Devices and systems for treating thrombus

Abstract

1. A medical device (100) for treating a thrombus or embolism, comprising: a first elongate element (110) having a first end and a second end, defining a lumen, and having a first diameter; a second elongate element (120) extending through at least a portion of the lumen of the first elongate element, the second elongate element (120) having a first end and a second end, the first end of the second elongate element being configured to extend beyond the first end of the first elongate element; a frame (132) extending from the first end of the second elongate element, the frame (132) having a second diameter in a deployed configuration, the second diameter being greater than the first diameter of the first elongate element; and a plurality of lines (150) coupled to the first elongate element and the frame, the plurality of lines (150) operable to be under tension when the frame is in the deployed configuration.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 63 / 432,886, filed December 15, 2022, which is incorporated herein by reference in its entirety for all purposes.

[0002] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to devices, systems and methods for treating thrombosis. [Background technology]

[0003] background Blockage of venous or arterial blood flow due to the formation of a blood clot within a blood vessel (thrombosis), or the escape of a blood clot from one location to another (embolism), can have serious, life-threatening consequences, such as ischemic stroke, acute limb ischemia, myocardial infarction (heart attack), pulmonary embolism, and deep vein thrombosis (DVT). An obstructive blood clot ("thrombus") within an artery can rapidly deprive tissues and organs of oxygen, while a venous thrombotic blockage can cause progressive swelling, posing a risk of acute and long-term tissue damage. One of the most serious examples of embolism is an ischemic stroke, in which the blockage of blood flow to the brain lasts for more than a few seconds and can lead to irreversible brain cell death and permanent neurological damage.

[0004] Thrombi can be treated (reduced or removed) by inducing thrombolysis. Thrombolysis refers to the dissolution, or "breaking down," of a clot. Thrombolysis can also be induced pharmacologically, such as by administering tissue plasminogen activator (tPA), the most common thrombolytic agent. Thrombolytic agents (commonly referred to as "thrombolytic drugs") can be administered intravenously or delivered proximal to the clot using a catheter. However, there are limitations to the effectiveness of thrombolytic drug administration. For example, to be effective, thrombolytic drugs should be administered within 3 hours, preferably within 2 hours, of acute ischemic stroke. Furthermore, patients taking blood thinners or certain other medications are typically not candidates for pharmacologic thrombolytic therapy. Among patients undergoing this treatment, approximately 25% experience unsuccessful clot lysis. Furthermore, because thrombolytic therapy is associated with a significant risk of bleeding, it is no longer a recommended treatment for acute myocardial infarction and is now reserved for patients with pulmonary embolism, for example, who are in shock and have a very poor prognosis.

[0005] Given the limitations of pharmacologically induced thrombolytic therapy, various medical devices have been developed for catheter-based ("endovascular") thrombus removal. Endovascular thrombectomy is commonly known as "transcatheter thrombectomy." Thrombectomy typically involves delivering a device to the thrombus using a catheter system. This device, for example, an aspiration catheter, can remove the thrombus by aspirating it from the vessel. Other thrombus removal procedures involve using a mechanical device to physically entangle the thrombus and then remove it upon removal from the vessel, with or without an aspiration catheter. Various types of mechanical devices have been used to entangle the thrombus, including wires, corkscrew coils, bristles, and baskets.

[0006] Some conventional thrombus removal devices can cause damage to blood vessel walls. Additionally, some conventional thrombus removal devices are prone to generating thrombus fragments that become emboli as they travel through the bloodstream. Emboli can lodge in arteries, veins, arterioles, or capillaries, cutting off blood supply to vital organs such as the brain, lungs, or heart. Emboli in the bloodstream can be life-threatening. In the case of DVT treatment, detached thromboemboli can travel to the lungs and cause a potentially fatal pulmonary embolism. Summary of the Invention

[0007] Abstract This specification describes devices, systems, and methods for treating thrombi. Briefly, various embodiments are disclosed for mechanically repairing blood flow paths, promoting lysis by blood flow, removing thrombus material, and capturing thrombus debris with a filter device. Additionally, devices, systems, and methods for maceration, aspiration, and other auxiliary processes are disclosed.

[0008] According to one example ("Example 1"), a medical device for treating either thrombi or emboli includes a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter; a second elongate element extending through at least a portion of the lumen of the first elongate element, the second elongate element having a first end and a second end, the first end of the second elongate element configured to extend beyond the first end of the first elongate element; a frame extending from the first end of the second elongate element, the frame having a second diameter when in a deployed configuration, the second diameter being greater than the first diameter of the first elongate element; and a plurality of lines coupled to the first elongate element and the frame, the plurality of lines operable to be tensioned when the frame is in the deployed configuration and operable to sever at least one of emboli or thrombi.

[0009] According to another example ("Example 2"), in addition to Example 1, the medical device further includes a vacuum source, and the lumen of the first elongate element is operable to be fluidly coupled to the vacuum source.

[0010] According to another example ("Example 3"), further to Example 1, the first elongate element comprises sufficient structural integrity to support advancement through an embolus or thrombus.

[0011] According to another example ("Example 4"), further to Example 1, the second elongate element is longitudinally movable relative to the first elongate element.

[0012] According to another example ("Example 5"), further to example 1, the second elongate element includes a lumen operable to accommodate a guidewire.

[0013] According to another example ("Example 6"), further to Example 5, the second elongate element includes at least one opening near the first end, and the second elongate element is operable to fluidly couple to a fluid source including at least one of a contrast agent source, a saline source, and a therapeutic agent source. The contrast agent and saline are actively or passively released during aspiration, thereby allowing direct observation of thrombus behavior and reducing blood loss while simultaneously removing contrast agent to reduce patient exposure to the contrast agent.

[0014] According to another example ("Example 7"), further to Example 1, the frame includes a nitinol structure operable to at least partially self-expand when transitioning from a delivery configuration to a deployed configuration.

[0015] According to another example ("Example 8"), in addition to Example 1, the frame includes a porous cover.

[0016] According to another example ("Example 9"), further to example 1, the frame defines a perimeter, and each line of the plurality of lines is coupled to the frame proximate the perimeter.

[0017] According to another example ("Example 10"), in addition to example 9, the frame includes a plurality of radial struts extending from the second elongate element toward the outer periphery of the frame.

