CN101027004A - Systems and methods for treating ischemic stroke - Google Patents

Abstract

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

Description

Systems and methods for treating ischemic stroke

technical field

The present invention relates generally to the field of medical therapy, and more particularly to a system and method for treating ischemic stroke, including removal of a thromboembolism from a cerebral artery of a patient.

Background technique

Stroke is the leading cause of death and disability and a growing global health care problem. In the United States alone, more than 700,000 people suffer from a major stroke each year, and more than 150,000 of them die. Even more troubling, this already troubling condition is expected to get worse as the "baby boomer" population ages, especially those who suffer from poor diet, obesity and/or other contributing factors to stroke. Among stroke survivors, approximately 90 percent suffer long-term moderate to severe impairment in movement, senses, memory or thinking. The total cost of the US health care system is over $50 billion per year.

Strokes can be caused by rupture of a cerebral artery ("hemorrhagic stroke") or blockage of a cerebral artery due to thromboembolism ("ischemic stroke"). Thromboembolism is a detached blood clot that travels through the bloodstream and settles thereby obstructing or blocking a blood vessel. Between these two types of stroke, ischemic stroke comprises the larger problem, with more than 600,000 people in the United States experiencing ischemic stroke each year.

Treatment of ischemic stroke can be accomplished by pharmacological ablation of thromboembolism and/or mechanical ablation of thromboembolism. Pharmacological elimination can be accomplished by injection of thrombolytic agents (eg, thrombolytic enzymes, urokinase, tissue plasminogen catalyst (TPA)) and/or anticoagulant drugs (eg, liver Phospholipids, warfarin). Pharmacological treatments are non-invasive and are usually effective in dissolving thromboembolism. Despite these generally favorable aspects, there are significant drawbacks to the use of pharmacological treatments. One drawback is the relatively large amount of time required for thrombolytic and/or anticoagulant agents to take effect and restore blood flow. Due to the time urgency of treating ischemic stroke, any additional time is potentially devastating. Another significant drawback is the increased likelihood of bleeding or hemorrhage elsewhere in the body caused by thrombolytic and/or anticoagulant agents.

Mechanical ablation of thromboembolic material in the treatment of ischemic stroke has been attempted using various catheter-based transluminal vascular interventional techniques. One interventional technique involves deploying a coil to the thromboembolism (eg, by helical action) in order to capture or surround the thromboembolism so that it can be removed from the patient. Despite improvements in the pharmacological treatment of ischemic stroke, such coil-based retrieval systems have only been partially successful (approximately 55%) in overcoming ischemic stroke due to thromboembolic material slipping off or being dissipated by the coil. In the latter case, dissipation of the thromboembolic material may result in additional strokes within the same artery or connecting arteries.

Another interventional technique involves deploying a basket or mesh structure distally (or downstream) from the thromboembolism in order to capture or surround the thromboembolism so that it can be removed from the patient. Also, while overcoming the drawbacks of pharmacological therapy, its apparent drawback is that manipulation of the basket or mesh structure distally from the obstructed segment without visualization of the angiographic roadmap of the vasculature increases the risk of damaging the vessel . Furthermore, removal of the basket or mesh structure may otherwise allow thromboembolic material to enter the attached artery. As mentioned above, this will cause an additional stroke in the connecting artery.

Yet another interventional technique for the treatment of ischemic stroke involves advancing a straw into the thrombus to remove it by suction (ie, negative pressure). Although generally safe, removal by suction is only effective for relatively soft thromboemboli. To enhance the effect of the suction technique, a rotating blade has been used to cut or break up the thromboembolism, which is subsequently removed through a suction tube. Although this rotating blade part improves the effect of this suction technique, it increases the risk of damage to the vessel due to the rotating blade.

The interventional techniques described above, as well as others in the prior art, all suffer from one or more deficiencies and are recognized as suboptimal for treating ischemic stroke. The present invention aims at overcoming or at least improving the disadvantages of the prior art.

Description of drawings

The many advantages of the present invention will become apparent to those skilled in the art from a reading of this specification in conjunction with the accompanying drawings, in which like reference numerals are used for like elements, and in which:

1 is a partial cross-sectional side view of one embodiment of a thromboembolic removal system, including guide and occlusion catheters, delivery and aspiration catheters, an aspiration pump, a thromboembolic receiver, and a thromboembolic separator;

Fig. 2 is a partial cross-sectional side view of a delivery and aspiration catheter forming part of the thromboembolic removal system shown in Fig. 1, showing the thromboembolic receiver element in an undeployed state;

3 is a partial cross-sectional side view of the delivery and aspiration catheter of the components of the thromboembolic removal system shown in FIG. 1, showing the thromboembolic receiver element in an expanded state;

Figure 4A is a perspective view illustrating an alternative embodiment of a thromboembolic receiver equipped with multiple engagement elements;

Figure 4B is a cross-sectional view along the plane labeled 4B-4B of Figure 4A;

Figure 4C is a perspective view showing the distal portion of the thromboembolic receiver of Figure 4A;

Figure 5 is a plan view of the alternative thromboembolic receiver of Figure 4, although the receiver is preferably a tubular structure, Figure 5 shows it opened and flattened into a sheet for easier viewing of its features;

6 is a top view showing an embodiment of a flexible region for flexibly coupling a thromboembolic receiver, such as the receiver of FIG. 4A , to an elongate member or delivery and aspiration catheter;

7 is a perspective view of an alternative thromboembolic receiver equipped with a plurality of engagement elements that are selectively deployable after deployment of the thromboembolic receiver;

Figure 8A is a perspective view of a thromboembolic receiver with features to facilitate reloading of the receiver into the catheter;

8B is a plan view similar to the view of FIG. 5 showing the thromboembolic receiver of FIG. 8A;

8C is a perspective view of the proximal portion of the thromboembolic receiver of FIG. 8A and the distal portion of the elongate member coupled to the thromboembolic receiver, showing retraction of the thromboembolic receiver into the delivery and aspiration catheter;

9 and 10 are partial cross-sectional side views of one embodiment of a thromboembolic stripper or separator for use with delivery and aspiration catheters;

11A is an enlarged view of a separator element forming part of the thromboembolic separator shown in FIGS. 9 and 10;

Figure 1 IB is a side elevational view of an alternative embodiment of a thromboembolism separator;

11C is an enlarged view of a separator element forming part of the thromboembolic separator shown in FIG. 11B;

11D is a side elevational view similar to FIG. 11C showing another alternative embodiment of a thromboembolism separator;

12 is a partial cross-sectional view of a patient showing the thromboembolism removal system of FIG. 1 used in an arterial system;

13 is a partial cross-sectional view of a patient showing the distal region of the thromboembolism removal system of FIG. 1 used in a cerebral artery;

Figure 14 is a partial cross-sectional side view showing advancement of a guide wire toward a thromboembolism;

Figure 15 is a partial cross-sectional side view showing the advancement of the guide and occlusion catheter while the balloon is deflated;

16 is a side view, partially in section, showing inflation of a balloon occluding member to inhibit blood flow in an artery containing a thromboembolism;

17 is a partial cross-sectional side view showing the delivery and aspiration catheter of FIGS. 1-3 being advanced to the point of a thromboembolism according to the method for using the system of FIG. 1;

Fig. 18 is a partial cross-sectional side view showing the thromboembolic receiver of Figs. 1-3 deployed;

