CN100591294C - System and method for treating ischemic stroke - Google Patents

Abstract

A thromboembolic removal system for treating ischemic stroke, including a guide and occlusion catheter, a delivery and aspiration catheter, an aspiration pump, a thromboembolic receiver, and a thromboembolic separator.

Description

The system and the method that are used for the treatment of cerebral infarction

Technical field

The present invention is broadly directed to the therapeutic treatment field, and more specifically relates to a kind of system and method that is used for the treatment of cerebral infarction (ischemic stroke), and it comprises from patient's cerebral arteries removes thromboembolism.

Background technology

Apoplexy is dead and maimed first cause, also is ever-increasing global health care issues.Singly, just have every year to surpass the misery that 700,000 people stand big apoplexy, and wherein surpass 150,000 people's death in the U.S..Puzzlement is more, expect that this pretty troublesome situation arrives old-age group and becomes even worse along with " baby boom " population, and particularly those stand bad diet, obesity and/or other cause the people of the factor that works of apoplexy.In the apoplexy survivor, about 90% people in action, be subjected to secular moderate to severe injury in sense organ, memory or the thinking.The total cost of US healthcare system is the annual $500 hundred million of surpassing.

Apoplexy can break by cerebral arteries (" hemorrhagic apoplexy ") or since the cerebral arteries emphraxis (" cerebral infarction ") that thromboembolism produces cause.To be that menses are popular advance and precipitation hinders thus or the separating blood grumeleuse of occluding vascular thromboembolism.Between these two kinds of apoplexy, cerebral infarction comprises bigger problem, and the U.S. is annual to stand cerebral infarction above 600,000 people.

Ischemic stroke treatment can be finished by the pharmacological elimination of thromboembolism and/or the machinery elimination of thromboembolism.Pharmacological elimination can be designed to dissolve or prevents that the thrombolytic agent of thromboembolism further growth from (for example finishing by injection, streptokinase, urokinase, organize plasminogen catalyst (TPA)) and/or anticoagulation medicine (for example, heparin, Warfarin (warfarin)).Pharmacological treatment is non-intervention and effective to the thrombus thromboembolism usually.Although these favourable aspects are usually arranged, are to use pharmacological treatment to have obvious defects.A kind of defective is that thrombolytic agent and/or anticoagulant take effect and to recover the required time quantum of blood flow relatively large.Because the time urgency of treatment cerebral infarction, any additional period all is destructive potentially.Another open defect be improved to bleed in other positions in the body that is caused by thrombolytic agent and/or anticoagulant or hemorrhage may.

Attempted using various machineries to eliminate through the thromboembolic material of the treatment cerebral infarction of the interventional technique of chamber blood vessel based on conduit.A kind of interventional technique comprises that coil (coil) is deployed into thromboembolism (for example, passing through screw action) can remove it from the patient so that capture or surround thromboembolism.Although the pharmacological treatment to cerebral infarction improves, because thromboembolic material slippage or dispersed by coil, this withdrawal system based on coil has only obtained part success (about 55%) overcoming on the cerebral infarction.Under one situation of back, dispersing of thromboembolic material may cause other apoplexy at same tremulous pulse or connection intra-arterial.

Another kind of interventional technique comprises from thromboembolism and launches basket or web frame to far-end (perhaps downstream), so that capture or surround thromboembolism it can be removed from the patient.Equally, although overcome the defective of pharmacological treatment, its open defect is do not having to have increased the risk of damaging blood vessel from occluded segment to the action of far-end maneuvers baskets or web frame under the visual situation of the angiography road sign of vascular system (angiographic roadmap).In addition, if not, take out basket or web frame and may make thromboembolic material enter the tremulous pulse of connection.As mentioned above, this will cause other apoplexy in connecting tremulous pulse.

Another interventional technique of treatment cerebral infarction comprises suction pipe is advanced to thromboembolism, so that by drawing (that is negative pressure) with its removal.Although normally safe, only the thromboembolism to soft relatively is effective by drawing removal.In order to strengthen the effect of aspiration technique, adopt the rotating blade cut-out or smashed thromboembolism, remove by suction pipe subsequently.Although this rotating blade part has improved the effect of this aspiration technique, increased because the risk of the damage blood vessel that rotating blade causes.

Above-mentioned interventional technique, and other technologies of the prior art, all having one or more defectives and being familiar with for the treatment cerebral infarction is suboptimum.Present invention is directed at the shortcoming that overcomes or improve prior art at least.

Description of drawings

By reading this description in conjunction with appended accompanying drawing, many advantages of the present invention it will be apparent to those skilled in the art that wherein identical Reference numeral is used for components identical, and wherein:

Fig. 1 is the partial cross section side view of thromboembolic removal system one embodiment, comprises guiding and occlusion catheter, conveying and draw catheter, lift suction pump, thromboembolic receiver and thromboembolic separator;

Fig. 2 forms the conveying of parts of thromboembolic removal system shown in Figure 1 and the partial cross section side view of draw catheter, has shown to be in the not thromboembolic receiver element of deployed condition;

Fig. 3 is the conveying of parts of thromboembolic removal system shown in Figure 1 and the partial cross section side view of draw catheter, has shown the thromboembolic receiver element that is in deployed condition;

Fig. 4 A is a perspective view of describing the alternative of the thromboembolic receiver that is equipped with a plurality of engaged elements;

Fig. 4 B is the planar cross sectional view that is labeled as 4B-4B along Fig. 4 A;

Fig. 4 C is the perspective view of distal portions of the thromboembolic receiver of displayed map 4A;

