CN103230310A - Thoracic aortic aneurysm coated stent and thoracic aortic aneurysm minimally invasive treatment system - Google Patents
Thoracic aortic aneurysm coated stent and thoracic aortic aneurysm minimally invasive treatment system Download PDFInfo
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- CN103230310A CN103230310A CN2013101384625A CN201310138462A CN103230310A CN 103230310 A CN103230310 A CN 103230310A CN 2013101384625 A CN2013101384625 A CN 2013101384625A CN 201310138462 A CN201310138462 A CN 201310138462A CN 103230310 A CN103230310 A CN 103230310A
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Abstract
The invention discloses a thoracic aortic aneurysm coated stent which comprises a metal stent and a polymer film which is sleeved on the external side of the metal stent. The metal stent comprises a laser cutting bare stent with one end located outside the polymer film, a laser cutting stent and a heat treatment stent; the laser cutting stent and the heat treatment stent are located inside the polymer film; the metal stent is in a waved structure; an overlapping part of the metal stent and the polymer film is in suture connection with the polymer film; and one end of the laser cutting bare stent, which is located on the external of the polymer film, is provided with a plurality of hanging rings which are used for connecting with a conveying system. According to the thoracic aortic aneurysm coated stent, a minimally invasive way can be employed to treat a thoracic aortic aneurysm to enable an aneurysm cavity and a parent artery lumen to be immediately isolated to repair lesion blood vessels. The invention also discloses a thoracic aortic aneurysm minimally invasive treatment system with the thoracic aortic aneurysm coated stent.
Description
Technical field
The present invention relates to technical field of medical instruments, more particularly, relate to a kind of aneurysm of thoracic aorta overlay film frame and aneurysm of thoracic aorta minimally-invasive treatment system.
Background technology
Aneurysm of thoracic aorta is congested projection or the swelling bubble in running through thoracic aorta.As time goes on, this swelling position may die down, even normotensive dynamics just may make it break, the swelling follicular rupture can bring fatal danger.In the U.S., there are every year 100000 people of surpassing to suffer from the aneurysm disease, there are every year 15000 people therefore dead approximately, in case aneurysm rupture, survival rate has only 15%.Newly-increased case 21000 examples are arranged every year, and wherein the man accounts for 60%, and the Ms accounts for 40%.In China, along with improving constantly and aged tendency of population of living standards of the people, the sickness rate of aortic aneurysm has been ascendant trend year by year.
For the aneurysm of thoracic aorta disease, traditional Therapeutic Method is that the excision aneurysm is rebuild aorta vessel simultaneously, though it is effective, but operation wound is big, particularly for the patient at advanced age who merges important organ illness such as the heart, brain, lung, kidney, its operative mortality surpasses 20%, in many sick and gerontal patients of depositing, operative mortality is higher, reaches more than 60%.
Along with the continuous development of modern medicine technology, the interventional minimally-invasive therapy just constantly is used in the various difficult miscellaneous diseases as a kind of emerging treatment means.Endovascular graft is the minimally-invasive treatment at aneurysm of thoracic aorta that occurs in recent years, and this is that the development of the endoluminal vascular surgical technic of characteristics makes the diagnosis and treatment pattern generation great variety of aneurysm of thoracic aorta with the Wicresoft.Its operation principle is to send to diseased region and discharge by the memory alloy stent that induction system will covered polymeric membrane, treats that support launches fully, isolated aneurysm cavity and parent artery inner chamber at once, reparation lesion vessels.
Therefore, how to research and develop a kind of aneurysm of thoracic aorta overlay film frame, make to completely cut off aneurysm cavity and parent artery inner chamber at once, repair lesion vessels, become the technical problem that those skilled in the art need to be resolved hurrily.
Summary of the invention
In view of this, the object of the present invention is to provide a kind of aneurysm of thoracic aorta overlay film frame, so that completely cut off aneurysm cavity and parent artery inner chamber at once, repair lesion vessels;
Another object of the present invention is to provide a kind of aneurysm of thoracic aorta minimally-invasive treatment system with above-mentioned aneurysm of thoracic aorta overlay film frame.
For achieving the above object, the invention provides following technical scheme:
A kind of aneurysm of thoracic aorta overlay film frame comprises metal rack and the polymeric membrane that is sheathed on the described metal rack outside;
Described metal rack comprises that an end is positioned at the outer cut bare bracket of described polymeric membrane and the laser cut stent and the heat treatment fixture that are positioned at described polymeric membrane;
Described metal rack is the wavy shaped configuration support, and sews up with described polymeric membrane with described polymeric membrane superposed part and to be connected;
The end that described cut bare bracket is positioned at described polymeric membrane outside is provided with a plurality of for the link that links to each other with induction system.
