Thrombectomy systems and related methods

Abstract

The present technology relates to systems and methods for removing a thrombus from a blood vessel of a patient. In some embodiments, the present technology is directed to a system including an elongate catheter having a distal portion configured to be positioned within a blood vessel of a patient, a proximal portion configured to be external to the patient, and a lumen extending therebetween. The system can also include a fluid delivery mechanism coupled to the fluid lumen and configured to apply fluid to at least partially fragment the thrombus.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Application No. 63 / 267,530, filed February 3, 2022, U.S. Application No. 63 / 269,380, filed March 15, 2022, U.S. Application No. 63 / 373,413, filed August 24, 2022, and U.S. Application No. 63 / 373,427, filed August 24, 2022, each of which is incorporated by reference in its entirety into this specification. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Field

[0003] TECHNICAL FIELD The present technology relates generally to medical devices, and more particularly to systems including aspiration and fluid delivery mechanisms for removing thrombi from mammalian blood vessels, and related methods. Summary of the Invention [Problem to be solved by the invention]

[0002]

[0004] Thrombotic material can lead to blockage of fluid flow within the mammalian vascular system. Such blockages can occur in various areas within the body, such as the pulmonary system, peripheral vascular system, deep vascular system, or within the brain. Pulmonary embolism typically occurs when a blood clot originating from another part of the body (e.g., the veins of the pelvis or legs) breaks off and travels to the lungs. Anticoagulant therapy is the current standard of care for treating pulmonary embolism, but it can be ineffective in some patients.

[0003]

[0005] In addition, conventional devices for removing thrombotic material may not be able to navigate tortuous vascular anatomy, may be ineffective in removing thrombotic material, and / or may lack the ability to provide sensor data or other feedback to the clinician during the thrombectomy procedure. Existing thrombectomy devices operate based on simple suction that works well for certain clots but is largely ineffective for difficult, organized clots. Many patients who present with deep clots in difficult-to-reach anatomical locations and / or deep vein thrombus (DVT) or PE remain untreated as long as they are at low risk for limb ischemia.

[0004]

[0006] More urgent cases are treated with catheter-directed thrombolysis, or lysis therapy, which may take hours or days to break up the clot.

[0007] More recently, other tools such as clot retrievers have been developed to treat DVT and pulmonary embolism (PE). Clot retrievers typically include a structure that is deployed from the distal end of a catheter in a vessel to capture a clot and then retracted back into the distal end of the catheter for clot removal. The structure can include a capture structure that includes a stent-like structure, an expandable capture basket, or passive capture features such as rakes, barbs, or prongs to engage the clot. These tools have not been widely adopted due to limited effectiveness against aspiration or standard of care, high mortality rates, and additional costs. In addition, advancing the capture structure distally from the end of the catheter creates additional challenges, such as limited visualization of the clot relative to the capture device and the risk of damaging the vessel wall with passive capture structures. Other recent developments have focused on slicing or macerating the clot, but these mechanisms are designed to reduce the risk of catheter clogging and do not address the issues of hard, large, organized clots. There remains a need for devices that address these and other problems with existing venous thrombectomy techniques, including, but not limited to, fast, easy to use, and effective devices for removing a variety of clot morphologies in difficult to reach anatomical locations. [Means for solving the problem]

[0005] Disclosure Summary

[0034] A thrombus removal device is provided that includes an elongate catheter having an aspiration lumen, an aspiration source coupled to the aspiration lumen, an expandable funnel coupled to the aspiration lumen and the elongate catheter, and at least one mechanical engagement element disposed within the expandable funnel, the at least one mechanical engagement element being operable to move the at least one mechanical engagement element within the expandable funnel.

[0006]

[0035] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the aspiration lumen.

[0036] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element substantially radially within the expandable funnel, across at least a portion of the expandable funnel.

[0007]

[0037] In one embodiment, the at least one mechanical engagement element includes a cutting portion.

[0038] In one embodiment, the at least one mechanical engagement element includes a blunt tip.

[0039] In one aspect, the device further includes a fluid source, a fluid lumen positioned on the elongate catheter and in fluid communication with the fluid source, and an injection orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the injection orifice configured to provide a fluid flow into the aspiration lumen or into the expandable funnel.

