CN205597973U - Thrombus remove device - Google Patents

Abstract

The utility model relates to the field of medical equipment, more specifically says, the utility model relates to a when patient acute ischemia nature apoplexy is attack, eliminate through the mechanicalness and block up at the encephalic endovascular thrombus of patient to reach the thrombectomy device that resumes the blood flow purpose. Its characterized in that: a thrombus remove device be a distal end confined bag column structure, the bag column structure constitute by skeleton texture and membrane structure, skeleton texture comprises metal material or macromolecular material, the membrane structure comprises the macromolecular material, has the microcellular structure on it, the bag column structure under external force, the shrink gets into in the conveying system, conveying system carry the system that arrests to reach target blood vessel position.

Description

A kind of thrombosis withdrawing device

Technical field

This utility model relates to a kind of medical apparatus and instruments, and more specifically, this utility model relates to a kind of being eliminated by mechanicalness be blocked in the thrombosis in patient's intracranial vessel for when patients acuity cerebral infarction fall ill, takes pin device with reach recovery blood flow purpose.

Background technology

In China, acute apoplexy (acute stroke) is first causing dead the third-largest reason with disabling.According to statistics, annual new carbuncle in the occipital region apoplexy about 2,000,000 people in the whole nation, person about 1,500,000 people that dies from apoplexy every year, apoplexy survivor about 6,500,000 people, the whole nation is annual for treating the direct cost of apoplexy more than 20,000,000,000 yuan, and wherein Ischemic Stroke (ischemic stroke) accounts for the 85% of all patients.And in the U.S., have the new carbuncle in the occipital region apoplexy patient of 25-50 ten thousand every year, and wherein dead more than 150,000 people, to add up according to U.S. American Heart Association, the whole America has patients with cerebral apoplexy 3,000,000 people.

Cerebral infarction once occurs, it is necessary within the shortest time, (effective time window) launches treatment, can have been eliminated by the machinery of the pharmacological elimination of thromboembolism and thromboembolism.Pharmacological elimination can pass through intravenous injection rt-PA (tissue-type plasminogen activator) or urokinase with thrombus, it is possible to by intra-arterial contact thrombolysis, antiplatelet aggregation and anticoagulant treatment etc..Although thromboembolism treatment has been shown to preferably improve neurological outcome, but, medicine thrombolytic still faces some problem demanding prompt solutions, first it is that thrombolytic time window is short, US National sacred disease and apoplexy institute (The National Institute Neurological Disorders and Stroke rt-PA Stroke Study Group, NINDS) research is thought, intravenous thrombolysis should be carried out within falling ill 3 hours, Arterial thrombolysis time window should be within 6 hours, and the patient that the shortest thrombolytic time window causes only 4.5%-6.3% can accept thromboembolism treatment；Secondly, the revascularization time of medicine thrombolytic is long, and the revascularization time is probably one of key factor affecting clinical prognosis, regardless of whether be intravenous thrombolysis or Arterial thrombolysis, the revascularization time at least needs 1-2 hour；And, some patients are not suitable for thromboembolism treatment.

In order to solve the problem of said medicine thrombolytic, machinery eliminates the method for thromboembolism has become study hotspot in recent years.In the prior art, following machinery is used to take pin device, to take out the endovascular thrombosis of Ischemic Stroke:

The utility model patent " for removing the device of removing thrombus from blood vessel " of Patent No. CN disclosed in China 101340849 A, by a caged or tubular structure, one distal member with the fiber extended radially out is taken in wherein, and safely eliminate thrombosis from Ink vessel transfusing with the help of fiber.

In the utility model patent " Intravascular Thrombus and embolus resectoscope " of Patent No. CN disclosed in China 101396295 A; there is the thrombectomy device of a thrombectomby spring and in shrinking or the basket of release conditions; basket is positioned at the far-end of thrombectomy device; arrest thrombosis by the winding of thrombectomby spring, and the clot produced during taking bolt with basket takes out to protect the far-end of blood vessel together with thrombosis fragment.

