A thrombectomy apparatus for extracting a thrombus from a blood vessel

Abstract

A thrombectomy apparatus for extracting a thrombus from a blood vessel is proposed. It comprises a carrier to be advanced through vasculature of a patient to a thrombus site within a blood vessel; an expandable member to be movably disposed within the carrier in a retracted position in a compressed state and at least partially outside the carrier in an extended and expanded position; a first clot capture element extendable from within a first microcatheter; at least one second clot capture element extendable from within at least one second microcatheter. The diameter of the distal end of the expandable member is comprised between 2 and 14 mm2 to enable the deployment of the clot capture elements within the interior of the expandable member and the adjustment of the expandable member to a diameter of the inner wall, avoiding shaving and fragmentation of the thrombus.

Description

[0001] A THROMBECTOMY APPARATUS FOR EXTRACTING A THROMBUS FROM A BLOOD VESSEL

[0002] FIELD OF THE INVENTION

[0003] The present invention generally relates to thrombectomy apparatuses. More specifically, the invention relates to a thrombectomy apparatus for extracting a thrombus from a blood vessel. In some embodiments, the invention includes use of a combination of a catheter and a clot-mobilizer system to remove vascular thrombi and thrombus material.

[0004] BACKGROUND OF THE INVENTION

[0005] Acute ischemic stroke is a major cause of morbidity and mortality, with an annual incidence of 118 cases per 100000 population / year and a mortality of 29 cases per 100000 population / year. These numbers position ischemic stroke as one of the main causes of death in developed countries together with cardiovascular diseases and cancer. In order to prevent or reduce complications related to this disease and to improve the prognosis of patients with ischemic stroke, it is necessary a clinical diagnosis to establish a proper reperfusion strategy in the shortest period of time. Until 2015 the treatment of choice for stroke was the recombinant tissue plasminogen activator (rtPA) administered intravenously 4.5 hours after symptom onset. However, this drug presents a narrow therapeutic window and not always gets recanalization. Consequently, intraarterial recanalization therapy as mechanical thrombectomy is performed by means of various devices (Merci®, Penumbra®, etc.). The objective is to remove thrombus through aspiration, disruption or capture / extraction, viewed as a therapeutic option for patients who are not candidates for rtPA or in whom rtPA has failed. With the aim of improving the clinical outcomes achieved with these devices, stent retrievers appear to give this technique a more widespread use (Solitaire TM, Trevo® and Revive).

[0006] Endovascular treatment of stroke has been performed since the 1990’s. Its growth in the number of treated patients has been slow but constant. The main obstacle to its more widespread use is the necessity of a coordinated medical system at different levels to make it possible for patients to get to a medical center capable of administering these highly complex treatments within 6-8 hours of symptom onset.

[0007] Early strategies for the endovascular treatment of stroke provided local perfusion of a fibrinolytic agent through a catheter directly into the thrombus to dissolve blood clots. Beginning in the 2000 decade, a device that seemed to be more effective than intra-arterial fibrinolysis appeared. It was a spiral that unfolded around the thrombus, facilitating its extraction (the MERCI® retrieval system).

[0008] Starting in 2006, a new system became popular. A large-gauge catheter was designed to be advanced to the thrombus. The catheter was connected to a continuous aspiration pump to aspirate the thrombus (the Penumbra System®).

[0009] In 2009, the use of clot capture elements such as stent retrievers started. Their use consists of crossing the thrombus with a microcatheter. Thereafter, the endoprosthesis is advanced through the microcatheter. Once the distal end of the microcatheter has reached the distal part of the thrombus, the endoprosthesis (stent retriever) is unsheathed, self-expanding through the thrombus and capturing it. It is recommended to wait a few minutes with the endoprosthesis expanded to enable proper engagement of the thrombus. The expanded stent is then withdrawn to drag the thrombus toward the catheter and out of the blood vessel. This last step can be done while aspirating through the catheter to try to reverse the blood flow in the vessel and to increase the likelihood of recovering the thrombus. In addition, when using a stent retriever, a guide balloon catheter is often used to slow or stop flow in the internal carotid artery while the stent retriever and aspiration catheter are advanced further distally to the site of the thrombus. The thrombus can be pulled distally from the occlusion site, and if the thrombus is not too large, into the balloon catheter by the stent retriever.

[0010] Stent retrievers have entirely displaced the first-generation devices described above due to their high efficacy and speed. Several prospective randomized trials have recently demonstrated the marked superiority of stent retriever assisted mechanical thrombectomy with standard intravenous tissue plasminogen activator (IV tPA) thrombolysis over medical therapy (IV tPA) alone for revascularization of acute ischemic stroke in patients presenting with proximal large vessel occlusion.

[0011] However, the use of stent retrievers presents different as-yet unsolved challenges. Thrombus fragmentation caused by the stent retriever and distal embolization in a new territory (previously non-occluded vessels). Prior aspiration catheters used with stent retrievers have bores that are often smaller than the diameter of the clot, thereby exacerbating the clot fragmentation problem. Once the clot has been moved from the occlusion site, if blood flow has not been stopped or significantly slowed (e.g., by a balloon catheter), flowing blood flow can fragment or dislodge the clot from the stent retriever and can cause a new occlusion, called a secondary embolism. Another common problem is prolonged revascularization time, as the fragmentation or detachment of the clot requires a multiple pass recanalization. Yet another example of unsolved challenges includes large-vessel occlusions involving bifurcations, branches or other vascular characteristics with their recalcitrant and high clot burden that leads to a reduction in the possibility of successful recanalization. Alternatively, small and / or tortuous vessels also present challenges including limited navigability. In any of the current challenges not addressed in the art refractory occlusions can lead to rescue interventions.

[0012] US2024032953A1 discloses a nested mechanical thrombectomy assembly that is deliverable as a single assembled unit and that includes an outermost mechanical thrombectomy device and at least one inner mechanical thrombectomy device, each mechanical thrombectomy device being actuatable from a radially compressed state to a radially expanded state. In the radially compressed state, the at least one inner mechanical thrombectomy device is disposed in the inner channel of the outermost mechanical thrombectomy device. Moreover, each of the outermost mechanical thrombectomy device and the at least one inner mechanical thrombectomy device is actuatable / deployable independently of one another.

[0013] In order to overcome the limitations of the existing technologies, improved systems, apparatus and methods for thrombectomy procedures are required. In particular, it would be desirable to provide deployment systems and assemblies with increased navigability and reduced fragmentation or distal migration, in order to improve and increase first pass revascularization. At least some of these objectives will be met by the various embodiments that follow.

[0014] DESCRIPTION OF THE INVENTION

[0015] To that end, according to a first aspect, present invention provides a thrombectomy apparatus comprising a carrier configured to be advanced through vasculature of a patient to a thrombus site within a blood vessel; an expandable member configured to be movably disposed within the carrier in a retracted position in a compressed state and at least partially outside the carrier in an extended and expanded position, a diameter of a distal end of the expandable member being greater in the extended and expanded position than in the retracted position, the expandable member being configured to adapt its shape and length to an inner wall of the blood vessel such that the expandable member becomes appositioned against the inner wall of the blood vessel to reduce blood flow through the blood vessel, and such that the expandable member lengthens as it narrows to retain a thrombus within the expandable member; a first clot capture element extendable from within a first microcatheter; and at least one second clot capture element extendable from within at least one second microcatheter.

[0016] According to the proposed thrombectomy apparatus, the diameter of the distal end of the expandable member is comprised in a range between 2 and 14 mm2to enable the deployment of the first and second clot capture elements within the interior of the expandable member and the adjustment of the expandable member to a diameter of the inner wall, avoiding shaving and fragmentation of the thrombus.

[0017] In some embodiments, the diameter of the distal end of the expandable member is comprised between 3 and 5.2 mm2. In other embodiments, the diameter of the distal end of the expandable member is comprised between 5.2 and 14 mm2.

[0018] The performance of clot capture elements in terms of blood flow restoration, thrombus retrieval efficiency, thrombus-apparatus interaction (i.e. , synergies), minimizing damage to the artery wall, and the complementarity between involved devices depends on specific designs and structures (e.g., strut thickness, cell pattern, material densities, etc.). Therefore, in some embodiments, the first clot capture element and / or the second clot capture element can be designed with sections having different shapes, densities, dimensions (e.g., volume, diameter, length, etc.), and / or material-vessel ratios (i.e., the proportion of the vessel's cross-sectional area occupied by the material structure of the clot capture element designed section). Consequently, different radial forces can be provided, along their lengths. For example, these sections can feature higher material-vessel ratios (i.e. higher radial force) compared to other sections and compared to the other clot capture element.

[0019] Furthermore, in some embodiments, the clot capture elements can be designed to exert a predefined or desired combined outward radial force. Additionally, at least one of the first and / or second clot capture elements can comprise at least two different sections. For instance, the first clot capture element can comprise a first section and a second section, and similarly, the second clot capture element can comprise a first section and a second section.

[0020] In some embodiments, the first section of the first capture element comprises a first materialvessel ratio, while the second section of the first clot capture element comprises a second material-vessel ratio. Likewise, the first section of the second capture element can have a third material-vessel ratio, and the second section of the second clot capture element can have a fourth material-vessel ratio.

[0021] In the proposed apparatus, the first material-vessel ratio can be higher or lower than the second material-vessel ratio, and the third material-vessel ratio can be higher or lower than the fourth material-vessel ratio.

[0022] In some embodiments, the combination of the first material-vessel ratio and third material-vessel ratio can be substantially equal than the combination of the second material-vessel ratio and fourth material-vessel ratio.

[0023] In some embodiments, at least one of the expandable member, first clot capture element or second clot capture element comprises a clot-adhesive coating. In such cases, the combined outward radial force exerted by the clot capture elements can be reduced. The presence of the clot-adhesive coating enhances the ability of the capture elements to bind to or improve attachment with the clot. Furthermore, the use of such a coating allows for a lighter structural design of the clot capture elements.

[0024] In some embodiments, the first and second clot capture elements can share the same design.

[0025] In some embodiments, the first and second clot capture elements can be longitudinally aligned. Alternatively, a distal end of the first capture element and a distal end of the second clot capture element can be arranged, or disposed, with an offset relative to each other.

[0026] In some embodiments, the thrombectomy apparatus comprises three clot capture elements, each one being extendable from within its microcatheter.

[0027] In some embodiments, the thrombectomy apparatus also includes an aspiration catheter to apply suction to the expandable member.

[0028] In some embodiments, the first microcatheter and the second microcatheter are each configured to be movably disposed within the aspiration catheter.

[0029] In some embodiments, the expandable member extends from a distal end of the aspiration catheter. In some embodiments, the first microcatheter and the second microcatheter are configured to be advanced distally from within the aspiration catheter.

[0030] In some embodiments, the first clot capture element and / or the second clot capture element is / are configured to anchor a push wire, coupled thereto, at a position distal to the expandable member, aspiration catheter or carrier.