Fig. 5 is the plane graph of the alternative thromboembolic receiver of Fig. 4, although receptor tubular structure preferably, Fig. 5 is shown as it and opens and flatten slabbing so that more easily observe its feature;

Fig. 6 shows to be used for the flexible top view that is couple to flexure region one embodiment that prolongs member or conveying and draw catheter of thromboembolic receiver (for example receptor of Fig. 4 A);

Fig. 7 is the perspective view that is equipped with after thromboembolic receiver is launched alternative thromboembolic receiver that can the unfolded a plurality of engaged elements of selectivity;

Fig. 8 A has to be used to promote that receptor is re-loaded to the perspective view of the thromboembolic receiver of the part in the conduit;

Fig. 8 B is the plane graph of the thromboembolic receiver of displayed map 8A like the view with Fig. 5;

Fig. 8 C is the proximal part of thromboembolic receiver of Fig. 8 A and the perspective view of distal portions that is couple to the prolongation member of thromboembolic receiver, shown thromboembolic receiver retract to carry and draw catheter in;

Fig. 9 and Figure 10 are the partial cross section side views of an embodiment of the thromboembolism detacher that together uses with conveying and draw catheter or separator;

Figure 11 A is the zoomed-in view of separator element that forms the parts of Fig. 9 and thromboembolic separator shown in Figure 10;

Figure 11 B is the lateral elevational view of the alternative of thromboembolic separator;

Figure 11 C is the zoomed-in view of separator element that forms the parts of the thromboembolic separator shown in Figure 11 B;

Figure 11 D is the lateral elevational view that similarly shows another alternative of thromboembolic separator with Figure 11 C;

Figure 12 is patient's the partial cross section view that shows the thromboembolic removal system of the Fig. 1 be used for Arterial system;

Figure 13 is patient's the partial cross section view of remote area that shows the thromboembolic removal system of the Fig. 1 be used for cerebral arteries;

Figure 14 shows that guide wire is to the propulsive partial cross section side view of thromboembolism;

Figure 15 shows that guiding and occlusion catheter advance the while air bag to be in the partial cross section side view of deflated state;

Figure 16 shows the balloon occlusion member inflation so that suppress to comprise the partial cross section side view of the endarterial blood flow of thromboembolism;

Figure 17 shows according to the method for the system that is used to use Fig. 1 the conveying of Fig. 1-Fig. 3 and draw catheter are advanced to partial cross section side view near the point of thromboembolism;

Figure 18 is the unfolded partial cross section side view of the thromboembolic receiver of displayed map 1-Fig. 3;

Figure 19 is that conveying and the draw catheter of displayed map 1-Fig. 3 advances so that the partial cross section side view of the thromboembolic receiver of Fig. 1-Fig. 3 (all or part of) engagement thromboembolism to far-end;

Figure 20 and Figure 21 have shown that the thromboembolic receiver of Fig. 1-Fig. 3 moves in guiding and the occlusion catheter so that remove the partial cross section side view of thromboembolism;

Figure 22 shows that the thromboembolic separator of using Fig. 1 and Fig. 9-Figure 11 C meshes the partial cross section side view of the distal portion of thromboembolism;

Figure 23 shows that the thromboembolic separator of using Fig. 1 and Fig. 9-Figure 11 C divides and/or softening thromboembolism and/or the auxiliary partial cross section side view of drawing;

Figure 24 is that the thromboembolic separator that shows the independent Fig. 1 of use and Fig. 9-Figure 11 C divides and/or softening thromboembolism and/or the auxiliary partial cross section view of drawing;

The thromboembolic receiver of Figure 25 and Figure 26 displayed map 4-Fig. 6 advances so that it surrounds the partial cross section view of thromboembolism to far-end; And

Figure 27 and Figure 28 are that displayed map 4-Fig. 6 thromboembolic receiver and conveying and draw catheter are withdrawn in guiding and the occlusion catheter so that remove the partial cross section side view of thromboembolism.

The specific embodiment

The various details illustrative examples.All features of actual implementation are not described for clarity, in this manual.Certainly to know, in the exploitation of any such practical embodiments, must make the decision of many application-specific, so that realize developer's specific purpose, the relevant and commercial relevant restriction of the system of for example complying with, this differs from one another according to embodiment.In addition, know that development effort may be complicated and consuming time, but benefit from those skilled in the art's of present disclosure non-creativeness work.The disclosed thromboembolic removal system of the application comprises various invention features and element independent or combination assurance patent protection.

System features

Fig. 1 has shown the one exemplary embodiment of thromboembolic removal system 10.This thromboembolic removal system 10 comprises guiding and occlusion catheter 12, conveying and draw catheter 14, thromboembolism detacher or separator 16 and lift suction pump 18.As hereinafter in greater detail, thromboembolic removal system 10 has advantageously provided the ability of removing thromboembolism from the intravital cerebral arteries of patient, has overcome the shortcoming and the limitation of prior art simultaneously.

Guiding and occlusion catheter 12 comprise the tubular catheter member 20 with the main tube cavity 22 that extends between close end 24 and distal portion 26.Catheter component 20 can be made up by the many compositions with suitable biocompatibility and strength characteristic and form, and can its size be defined as many suitable sizes and length according to the position of the inlet point that enters vascular system, thromboembolism, difference and any situation (extenuating circumstance) that alleviates of patient's anatomical structure.In an exemplary embodiment, catheter component 20 can be made of and size is defined as length and the diameter from 5French (0.065 inch) to 9French (0.117 inch) that has from 70cm to 110cm the nylon that has embedded stainless steel braid.Balloon occlusion member 28 be arranged on distal portion 26 or near.For obstructive component 28 being carried out selectivity inflation, the inflation port 30 that provides at least one tube chamber (not shown) in the wall through being arranged at tubular catheter member 20 to be communicated with obstructive component 28 fluids.Sealing member 32 is provided carries and draw catheter 14 does not leak to have, the main tube cavity 22 of hemostasis mode by guiding and occlusion catheter 12 so that make.

