strength; With the distal end of conductive filament head spring housing at far-end core silk 5, the JHM-1GY-110H type laser-beam welding machine with Wuhan sky above Hubei and Hunan industrial lasers equipment company limited is made is welded to connect conductive filament head spring, rustless steel flat filament and far-end core silk 5; Technological parameter is: electric current 80～100A, pulsewidth 4.0～6.0ms, frequency; 6～8HZ, weld interval 1～3s.At last far-end core silk near-end and near-end core silk far-end are put in fixedly NiTi pipe 6; Connect or brazing mode is fixedly connected the three with medical AB is gluing, the welding of soldering processes stop is identical, and AB is gluing when connecing; Glue is evenly spread upon far-end core silk near-end and near-end core silk far-end connecting portion surface; Again far-end core silk near-end and near-end core silk far-end are put in fixedly NiTi pipe 6, wipe unnecessary AB glue, place that the glue solidifies in 24 hours.Fixedly NiTi pipe 6 external diameters are 0.33～0.97mm, and internal diameter is 0.25～0.89mm, and length is 40mm.
Two, carry the making of reclaiming the conduit outer tube
1, outer pipe shaft is made
With inner layer material, wire of intermediate layer net, helical spring or steel wire+helical spring, outer high molecular polymer are nested with in proper order on the plug of Nitinol, rustless steel or politef; Near distal end, be nested with the upper exterior tube indicating; Be nested with fluorinated ethylene propylene (FEP) FEP heat shrink films again, internal layer, intermediate layer and skin fuse together, and take out plug and process outer pipe shaft; Technological parameter is: 380～450 ° of F of rheology temperature, rheology speed 0.08～0.16cm/s.The internal diameter of outer tube is 0.61～2.1mm, and external diameter is 0.81～2.5mm, and length is 140～150cm.
Inner layer material is a politef, and internal diameter is 0.61～2.1mm, and wall thickness is 0.025～0.06mm, and length is 140～150cm.
Steel wire is with 8～32 of the rustless steel of diameter 0.01～0.06mm, tungsten filament or NITI silks, and PPI is 30～120, on the braider of Grand Technology's customization, weaves.
Helical spring forms in the L80 model precision spring coiling machine coiling of U.S. Roth Greaves & Associates.Inc manufactured with rustless steel, tungsten filament or the NITI silk of diameter 0.01～0.07mm; Pitch is 0.012～0.1mm, and external diameter is 0.71～2.2mm.
Outer high molecular polymer, internal diameter is 0.81～2.5mm, external diameter is 1.0～2.7mm, length is 140～150cm, is Pebax, nylon, material from near-end to far-end hardness gradually classification reduce, be respectively 72D, 63D, 55D, 40D.
Outer tube indicating external diameter is 0.71～2.2mmm, and wall thickness is 0.025～0.05mm, and length is that 0.8～1.5mm material is platinum, platinum alloy, gold, Nitinol or rustless steel.
2, joint is bonding
KH228 type point gum machine with U.S. MORCSONDFO.INC produces is smeared layer of even ultraviolet cured adhesive UV glue on the far-end contact surface of proximal outer tube outer rim and joint; The near-end of the outer tube remote stomidium from joint is put in to rigging position, and the DYMAX type purple light machine irradiation of producing with Shenzhen specific lamp light device factory then is with its curing.Outside outer tube pipe shaft, be nested with the strain relief sleeve pipe, the strain relief sleeve pipe tightened up the remote location at joint with hot-air blower near joint.
Joint adopts Merlon, internal diameter 4.1mm.
The strain relief sleeve pipe adopts polyolefin, and internal diameter is 3.0mm.
Three, carry the making of reclaiming pipe in the conduit
In pipe two-layerly constitute by inside and outside, its processing technique equipment parameter and outer tube processing technique equipment, parameter are identical.
Inner tube diameter is 0.43～1.82mm, and external diameter is 0.60～2.0mm, and length is 160～170mm.
Inner layer material politef, internal diameter are 0.43～1.82mm, and wall thickness is 0.025～0.06mm, and length is 160～170cm.
Outer high molecular polymer, internal diameter is 0.61～2.0mm, and external diameter is 0.81～2.2mm, and length is 160～170cm; Be nylon, the nylon elastomer of U.S. pebax, polyurethane PU, material from near-end to far-end hardness gradually classification reduce, be respectively 72D like pebax; 63D, 55D, 40D.