Preferably, in above-mentioned aneurysm of thoracic aorta overlay film frame, described metal rack is straight-tube shape or awl tubular structure.
Preferably, in above-mentioned aneurysm of thoracic aorta overlay film frame, when described cut bare bracket was compressed, described link can close up to described cut bare bracket center.
Preferably, in above-mentioned aneurysm of thoracic aorta overlay film frame, an end relative with described link on the described cut bare bracket is provided with club shaped structure, and described club shaped structure is provided with for described cut bare bracket and sews up the oval hole slot that is connected with described polymeric membrane.
Preferably, in above-mentioned aneurysm of thoracic aorta overlay film frame, described club shaped structure is provided with the indicating of adopting platinum filament, spun gold, platinum wire, tungsten alloy filament or billon filament winding to become.
Preferably, in above-mentioned aneurysm of thoracic aorta overlay film frame, described polymeric membrane is provided with the indicating of adopting platinum filament, spun gold, platinum wire, tungsten alloy filament or billon filament winding to become away from an end of described cut bare bracket.
A kind of aneurysm of thoracic aorta minimally-invasive treatment system, comprise aneurysm of thoracic aorta overlay film frame and induction system, described aneurysm of thoracic aorta overlay film frame is arranged in the described induction system, and form with described induction system and to be slidingly matched, described aneurysm of thoracic aorta overlay film frame is as above each described aneurysm of thoracic aorta overlay film frame.
Preferably, in above-mentioned aneurysm of thoracic aorta minimally-invasive treatment system, described induction system comprises:
Rotary handle and fixed handle rotatably;
Epitheca and interior sheath, described epitheca slidably is connected with interior sheath, and is formed for taking in the space of described aneurysm of thoracic aorta overlay film frame between the two, and described rotary handle is used for discharging described aneurysm of thoracic aorta overlay film frame.
Preferably, in above-mentioned aneurysm of thoracic aorta minimally-invasive treatment system, described in sheath comprise head end, receptor, guider, backguy holder, stop, double lumen tube and mandrel from the end to end away from described fixed handle;
Described head end, receptor, guider and stop all are fixed on the described mandrel, and described backguy holder and described mandrel form and be slidingly matched;
One end of described backguy holder fixedly has equally distributed 6～12 steady pins, and described steady pin can be fixed on the described receptor along the link of described guider with the aneurysm of thoracic aorta overlay film frame;
The other end of described backguy holder is connected with backguy, and the backguy chamber of described double lumen tube is passed in described backguy, and described mandrel passes the mandrel chamber of described double lumen tube.
Preferably, in above-mentioned aneurysm of thoracic aorta minimally-invasive treatment system, described epitheca is divided into far-end epitheca and near-end epitheca, and described far-end epitheca is provided with the Connection Block of band haemostatic valve near an end of described fixed handle, and the other end is provided with indicating;
Described near-end epitheca is made by the high molecular polymer of monolayer, links to each other with described Connection Block by threaded connector away from an end of described fixed handle, and the other end and described fixed handle are slidingly matched, and are moved by described rotary handle driving axial;
Described fixed handle is provided with the safety lock of locking and the described rotary handle rotation of release, and the tail end of described fixed handle is provided with mandrel joint and backguy joint;
One end of described backguy passes from the backguy joint, through the Y joint, is fixed on the wire locking device, and described wire locking device is connected with described backguy joint by the Y joint, and described mandrel near-end is connected with the mandrel joint.
From above-mentioned technical scheme as can be seen, aneurysm of thoracic aorta overlay film frame provided by the invention, by with the link on the far-end bare bracket, when overlay film frame is pre-loaded into induction system, the link part of bare bracket can be drawn in fully to the overlay film frame center, has reduced the diameter of entire bracket compressive state as far as possible, thereby reduces the overall dimensions of induction system, improve compliance and the clinical applicability of package unit, be beneficial to quick, the convenient enforcement of operation.The present invention can adopt the mode of Wicresoft that aneurysm of thoracic aorta is treated, and makes to completely cut off aneurysm cavity and parent artery inner chamber at once, repairs lesion vessels.
Description of drawings
In order to be illustrated more clearly in the embodiment of the invention or technical scheme of the prior art, to do to introduce simply to the accompanying drawing of required use in embodiment or the description of the Prior Art below, apparently, accompanying drawing in describing below only is some embodiments of the present invention, for those of ordinary skills, under the prerequisite of not paying creative work, can also obtain other accompanying drawing according to these accompanying drawings.