[0018] According to another example ("Example 11"), in addition to example 10, each line of the plurality of lines is coupled to the frame at the plurality of radial struts.

[0019] According to another example ("Example 12"), in addition to Example 9, the frame includes a plurality of peripheral struts extending between the plurality of radial struts proximate the outer periphery of the frame, and the plurality of lines are coupled to the frame at the plurality of peripheral struts between the plurality of radial struts.

[0020] According to another example ("Example 13"), further to Example 1, each line of the plurality of lines comprises an elastic polymer or composite material, such as ePTFE filaments.

[0021] According to another example ("Example 14"), in addition to Example 1, each line of the plurality of lines is a braided fiber.

[0022] According to another example ("Example 15"), further to example 1, the plurality of lines are bonded to an outer surface of the first elongate element.

[0023] According to another example ("Example 16"), in addition to Example 1, the medical device further includes a secondary cutter coupled to the second elongate element proximate the first end of the first elongate element.

[0024] According to another example ("Example 17"), in addition to example 1, the medical device further includes an expandable member coupled to the first elongate element.

[0025] According to another example ("Example 18"), in addition to Example 17, the expandable member is positioned inside the plurality of lines such that the plurality of lines are under tension when the expandable member is expanded.

[0026] According to another example ("Example 19"), in addition to Example 1, the second elongate element is rotatable relative to the first elongate element, and the plurality of lines are operable to be under tension when the second elongate element is rotated.

[0027] According to another example ("Example 20"), in addition to Example 1, the lines are bonded to an outer surface of the second elongate element.

[0028] According to one example ("Example 21"), a method of performing thrombectomy includes advancing a medical device toward a thrombus, wherein the medical device includes a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter; a second elongate element extending through at least a portion of the lumen of the first elongate element, the second elongate element having a first end and a second end, the first end of the second elongate element configured to extend beyond the first end of the first elongate element; a frame extending from the first end of the second elongate element, the frame configured to be deployed; a frame having a second diameter when in the deployed configuration, the second diameter being greater than the first diameter of the first elongate element, and a plurality of lines coupled to the first elongate element and the frame, the plurality of lines operable to be tensioned when the frame is in the deployed configuration; extending the medical device through the thrombus so that the frame and the plurality of lines are positioned beyond the thrombus; deploying the frame to the deployed configuration so that the plurality of lines are tensioned; and longitudinally translating the medical device so that the lines cut the thrombus.

[0029] According to another example ("Example 22"), in addition to example 21, the method further includes rotating the second elongate element relative to the first elongate element.

[0030] According to another example ("Example 23"), in addition to example 21, the method further includes providing a contrast agent near the thrombus through a second lumen of the second elongate element.

[0031] According to another example ("Example 24"), in addition to Example 21, the method further includes aspirating the severed thrombus portion through the first lumen of the first elongate element.

[0032] According to one example ("Example 25"), a medical device for treating at least one of thrombi and embolisms includes: an elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, wherein the first end includes an opening to the lumen; a plurality of lines coupled to the first elongate element such that the plurality of lines extend across the opening, the plurality of lines operable to be tensioned when the elongate element is in a deployed configuration, and operable to sever at least one of emboli or thrombi.

[0033] According to one example ("Example 26"), a medical device for treating at least one of thrombi and embolisms includes: a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, the first end including an opening to the lumen; a frame coupled to the first end of the first elongate element, the frame having a delivery configuration and a deployed configuration; a second elongate element having a first end and a second end, the second elongate element at least partially disposed within the lumen of the first elongate element and extending away from the first end of the first elongate element; and a plurality of lines coupled to the first and second elongate elements, the plurality of lines operable to be tensioned when the frame is in the deployed configuration and operable to sever at least one of emboli or thrombi.

[0034] According to one example ("Example 27"), a medical device for treating at least one of thrombi and embolisms includes: an elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, wherein the first end includes an opening to the lumen; a braided frame having a delivery configuration and a deployed configuration; and a plurality of lines between the elongate element and the braided frame, the plurality of lines operable to be tensioned when the braided frame is in the deployed configuration and operable to sever at least one of emboli or thrombi.

[0035] According to one example ("Example 28"), a medical device for treating at least one of thrombi and emboli includes: a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, wherein the first end includes an opening to the lumen; a second elongate element extending through at least a portion of the lumen of the first elongate element, the second elongate element having a first end and a second end, the first end of the second elongate element configured to extend beyond the first end of the first elongate element; an expandable member disposed around the second elongate element; and a plurality of lines extending between the second elongate element and the expandable element, the plurality of lines operable to be tensioned when the expandable element is in a deployed configuration and operable to sever at least one of emboli or thrombi.

[0036] According to another example ("Example 29"), further to example 28, the plurality of lines extend proximally and distally from the expandable member to the second elongate element.

[0037] The foregoing examples are merely illustrative and should not be construed as limiting or narrowing the scope of the inventive concepts otherwise provided by this disclosure. While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0038] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the present disclosure.

[0039] [Figure 1] FIG. 1 illustrates a device for performing thrombectomy according to one embodiment.

[0040] [Figure 2A] FIG. 2A shows a device for performing thrombectomy in a deployed configuration and a constrained configuration according to one embodiment. [Figure 2B] FIG. 2B illustrates a device for performing thrombectomy in a deployed configuration and a constrained configuration according to one embodiment.

[0041] [Figure 3] FIG. 3 is a series of diagrams illustrating an example of a method of use of a thrombus removal device according to one embodiment. [Figure 4] FIG. 4 is a series of diagrams illustrating an example of a method of use of a thrombus removal device according to one embodiment. [Figure 5] FIG. 5 is a series of diagrams illustrating an example of a method of use of a thrombus removal device according to one embodiment.

[0042] [Figure 6] FIG. 6 illustrates a device for performing thrombus removal comprising a membrane and fluidly coupled to a suction source and a fluid source, according to one embodiment.

[0043] [Figure 7] FIG. 7 illustrates a device for performing thrombectomy having a cutting line coupled to an inner elongate member, according to one embodiment.

[0044] [Figure 8] FIG. 8 shows a device for performing thrombectomy comprising a frame and having a cutting line in a forward position, according to one embodiment.