19 is a partial cross-sectional side view showing the delivery and aspiration catheter of FIGS. 1-3 advanced distally to engage the thromboembolic receiver (in whole or in part) of FIGS. 1-3;

20 and 21 show partial cross-sectional side views of the thromboembolic receiver of FIGS. 1-3 moved into the guide and occlusion catheter for removal of the thromboembolism;

22 is a partial cross-sectional side view showing the use of the thromboembolic separator of FIGS. 1 and 9-11C to engage the distal portion of a thromboembolism;

23 is a partial cross-sectional side view showing the use of the thromboembolism separator of FIGS. 1 and 9-11C to disrupt and/or soften a thromboembolism and/or assist in suction;

24 is a partial cross-sectional view showing the use of the thromboembolism separator of FIGS. 1 and 9-11C alone to disrupt and/or soften a thromboembolism and/or to assist suction;

25 and 26 show partial cross-sectional views of the thromboembolic receiver of FIGS. 4-6 advanced distally so that it surrounds a thromboembolism; and

27 and 28 are partial cross-sectional side views showing the withdrawal of the thromboembolic receiver and delivery and aspiration catheters of FIGS. 4-6 into the guide and occlusion catheters for removal of the thromboembolism.

Detailed ways

Illustrative embodiments of the present invention will be described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, many application-specific decisions must be made in order to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which vary from implementation to implementation. Furthermore, it is understood that a development effort could be complex and time consuming but was nonetheless the uninventive endeavor of those skilled in the art with the benefit of this disclosure. The thromboembolism removal system disclosed in this application contains various inventive features and elements that alone or in combination warrant patent protection.

system features

FIG. 1 shows an exemplary embodiment of a thromboembolism removal system 10 . The thromboembolism removal system 10 includes a guide and occlusion catheter 12 , a delivery and aspiration catheter 14 , a thromboembolism stripper or separator 16 and an aspiration pump 18 . As described in more detail below, the thromboembolism removal system 10 advantageously provides the ability to remove a thromboembolism from a cerebral artery in a patient while overcoming the disadvantages and limitations of the prior art.

The guide and occlusion catheter 12 includes a tubular catheter member 20 having a main lumen 22 extending between a proximal end 24 and a distal end 26 . Catheter member 20 can be constructed from a number of components with appropriate biocompatibility and strength characteristics, and can depend on the entry point into the vasculature, the location of the thromboembolism, differences in patient anatomy, and any extenuating circumstances. It is sized to a number of suitable sizes and lengths. In an exemplary embodiment, catheter member 20 may be constructed of nylon with an embedded stainless steel braid and sized to have a length from 70 cm to 110 cm and a diameter from 5 French (0.065 inches) to 9 French (0.117 inches). A balloon blocking member 28 is disposed at or near the distal end portion 26 . For selective inflation of the blocking member 28 , an inflation port 30 is provided in fluid communication with the blocking member 28 via at least one lumen (not shown) provided in the wall of the tubular conduit member 20 . A seal 32 is provided to allow passage of the delivery and aspiration catheter 14 through the main lumen 22 of the guide and blocker catheter 12 in a leak-free, hemostatic manner.

Delivery and aspiration catheter 14 includes a tubular catheter element 34 having a main lumen 36 extending between a distal end 38 and a proximal end 40 . Catheter member 34 may be constructed of a number of components with appropriate biocompatibility and strength characteristics and may be defined in a number of sizes and lengths depending on the point of entry into the vasculature, the location of the thromboembolism, variations in patient anatomy, and mitigating conditions. In an exemplary embodiment, catheter member 34 may be constructed of PEBAX with an embedded stainless steel braid and is sized to have a length from 130 cm to 170 cm and a diameter from 2.5 French (0.032 inches) to 5 French (0.065 inches).

Delivery and aspiration catheter 14 also includes a hub assembly 42 coupled to proximal portion 40 to couple lumen 36 to aspiration pump 18 . The hub assembly 42 also includes a seal 44 to allow the passage of the thromboembolic separator 16 (and, as described below, the pushing means to deploy the receiver element 46 ) through the lumen 36 in a leak-free, hemostatic manner. The lumen is preferably sheathed with PTFE or another of various suitable lubricating materials known in the art.

As best seen with reference to FIGS. 2-3 , the thromboembolic receiver element 46 is capable of remaining within the lumen 36 ( FIG. Push out and/or pull out to deploy (Figure 3). Thromboembolic receptacle 46 may be constructed from a number of components with suitable biocompatibility and strength characteristics, and may be defined in any number of suitable sizes and shapes depending on the location of the thromboembolism, patient anatomical variability, and the size and shape of the thromboembolism. As best seen in FIGS. 3 and 5 , the thromboembolic receiver 46 is formed from a plurality of strut members 47 which, when deployed, create a plurality of generally diamond-shaped openings 49 along the periphery of the thromboembolic receiver 46 . According to one embodiment, as shown in FIGS. 18-23 , the resulting point of the distal region of the thromboembolic receiver 46 is fitted with a blunt point part 51 so that the thromboembolic receiver 46 can move freely without obstruction or otherwise. Paste through cerebral arteries in the case of arterial or branch vessel walls leading to cerebral arteries.

A pusher element 48 is provided within the catheter element 34 for advancing the receiver element 46 from within the lumen 36 or to a fully or partially deployed condition. By way of example only, the pusher element 48 comprises a suitably constructed (e.g., wire or wire-wound) elongate member 50 having a proximal terminal 54 sized to contact (or be coupled to) a component forming the receiver element 46 The distal abutment 52. Although not shown, it is understood that the pushing member 48 may include any suitable means for pushing the receiver member 46 to deploy, including but not limited to having a distal portion sized to contact the proximal terminal end 54 of the receiver member 46. the catheter. In one embodiment, such an advancement catheter may have an internal lumen sized to receive and/or pass through the thromboembolic separator 16 .

FIG. 4A shows a thromboembolic receiver 146 of an alternative embodiment. Thromboembolic receptacle 146 may be constructed of multiple components with appropriate biocompatibility and strength characteristics, and may be defined in any number of suitable sizes and lengths depending on the location of the thromboembolism, patient anatomical variability, and the size and shape of the thromboembolism. In a preferred embodiment, the thromboembolic receiver 146 is constructed of Nitinol with "shape memory" or superelastic properties. In this way, the thromboembolic receiver 146 can remain in a constrained form or shape prior to deployment. The receiver may be formed by laser cutting the part into lengths of nitinol tubing, and then chemically etching and shaping the material one or more times using methods known to those of ordinary skill in the art.

Referring to FIG. 4A , receiver 146 is mounted to elongate member 151 , which is preferably proportioned to extend through lumen 36 ( FIG. 1 ) of delivery and aspiration catheter 14 . Strut members or "feet" 162 extend between receptacle 146 and extension member 151 and are preferably attached to extension member 151 using adhesives, shrink tubing, or other known methods. In a preferred embodiment, member 151 is an elongated rod, catheter, wire or other elongated member. In this embodiment, the thromboembolic receiver 146 is configured to be constrained in a compressed position within the delivery and aspiration catheter 14 (in a manner similar to that shown in FIGS. 1-3 ). Alternatively, the extension member 151 may be the delivery and aspiration catheter 14 , in which case the receiver 146 and the delivery and aspiration catheter 14 are adapted to extend through the guide and occlusion catheter 12 .

