Intracranial vessel is got bolt device and is got pin deviceTechnical field
The present invention relates to medical apparatus and instruments, be specifically related to a kind of medical apparatus and instruments of getting involved blood vessel, particularly a kind of intracranial vessel is got bolt device.The invention still further relates to and a kind ofly comprise that this intracranial vessel of getting bolt device gets pin device.
Background technology
Intravascular Thrombus is commonly encountered diseases and frequently-occurring disease clinically, and Intracranial thrombus is the most important thing, and it causes cerebral embolism, has the advantages that sickness rate is high, disability rate is high, mortality rate is high and relapse rate is high, is the principal disease that middle-aged and elderly people is lethal and disable.And along with continuous increase and the growth in the living standard of aging population, the sickness rate of cerebrovascular is in continuous rising.According to investigation, China has 3,000,000 newly-increased cerebral thrombosis colony at present every year, and acute cerebral thrombosis accounts for the ratio of apoplexy, also by 55.8%, rises to 81.6%, becomes the first disease of brain.
The logical again of blood vessel is the key for the treatment of acute ischemic cerebral apoplexy.The Therapeutic Method of Intracranial thrombus mainly contains two kinds at present: medicine thrombolytic and machinery are got bolt.
Medicine thromboembolism treatment is that thrombolytics is injected near the endovascular focus at pathological changes place, focus local moment form very high thrombolytics concentration, accelerate thromboembolism speed, and then increase the chance of revascularization.But according to the state-run sacred disease of the U.S. and apoplexy academy's (NINDS) result of study, intravenous thrombolysis should be carried out in 3 hours in morbidity, tremulous pulse thrombolytic time window is within 6 hours.Because medicine thromboembolism treatment time window is shorter, and thromboembolism treatment is only applicable to the thrombosis of small volume, and its therapeutic effect to large volume thromboembolism is unsatisfactory, so finally approximately only have 3～5% patient to be applicable to doing medicine thromboembolism treatment.
It is to be delivered to lesion locations by getting bolt device that machinery is got bolt, then by sheath pipe, thrombosis is taken out to external.Machinery is got bolt and is comprised following several method: thrombectomy, and it is comparatively thorough that this method is got bolt, but excessive to vascular damaged, very easily causes various concurrent inflammation; The broken bolt of laser, this method operation easier is large, and laser energy is too low invalid, the too high injured blood vessel of energy, and equally easily cause various complication; Catching device is got bolt, and this method is simple to operate, very little to vascular damaged, but often can not entangle blood clot; Catch bolt net and get bolt, this method is simple to operate, but long-pending compared with using in intracranial vessel greatly because catching bolt dictyosome.
Chinese utility model patent 03210077.9 discloses a kind of elliposoidal blood vessel distal protector; it comprises and is provided with the fusiform elliposoidal protector main body of skeleton and the polymeric membrane of porous; polymeric membrane covers skeleton top; with allow normal blood flow by and the speckle by coming off or the solid particles such as thrombosis that form are filtered, thereby protection downstream blood vessel is not blocked.200620164685.4 of Chinese utility model patents disclose a kind ofly gets bolt device for artery of lower extremity, it is comprised of umbrella, spindle rod, push-and-pull seal wire, internal and external casing, overcoat tube core, umbrella is made by shape-memory alloy wire, by two long short three-jaws by certain angle and main shaft dry weld together form, and umbrella periphery is with network structure, to filter thrombosis.U.S. Patent application 2007/0005103,2008/0243170,2011/0098738 also discloses the pin device of catching of like configurations, and drainage screen or film that it includes framework and is attached to framework, in order to filter thrombosis.Above-mentioned to get pin device volume larger, thereby cannot in intracranial vessel, use.