[0031] In some embodiments, the first clot capture element and the second clot capture element are configured to be advanced independently from one to another or in tandem.

[0032] In some embodiments, the first clot capture element and the second clot capture element are configured to be advanced sequentially or parallelly from within the expandable member, aspiration catheter or carrier.

[0033] In some embodiments, the first clot capture element and the second clot capture element are configured to be deployed and retracted more than once during a thrombectomy.

[0034] In some embodiments, the first clot capture element and / or the second clot capture element can comprise closed cells.

[0035] In some embodiments, the first clot capture element and / or the second clot capture element can comprise a continuous scaffold.

[0036] In some embodiments, the thrombus site is a vascular artery.

[0037] In some embodiments, the carrier is configured to be positioned proximal to a vascular artery. The vascular artery can be a middle cerebral artery, a basilar artery, or an internal carotid artery.

[0038] In some embodiments, the carrier and / or the expandable member can be operably connected to a proximal control handle configured to facilitate controlled deployment and / or retraction of the expandable member. For example, the control handle may include one or more actuation mechanisms — such as sliders, rotatable elements, or push-pull controls, among others — that are operable by a clinician from outside the patient's body.

[0039] The expandable member can be configured to be deployed at a vascular bifurcation. In some embodiments, the expandable member comprises a first section and a second section proximal to the first section, wherein at least part of the second section has a diameter smaller than a diameter of the first section, and wherein the first section is configured to provide outward radial forces higher than in the second section.

[0040] The expandable member can be self-expandable.

[0041] A method of extracting a thrombus from a thrombus site in a blood vessel of a patient is also disclosed. The method can comprise the following steps: advancing a carrier through vasculature toward a thrombus proximal to a vascular bifurcation; positioning a distal end of the carrier to a deployment site in the blood vessel; advancing an expandable member (and optionally an aspiration catheter) within the carrier; placing the expandable member outside of the carrier proximal to a deployment site relative to the thrombus position; expanding the expandable member, a diameter of a distal end of the expandable member being greater in the extended and expanded position than in the retracted position; advancing a first clot capture element distally through the expandable member toward the thrombus and into a first branch of the bifurcation; deploying the first clot capture element to capture the thrombus; advancing at least one second clot capture element distally through the expandable member toward the thrombus and into a second branch of the bifurcation; deploying the second clot capture element to capture the thrombus; moving the first and second clot capture elements and thrombus proximally toward the expandable member; (optionally) applying suction through the aspiration catheter to the expandable member; and moving the expandable member and the thrombus proximally within the vasculature, the expandable member adapting its shape and length to a surrounding blood vessel by lengthening as it narrows to retain the thrombus within the expandable member.

[0042] The method can further comprise expanding the first section with a greater radially outward force than the second section, to place the first section into contact with an inner wall of the blood vessel, thereby reducing blood flow (i.e. fully or partially stopping / reducing) past the expandable member.

[0043] The method can further comprise advancing a microcatheter within the expandable member or the carrier, the first clot capture element being disposed within the microcatheter. In the embodiments in which aspiration is applied, the microcatheter can be advanced within the aspiration catheter. The method can further comprise advancing the first clot-capture element after positioning a distal end of the carrier to the deployment site in the blood vessel, wherein the first clot capture element is advanced to an anchoring site distal to the deployment site.

[0044] The method can further comprise advancing the carrier along a push wire of the first clot capture element at the anchoring site.

[0045] The method can further comprise engaging the thrombus with the first clot capture element and moving the thrombus proximally at least partially into the expandable member.

[0046] The method can further comprise advancing the second clot-capture element after positioning a distal end of the carrier to the deployment site in the blood vessel, wherein the second clot capture element is advanced to an anchoring site distal to the deployment site.

[0047] The method can further comprise advancing the carrier along a push wire of the second clot capture element at the anchoring site.

[0048] The method can further comprise engaging the thrombus with the second clot capture element and moving the thrombus proximally at least partially into the expandable member.

[0049] In some embodiments, the method can further comprise advancing distally the second clot capture element via a second microcatheter from within the aspiration catheter to a second anchoring site.

[0050] The method can further comprise retracting the first clot capture element after the carrier is positioned at the anchoring site.

[0051] The method can further comprise advancing distally the first clot capture element via a second microcatheter from within the aspiration catheter to a second anchoring site.

[0052] In some examples, the step of applying suction through the aspiration catheter to the expandable member comprises applying suction when the first clot capture element contacts the thrombus. In some examples, the step of applying suction through the aspiration catheter to the expandable member comprises applying suction during the step of moving the first and second clot capture elements and thrombus proximally toward the expandable member.

[0053] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0055] FIG. 1 A is a side elevation view of a thrombectomy apparatus with two clot capture elements in a deployed configuration, according to an embodiment.

[0056] FIG. 1 B is another example of the thrombectomy apparatus from FIG. 1A with the clot capture elements deployed in another configuration, according to an embodiment.

[0057] FIG. 1C and 1 D show detailed cross section views of the thrombectomy apparatus distal end with the clot capture elements stowed within the aspiration catheter, according to an embodiment.

[0058] FIG. 2A-D are schematic views of the expandable member, according to different embodiments.

[0059] FIG. 3A-D are schematic views of the expandable member, according to different embodiments.

[0060] FIG. 4 is a graph showing exemplary data regarding pressure compared to diameter of the expandable member described herein.

[0061] FIG. 5A and 5B are flow diagrams illustrating a method of a thrombectomy procedure including anchored advancement of a thrombectomy apparatus described herein.

[0062] FIG. 6A-6F are illustrations of the thrombectomy apparatus deployed in the cerebral vasculature to show examples of anchoring position and deployment sites for the clot capture elements and the expandable member.

[0063] FIG. 7A shows a detailed segment of the common carotid artery to illustrate examples of anchoring and deployment locations for a thrombectomy apparatus described herein.

[0064] FIG. 7B also shows a detailed view of the cerebral vasculature with an example of position for the thrombectomy apparatus as it can be used within the basilar artery.

[0065] FIG. 8 illustrates anatomy of select cerebral vasculature including the internal carotid artery, middle cerebral artery, and anterior cerebral artery with additional detail of associated segments and branches to highlight exemplary positioning of a thrombectomy apparatus described herein. FIG. 9A-9E illustrate the cerebral vascular anatomy of FIG. 8 with sequential positioning and configurations of the clot capture elements and the expandable member as they can be delivered through the vasculature according to methods described herein.

[0066] FIG. 10A-15 also illustrate the cerebral vascular anatomy of FIG. 8 with additional embodiments of positioning and configurations of the clot capture elements and the expandable member as they can be delivered through the vasculature according to methods described herein.

[0067] FIG. 16 and 17 are anterior coronal cross section views of cerebral vasculature across exposing the internal carotid artery, middle cerebral artery, associated branches and segments for exemplary positioning and deployment locations of a thrombectomy apparatus described herein.

[0068] FIG. 18 is another cross section of the brain at a coronal plane showing exemplary positioning and deployment locations of a thrombectomy apparatus described herein.

[0069] FIG. 19 is yet another illustration of a coronal cross section of a brain to expose the middle cerebral artery and associated branches for additional embodiments of anchoring and deployment locations of a thrombectomy apparatus described herein.

[0070] FIG. 20A illustrates an interoperative view of cerebral vasculature with select tissue removed to expose the internal carotid artery and middle cerebral artery including associated branches and vasculature.

[0071] FIG. 20B illustrates the exemplary vasculature from FIG. 20A with the thrombectomy apparatus in position proximal to the thrombus and both clot capture elements deployed to engage the thrombus material.

[0072] FIG. 21 A illustrates an interoperative view of the middle cerebral artery and associated branches including an illustrative example of the patient’s position in the lower right of the image.

[0073] FIG. 21 B shows the interoperative view in FIG. 21 A with the expandable member in a base position within the internal carotid artery and a first anchor deployed to anchor 1 in the middle cerebral artery.

[0074] FIG. 21 C now shows the additional advancement of the expandable member from the position illustrated in FIG. 21 B with the expandable member in an expanded configuration proximal to the thrombus and both clot capture elements deployed to engage the thrombus at the MCA bifurcation.

[0075] FIG. 22 is a detailed cross-section view of another embodiment of a thrombectomy apparatus described herein.

[0076] FIG. 23 is a detailed cross-section view of the thrombectomy apparatus shown in FIG. 22 with the expandable member in a deployed configuration and the clot capture elements stowed.

[0077] FIG. 24 is another detailed cross-section view of the thrombectomy apparatus show in FIG. 22 with the expandable member in a deployed configuration and the clot capture elements transitioning from a stowed configuration to a deployed configuration.

[0078] FIG. 25 is another detailed cross-section view of the thrombectomy apparatus show in FIG. 22 with the expandable member in a deployed configuration and the clot capture elements deflected as they are deployed through the expandable member.

[0079] DETAILED DESCRIPTION OF THE INVENTION

[0080] A thrombectomy apparatus (or system) can generally comprise an expandable member to be delivered proximally to a thrombus within a vessel. Additionally, one or more clot capture elements (e.g. stent retrievers) can extend through microcatheters within a lumen of the expandable member or the catheter. Each of the clot capture elements can be deployable from a microcatheter to engage the thrombus. In some embodiments, each clot capture element can be configured to provide an anchor during an anchored advancement of the thrombectomy apparatus through the vasculature (e.g., tortuous vasculature) for improved navigability of the expandable member to the thrombus site. The thrombectomy apparatus can also comprise a carrier for the navigation of the expandable member through the vasculature.

[0081] FIG. 1A shows an embodiment of a thrombectomy apparatus 100 in an expanded or deployed configuration, which in this particular embodiment includes an expandable member 111 (e.g., expandable funnel), an aspiration catheter 110, a carrier 115; a first clot capture element 106 (e.g., stent retriever) extended distally from microcatheter 107; and a second clot capture element 108 (e.g., stent retriever) extended distally from microcatheter 109. Please note that although not illustrated, the thrombectomy apparatus can include more than two clot capture elements. For example, in some particular embodiments it can include three clot capture elements. As illustrated in FIG. 1 A, the expandable member 111 is in the deployed configuration and shown to be expanded as it can be when positioned within a vessel or lumen. FIG. 1 B, also illustrates the thrombectomy apparatus 100 showing a different deployment configuration for clot capture elements 106 and 108. Referring to FIG. 1A, clot capture element 106 is deployed distal to clot capture element 108 while in FIG. 1 B, the clot capture elements 106 and 108 are deployed to the same position (e.g., adjacent to one another). Selectable deployment or deployment configurations can be determinable with manipulation of the microcatheters (e.g., microcatheters

[0082] 107 and 109), the orientation of the carrier 115, orientation of the aspiration catheter 110, positioning of the microcatheters 107, 109, within the aspiration catheter 110, etc. The carrier 115 can be a delivery catheter, a guide catheter, a distal access catheter, an aspiration catheter / sheath, or a long sheath.