In either case, the thromboembolic receiver 146 can be automatically deployed by simply pushing the thromboembolic receiver 146 out of the element that constrains it in the undeployed state (e.g., the introduce and block catheter 12 or the delivery and aspiration catheter 14)— Due to the shape memory or superelastic properties of Nitinol. Once deployed, the thromboembolic receptacle 146 may be used to receive a thromboembolism. The dimensions of the receptacle 146 are preferably selected so that when it is in an expanded state at body temperature, the outer surface of the distal portion of the receptacle contacts the surrounding vessel wall. In embodiments suitable for most intracranial vessels, the receiver is expandable to a maximum outer diameter of approximately 2-6mm, and more preferably 2-5mm. For other applications such as common intra-carotid procedures, a maximum outer diameter in the range of about 6-9mm is appropriate.

Thromboembolic receptacle 146 may be formed having various suitable geometries and features without departing from the scope of the present invention. According to one embodiment shown in FIGS. 4A and 5 , the thromboembolic receiver 146 is formed from a strut member that, when deployed, creates a plurality of generally rectangular openings 149 along the periphery of the thromboembolic receiver 146 (best viewed in FIG. 5 ). arrived). As an example, this may be accomplished by providing a plurality of longitudinal strut members or "posts" 150 (generally parallel to the longitudinal axis of delivery and aspiration conduit 14) and a plurality of transverse strut members 152 (extending generally perpendicular between adjacent posts). In a preferred embodiment, the strut members collectively define a generally cylindrical distal portion having a central lumen 147 as shown in Figure 4B.

Lateral strut member 152 may include a number of bends or undulations, such as bend 153a shown near the intersection between lateral strut member 152 and upright 150 and bend 153b in the middle of the intersection shown in FIG. 5 . These bends or undulations help to allow the thromboembolic receptor 146 to collapse into a compressed or constrained state, which is required for positioning the thromboembolic receptor 146 within the delivery and aspiration catheter 14 or the guide and occlusion catheter 12 .

In a preferred embodiment, the transverse strut members 152 form a proximal cuff 154 proximate to the delivery and aspiration catheter 14, a distal cuff 156 positioned at the distal or open end of the thromboembolic receiver 146, and a proximal cuff and a distal cuff positioned between the proximal cuff and the distal cuff. An intermediate envelope 158 at a point in between. Each wrapper (proximal wrapper 154, intermediate wrapper 158, and distal wrapper 156) is designed to enhance the structural support and stability of the thromboembolic receiver 146 and to help maintain the thromboembolic receiver 146 in the desired shape after deployment. Circumferential rings (in order to improve attachment to the vessel wall to optimize recovery of thrombus).

The structural support provided by the envelopes 154 - 158 may be enhanced by providing one or more stabilizing strut members 160 within the one or more generally rectangular openings 149 . According to an embodiment, these stabilizing strut members 160 may take the form of a "V" extending from either the proximal or distal end of a given generally rectangular opening 149 within the thromboembolic receiver 146 . In a preferred embodiment, such "V" shaped stabilizing strut members 160 are provided within the proximal and distal sets of generally rectangular openings 149 within the thromboembolic receiver 146 . This advantageously increases the structural stability of the proximal and distal regions of the thromboembolic receiver 146 . Regardless of their particular shape, the stabilizing strut members 160 preferably include folded regions or apexes 169 that allow them to fold at the apex 169 (see arrow A in FIG. 5 ) when the receiver is compressed to the retracted position. In addition, the receptacle is preferably constructed to allow the strut member 160 to fold in the area where it intersects with other elements forming the receptacle, (eg, in the embodiment of FIG. 5 , the intersection area between the strut member 160 and the post 150).

While structural stability of the thromboembolic receiver 146 is a desired goal, certain aspects of flexibility are also desired. According to one embodiment, relative flexibility is provided at the junction between the thromboembolic receiver 146 and the elongate member 151 (or the distal end of the delivery and aspiration catheter 14). By way of example only, this is accomplished by providing a plurality of connector strut members or "feet" 162 (as best viewed in FIG. The adjacent flex zone 164 is achieved. Flexure region 164 may be formed in any shape that increases the flexibility of strut member 162 without including the user's ability to transmit axial forces along the length of strut member 162 . In an alternative embodiment shown in FIG. 6 , the flexure region 164a may include a plurality of serpentine “S” shaped struts 166a at the proximal end of the connector strut 162 . According to another embodiment, flexure regions or spring regions 168 ( FIG. 5 ) (which may include one or more "S" shaped bends or be designed to provide flexible while maintaining sufficient column strength). In both examples, the flex zones 164, 168 are advantageous in that they allow the thromboembolic receiver 146 to better track and advance along tortuous blood vessels without sacrificing the required column strength.

According to another embodiment, the thromboembolic receiver 146 may also include various features to enhance the engagement between the thromboembolic receiver 146 and the thromboembolic receiver. By way of example only, this may be achieved by providing a plurality of engagement elements 170 on the thromboembolic receiver. As best seen in FIGS. 4A , 4B, and 5 , according to one embodiment, the engagement element 170 may be in the form of a collar coupled at or near the distal end of the thromboembolic receiver 146 and extending between adjacent posts 150 . "V" shaped structure. The engagement element is preferably angled into the lumen 147 of the thromboembolic receiver (see FIGS. 4B and 4C ) so as to allow engagement of intraluminally trapped thromboemboli. Many engagement elements 170 may be employed without departing from the scope of the present invention. In one embodiment, three (3) separate engagement elements 170 may be employed, each disposed at one hundred twenty (120) degrees from each other along the periphery of the thromboembolic receiver 146 . In a preferred embodiment, the engagement elements 170 take the form of a plurality of stabilizing strut members 160 as shown in FIGS. 4A and 5 .

Engagement element 170 may automatically deploy when thromboembolic receiver 146 is deployed (as shown in FIGS. 4-5 ). According to another aspect of the present invention shown in FIG. 7, engagement element 170a may also be selectively deployed at any point after deployment of thromboembolic receiver 146a. According to the embodiment of FIG. 7 , selective deployment of engagement element 170a is achieved by passing one or more elongate elements 172 through thromboembolic receiver 146a so as to prevent engagement element 170a from extending medially into the lumen of thromboembolic receiver 146 . When deployment is desired, the user need only pull the elongate element 172 in the proximal direction (toward the user) until the engagement element 170a is set independent of the elongate element 172 limit. When this occurs, the "shape memory" or superelastic properties of the engagement elements 170a cause them to assume a natural state, extending medially into the lumen of the thromboembolic receiver 146a. In this manner, the engagement element 170a will engage the thromboembolism and thereby facilitate or enhance the ability of the thromboembolism receiver 146a to remove the thromboembolism.

The thromboembolic receiver may be provided with features that allow the physician to retract the receiver into the delivery and aspiration catheter after the receiver has been partially or fully deployed within the blood vessel. This may be necessary if the physician receives angiographic or tactile feedback indicating that a separator is the preferred tool for removing a particular embolism or that a different sized receiver is better suited for a particular procedure.

FIG. 8A shows an example of an embodiment of a thromboembolic receiver 146b similar to receiver 146 of FIG. 4 but including features to facilitate reloading of the receiver into delivery and aspiration catheter 14 . As shown, the receiver 146b of the embodiment of FIG. 8A includes a single distal envelope 152b and a plurality of longitudinal strut members 150b extending proximally from the envelope 152b.