In the utility model patent " endovascular thrombosis grabber " of Patent No. CN 102316809 A of China's announcement, having the line main body haunted freely and be located at the thrombosis capture portion of its front end, the motion of the elastica circle body by being erected between fixed part and movable part is attached to the thrombosis of blood vessel wall to capture removing.

In the utility model patent " for the device of removal of thromboses " of Patent No. CN disclosed in China 101035474 A, there is the guide wire that a far-end is equipped with the fiber component of an orthohormbic structure, from body cavity and blood vessel, take out foreign body and thrombosis by the motion before and after it.

In the utility model patent " for the method and apparatus of restoration of blood flow " of Patent No. CN 102014772 A of China's announcement, have a self expandable taper overlay structure by interconnective line or filament or the cancellated parts of pillar, by microtubular with push after wire is introduced into inaccessible blood vessel self expandable to recover blood flow.

In the utility model patent " for treating the system and method for cerebral infarction " of Patent No. CN disclosed in China 101027004 A, there is guiding and occlusion catheter, conveying and draw catheter, lift suction pump, thromboembolic receiver and thromboembolic separator, lift suction pump by Biochemical analyzer to thromboembolic receiver, thus is withdrawn from external by draw catheter.

In the utility model of Patent No. ZL 200620164685.4 of China's bulletin " takes bolt device ", have by the umbrella of the two of elastic memory function long short three-jaws, with periphery have net formed a circular configuration take pin device, by drawing push-pull bar to make three-jaw close up outward, thrombosis pocket is recovered in trocar sheath in umbrella portion, thrombosis is taken out.

In the utility model patent " System and Method for Treating Ischemic Stroke " of Patent No. US 7931659 B2 of U.S. Publication, there is a receptor being surrounded into hollow tubular by many filaments being fixed on an elongated extension tube end, by extension tube, receptor is placed in blood vessel embolism position, and thrombosis taken in the intracavity of receptor hollow and takes out external.

In the utility model patent " Clot Retriever Device " of Patent No. US 2006/0047286 A1 of U.S. Publication, there is one and be fixed on the expansible of pusher end and the recovery basket shunk, it has one can control the uncovered in order to be captured in basket by thrombosis of opening and closing by being fixed on the tinsel of basket end.

In the utility model patent " Clot Retriever Device " of Patent No. US 2002/0049452 A1 of U.S. Publication, have one or more be fixed on slender conduit can in compression element movable have a shape memory take latch, after being transported to thromboembolism position by slender conduit, take in latch is flared out being captured by thrombosis and be wrapped in.

In the utility model patent " Clot Retrieval Mechanism " of Patent No. US 2009/0240238 A1 of U.S. Publication, have one be fixed on a slender axles end can the snare of self-expanding and an attached to it folding sack being made up of flexible non-porous material, by slender axles, device is placed in thromboembolism position along internal passage, opens sack by thrombosis bag in the inner.

In the utility model patent " Thrombectomy Device " of Patent No. WO 2012/065748 A1 disclosed in WIPO, have one be fixed in a guide wire by many grids form be similar to rack form take pin device, have on it pair of connectors with together with spiral disc be spun on the crack of side, after device being delivered to thromboembolism position by guide wire, thrombosis is taken out support.

Separately there is the utility model patent " Methods and Apparatus for Flow Restoration " of Patent No. WO 2009/105710 A1 disclosed in WIPO, it is the patent families of the utility model patent " for the method and apparatus of restoration of blood flow " of Patent No. CN 102014772 A that above-described China announces, is not repeated to illustrate.