[0083] Deployment of each clot capture element 106, 108 can be independent, sequential or parallel to one another. In some embodiments, each clot capture element can be distally advanced simultaneously as illustrated in FIG. 1 B showing clot capture element 106 and clot capture element

[0084] 108 are advanced in tandem with one another. For example, each clot capture element can be advanced simultaneously or essentially simultaneously relative to one another. It should be noted that FIG. 1A and 1 B illustrate the clot capture elements deployed from within their respective microcatheters to illustrate embodiments of configurations of each element relative to one another. However, the microcatheter associated with each clot capture element can be advanced to any length distal to the expandable member or distal tip of the carrier before the clot capture element is deployed from therein.

[0085] The clot capture elements 106, 108 can be deployed from within a catheter of the thrombectomy apparatus 100. In FIG 1C and 1 D, detailed views of the distal end of a thrombectomy apparatus 100 from FIG. 1A and 1 B is shown. Here, cross section of the distal end of the apparatus exposes examples of position and orientation of the carrier 115, aspiration catheter 110, expandable member 111 , microcatheters 107 and 109, and clot capture elements 106 and 108. In both FIG. 1C and 1 D, the clot capture elements 106 and 108 are compressed each within a microcatheter 107 and 109, respectively. Referring to FIG. 1C, the expandable member 111 is in a deployed configuration within the vessel and is shown transitioned to a stowed configuration in FIG. 1 D while the microcatheters 107 and 109 remain in position. The microcatheters 107 and 109 are shown extending through the central lumen of the aspiration catheter 110 that is positioned in the carrier 115. In some embodiments, the microcatheters can be delivered, retracted, deployed, compressed, etc. while the expandable member 111 is in an expanded state, as in FIG. 10, or while the expandable member 111 is in a compressed state as illustrated in FIG. 1 D.

[0086] In some embodiments, the thrombectomy apparatus 100 can be delivered through the vasculature to a thrombus site via the carrier 115 in a delivery configuration, where the expandable member 111 and each of the clot capture elements 106, 108 can be compressed. For example, each clot capture element can be compressed within their corresponding microcatheter 107, 109 and the microcatheter can be positioned within a lumen of the aspiration catheter 110 or carrier 115 or a lumen of the expandable member 111 when delivered to an anatomical position proximal to the thrombus site. Each of the clot capture elements 106, 108 can be configured to be deployed and extended distally from an opening in the aspiration catheter 110, carrier 115, or expandable member 111. Each clot capture element 106, 108 can be extended or deployed simultaneously such that each microcatheter 107, 109 is extended distally at the same or similar distance and rate. In some embodiments, each clot capture element microcatheter can be extended independently. For example, the first microcatheter 107 comprising a clot capture element 106 stowed therein can be advanced distally from within the aspiration catheter 110, then the second microcatheter 109 can be extended and advanced distally after the first microcatheter 107 has been advanced.

[0087] In some embodiments, the advancement of multiple clot capture elements can be based on the deployment site and associated anatomic structure. For example, at a vascular bifurcation, each clot capture element 106, 108 can be advanced in tandem into the same vessel and same path relative to the bifurcation. In some embodiments, each clot capture element 106, 108 can be advanced in tandem with one another, but be navigated into independent branches of a bifurcated vessel. In some embodiments, each clot capture element 106, 108 can be advanced distally from within the aspiration catheter sequentially (e.g., independently) and be navigated into the same vessel or different vessels (e.g., different paths of a bifurcated vessel).

[0088] Deployment or advancement of the clot capture elements can refer to advancement of the microcatheter carrying the clot capture element in a compressed or delivery configuration. The microcatheters 107, 109 can have dimensions to facilitate accommodation of multiple (e.g., more than one) clot capture elements through the expandable member 111. For example, the expandable member 111 can comprise an inner circumference configured to accommodate two or more microcatheters carrying clot capture elements disposed therein. The clot capture elements 106, 108 can be coupled to the distal end of a push or deployment element. The deployment element can be an elongate member configured to advance the clot capture element 106, 108 distally from the distal end of the microcatheter 107, 109. Each clot capture element 106, 108 can be configured to be advanced (e.g., deployed) from within the microcatheter 107, 109 and subsequently retracted back into the microcatheter 107, 109. For example, the clot capture elements 106, 108 can be configured to be deployed more than once during a procedure. The first microcatheter 107 can be advanced from the expandable member 111 then the clot capture element 106 can be deployed from the advanced microcatheter 107 when the distal end of the microcatheter 107 is in position proximal to the thrombus or deployment site. The clot capture element 106 can subsequently be retracted back into the microcatheter 107 transitioning from an expanded (e.g., deployed configuration back to a compressed (e.g., delivery) configuration ready to be advanced and deployed again as needed.

[0089] In some embodiments, the inner diameter of the aspiration catheter 110 is greater than the combination of each diameter of the microcatheters 107, 109 extending therethrough. In some embodiments, the combined dimensions of the microcatheters 107, 109 (e.g., diameter) can be less than the interior dimension (e.g., diameter) of the aspiration catheter 110. In some embodiments, the combined dimensions of the microcatheters 107, 109 can be equal to the interior dimensions of the aspiration catheter 110. In some embodiments, the combined dimensions of the microcatheters 107, 109 can be greater than the interior dimension of the aspiration catheter 110. For example, the combined diameters of the microcatheters 107, 109 can be greater than the interior diameter of the aspiration catheter 110, but can be compressed or compressible to conform to the interior dimension of the aspiration catheter 110.

[0090] In some embodiments, the first microcatheter 107 can comprise a first diameter and a second microcatheter 109 can comprise a second diameter, where the first diameter are equal to one another, or one diameter is different (e.g., greater than or less than) than the other. For example, the first microcatheter 107 can have a diameter that is larger than the other microcatheters extending through the aspiration catheter 110. In such an example, the microcatheter with the larger diameter can facilitate improved anchoring function, as described herein. In some embodiments, the microcatheter with the smaller diameter can facilitate improved anchoring function, as described herein. In some embodiments, not shown, the thrombectomy apparatus can include more than two clot capture elements (e.g., three clot capture elements) and more than two microcatheters (e.g., three microcatheters). In some embodiments, the inner diameter of the aspiration catheter 110 is greater than the combination of each diameter of the microcatheters extending therethrough. In some embodiments, the combined dimensions of the microcatheters (e.g., diameter) can be less than the interior dimension (e.g., diameter) of the aspiration catheter 110. In some embodiments, the combined dimensions of the microcatheters can be equal to the interior dimensions of the aspiration catheter 110. In some embodiments, the combined dimensions of the microcatheters can be greater than the interior dimension of the aspiration catheter 110. For example, the combined diameters of the microcatheters can be greater than the interior diameter of the aspiration catheter 110. In some embodiments, the microcatheters can be compressed or compressible to conform to the interior dimension of the aspiration catheter 110. For example, the combined diameters of the microcatheters fit in the interior dimensions of the aspiration catheter 110. In some embodiments, the microcatheters are configured to be advanced parallelly, sequentially or in tandem through the aspiration catheter 110 lumen. For example, the microcatheters can be used to conform the interior dimensions of the aspiration by selecting the order in which the microcatheters are advanced.

[0091] In some embodiments, one of the clot capture elements can be larger than the other clot capture element. In such a configuration, a user can select the larger or smaller clot capture element to be initially advanced. For example, when the thrombectomy apparatus 100 is advanced through the vasculature to an initial deployment site, the larger clot capture element can be initially advanced from the initial deployment site distally towards the thrombus site. It can be advantageous to initially advance the larger clot capture element if the anchored advancement of the thrombectomy apparatus 100 includes advancing the larger clot capture element to an anchor site in a larger vessel. In some embodiments, the smaller clot capture element can be initially advanced to the anchor site if the target anchor site is within a smaller diameter vessel.

[0092] Each microcatheter 107, 109 can be advanced and retracted when the expandable member 111 is deployed or compressed. For example, the aspiration catheter 110 can be advanced through the vasculature to a deployment site. At the deployment site, each clot capture element 106, 108 can be advanced distally from the aspiration catheter 110 via respective microcatheters 107, 109 before the expandable member 111 has been advanced and expanded apposition to the interior lumen of the vessel. In some embodiments, at the deployment site, the expandable member 111 can be advanced to a deployed or expanded position before one or more of the microcatheters 107, 109 are deployed such that the clot capture elements 106, 108 are deployed after the expandable member 111 has been expanded.

[0093] In some embodiments, the position of the clot capture elements 106, 108 within the apparatus can provide for additional variation of deployment configurations. For example, in FIG. 1C and FIG. 1 D, the clot capture elements 106, 108 are generally positioned parallel to one another while compressed within their respective microcatheters 107, 109. In some embodiments, the distal end of one microcatheter can be positioned proximal or distal to the other microcatheter distal end. For example, the distal end of the microcatheter associated with the larger clot capture element can be positioned proximal to the distal end of the microcatheter associated with the smaller clot capture element such that the smaller clot capture element can be selectively deployed in advance of the larger when both clot capture elements are advanced at the same rate from the proximal end of the apparatus 100. In another embodiment, the distal end of the microcatheter associated with the smaller clot capture element can be positioned proximal to the distal end of the microcatheter associated with the larger clot capture element such that the larger clot capture element can be selectively deployed in advance of the smaller when both clot capture elements are advanced at the same rate from the proximal end of the apparatus 100.

[0094] The clot capture elements 106, 108 can be disposed aligned or with an offset relative to each other. In some embodiments, they share the same design, while in others they comprise an asymmetric design, i.e. they are different to each other. In some embodiments, the clot capture elements 106, 108 feature sections having different shapes, densities, dimensions, and / or material-vessel ratios. In some embodiments, the clot capture elements 106,108 are designed to exert a predefined / desired combined outward radial force. Likewise, they can comprise or be formed by at least two different sections.

[0095] In some specific embodiments, each of the sections of the first clot capture element 106 comprises a given material-vessel ratio. Likewise, each of the sections of the second clot capture element 108 comprises a given material-vessel ratio. More specifically, a (first) material-vessel ratio of a first section of the first clot capture element 106 can be higher or lower than a (second) materialvessel ratio of a second section of the first clot capture element 106. In the same manner, a (third) material-vessel ration of a first section of the second clot capture element 108 can be higher or lower than a (fourth) material-vessel ration of a second section of the second clot capture element Y1

[0096] 108. In yet some embodiments, a combination of the (first) material-vessel ratio and (third) material-vessel ratio is similar, or alike, to a combination of the (second) material-vessel ratio and (fourth) material-vessel ratio.