[0008]

[0040] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the fluid flow.

[0041] In one aspect, the at least one mechanical engagement element is in fluid communication with the fluid lumen and is further configured to provide a second fluid flow into the aspiration lumen or into the expandable funnel.

[0009]

[0042] In one aspect, the expandable infundibulum includes an infundibulum frame configured to cause the infundibulum to self-expand to a fully expanded configuration.

[0043] In one aspect, the expandable funnel further comprises a flexible material disposed over at least a portion of the funnel rim.

[0010]

[0044] In one aspect, the device further includes an actuatable rim mechanically coupled to the at least one mechanical engagement element, the actuatable rim positioned at least in part proximally from the infundibulum rim.

[0011]

[0045] In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, and relative movement between the sheath and the elongate catheter to bring the sheath into contact with the actuatable frame moves the at least one mechanical engagement element within the expandable funnel.

[0012]

[0046] In one aspect, contacting the sheath with the actuatable frame does not collapse the expandable funnel or reduce the diameter of the funnel.

[0047] In one embodiment, the at least one mechanical engagement element is coupled to the funnel frame with a hinge.

[0013]

[0048] In one aspect, a distal portion of the at least one mechanical engagement element extends from the hinge into the expandable funnel and a proximal portion of the at least one mechanical engagement element extends outside of the funnel.

[0014]

[0049] In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, and relative movement between the sheath and the elongate catheter to bring the sheath into contact with a proximal portion of the at least one mechanical engagement element causes a distal portion of the at least one mechanical engagement element to move about a hinge within the expandable funnel.

[0015]

[0050] In one aspect, the device further includes a sheath configured to rotate about the elongate catheter, where rotating the sheath into contact with a proximal portion of the at least one mechanical engagement element causes a distal portion of the at least one mechanical engagement element to move about a hinge within the expandable funnel.

[0016]

[0051] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to collide at a pinch point upon actuation.

[0052] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to create a shear action upon actuation.

[0017]

[0053] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements collectively actuated as a group.

[0054] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements that are individually and independently actuated.

[0018]

[0055] In one aspect, the at least one mechanical engagement element includes a first group of mechanical engagement elements that are operable independently from a second group of mechanical engagement elements.

[0056] In one aspect, the at least one mechanical engagement element includes a first mechanical engagement element disposed within the expandable funnel at a first axial location and a second mechanical engagement element disposed within the expandable funnel at a second axial location distal to the first axial location.

[0019]

[0057] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements configured to move towards a central point within the expandable funnel.

[0058] In one aspect, the at least one mechanical engagement element includes a stationary configuration in which the at least one mechanical engagement element is positioned adjacent to or against the flexible material.

[0020]

[0059] In one aspect, the flexible material further includes at least one pocket corresponding to each of the at least one mechanical engagement elements, and the at least one mechanical engagement element includes a stationary configuration such that the at least one mechanical engagement element is positioned within a corresponding pocket within the flexible material.

[0021]

[0060] In one aspect, the flexible material further includes at least one slit corresponding to each of the at least one mechanical engagement elements, the at least one mechanical engagement element including a static configuration in which the at least one mechanical engagement element is covered by the flexible material and an actuated configuration in which the at least one mechanical engagement element moves through the corresponding slit into the expandable funnel.

[0022]

[0061] In one aspect, actuation of the at least one mechanical engagement element causes the at least one mechanical engagement element to pivot within the expandable funnel.

[0062] In one aspect, the elongate catheter extends along a longitudinal axis, and further, the expandable funnel and at least a portion of the at least one mechanical engagement element are configured to maintain their respective axial positions relative to the longitudinal axis during actuation of the at least one mechanical engagement element.

[0023]

[0063] In one aspect, the at least one mechanical engagement element does not extend beyond the distal end of the expandable funnel.

[0064] A medical device is provided that includes an elongate catheter, an expandable member positioned at a distal end of the elongate catheter, and at least one mechanical engagement element disposed within the expandable member, the at least one mechanical engagement element being operable to move the at least one mechanical engagement element within the expandable funnel.