As shown in FIG. 8B, the structural support members 160b are arranged in a distal row 171a and a more proximal row 171b adjacent to the cuff 152b. As with the FIG. 4 embodiment, the plurality of structural support members 160b in the distal row are biased inwardly into the central lumen 147b of the receptacle 146b to serve as engagement members 170b for engaging the thromboembolism.

Three types of stabilizing strut members extend toward the proximal end of receiver 146b. First, strut members 162b extend distally from the apices of those of the structural support members 160b of distal row 171a that are not engaging members. These strut members 162b are coupled at an intermediate point to the vertices of the longitudinally aligned support members 160b in the proximal column 171b. Second, strut member 162c forms a proximal extension of longitudinal strut member 150b and includes an eyelet 163 at its proximal end. Third, strut members 162d extend from the vertices of those of the proximal row of structural support members 160b that are longitudinally aligned with engagement members 170b. The flexibility of receiver 146b is increased by configuring some or all of the strut members to include flexure regions of the type described in connection with previous embodiments (see, eg, flexure region 168 of FIG. 5 ).

Referring to Figure 8C, the receiver 146b includes a pusher or elongate member 151b that includes a lumen 165 at its distal end. During assembly of the receptacle 146b, the proximal ends of the strut members 162b, 162d are positioned within the lumen 165 and allowed to slide freely within the lumen 165, as shown. The proximal ends of strut members 162c are bonded to the outer surface of elongate member 151b using heat shrink tubing 167 or other suitable material. Eyelets 163 facilitate bonding by allowing bonding material to flow into the opening of the eyelet thereby exposing a greater portion of each strut member 162c to the bonding material. If desired, post members 162b and 162d may be slightly larger than post member 162c at the proximal end of the receptacle to allow easy identification of them for insertion into lumen 165 during assembly.

If it is necessary to retract receptacle 146b from a fully or partially deployed state into delivery and aspiration catheter 14, extension member 151b is withdrawn in a proximal direction relative to the catheter as shown in FIG. 8C. As the receptacle 146b moves into the catheter 14, the receptacle begins to fold at the apex of the structural support member 160b, thereby pushing the strut members 162b, 162d in the proximal direction. Due to the fact that certain structural support members 160b are interconnected at their apexes by strut members 162b, folding is easier to achieve than with receiver 146 of FIG. 4 . Thus, the folding of one member 160b in the proximal row 171b will facilitate the folding of the corresponding member 160b in the distal row 171a. The strut members 162b, 162d are allowed to slide freely within the lumen 165 of the elongate member 151b so that they do not resist folding of the member 160b during withdrawal of the receptacle 146b back into the catheter 14 .

A first embodiment of a thromboembolic separator is shown in FIG. 9 . The thromboembolic separator 16 of the first embodiment includes an elongate member 56 having a proximal end 58 and a distal end 60 . The elongate member 56 can be constructed from a number of components with appropriate biocompatibility and strength characteristics, and can be sized in any number of suitable dimensions depending on the point of entry into the vasculature, the location of the thromboembolism, differences in patient anatomy, and any mitigating circumstances. size and length. In an exemplary embodiment, elongate member 56 may be constructed of stainless steel and/or Nitinol and is sized to have a length between 150 cm and 200 cm and a diameter of from 0.010 inches to 0.021 inches. A lubricious surface (e.g., a PTFE coating, a hydrophilic coating, or other suitable coating) may be applied to all or a portion of the elongate element 56 to facilitate movement of the element within the lumen of the delivery/aspiration catheter 14 and/or the vasculature. movement within.

If desired, elongate element 56 may take the form of a guide wire of the type used in various vascular applications. Thus, the elongate element may optionally include a coiled distal portion 57 having sufficient flexibility to prevent damage to vascular tissue during advancement of the guide wire (FIG. 1 IB). In the exemplary embodiment, the coiled distal portion 57 has a length of between about 27-33 cm. The coil is preferably positioned around an inner mandrel or core (not shown) of the type often found in coiled guidewires.

The "working end" of the separator 16 includes a generally blunt pointed element 62 to which is attached or forms part of the distal end 60 of the elongate element 56 and a separator element 64 which is attached to or forms part of the elongate element 56 . Tip member 62 is preferably sized to pass through or against a thrombus in order to soften or break up the thrombus for removal. The blunt nature of the tip element 62 advantageously prevents trauma so that it does not cause damage to the interior of the vasculature during use. Separator 16 also helps to remove blockages or flow restrictions that may form within lumen 36 due to passage of thromboembolic material therethrough during aspiration.

In one embodiment, as best shown in FIG. 11A , the separator element 64 may take the form of a generally conical basket in shape with a proximally facing opening 66 along the elongate element 56 . Separation basket 64 is sized to facilitate the thromboembolic fragmentation process and to receive such thromboembolic fragments to facilitate their removal. In an embodiment, a separator basket 64 is provided with a mesh 68 and one or more support members 70 . Support member 70 is sized to bias mesh 68 into the generally open position shown and, if desired, allows mesh 68 to follow separator 16 through delivery and suction conduits 14, the conduit-type pushers described above, and/or Thromboembolism itself assumes a generally closed position (not shown but generally flush with elongate member 56).

An alternative embodiment of a separator 16a is shown in FIGS. 11B and 11C , where like reference numerals are used to identify similar parts to those shown in FIGS. 9 , 10 and 11A . The separator 16a differs from the separator 16 of FIGS. 9, 10 and 11A mainly in the parts of the separator element 64a. Referring to Figure 1 IB, the separator element 64a is a conical member formed from a polymeric material, such as polyurethane or Pebax(R) polyether block amide. The separator element 64a is preferably a solid member with the surface 65 facing in the proximal direction and the taper of the element oriented in the distal direction. The contour of surface 65 can be defined in a number of ways. For example, surface 65 may be slightly concave as shown in FIG. 11B , substantially planar as shown in FIG. 11C , or slightly convex as shown in FIG. 11D .

The separator element 64a is positioned at the coiled distal portion 57 of the elongate element 56 . The pitch within a portion of the coiled portion 57 increases in a specific area of the coiled distal portion 57 . Opening up the space within the coil in this way may facilitate bonding between the polymer material of the separator element and the coil material during the molding process. The spacing between the separator element 64a and the distal end portion 60 of the elongate element 56 is preferably long enough to allow the distal-most portion of the elongate element to be flexible enough to move automatically through the vasculature, but short enough to prevent a gap in the elongate element 56 during advancement. The most distal part of the fold. In an exemplary embodiment, the distal end of separator element 64a may be positioned approximately 3-9 mm from distal end 60 . It should be noted that the mandrel or core (not shown) within the coiled portion 57 of the elongate element 56 may have a tapered diameter selected to enhance the flexibility of the coiled portion.

A handle member 72 (FIG. 9) is provided at the proximal end portion 58 of the separator to provide the user with a purchase point for advancing and/or manipulating the atraumatic tip element 62 and the separator 64/64a. In one embodiment, handle member 72 may be coupled to elongate element 56 in any suitable manner, including but not limited to providing a generally rigid extension (not shown) disposed within elongate element 56 to couple the two elements together. Show). This coupling is strengthened or enhanced by using a number of bonding or fusing techniques.

Separator 16 may be provided in a variety of different configurations without departing from the scope of the present invention. For example, in addition to the "self-deploying" embodiment described above, the separation basket 64 of FIG. A mechanism that biases or opens to a generally radially expanded position (shown by the arrow in Figure 11A).