When actual clinical uses, for there is the mechanical embolectomy of the arteriocerebral Ischemic Stroke of tremulous pulse and Vertebral-basilar artery etc. in the brain, it is all based on the interventional technique through chamber blood vessel of conduit.At computer-controlled digital subtraction angiography (Digital Subtraction Angiography, DSA) under the support of system, after femoral artery puncture, microtubular is delivered to thromboembolism position together with taking bolt apparatus, launch basket or web frame, in order to capturing or surround thromboembolism can be from removing in the patient；Or, some examples as described in above-mentioned patent documentation, suction pipe is advanced at thromboembolism, by negative pressure absorbing, thromboembolism suction catheter is removed；Again or, apply laser thrombolysis device, thrombosis is crushed to molecule so that it is pass through microcirculation and dissolved by human body natural.Although these above-mentioned apparatuses overcome the defect of pharmacological treatment, significantly improve recanalization rate, improve clinical prognosis, reducing the incidence rate that cerebral hemorrhage converts, being additionally, since is that machinery takes bolt simultaneously, substantially reduce and pass through journey again, decrease operating time, thus striven for the more time for reversible ischemic tissue of brain, say in a sense, extend the therapeutic time window of Ischemic Stroke such that it is able to make more patient be benefited.But, its open defect is, in the case of cannot looking at thrombosis straight, the catching device of basket or web form tends not to entangle blood clot and causes taking bolt failure, and its volume is the most excessive, it is impossible to use in the cerebral arterieies such as middle cerebral artery M1, M2 section that blood vessel diameter is thinner；The mode of negative pressure absorbing is despite safety, but removed only effective to the softest thromboembolism by absorption, in order to strengthen drawing effect, rotating blade or resectoscope fragmentation thrombosis are used, although this rotating blade feature improves the effect of this aspiration technique, but considerably increases the risk that blood vessel wall causes damage；Laser and ultrasound wave be the effective energy despite cleaning, but such as misoperation, easily peripheral vessels is caused damage, and energy is too low the most invalid, too high then injured blood vessel, therefore gives how high-octane laser intensity and can be only achieved optimum curative effect, need to study further；The pin device far-end that takes of supporting structure is open structure, and the thrombosis fragment produced in operation process is easily escaped from far-end and blocked the thinner blood vessel of far-end and perforating branches blood vessel, causes vascular reocclusion.Further, in actual clinical, some more obstinate thrombosis, also cannot be fully erased after repeatedly taking bolt operation, now need to free be placed in taking pin device at thromboembolism so that blood flow is unimpeded.

Knowable to discussed above, above-mentioned patent documentation takes pin device, and other technologies of the prior art, all there is one or more defect and to be realized for treatment Ischemic Stroke be non-optimal, this utility model is directed to the shortcoming overcoming or at least improving prior art.

Utility model content

In order to solve above-mentioned technical problem, this utility model provides a kind of thrombosis withdrawing device of improvement, system solves the problem and repeatedly take bolt and blood vessel wall speckle present in prior art and problem that broken thrombi easily comes off and causes distal vessels thromboembolism again, have the following characteristics that easy and simple to handle, take bolt accurately and reliably, once take bolt and i.e. can be taken off whole thrombosis；Take to tie while the semi-transparent polymeric membrane of system can ensure to load thrombosis and guarantee passing through of blood flow；Take tie system surface lubrication layer be effectively reduced the damage to blood vessel of this device；During this device withdraws, thrombosis is without the risk come off.

To achieve the above object, this utility model have employed following technical scheme: a kind of thrombosis withdrawing device, including capturing system and induction system, it is characterised in that: described capturing system is the bag shaped structure that a far-end is closed, and described bag shaped structure is made up of framing structure and membrane structure；Framing structure is made up of metal material or macromolecular material；Membrane structure is made up of macromolecular material, and it has microcellular structure；Described bag shaped structure, under applied external force, retracts in induction system；Described induction system conveying capturing system arrives target vascular site.Described guiding system is to have the macromolecular material of low-friction coefficient, can be by induction system and take bolt system accommodating wherein.Under the external stress applied by microtubular, take the far-end tying in system is flatly folded in microtubular and being transported to thromboembolism position, when microtubular withdraws, when causing taking the external stress disappearance tying system, take tie system self-expanding be deployed into complete cage structure, then withdraw and whole take pin device and microtubular, thrombosis then can enter to take and tie system, subsequently, the most proximally withdraw including this utility model device and microtubular, and finally include that this utility model device is extracted out external by guiding catheter inner chamber together with microtubular, finally from vascular system, remove described guiding catheter.