[0045] [Figure 9] FIG. 9 shows a device for performing thrombectomy with the cutting line in a forward position, according to one embodiment.

[0046] [Figure 10] FIG. 10 illustrates a device for performing thrombectomy with a cutting line coupled between a grooved first elongate element and a second elongate element, according to one embodiment.

[0047] [Figure 11] FIG. 11 shows a device for performing thrombectomy having a cutting line coupled to a braided frame, according to one embodiment. [Figure 12] FIG. 12 shows a device for performing thrombectomy having a cutting line coupled to a braided frame, according to one embodiment.

[0048] [Figure 13] FIG. 13 shows a device for performing thrombectomy having a secondary cutter, according to one embodiment.

[0049] [Figure 14] FIG. 14 shows a device for performing thrombectomy having an occlusion balloon, according to one embodiment.

[0050] [Figure 15]FIG. 15 shows a device for performing thrombectomy having a rotatable second elongate element to tension the cutting line, according to one embodiment.

[0051] [Figure 16] FIG. 16 shows a device for performing thrombectomy having a frame with rotatable cutting posts, according to one embodiment.

[0052] [Figure 17] FIG. 17 shows a device for performing antegrade thrombectomy having a balloon for transitioning the cutting line to a deployed configuration, according to one embodiment.

[0053] [Figure 18] FIG. 18 shows a device for performing retrograde thrombectomy having a balloon for transitioning the cutting line to a deployed configuration, according to one embodiment.

[0054] [Figure 19] FIG. 19 illustrates a device for performing antegrade and retrograde thrombectomy having a balloon for transitioning the cutting line to a deployed configuration, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0055] Detailed Description Definitions and Terminology The present disclosure is not intended to be construed in a limiting sense, for example, the terms used in this application should be interpreted broadly in accordance with the meaning that one of ordinary skill in the art would assign to such terms.

[0056] With respect to terms related to imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements that include and are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, to the extent that it would be understood and readily grasped by one of ordinary skill in the relevant art. Such deviations may result from, for example, measurement error, differences in the calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, fine-tuning made to optimize performance and / or structural parameters to account for variations in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and / or the like. If it is determined that the value of such reasonably small deviations would not be readily grasped by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean ±10% of the stated value.

[0057] Description of Various Embodiments Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0058] The clot removal device shown in FIG. 1 is provided as an example of various device features, and while combinations of the illustrated features are clearly within the scope of the present invention, this example and its illustration do not suggest that the inventive concepts provided herein are limited to fewer, additional, or alternative features to one or more of the features illustrated in FIG. 1. For example, in various embodiments, the clot removal device shown in FIG. 1 can include a filter membrane as described with reference to FIG. 6. It should also be understood that the reverse is true. One or more of the components illustrated in FIG. 1 can be used in addition to, or as a substitute for, components illustrated in other figures.

[0059] The present disclosure relates to and is presented herein as a medical device for performing thrombectomy. The medical device can fragment and remove a vascular defect or vascular obstruction, such as a thrombus or embolus (e.g., a blood clot or plaque), from a patient's lumen. The medical device can also restrict the passage of an embolus through the vasculature after it has fragmented. The medical device can also atraumatically deploy and fragment the embolus within the patient's vasculature. The medical device 100 can also visualize and / or treat the thrombus during removal. The medical device can also actively and / or passively capture fragmented portions of the thrombus.

[0060] Referring to FIG. 1 , a medical device 100 is shown. The medical device 100 includes a first elongate element 110 having a first end 112 and a second end 114, the first elongate element 110 defining a lumen 116 and having a first diameter D1. The medical device 100 further includes a second elongate element 120. The second elongate element 120 extends through at least a portion of the lumen 116 of the first elongate element 110. The second elongate element 120 has a first end 122 and a second end 124. The first end 122 of the second elongate element 120 is configured to extend beyond the first end 112 of the first elongate element 110. The medical device 100 includes a frame 130 extending from the first end 122 of the second elongate element 120. The frame 130 has a second diameter D2 when in the deployed configuration, the second diameter D2 being greater than the first diameter D1 of the first elongate element 110. The medical device 100 further includes a plurality of lines 150 coupled to the first elongate element 110 and the frame 130, the plurality of lines 150 operable to be tensioned when the frame 130 is in the deployed configuration. The plurality of lines 150 are operable to sever either an embolus or a thrombus.

[0061] With further reference to FIG. 1 , the first elongate element 110 can be a catheter or sheath that can be advanced through a patient's vasculature. The first elongate element 110 can be manipulated from outside the patient's body by a user (e.g., a surgeon) while advancing the first end 112 toward a thrombus within the patient's vasculature and positioning it near the thrombus. In some embodiments, the first elongate element 110 is in fluid communication with a suction source 1000 (e.g., a vacuum, see FIG. 6 ) to provide active suction for removing the thrombus. Thus, the lumen 116 of the first elongate element 110 can provide a passageway for removing the thrombus when fluidly coupled to the suction source 1000. In some embodiments, the first elongate element 110 is capable of passive thrombus removal / transportation. The first elongate element 110 can be provided in a variety of diameters and lengths. The diameter of the first elongate element 110 is selected so that the first elongate element 110 can be positioned and moved within the patient's vasculature. Additionally, the diameter of the first elongate element 110 can be large enough to remove the thrombus (e.g., a cut portion of the thrombus) through the lumen 116 of the first elongate element 110. The first elongate element 110 further comprises sufficient structural integrity (e.g., columnar strength) to be advanced through a patient's vessel and through at least a portion of the thrombus.

[0062] 1 , the second elongate element 120 is positioned to extend through at least a portion of the lumen 116 of the first elongate element 110. The second elongate element 120 is sized to be accommodated within the lumen 116 of the first elongate element 110 and to provide sufficient space to accommodate and / or transport portions of the thrombus through the lumen 116 of the first elongate element 110. The second elongate element 120 may be longitudinally movable within the first elongate element 110, thereby allowing the second elongate element 120 to be advanced or retracted within the lumen 116 of the first elongate element 110. The advancement of the second elongate element 120 within the lumen 116 of the first elongate element 110 is shown in FIGS. 2A and 2B . By advancing and retracting (e.g., telescopically) the second elongate element 120, the device 100 may be reconfigured between a delivery configuration, a deployed configuration, and a retrieval or removal configuration. It is understood that in some embodiments, a restraint (not shown) can be implemented to restrain the medical device 100 in the delivery configuration during delivery of the medical device 100 to the target site.