Chinese invention patent application 01114889.6 discloses a kind of recyclable temporary thrombus filter that can be used for intracranial vessel, and it is comprised of filter, guide head, guide bar, connector and epitheca, and its middle filtrator is formed by shape-memory alloy wire braiding.U.S. Patent application 2011/0160763 also discloses a kind of pin device of getting that can be used for intracranial vessel, and it comprises skeleton, and skeleton can be formed by shape-memory alloy wire braiding, to catch thrombosis.When these are got pin device and reclaim after catching thrombosis, thrombosis fixing insecure, easily come off, and complex structure.
In addition, utilize the current pin device of getting, in speckle and the broken thrombi of getting on bolt process medium vessels wall, be easy to come off, flow to distal vessels, cause new thromboembolism.It is reported approximately have 70% blood vessel to get involved to get and in bolt operation, observed thrombosis fragment and fragment flows to distal vessels, this has increased patient vessel's risk of thromboembolism again.
Therefore, need a kind of improved intracranial vessel to get pin device, this device should meet following condition: 1) get bolt process simply, conveniently; 2) volume is little, can be transported to easily the distal vessels of intracranial; 3) compliance is good, and capture rate is high, and support force is moderate, and getting in bolt process not can injured blood vessel inwall; 4) while reclaiming after catching thrombosis, thrombosis fixation, difficult drop-off.
Summary of the invention
In view of this, the invention provides a kind of improved getting and tie system, this system has solved the blood vessel wall speckle and the broken thrombi that in prior art, exist and has easily come off and cause the distal vessels problem of thromboembolism again, and volume is little, compliance is good.
According to an aspect of the present invention, the present invention proposes a kind of taking thrombus device, and it comprises outer support and internal layer support, and ectonexine support is all configured to netted, and outer support is coated on outside internal layer support, forms gap between the two.Certainly, getting bolt device can be also multiple structure.
Preferably, the mesh of described outer support is greater than the mesh of internal layer support.According to embodiments of the invention, the mesh area of outer support is 3-15mm2, the mesh area of internal layer support is 2-10mm2.
With this, construct, after release, thrombosis major part is by getting the entering and fraction enters into internal layer internal stent compared with large mesh of outer support of bolt device, and most of thrombosis is all stayed in the gap between interior support arm.Like this, interior support arm can play the fixing effect of extruding to the thrombosis of staying in gap, and anti-tampon comes off when withdrawing.
According to the present invention, outer support is connected or is all connected with far-end at near-end at near-end with internal layer support.According to the present invention, outer support and internal layer support can connect by being weldingly connected, or utilize metal canula or tinsel are wound around and are connected.Metal canula and tinsel material can be platinum, gold, tungsten, platinum tungsten, platinoiridita etc., can double as developing mark.
Preferably, the near-end of ectonexine support and/or far-end are configured to elliptical openings or circular open, or are configured to sealing.More preferably, get bolt device at the opening ovalize of its proximal end.When getting bolt device, push-and-pull can guarantee effectively to catch like this area.
Preferably, outer support and/or internal layer support along get bolt device longitudinally the spacing between the center of adjacent mesh can be identical or reduce gradually to far-end from the near-end of support, mesh is distributed in close nearly thin mode far away.According to embodiments of the invention, spacing is 3-15mm.
According to the present invention, ectonexine support obtains by laser cut metal tubing, and wherein metal pipe material can be Nitinol, cobalt-nickel alloy, rustless steel etc.Or, get bolt device and there is the metal of shape memory effect or there is elastomeric macromolecular sheet material by cut, then curling, heat treatment shaping and forming.The compliance and the adherent property that make like this to get bolt device are good.
According to the present invention, to get bolt device and be on the whole near cylindrical, outer stent length is 30～60mm, and diameter is 2～6mm, and wall thickness is 0.04～0.10mm, and internal layer stent length is 20～50mm, and diameter is 2～5mm, and wall thickness is 0.04～0.08mm.