Interior pipe indicating internal diameter is 0.51～1.9mm, and wall thickness is 0.025～0.05mm, and length is 0.8～1.5mm, and material is platinum, platinum alloy, gold, Nitinol or rustless steel.
Animal experiment is selected one of 20 kilograms of tests of body weight beasle dog for use, in this dog body tangible vascular occlusion is arranged, the quick blood flow reconstructing device of embodiment 1 and accessory thereof (carrying interior pipe of recovery conduit and outer tube, a loading bin) cover.Puncture through femoral artery, under angiography, behind the affirmation thromboembolism position, under X ray is kept watch on, at first send into seal wire, will carry the recovery conduit to be pushed to preset position through the guiding function of seal wire.Carry the indicating of recovery conduit distal outer tube to cross thromboembolism position arrival blood vessel far-end through carrying the far-end indicating of reclaiming the conduit outer tube to judge whether its position is suitable, observing under the X ray.The fixing conveying reclaimed the conduit outer tube; Withdrawing from externally with carry reclaiming in the conduit pipe seal wire, packing into the tennis seal wire in the delivery conduit outer tube and advance, stride across the thromboembolism position to the indicating of netted sacculus far-end toward far-end through loading bin; Keep tennis seal wire invariant position; Return to remove to carry and reclaim the conduit outer tube, because the visuality of indicating under X ray at its netted sacculus two ends, the netted sacculus of under digital subtraction angiography DSA develops, observing the tennis seal wire is released fully.Lasting placement was installed in the blood vessel 45～120 minutes, promoting the circulation of blood pipe radiography observe the unobstructed property of blood flow at this place good after, will carry and reclaim the conduit outer tube and advance, until under the X ray supervision, netted sacculus being taken in the outer tube fully to far-end.With the tennis seal wire with carry to reclaim the conduit outer tube and withdraw from externally as a whole together, accomplish this operation process.With the blood flow state at blood vessel interimage observation vascular occlusion place, occluding vascular is unobstructed, restoration of blood flow, and do not have distal vessels and stop up.This operation process required time is short, operation safety, and success rate is high, requires relatively low to doctor's operating technology.
Claims (10)
1. quick blood flow reconstructing device, it is characterized in that: said quick blood flow reconstructing device is provided with the tennis seal wire, and the tennis seal wire is provided with seal wire; The far-end of seal wire is provided with netted sacculus (3); Netted sacculus (3) release conditions are cylindric, the RF of two ends for shrinking, and its axis is coaxial with seal wire; Netted sacculus (3) forms sliding-contact with seal wire, and far-end core silk (5) is gone up, the inside of netted sacculus (3) is provided with stop (2).
2. quick blood flow reconstructing device according to claim 1; It is characterized in that: said seal wire is connected with the near-end core silk (7) that is positioned at near-end by the far-end core silk (5) that is positioned at far-end; Be equipped with fixedly NiTi pipe (6) in the junction, the seal wire free state is that linearity is thread.
3. quick blood flow reconstructing device according to claim 2 is characterized in that: the distal end of said seal wire is connected with conductive filament head (1).
4. quick blood flow reconstructing device according to claim 3 is characterized in that: said conductive filament head (1) adopts platinum wire, tungsten alloy or billon silk, stainless steel silk to turn to coil spring shape.
5. quick blood flow reconstructing device according to claim 1 is characterized in that: indicating (4) is equipped with at the two ends of said netted sacculus (3).
6. quick blood flow reconstructing device according to claim 1 is characterized in that: said tennis seal wire is arranged on to carry and reclaims in the conduit, forms sliding-contact with carrying the recovery conduit.
7. quick blood flow reconstructing device according to claim 6 is characterized in that: outer tube (9) and the interior pipe (11) that conduit is provided with coaxial setting reclaimed in said conveying, and outer tube (9) and interior pipe (11) form and be slidingly connected.
8. quick blood flow reconstructing device according to claim 7; It is characterized in that: the far-end outer rim of said outer tube (9) is equipped with outer tube indicating (8); Outer tube (9) near-end is connected with outer tube joint (12), and outer tube (9) near-end and outer tube joint (12) junction are equipped with outer tube strain relief sleeve pipe (13); Said outer tube (9) is a three-decker, and internal layer adopts politef, and the intermediate layer is steel wire, helical spring or steel wire+helical spring; Outer nylon, nylon elastomer or the polyurethane of adopting.