[0097] Aspiration can be supplied via the aspiration catheter 110 when the microcatheters 107, 109 are extended therethrough. In some embodiments, when the apparatus 100 is positioned and clot capture elements 106, 108 are deployed, aspiration can be supplied via the aspiration catheter

[0098] 110 and / or expandable member 111 after the microcatheters 107, 109 have been retracted proximally. In some embodiments, the aspiration (e.g., suction) can be increased when the microcatheters 107, 109 are removed proximally from the apparatus 100. In some embodiments, the microcatheters 107, 109 can be retracted proximally outside of the body or sufficiently outside of the body to allow increased suction via the aspiration catheters.

[0099] In some embodiments, the expandable member 111 can be coupled to the aspiration catheter 110. In some embodiments, the expandable member 111 can be connected to the aspiration catheter 110.

[0100] FIG. 2A shows an embodiment of the expandable member 111 showing two distinct tubular sections, a first section 20 and a second section 30. Fig. 2B shows another embodiment with a small or shortened cylindrical and tubular first section 20.

[0101] Particularly, the second section 30 can comprise two sub sections, a first sub section 31 and a second sub section 32. The subsection 32 can be generally cylindrical and separated from section 20 by the tapered section 31 . The first sub section 31 (or portion of the second section 30 adjacent to the first section 20) is cone-shaped or funnel-shaped. Because of its shape, this sub section 31 has features enabling it to withstand the blood pressure without collapsing. The sub section 31 is also the transition from the larger diameter of section 20 to the smaller diameter of sub section 32 (or portion of the second section 30 having a tubular uniform diameter). The expandable member

[0102] 111 can be coupled or connected to a catheter (e.g., aspiration catheter 110) or alternatively to a hypotube, by means of second sub section 32.

[0103] FIG. 2C and 2D show other embodiments of the expandable member 111 now with the two clot capture elements 106 and 108 in an extended or deployed configuration out from a tapered section 13. Push wires 106a and 108a proximal to clot capture elements 106 and 108, respectively, are shown extending adjacent to the interior geometry of the expandable member 111. The push wires 106a and 108a of the clot capture elements 106 and 108 can be configured to control the deployment and positioning of the clot capture elements 106 and 108. In some embodiments, the push wires 106a and 108a can be further configured to provide structural support to the tapered section 13 or other sections of the expandable member 111 in a deployed configuration to support the structural integrity and occlusion of the vessel by the expandable member 111. While FIG. 2C shows the clot capture elements extending along a similar angle as provided by the tapered section 13, it can be appreciated that the clot capture elements 106 and 108 can proceed through further distal advancement and be guided through the vessel according to a path device by the vessel, and can also extend parallelly in the distal direction, as described in other embodiments.

[0104] Referring to FIG. 3A, therein another embodiment of the expandable member 111 of the proposed thrombectomy apparatus 100 is shown. In this case, a mesh structure including closed loops 23 around the distal perimeter of the distal segment 20 is highlighted. The proximal end 120 is shown comprising the tapered section 13 and a proximal section that would be in communication with or continuing from the aspiration catheter 110. The first section 20 is configured to expand within the vessel when in a deployed configuration and provide a sufficient diameter therethrough for deployment of the clot capture elements 106 and 108 as well as retrieval of the thrombus during a thrombectomy procedure. In some embodiments, the closed loops 23 at the distal end of the expandable member 111 can be configured to provide a spring bias to open the expandable member 111 from the distal end as it transitions to a deployed configuration. The expandable member 111 can be self-expandable and can adapt its shape to a surrounding blood vessel to be appositioned against the inner wall of a blood vessel to receive and retain a thrombus.

[0105] In some embodiments, the closed loops 23 facilitate the expansion of the expandable member 111 once it comes out of the carrier 115. Moreover, these closed loops 23 act as a spring or fixing point by limiting the movement between the helicoidal filaments of the mesh and thus increasing the outward radial force. The closed loops 23 also provide a smooth distal end to reduce possible vessel damage and improve navigability of the expandable funnel 111 within the blood vessel. The rest of the first section 20 creates the space which will accommodate the thrombus once it has been aspirated. The first section 20 is adaptable to the vessel geometry and, because of its configuration (e.g., diameter and (first) braiding angle P), provides outward radial forces higher than in the second section 30 so that it is better appositioned against the inner wall of the vessel. The radial forces in the end portions of the first section 20 are particularly higher than in an intermediate portion thereof, e.g., because of the spring action of closed loops 23. Alternatively, the radial forces in the first section 20 could be uniformly distributed along all one or more or all of the sections of the expandable member 111.

[0106] FIG. 3B further details another embodiment of the expandable member 111 in this case comprising a small or shortened generally cylindrical and tubular first section 20 and closed loops 23 at its distal end.

[0107] In some embodiments, where the expandable member 111 comprises a shortened distal section (e.g., section 20) or the distal perimeter of the expandable member 111 is the close loops around the perimeter of the tapered section, the clot capture elements 106 and 108 can have less contact, if any, with the interior of the distal end of the expandable member 111 to improve the movement (e.g., deployment and retraction) of the clot capture elements 106 and 108 during a thrombectomy procedure.

[0108] FIG. 3C shows the expandable member from FIG. 2C now with the mesh structure including the cited closed loops 23.

[0109] In some embodiments, the mesh can have sets (e.g., two sets) of helicoidal filaments turning respectively in opposite directions and being intertwined. In some embodiments, density of the mesh can define the elasticity of the expandable member 111. For example, the tapered section can comprise a greater density configured to support the tapered geometry between the distal segment and the proximal portion. As detailed in Table 1 the mesh angle (or braiding angle (P)) with regard to a longitudinal direction can be variable.

[0110] The helicoidal filaments can be made of a metal (including metal alloys), polymers, a composite including Nitinol or Nitinol / Platinum, or also DFT (Drawn Filled Tube), for example Nitinol-Platinum DFT with a percentage of Platinum from 10% to 40%, in particular with 40% Platinum (Niti#1 -DFT- 40%Pt), among other materials having suitable mechanical properties.

[0111] The mesh angle or braiding angle (P) of the first section 20 allows the mesh to be adapted to a curve of the blood vessel, avoiding the kinking and creating a free space inside the mesh for unobstructed suction.

[0112] On the other hand, the first sub section 31 can comprise a (second) braiding angle (a) that can change at the proximal and distal ends of the first sub section 31. A braiding angle (a) change at the distal end of sub section 31 also works with the closed loops 23 to maintain first section 20 in an open position and create the space for the thrombus. A covering over sub section 31 can reduce or stop the blood flow during the capture and removal of the thrombus and protect the captured thrombus during the withdrawal to the carrier 115.

[0113] Fig. 3D illustrates some of the main specifications of the expandable member 111. Table 1 indicates the main specifications of the expandable member 111 , for particular embodiments.

[0114] Table 2 indicates the measuring method used for calculating such parameters.

[0115] Table 1 : Main specifications:

[0116] In an embodiment, the parameters of the expandable member 111 are such indicated in Table 1 for a big blood vessel (“Big Ref.”) of e.g., 4.5 mm diameter, such as the final part of the carotid or the carotid siphon. In another embodiment, the parameters of the expandable member 111 are such indicated in Table 1 for a small blood vessel (“Small Ref.”) of e.g., 2.5 mm diameter, such as the Internal Carotid Artery (ICA) or the Middle Cerebral Artery (MCA).

[0117] Table 2. Measuring methods used for calculating the parameters of Table 1.

[0118] As mentioned, the expandable member 111 can be in two configurations: in a retracted form (or compressed state) inside the carrier 115 while approaching the thrombus site, and in an extended and expanded (deployed) form when there is no interaction with the carrier 115 or the blood vessel. The parameters specified herein relate to the expandable member 111 in its natural (relaxed) form, i.e., extended and expanded (deployed) position.

[0119] The expandable member 111 and / or clot capture elements 106, 108 or associated catheters 107, 109 can include radiopaque markers made of platinum, tungsten, barium derivatives, gold, iridium, among others, at its distal end and / or other strategic points which allow a physician to know the precise location of the expandable member 111 while using fluoroscopy. The radiopaque material can be deposited on the helicoidal filaments once manufactured (if the expandable member has a coating, the material can also be dispersed on the surface of the coating). Alternative possibilities to confer radiopacity to the helicoidal filaments of the expandable member 111 of different material and opacity grade (e.g., Nitinol and Platinum). In a particular embodiment, Nitinol wires with a Platinum core are used (e.g., DFT filaments). Likewise, the carrier 115 can also include radiopaque markers.

[0120] As noted above, the expandable member 111 can have a coating, for example covering the first section 20 only, covering the second section 30 only, covering the first sub section 31 and / or the second sub section 32, or covering the whole segment 30. In one embodiment, the coating is applied about attachment of segment 30 to the aspiration catheter 110 by dipping segment 30 into a liquid polymer, therefore allowing the polymer to solidify. Optionally, a mandrel can be disposed inside the mesh of segment 30 when it is dipped into the polymeric coating material. Alternatively, the coating material can be sprayed onto the mesh. In other alternative embodiments, the coating can be applied before attaching segment 30 to the aspiration catheter 110. In such embodiments, the coating does not reach the proximal end 120 of sub section 32, but there is an uncoated space between the helicoidal filaments, leaving them free to allow assembly with the aspiration catheter.

[0121] The coating prevents damage to the arteries, avoiding direct contact with the helicoidal filaments. Moreover, the coating provides a watertight compartment so that the thrombus can be sucked in and protected during removal. In an embodiment, to apply the coating, the mesh is attached to the aspiration or funnel catheter and then the coating is applied.

[0122] An interior or exterior glaze can be also applied to the coating to improve its properties. By applying a hydrophilic or hydrophobic coating to the exterior surface of the segment 30, the exterior surface can be more easily displaced into the carrier and through the blood vessel by reducing the coefficient of friction. In the same way, by applying a treatment in the interior surface of the segment 30 an adhesion effect that retains the thrombus once it is inside can be achieved. A hydrophilic or hydrophobic membrane can be applied to the exterior surface of the member and to be easily displaced into the carrier and through the blood vessel by reducing the coefficient of friction.

[0123] The coating can be made of an elastic and / or elastomeric material. In one particular embodiment, the coating is silicone. Alternatively, polyurethanes or other types of plastic materials can be used. A blend of polyurethane and silicone can also be employed.

[0124] To achieve the double behavior of the coating (lubricious on the exterior surface of segment 30 and tacky or rough inside), the coating can be treated by the addition of a material as explained or can have constitutively such features by the structure of the mesh itself.

[0125] The coating can include holes to avoid collapse of the segment 30. Such holes can be formed after the coating has been applied by perforating the coating.