According to a further aspect of the invention, the present invention proposes a kind of intracranial vessel and gets pin device, and this is got pin device and comprises and get bolt device, guiding wire or target seeker, push-and-pull seal wire and epitheca pipe.Target seeker or guiding wire are connected with epitheca pipe, get bolt device and are connected with push-and-pull seal wire, mounted push-and-pull seal wire and get bolt device and held in epitheca pipe by pressure.Getting bolt device can change by the push-and-pull of push-and-pull seal wire between retrieving position and expanded position, at retrieving position, gets bolt device to be recycled in epitheca pipe, at expanded position, gets bolt device and is pushed out epitheca pipe.The pin device of getting of the present invention is characterised in that: it comprises the above-mentioned bolt device of getting.According to the pin device of getting of the present invention, can fixedly secure thrombosis, improve and catch stability, anti-tampon comes off.
Preferably, push-and-pull seal wire is arranged to press close to blood vessel wall at expanded position with the traction junction point of getting bolt device.Can improve so effective capture rate of large volume thrombosis.
Preferably, get bolt device and be near cylindrical in expanded position integral body.Making like this to get bolt utensil has good radial support power, has good blood vessel adherent property after being discharged into blood vessel from epitheca pipe.
During use, by getting bolt device and be positioned in the middle of the thrombosis of intracranial vessel, withdraw epitheca pipe, make to get bolt device and open in thrombosis centre position.Then, by the shutoff of near-end blood vessel, finally will get bolt device and epitheca pipe withdraws to external.
According to taking thrombus device of the present invention and get pin device, can effectively catch speckle and thrombosis fragment, increase thrombosis and caught stability, prevented that thrombosis from coming off, thereby reduced again the risk of thromboembolism.Taking thrombus device of the present invention and get pin device and be particularly suitable for intracranial vessel and get bolt, certainly, also can be for other taking thrombus.In addition, taking thrombus apparatus structure of the present invention is simple, gets bolt process conveniently easily.
Accompanying drawing explanation
By the detailed description of with reference to the accompanying drawings embodiment of the present invention being carried out, feature of the present invention and advantage thereof will be apparent.In the drawings:
Fig. 1 is the general illustration of getting pin device of the embodiment of the present invention.
Fig. 2-7th, the schematic diagram of getting bolt device of the embodiment of the present invention.
Fig. 8 has shown the mesh arrangement of getting the ectonexine support of bolt device of the present invention.
The specific embodiment
Below with reference to Fig. 1-8, describe embodiments of the invention in detail.
For convenience of description, below describe and used term " near-end " and " far-end ", wherein " near-end " refers to from the one end close to operating side, and far-end refers to the one end away from operating side.
Fig. 1 has shown the general illustration of getting pin device 1, and it comprises epitheca pipe 2, push-and-pull seal wire 3 and gets bolt device 10.Get bolt device 10 and be connected with push-and-pull seal wire 3, mounted push-and-pull seal wire 3 and get bolt device 10 and pressed and hold in epitheca pipe 2.Getting bolt device 10 can change by the push-and-pull of push-and-pull seal wire 3 between retrieving position and expanded position, at retrieving position, gets bolt device 10 to be recovered in epitheca pipe 2, at expanded position, gets bolt device 10 and is pushed out into outside epitheca pipe 2.In addition, get pin device 1 and also comprise guiding wire (not shown), guiding wire, through epitheca pipe 2, is got pin device 1 in order to guiding in blood vessel.
In addition, as shown in Figure 1, get on bolt device 10 and be also provided with developing mark 6, to help location to get bolt device 10.Be understandable that, on epitheca pipe, also can be provided with developing mark (not shown).
As shown in Fig. 2-7, get bolt device 10 for support casing supporting structure, integral body is near cylindrical, it comprises two parts, i.e. internal layer support 20 and outer support 30, and wherein ectonexine support is all configured to netted, outer support 30 is coated on outside internal layer support 20, and leaves gap between the two.In addition, the mesh of outer support 30 is greater than the mesh of internal layer support 20.In this example, the mesh area of outer support is 3～15mm2, the mesh area of internal layer support is 2～10mm2.