The structural representation of the aneurysm of thoracic aorta overlay film frame that Fig. 1 provides for the embodiment of the invention;
Fig. 2 is the partial enlarged drawing of A among Fig. 1;
The structural representation of the induction system that Fig. 3 provides for the embodiment of the invention;
The partial structurtes sketch map of the induction system that Fig. 4 provides for the embodiment of the invention;
Fig. 5 is the cutaway view in A-A cross section among Fig. 4;
Fig. 6 is the partial enlarged drawing of B among Fig. 4.
Wherein, 1 is the cut bare bracket; 2 are indicating; 3 is laser cut stent; 4 is heat treatment fixture; 5 is polymeric membrane; 6 is the aneurysm of thoracic aorta overlay film frame; 7 are indicating; 8 is link; 9 is club shaped structure; 91 is oval hole slot; 10 is head end; 11 is double lumen tube; 12 is the far-end epitheca; 13 is Connection Block; 14 is the near-end epitheca; 15 is fixed handle; 16 is safety lock; 17 is rotary handle; 18 are backguy; 19 is loading area; 20 is receptor; 21 is guider; 22 is steady pin; 23 is stop; 24 is mandrel; 25 are the backguy holder; 26 is Rule cone joint; 27 are indicating; 28 is threaded connector; 29 is the mandrel joint; 30 are the backguy joint; 31 is the Y joint; 32 is wire locking device.
The specific embodiment
Core of the present invention is to provide a kind of aneurysm of thoracic aorta overlay film frame, so that completely cut off aneurysm cavity and parent artery inner chamber at once, repairs lesion vessels;
Another core of the present invention is to provide a kind of aneurysm of thoracic aorta minimally-invasive treatment system with above-mentioned aneurysm of thoracic aorta overlay film frame.
Below in conjunction with the accompanying drawing in the embodiment of the invention, the technical scheme in the embodiment of the invention is clearly and completely described, obviously, described embodiment only is the present invention's part embodiment, rather than whole embodiment.Based on the embodiment among the present invention, those of ordinary skills belong to the scope of protection of the invention not making the every other embodiment that obtains under the creative work prerequisite.
See also Fig. 1 and Fig. 2, the structural representation of the aneurysm of thoracic aorta overlay film frame that Fig. 1 provides for the embodiment of the invention; Fig. 2 is the partial enlarged drawing of A among Fig. 1.
The aneurysm of thoracic aorta overlay film frame that the embodiment of the invention provides comprises metal rack and the polymeric membrane 5 that is sheathed on the metal rack outside.
Metal rack comprises that an end is positioned at the cut bare bracket 1 and the laser cut stent 3 and the heat treatment fixture 4 that are positioned at polymeric membrane 5 outside the polymeric membrane 5.Metal rack is the wavy shaped configuration support, and sews up with polymeric membrane 5 with polymeric membrane 5 superposed part and to be connected.The end that cut bare bracket 1 is positioned at polymeric membrane 5 outsides is provided with a plurality of for the link 8 that links to each other with induction system.
Cut bare bracket 1 is laser cut stent, and each section support is evenly distributed in polymeric membrane 5, adjacent two metal rack crests relative with crest (trough and trough are relative).Aneurysm of thoracic aorta overlay film frame 6 naturalness are cylindric, and both ends open can be along its radial contraction.
Heat treatment fixture 4 employing memory alloy wires such as nitinol alloy wire, titanium silk, stainless steel silk are that the braided wires braiding forms, the braided wires diameter is preferably 0.254～0.4064mm, every joint support has 6～12 crests (trough), be spaced apart 3.0～5.6mm between adjacent two metal racks, each aneurysm of thoracic aorta overlay film frame 6 has outside 1 section cut bare bracket 1(overlay film), in the 1-3 section laser cut stent 3(overlay film), 4～10 sections heat treatment fixture 4.Maximum outside diameter after heat treatment fixture 4 discharges fully is 24.5～46.5mm, and length is 10～12.5mm.
The laser cut stent 3 that is positioned at polymeric membrane 5 adopts memorial alloy Nitinol pipe to form through cut, the Nitinol external diameter of pipe is 2～12mm, wall thickness is 0.1～0.6mm, length is 10～30mm, with being laser-cut into " Z " shape (being the waveform lines), have 6～12 crests (trough), it is 24～46mm that the reuse vacuum heat-treating method expands into external diameter.
Being positioned at coated by high-molecular film 5 outer cut bare brackets 1 adopts memorial alloy Nitinol pipe to form through cut, the Nitinol external diameter of pipe is 2～12mm, wall thickness is 0.1～0.6mm, length is 10～30mm, with being laser-cut into " Z " shape (being the waveform lines), have 6～12 crests (trough), each crest of support one end (trough) is located design a link 8, the reuse vacuum heat-treating method expands into the taper that far-end (not with barbed end) is little, near-end is big, the far-end external diameter is 22～44mm, and near-end and far-end are 18 °～28 ° cone angles.