[0024]

[0065] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable member.

[0066] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element substantially radially within the expandable member across at least a portion of the expandable member.

[0025]

[0067] In one embodiment, the at least one mechanical engagement element includes a cutting portion.

[0068] In one embodiment, the at least one mechanical engagement element includes a blunt tip.

[0069] In one aspect, the device further includes a fluid source, a fluid lumen positioned on the elongate catheter and in fluid communication with the fluid source, and an ejection orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the ejection orifice configured to deliver a fluid flow into the expandable member.

[0026]

[0070] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the fluid flow.

[0071] In one aspect, the at least one mechanical engagement element is in fluid communication with the fluid lumen and is further configured to provide a second fluid flow into the aspiration lumen or into the expandable funnel.

[0027]

[0072] In one aspect, the expandable member includes a frame configured to cause the expandable member to self-expand to a fully expanded configuration.

[0073] In one aspect, the expandable member further includes a flexible material disposed over at least a portion of the frame.

[0028]

[0074] In one aspect, the device further includes an actuatable frame mechanically coupled to the at least one mechanical engagement element, the actuatable frame having at least a portion positioned proximally from the frame.

[0029]

[0075] In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, and relative movement between the sheath and the elongate catheter to bring the sheath into contact with the actuatable frame moves at least one mechanical engagement element within the expandable member.

[0030]

[0076] In one aspect, contacting the sheath with the actuatable frame does not collapse the expandable member or reduce the diameter of the expandable member.

[0077] In one embodiment, the at least one mechanical engagement element is coupled to the frame with a hinge.

[0031]

[0078] In one aspect, a distal portion of the at least one mechanical engagement element extends from the hinge into the expandable member and a proximal portion of the at least one mechanical engagement element extends outside of the expandable member.

[0032]

[0079] In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, and relative movement between the sheath and the elongate catheter to bring the sheath into contact with a proximal portion of the at least one mechanical engagement element causes a distal portion of the at least one mechanical engagement element to move about a hinge within the expandable member.

[0033]

[0080] In one aspect, the device further includes a sheath configured to rotate about the elongate catheter, where rotating the sheath into contact with a proximal portion of the at least one mechanical engagement element causes a distal portion of the at least one mechanical engagement element to move about a hinge within the expandable member.

[0034]

[0081] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to collide at a pinch point upon actuation.

[0082] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to create a shear action upon actuation.

[0035]

[0083] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements collectively actuated as a group.

[0084] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements that are individually and independently actuated.

[0036]

[0085] In one aspect, the at least one mechanical engagement element includes a first group of mechanical engagement elements that are operable independently from a second group of mechanical engagement elements.

[0086] In one aspect, the at least one mechanical engagement element includes a first mechanical engagement element disposed within the expandable member at a first axial location and a second mechanical engagement element disposed within the expandable member at a second axial location distal to the first axial location.

[0037]

[0087] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements configured to move towards a central point within the expandable member.

[0088] In one aspect, the at least one mechanical engagement element includes a stationary configuration in which the at least one mechanical engagement element is positioned adjacent to or against the flexible material.

[0038]

[0089] In one aspect, the flexible material further includes at least one pocket corresponding to each of the at least one mechanical engagement elements, and the at least one mechanical engagement element includes a stationary configuration such that the at least one mechanical engagement element is positioned within a corresponding pocket within the flexible material.

[0039]

[0090] In one aspect, the flexible material further includes at least one slit corresponding to each of the at least one mechanical engagement elements, the at least one mechanical engagement element including a static configuration in which the at least one mechanical engagement element is covered by the flexible material and an actuated configuration in which the at least one mechanical engagement element moves through a corresponding slit into the expandable member.

[0040]

[0091] In one aspect, actuation of the at least one mechanical engagement element causes the at least one mechanical engagement element to rotate within the expandable member.

[0092] In one aspect, the elongate catheter extends along a longitudinal axis, and further, the expandable funnel and at least a portion of the at least one mechanical engagement element are configured to maintain their respective axial positions relative to the longitudinal axis during actuation of the at least one mechanical engagement element.