[0063] In some embodiments, the second elongate element 120 includes a lumen 126 operable to accommodate a guidewire 160 (see FIG. 4). The medical device 100 can be advanced to the target site by tracking over the guidewire 160. The lumen 126 of the second elongate element 120 can also be operable to deliver a fluid to the target site. For example, in some embodiments, the lumen 126 is fluidly coupled to a fluid source 2000 (see FIG. 6). The fluid source 2000 can include various fluids or combinations of fluids. For example, the fluid source can include a contrast fluid configured for implementation in visualization of the target site, saline (e.g., to replace fluid that may be removed during aspiration), or a therapeutic agent that acts to inhibit coagulation and / or break up blood clots. It is understood that any useful fluid can be delivered to the target site via the lumen 126 of the second elongate element 120. The fluid source 200 allows for active infusion and / or passive aspiration-enhanced flow.

[0064] In some embodiments, the second elongate element 120 includes at least one opening 128 near the first end 122. The opening 128 may be at a longitudinal end (e.g., the end through which the guidewire 160 passes), or the opening 128 may be disposed through a sidewall of the second elongate element 120. For example, as shown in FIG. 1 , the second elongate element 120 includes multiple openings 128 through the sidewall at the first end 122 of the device (spaced circumferentially and longitudinally near the first end 122 of the second elongate element 120). The openings 128 allow for fluid delivery to the first end 122 of the second elongate element 120 when it is positioned at a target site, where the fluid may be deployed along the longitudinal axis or radially outward from the second elongate element 120.

[0065] With continued reference to FIG. 1 , a frame 130 extends longitudinally outward from the second elongate element 120. The frame 130 is operable to be disposed in a delivery configuration (e.g., a collapsed configuration, see FIG. 2B ) and a deployed configuration (e.g., an expanded configuration, see FIG. 2A ). The frame 130 includes a plurality of main struts 132 (e.g., radial struts) extending from the second elongate element 120. The main struts 132 may be spaced apart around the circumference of the second elongate element 120. The frame 130 may further include support struts 134 interconnecting the main struts 132 and providing structural support to the main struts 132. The support struts 134 may be provided in various configurations and at various locations along the main struts 132. As shown, one ring of support struts 134 may be provided, although any number of rings of support struts 134 may be provided.

[0066] The frame 130 may further include peripheral struts 136. The peripheral struts 136 interconnect the ends of the main struts 132. The peripheral struts 136 define the outer periphery or circumference of the frame 130. The peripheral struts 136 are operable to contact tissue (e.g., a vessel wall) when in the deployed configuration. The peripheral struts 136 may be provided in a variety of shapes, including, but not limited to, an arcuate shape, as shown in FIG. 1 . The arcuate shape of the peripheral struts 136 may provide an atraumatic surface for contacting tissue and limit tissue disruption during the performance of a procedure. In some embodiments, the frame 130 includes attachment locations 138 operable to attach multiple lines 150. In some embodiments, the attachment locations 138 may include eyelets through which the lines 150 can extend. In other embodiments, the attachment locations 138 are defined on the frame 130 and are not specific structures integral to the structure of the frame 130. In some embodiments, the attachment locations 138 can be located along the perimeter struts 136. In other embodiments, the attachment locations 138 can be at the intersections of the perimeter struts 136 and the main struts 132 (see FIG. 7). The attachment of the lines 150 to the frame 130 can be achieved in a variety of ways, including, but not limited to, knots, adhesives, bonding, etc. In some embodiments, the lines 150 can be attached to the attachment locations 138 by looping the lines through eyelets. This allows for double or parallel placement of the lines 150 at each attachment location 138.

[0067] The frame 130 can be formed from a variety of materials, including, but not limited to, Nitinol (NiTi). Additionally or alternatively, other materials can be used for the frame 130, such as stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or other suitable biocompatible materials and combinations thereof. The superelastic properties and flexibility of NiTi can improve the conformability of the frame 130. Furthermore, NiTi can be molded to a desired shape. That is, NiTi can be molded so that the frame self-expands to a desired shape when the frame 130 is unconstrained, such as when the frame 130 is deployed. In some embodiments, the frame 130 can additionally or alternatively be deployed using a push-pull deployment method. For example, the frame 130 can be controllably configured to expand over a range of different degrees, thereby allowing the outer diameter to be controlled to various sizes, i.e., diameters. The frame 130 can be controllably configured to a contracted configuration in which the outer diameter is smaller than the inner diameter of the first elongate element 110. By advancing the second elongate element 120 longitudinally from the first elongate element 110, tension is applied to the lines 150, causing the frame 130 to collapse inward. In some embodiments, a deployment mechanism can be provided.

[0068] The frame 130 is configured to be movable along a central longitudinal axis relative to the first elongate element 110. The frame 130 can be at least partially received within the first elongate element 110, for example, by advancing the first end 112 of the first elongate element 110 over at least a portion of the frame 130. That is, in the collapsed configuration, the frame 130 is at least partially slidably received within the first elongate element 110 and is extendable therefrom. In some embodiments, the frame 130 self-expands as it is extended from the first elongate element 110.

[0069] The frame 130 is structurally or materially configured to maintain at least some degree of continuous flow through the conduit upon deployment (e.g., with only minor disruption to the flow). The struts 132, 134, 136 are separated from one another, and spaces are formed between the struts 132, 134, 136 as the frame 130 expands outward. The struts 132, 134, 136 may be formed to define an open interior bounded by, for example, a mesh-like or ribbed structure (e.g., membrane 170). The spaces between the struts 132, 134, 136 may be generally longitudinally oriented (e.g., along a central longitudinal axis) or may have other configurations (e.g., diagonal, spiral, or other).

[0070] 1 , in the deployed configuration, the struts 132, 134, 136 of the frame 130 are spaced apart to define spaces between the struts 132, 134, 136, allowing fluid to flow around the first elongate element 110 and through the spaces between the struts 132, 134, 136 of the frame 130. The frame 130 has gaps between the struts 132, 134, 136, defining a plurality of open spaces between the struts 132, 134, 136 and an open interior space through which fluid can flow when the frame 130 is in the deployed configuration. In some examples, fluid can also flow through the spaces between the struts 132, 134, 136 when the frame 130 is transitioning between the collapsed configuration and the deployed configuration.