[0126] The dimensions of segment 30 depend on the dimensions of the blood vessel in which it will be used to capture a thrombus. The dimensions of the sub sections of segment 30 and the braid angles of the mesh help segment 30 provide a reduced radially outward force when compressed into the carrier and sufficient outward force when expanded to avoid collapse from the blood pressure. FIG. 4 illustrates a possible work curve of one embodiment of the segment 30. Y-axis defines the device pressure (mmHg) whereas X-axis defines the diameter of the arteries (mm). The horizontal dotted line marks the blood pressure limit. In some embodiments, the diameter range of the arteries in which the expandable funnel 1 of this invention can be used is 2 to 5 mm. The segment 30 is designed so that it can expand without being blocked by the artery working in a standard range of 2 to 5 mm and so that it can cope with a blood pressure greater than 200 mmHg. As shown by FIG. 4, this particular embodiment cannot be compressed to a diameter less than 2 mm. Compression of the segment 30 within the carrier 115 can result in radially outward forces high enough to inhibit advancement of the expandable member 111 within the carrier.

[0127] In use, the thrombectomy apparatus 100 is advanced through the carrier 115 to a thrombus site within a blood vessel of the patient. During advancement in the carrier 115, the expandable member 111 is in a delivery configuration in which the helicoidal filaments form a first distally facing angle with respect to each other. When segment 30 emerges from the carrier 115, it begins to self-expand to a deployment configuration. In embodiments in which the mesh forms closed loops at the distal end of segment 30, the spring action of the closed loops of the helicoidal filaments helps the distal section expand into apposition with the blood vessel proximate to the thrombus site. In the deployment configuration, the first and second sets of helicoidal filaments form a second distally facing angle less than the first angle (i.e., the filaments are less longitudinally aligned in the deployment configuration than they were in the delivery configuration). Sub section 31 also self-expands to a conical or funnel shape. The distal end of sub section 31 helps support the proximal end in its deployment configuration.

[0128] The coating on the outside of sub section 31 , and in some embodiments section 20, reduce, partially stops or fully stops blood flow to the thrombus site. The optional holes through the coating permit a small amount of blood to pass through the expandable member 111 to avoid collapse of sub section 31 caused by the blood pressure and also by the difference of pressure between the blood pressure (externally) and the vacuum applied (internally). Once blood flow has been reduced or stopped, suction can be applied through the catheter to the interior spaces of sub section 31 and section 20 to aspirate the thrombus. Expandable member 111 capturing the thrombus can then be removed from the patient. In the capture configuration (i.e., when the thrombus is inside), the first and second sets of filaments form a third distally-facing angle less than the first distally-faced angle (i.e., the filaments become more longitudinally aligned) as the expandable funnel assumes longer and smaller diameter shape. In some embodiments, the aspiration catheter 110 is a PTFE-lined braided catheter covered by an outer jacket (e.g., made of a suitable PEBAX material). The aspiration catheter’s braid and liner extend distally from the outer jacket. A layer of polymer material can be placed around the protruding braid and liner, and a mandrel can be placed within the braid and liner. Thereafter, the second sub section 32 can be placed over this polymer section, and another layer of polymer can be placed over the mesh of sub section 32. This outer layer of polymer material is then melted so that polymer flows through the cells of the mesh, the mandrel is removed, and a smooth surface is left over the entire aspiration catheter 110. This attachment approach adds structure and stiffness to the attachment section of the aspiration catheter 110, so it should be as short as possible without compromising the integrity of the attachment of segment 30 to the aspiration catheter 110.

[0129] Other techniques of connecting segment 30 (e.g., at proximal end 120) to the aspiration catheter 110 can be used, as understood by skilled artisans. For example, in other embodiments, if the aspiration catheter 110 is a metal hypotube, the mesh of the sub section 32 is welded to a Nitinol ring. This ring is welded directly to the hypotube. Alternatively, a Stainless-steel ring can be glued to the mesh of the sub section 32. Then, the Stainless-steel ring is welded to the hypotube. Another option is to directly mesh the segment 30 over a perforated ring so that the filaments pass through the holes.

[0130] The thrombectomy apparatus 100 described herein can be configured for improved navigability and capacity to advance through tortuous vasculature such as cerebral vasculature. FIG. 5A and 5B illustrate flow charts of exemplary methods of use. Accordingly, the multiple clot capture elements (e.g., stent retrievers) 106, 108 can be configured for anchored advancement. Anchored advancement can allow for increased advancement of the thrombectomy apparatus 100 through one or more vessels to a closer position or more advantageous position relative to the thrombus. Where the thrombectomy apparatus 100 comprises at least two clot capture elements 106, 108, a first clot capture element can provide an anchor that can be used to guide and drive continued distal advancement of the aspiration catheter 110, expandable member (e.g., funnel) 111 , additional clot capture elements, other elements of the thrombectomy apparatus or a combination thereof.

[0131] Referring to FIG. 5A, a flow diagram of a method for a thrombectomy procedure using the thrombectomy apparatus 100 including an anchored advancement of the thrombectomy apparatus 100 through the vasculature to the thrombus site is shown. At step 200, the thrombectomy apparatus 100 including the carrier 115, expandable member 111 , and clot capture elements 106 and 108 are advanced through a vessel and positioned at a deployment site at step 205. Then, the microcatheter 107 comprising the first clot capture element 106 can be deployed from the thrombectomy apparatus 100 at the deployment site to an anchor site, distal to the anchor site and more proximal to the thrombus material. Then the first clot capture element 106 is deployed at the anchor site in step 215 and the thrombectomy apparatus 100 is advanced from the deployment site to the anchor site at step 220. The microcatheter or push wire (of the first clot capture element) can provide a guide for the advancement of the thrombectomy apparatus 100 from the deployment site to the anchor site. At step 225, the position of the distal end of the carrier 115 and / or the position of the expandable member 111 are assessed for proximity to the thrombus material. If the position is sufficient for the thrombectomy procedure to proceed, the expandable member 111 can be deployed at step 230, the first clot capture element 106 can be retracted from the anchor site back into the microcatheter 107 and / or the second clot capture element 108 can then be deployed to engage the thrombus material at step 235. In some embodiments, the first clot capture element 106 can be retracted into the microcatheter 107 and then re-deployed for additional navigation (e.g., anchored advancement) or to support a dual clot capture element engagement of the thrombus material. Finally, the clot material is retracted into the expandable member 111 and aspiration catheter 110 at step 240.

[0132] If the position of the carrier 115 or expandable member 111 needs to be adjusted to a more proximal position relative to the thrombus, the anchored advancement can continue repeatedly from step 226 until a sufficient placement of the expandable member 111 for deployment is achieved.

[0133] In any embodiments described herein, the position of the expandable member 111 can be at a position in the vessel relative to the thrombus, or otherwise any other deployment site providing for additional subsequent advancement or initiating the thrombectomy procedures described herein.

[0134] In any method for a thrombectomy procedure using a thrombectomy apparatus 100 described herein can comprise the additional step of applying suction before, during and / or after any of the steps described herein, through the aspiration catheter 110, expandable member 111 or an additional catheter (e.g., guide catheter, long sheath or distal access catheter). In some embodiments, applying suction (e.g., aspiration) before, during, after, or a combination thereof relative to when the thrombus is engaged with one or more clot capture elements can increase the success and recanalization of the vessel during thrombectomy procedures described herein. For example, positive thrombectomy outcomes such as recanalization, clot capture, removal, preventing clot migration, can be significantly increased when aspiration is provided the clot capture element begins to engage the thrombus material.

[0135] In some embodiments, the expandable member 111 can be configured to maintain the funnel (e.g., tapered sub section 31) thereby occluding the vessel and aspirating while retrieving the one or more of the clot capture elements 106, 108. For example, where the thrombectomy apparatus 100 comprises two clot capture elements (e.g., stent retrievers), the first clot capture element 106 can be retrieved while aspirating through the funnel, and subsequently the second clot capture element 108 can be retrieved. In some embodiments, occluding the blood vessel with the expandable member 111 can continue until the funnel is retracted within the carrier 115.

[0136] FIG. 5B illustrates an alternative technique that can be referred to as a “kissing” technique for using the thrombectomy apparatus 100 with a thrombus positioned at a bifurcation within a vessel. Here, at step 250, the thrombectomy apparatus 100 is advanced via the carrier 115 to be in position relative to the thrombus, vasculature, deployment configuration, etc. When the distal end of the thrombectomy apparatus 100 is positioned relative to the thrombus at the bifurcation 255, the microcatheters 107 and 109 are advanced. As illustrated in this embodiment, the first microcatheter 107 having the first clot capture element 106 is advanced 260 then the second microcatheter 109 comprising the second clot capture element 108 is advanced 265. However, there can be any combination of advancement of each microcatheter 107, 109 including simultaneous advancement. Then, at step 270, the expandable member 111 within the carrier 115 is advanced into position relative to the thrombus and bifurcation. If the expandable member 111 is in position 275, it is then deployed at step 285 with the clot capture elements 106 and 108 then deployed 290 to engage the thrombus or be in position relative to the thrombus and the bifurcation. The kissing technique provides for the thrombectomy apparatus 100 to deploy the dual clot capture elements 106, 108 down each branch of the bifurcation and then in a kissing-type manner be retracted proximally to retain and draw the thrombus towards the aspiration catheter 110. The kissing technique across the bifurcation provides each of the clot capture elements 106, 108 being retracted after engaging the thrombus and coming together as they are drawn towards the aspiration catheter 110 from their deployed position relative to the bifurcation. If the expandable member 111 is not initially positioned proximal to the thrombus, it can be repositioned with the clot capture elements 106, 108 potentially needing to be retracted then redeployed as illustrated starting at step 280.

[0137] In some embodiments of anchored advancement methods, the carrier 115, aspiration catheter 110, and clot capture elements 106, 108 can be initially advanced through a vessel to a deployment site. When the distal end of the carrier 115 is positioned at the deployment site, the first microcatheter 107 can be advanced distally from within the aspiration catheter 110 further into the vessel. The first clot capture element 106 (e.g., now anchor element) can then be deployed from the microcatheter 107 by advancing a push wire coupled to the proximal end of the anchor element 106 to deploy and expand the anchor element 106 from the microcatheter 107. In some embodiments, the anchor element 106 can be deployed by first advancing the microcatheter 107 to an anchor site and then retracting the microcatheter 107 proximally along the push wire that can maintain a position of the anchor element 106 relative to the distal end of the microcatheter 107.

[0138] When the anchor element 106 is expanded and deployed at the anchor site, the push wire will remain extending through the aspiration catheter 110 to provide a guide for subsequent advancement of the aspiration catheter 110 following the guide path provided by the push wire.

[0139] In some embodiments, the aspiration catheter 110 can be advanced along the push wire of the anchor element 106 until the distal end of the aspiration catheter 110 is positioned at the anchor site proximal to the anchor element 106. In some embodiments, the deployed anchor element can then transition back into the microcatheter 107 at the anchor site. For example, the anchor element 106 can be positioned at the anchor site and the aspiration catheter 110 can be advanced to the anchor site where the previously retracted microcatheter 107 of the anchor element 106 can then be advanced over the anchor element 106 to recompress the anchor element 106 for subsequent deployment for thrombus removal or to be advanced as an anchor again.