Generally, so-called guiding catheter, it has ratio for placing the internal diameter that the microtubular of this utility model device is bigger.So, whole thrombosis and be in its swelling state take tying system just can move and be placed in guiding catheter.During treating, microtubular is the most generally advanced to by guiding catheter.

In terms of the present utility model, " far-end " and " near-end " is appreciated that and observes from the direction of the doctor in charge.Far-end is remote from one end of the doctor in charge, and it relates to the one end of this utility model device being transported to further in vascular system；And near-end is corresponding with far-end, i.e. the other end of this utility model device far-end.

Preferably, described bag shaped structure having developing mark, its entirety has developability.

The material of described developing mark is the developing materials such as platinum alloy, gold, tungsten, barium sulfate.

Described framing structure is formed by cut or braiding, tapered structure, and near-end is big footpath, and far-end is path.

Having lubricating layer in described membrane structure, lubricating layer is the coating that the coefficient of friction such as hydrophilic coating or PTFE is less.

Described membrane structure is fixed in framing structure.

Described induction system is seal wire propulsion system (OTW) or rapid exchange system (RX).

Described seal wire propulsion system is a delivery guidewire, has proximally and distally, and proximally arrives distal end tapers down, and it is with capturing system by mechanical assembly, and bonding or welding the mode of glue is attached.

Described delivery guidewire is Nitinol or stainless steel and other metal materials.

Having conveying pipe or lubricating layer outside described delivery guidewire, it forms whole induction system together with delivery guidewire；Described induction system has a guiding system, the PTFE guiding system material to be the macromolecular material that coefficient of friction is little.

Compared with prior art, advantage of the present utility model and good effect be: takes and ties system and can effectively capture thrombosis, simultaneously, polymeric membrane in cage structure ensure that this utility model device is during withdrawing, thrombosis is without departing from this utility model device, microcellular structure on its polymeric membrane in turn ensure that passing through of blood flow, thus ensure that the effect taking bolt, substantially has only to once take bolt and i.e. can reach the purpose for the treatment of.With traditional take bolt operation compared with, operation process is greatly simplified, and has both alleviated the workload of doctor, has got valuable treatment time for patient again, striven for the more time for reversible ischemic tissue of brain.

Accompanying drawing explanation

Fig. 1 shows the schematic diagram taking pin device.

Fig. 2 shows and takes the schematic diagram tying system.

Fig. 3 shows the schematic diagram of developing mark.

Fig. 4 shows the schematic diagram of cage structure.

Fig. 5 shows the plane outspread drawing of cage structure.

Fig. 6 shows the schematic diagram of the polymeric membrane in cage structure.

Fig. 7 shows the schematic diagram of induction system.

Fig. 8 shows the schematic diagram of guiding system.

Fig. 9 shows the schematic diagram of inaccessible blood vessel.

Figure 10 shows that delivery conduit passes through the schematic diagram of inaccessible blood vessel.

Figure 11 shows that this utility model device arrives the schematic diagram of target location by delivery conduit.

Figure 12 shows that taking of this utility model device ties the schematic diagram after system is opened.

Figure 13 shows that this utility model device takes the schematic diagram of bolt.

Figure 14 show this utility model device take tie system near-end be recovered to microtubular schematic diagram.

Figure 15 shows that this utility model device takes bolt and terminates the schematic diagram of rear restoration of blood flow.

Detailed description of the invention

Embodiment of the present utility model is described in detail referring to Fig. 1-Figure 13.