[0041]

[0093] In one aspect, the at least one mechanical engagement element does not extend beyond the distal end of the expandable member.

[0094] A thrombus removal device is provided that includes an elongated catheter having an aspiration lumen and a fluid lumen, an aspiration source coupled to the aspiration lumen, a fluid source coupled to the fluid lumen, an expandable funnel coupled to the aspiration lumen and the elongated catheter, an injection orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the injection orifice configured to supply a fluid flow into the aspiration lumen or into the expandable funnel, and at least one mechanical engagement element disposed within the expandable funnel, the at least one mechanical engagement element being operable to move the at least one mechanical engagement element in the expandable funnel toward a plane of the fluid flow.

[0042]

[0095] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the aspiration lumen.

[0096] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element substantially radially within the expandable funnel across at least a portion of the expandable funnel.

[0043]

[0097] In one embodiment, the at least one mechanical engagement element includes a cutting portion.

[0098] In one embodiment, the at least one mechanical engagement element includes a blunt tip.

[0099] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the fluid flow.

[0044]

[0100] In one aspect, the at least one mechanical engagement element is in fluid communication with the fluid lumen and is further configured to provide a second fluid flow into the aspiration lumen or into the expandable funnel.

[0101] In one aspect, the expandable infundibulum includes an infundibulum frame configured to cause the infundibulum to self-expand to a fully expanded configuration.

[0045]

[0102] In one aspect, the expandable funnel further comprises a flexible material disposed over at least a portion of the funnel rim.

[0103] In one aspect, the device further includes an actuatable rim mechanically coupled to the at least one mechanical engagement element, the actuatable rim positioned at least in part proximally from the infundibulum rim.

[0046]

[0104] In one aspect, the device further includes a sheath configured to slide axially over the elongate catheter, and relative movement between the sheath and the elongate catheter to bring the sheath into contact with the actuatable frame moves the at least one mechanical engagement element within the expandable funnel.

[0047]

[0105] In one aspect, contacting the sheath with the actuatable frame does not collapse the expandable funnel or reduce the diameter of the funnel.

[0106] In one embodiment, the at least one mechanical engagement element is coupled to the funnel frame with a hinge.

[0048]

[0107] In one aspect, a distal portion of the at least one mechanical engagement element extends from the hinge into the expandable funnel and a proximal portion of the at least one mechanical engagement element extends outside of the funnel.

[0049]

[0108] In one aspect, a sheath configured to slide axially over the elongate catheter, where relative movement between the sheath and the elongate catheter to bring the sheath into contact with a proximal portion of the at least one mechanical engagement element causes a distal portion of the at least one mechanical engagement element to move about a hinge within the expandable funnel.

[0050]

[0109] In one aspect, the device further includes a sheath configured to rotate about the elongate catheter, where rotating the sheath into contact with a proximal portion of the at least one mechanical engagement element causes a distal portion of the at least one mechanical engagement element to move about a hinge within the expandable funnel.

[0051]

[0110] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to collide at a pinch point upon actuation.

[0111] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to create a shear action upon actuation.

[0052]

[0112] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements collectively actuated as a group.

[0113] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements that are individually and independently actuated.

[0053]

[0114] In one aspect, the at least one mechanical engagement element includes a first group of mechanical engagement elements that are operable independently from a second group of mechanical engagement elements.

[0115] In one aspect, the at least one mechanical engagement element includes a first mechanical engagement element disposed within the expandable funnel at a first axial location and a second mechanical engagement element disposed within the expandable funnel at a second axial location distal to the first axial location.

[0054]

[0116] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements configured to move towards a central point within the expandable funnel.

[0117] In one aspect, the at least one mechanical engagement element includes a stationary configuration in which the at least one mechanical engagement element is positioned adjacent to or against the flexible material.

[0055]

[0118] In one aspect, the flexible material further includes at least one pocket corresponding to each of the at least one mechanical engagement elements, and the at least one mechanical engagement element includes a stationary configuration such that the at least one mechanical engagement element is positioned within a corresponding pocket within the flexible material.