[0140] The anchored advancement can continue repeatedly to facilitate navigation of the aspiration catheter 110 and thrombectomy apparatus 100 further into tortuous vasculature to advantageously position the aspiration catheter 110 and expandable member 111 proximal to a thrombus site. In some embodiments, the anchored advancement can be configured to navigate to an anchor site and beyond, repeatedly. In some embodiments, the anchored advancement can be capable of navigating and accommodating a thrombectomy procedure at a vascular bifurcation. Anchored advancement can include the simultaneous or sequential anchoring using each clot capture element 106, 108 within the thrombectomy apparatus 100. For example, the first clot capture element 106 can be advanced in the microcatheter 107 from a deployment site distally to an anchoring site. When the first clot capture element 106 is positioned at the first anchoring site, the second clot capture element 108 can be advanced beyond the first anchoring site to a second anchoring site. In some embodiments, the second anchoring site can be distal to, proximal to, or in a different branch of a vascular bifurcation relative to the first anchoring site.

[0141] During removal of the thrombus, anchored advancement as described herein can be performed prior to deploying (e.g., expanding) the expandable member 111. For example, the aspiration catheter 110 can be advanced to a deployment site and the expandable member 111 can remain in a stowed position while one or more of the clot capture elements 106, 108 are advanced distally from the aspiration catheter 110 to an anchoring site. In some embodiments, during removal of a thrombus, the anchored advancement as described herein can be performed after the expandable member 111 has been deployed and expanded. For example, the expandable member 111 can be deployed at the deployment site then one or more of the clot capture elements 106, 108 can be advanced distally from the expanded member to an anchoring site.

[0142] In some embodiments, aspiration can be supplied before, during, or after or a combination thereof relative to when the clot capture elements 106, 108 have been advanced to an anchoring site. In some embodiments, aspiration can be supplied before, during, after or a combination thereof relative to when the expandable member 111 is deployed.

[0143] An example of anchored delivery can be relative to the anatomic region or site of the thrombus. Some embodiments, of anatomic sites and regions where anchored advancement can be advantageous include, but not limited to, Middle Cerebral Artery (MCA) or MCA bifurcation, Segment M1 or M1 bifurcation, Segment M2, Segment M3, Internal Carotid Artery (ICA), Carotid syphon, Basilar artery, Carotid artery segments (communicating, ophthalmic, clinoidal, cavernous, lacerum, petrous and cervical segments) or other tortuous paths. Those target sites or other target sites can be considered when Refractory Acute Cerebral Large Vessel Occlusion (ACLVO), refractory occlusions (for example in the ICA terminal, in the Basilar tip, in the Carotid syphon terminus, among others) occur. For example, at any of these sites, anchored delivery can include advancing the carrier 115 including the expandable member 111 , aspiration catheter 110, and microcatheters 107, 109 to an initial deployment site. From this initial deployment site, the first microcatheter 107 with first clot capture element 106 is advanced through the carrier 115 lumen to a first anchor site (i.e. , first clot capture element 106 relative to the clot and positioned to also be anchor). Then, deploy using the push wire, the clot capture element (e.g., anchor element) is advanced distally from the microcatheter 107. In some embodiments, the microcatheter 107 is retracted while the push wire is maintained in a static position to reveal the clot capture element 106 and expand it from the distal end of the microcatheter 107. In some embodiments, the push wire remains in a static position while the microcatheter 107 is retracted proximally from the thrombectomy apparatus 100 (e.g., proximally through the carrier 115 lumen). Then, the carrier 115 is advanced along the push wire and guided towards the anchor site. For example, the push wire of the clot capture element 106 at the anchoring site becomes a guide wire for additional advancement of the carrier 115. The second microcatheter 109 can be deployed when the carrier 115 is proximal to the anchoring site. The second microcatheter 109 can be deployed for an additional and distal anchoring beyond the first anchoring site. In some embodiments, the second microcatheter 109 and corresponding second clot capture element 108 can be deployed to engage the thrombus if the carrier 115 is positioned appropriate to the thrombus site. In some embodiments, alternatively, or additionally, the expandable member 111 can be deployed to an expanded position and aspiration can be supplied to the interior of the expandable member 111 (via, e.g., an aspiration catheter 110 attached to, and communicating with, the distal region of the expandable member 111) to pull thrombus material into the expandable member 111 , while the clot capture elements (e.g., first clot capture element 106 and / or second clot capture element 108), or a combination thereof are deployed to engage the thrombus.

[0144] In some embodiments, the thrombectomy apparatus 100 described herein can be used to access difficult vasculature and successfully remove thrombus material from otherwise difficult regions of the cerebral vasculature. The following figures illustrate examples of anatomical sites for deployment, anchoring, advancement, bifurcation thrombectomies, and other examples of positioning and orientation of the thrombectomy apparatus described herein.

[0145] FIG. 6A is an illustration the sagittal cross section of a brain as seen from a lateral side elevation view exposing cerebral vasculature from the internal carotid artery to the vertebral artery including the anterior cerebral artery, middle cerebral artery and posterior artery as well as associated branches to provide exemplary anchor sites for the thrombectomy device during a thrombectomy procedure, as described herein. An example of a thrombus site in the middle cerebral artery is also shown. FIG. 6B shows an example of the thrombectomy device now visible in the vasculature illustrated in FIG. 6A and including the expandable member 111 in a stowed configuration including a stowed second clot capture element 108 positioned therein. An anchoring clot capture element is illustrated as deployed from the expandable member 111 and in an advanced position at anchor location 1 in the C4 location of the internal carotid artery siphon. The anchor is expanded and opposition against the vessel wall to provide a guide for continued advancement of the expandable member 111 further into the vessel towards the thrombus location.

[0146] FIG. 6C shows the expandable member 111 as it can have been advanced through the internal carotid artery using subsequent anchoring of a clot capture element through anchor position 1 and anchor position 2 with the expandable member 111 now in an expanded configuration proximal to the thrombus in the middle cerebral artery. The first clot capture element 106 is now in the engagement configuration deployed towards the thrombus at the MCA bifurcation before the deployment of the second clot capture element 108 from within the expandable member 111.

[0147] FIG. 6D shows the vascular anatomy illustrated in FIGS. 6A to 6C with an expandable member 111 positioned proximal to the thrombus and both clot capture elements deployed to engage the thrombus at the M2 vascular bifurcation. FIG. 6E is a detailed expanded view of a section of FIG. 6D showing the expandable member 111 in an expanded configuration proximal to the thrombus and both clot capture elements deployed to engage the thrombus at the M2 bifurcation. FIG. 6F is another detailed view of the position and configuration of the dual clot capture elements as they can be deployed in the “kissing technique” described in FIG. 5B to address a thrombus position at or adjacent to a vascular bifurcation. Here, the first clot capture element 106 is shown extending across the bifurcation into the first M2 branch and the second clot capture element 108 is extending across the bifurcation into the second M2 branch both of which are engaging the thrombus and substantially converging in the M1 main segment proximal to the bifurcation in a “kissing” manner between clot capture element 106 and clot capture element 108. Accordingly, as they would be withdrawn, they would continue to converge on the thrombus at the bifurcation to reduce the potential of distal migration and improve the first pass success of the thrombus removal.

[0148] FIG. 7A is a detailed segment view of the common carotid artery from FIG. 6A with indicators identifying examples of arterial segments based on Bouthiller classification for placement and positioning of the thrombectomy device 100. FIG. 7B is a bottom view of a transverse cross section of the brain exposing details of cerebral vasculature between the anterior cerebral artery and vertebral artery including the middle cerebral artery, internal carotid artery, posterior cerebral artery and basilar artery for exemplary positioning and navigation of the thrombectomy device 100.

[0149] FIG. 8 illustrates anatomy of select cerebral vasculature including the internal carotid artery, middle cerebral artery, and anterior cerebral artery with additional detail of associated segments and branches to highlight exemplary positioning of a thrombectomy apparatus 100 described herein. Exemplary thrombus site locations are identified with circular elements. The extreme difficulty in accessing thrombi in the cerebral vasculature provides an unmet need for a thrombectomy apparatus 100 adapted to navigate through the tortuous vessels for mechanical and aspirational engagement of thrombus material.

[0150] FIG. 9A to FIG. 9E illustrate the cerebral vascular anatomy of FIG. 8 with sequential positioning and configurations of the clot capture elements 106, 108 and the expandable member 111 as it can be delivered through the vasculature according to methods described herein. In FIG. 9A, the expandable member 111 , clot capture elements 106, 108 and carrier 115 are navigated to the internal carotid artery as an initial or base position. Both clot capture elements 106, 108 are stowed withing the expandable member 111 and ready for deployment to the first anchor position in the M1 branch of the middle carotid artery.

[0151] FIG. 9B now shows a subsequent position and configuration from FIG. 9A with the clot capture element anchor 106 deployed from the expandable member 111 with the microcatheter 107 that delivered the anchor to a first anchor position. The expandable member 111 is deployed and in an expanded configuration against the interior of the blood vessel with the microcatheter 107 now adapted to guide the expandable member 111 including the second clot capture element 108 still stowed therein. FIG. 9C continues from FIG. 9B showing the expandable member 111 now advanced as guided by the microcatheter towards the first anchor position.

[0152] FIG. 9D continues from FIG. 9C. In some embodiments, there can be more than one anchor position during a procedure described herein. When there are one or more anchor positions, a single clot capture element can be deployed or both clot capture elements can be deployed together or sequentially. Here, a second anchor site proximal to genu has an anchoring clot capture element deployed at a second anchor site with the microcatheter extending from the anchor adapted to guide the expandable member 111 further into the vessel. FIG. 9E shows an example of a second anchoring clot capture element advanced beyond the first anchoring clot capture element seen in FIG. 9D. Here, the second anchoring clot capture element 108 can be adapted to engage the thrombus and the expandable member 111 can be deployed prepared to receive the thrombus material therein. In some embodiments, the expandable member 111 can be yet further advanced using both deployed clot capture elements as simultaneous anchors where the first anchoring clot capture element 106 can be retracted as the expandable member 111 advances to the second anchoring clot capture element 108.

[0153] FIG. 10A and 10B show an alternative or additional step in the advancement of the expandable member 111 to a position more proximal to the thrombus. In FIG. 10A, the expandable member 111 has advanced through genu in an MCA branch as supported for a clot capture element anchor. In this position, the expandable member 111 can now expand and deploy one or more of the clot capture elements to engage the thrombus. FIG. 10B shows a subsequent configuration from FIG. 10A with both clot capture elements deployed after the expandable member 111 has been deployed and expanded against the inner vessel wall. Aspiration can be provided before during and after the clot capture elements are deployed to engage the thrombus material.