9. quick blood flow reconstructing device according to claim 7; It is characterized in that: pipe indicating (10) in the far-end outer rim of pipe (11) dress in said; In pipe (11) near-end be connected with inner pipe joint (14), pipe strain relief sleeve pipe (15) in interior pipe (11) near-end and inner pipe joint (14) junction are equipped with, manage in said (11) two-layer inside and outside being; Internal layer adopts politef, outer nylon, nylon elastomer or the polyurethane of adopting.
10. the method for preparing of a quick blood flow reconstructing device; May further comprise the steps: one, preparation tennis seal wire, 1, the braiding webmaster, adopt nitinol alloy wire, titanium silk, platinum wire, platinumiridio silk, stainless steel silk; Diameter is 0.038mm～0.30mm; Quantity is 8～48, the braiding webmaster, and every foot node number that has of webmaster is 10～72; 2, the far-end of grinding far-end core silk and proximal end are the tapering transition section; Adopt nitinol alloy wire; External diameter is 0.25～0.97mm, and length is 500～3000mm, and being ground to distal length is that 90～140mm, proximal length are the taper of 20～30mm; Technological parameter is: 2000 rev/mins of rotating speeds, amount of feeding 3mm/s; Near-end core silk adopts and scribbles the politef stainless steel silk, and external diameter is 0.25～0.97mm, and length is 2500～0mm, grinding near-end core silk far-end and near-end, the long 20～30mm of its far-end grinding taper, the long 30～40mm of near-end grinding taper; 3, netted sacculus is made, and it is on the netted sacculus mould of taper that the webmaster that braiding is good is nested with at cylindric, two ends, below vacuum 10-3 handkerchief; From room temperature with 10～20min time; Be warming up to 450～550 ℃, be incubated 30 minutes, naturally cool to room temperature in the stove; Webmaster is taken off from netted sacculus mould, is platinum, platinum alloy, gold, Nitinol or the rustless steel indicating of 0.37～1.2mm with the braided wires overcoat top external diameter at webmaster two ends, adopts soldering to connect 230 ± 30 ℃ of welding temperatures; 4, make the conductive filament head spring: adopting diameter is platinum wire, tungsten alloy or billon silk, the stainless steel silk of 0.05～0.25mm, is 0.20～0.97mm around causing external diameter, long 7～150mm, and pitch is the conductive filament head spring of 0.06～0.26mm; 5, the assembling of tennis seal wire; Netted sacculus one end is enclosed within far-end core silk far-end; With material is that rustless steel, external diameter are that 0.33～1.16mm, internal diameter are that the stop of 0.2～1.0mm is nested with on far-end core silk; Then the netted sacculus other end is enclosed within on the far-end core silk, stop is weldingly fixed on the far-end core silk welding temperature: 230 ± 30 ℃; With the distal end of conductive filament head spring housing at far-end core silk, conductive filament head spring, rustless steel flat filament and far-end core silk 5 are welded to connect, technological parameter is: electric current 80～100A, pulsewidth 4.0～6.0ms, frequency, 6～8HZ, weld interval 1～3s; Far-end core silk near-end and near-end core silk far-end are put in fixedly NiTi pipe, connect or soldering is fixedly connected the three with medical AB is gluing; Two, carry to reclaim the making of conduit outer tube, 1, outer pipe shaft makes, with inner layer material; Wire of intermediate layer net, helical spring or steel wire+helical spring, cladding material are nested with in proper order on the plug of Nitinol, rustless steel or politef, near distal end, are nested with the upper exterior tube indicating; Be nested with the fluorinated ethylene propylene (FEP) heat shrink films again; Technological parameter is: 380～450 ° of F of rheology temperature, and rheology speed 0.08～0.16cm/s takes out plug and processes outer pipe shaft; 2, joint is bonding, on the far-end contact surface of proximal outer tube outer rim and joint, smears ultraviolet cured adhesive, the near-end of the outer tube remote stomidium from joint is put in to rigging position, with the irradiation of purple light machine with its curing; Outside outer tube pipe shaft, be nested with the strain relief sleeve pipe, the strain relief sleeve pipe tightened up the remote location at joint with hot-air blower near joint; Three, carry to reclaim the making of pipe in the conduit, interior pipe two-layerly is made up of inside and outside, with inner layer material; Cladding material is nested with on the plug of Nitinol, rustless steel or politef; The pipe indicating is nested with the fluorinated ethylene propylene (FEP) heat shrink films again near distal end, being nested with, and technological parameter is: 380～450 ° of F of rheology temperature; Rheology speed 0.08～0.16cm/s takes out plug and processes interior pipe shaft.
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