Polymeric membrane 5 adopts lateral density to make greater than the polyester fiber fabric of 200 line/inches greater than 85 line/inches, vertical density, is cylindric, and external diameter is 22～44.5mm, and thickness is 0.09～0.15mm, and length is 75～210mm.
In the present invention's one specific embodiment, metal rack is straight-tube shape or awl tubular structure.Be that aneurysm of thoracic aorta overlay film frame 6 is cylindric, be divided into two kinds of designs of straight shape and taper.When cut bare bracket 1 was compressed, link 8 can close up to cut bare bracket 1 center, at utmost reduced the diameter after the support compression.
Further, an end relative with link 8 on the cut bare bracket 1 is provided with club shaped structure 9, club shaped structure 9 is provided with for cut bare bracket 1 and sews up the oval hole slot 91 that is connected with polymeric membrane 5, be used for being connected of cut bare bracket 1 and polymeric membrane 5, can effectively reduce the diameter after the junction is compressed, and prevent that blood flow from causing the overlay film displacement.
Cut bare bracket 1 bottom crest (trough) of the present invention is located not overlapping with polymeric membrane 5, but the oval hole slot 91 on the club shaped structure 9 that stretches out by the end is connected with polymeric membrane 5, it is adherent both to have supported polymeric membrane 5, and anti-displacement reduces to load compression diameter again.
Further, club shaped structure 9 is provided with the indicating 2 of adopting platinum filament, spun gold, platinum wire, tungsten alloy filament or billon filament winding to become, and indicating 2 is used for precisely locating under X ray monitors.
In like manner, polymeric membrane 5 is provided with the indicating 7 of adopting platinum filament, spun gold, platinum wire, tungsten alloy filament or billon filament winding to become away from an end of cut bare bracket 1, and indicating 7 is used for precisely locating under X ray monitors.
In the present invention's one specific embodiment, the indicating 2 employing diameters on the cut bare bracket 1 are that platinum filament, spun gold, platinum wire, tungsten alloy filament or the billon filament winding system of 0.0508～0.18mm forms.Covering indicating 7 employing external diameters is platinum filament, spun gold, platinum wire, tungsten alloy filament or the billon silk of 0.50～0.75mm, is connected with polymeric membrane 5 by polyester fiber fabric suture.
The preparation method of the disclosed aneurysm of thoracic aorta overlay film frame of the embodiment of the invention may further comprise the steps:
1, nitinol alloy wire, titanium silk, stainless steel silk are adopted in heat treatment fixture 4 typings, and the braided wires diameter is 0.254～0.4064mm, makes heat treatment fixture, and every joint support has 6～12 crests (trough).Best for using diameter 0.3556mm nitinol alloy wire, 10 crests (trough) are the heat treatment typing in the ZSK2-12-6 type vacuum heat treatment furnace that industrial furnace factory in Wuhan makes, below vacuum 10-3 handkerchief, with 10～20min time, be warming up to 450～570 ℃ from room temperature, be incubated 20 minutes, cool to 350～470 ℃ with the furnace, take out support, the heat treatment fixture 4 that will be attached to rapidly on the shaper is put into cold water, heat treatment fixture 4 is taken off from mould again.
2, the two ends of heat treatment fixture 4 wrapping wires are cut short in heat treatment fixture 4 welding, and the wrapping wire end is positioned at mid-stent, and the wrapping wire end is stitched together, and uses laser-beam welding machine, the wrapping wire end is welded to connect, and forms complete heat treatment fixture.The laser welding process parameter is: electric current 80～100A, pulsewidth 4.0～6.0ms, frequency, 6～8HZ, weld interval 1～3s.
3, polymeric membrane 5 heat treatments typing, lateral density is become the size of designing requirement greater than the cylindric polymeric membrane blanking of 200 line/inches greater than 85 line/inches, vertical density, external diameter is 22～44.5mm, thickness is 0.09～0.15mm, length is 75～210mm, and both ends keep 10～15mm allowance.Polymeric membrane after purified water is moistening is enclosed within on the shaper, with non-dust cloth and nylon suture polymeric membrane and shaper is fixed, and with the electric-heated thermostatic water bath typing, heat setting temperature is 50～100 ℃, and shaping time is 5～30min.