[0154] Additional embodiments are illustrated in FIGs. 11-15 where FIG. 11 shows example position of the expandable member 111 in an expanded configuration proximal to a thrombus with a first and second clot capture elements deployed therefrom to engage the thrombus in the MCA. FIG. 12 shows an example position of the funnel being deployed and subsequently FIG. 13 and FIG. 14 illustrate embodiments of clot capture element deployment from the position of the expandable member 111 shown in FIG. 12 with the clot capture element extended to the thrombus positioned in the insular segment of the M2 branch.

[0155] FIG. 16 and FIG. 17 are anterior cross section views of cerebral vasculature across a coronal plane exposing the internal carotid artery, middle cerebral artery, associated branches and segments for exemplary positioning and deployment locations of a thrombectomy device described herein. In FIG. 17, the expandable member 111 is shown in a deployed configuration within the ICA while the first clot capture element 106 is anchored in the M1 segment and the second clot capture element 108 is deployed to engage the thrombus in the MCA bifurcation. In some embodiments, either of the clot capture elements can be deployed to provide improved navigation and integrity for advancement of the other clot capture element. FIG. 18 and FIG. 19 are shown to illustrate additional anatomical sites that are available for advancement, deployment, and removal of thrombus within the cerebral vasculature.

[0156] FIG. 20A illustrates an interoperative view of cerebral vasculature with select tissue removed to expose the internal carotid artery and middle cerebral artery including associated branches and vasculature. A thrombus positioned in the M1 branch of the MCA is illustrated as an exemplary target site for thrombus removal by the thrombectomy apparatus 100. FIG. 20B illustrates the exemplary vasculature from FIG. 20A with the thrombectomy apparatus 100 in position proximal to the thrombus and both clot capture elements deployed to engage the thrombus material. The expandable member 111 has been navigated to a position proximal to the thrombus and deployed from the carrier 115 to expand against the interior surface of the vessel ready to aspirate and receive the thrombus material therein.

[0157] FIG. 21 A illustrates an interoperative view of the middle cerebral artery and associated branches including an illustrative example of the patient’s position in the lower right of the image. FIG. 21 B shows the interoperative view in FIG. 21A with the expandable member 111 in a base position within the internal carotid artery and a first anchor deployed to anchor 1 in the middle cerebral artery as the thrombectomy device is configured to be advanced along the microcatheter guide of the first anchor for additional advancement towards the thrombus in the MCA bifurcation. FIG. 21 C now shows the additional advancement of the expandable member 111 from the position illustrated in FIG. 21 B with the expandable member 111 in an expanded configuration proximal to the thrombus and both clot capture elements deployed to engage the thrombus at the MCA bifurcation.

[0158] In some alternative embodiments, the thrombectomy apparatus can be configured to route the microcatheters and corresponding clot capture elements to be deflected (e.g., biased outwardly) and guided as they are deployed form the apparatus. For example, FIGs. 22-25 show an example of another thrombectomy apparatus 100 configured to deflect the microcatheters 107, 109 when they are deployed towards the interior of the expandable member 111 such that they contact the interior of the expandable member 111 and add structural integrity to the sides of the expandable member 111 distal section and reduce the instance of collapse when aspiration is supplied. In this manner, the additional structural support can allow for increased aspiration as improve the retention and removal of thrombus material during a procedure. The deflection can be provided by the clot capture elements 106, 108, the microcatheter 107, 109, the push or guide wires 106a, 108a, or the expandable member 111 itself.

[0159] FIG. 22 is a detailed cross-section view of another embodiment of the thrombectomy apparatus 100 shown in a vessel with the expandable member 111 compressed and stowed in an aspiration catheter 110 and two clot capture elements 106, 108 also retracted within the aspiration catheter 110 such that the distal end of each clot capture element microcatheter is positioned adjacent to the distal end of the aspiration catheter 110 such that the microcatheters can provide a directional bias of each clot capture element when deployed.

[0160] FIG. 23 is another detailed cross section view of the distal end of the thrombectomy apparatus 100 from FIG. 22 now showing the expandable member 111 deployed from the carrier 115 and expanded against the interior lumen of a blood vessel and the clot capture elements 106, 108 still in a deployed configuration within the microcatheters 107, 109.

[0161] FIG. 24 illustrates further detail of the thrombectomy apparatus 100 from FIG. 23 with the mesh of the expandable member 111 removed to show the deflection of each microcatheter 107, 109 or push wire of the clot capture elements 106, 108 initially towards the interior of the expandable member 111 and provide additional integrity of the expandable member 111 to prevent or reduce collapse that can be associated with aspiration during a thrombectomy procedure.

[0162] FIG. 25 illustrates yet further detail from FIG. 24 with the expandable member 111 deployed and the mesh of the expandable member 111 removed to highlight an example of the outwardly biased deflection 145 provided by the clot capture elements 106, 108 to direct an initial deployment direction of the clot capture element push wire (e.g., guide wire) towards an interior of the funnel and bolster the integrity of the funnel apposition against the interior lumen of the blood vessel.

[0163] In some embodiments described herein, the thrombectomy apparatus 100 can be considered a triple thrombectomy removal system comprising the mechanical clot capture elements with a dual clot capture element configuration in combination with an aspiration system comprising the expandable member 111 (e.g., funnel) and aspiration supplied through the aspiration catheter 110. The configurations described herein, and associated methods reduce or eliminate the potential of distal migration or fragmentation while increasing first pass success for removal of all or the entire thrombus material from the vessel.

[0164] Experimental Results In some embodiments, the general methodology using two clot capture elements is to navigate the carrier 115 (e.g., a delivery catheter, guide catheter, long sheath, among others) until a location proximally disposed (not necessarily close) to the thrombus site, the expandable member 111 could be navigated through the carrier until the distal part of the carrier, the middle part or the proximal part, depending on the procedure and if more strength is required in a specific section. After locating the carrier, the microcatheters 107, 109 can be navigated until the thrombus site, by means of a guide wire (e.g., push wire) with one for each microcatheter. After reaching the thrombus site with the microcatheters, the physician can decide to dispose them in parallel, one before the other or one totally crossing the obstruction (clot / thrombus) and the other in a middle or proximal part of the obstruction. After that, the clot capture elements 106, 108 (e.g., stentretrievers) will be introduced in the microcatheters 107, 109 until the target location for deployment. In interventions with the thrombus site being located in bifurcations or branches, the stent-retrievers 106, 108 will be deployed one in each branch of the bifurcation (i.e., previously locating each microcatheter in one branch). After deploying the clot capture elements 106, 108, the expandable member 111 could be deployed by means of proximally retrieving the carrier. After capturing the clot with the stent-retrievers 106, 108, they are pulled / retrieved proximally until the funnel mouth. The whole system is retrieved proximally until outside the body.

[0165] Some embodiments of clot capture elements can include commercial devices or use with commercial devices such as Navien aspiration catheter; Rebar-18 microcatheter; Solitaire devices; Phenom 21 microcatheters or any other compatible with the inside of the aspiration catheter 110 (e.g., funnel catheter).

[0166] In some embodiments, the additional procedure named “anchoring” described herein could be used to increase the performance of the navigability of the system. For example, anchoring can include disposing a first stent-retriever (or a guidewire carried by a microcatheter) crossing the thrombus site to use the proximal pusher of the stent-retriever (or the guidewire) as guider / anchor of the whole system (it has a path to follow). The carrier of the apparatus reaches higher sites when using anchoring.

[0167] Some examples of target sites (e.g., thrombus sites, deployment sites, anchoring sites, etc.) can include: Large-vessel occlusion involving bifurcation / branches (among others) which usually have a recalcitrant and high clot burden, leading to a reduction in the possibility of successful recanalization. In addition, refractory occlusions usually lead to rescue interventions. Additional non-limiting examples of target sites where at least two stent-retrievers together with the funnel perform could be the Middle Cerebral Artery (MCA) or MCA bifurcation, Segment M1 or M1 bifurcation, Internal Carotid Artery (ICA), Carotid syphon, Basilar artery, Carotid artery segments (communicating, ophthalmic, clinoidal, cavernous, lacerum, petrous and cervical segments) or other tortuous paths. Those target sites or other target sites can be considered when Refractory Acute Cerebral Large Vessel Occlusion (ACLVO), refractory occlusions (for example in the ICA terminal, in the Basilar tip, in the Carotid syphon terminus, among others) occur.

[0168] In any of the embodiments of the thrombectomy apparatus 100 described herein, the expandable member 111 can comprise a tubular section, a conical section or both. In some embodiments, the expandable member 111 can comprise different sizes, shapes and dimensions. In some embodiments, the expandable member 111 can comprise shape memory materials, such as nitinol. In some embodiments, the expandable member 111 can be made / manufactured from a tube. In some embodiments, the expandable member 111 can be made / manufactured by laser cutting. In some embodiments, the expandable member 111 can comprise struts. In some embodiments, the expandable member 111 can comprise wires or braided wires. In some embodiments, the expandable member 111 has a distal region (e.g., closed loops or other distal region features) acting as springs to provide an expansion force in addition to the expansion force of the shape memory material forming the expandable member 111.

[0169] In some embodiments, expansion of the expandable member 111 can be configured to be used in target sites in a blood vessel with length restrictions (e.g., having a short deployment or landing site, where the device is deployed). In some other embodiments, the blood vessel can be peripheral vessels or coronary vessels. Accordingly, the conical shape (e.g., tapered section or funnel) can expand to contact the interior wall of the blood vessel. For example, the radial force providing expansion of the conical shaped expandable member 111 can be configured to adapt a shape, length, or other dimension of the conical shape to the contact, complement, engage, or otherwise adapt to the vessel wall anatomy (e.g., regular or irregular surfaces, cavitations, etc. of the tunica intima).

[0170] In some embodiments, the expandable member 111 can be configured to expand outward and contact an interior of a blood vessel. Accordingly, an exterior of the distal region can expand to contact the interior wall of the blood vessel and can adapt its shape and length to the wall anatomy. In some embodiments, the distal region of the expandable member 111 can expand to contact the interior of the blood vessel. In some embodiments, the expandable member 111 can comprise the tubular section, the conical section or both sections. In some embodiments, one or more sections (conical, tubular, or both) of the expandable member 111 can be adaptable to the vessel geometry. For example, one or more sections of the expandable member 111 can be configured to expand as it is deployed and conform to an interior surface and / or the geometric characteristics of the vessel. In some embodiments, conforming to the vessel can involve the expandable member 111 being adjusted or adjustable relative to one or more dimensions to accommodate navigation and use within a blood vessel. For example, in a deployed state, the length of the expandable member 111 (e.g., one or more sections) can increase as a diameter decreases. In some embodiments, the increase in length can be proportional to the decrease in diameter. In another example, the length of the expandable member 111 can decrease as the diameter of the expandable member 111 increases. In some embodiments, the changes in the length can be inversely related to changes in a diameter of the expandable member 111. In some embodiments, changes in the length can be directly related to a change in the diameter of the expandable member 111.