[0056]

[0119] In one aspect, the flexible material further includes at least one slit corresponding to each of the at least one mechanical engagement elements, the at least one mechanical engagement element including a static configuration in which the at least one mechanical engagement element is covered by the flexible material and an actuated configuration in which the at least one mechanical engagement element moves through the corresponding slit into the expandable funnel.

[0057]

[0120] In one aspect, actuation of the at least one mechanical engagement element causes the at least one mechanical engagement element to pivot within the expandable funnel.

[0121] In one aspect, the elongate catheter extends along a longitudinal axis, and further, the expandable funnel and at least a portion of the at least one mechanical engagement element are configured to maintain their respective axial positions relative to the longitudinal axis upon actuation of the at least one mechanical engagement element.

[0058]

[0122] In one aspect, the at least one mechanical engagement element does not extend beyond the distal end of the expandable funnel.

[0123] 1. A thrombus removal device comprising: an elongated catheter having an aspiration lumen; an aspiration source coupled to the aspiration lumen; an expandable funnel coupled to the aspiration lumen and to the elongated catheter, the expandable funnel including a frame; at least one mechanical engagement element disposed within the expandable funnel; and a sheath slidably disposed along the exterior of the elongated catheter, wherein relative movement between the sheath and the elongated catheter brings the sheath into contact with a portion of the expandable funnel to move the at least one mechanical engagement element within the funnel.

[0059]

[0124] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward said aspiration lumen.

[0125] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element substantially radially within the expandable funnel, across at least a portion of the expandable funnel.

[0060]

[0126] In one embodiment, the at least one mechanical engagement element includes a cutting portion.

[0127] In one embodiment, the at least one mechanical engagement element includes a blunt tip.

[0128] In one aspect, the device further includes a fluid source, a fluid lumen positioned on the elongate catheter and in fluid communication with the fluid source, and an injection orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the injection orifice configured to provide a fluid flow into the aspiration lumen or into the expandable funnel.

[0061]

[0129] In one aspect, the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the fluid flow.

[0130] In one aspect, the at least one mechanical engagement element is in fluid communication with the fluid lumen and is further configured to provide a second fluid flow into the aspiration lumen or into the expandable funnel.

[0062]

[0131] In one aspect, the expandable infundibulum includes an infundibulum frame configured to cause the infundibulum to self-expand to a fully expanded configuration.

[0132] In one aspect, the expandable funnel further comprises a flexible material disposed over at least a portion of the funnel rim.

[0063]

[0133] In one aspect, the device further includes an actuatable rim mechanically coupled to the at least one mechanical engagement element, the actuatable rim positioned at least in part proximally from the infundibulum rim.

[0064]

[0134] In one embodiment, the at least one mechanical engagement element is coupled to the funnel frame with a hinge.

[0135] In one aspect, a distal portion of the at least one mechanical engagement element extends from the hinge into the expandable funnel and a proximal portion of the at least one mechanical engagement element extends outside of the funnel.

[0065]

[0136] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to collide at a pinch point upon actuation.

[0137] In one aspect, the at least one mechanical engagement element includes a pair of mechanical engagement elements configured to create a shear action upon actuation.

[0066]

[0138] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements collectively actuated as a group.

[0139] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements that are individually and independently actuated.

[0067]

[0140] In one aspect, the at least one mechanical engagement element includes a first group of mechanical engagement elements that are operable independently from a second group of mechanical engagement elements.

[0141] In one aspect, the at least one mechanical engagement element includes a first mechanical engagement element disposed within the expandable funnel at a first axial location and a second mechanical engagement element disposed within the expandable funnel at a second axial location distal to the first axial location.

[0068]

[0142] In one aspect, the at least one mechanical engagement element includes a plurality of mechanical engagement elements configured to move towards a central point within the expandable funnel.

[0143] In one aspect, the at least one mechanical engagement element includes a stationary configuration in which the at least one mechanical engagement element is positioned adjacent to or against the flexible material.

[0069]

[0144] In one aspect, the flexible material further includes at least one pocket corresponding to each of the at least one mechanical engagement elements, and the at least one mechanical engagement element includes a stationary configuration such that the at least one mechanical engagement element is positioned within a corresponding pocket within the flexible material.