[0071] Among other benefits, continuous perfusion of downstream body systems can also be beneficial. As another example, maintaining downstream perfusion can ensure positional accuracy of device 100 during intravascular procedures. This is because allowing continuous fluid flow reduces the need to withstand or resist pressures associated with temporary occlusion of the vessel. In other situations, it may be desirable to block or partially block fluid flow when device 100 is deployed to its expanded state. In such cases, struts 132, 134, 136 can include membranes 170 (e.g., for blocking or filtering) (see FIG. 6 ) extending between struts 132, 134, 136 to block or filter spaces that allow fluid to pass through but trap particulate material above a certain size. Membrane 170 can be a porous cover having pores, for example, to facilitate filtration and perfusion as described herein.

[0072] Continuing with reference to FIG. 1 , frame 130 defines a perimeter provided, for example, by peripheral struts 136. A plurality of lines 150 are coupled to the frame at or near the perimeter such that, when frame 130 is in the deployed configuration, lines 150 extend substantially toward the vessel wall. For example, lines 150 can be coupled to peripheral struts 136, or lines can be coupled to main struts 132 near the perimeter of frame 130. In some embodiments, lines 150 are formed from suture lines. For example, lines 150 can be formed from expanded polytetrafluoroethylene (ePTFE) filaments. In some embodiments, lines 150 are formed from braided fibers. In some embodiments, lines can be coated or include a drug (e.g., an anticoagulant) that can aid in cutting.

[0073] In some embodiments, the plurality of lines 150 are coupled to the outer surface of the first elongate element 110. By coupling the lines 150 to the first elongate element 110, an interior space 180 is defined between the lines 150 and the frame 130. The lumen 116 of the first elongate element 110 is in fluid communication with the interior space 180, so that emboli that are cut by the lines 150 and enter the interior space 180 do not have to pass through another barrier (e.g., pass through the lines 150 a second time) to be removed through the lumen 116 of the first elongate element 110. Referring to FIG. 7 , in some embodiments, the lines 150 are coupled to the outer surface of the second elongate element 120.

[0074] 2A and 2B, the frame 130 can be transitioned between an expanded configuration (FIG. 2A) and a collapsed configuration (FIG. 2B). The device 100 can be transitioned to the collapsed configuration to capture and remove portions of an embolus and for repositioning within and / or removal from the vessel.

[0075] 3-5 illustrate exemplary devices, systems, and methods for treating thrombi. In general, the described embodiments and concepts can be applied to virtually any vascular region containing thrombi, including neurovascular, cardiovascular, and peripheral vascular systems, as well as both arterial and venous systems. The described embodiments and concepts generally relate to (1) opening a blood flow pathway through a blood vessel blocked by a thrombus, and (2) capturing and removing a quantity of thrombus material.

[0076] 3 illustrates an example blood vessel segment 210 including a thrombus 230 at a thrombus site 235. The thrombus 230 may be attached to or lodged in a blood vessel wall 225, for example, or may be lodged within the blood vessel 220. The thrombus 230 may partially or completely block blood flow 226 through the blood vessel 220. While the example of FIG. 3 illustrates a thrombus 230 that partially blocks blood flow 226 through the blood vessel 220, the devices and techniques described herein may also be used with a clot or thrombus that completely blocks blood flow through the blood vessel.

[0077] Typically, access to the thrombus 230 can be achieved initially by a flexible guidewire 160. In some instances, other devices, such as one or more guide catheters (not shown), can be used to navigate through the patient's vasculature to a location near the target thrombus. In some instances, access to the thrombus can be achieved by a combination of one or more guide catheters and guidewires. For example, a combination of successively smaller guide catheters can be deployed in a telescopic fashion. In some embodiments, the guidewire 160 can be inserted into the blood vessel 220 such that the distal end of the guidewire 160 extends beyond the thrombus site 235.

[0078] In some embodiments, guidewire 160 is removed from first elongate element 110. In this embodiment, guidewire 160 helped guide first elongate element 110 to the desired location. According to some embodiments, with first elongate element 110 in the desired location, guidewire 160 can be removed to provide space within the lumen of first elongate element 110 for insertion of other devices to treat thrombus 230 or other vascular occlusions or conditions. In some embodiments, guidewire 160 is left in place, such that guidewire 160 can be used to facilitate additional deployment operations.

[0079] While Figures 3-5 show embodiments in which the target thrombus 230 is generally concentric with the vessel wall 225, in some embodiments, the thrombus is eccentrically positioned within the vessel. That is, the location of the thrombus may be biased to a particular side of the vessel. In such embodiments, device 100 may be inserted around the thrombus (rather than penetrating it). However, the principles of operation of device 100 in the context of an eccentrically positioned thrombus are generally the same as those described herein with respect to the concentric thrombus of Figures 3-5.

[0080] 4 shows device 100 in an expanded (e.g., deployed) configuration near thrombus 230. In some embodiments, this positioning can be achieved by extending first elongate element 110 while simultaneously maintaining or restraining second elongate element 120 in its previous axial position relative to thrombus 230. Second elongate element 120 can also be retracted while maintaining or restraining first elongate element 110 in its previous axial position relative to thrombus 230.

[0081] As mentioned above, the frame 130 of the device 100 can be self-expanding in some embodiments. That is, the frame 130 can have shape-memory properties that urge the frame into an expanded configuration (see FIG. 1 ) when unconstrained (e.g., after exiting a delivery catheter). In some embodiments, the frame 130 can assume a partially expanded configuration when partially constrained (e.g., by a thrombus 230 or a vessel wall 225). The device 100 expands such that the frame 130 (e.g., the peripheral struts 136) substantially contacts the interior vessel wall 225. In embodiments including the membrane 170, the membrane 170 substantially contacts the interior vessel wall 225. In this manner, one or more dislodged thrombus fragments that are separated from the thrombus 230 by the expansion of the frame 130 can be captured by the membrane 170.