4, laser cut stent 3 is made, polymeric membrane 5 inner lasers cutting support: with external diameter 2～12mm, and wall thickness 0.1～0.6mm, the Nitinol pipe of length 10～30mm adopts the laser machine, cuts into " Z " shape, technological parameter is: electric current 80～110A, pulsewidth 3.0～6.0ms, frequency 6～8HZ.The ZSK2-12-6 type vacuum heat treatment furnace that reuse Wuhan industrial furnace factory makes is expanded the typing processing to support, expands into the pipe of external diameter 2～5mm, and both ends open is 10～20mm along the length of axis.Technological parameter is: vacuum=10-3Pa, with 10～20min time, be warming up to 450～550 ℃ from room temperature, and be incubated 30 minutes, naturally cool to room temperature in the stove.Cut bare bracket 1: be 2～12mm with external diameter, wall thickness 0.1～0.6mm, the Nitinol pipe of length 10～30mm cuts into " Z " shape, and it highly is 2mm that each summit of rack far end all has, the isosceles link of bottom side length 1.3mm, barb hem width 0.167mm, all there is club shaped structure 9 on each summit of near-end, is cut with aperture on the club shaped structure 9, passes suture when being used for fixed laser cutting bare bracket 1 with polymeric membrane, aperture is wide 0.3302mm, the ellipse of long 0.769mm.Cut bare bracket 1 processing technique and equipment are with overlay film inner laser cutting support.
5, overlay film frame assembling, cut bare bracket 1, laser cut stent 3, heat treatment fixture are enclosed within on the stitching mould in order, support puts polymeric membrane outward, laser cut stent 3 is except the club shaped structure 9 of far-end, other positions all expose outside polymeric membrane, sew up at the position that each support overlaps with polymeric membrane with polyester fiber fabric suture.In the thread end of bare bracket, near the place, suture site, be that 0.0508～0.18mm platinum, tungsten, platinum alloy or billon filament winding become indicating with diameter.The indicating external diameter of overlay film frame distal end is 0.50～0.75mm, adopts platinum, tungsten, platinum alloy or billon, is connected with polymeric membrane by polyester fiber fabric suture.
See also Fig. 3-Fig. 6, the structural representation of the induction system that Fig. 3 provides for the embodiment of the invention; The partial structurtes sketch map of the induction system that Fig. 4 provides for the embodiment of the invention; Fig. 5 is the cutaway view in A-A cross section among Fig. 4; Fig. 6 is the partial enlarged drawing of B among Fig. 4.
The aneurysm of thoracic aorta minimally-invasive treatment system that the embodiment of the invention provides, comprise aneurysm of thoracic aorta overlay film frame and induction system, the aneurysm of thoracic aorta overlay film frame is arranged in the induction system, and be slidingly matched with induction system formation, wherein, the aneurysm of thoracic aorta overlay film frame is the as above disclosed aneurysm of thoracic aorta overlay film frame of embodiment.Because aneurysm of thoracic aorta minimally-invasive treatment disclosed by the invention system has adopted the aneurysm of thoracic aorta overlay film frame in above-described embodiment, therefore have all technique effects of above-mentioned aneurysm of thoracic aorta overlay film frame concurrently, this paper does not repeat them here.
Further, induction system comprises rotary handle 17, fixed handle 15, epitheca and interior sheath.Wherein, rotary handle 17 and fixed handle 15 can relatively rotate, and epitheca slidably is connected with interior sheath, and are formed for taking in the space of aneurysm of thoracic aorta overlay film frame 6 between the two, and rotary handle 17 is used for discharging aneurysm of thoracic aorta overlay film frame 6.Induction system disclosed by the invention can be same as the prior art, and purpose is the aneurysm of thoracic aorta overlay film frame is carried.
For the ease of the conveying to the aneurysm of thoracic aorta overlay film frame, the present invention has also made a little structural adjustment to induction system.Interior sheath comprises head end 10, receptor 20, guider 21, backguy holder 25, stop 23, double lumen tube 11 and mandrel 24 from the end to end away from fixed handle 15.
One end of backguy holder 25 fixedly has equally distributed 6～12 steady pins 22, and steady pin 22 can be fixed on the receptor 20 along the link 8 of guider 21 with aneurysm of thoracic aorta overlay film frame 6.The other end of backguy holder 25 is connected with backguy 18, and the backguy chamber of double lumen tube 11 is passed in backguy 18, and mandrel 24 passes the mandrel chamber of double lumen tube 11.
Epitheca is divided into far-end epitheca 12 and near-end epitheca 14, and far-end epitheca 12 is provided with the Connection Block 13 of being with haemostatic valve near an end of fixed handle 15, and the other end is provided with indicating 27.