Conveying and draw catheter 14 comprise the tubular catheter element 34 with the main tube cavity 36 that extends between distal portion 38 and close end 40.Catheter component 34 can be constituted and can be defined as many sizes and length according to the position of the inlet point that enters vascular system, thromboembolism, the difference and the situation size of alleviating of patient's anatomical structure by the many compositions with suitable biocompatibility and strength characteristic.In an exemplary embodiment, catheter component 34 can be made of and size is defined as length and the diameter from 2.5French (0.032 inch) to 5French (0.065 inch) that has from 130cm to 170cm the PEBAX with embedded stainless steel braid.

Conveying and draw catheter 14 also comprise the maincenter assembly 42 that is couple to close end 40, so that tube chamber 36 is couple to lift suction pump 18.Maincenter assembly 42 also comprise sealing member 44 so as to allow that thromboembolic separator 16 (and as hereinafter the thrust unit of described expansion receiver element 46) is not leaked to have, the hemostasis mode is by tube chamber 36.Tube chamber preferably is coated with another of PTFE or various proper lubrication materials well known in the art.

Arrive as reference Fig. 2-Fig. 3 institute optimal viewing, thromboembolic receiver element 46 can be held in tube chamber 36 (Fig. 2) to be regained or deployed condition (Fig. 2) and can selectivity release and/or extract from distal portion 38 and enter deployed condition (Fig. 3) not.Thromboembolic receiver 46 can be made of the many compositions with suitable biocompatibility and strength characteristic, and can be defined as many suitable size and dimensions according to the position of thromboembolism, the difference of patient's anatomical structure and the size and dimension size of thromboembolism.Arrive as institute's optimal viewing among Fig. 3 and Fig. 5, thromboembolic receiver 46 is formed by a plurality of pillar components 47, and it produces a large amount of almost diamond openings 49 in the periphery of launching tailing edge thromboembolic receiver 46.According to an embodiment, as Figure 18-shown in Figure 23, the end point of the remote area of thromboembolic receiver 46 (resulting point) is equipped with blunt sharp part 51 so that thromboembolic receiver 46 is not having to hinder or otherwise stick under the situation of leading to arteriocerebral tremulous pulse or branch vessel wall to pass through cerebral arteries.

In duct element 34, provide pushing member 48 for use in receiver element 46 is advanced or be pushed to unfolded wholly or in part state in tube chamber 36.Only as an example, pushing member 48 comprises that () prolongation member 50 for example, line or coiling, it has size and is defined as the distal abutment 52 that contact forms parts (perhaps the coupling thereon) proximal terminal 54 of receiver element 46 appropriate structuring.Although not shown, know that pushing member 48 can comprise and manyly be used to promote receiver element 46 and carry out unfolded appropriate device, be defined as the conduit of distal portion of the proximal terminal 54 of contact receiver element 46 including, but not limited to having size.In one embodiment, this propulsion bulb can have size and is defined as and receives and/or by establishing tube chamber in the thromboembolic separator 16.

Fig. 4 A has shown the thromboembolic receiver 146 of alternative.Thromboembolic receiver 146 can be made of a plurality of compositions with suitable biocompatibility and strength characteristic, and can be defined as many suitable sizes and length according to the position of thromboembolism, the difference of patient's anatomical structure and the size and dimension size of thromboembolism.In a preferred embodiment, thromboembolic receiver 146 is made of the Nitinol with " shape memory " or super elastic characteristics.In this way, thromboembolic receiver 146 can be held in constrained form or shape before launching.Receptor can be by being laser-cut into part the Nitinol tubing of certain-length, and use method known to a person of ordinary skill in the art that material is carried out the one or many chemical etching subsequently and shape set forms.

With reference to Fig. 4 A, receptor 146 is installed to and prolongs on the member 151, prolongs member 151 and preferably sets tube chamber 36 (Fig. 1) extension of (proportion) one-tenth through conveying and draw catheter 14.Pillar component or " leg " 162 extend and preferably use bonding, shrinkable tubing or other known methods to be attached between receptor 146 and prolongation member 151 and prolong on the member 151.In a preferred embodiment, member 151 is rod, conduit, line or other prolongation members that prolong.In the present embodiment, setting thromboembolic receiver 146 makes its in conveying and draw catheter 14 (in Fig. 1-similar mode of mode shown in Figure 3) be limited in compression position.As alternative, prolonging member 151 can be to carry and draw catheter 14, and receptor 146 and conveying and draw catheter 14 are suitable for extending through guiding and occlusion catheter 12 in this case.

In either case, thromboembolic receiver 146 can be limited in the element of deployed condition not (for example, guiding and occlusion catheter 12 or conveying and draw catheter 14) with it and launch automatically by thromboembolic receiver 146 is released simply-because the shape memory or the super elastic characteristics of Nitinol.In case launch, thromboembolic receiver 146 can be used to receive thromboembolism.When the size of preferred selected receptor 146 is in swelling state with convenient its under body temperature, the blood vessel wall around the outer surface contact of the distal portions of receptor.In being suitable for the embodiment of most of intracranial vessels, receptor may be expanded to the maximum outside diameter of about 2-6mm, and 2-5mm more preferably.For other application of for example common carotid artery internal program, approximately the maximum outside diameter in the 6-9mm scope is suitable.