It should be appreciated that the introducer and occlusion catheter 12, the delivery and aspiration catheter 14, the thromboembolism separator 16, and/or the thromboembolism receiver 46 may be provided with a number of features to facilitate visualization of these elements during introduction and use, including but not limited to In the distal region with fitted radiopaque markers for improved radiographic imaging.

As previously discussed in connection with FIG. 1 , various elements described herein may be provided as components of system 10 for removing thromboembolic material. The thromboembolism removal system 10 may include a guide and occlusion catheter 12, a delivery and aspiration catheter 14, a thromboembolism separator 16/16a, a thromboembolism receiver (such as receiver 46 or 146) and an aspiration pump 18, as well as guide wires and /or other tools suitable for the program. In one embodiment, multiple receivers 46/146 may be provided to allow the physician to sequentially retrieve several thromboemboli during the procedure. For simplicity, each separate receptacle may be provided with a separate delivery and suction conduit. The system 10 may be additionally furnished with instructions for use or their equivalents illustrating the various uses described herein.

system use

A method of using the thromboembolism removal system 10 will now be described with reference to FIGS. 12-28 . As generally shown in FIGS. 12-13 , in a first exemplary method, the thromboembolic removal system 10 is introduced into the vasculature of a patient, such as by the Seldinger technique. FIG. 14 shows the first step of the procedure, which involves advancing the guidewire 104 close to the point of the thromboembolism 100 . Guide wire 104 may include a number of commercially available guide wires, the operation of which is well known in the art. In one approach, however, the elongate member 56 of the separator 16 ( FIG. 11B ) acts as the guide wire 104 .

Figure 15 shows a second step which involves advancing the guide and occlusion catheter 12 over the guide wire 104 to approximately the point of thromboembolism. The next step shown in FIG. 16 preferably includes inflating the balloon occlusion member 28 to inhibit blood flow within the cerebral artery 102 containing the thromboembolism 100 . As shown in FIG. 17 , the delivery and aspiration catheter 14 is then advanced through the introducer and occlusion catheter 12 to position the distal end 38 of the delivery and aspiration catheter 14 near the point of the thromboembolism 100 . Advancing the delivery and aspiration catheter 14 over a guide wire 104 extending through the guide and occlusion catheter 12 and/or an exchange-length guide wire (not shown but well known in the art) may facilitate this.

At this point, the thromboembolic receiver 46 is deployed from the distal end 38 of the delivery and aspiration catheter 14 as shown in FIG. 18 . In one embodiment, the balloon obstruction 28 is inflated at this point (as opposed to being inflated prior to advancing the delivery and aspiration catheter 14 as shown in FIG. 16 ). subsequently. Advancing delivery and aspiration catheter 14 distally—as shown in FIG. At this point, as shown in FIGS. 20 and 21 , the delivery and aspiration catheter 14 can be withdrawn back into the guide and occlusion catheter 12 to remove the thromboembolism 12 from the patient 16 .

To enhance the ability to remove the thromboembolism 100 , or in the event that the thromboembolism receiver 46 does not initially engage the thromboembolism 100 , the suction pump 18 may be activated to create a negative pressure within the delivery and suction catheter 14 . In this way, negative pressure is created within cerebral artery 102 and applied to thromboembolism 100 . As mentioned above, separator 16 (or separator 16a of FIGS. 11B-11D ) may be employed during this process (e.g., advanced and retracted into lumen 36 of delivery and aspiration catheter 14) to remove Any obstruction or flow restriction due to passage of thromboembolic material through lumen 36 . The negative pressure is used to draw the thromboembolism 100 (partially or completely) into the thromboembolism receptacle 46 . The delivery and aspiration catheter 14 can then be withdrawn into the guide and occlusion catheter 12 to remove the thromboembolism 100 from the patient.

To further enhance the ability to remove the thromboembolism 100 or in situations where the suction pump 18 is insufficient to draw all or most of the thromboembolism 100 into the receiver 46, the thromboembolism separator 16/16a may be advanced into contact with a portion of the thromboembolism or All pass through the thromboembolism 100 as shown in FIG. 22 and use it to bias or engage the distal end of the thromboembolism 100 . This will increase the surface area for engagement with the thromboembolism 100, which will advantageously allow its withdrawal back into the guide and occlusion catheter 12, for example by simultaneously withdrawing the separator 16/16a and the delivery and aspiration catheter 14 back into the guide and occlusion catheter 12. Block the inside of the catheter 12.

As shown in FIG. 23, the separator 16/16a can also be selectively advanced and retracted through the thromboembolism 100 (or held out of the receiver 46). This will serve to break up or otherwise soften the thromboembolism 100 . Advancing or retracting the separator 16/16a will also serve to remove obstructions or flow restrictions caused by thromboembolic material passing through the lumen 36 of the delivery and aspiration catheter 14 during aspiration. In either case, suction pump 18 suctions or biases thromboembolic debris 106 or softened thromboembolism 100 into thromboembolic receiver 46 and/or catheter 14 . Subsequently, the delivery and aspiration catheter 14 is withdrawn to draw the thromboembolic receiver 46 into the guide and occlusion catheter 12 to remove the thromboembolism 100 from the patient.

Selective advancement of the separator element 64 via thromboembolism and retraction of the separator element into the delivery and aspiration catheter 14 , preferably in conjunction with aspiration, may also be used to bring small pieces of thromboembolic material into the catheter 14 . For example, the separator element 64 may pass through the thromboembolic material, translating some of the material and thus creating channels within the material as it moves distally. Once the separator element is positioned further within or distal to the thrombus, some of the translated material may flow back into the channel. Subsequent withdrawal of separator element 64 through material (eg, refilled channels) draws some of the material into conduit 14 . To facilitate this procedure, the separator element 64 and catheter 14 are preferably provided such that the tolerance between the diameter of the catheter lumen 36 and the largest diameter of the separator element 64 is relatively close. For example, in the exemplary embodiment, the outer diameter of separator element 64 differs from the diameter of lumen 36 by approximately 0.003-0.008 inches.

An alternative method is described next, in which the receiver and stripper are preferably used independently of each other, although they can also be used in combination as described in connection with the first exemplary method. The method is described as being performed using the thromboembolic receiver 146 and separator 16a, however it should be understood that other embodiments of these elements may alternatively be used in the described method.

According to the alternative method. An initial determination is made as to whether to employ receiver 146 or splitter 16a first. These determinations can be made randomly, although in a preferred approach the physician selects the appropriate tool based on a determination of the likely nature of the thromboembolic material to be removed. Specifically, the doctor will assess the patient to determine whether the material may be hard or soft/gel-like. Such assessment may include assessing, for example, the response of the guidewire or the tip of the separator when in contact with the thromboembolism, the location of the thromboembolic material, the patient's symptoms, and/or one of the ways in which a stroke caused by a thromboembolism manifests itself or multiple factors.

As discussed in connection with the first exemplary method, the guide and occlusion catheter 12 is introduced into the patient's vasculature, and the occlusion balloon 28 is inflated to inhibit blood flow within the vessel (see, eg, FIGS. 14-16 ).

The delivery and aspiration catheter 14 passes through the guide and blocker catheter 12 and is positioned with its distal end in close proximity to the thromboembolism 100 . If the physician elects to use the separator 16a prior to using the receiver 146, or if the evaluation determines that the thromboembolic material may be somewhat soft or gelatinous, the suction pump 18 is activated to create a negative pressure in the delivery and suction catheter 14, and Negative pressure is thus applied to the thromboembolism 100 to draw thrombus material into the catheter 14 .