[0070]

[0145] In one aspect, the flexible material further includes at least one slit corresponding to each of the at least one mechanical engagement elements, the at least one mechanical engagement element including a static configuration in which the at least one mechanical engagement element is covered by the flexible material and an actuated configuration in which the at least one mechanical engagement element moves through the corresponding slit into the expandable funnel.

[0071]

[0146] In one aspect, actuation of the at least one mechanical engagement element causes the at least one mechanical engagement element to pivot within the expandable funnel.

[0147] In one aspect, the elongate catheter extends along a longitudinal axis, and further, the expandable funnel and at least a portion of the at least one mechanical engagement element are configured to maintain their respective axial positions relative to the longitudinal axis during actuation of the at least one mechanical engagement element.

[0072]

[0148] In one aspect, the at least one mechanical engagement element does not extend beyond the distal end of the expandable funnel.

[0149] 1. A method for removing a thrombus from a patient, comprising: inserting a thrombus removal catheter into the patient; expanding a distal expandable member of the catheter adjacent to a target thrombus; aspirating the target thrombus into the distal expandable member; actuating at least one mechanical engagement element in a funnel to contact the target thrombus; and aspirating the target thrombus from the thrombus removal catheter.

[0073]

[0150] In one aspect, the method further includes directing at least two intersecting jets into a target thrombus within the distal expandable member.

[0151] In one aspect, actuating the at least one mechanical engagement element further comprises severing the target thrombus with the at least one mechanical engagement element.

[0074]

[0152] In one aspect, actuating the at least one mechanical engagement element further comprises clamping the target thrombus with the at least one mechanical engagement element.

[0153] In one aspect, actuating the at least one mechanical engagement element further comprises shearing the target thrombus with the at least one mechanical engagement element.

[0075]

[0154] In one aspect, actuating the at least one mechanical engagement element further comprises moving the at least one mechanical engagement element toward an aspiration lumen of the thrombectomy catheter.

[0076]

[0155] In one aspect, actuating the at least one mechanical engagement element further comprises moving the at least one mechanical engagement element radially across the distal expandable member.

[0077]

[0156] In one aspect, actuating the at least one mechanical engagement element further comprises moving the at least one mechanical engagement element toward a plane of the intersecting jets.

[0078]

[0157] 1. A thrombus removal device comprising: an elongate shaft having a distal end; at least one aspiration lumen in the elongate shaft; an expandable funnel disposed at or near the distal end, the expandable funnel including a nested frame structure including an actuatable frame structure proximal to the funnel frame structure, and at least one mechanical engagement element coupled to or integral with the actuatable frame structure; and a sheath slidably disposed over the elongate shaft, the sheath configured to engage the actuatable frame structure to actuate the at least one mechanical engagement element between an open or expanded configuration and a closed or actuated configuration.

[0079]

[0158] In one aspect, by engaging the actuatable framework with the sheath, no engagement occurs between the sheath and the infundibulum framework.

[0159] In one aspect, the device further includes a flexible material disposed around the funnel framework and around at least a portion of the actuatable framework.

[0080]

[0160] In one aspect, the flexible material is not disposed around the at least one mechanical engagement element.

[0161] In one aspect, the device further includes at least one pocket disposed in the flexible material, the pocket configured to receive the at least one mechanical engagement element when the at least one mechanical engagement element is in the open configuration.

[0081]

[0162] In one aspect, the device further includes at least one slit in the flexible material over each of the at least one pocket, the at least one slit configured to allow the mechanical engagement element to exit the at least one pocket upon actuation between the open configuration and the closed or actuated configuration.

[0082]

[0163] In one embodiment, the device further comprises a cutting or serrated edge on at least one of the mechanical engagement elements.

[0164] In one aspect, the at least one mechanical engagement element is oriented toward the aspiration lumen in the closed or activated configuration.