Fig. 1～Fig. 8 illustrates the structure of this utility model device, and related description is as follows:

A kind of thrombosis withdrawing device as shown in Figure 1, ties system, induction system and guiding system including taking, described in take that to tie system be the bag shaped structure that far-end is closed, described bag shaped structure is made up of framing structure and membrane structure；Framing structure is made up of metal material or macromolecular material；Membrane structure is made up of macromolecular material, and it has microcellular structure；Described bag shaped structure, under applied external force, retracts in induction system；Described induction system conveying capturing system arrives target vascular site.Described induction system includes an elongated delivery guidewire, and delivery guidewire has lubricating layer；Described guiding system is to have the macromolecular material of low-friction coefficient, can be by induction system and take bolt system accommodating wherein.

Taking of this utility model device as shown in Figure 2 ties system.It is said that in general, often set thrombosis withdrawing device is an independent packaging, takes when the supply of material and tie system and be positioned over outside import system.During Clinical practice, the doctor in charge ties system be recovered in import system firstly the need of taking.

As shown in Figure 3 take the developing mark tying system.It is divided into near-end developing mark and far-end developing mark.Near-end developing mark is mainly used in connection and takes and tie system and induction system, and to this utility model device location under X-ray；Far-end developing mark is then mainly used in taking and ties the closing of system far-end and fix, and to this utility model device location under X-ray.

Cage structure as shown in Figure 4 and Figure 5 and plane outspread drawing thereof.It ties the skeleton of system as whole taking, it is provided that the support force that polymeric membrane opens.This example passes through laser cut Nitin alloy pipe, and makes it have certain pyramidal structure through heat treatment shaping and polishing process.Opening finally by developing mark stationary remote so that it has far-end enclosed construction.

Polymeric membrane as shown in Figure 6.It ties the funtion part of system as whole taking, it is provided that load the container of thrombosis.This example select macromolecule member material be PTFE ultrathin membrane, after through laser post-treatment so that it is there is the microcellular structure about 100 μm, finally use ultra-fine medical line to be fixed in cage structure, thus define the whole main part taking and tying system.

Induction system as shown in Figure 7.Core filaments in the middle of it is for having hyperelastic titanium-nickel wire, and far-end makes its nearer end have thinner external diameter through grinding, thus is more easy to pass through curved blood vessel；It addition, be fixed with gold turn at far-end, it is ensured that induction system preferable far-end support force, and enhance its bending property；The outside of whole core filaments and gold turn scribble the macromolecular material of polyurethane and be mixed with can in X-ray under the barium sulfate of development, it is ensured that the developability of whole induction system, facilitate doctor to operate；Scribble maleic acid hydrophilic coating in the outside of coating of polyurethane, it is ensured that the superslide of induction system, reduce resistance during propelling movement.

Guiding system as shown in Figure 8.It is the extruding pipe of PTFE material, has less coefficient of friction, is mainly used in importing this utility model device in induction system, and its internal diameter is general consistent with the induction system internal diameter of selection.

Fig. 9～Figure 15 illustrates the operating process of this utility model device, and correlated process is as follows:

The schematic diagram of inaccessible blood vessel as shown in Figure 9: by high-quality digital subtraction angiography (DSA), determine the positions and dimensions of thrombosis and the diameter of lesion vessels, and check result according to DSA, selecting this utility model device specification being suitable for, its length available should be at least equal with thrombosis length.

The intervention operation method of employing standard, places a suitable guiding catheter.Rotate haemostatic valve (RHV) by one to be connected on guiding catheter joint, then connect a flexible pipe, for continuous flushing.

Delivery conduit as shown in Figure 10 is by the schematic diagram of inaccessible blood vessel: select a suitable induction system.Rotate haemostatic valve (RHV) by one to be connected on induction system joint, then connect hoses on continuous flushing system.By a suitable delivery guidewire, push induction system, until induction system far-end is positioned at the far-end of thrombosis (or foreign body), finally withdraw from delivery guidewire.