[0082] Once the frame 130 is expanded, it is positioned against the vessel wall 225. The frame 130 and line 150 are positioned distal to the thrombus 230, such that the frame 130 is positioned on the opposite side of the first elongate element 110 within the vessel. The line 150 is tensioned by positioning the second elongate element 120 relative to the first elongate element 110, while maintaining tension on the line 150 between the frame 130 and the first elongate element 110, allowing the frame 130 to seat within the vessel. With the line 150 under tension, the line 150 can sever a portion of the thrombus 230, breaking it into smaller pieces. This can be accomplished by pulling the device 100 proximally so that the line 150 and frame 130 pass the location where the thrombus is present. For example, the device 100 is pulled in a direction counter to the flow (e.g., blood flow) through the vessel. As line 150 is pulled through thrombus 230, thrombus 230 breaks up into small pieces. As thrombus 230 breaks up, portions of thrombus 230 may break loose and form emboli. The frame can capture emboli as blood continues to flow downstream. In embodiments that include membrane 170, membrane 170 can further capture emboli as blood passes through membrane 170. In some embodiments, membrane 170 can have a hydrophobic coating.

[0083] 5 , once the thrombus 230 has fragmented, the first elongate element 110 can remove the loosened thrombus 230 pieces. This is accomplished by providing suction through the lumen 116 of the first elongate element 110 via the suction source 1000. Because the line 150 has fragmented the thrombus 230, the clot pieces are small enough to pass through the lumen 116 of the first elongate element 110. The frame 130 can further function to remove at least a portion of the thrombus from the vessel wall 225 as the device 100 is pulled along the vessel wall 225. These portions can also be removed through the lumen 116 of the first elongate element 110. It will be appreciated that some of the clot may not be drawn into the lumen 116 of the first elongate element 110, but that the frame 130 and / or membrane 170 can contain the clot during removal.

[0084] During the procedure, a contrast agent can be provided through the second elongate element 120. A lumen 126 extends through the second elongate element 120, and the contrast agent can be transported through the lumen 126 and thereby delivered through the opening 128. The contrast agent can be released at any time during the procedure, including before, during, and after the placement, advancement, and deployment of the device 100. The contrast agent can be delivered to either side of the thrombus 230, including upstream or downstream.

[0085] The frame 130, including portions of the membrane 170, can contact the inner wall of the blood vessel. Thus, if thrombus fragments detach from the thrombus 230 as a result of displacement or severing of thrombus material by the frame 130, the thromboemboli can be captured by the membrane 170. For example, the released thromboemboli can be carried distally by blood through the blood flow path and into the space defined by the membrane 170. While blood can then pass through the membrane 170, e.g., through small pores in the membrane 170, the thromboemboli may be too large to pass through the pores of the membrane 170 and thus can be trapped or captured within the membrane 170. In this manner, the detached thrombus fragments can be prevented from becoming fugitive thromboemboli in the bloodstream. In some embodiments, the frame 130 can be configured to retain thromboemboli.

[0086] In the case of a neurovascular thrombus occlusion, restoring perfusion as described above is an initial treatment aimed at saving the patient's life. Restoring downstream perfusion, even partial perfusion, restores blood flow to downstream neural tissue. Restoring blood flow can minimize and / or eliminate the pressure of blood pushing against the thrombus 230 and the vacuum or negative pressure located immediately distal to the thrombus 230. Reducing or eliminating the pressure differential on the sides of the thrombus 230 can increase the effectiveness of the device 100.

[0087] In some embodiments, the structure of the frame 130 allows a portion of the thrombus 230 to penetrate between the lines 150 and / or struts 132, 134, and 136 and enter the interior space 180 of the frame 130. Opening or widening the blood flow passages as described above increases the amount of blood flowing over the surface of the thrombus 230, promoting thrombolysis of the thrombus 230. That is, by creating additional blood flow over the surface of the thrombus 230, the natural tendency of blood to dissolve the thrombus can be enhanced. The lytic action of the blood can partially erode the surface 232 of the thrombus 230 by dissolving a portion of the thrombus 230 or by removing some of the thrombus particles. The removed thrombus particles can be trapped by the membrane 170 and prevented from forming thromboemboli in the bloodstream.

[0088] 7, in some embodiments, a line 150 can be provided extending between the frame 130 and the second elongate element 120. The line 150 can be tensioned by drawing the second elongate element 120 into the first elongate element 110, which deflects the line 150. It will be appreciated that the line 150 can be coupled to a variety of other components and at a variety of locations, including on the interior surface of the first elongate element 110.

[0089] These embodiments can be performed as a retrograde thrombectomy, where device 100 is extended through thrombus 230, device 100 is deployed, and device 100 is translated longitudinally back through thrombus 230 to disrupt thrombus 230.

[0090] In other embodiments, device 100 can be provided as a forward thrombectomy device. For example, FIGS. 8 and 9 show a device including a line 150 positioned over first elongate element 110 and frame 130. In these embodiments, device 100 is deployed within the patient's vasculature and then advanced forward. As device 100 advances, line 150 cuts through thrombus 230. The thrombus 230 is crushed and can be removed through lumen 116 of first elongate element 110. For example, FIG. 8 shows device 100 with frame 130 deployed and line 150 positioned extending between frame 130 and second elongate element 120. Frame 130 facilitates blood flow through frame 130 during thrombectomy. Any of the features discussed herein, including but not limited to membrane 170, can also be implemented. 9, first elongate element 110 is tapered or grooved at first end 112, with line 150 coupled across the opening of first elongate element 110. In each embodiment, line 150 leads as device 100 is advanced, contacting and severing thrombus 230. With specific reference to FIG. 9, in embodiments in which first end 112 is tapered or grooved, first end 112 is constrained (e.g., constrained by a constraining member) to a diameter substantially similar to the diameter of the remainder of first elongate element 110 and can expand (e.g., self-expand) to the larger grooved diameter upon release from the constraining configuration.