As shown in FIG. 24 , separator 16 a is deployed from the distal end of delivery and aspiration catheter 14 and moved into contact with thromboembolic material 100 . The separator can be advanced and retracted as many times as needed. When advanced and retracted as shown, the separator may facilitate the drawing of thromboembolic material into catheter 14 in one or more ways. First, movement of the separator in contact with the thromboembolism can loosen, separate, or soften the sheet of thromboembolic material so that the thromboembolic sheet can be drawn into the catheter. Second, advancing and retracting the separator 16a serves to remove obstructions or flow restrictions within the lumen 36 of the delivery and aspiration catheter 14 due to the passage of thromboembolic material through the lumen 36 . Furthermore, during retraction of the stripper 16a, its proximal surface 35 pushes or inserts loose material towards and/or into the distal end of the catheter 14 for subsequent suction out of the body.

If use of the stripper 16a just described indicates that the blood vessel contains a hard mass of thromboembolic material that cannot be aspirated without further intervention, the stripper 16a is preferably withdrawn from the catheter 14 and the thromboembolic receiver 146 is passed through the delivery and aspiration catheter 14 and Expand within the blood vessel. If the system provides multiple sized receivers, the physician selects the receiver with the appropriate size for the vessel being treated.

25-28, once the receiver 146 is deployed, it expands into contact with the surrounding vessel wall. As receptor 146 is advanced toward body thromboembolic material 200, the walls of receptor 146 slide around body 200 to engage and/or surround (partially or completely) the thromboembolism. Engagement element 170 engages thromboembolism 200, thereby retaining it within the receptacle. If desired, the delivery and aspiration catheter 14 can be advanced slightly in the distal direction as indicated by the arrow in FIG. shrink slightly. Additionally, the suction pump 18 (FIG. 1) may be activated to facilitate retaining the thromboembolism 200 in the receiver. The delivery and aspiration catheter 14, receiver 146, and thromboembolism 100 are withdrawn back to the guide and occlusion catheter 12 and withdrawn from the body. If other thromboembolic material remains in the vessel, a new delivery and aspiration catheter 14 can be passed into the vessel and a new receiver deployed through catheter 14 to retrieve the body of other thromboembolic material.

Naturally, the physician may choose to initially deploy the receiver rather than the separator, for example if the initial assessment determines that the thromboembolic material may be hard. The method is then performed using the receiver 146 as described in the previous paragraph. If it is subsequently determined that residual thromboembolic material (eg, soft or gelatinous material) is present in the vessel, receptacle 146 is preferably removed from the body and separator 16a is passed through delivery and aspiration catheter 14 . The suction pump 18 is activated and the separator 16a is operated to facilitate suction of the soft material in the manner described above.

While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and described in detail in this application. It should be understood, however, that the description of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention .

Claims (90)

1. one kind is used for from the system of patient's blood vessel removal thromboembolic material, and described system comprises:

Set and be used to be transported to endovascular conduit, described conduit comprises catheter lumen;

First receptor that prolongs member and be positioned at the distal portions of the described first prolongation member, described receptor forms by being configured to form the telescopic a plurality of structural members with center cavity, and described a plurality of structural members comprise the engaged element that extends in the described center cavity; And

Second prolongs member, its can through described catheter lumen extend and its on have separator element, described separator element be shaped to make that described separator element contacts with endovascular thromboembolic material main body mobile with pieces of thromboembolic material from described body portion from.

2. system according to claim 1 is characterized in that: comprise that further fluid is couple to the absorption source of described catheter lumen.

3. system according to claim 1 is characterized in that: described engaged element comprises the apex region in the center cavity that extends to described receptor.

4. system according to claim 3 is characterized in that: described a plurality of structural members comprise 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.

5. system according to claim 1, it is characterized in that: described receptor can be radially expanded to expanding position from compression position, in described compression position, described receptor size is defined as in described catheter lumen and moves, above receptor size described in the described expanding position is defined as main body in described endovascular thromboembolic material, advance so that described main body is received in the center cavity of described receptor, and wherein said engaged element is orientated the main body in the described center cavity of engagement.

6. system according to claim 4 is characterized in that: described structural member further comprises a plurality of circumferential hoops that separate.

7. system according to claim 6 is characterized in that: described structural member further comprises a plurality of vertical pillars that extend between described circumferential hoop.

8. system according to claim 7 is characterized in that: each engaged element is positioned mutually between the reply of described vertical pillar.

9. system according to claim 7 is characterized in that: each vertical pillar comprises at least one spring bending.

10. system according to claim 6, it is characterized in that: described a plurality of circumferential hoops comprise proximal loop, distal loop and adapter ring, and wherein said v shape element comprise the far-end v shape element line that is positioned between described distal loop and the described adapter ring and be positioned described adapter ring and described proximal loop between near-end v shape element line.

11. system according to claim 10 is characterized in that: described engaged element comprises a plurality of v shape elements that are in the described distal column.

12. system according to claim 2 is characterized in that: described separator element comprises having to the proximal part on the surface of near-end orientation and the distal portions of convergent.

13. system according to claim 12 is characterized in that: described separator element has the general conical profile that extends to described distal portions to the part of near-end orientation from described.

14. system according to claim 12 is characterized in that: described surface to the near-end orientation is a concave surface.

15. system according to claim 12 is characterized in that: described surface to the near-end orientation is the plane substantially.

16. system according to claim 12 is characterized in that: described surface to the near-end orientation is a convex surface.

17. system according to claim 12 is characterized in that: described prolongation member comprises the flexible distal tip, and wherein said separator element and described distal tip separate to near-end.

18. system according to claim 1 is characterized in that: further comprise:

Has the prolongation sheath that sets with the protecting pipe that receives described conduit; And

Be positioned at the occlusion balloons on the described sheath, described air bag can inflate so that the blood flow in the occluding vascular.

19. system according to claim 18 is characterized in that: further comprise operation instruction, the method for using described system has been set forth in described explanation, comprises step:

Determine the possible character of the main body of thromboembolic material;

Described sheath is positioned in the patient's that will treat the blood vessel;

Use described occlusion balloons to block described blood vessel;

If determine that the possible character of described thromboembolic material is hard:

The described receptor that will be in compression position is positioned in the described conduit;

Through described sheath lumens described conduit is led in the described blood vessel;

Extend described receptor from described conduit;

Described receptor is advanced to the main body top that is positioned at described thromboembolic material to small part, described main body is received in the center cavity of described receptor, and makes described engaged element mesh described main body; And

Described receptor is withdrawn in the described sheath;

If determine that the described of described thromboembolic material may character be soft:

With described conduit in described sheath lumens is led to described blood vessel and with described catheter positioning near the main body of described thromboembolic material;

Use described absorption source, draw so that with the thromboembolic material suction and by described catheter lumen through described catheter lumen;

On distal direction, advance described separator element so that described separator element contacts the part of the main body of described thromboembolic material from described catheter lumen; And

Draw back described separator element towards described catheter lumen.