Without departing from the scope of the invention, thromboembolic receiver 146 can form has various suitable geometric shapes and feature.According to a Fig. 4 A and an embodiment shown in Figure 5, thromboembolic receiver 146 is formed by individual pillar component, and it produces the opening 149 (optimal viewing arrives among Fig. 5) of a large amount of essentially rectangulars in the periphery of launching tailing edge thromboembolic receiver 146.As an example, this can realize by a plurality of vertical pillar members or " column " 150 (being roughly parallel to the longitudinal axis of conveying and draw catheter 14) and a plurality of transverse strut members 152 (approximate vertical is extended between adjacent upright posts) are provided.In a preferred embodiment, the common distal portions that limits roughly column of pillar component with the center cavity 147 shown in Fig. 4 B.

Transverse strut members 152 can comprise many bendings or fluctuation, near crooked 153a shown in for example intersection point between transverse strut members 152 and the column 150 and the intermediary crooked 153b of intersection point shown in Figure 5.These bendings or fluctuation help to allow thromboembolic receiver 146 to be folded into compression or constrained state, and this is to be arranged in conveying and draw catheter 14 or guiding and the occlusion catheter 12 thromboembolic receiver 146 needed.

In a preferred embodiment, transverse strut members 152 forms the distal cuff 156 of the most close conveyings and the proximal cuff 154 of draw catheter 14, the far-end that is positioned at thromboembolic receiver 146 or open end and the middle big envelope 158 of certain point between proximal cuff and distal cuff.Each big envelope (proximal cuff 154, middle big envelope 158 and distal cuff 156) is for being designed to strengthen the support structure and the circumferential hoop (so that being improved to the recovery of optimizing thromboembolism adhering to of blood vessel wall) stable and that help after expansion thromboembolic receiver 146 to be remained on required form of thromboembolic receiver 146.

Can strengthen by one or more steady brace members 160 are provided in one or more essentially rectangular openings 149 by the support structure that big envelope 154-158 is provided.According to an embodiment, these steady brace members 160 can adopt the close end of the given essentially rectangular opening 149 in the thromboembolic receiver 146 or " V " form that distal portion is extended.In a preferred embodiment, this " V " shape steady brace member 160 is provided in the near-end and far-end group of the essentially rectangular opening 149 in the thromboembolic receiver 146.So advantageously increase the structural stability of the near-end and the remote area of thromboembolic receiver 146.Its given shape no matter, steady brace member 160 preferably includes fold domain or summit 169, its allow they when receptor is compressed to punctured position on the summit 169 (referring to the arrow A among Fig. 5) folding.In addition, receptor preferably is built into and allows pillar component 160 folding with the zone of other elements intersect that form receptor, (for example in the embodiment of Fig. 5, the intersecting area between pillar component 160 and the column 150).

Although the structural stability of thromboembolic receiver 146 is required targets, also wish to have the flexible of particular aspects.According to an embodiment, the abutment between thromboembolic receiver 146 and prolongation member 151 (the perhaps distal portion of conveying and draw catheter 14) provides flexible relatively.Only as an example, this by provide a plurality of in proximal cuff and prolong the adapter pillar components that extend between the member 151 or " leg " 162 (optimal viewing in as Fig. 5) with comprise near near the distal portion that prolongs member 151 flexion zones 164 realize.Flexion zones 164 can form Any shape, as long as this shape can increase the flexible of pillar component 162 under the situation that does not comprise the user capability that transmits axial force along the length of pillar component 162.In alternative shown in Figure 6, flexion zones 164a can comprise a plurality of sinuous serpentine pillar 166a of the close end that is positioned at adapter pillar 162.According to another embodiment, can provide flexion zones or spring zone 168 (Fig. 5) (it can comprise that one or more serpentines are crooked or be designed to provide the flexible shape that keeps enough post intensity simultaneously) at the abutment between adjacent vertical pillar member or the column 150.In these two kinds of examples, the advantage of these flexion zones 164,168 is that they allow thromboembolic receiver 146 to follow the tracks of better and advance along zigzag blood vessel under the situation of not sacrificing required post intensity.

According to another embodiment, thromboembolic receiver 146 can also comprise that various parts are to strengthen the engagement between thromboembolic receiver 146 and the thromboembolism.Only as an example, this can realize by a plurality of engaged elements 170 are provided on thromboembolic receiver.Arrive as optimal viewing among Fig. 4 A, Fig. 4 B and Fig. 5, according to an embodiment, engaged element 170 can take to be coupled in distal portion or near " V " shape structure and that extend of thromboembolic receiver 146 between adjacent upright posts 150.Engaged element is preferably the tube chamber 147 (referring to Fig. 4 B and Fig. 4 C) that angle enters thromboembolic receiver so that the engagement of the thromboembolism that allows to capture in the tube chamber.Can adopt many engaged elements 170 without departing from the scope of the invention.At an embodiment, the engaged element 170 that can adopt three (3) to separate, each engaged element are set to spend each other in 120 (120) along the periphery of thromboembolic receiver 146.In a preferred embodiment, engaged element 170 is taked the form of Fig. 4 A and a plurality of steady brace members 160 shown in Figure 5.