[0171] In some embodiments, the expandable member 111 can be configured to modulate a flow of blood through the vessel. As the expandable member 111 is deployed into an expanded state, a flow of blood within the vessel can be partially reduced or completely stopped. Expansion of the expandable member 111 can be sufficient to maintain an expanded state against pressure from the flow of blood thereby reducing or stopping a flow of blood past the expandable member 111 during a thrombectomy procedure. In some embodiments, decreasing the flow of blood within the vessel can promote successfully capture and extraction of the thrombus by a thrombectomy apparatus 100 described herein.

[0172] In additional aspects, the thrombectomy apparatus 100, components thereof, and any associated method can include aspects, features, characteristics or combinations taken from any or all in any combination of the following commonly owned application Number W02020 / 099386 A1 entitled “THROMBECTOMY DEVICE, SYSTEM AND METHOD FOR EXTRACTION OF A VASCULAR THROMBUS FROM A BLOOD VESSEL” filed 22 DEC 2022, of which is incorporated by reference herein in its entirety for all purposes.

[0173] In some embodiments, any of the clot capture elements 106, 108, both, and / or the expandable member 111 can comprise a clot-adhesive coating to promote binding to the clot or thrombus, particularly to extracellular DNA present within the thrombus. This enhances clot capture, retention, and retrieval while reducing the risk of distal embolization.

[0174] Stroke-related thrombi are known to contain dense meshes of extracellular DNA, which can serve as anchoring platforms for thrombectomy devices. These extracellular DNA structures, referred to as Neutrophil Extracellular Traps (NETs), are composed of decondensed chromatin that includes DNA and associated proteins, such as citrullinated histones, as well as neutrophil granule proteins including myeloperoxidase, neutrophil elastase, and cathepsin G.

[0175] In an embodiment, the clot-adhesive coating comprises a NETs ligand. In other embodiments, the clot-adhesive coating further includes a substrate and a linker. The NETs ligand can be configured to target various NETs components, such as: chromatin (DNA and associated proteins, such as topoisomerases); citrullinated histones; neutrophil granule proteins; or any other compound that can be found within a thrombus, such as those from leukocytes.

[0176] Examples of NETs ligands include DNA ligands, topoisomerases, and histone ligands. In particular, DNA ligands can include: intercalating ligands, groove-binding ligands, and DNA alkylating agents.

[0177] Intercalating ligands can be selected from the group consisting of ciprofloxacine, methylene blue, berberine, proflavin, daunomycin, and doxorubicin.

[0178] Groove-binding ligands can be minor groove-binding ligands or major groove-binding ligands, selected from the group consisting of sulindac, netropsin, tallimustine, hairpin polyamides, bis(benzimidazoles), aureolic acids and bisquaternary ammonium heterocycles.

[0179] DNA alkylating agents are selected from the group consisting of bis-chloroethylamine or bis- bromoethylamine derivatives such as chlorambucil, norchlorambucil, bendamustin, bromo benzoic mustard or melphalan.

[0180] Busulfan, N-(2-(2-(2-azidoethoxy)ethoxy)ethyl)-5-(bis(2-chloroethyl)amino)benzofuran-2- carboxamide (MBF) and 4-[Bis-(2-bromoethyl)amino]benzoic acid can also be selected as the DNA alkylating agent.

[0181] Particularly, the NETs ligand is selected from the group consisting of Digoxigenin, Distamycin, Ciprofloxacin, Thioridazine, Netropsin, Trabectedin, Sulindac, Piperaquine, Atabrine (Mepacrine), Mitonafide, Chloroquine, Amsacrine, Indomethacin, Methylene blue, berberine, proflavin, daunomycin, doxorubicin, tallimustin, hairpin polyamides, bis(benzimidazole), aureolic acids and bisquaternary ammonium heterocycles) and derivatives of any one of the above.

[0182] In some embodiments, the linker comprises a polyethylene linker or a polyether linker.

[0183] The substrate can be a polymer or a co-polymer. Non-limiting examples include polydopamine, PEG-bis- amine and copolymer polydopamine and PEG-bis-amine. A further example of suitable substrate comprises for instance a sequential layering of polymers and / copolymers, independently one another; a non-limitative example of substrate is represented by a sequential layering of polydopamine and PEG- bis-amine.

[0184] In further embodiments, a secondary coating or over-coating can be provided on top of the clotadhesive coating to offer protective or release-modifying effects. This over-coating can comprise one or more saccharides or polysaccharides, or combination thereof. Particularly, mannitol can be used as the over-coating.

[0185] The clot-adhesive coating can be applied through dip-coating of the entire device or a portion thereof into a solution or suspension containing the coating materials. Alternatively, the coating can be applied by direct deposition using standard techniques known in the art.

[0186] In an embodiment, at least the clot capture element 106 is fully or partially coated with the clotadhesive coating. In another embodiment, both clot capture elements 106, 108 are fully or partially coated with the clot-adhesive coating.

[0187] In other embodiments, both two clot capture elements 106, 108, or just one of them is / are fully or partially additionally coated with the secondary coating, which can include a water-soluble or biodegradable over-coating.

[0188] In an embodiment, the expandable member 111 is fully or partially coated with the clot-adhesive coating, particularly, on its inner face. In another embodiment, the expandable member 111 is fully or partially additionally coated with the secondary coating.

[0189] The disclosed coatings can be applied to either or both the inner and outer surfaces of the expandable member 111 and / or clot capture elements 106, 108. The coating can be continuous or localized, depending on the desired interaction with the clot. It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0190] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein can be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein can also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0191] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements can also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements can be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature can have portions that overlap or underlie the adjacent feature.

[0192] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and can be abbreviated as " / ".

[0193] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0194] Although the terms “first” and “second” can be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0195] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0196] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps can alternatively be exclusive, and can be expressed as “consisting of’ or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps. As used herein in the specification and claims, including as used in the embodiments and unless otherwise expressly specified, all numbers can be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” can be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value can have a value that is + / - 0.1 % of the stated value (or range of values), + / - 1 % of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all subranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11 , 12, 13, and 14 are also disclosed.

[0197] Although various illustrative embodiments are described above, any of a number of changes can be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed can often be changed in alternative embodiments, and in other alternative embodiments one or more method steps can be skipped altogether. Optional features of various device and system embodiments can be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0198] The embodiments and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter can be practiced. As mentioned, other embodiments can be utilized and derived there from, such that structural and logical substitutions and changes can be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter can be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed.

[0199] Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose can be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

1. CLAIMS1 . A thrombectomy apparatus for extracting a thrombus from a blood vessel, comprising: a carrier (115) configured to be advanced through vasculature of a patient to a thrombus site within a blood vessel; an expandable member (111) configured to be movably disposed within the carrier (115) in a retracted position in a compressed state and at least partially outside the carrier in an extended and expanded position, a diameter of a distal end of the expandable member (111) being greater in the extended and expanded position than in the retracted position, the expandable member (111 ) being configured to adapt its shape and length to an inner wall of the blood vessel such that the expandable member (111) becomes appositioned against the inner wall of the blood vessel to reduce blood flow through the blood vessel, and such that the expandable member (111) lengthens as it narrows to retain a thrombus within the expandable member (111); a first clot capture element (106) extendable from within a first microcatheter (107); characterized in that: the thrombectomy apparatus further comprises at least one second clot capture element (108) extendable from within at least one second microcatheter (109); and wherein the diameter of the distal end of the expandable member (111 ) is comprised in a range between 2 and 14 mm2to enable the deployment of the first and second clot capture elements (106, 108) within the interior of the expandable member (111) and the adjustment of the expandable member (111) to a diameter of the inner wall, avoiding shaving and fragmentation of the thrombus.

2. The thrombectomy apparatus according to claim 1 , wherein the first clot capture element (106) and the second clot capture element (108) comprise different shapes, densities, dimensions and / or material-vessel ratios, and are longitudinally aligned or disposed with an offset relative to each other.

3. The thrombectomy apparatus according to claim 1 or 2, wherein the first clot capture element (106) comprises a first section and a second section and the second clot capture element (108) comprises a first section and a second section, the first section of the first capture element (106) comprising a first material-vessel ratio and the second section of the first clot capture element (106) comprising a second material-vessel ratio, the first section of the second capture element (108) comprising a third material-vessel ratio and the second section of the second clot captureelement (108) comprising a fourth material-vessel ratio, such that the first and second clot capture elements (106, 108) can exert different radial forces along their lengths.

4. The thrombectomy apparatus according to any one of the previous claims, wherein the diameter of the distal end of the expandable member (111 ) is comprised between 3 and 5.2 mm2or between 5.2 and 14 mm2.

5. The thrombectomy apparatus according to any one of the previous claims, wherein the thrombectomy apparatus further comprises an aspiration catheter (110) that is adapted to apply suction to the expandable member (111), the first microcatheter (107) and the second microcatheter (109) being each configured to be movably disposed within the aspiration catheter (110).

6. The thrombectomy apparatus according to claim 5, wherein the expandable member (111) extends from a distal end of the aspiration catheter (110).

7. The thrombectomy apparatus according to claim 5 or 6, wherein the first microcatheter (107) and the second microcatheter (109) are configured to be advanced distally from within the aspiration catheter (110).

8. The thrombectomy apparatus according to any one of claims 5-7, wherein the first clot capture element (106) and / or the second clot capture element (108) is / are configured to anchor a push wire coupled thereto at a position distal to the expandable member (111), aspiration catheter (110) or carrier (115).

9. The thrombectomy apparatus according to any one of previous claims, wherein the first clot capture element (106) and the second clot capture element (108) are configured to be advanced independently from one to another or in tandem.

10. The thrombectomy apparatus according to any one of previous claims 5-9, wherein the first clot capture element (106) and the second clot capture element (108) are configured to be advanced sequentially or parallelly from within the expandable member (111), aspiration catheter (110) or carrier (115).11 . The thrombectomy apparatus according to any one of the previous claims, wherein the first clot capture element (106) and the second clot capture element (108) are configured to be deployed and retracted more than once during a thrombectomy.

12. The thrombectomy apparatus according to any one of the previous claims, wherein the thrombus site is a vascular artery including a middle cerebral artery, a basilar artery, or an internal carotid artery.

13. The thrombectomy apparatus according to any one of the previous claims, wherein the carrier (115) is configured to be positioned proximal to a vascular artery.

14. The thrombectomy apparatus according to any one of the previous claims, wherein the expandable member (111) is configured to be deployed at a vascular bifurcation.

15. The thrombectomy apparatus according to any one of the previous claims, wherein at least one of the expandable member (111), first clot capture element (106) and second clot capture element (108) comprise a clot-adhesive coating.

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