20. a method that is used for removing from patient's blood vessel thromboembolic material said method comprising the steps of:

Provide to set and be used to be transported to endovascular conduit, described conduit comprises catheter lumen, further provide first to prolong member and be positioned at described first receptor that prolongs on the distal portions of member, described receptor forms by being configured to form the telescopic a plurality of structural members with center cavity, described a plurality of structural member comprises the engaged element that extends in the described center cavity, and the second prolongation member that can extend and have on it separator element through described catheter lumen further is provided;

Sheath is positioned in the patient's that will treat the blood vessel, described sheath has position occlusion balloons thereon;

Use described occlusion balloons to block described blood vessel;

Determine the possible character of described endovascular thromboembolic material;

If determine that the possible character of described thromboembolic material is hard:

The described receptor that will be in compression position is located in the described conduit;

Through described sheath described conduit is led in the described blood vessel;

Extend described receptor from described conduit;

Described receptor is advanced into the main body top that small part is positioned at described thromboembolic material, described main body is received in the center cavity of described receptor, and makes described engaged element mesh described main body; And

Described receptor is withdrawn in the described sheath;

If determine that the possible character of described thromboembolic material is soft:

With described conduit in described sheath lumens is led to described blood vessel and with described catheter positioning near the main body of described thromboembolic material;

Use described absorption source, draw so that with the thromboembolic material suction and by described catheter lumen through described catheter lumen;

On distal direction, advance described separator element so that described separator element contacts the part of the main body of described thromboembolic material from described catheter lumen; And

Draw back described separator element towards described catheter lumen.

21. method according to claim 20 is characterized in that: further may further comprise the steps,

Along with described receptor to small part is arranged on described thromboembolic material main body top, use described absorption source to apply suction through described catheter lumen, described suction is convenient to keep described thromboembolic material by described receptor.

22. method according to claim 20 is characterized in that: further may further comprise the steps,

Along with described receptor to small part is arranged on described thromboembolic material main body top, the proximal part of described relatively receptor slides the distal portions of described conduit so that described receptor is exerted pressure to described thromboembolism main body on radially inner direction.

23. method according to claim 20 is characterized in that: the step of drawing back described separator element towards described catheter lumen prevents that the thromboembolic material obstruction other materials that enters described tube chamber is drawn in the described catheter lumen.

24. method according to claim 20 is characterized in that: the step of drawing back described separator element towards described catheter lumen is inserted described catheter lumen with thromboembolic material.

25. method according to claim 20 is characterized in that: described method further comprise repeat to advance and draw back described separator element step once or repeatedly.

26. method according to claim 20 is characterized in that: the step that advances the step of described separator element and/or draw back described separator element is smashed the thromboembolic material that accumulates in the described catheter lumen.

27. method according to claim 20 is characterized in that: further may further comprise the steps, if determine that in described determining step the possible character of described thromboembolic material is soft:

After described catheter lumen is drawn back the step of described separator element, take out described separator element from described conduit;

Extend described receptor from described conduit;

Described receptor is advanced to the residue main body top that is positioned at described endovascular thromboembolic material to small part;

Make described residue main body be received in the described center cavity and make described engaged element mesh described main body; And

Described receptor is withdrawn in the described sheath.

28. method according to claim 20 is characterized in that: further may further comprise the steps, if determine that in described determining step the possible character of described thromboembolic material is hard:

At least after the step that advances described receptor, described separator element is incorporated in the described blood vessel;

Use described absorption source to draw so that with the thromboembolic material suction and by described catheter lumen through described catheter lumen;

On distal direction, advance described separator element so that make the part of the residue main body of described separator element contact thromboembolic material from described catheter lumen; And

Draw back described separator element towards described catheter lumen.

29. method according to claim 28 is characterized in that: the step that described separator element is introduced described blood vessel comprises through described receptor extends described separator element.

30. method according to claim 28 is characterized in that: the step of described separator element being introduced described blood vessel is carried out after the step that described receptor is withdrawn in the described sheath.

31. method according to claim 20 is characterized in that: the step that advances the step of described separator element and/or draw back described separator element is smashed described endovascular thromboembolic material.

32. a method that is used for removing from the patient vessel thromboembolic material said method comprising the steps of:

Conduit with tube chamber is provided, described tube chamber comprises the distal portion with fixed inner diameter, and further providing can be through described tube chamber extension and the prolongation member that has separator element on it, and the maximum gauge of described separator element is less than the diameter of described tube chamber distal portion;

Described conduit inserted blood vessel and with described catheter positioning near the thromboembolic material main body;

Extract so that with the thromboembolic material suction and by described tube chamber through described tube chamber;

On distal direction, advance described separator element so that make described separator element contact the part of described thromboembolic material main body from described tube chamber; And

Draw back described separator element towards described tube chamber.

33. method according to claim 32 is characterized in that: draw back step and prevent that the thromboembolic material obstruction other materials that enters described tube chamber is drawn in the described tube chamber.

34. method according to claim 32 is characterized in that: the described step of drawing back is inserted into thromboembolic material in the described tube chamber.

35. method according to claim 32 is characterized in that: described method further comprises and repeats described propelling and draw back the step one or many.

36. method according to claim 32 is characterized in that: described propelling and/or withdrawal step are smashed and are assembled described intraluminal thromboembolic material.

37. method according to claim 32 is characterized in that: in described propelling and/or draw back in the step process, described prolongation member is smashed described endovascular thromboembolic material main body.

38. method according to claim 32 is characterized in that: described method further is included in the step of blocking described blood vessel before the described forward step.

39. according to the described method of claim 38, it is characterized in that: described obstruction step is included in the step that described forward step is inflated occlusion balloons at described blood vessel before.

40. method according to claim 32 is characterized in that: describedly provide step that described separator element is provided to have to the proximal part on the surface of near-end orientation and the distal portions of convergent so that comprise.

41., it is characterized in that: described in the described process of drawing back step, on proximal direction, carry thromboembolic material to the surface of near-end orientation according to the described method of claim 40.

42. according to the described method of claim 40, it is characterized in that: described surface to the near-end orientation comprises concave surface.

43. according to the described method of claim 40, it is characterized in that: the described step that provides provides described surface to the near-end orientation so that comprise basically plane.

44. according to the described method of claim 40, it is characterized in that: the described step that provides provides described surface to the near-end orientation so that comprise convex surface.

45. method according to claim 32, it is characterized in that: described method comprises the step of the receiving element on the distal portions that extension rod is provided and is positioned at described bar, and wherein said method may further comprise the steps: described receiving element expands, described expansible receiving element is moved into the contact thromboembolic material, and with thromboembolic material and the engagement of described receiving element.

46. according to the described method of claim 45, it is characterized in that: described engagement step comprises described receiving element to small part is retracted on the thromboembolic material.

47., it is characterized in that: said method comprising the steps of: before advancing described separator element step, described receiving element is transmitted by described catheter lumen according to the described method of claim 45.

48., it is characterized in that: said method comprising the steps of: after the step that advances described separator element, described receiving element is transmitted by described catheter lumen according to the described method of claim 45.

49. method according to claim 32 is characterized in that: described blood vessel is a cerebral arteries.

50. method according to claim 32 is characterized in that: said method comprising the steps of: guide wire is fed in the described blood vessel, and wherein above described guide wire, advance at conduit described in the described inserting step process.

51. according to the described method of claim 50, it is characterized in that: described guide wire comprises described prolongation member.

52. a system that is used for removing from cerebrovascular thromboembolic material, 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 be through described tube chamber extension and the prolongation member that has separator element on it, the maximum gauge of described separator element is less than the diameter of described tube chamber distal portion.

53. according to the described system of claim 52, it is characterized in that: described separator element comprises having to the proximal part on the surface of near-end orientation and the distal portions of convergent.

54. according to the described system of claim 53, it is characterized in that: described separator element has the general conical profile of extending to described distal portions to the part of near-end orientation from described.