Near-end epitheca 14 is made by the high molecular polymer of monolayer, links to each other with Connection Block 13 by threaded connector 28 away from an end of fixed handle 15, and the other end and fixed handle 15 are slidingly matched, and are moved by rotary handle 17 driving axials;
Fixed handle 15 is provided with the safety lock 16 of locking and 17 rotations of release rotary handle, and the tail end of fixed handle 15 is provided with mandrel joint 29 and backguy joint 30;
One end of backguy 18 passes from backguy joint 30, through Y joint 31, is fixed on the wire locking device 32, and wire locking device 32 is connected with backguy joint 30 by Y joint 31, and mandrel 24 near-ends are connected with mandrel joint 29.
The present invention is designed to the back with the delivery mode of aneurysm of thoracic aorta overlay film frame in induction system and discharges, namely by rotary handle 17 the aneurysm of thoracic aorta overlay film frame is all sent in induction system earlier, discharge aneurysm of thoracic aorta overlay film frame far-end by backguy again, the back discharges accurate location and the safe release that design is conducive to support.
Aneurysm of thoracic aorta overlay film frame 6 is placed on the loading area 19 of induction system, steady pin 22 on the interior sheath passes the link 8 on the aneurysm of thoracic aorta overlay film frame 6, the far-end of aneurysm of thoracic aorta overlay film frame 6 is fixed in the induction system in the receptor on the sheath 20, individual safety lock 16 is arranged on the fixed handle 15, when pressing safety lock 16, rotary handle 17 can be at fixed handle 15 internal rotation, when the aneurysm of thoracic aorta overlay film frame discharges, by rotation rotary handle 17 the far-end epitheca is removed for 12 times, after aneurysm of thoracic aorta overlay film frame 6 is located in blood vessel fully, continue rotation rotary handle 17, aneurysm of thoracic aorta overlay film frame 6 is discharged in far-end epitheca 12 fully, realize this moment discharging for the first time (the overlay film frame far-end does not also discharge), after reaffirming the position of aneurysm of thoracic aorta overlay film frame 6, backguy 18 is back removed, steady pin 22 on interior sheath comes out completely in receptor 20, link 8 on the far-end bare bracket 1 of aneurysm of thoracic aorta overlay film frame 6 discharges from induction system at this moment, open and be adjacent to blood vessel wall, namely finished the back release of support.
The making of induction system
1, interior sheath is made
Be 1.0～1.2mm at internal diameter, external diameter is 1.2～1.4mm, length is the Nitinol of 1120～1420cm or the mandrel far-end that stainless steel alloy is made, and by injection moulding head end on the injection machine, technological parameter is: injection pressure: 20-40Mpa, melten gel temperature: 230 ± 10 ℃, locked mode pressure: 120 ± 10BAR, dwell pressure: 25 ± 10BAR, injection time: 1.5 ± 0.5S, dwell time: 2 ± 1S, cool time: 15 ± 5S.
The steady pin 22 that 6-12 root rustless steel or Nitinol are made is bonded in backguy holder 25 far-ends, and steady pin 22 diameters are 0.25-0.55mm, and length is 10-20mm; Be that 0.35-0.45mm, length are that stainless steel silk or the nitinol alloy wire of 1320-1620mm is bonded in backguy holder 25 near-ends with a diameter, make backguy 18.Backguy holder 25, stop 23 are inserted in from mandrel 24 near-ends in order, the groove on each steady pin 22 alignment guide 21 on the backguy holder 25 is fixed on stop 23 on the mandrel 24 by soldering processes again, and technological parameter is with guider 21.
Be 3.8-4.8mm at an external diameter, the side opening diameter is 0.4-0.5mm, the interstitial hole diameter is 1.3-1.5mm, length be double lumen tube 11 near-ends of 950-1250mm to put internal diameter be 3.82-4.85mm, external diameter is 3.85-5.0mm, length is the stainless steel tube of 300mm, two parts proximal face flush, connect fixingly with AB is gluing, backguy 18 and mandrel 24 are passed from backguy hole and the mandrel hole of double lumen tube 11 respectively, form sheath in the carrier.
2, epitheca is made
Epitheca is divided into far-end epitheca 12 and near-end epitheca 14.
Near-end epitheca 14 is made for the monolayer high molecular polymer, and internal diameter is 4.7～5.7mm, and external diameter is 5.5～6.5mm, and length is 150～200mm.Its far-end is bonded with the inner thread piece of band female Luer, and near-end connects rotatable rotary handle 17.