[0091] Referring to FIG. 10 , device 100 can be provided as an antegrade thrombectomy device including a first elongate element 110 and a second elongate element 120. First elongate element 110 can be tapered or fluted at a first end 112. First end 112 can also be supported by a support frame 200, which can be self-expanding in some embodiments. A plurality of lines 150 extend from the first end 112 of the first elongate element to the first end 122 of the second elongate element 120. Lines 150 can function as cutters for thrombus or clots. Second elongate element 120 can include ports or apertures 128, as described above with respect to other embodiments. Fragments of the clot or thrombus can be fragmented and then received in lumen 116 of first elongate element 110 for removal. 9, the device 100 of FIG. 10 can similarly be constrained so that the first end 112 has a similar diameter and then assumes a grooved or tapered shape when released. Additionally, the grooved or tapered shape of the first end 112 can be adjusted or collapsed by applying tension to the line 150, which causes the second end to at least partially collapse to a smaller diameter.

[0092] 11 and 12 , the device 10 may include an expandable (e.g., self-expanding or otherwise) frame 130. The frame 130 may be formed from a braided structure (e.g., braided nitinol, braided stainless steel, etc.). A line 150 may be coupled to the frame 130 and the first elongate element 110, as previously described. The line 150 may cut a thrombus or clot, which may be removed through the first elongate element 110, as previously described. The frame 130 may be provided in a variety of shapes and configurations to suit the procedure, location, and anatomical requirements. For example, one shape or configuration may be provided for use in pulmonary embolus removal, while another shape or configuration may be used in the iliac vein. In some embodiments, the frame 130 may be coupled to the second elongate element 120 (see figures) to control, deploy, and recapture the frame 130 during use.

[0093] 13 , the device can be provided with a secondary cutter 190. The secondary cutter 190 can be positioned proximal to the first end 112 of the first elongate element 110, such that a portion of the clot received in the first elongate element 110 can be further crushed or macerated to be contained within the first elongate element 110. The secondary cutter 190 can be positioned, for example, on the second elongate element 120, proximal to the opening of the first elongate element 110 at the first end 112. In some embodiments, the secondary cutter 190 can include a plurality of blades spaced apart circumferentially about the second elongate element 120. The blades can be longitudinally positioned such that the blades crush the clot when received substantially longitudinally in the first elongate element 110. It is understood that various configurations are contemplated herein, including the number of secondary cutters (e.g., one, two, three, four, five, or more), the shape of the secondary cutters (straight, tapered, arcuate, etc.), and the orientation of the secondary cutters (parallel to the longitudinal axis of the second elongate element 120, at an angle relative to the second elongate element 120). The secondary cutter 190 can center the frame 130 and second elongate element 120 within the first elongate element 110. In some embodiments, the secondary cutter 190 can also help center the device 100 within the patient's vessel and thrombus. This can aid in not only positioning the frame 130 during use, but also in deployment and retrieval.

[0094] 14 , in some embodiments, the device 100 can include a balloon or expandable member 195 positionable on the first elongate element 110. For example, the balloon 195 can be integral with the first elongate element 110. The balloon 195 can be positioned and inflated during the procedure to limit the formation of an embolism as the thrombus softens. The balloon 195 can also restrict blood flow during thrombus removal, thereby reducing the amount of suction required for the retrograde procedure. The balloon 195 can be inflated to completely occlude the vessel, or can be used to partially occlude the vessel.

[0095] Referring to FIG. 15 , a device 100 is shown in which the second elongate element 120 can be rotated or torqued relative to the first elongate element 110. This allows the line 150 to be further tensioned by wrapping it around the second elongate element 120. As the line 150 wraps around the second elongate element 120, the exposed portion of the line 150 decreases. This allows for increased tension for cutting and positions the line to cut more difficult clots (e.g., if a clot is located in the interior space 180, the line 150 can be shortened to cut into smaller pieces). This torque capability can also facilitate incremental cutting and penetration of difficult clots. It is understood that any of the embodiments having first and second elongate elements 110, 120 shown or described herein can implement this rotational configuration, and the present disclosure is not limited to the embodiment of FIG. 15 .

[0096] 16, the frame 130 can be formed from cut nitinol tubing. The frame 130 can include cutting struts 140 that, upon contact with a thrombus, can cut the thrombus by either axial or rotational movement of the frame 130. For example, the frame 130 can be cut such that the cutting struts 140 are oriented to cut the thrombus when a user pushes or pulls against the device 10. The shape of the cutting struts 140 can be optimized to cut through the thrombus. The device 100 shown in FIG. 16 can be performed in both retrograde and / or antegrade thrombectomy procedures.

[0097] 17 , in one embodiment, the device 100 includes a balloon 195 disposed at the first end 112 of the first elongate element 110. The balloon 195 contacts the line 150, and when the balloon 195 is inflated, the line 150 reconfigures to the deployed configuration. The line 150 extends, for example, around the outer surface of the balloon 195, such that when in the deployed configuration, the line 150 is positioned radially further away (e.g., spaced apart) from the first and second elongate elements 110, 120 along a central portion 152 of the line 150, and the line 150 is under tension. The line 150 can be further tensioned by longitudinally translating the second elongate element 120 relative to the first elongate element 110 and / or by rotating the second elongate element 120 relative to the first elongate element 110, as described above. The device 100 can be used for both retrograde and / or antegrade procedures. For example, FIG. 17 illustrates a device 100 that can be implemented in an antegrade configuration, FIG. 18 illustrates a device 100 that can be implemented in a retrograde configuration, and FIG. 19 illustrates a device that can be implemented in both antegrade and retrograde configurations. The balloon 195 and line 150 can be provided on various components and in various locations. For example, FIG. 17 illustrates a balloon disposed around the first elongate element, and FIGS. 18 and 19 illustrate a balloon 195 disposed around the second elongate element 120. The balloon 195 can be positioned proximal or distal to an aperture 128 that can be implemented to provide contrast. The line 150 can be coupled to the first elongate element 110 and the second elongate element 120 (see FIG. 17 ) or can be coupled to the second elongate element 120 (see FIGS. 18 and 19 ). It will be understood that various features described with respect to the other embodiments can also be implemented in the embodiments of FIGS. 17-20 . These include, but are not limited to, a secondary cutter 190, rotation for tensioning, contrast media, braided structures, etc. As shown in Figures 18 and 19, a ring 154 can be provided to limit contact between the balloon 195 and the line 150, thus reducing the chance of the line 150 cutting the balloon 195.The line 150 can be bonded to the ring or placed against the ring 154 to limit contact. The ring 154 can be expandable and contractible with the balloon 195 or can have a fixed diameter.