[0083]

[0165] A method for removing a thrombus from a patient's blood vessel with a thrombus removal device is provided, the method including the steps of: introducing a distal portion of the thrombus removal device to a location of the thrombus within the blood vessel; retracting a sheath along an elongate axis of the thrombus removal device to open a funnel at the location of the thrombus; manipulating a suction source of the thrombus removal device to at least partially capture the thrombus in the funnel; advancing the sheath along the elongate axis to engage a framework structure of the funnel and actuating at least one mechanical engagement element of the funnel from an open configuration to a closed configuration.

[0084]

[0166] In one aspect, actuating at least one mechanical engagement element from an open configuration to a closed configuration does not collapse the funnel.

[0167] In one aspect, the at least one mechanical engagement element moves toward the aspiration lumen of the elongate shaft in the closed configuration.

[0085]

[0168] A thrombus removal device is provided that includes an elongate shaft, at least one aspiration lumen in the elongate shaft, a funnel disposed at a distal end of the elongate shaft, and an array of mechanical engagement elements operably positioned within the funnel, the array including one or more axially spaced layers of mechanical engagement elements operable to engage thrombus material.

[0086]

[0169] A method for removing a thrombus from a patient's blood vessel with a thrombus removal device is provided, the method including the steps of obtaining a pre-treatment image representative of the thrombus, introducing a distal portion of an elongate catheter within the blood vessel to a target location proximate the thrombus, operating a suction source on the elongate catheter, removing the thrombus from the patient with the suction source by the thrombus removal device, and determining a volume of the thrombus removed from the patient.

[0087]

[0170] In one aspect, the method further includes calculating a pre-treatment volume of the thrombus from the pre-treatment images.

[0171] In one aspect, determining the volume further comprises obtaining a post-treatment image of the thrombus, calculating a post-treatment volume of the thrombus from the post-treatment image, and comparing the post-treatment volume to a pre-treatment volume.

[0088]

[0172] In one aspect, the method further comprises measuring a parameter related to the step of removing the thrombus.

[0173] In one aspect, measuring the parameter further comprises measuring flow rate or pressure.

[0089]

[0174] In one aspect, the step of determining the volume further comprises estimating or calculating the volume of the removed thrombus based on the measured parameters.

[0175] In one aspect, the method further includes calculating a pre-treatment volume of the thrombus from the pre-treatment image, and comparing the estimated or calculated volume of the removed thrombus to the pre-treatment volume.

[0090]

[0176] In one aspect, the method further includes moving the distal portion of the catheter to another location near the other thrombus and removing the other thrombus.

[0177] In one aspect, the method further includes generating an indicator that sufficient thrombus has been removed and displaying a representation of the indicator.

[0091]

[0178] In one embodiment, the indicator is based on one of the thrombus, another thrombus, and a combination of these thrombus.

[0179] A console for controlling the thrombus removal catheter is provided that includes a pump for controlling suction through the thrombus removal catheter, a sensor for measuring the volume of thrombus removed through the thrombus removal catheter, and a processor containing instructions for determining a pre-treatment volume of thrombus at the treatment site and comparing the volume of removed thrombus to the previous volume.

[0092]

[0180] A clot removal device console is provided that includes a suction source, a canister fluidly coupled to the suction source, the canister configured to be fluidly coupled to an aspiration lumen of the clot removal device, and a sensor disposed in the canister, the sensor configured to characterize or determine an amount of fluid or biological material removed from a patient.

[0093]

[0181] In one aspect, the sensor includes a weigh scale.

[0182] In one aspect, the sensor includes a camera.

[0183] In one embodiment, the canister further comprises a filter configured to allow blood and / or liquid to exit the canister, but not allow blood clots to exit.

[0094]

[0184] In one embodiment, the console further includes a fluid source and a second sensor disposed on or within the fluid source.

[0185] In one embodiment, the second sensor includes a flow sensor or weigh scale configured to measure the volume or weight of fluid delivered from the fluid source.