55. according to the described system of claim 53, it is characterized in that: described surface to the near-end orientation is a concave surface.

56. according to the described system of claim 53, it is characterized in that: described surface to the near-end orientation is basic to be the plane.

57. according to the described system of claim 53, it is characterized in that: described surface to the near-end orientation is a convex surface.

58. according to the described system of claim 52, it is characterized in that: described prolongation member comprises the flexible distal tip, and wherein said separator element from described distal tip to near-end at interval.

59. according to the described system of claim 52, it 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.

60., it is characterized in that: further comprise and in described cerebrovascular, to expand so that in the occlusion balloons of the described blood vessel of certain regional internal congestion of described conduit according to the described system of claim 52.

61. according to the described system of claim 52, it is characterized in that: comprise that further 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.

62. according to the described system of claim 52, further comprise operation instruction, the method for using described system has been set forth in described explanation, may further comprise the steps:

Described conduit inserted blood vessel and with described catheter positioning near the thromboembolic material main body;

Use described absorption source to draw so that thromboembolic material is sucked and the described tube chamber of process through described tube chamber;

On distal direction, advance described separator element so that make described separator element contact the part of described thromboembolic material main body from described tube chamber; And

Draw back described separator element towards described tube chamber.

63. according to the described system of claim 52, it is characterized in that: the external diameter of described conduit is in about 0.032 inch to 0.065 inch scope.

64. an equipment that is used for extracting out from blood vessel thromboembolic material, described equipment comprises:

Prolong member; And

Be positioned at the receptor of the distal portions of described prolongation member, described receptor forms by being configured to form the telescopic a plurality of structural members with center cavity, described a plurality of structural member comprises engaged element, and described engaged element comprises the apex region that extends in the described center cavity.

65. according to the described equipment of claim 64, it is characterized in that: a plurality of described structural members comprise a plurality of roughly v shape elements with summit of portrait orientation, and wherein said engaged element is a plurality of described v shape elements.

66. according to the described equipment of claim 64, it is characterized in that: described receptor can be radially expanded to expanding position from compression position, in the size of receptor described in the compression position was defined as the feeding blood vessel, described receptor size was defined as the inner surface that contacts described blood vessel under body temperature in expanding position.

67. according to the described equipment of claim 66, it is characterized in that: at described expanding position, described receptor can slide so that described main body is received in the described center cavity above described endovascular thromboembolic material main body, and wherein said engaged element is orientated the described main body in the described tube chamber of engagement.

68. according to the described equipment of claim 66, it is characterized in that: at described expanding position, the maximum swelling diameter of described receptor is in the scope of about 2-6mm.

69. according to the described equipment of claim 66, it is characterized in that: at described expanding position, the maximum swelling diameter of described receptor is in the scope of about 6-9mm.

70. according to the described equipment of claim 65, it is characterized in that: described structural member further comprises a plurality of circumferential hoops that separate.

71., it is characterized in that: a distal portion that is positioned at described receptor in the described circumferential hoop according to the described equipment of claim 70.

72., it is characterized in that: a close end that is positioned at described receptor in the described circumferential hoop according to the described equipment of claim 70.

73. according to the described equipment of claim 70, it is characterized in that: described structural member further is included in a plurality of vertical pillars that extend between the described circumferential hoop.

74. according to the described equipment of claim 70, it is characterized in that: each engaged element is positioned between described vertical pillar corresponding a pair of.

75. according to the described equipment of claim 73, it is characterized in that: each vertical pillar comprises at least one spring zone.

76. according to the described equipment of claim 65, it is characterized in that: described structure further comprises;

A plurality of circumferential hoops that separate;

The a plurality of vertical pillars that between described circumferential hoop, extend;

Wherein each v shape element is arranged between the adjacent struts of described vertical pillar.

77. according to the described equipment of claim 76, it is characterized in that: described a plurality of circumferential hoops comprise proximal loop, distal loop and adapter ring, and wherein said v shape element comprises the distal column of the v shape element that is positioned between described distal loop and the described adapter ring, and the proximal row that is positioned at the v shape element between described adapter ring and the described proximal loop.

78. according to the described equipment of claim 77, it is characterized in that: described engaged element comprises a plurality of described v shape element that is arranged in described distal column.

79. according to the described equipment of claim 77, it is characterized in that: described engaged element comprises a plurality of described v shape element that is positioned at described proximal row.

80. according to the described equipment of claim 66, it is characterized in that: further comprise conduit with catheter lumen, described receptor can insert described catheter lumen when being in described compression position, described receptor is configured so that the propelling that described receptor leaves described conduit causes described receptor to be self-expanding to its expanding position.

81. 0 described equipment according to Claim 8 is characterized in that: described receptor is configured so that described receptor drawing back in the described conduit causes described receptor to be retracted to described compression position.

82. 1 described equipment according to Claim 8 is characterized in that:

Described prolongation member comprises the far-end tube chamber; And

A plurality of described structural members comprise:

A plurality of first vertical pillars with the proximal part that is connected to described prolongation member, and

A plurality of second vertical pillars with the close end that can slide at the described distal tube intracavity of described prolongation member.

83. 2 described equipment according to Claim 8 is characterized in that:

A plurality of described structural members comprise a plurality of roughly v shape elements with summit of portrait orientation, and wherein said engaged element is a plurality of described v shape elements; And

At least a portion of described a plurality of second vertical pillars is couple to the summit of described v shape element.

84. 3 described equipment according to Claim 8 is characterized in that: at least one of described a plurality of second vertical pillars comprise be couple to first roughly the apex region of v shape member distal portions and be couple to and described first second mid portion of the apex region of v shape member roughly that vertically align of v shape member roughly.

85., it is characterized in that: further comprise according to the described equipment of claim 64:

Has the prolongation sheath that sets the sheath lumens that is used to receive described conduit; And

Be positioned at the occlusion balloons on the described sheath, described air bag is inflatable to be the blood flow of occluding vascular.

86. a method that is used to mesh endovascular thromboembolism main body said method comprising the steps of:

Provide by being configured to form the receptor that telescopic a plurality of structural members with center cavity form, a plurality of described structural members comprise engaged element, and described engaged element comprises the apex region that extends in the described center cavity; And

Above the main body of endovascular thromboembolic material, advance described receptor, make described main body receive in the described center cavity, and make described engaged element mesh described intraluminal main body.

87. 6 described methods is characterized in that: further may further comprise the steps: draw back described receptor from described blood vessel in the time of in described main body is in described center cavity according to Claim 8.

88. 6 described methods according to Claim 8 is characterized in that:

The described step that provides further provides conduit, and described receptor can slide in described conduit, and wherein said receptor can be radially expanded to expanding position from compression position;

Said method comprising the steps of:

The described receptor that will be in described compression position is positioned in the described conduit;

With described catheter positioning position near described thromboembolic material main body in described blood vessel; And

Described forward step comprises from described conduit and extends described receptor.

89. 8 described methods according to Claim 8 is characterized in that: further may further comprise the steps:

After described forward step, the proximal part of described relatively receptor slides the distal portions of described conduit so that described receptor is exerted pressure to described thromboembolism main body on radially inner direction.

90. 6 described methods according to Claim 8 is characterized in that: further may further comprise the steps:

Sheath is positioned in the described blood vessel, and described sheath has position occlusion balloons thereon; And

Use described occlusion balloons to block described blood vessel.

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