When thromboembolic receiver 146 was launched (as Fig. 4-shown in Figure 5), engaged element 170 can launch automatically.According to another aspect of the present invention shown in Figure 7, engaged element 170a can also launch the back in point selection expansion arbitrarily at thromboembolic receiver 146a.According to the embodiment of Fig. 7, by one or more prolongation elements 172 are realized that by thromboembolic receiver 146a the selectivity of engaged element 170a launches to extend in the tube chamber of thromboembolic receiver 146 from the centre so that prevent engaged element 170a.When needs launched, the user only need (towards the user) pulling prolong element 172 on proximal direction, be independent of the restriction that prolongs element 172 up to engaged element 170a is set at.When this situation occurring, " shape memory " or the superelastic nature of engaged element 170a make them present naturalness, extend to from the centre in the tube chamber of thromboembolic receiver 146a.In this way, engaged element 170a will mesh thromboembolism and thereby help or will strengthen the ability of thromboembolic receiver 146a removal thromboembolism.

Thromboembolic receiver can be provided with allow the doctor after receptor partly or entirely has been deployed in the blood vessel, receptor to be withdrawn into to carry and draw catheter in part.This may be necessary, if the doctor receives angiography or tactile feedback, it indicates separator is to be used to remove the preferred kit of specific thromboembolism or the receptor of different size is more suitable for particular procedure.

Fig. 8 A shown with the receptor 146 of Fig. 4 similar but comprise be convenient to receptor be re-loaded to carry and draw catheter 14 in the example of embodiment of thromboembolic receiver 146b of part.As shown in the figure, the receptor 146b of the embodiment of Fig. 8 A comprises single distal cuff 152b and from a plurality of vertical pillar member 150bs of big envelope 152b to proximal extension.

Shown in Fig. 8 B, structural support members 160b is configured in the distal column 171a adjacent with big envelope 152b and more among the proximal row 171b.The same with Fig. 4 embodiment, a plurality of structural support members 160b in the distal column inwardly are biased in the center cavity 147b of receptor 146b so that as the mesh component 170b that is used to mesh thromboembolism.

Three types steady brace member extends towards the close end of receptor 146b.First kind, pillar component 162b from the structural support members 160b of distal column 171a those not as the summit of the supporting member of mesh component to remote extension.These pillar components 162b is couple to the summit of the supporting member 160b of the vertical alignment among the proximal row 171b at intermediate point.Second kind, pillar component 162c forms the near-end extension of vertical pillar member 150b and comprises eyelet 163 at its close end.The third, extend on the summit of pillar component 162d those supporting members that vertically align with mesh component 170b from the structural support members 160b of proximal row.Increased the flexible of receptor 146b by some or all pillar components being configured to the flexion zones that comprises the type of describing in conjunction with the embodiment of front (for example referring to Fig. 5 flexion zones 168).

With reference to Fig. 8 C, receptor 146b comprises pusher or prolongs member 151b that it comprises tube chamber 165 in its distal portion.In the assembling process of receptor 146b, as shown in the figure, the close end of pillar component 162b, 162d is positioned in the tube chamber 165, and allows to be free to slide in tube chamber 165.Use heat-shrinkable pipe 167 or other suitable materials that the close end of pillar component 162c is attached to the outer surface that prolongs member 151b.Eyelet 163 makes the more major part of each pillar component 162c expose to bond material by the opening that allows bond material to flow into eyelet to be convenient to combination thus.If desired, pillar component 162b and 162d can be a bit larger tham the pillar component 162c at the close end place of receptor, so that allow easily they to be discerned to insert tube chamber 165 at assembling process.

If must with receptor 146b from deployed condition wholly or in part be recovered to carry and draw catheter 14 in, shown in Fig. 8 C, conduit is drawn back and is prolonged member 151b relatively on proximal direction.Along with receptor 146b moves into conduit 14, receptor begins to fold on the summit of structural support members 160b, promotes pillar component 162b, 162d thus on proximal direction.Because by the fact of pillar component 162b interconnection, Billy is folding with the receptor 146 easier realizations of Fig. 4 on its summit for specific structural support members 160b.Thereby a member 160b among the proximal row 171b folding will promote folding of respective members 160b among the distal column 171a.Allow pillar component 162b, 162d in the tube chamber 165 that prolongs member 151b, to be free to slide, so that they are withdrawn into the folding of non resistance member 160b in the process of conduit 14 at receptor 146b.

First embodiment that has shown thromboembolic separator among Fig. 9.The thromboembolic separator 16 of first embodiment comprises the prolongation element 56 with close end 58 and distal portion 60.Prolonging element 56 can be formed by the many compositions structures with suitable biocompatibility and strength characteristic, and can be defined as many suitable sizes and length according to the position of the inlet point that enters vascular system, thromboembolism, difference and any situation size that alleviates of patient's anatomical structure.In an exemplary embodiment, prolonging element 56 can be made of and size is defined as and has 150cm to the length the 200cm and from 0.010 inch to 0.021 inch diameter rustless steel and/or Nitinol.Lubricated surface (for example, PTEE coating, hydrophilic coating or other suitable coating) can be coated to and prolong all or part of of element 56 so that element moving in the tube chamber of conveying/draw catheter 14 and/or in the vascular system.

If desired, prolong element 56 can be taked the type used in various vascular applications guide wire form.Thereby, prolong element and can randomly comprise having the flexible coil type distal portions 57 (Figure 11 B) that is enough in the progradation of guide wire, to prevent to the damage of vascular tissue.In an exemplary embodiment, coil type distal portions 57 has the length between about 27-33cm.The inner axis of heart of the type that the coil preferred orientation is often found in coiled guide wires or core (not shown) are on every side.