Far-end epitheca pipe shaft is made: with inner layer material, the wire of intermediate layer net, helical spring or steel wire+helical spring, outer high molecular polymer is nested with in proper order at Nitinol, on the plug of rustless steel or politef, be nested with indicating 27 near the distal end, be nested with fluorinated ethylene propylene (FEP) FEP heat shrink films again, on the Reflow-2203-44 type rheology machine that U.S. USA AT INC produces, with internal layer, intermediate layer and skin fuse together, take out plug, make far-end epitheca pipe shaft, technological parameter is: rheology temperature 380～450 ℉, rheology speed 0.08～0.16cm/s.The internal diameter of far-end epitheca is 3.9～5.3mm, and external diameter is 4.6～6.0mm, and length is 55～85cm.
Far-end epitheca inner layer material is politef, and internal diameter is 3.9～5.3mm, and wall thickness is 0.025～0.06mm, and length is 55～85cm.
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, weaves at braider.
Helical spring forms in the coiling of L80 model precision spring coiling machine with rustless steel, tungsten filament or the NITI silk of diameter 0.01～0.07mm, and pitch is 0.012～0.1mm, and external diameter is 4.0～5.4mm.
The outer high molecular polymer of far-end epitheca, internal diameter is 4.6～6.0mm, and external diameter is 4.8～6.2mm, and length is 55～85cm, is Pebax, nylon.
Far-end epitheca indicating external diameter is 4.0～5.4mmm, and wall thickness is 0.025～0.05mm, and length is that 0.8～1.5mm material is platinum, tungsten, platinum alloy or billon.
Far-end epitheca joint is made: far-end epitheca near-end by injection machine on injection molding joint, technological parameter is: injection pressure: 20-40Mpa, and the melten gel temperature: 230 ± 10 ℃, locked mode pressure: 120 ± 10BAR, dwell pressure: 25 ± 10BAR, the injection time: 1.5 ± 0.5S.
Dwell time: 2 ± 1S, cool time: 15 ± 5S.The silica gel haemostatic valve is housed in the joint, and the joint end is smeared layer of even ultraviolet cured adhesive UV glue with point gum machine at contact surface with the end cap joint of band standard Luer conicity joint, shines its curing with the purple light machine then, forms the far-end epitheca.
Assembling
Animal experiment, select one of 35 kilograms of piglets of body weight for use, in this pig body tangible aneurysm of thoracic aorta, Human Thoracic Aortic Dissection or false aneurysm are arranged, puncture through femoral artery, after under angiography, confirming aneurysm site, under X ray monitors, at first send into seal wire, the guiding function by seal wire with the aneurysm of thoracic aorta stent pushing to default position.Judge by the indicating of induction system far-end epitheca and aneurysm of thoracic aorta overlay film frame near-end whether its position is suitable, observe induction system far-end epitheca under the X ray and the aneurysm of thoracic aorta far-end is crossed in the indicating of aneurysm of thoracic aorta overlay film frame near-end, and the indicating of aneurysm of thoracic aorta overlay film frame near-end is positioned at left subclavian artery opening part lower edge.Keep the fixed handle invariant position, open the safety lock on the handle, the rotary handle that turns clockwise, epitheca return to be removed, and rack far end is sent in epitheca, continues back to remove epitheca to mount proximal end and launches fully.Remove wire locking device, withdraw from backguy, aneurysm of thoracic aorta overlay film frame near-end launches, be attached at blood vessel wall, keep the seal wire invariant position, induction system is withdrawn from external, kept somewhere the aneurysm of thoracic aorta overlay film frame, with prior deaeration, the sacculus that size is suitable is delivered in the aneurysm of thoracic aorta overlay film frame along seal wire, contrast agent dilating sacculus by injection dilution in sacculus, to the position that bracket end contacts with blood vessel, expand respectively, withdraw from sacculus, utilize angiography catheter injection non-ionic contrast medium, observe the position of support, whether phenomenons such as internal hemorrhage due to trauma or support kink are arranged, determine that the position is errorless after, withdraw from all kinds of conduits and seal wire.This operation process required time is short, and operation safety, and success rate height require relatively low to doctor's operating technology.
To the above-mentioned explanation of the disclosed embodiments, make this area professional and technical personnel can realize or use the present invention.Multiple modification to these embodiment will be apparent concerning those skilled in the art, and defined General Principle can realize under the situation that does not break away from the spirit or scope of the present invention in other embodiments herein.Therefore, the present invention will can not be restricted to these embodiment shown in this article, but will meet the wideest scope consistent with principle disclosed herein and features of novelty.