[0098] The present invention has been described above both generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Therefore, it is intended that the embodiments cover the modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents.

Claims

1. a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter; a second elongate element extending through at least a portion of the lumen of the first elongate element, the second elongate element having a first end and a second end, the first end of the second elongate element being configured to extend beyond the first end of the first elongate element; a frame extending from the first end of the second elongate element, the frame having a second diameter when in a deployed configuration, the second diameter being greater than the first diameter of the first elongate element; and a plurality of lines coupled to the first elongate element and the frame, the plurality of lines operable to be tensioned when the frame is in a deployed configuration and operable to sever at least one of an embolus or a thrombus; A medical device for treating either a thrombus or an embolism, comprising:

2. 10. The medical device of claim 1, further comprising a vacuum source, the lumen of the first elongate element being operable to be fluidly coupled to the vacuum source.

3. 10. The medical device of claim 1, wherein the first elongate element comprises sufficient structural integrity to support advancement through an embolus or thrombus.

4. The medical device of claim 1 , wherein the second elongate element is longitudinally movable relative to the first elongate element.

5. The medical device of claim 1 , wherein the second elongate element includes a lumen operable to accommodate a guidewire.

6. 6. The medical device of claim 5, wherein the second elongate element includes at least one opening near the first end, the second elongate element operable to fluidly couple to a fluid source including at least one of a contrast agent source, a saline source, and a therapeutic agent source.

7. The medical device of claim 1 , wherein the frame comprises a nitinol structure operable to at least partially self-expand when transitioning from a delivery configuration to a deployed configuration.

8. The medical device of claim 1 , wherein the frame includes a porous covering.

9. The medical device of claim 1 , wherein the frame defines a perimeter and each line of the plurality of lines is coupled to the frame proximate the perimeter.

10. 10. The medical device of claim 9, wherein the frame includes a plurality of radial struts extending from the second elongate element toward the periphery of the frame.

11. The medical device of claim 10 , wherein each line of the plurality of lines is coupled to the frame at the plurality of radial struts.

12. 10. The medical device of claim 9, wherein the frame includes a plurality of peripheral struts extending between the plurality of radial struts proximate the periphery of the frame, and the plurality of lines are coupled to the frame at the plurality of peripheral struts between the plurality of radial struts.

13. The medical device of claim 1 , wherein each line of the plurality of lines comprises an ePTFE filament.

14. The medical device of claim 1 , wherein each line of the plurality of lines is a braided fiber.

15. The medical device of claim 1 , wherein the plurality of lines are bonded to an exterior surface of the first elongate element.

16. The medical device of claim 1 , further comprising a secondary cutter coupled to the second elongate element proximate a first end of the first elongate element.

17. The medical device of claim 1 , further comprising an expandable member coupled to the first elongate element.

18. 18. The medical device of claim 17, wherein the expandable member is positioned inside the plurality of lines such that the plurality of lines are under tension when the expandable member is expanded.

19. 10. The medical device of claim 1, wherein the second elongate element is rotatable relative to the first elongate element, and the plurality of lines are operable to be under tension when the second elongate element is rotated.

20. The medical device of claim 1 , wherein the plurality of lines are bonded to an exterior surface of the second elongate element.

21. advancing a medical device toward the thrombus, the medical device including: a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter; a second elongate element extending through at least a portion of the lumen of the first elongate element, the second elongate element having a first end and a second end, the first end of the second elongate element configured to extend beyond the first end of the first elongate element; a frame extending from the first end of the second elongate element, the frame having a second diameter when in a deployed configuration, the second diameter being greater than the first diameter of the first elongate element; and a plurality of lines coupled to the first elongate element and the frame, the plurality of lines operable to be tensioned when the frame is in the deployed configuration. extending the medical device through the thrombus so that the frame and the plurality of lines are positioned beyond the thrombus; deploying the frame to a deployed configuration such that the lines are under tension; and longitudinally translating the medical device so that the line severs the thrombus; 10. A method of performing a thrombectomy, comprising:

22. The method of claim 21 , further comprising rotating the second elongate element relative to the first elongate element.

23. The method of claim 21 , further comprising providing a contrast agent in the vicinity of the thrombus through a second lumen of the second elongate element.

24. 22. The method of claim 21, further comprising aspirating the severed portion of the thrombus through the first lumen of the first elongate element.

25. an elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, wherein the first end includes an opening to the lumen; and a plurality of lines coupled to the first elongate element such that the plurality of lines extend across the opening, the plurality of lines operable to be tensioned when the elongate element is in a deployed configuration and operable to sever at least one of an embolus or a thrombus; A medical device for treating at least one of a thrombus and an embolism, comprising:

26. a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, wherein the first end includes an opening to the lumen; a frame coupled to the first end of the first elongate element, the frame having a delivery configuration and a deployed configuration; a second elongate element having a first end and a second end, the second elongate element being at least partially disposed within the lumen of the first elongate element and extending away from the first end of the first elongate element; and a plurality of lines coupled to the first elongate element and the second elongate element, the plurality of lines operable to be tensioned when the frame is in a deployed configuration and operable to sever at least one of an embolus or a thrombus; A medical device for treating at least one of a thrombus and an embolism, comprising:

27. an elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, wherein the first end includes an opening to the lumen; a braided frame having a delivery configuration and a deployment configuration; and a plurality of lines between the elongate element and the braided frame, the plurality of lines operable to be tensioned when the braided frame is in a deployed configuration and operable to sever at least one of an embolus or a thrombus; A medical device for treating at least one of a thrombus and an embolism, comprising:

28. a first elongate element having a first end and a second end, the first elongate element defining a lumen and having a first diameter, wherein the first end includes an opening to the lumen; a second elongate element extending through at least a portion of the lumen of the first elongate element, the second elongate element having a first end and a second end, the first end of the second elongate element configured to extend beyond the first end of the first elongate element; an expandable member disposed about the second elongate element; and a plurality of lines extending between the second elongate element and the expandable element, the plurality of lines operable to be tensioned when the expandable element is in a deployed configuration and operable to sever at least one of an embolus or a thrombus; A medical device for treating at least one of a thrombus and an embolism, comprising:

29. 28. The medical device of claim 27, wherein the plurality of lines extend proximally and distally from the expandable member to the second elongate element.

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