" working end " of separator 16 comprises to be adhered to or forms the roughly blunt sharp element 62 of parts of the distal portion 60 that prolongs element 56 and the separator element 64 of adhering to or forms the parts of prolongation element 56.The gravel size decision of tip element 62 be defined as by or against (against) thromboembolism so that softening or smash thromboembolism to remove.The blunt attribute of tip element 62 advantageously prevents damage, so that it can in use not cause the damage of the inside of vascular system.Separator 16 also help to remove may since in the suction process thromboembolic material through its by and tube chamber 36 in the obstruction or the flow restriction of formation.

In one embodiment, as Figure 11 A best image, separator element 64 can take to be roughly in shape the conical basket that has along prolongation element 56 towards the opening 66 of near-end.Separating bowl 64 sizes are defined as and help thromboembolic fragmentation process, and receive this thromboembolic fragments so that help their removal.In one embodiment, separating bowl 64 is set to have net 68 and one or more supporting member 70.The size of supporting member 70 limits the roughly release position shown in net 68 is biased to, and then allow if desired net 68 along with separator 16 by carrying and draw catheter 14, conduit type pusher as described above and/or thromboembolism itself present the position roughly sealed (but not shown roughly prolong element 56 relatively concordant).

The alternative that has shown separator 16a among Figure 11 B and Figure 11 C, wherein identical Reference numeral are used to discern and the similar part of part shown in Fig. 9, Figure 10 and Figure 11 A.Separator 16a mainly has any different at the part of separator element 64a and the separator 16 of Fig. 9, Figure 10 and Figure 11 A.With reference to Figure 11 B, separator element 64a is the conical member that is formed by polymeric material, for example polyurethane or Pebax

Polyethers abaculus amide.Separator element 64a is solid component preferably, and surface 65 is towards proximal direction, and the taper of element is oriented on the distal direction.The profile on surface 65 can limit in many ways.For example, surface 65 can be concave surface slightly, the basic plane shown in Figure 11 C or the convex surface slightly shown in Figure 11 D shown in Figure 11 B.

Separator element 64a is positioned at the coil type distal portions 57 that prolongs element 56.Pitch in the part of coil type part 57 increases in the specific region of coil type distal portions 57.Interval in the open by this way coil can be so that bonding between the polymeric material of separator element and the coil method in forming process.Separator element 64a and prolong spacing between the distal portion 60 of element 56 preferably long to the extreme distal end that allows to prolong element have be enough to through vascular system move automatically flexible, prevent folding of in the progradation that prolongs element 56 extreme distal end but be short to.In an exemplary embodiment, the distal portion of separator element 64a can be positioned to apart from distal portion 60 about 3-9mm.Should be noted that coil type part 57 interior axle or the cores (not shown) that prolong element 56 can have the flexible tapered diameter that is chosen to be intensifier coil formula part.

Close end 58 at separator provides handle component 72 (Fig. 9) so that the control point (purchase point) of propelling and/or manipulation atraumatic tip element 62 and separator 64/64a is provided to the user.In one embodiment, handle component 72 can be couple in any appropriate manner and prolong element 56, prolongs in the element 56 so that these two elements are couple to together roughly inflexible extension (not shown) including, but not limited to providing to be arranged on.Strengthen or strengthen this coupling by using many bonding or fusion technique.

Without departing from the scope of the invention, can provide separator 16 with various configuration.For example, except above-described " self-deploying " embodiment, the separating bowl 64 of Figure 11 A can selectivity launches, for example by for separating bowl 64 assembling selectivitys with supporting member 70 from initial position biasing that roughly prolongs element 56 concordant placements relatively or the mechanism that is opened to the position (shown in the arrow Figure 11 A) of roughly expanded radially.

Will be appreciated that, guiding and occlusion catheter 12, conveying and draw catheter 14, thromboembolic separator 16 and/or thromboembolic receiver 46 many parts can be set so that introduce and use in these elements visual, including, but not limited to having assembling radiation opaque labelling so that improve the remote area of radiography imaging.

Discuss in conjunction with Fig. 1 as the front, various elements that the application the describes parts as the system 10 that is used to remove thromboembolic material can be provided.Thromboembolic removal system 10 can comprise guiding and occlusion catheter 12, conveying and draw catheter 14, thromboembolic separator 16/16a, thromboembolic receiver (for example receptor 46 or 146) and lift suction pump 18, and guide wire and/or other are suitable for the instrument of this program.At an embodiment, can provide a plurality of receptors 46/146 to allow doctor's order during program to regain some thromboembolism.For simply, the receptor that respectively separates can be provided with conveying and draw catheter separately.System 10 can add and be equipped with operation instruction or its equivalent that is used to set forth the described all usages of the application.

System uses

The method of using thromboembolic removal system 10 is described now with reference to Figure 12-Figure 28.Show roughly that as Figure 12-Figure 13 institute in first exemplary method, thromboembolic removal system 10 is incorporated into patient's vascular system, for example by the Seldinger technology.Figure 14 has shown the first step of this process, and this step comprises guide wire 104 is advanced to point near thromboembolism 100.Guide wire 104 can comprise the guide wire that many commerce can be buied, and its operation is well-known in the art.Yet in one approach, the prolongation member 56 of separator 16 (Figure 11 B) is as guide wire 104.

Figure 15 showed for second step, and it is included in that guide wire 104 tops will be guided and occlusion catheter 12 is advanced to point near thromboembolism.Shown in Figure 16 next step preferably includes to be inflated balloon occlusion member 28, so that suppress to comprise the blood flow in the cerebral arteries 102 of thromboembolism 100.As shown in figure 17, with after guiding and occlusion catheter 12 advance carry and draw catheter 14 so that carry and the distal portion 38 of draw catheter 14 is positioned at point near thromboembolism 100.Advance in the guide wire of guide wire 104 that extends through guiding and occlusion catheter 12 and/or exchange length (exchange-length) (not shown but this area is well-known) top and to carry and draw catheter 14 can promote this situation.