Fig. 2-7 have shown the different embodiment that get bolt device of the present invention.For for simplicity, in figure, do not show developing mark 6.As shown in Fig. 3,4,6 and 7, ectonexine support can only connect at near-end.Or as shown in Fig. 2 and 5, ectonexine support can all be connected with far-end at near-end.Connection can be welded to connect, utilize metal canula to connect or utilize tinsel to be intertwined and connected etc.In addition, spacing between the center of the longitudinally adjacent mesh of ectonexine support can be identical, can be also to reduce gradually to far-end from the near-end of support, as shown in Figure 8, make mesh be the close nearly formula of dredging far away and distribute, be i.e. L1>L2>L3.In this example, spacing range is 3～15mm.
On the other hand, as in Figure 2-4, the near-end of ectonexine support can all seal.Or as shown in Fig. 5-7, the near-end of ectonexine support is opening all.Or ectonexine support all seals at near-end and far-end, as shown in Fig. 2 and 5, or be sealing one open design, as Fig. 3,4,6 and 7.In addition,, as shown in Fig. 2-7, the near-end of ectonexine support and far-end can be oval enlarging, sealing contraction mouth or circular open.
Get that metal pipe material (as dilval etc.) that bolt device 10 has a shape memory effect by cut forms and through heat treatment shaping.Certainly, getting bolt device 10 also can have the metal sheet of shape memory effect by cutter, then curling, heat treatment shaping and forming.The suitable dimension of getting bolt device 10 is as follows: outer stent length is 30～60mm, and diameter is 2～6mm, and wall thickness is 0.04～0.10mm, and internal layer stent length is 20～50mm, and diameter is 2～5mm, and wall thickness is 0.04～0.08mm.Also can replace metal material with elastomeric macromolecular material.Above-mentioned suitable material is well-known to those skilled in the art, at this, is not described in detail.
Push-and-pull seal wire 3 is arranged as at expanded position and presses close to blood vessel wall with the traction junction point of getting bolt device 10.Can improve so effective capture rate of large volume thrombosis.
Using method of getting pin device 1 of the present invention is as follows.
During interventional therapy, first by angiography, determine intracranial vessel lesion locations, then from femoral artery or brachial artery, will get in pin device 1 importing blood vessel, make guiding wire pass lesion locations, by guiding wire, epitheca pipe 2 is passed to lesion locations and locates by the developing mark (not shown) on epitheca pipe 2, get during this time bolt device 10 and be positioned at epitheca pipe 2 always, in retrieving position.Then, withdraw guiding wire, by push-and-pull seal wire 3, will get bolt device 10 and shift epitheca pipe 2 far-ends onto, withdraw epitheca pipe 2 to lesion locations, will get bolt device 10, discharge, by getting developing mark 6 on bolt device 10, can locate and get bolt device 10.Due to the shape memory effect of shape memory metal or the elastic reaction of high resiliency macromolecular material, get bolt device 10 and be transformed into expanded position under the effect of blood heat, blood vessel wall reclines.Then, fixedly the position of epitheca pipe 2, pulls push-and-pull seal wire 3, withdraws to get bolt device 10 and catch thrombosis, until will get bolt device 10, is recovered in epitheca pipe 2.Finally, will get pin device 1 integral body and withdraw from outside human body, complete the bolt process of getting.
Adopt current getting to tie system while getting bolt, the speckle in blood vessel wall and broken thrombi are easy to because External Force Acting fragmentation comes off, and flow to distal vessels and cause new thromboembolism, increase patient's operation risk.The thrombosis that design of the present invention can firmly be held and catch, effectively prevents from getting pin device the coming off of thrombosis in removal process.
More than describe for be that intracranial vessel is got bolt.Be understandable that, of the present invention get bolt device and get pin device under suitable size, also can be suitable for getting bolt in other blood vessel.It will be understood by those skilled in the art that above description is exemplary.In the situation that not deviating from thought of the present invention and scope, those skilled in the art still can make numerous modifications and variations to the present invention.