Claims (10)
1. an aneurysm of thoracic aorta overlay film frame is characterized in that, comprises metal rack and the polymeric membrane (5) that is sheathed on the described metal rack outside;
Described metal rack comprises that an end is positioned at the outer cut bare bracket (1) of described polymeric membrane (5) and is positioned at laser cut stent (3) and the heat treatment fixture (4) of described polymeric membrane (5);
Described metal rack is the wavy shaped configuration support, and sews up with described polymeric membrane (5) with described polymeric membrane (5) superposed part and to be connected;
Described cut bare bracket (1) is positioned at the outside end of described polymeric membrane (5) and is provided with a plurality of for the link that links to each other with induction system (8).
2. aneurysm of thoracic aorta overlay film frame as claimed in claim 1 is characterized in that, described metal rack is straight-tube shape or awl tubular structure.
3. aneurysm of thoracic aorta overlay film frame as claimed in claim 1 is characterized in that, when described cut bare bracket (1) was compressed, described link (8) can close up to described cut bare bracket (1) center.
4. aneurysm of thoracic aorta overlay film frame as claimed in claim 1, it is characterized in that, described cut bare bracket (1) is gone up an end relative with described link (8) and is provided with club shaped structure (9), and described club shaped structure (9) is provided with for described cut bare bracket (1) and sews up the oval hole slot (91) that is connected with described polymeric membrane (5).
5. aneurysm of thoracic aorta overlay film frame as claimed in claim 4 is characterized in that, described club shaped structure (9) is provided with the indicating (2) of adopting platinum filament, spun gold, platinum wire, tungsten alloy filament or billon filament winding to become.
6. aneurysm of thoracic aorta overlay film frame as claimed in claim 1, it is characterized in that described polymeric membrane (5) is provided with the indicating (7) of adopting platinum filament, spun gold, platinum wire, tungsten alloy filament or billon filament winding to become away from an end of described cut bare bracket (1).
7. aneurysm of thoracic aorta minimally-invasive treatment system, comprise aneurysm of thoracic aorta overlay film frame and induction system, described aneurysm of thoracic aorta overlay film frame is arranged in the described induction system, and be slidingly matched with described induction system formation, it is characterized in that described aneurysm of thoracic aorta overlay film frame is as each described aneurysm of thoracic aorta overlay film frame of claim 1-6.
8. aneurysm of thoracic aorta minimally-invasive treatment as claimed in claim 7 system is characterized in that described induction system comprises:
Rotary handle (17) and fixed handle (15) rotatably;
Epitheca and interior sheath, described epitheca slidably is connected with interior sheath, and is formed for taking in the space of described aneurysm of thoracic aorta overlay film frame (6) between the two, and described rotary handle (17) is used for discharging described aneurysm of thoracic aorta overlay film frame (6).
9. aneurysm of thoracic aorta minimally-invasive treatment as claimed in claim 8 system, it is characterized in that described interior sheath comprises head end (10), receptor (20), guider (21), backguy holder (25), stop (23), double lumen tube (11) and mandrel (24) from the end to end away from described fixed handle (15);
Described head end (10), receptor (20), guider (21) and stop (23) all are fixed on the described mandrel (24), and described backguy holder (25) forms with described mandrel (24) and is slidingly matched;
One end of described backguy holder (25) fixedly has equally distributed 6～12 steady pins (22), and described steady pin (22) can be fixed on the described receptor (20) along the link (8) of described guider (21) with aneurysm of thoracic aorta overlay film frame (6);
The other end of described backguy holder (25) is connected with backguy (18), and the backguy chamber of described double lumen tube (11) is passed in described backguy (18), and described mandrel (24) passes the mandrel chamber of described double lumen tube (11).
10. aneurysm of thoracic aorta minimally-invasive treatment as claimed in claim 9 system, it is characterized in that, described epitheca is divided into far-end epitheca (12) and near-end epitheca (14), described far-end epitheca (12) is provided with the Connection Block (13) of being with haemostatic valve near an end of described fixed handle (15), and the other end is provided with indicating (27);
Described near-end epitheca (14) is made by the high molecular polymer of monolayer, end away from described fixed handle (15) links to each other with described Connection Block (13) by threaded connector (28), the other end and described fixed handle (15) are slidingly matched, and are moved by described rotary handle (17) driving axial;
Described fixed handle (15) is provided with the safety lock (16) of locking and the described rotary handle of release (17) rotation, and the tail end of described fixed handle (15) is provided with mandrel joint (29) and backguy joint (30);
One end of described backguy (18) passes from backguy joint (30), through Y joint (31), be fixed on the wire locking device (32), described wire locking device (32) is connected with described backguy joint (30) by Y joint (31), and described mandrel (24) near-end is connected with mandrel joint (29).
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| CN201310138462.5A CN103230310B (en) | 2013-04-19 | 2013-04-19 | Thoracic aortic aneurysm coated stent and thoracic aortic aneurysm minimally invasive treatment system |
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