As shown in figure 18, at this point, thromboembolic receiver 46 is launched from the distal portion 38 of conveying and draw catheter 14.At an embodiment, balloon occlusion 28 inflate at this point (with as shown in figure 16 advance to carry and draw catheter 14 before inflate opposite).Subsequently.To far-end advance to carry and draw catheter 14-as shown in figure 19-make thromboembolic receiver 46 engagements and/or (some or all of) surround thromboembolism 100.At this point, as Figure 20 and shown in Figure 21, conveying and draw catheter 14 can be withdrawn in guiding and the occlusion catheter 12 so that remove thromboembolism 12 from patient 16.

In order to strengthen removing the ability of thromboembolism 100, perhaps initially do not mesh under the situation of thromboembolism 100 in thromboembolic receiver 46, can activate lift suction pump 18 so that in conveying and draw catheter 14, set up negative pressure.In this way, negative pressure is created in the cerebral arteries 102 and is applied to thromboembolism 100.As mentioned above, can in this process, adopt separator 16 (the perhaps separator 16a of Figure 11 B-Figure 11 D) (for example it is advanced and is withdrawn into carry and the tube chamber 36 of draw catheter 14 in) so that remove because thromboembolic material is passed through any obstruction or the flow restriction that produce through tube chamber 36.Negative pressure is used for thromboembolism 100 (partly or entirely) is sucked in the thromboembolic receiver 46.Subsequently, conveying and draw catheter 14 can be withdrawn in guiding and the occlusion catheter 12 so that remove thromboembolism 100 from the patient.

In order further to strengthen removing the ability of thromboembolism 100 or be not enough to all or most of thromboembolism 100 are sucked under the situation of receptor 46 at lift suction pump 18, thromboembolic separator 16/16a can be advanced to contact with the part of thromboembolism or, and setover or mesh the distal portion of thromboembolism 100 with it as shown in figure 22 all by thromboembolism 100.The surface area that this will increase with thromboembolism 100 engagement will advantageously allow it to be withdrawn in guiding and the occlusion catheter 12 like this, for example by separator 16/16a and conveying and draw catheter 14 are withdrawn in guiding and the occlusion catheter 12 simultaneously.

As shown in figure 23, separator 16/16a can also advance and regain (or remaining on receptor 46 outsides) through thrombosis thromboembolism 100 by selectivity.This will be used to smash or otherwise softening thromboembolism 100.Advance or regain separator 16/16a and also will be used for removing at suction process because thromboembolic material is passed through obstruction or the flow restriction that the tube chamber 36 of conveying and draw catheter 14 produces.In either case, lift suction pump 18 sucks thromboembolic fragments 106 or remollescent thromboembolism 100 or be biased in thromboembolic receiver 46 and/or the conduit 14.Subsequently, draw back conveying and draw catheter 14 so that thromboembolic receiver 46 is drawn in guiding and the occlusion catheter 12 so that remove thromboembolism 100 from the patient.

Separator element 64 is recovered in conveying and the draw catheter 14 through the selectivity propelling and the separator element of thrombosis thromboembolism, and preferred combination is drawn, and can also be used for bringing the fritter thromboembolic material into conduit 14.For example, separator element 64 can be passed through thromboembolic material, some material of translation and thereby along with it moves and form passage in material to far-end.In case separator element further navigates in the thromboembolism or the far-end of thromboembolism, the material of some translation may flow back in this passage.Separator element 64 is drawn into some material in the conduit 14 through the follow-up withdrawal of material (for example, the passage through refilling).In order to promote this program, preferably provide the tolerance between the maximum gauge of diameter that separator element 64 and conduit 14 make catheter lumen 36 and separator element 64 quite tight.For example, in one exemplary embodiment, the diameter of the external diameter of separator element 64 and tube chamber 36 differs about 0.003-0.008 inch.

Next describe a kind of alternative approach, wherein preferably use receptor and detacher independently of one another, though also can be with describing as being used in combination in conjunction with first exemplary method.This method is described as using thromboembolic receiver 146 and separator 16a to carry out, however will be appreciated that in described method can alternative these elements of use other embodiment.

According to alternative approach.Carrying out about at first adopting receptor 146 still is that the initial of separator 16a determined.These determine and can carry out at random that although in a preferred method, the doctor is based on definite selection proper implements of the possible character of the thromboembolic material that will remove.Specifically, the doctor will evaluate the patient with determine material may be hard or soft/gelatinous.This evaluation can comprise for example response of the tip of guide wire or separator when contacting with thromboembolism of assessment, thromboembolic material position, patient's symptom and/or be shown one or more factors in himself the mode by the apoplexy that thromboembolism causes.

As discussing in conjunction with first exemplary method, guiding and occlusion catheter 12 are incorporated into patient's vascular system, and occlusion balloons 28 is inflated so that suppress endovascular blood flow

(for example referring to Figure 14-Figure 16).

Carry and draw catheter 14 by guiding and occlusion catheter 12 and be positioned to make its remote end part in position near thromboembolism 100.If the doctor uses separator 16a before being chosen in and using receptor 146, if perhaps assessment result has determined that thromboembolic material may be that some is soft or gelatinous, activate lift suction pump 18 so as carry and draw catheter 14 in set up negative pressure, and thereby negative pressure is applied to thromboembolism 100 so that with thrombosis material suction catheter 14.