This utility model device as shown in figure 11 arrives the schematic diagram of target location by delivery conduit: open the package, pin device is taken with normal saline flushing is whole, then tie system be recovered in guiding system taking, be transported to target location finally by guiding system taking pin device.The developing mark making this utility model device far-end aligns with the developing mark guiding system far-end.

Taking of this utility model device as shown in figure 12 ties the schematic diagram after system is opened: the near-end of fixing delivery guidewire, guarantee that taking of this utility model device far-end ties system and will not shift, the most proximally withdraw guiding system, until guiding the developing mark of system far-end to align with taking the developing mark tying system near-end, now take tying system discharge the most completely, meanwhile, 3-5 minute is stood in lesion locations so that it is self-expanding completely.

The schematic diagram taking bolt of this utility model device as shown in fig. 13 that: will take tie system and guiding system slowly and smoothly withdraw as an entirety, until whole thrombosis are recovered to take and tie in system, finally tie system taking and guiding system is passed through guide sheath pipe or extracts out external together with guide sheath pipe.

This utility model device as shown in figure 14 takes and ties system near-end and be recovered to microtubular schematic diagram: will take to tie and unite and guiding system the most slowly and smoothly withdraws as an entirety, tying in system near-end recovery microtubular until taking, finally tying system taking and guiding system is passed through guiding catheter or extracts out external together with guiding catheter.

This utility model device as shown in figure 15 takes bolt and terminates the schematic diagram of rear restoration of blood flow；After inaccessible endovascular thrombosis is taken out, inaccessible endovascular blood flow then recovers normal.

Above example description is directed to intracranial vessel and takes bolt.It will be understood by those skilled in the art that above description is the most exemplary.Take bolt device for example, it is to be understood that of the present utility model and take pin device and can also be suitable for other Ink vessel transfusing under suitably sized and take bolt.And, each feature in above-described embodiment can use as described in example but it also may is used alone or uses in any combination way.In a word, in the case of without departing substantially from thought of the present utility model and scope, those skilled in the art still can to this utility model many modifications may be made and change.

Claims (10)

1. a break catching apparatus, including capturing system and induction system, it is characterised in that: described capturing system is the bag shaped structure that a far-end is closed, and described bag shaped structure is made up of framing structure and membrane structure；Framing structure is made up of metal material or macromolecular material；Membrane structure is made up of macromolecular material, and it has microcellular structure；Described bag shaped structure, under applied external force, retracts in induction system；Described induction system conveying capturing system arrives target vascular site.

A kind of break catching apparatus the most according to claim 1, it is characterised in that: having developing mark on described bag shaped structure, its entirety has developability.

A kind of break catching apparatus the most according to claim 2, it is characterised in that: the material of described developing mark is platinum alloy, gold, tungsten, barium sulfate.

A kind of break catching apparatus the most according to claim 1, it is characterised in that: described framing structure is formed by cut or braiding, tapered structure, and near-end is big footpath, and far-end is path.

A kind of break catching apparatus the most according to claim 1, it is characterised in that: having lubricating layer in described membrane structure, lubricating layer is the coating that coefficient of friction is less.

A kind of break catching apparatus the most according to claim 1, it is characterised in that: described membrane structure is fixed in framing structure.

A kind of break catching apparatus the most according to claim 1, it is characterised in that: described induction system is seal wire propulsion system (OTW) or rapid exchange system (RX).

A kind of break catching apparatus the most according to claim 7, it is characterized in that: described seal wire propulsion system is a delivery guidewire, has proximally and distally, and proximally arrives distal end tapers down, it is with capturing system by mechanical assembly, and bonding or welding the mode of glue is attached.

A kind of break catching apparatus the most according to claim 8, it is characterised in that: described delivery guidewire is Nitinol or stainless steel is made.

A kind of break catching apparatus the most according to claim 8, it is characterised in that: having conveying pipe or lubricating layer outside described delivery guidewire, it forms whole induction system together with delivery guidewire；Described induction system has a guiding system, the PTFE guiding system material to be the macromolecular material that coefficient of friction is little.