As shown in figure 24, separator 16a launches and is moved into thromboembolic material 100 to contact from the distal portion of conveying and draw catheter 14.If desired, separator can be advanced and regains repeatedly.When advancing as shown in figure and regaining, separator can promote thromboembolic material is drawn in the conduit 14 in one or more modes.At first, can become flexible, separate or softening pieces of thromboembolic material with the moving of separator of thromboembolism contact, so that the thromboembolism sheet can be drawn in the conduit.The second, advance and regain that separator 16a is used to remove since thromboembolic material through tube chamber 36 by obstruction or flow restriction in the tube chamber 36 of the conveying that causes and draw catheter 14.In addition, in the withdrawal process of detacher 16a, its proximal end face 35 loosening material is pushed to or insert to and/or push or insert the distal portion of conduit 14 so that subsequent aspiration goes out external.

If the use of the detacher 16a of Miao Shuing just now shows blood vessel and is included in not the thromboembolic material lump that can not draw under the situation about further getting involved, preferably with detacher 16a from conduit 14 extract out and with thromboembolic receiver 146 by carrying and draw catheter 14 and in blood vessel, launching.If system is provided with the receptor of a plurality of sizes, the doctor selects to have for the blood vessel of just treating the receptor of appropriate size.

Referring to Figure 25-Figure 28, in case receptor 146 launches, it expand into on every side blood vessel wall and contacts.Along with receptor 146 advances towards body thromboembolic material 200, the wall of receptor 146 in main body 200 slip around so that engagement and/or surround (partly or entirely) thromboembolism.Engaged element 170 engagement thromboembolism 200 hold it in the receptor thus.If desired, can be indicated as the arrow of Figure 27, on distal direction, advance slightly and carry and draw catheter 14, so that " hold " pillar component 162 towards each other, thereby make receptor 146 shrink slightly on radially inner direction.In addition, can activate lift suction pump 18 (Fig. 1) so that thromboembolism 200 is remained on receptor.Carry and draw catheter 14, receptor 146 and thromboembolism 100 are withdrawn into guiding and occlusion catheter 12 and draw back from health.If other thromboembolic material remain in the blood vessel, new conveying and draw catheter 14 can be fed in the blood vessel, and new receptor is launched so that regain other thromboembolic material main bodys through conduit 14.

Naturally, the doctor can select the initial deployment receptor, rather than separator, if for example initial evaluation result determines that thromboembolic material may be hard.Carry out this method as the described use receptor 146 of earlier paragraphs subsequently.If follow-uply determine in blood vessel, to exist residual thromboembolic material (for example, soft or gel-like material), preferably take out receptor 146 from health, and with separator 16a by carrying and draw catheter 14.Activate lift suction pump 18 and handle separator 16a so that promote the absorption of soft material in the above described manner.

Although the present invention is subjected to various modifications and alternative influence easily, shown specific embodiment and describing in detail in this application with example forms in the accompanying drawings.Yet, should be appreciated that the description of specific embodiment and be not inclined to limit the invention to disclosed specific form that and on the contrary, the present invention covers all modifications, equivalent and the alternative that falls in the spirit and scope of the present invention.

Claims (13)

1. one kind is used for from the system of cerebrovascular removal thromboembolic material, and described system comprises:

Set and be used to insert cerebrovascular elongate catheter, described conduit has the tube chamber through its extension, and described tube chamber comprises the distal portion with fixed inner diameter;

The absorption source that couples with described tube chamber fluid;

Can extend and have the prolongation member of distal tip through described tube chamber, described prolongation member has position separator element thereon, to the near-end interval, the maximum gauge of described separator element is less than the fixed inner diameter of described tube chamber from described distal tip for described separator element.

2. system according to claim 1 is characterized in that: during utilizing described absorption source to draw, described separator element can be pushed into described tube chamber and can draw back from described tube chamber.

3. system according to claim 1 is characterized in that: described tube chamber comprises internal diameter, and the maximum gauge of wherein said separator element is in the scope less than the internal diameter 0.003-0.008 inch of described tube chamber distal portion.

4. system according to claim 1 is characterized in that: the external diameter of described conduit is in 0.032 inch to 0.065 inch scope.

5. system according to claim 1 is characterized in that: described separator element has fixed maximum gauge.

6. system according to claim 1 is characterized in that: described separator element is a solid component.

7. system according to claim 6 is characterized in that: described separator element comprises the distal portion of close end and convergent, described close end have to proximal end face to the surface.

8. system according to claim 7 is characterized in that: described to proximal end face to the surface be concave surface.

9. system according to claim 7 is characterized in that: described to proximal end face to the surface basic be the plane.

10. system according to claim 7 is characterized in that: described to proximal end face to the surface be convex surface.

11. system according to claim 6 is characterized in that: the distal tip of described prolongation member is flexible.

12. system according to claim 1, it is characterized in that: described system comprises that also be positioned at can be through the inflatable receiving element on the extension rod that described tube chamber extends, described receiving element can in described blood vessel, advance for contact with thromboembolic material and can to the small part contraction to mesh thromboembolic material.

13. system according to claim 12, it is characterized in that: described receiving element forms by being configured to form the telescopic a plurality of structural members with center cavity, a plurality of structural members comprise engaged element, described engaged element comprises the apex region that extends in the described center cavity, wherein, described a plurality of structural member comprises a plurality of roughly v shape elements with summit of portrait orientation, and wherein said engaged element comprises a plurality of described v shape elements.

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