[0095]

[0008] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings. [Brief description of the drawings]

[0096] [Figure 1]

[0009] FIG. 1 illustrates a portion of a thrombus removal system including a distal portion of an elongated catheter configured in accordance with an embodiment of the present technology. [Figure 1A] 2 illustrates the above portion of the thrombus removal system. [Figure 1B] 2 illustrates the above portion of the thrombus removal system. [Figure 1C] 2 illustrates the above portion of the thrombus removal system. [Figure 1D] 2 illustrates the above portion of the thrombus removal system. [Figure 1E] 2 illustrates the above portion of the thrombus removal system. [Figure 1F] 2 illustrates the above portion of the thrombus removal system. [Figure 1G] 2 illustrates the above portion of the thrombus removal system. [Figure 1H] 2 illustrates the above portion of the thrombus removal system. [Figure 1I] 2 illustrates the above portion of the thrombus removal system. [Figure 1J] 2 illustrates the above portion of the thrombus removal system. [Figure 1K] 2 illustrates the above portion of the thrombus removal system. [Figure 1L] 2 illustrates the above portion of the thrombus removal system. [Figure 2A] FIG. 2A is a plan view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. [Figure 2B] FIG. 2B is a plan view illustrating the above configuration. [Figure 2C] FIG. 2C is a plan view illustrating the above configuration. [Figure 2D] FIG. 2D is a plan view illustrating the above configuration. [Figure 2E] FIG. 2E is a plan view illustrating the above configuration. [Diagram 3]

[0011] Figure 3A is an elevation view illustrating an irrigation port and fluid flow configuration of a thrombus removal system in accordance with an embodiment of the present technology. Figure 3B is an elevation view illustrating the configuration. Figure 3C is an elevation view illustrating the configuration. Figure 3D is an elevation view illustrating the configuration. Figure 3E is an elevation view illustrating the configuration. Figure 3F is an elevation view illustrating the configuration. Figure 3G is an elevation view illustrating the configuration. Figure 3H is an elevation view illustrating the configuration. [Figure 4A]

[0012] FIG. 1 illustrates an embodiment of a thrombus removal system that includes a saline source, an aspiration system, and one or more controllers that control irrigation and / or aspiration of the system. [Figure 4B] FIG. 2 illustrates an embodiment of the system. [Figure 4C] FIG. 2 illustrates an embodiment of the system. [Figure 4D] FIG. 2 illustrates an embodiment of the system. [Figure 5A] FIG. 5A illustrates one embodiment of a distal portion of an elongate medical device. [Figure 5B] FIG. 5B illustrates the above embodiment. [Figure 6A]

[0014] FIG. 1 illustrates another embodiment of a distal portion of an elongated medical device. [Figure 6B] FIG. 2 is a diagram illustrating the embodiment. [Figure 6C] FIG. 2 is a diagram illustrating the embodiment. [Figure 6D] FIG. 2 is a diagram illustrating the embodiment. [Figure 6E] FIG. 2 is a diagram illustrating the embodiment. [Figure 7A]

[0015] FIG. 1 illustrates another embodiment of a distal portion of an elongated medical device. [Figure 7B] FIG. 2 is a diagram illustrating the embodiment. [Figure 7C] FIG. 2 is a diagram illustrating the embodiment. [Figure 7D] FIG. 2 is a diagram illustrating the embodiment. [Figure 7E] FIG. 2 is a diagram illustrating the embodiment. [Figure 8A] FIG. 8A illustrates one embodiment of a distal portion of an elongate medical device. [Figure 8B] FIG. 8B illustrates the above embodiment. [Figure 8C] FIG. 8C illustrates the above embodiment. [Figure 9A] FIG. 9A illustrates another embodiment of a distal portion of an elongate medical device. [Figure 9B] FIG. 9B illustrates the above embodiment. [Figure 10A] FIG. 10A illustrates one embodiment of a distal end of an elongate medical device that includes a mechanical engagement element configured to function as a cutter. [Figure 10B] FIG. 10B illustrates the above embodiment. [Figure 10C] FIG. 10C illustrates the above embodiment. [Figure 10D] FIG. 10D illustrates the above embodiment. [Figure 11A] FIG. 11A illustrates a variation of a mechanical engagement element that is disposed facing radially inward and actuated via a hinge or pivot region to move in a proximal direction. [Figure 11B] FIG. 11B is a diagram showing the above modification. [Figure 11C] FIG. 11C is a diagram showing the above modification. [Figure 11D] FIG. 11D is a diagram showing the above modification. [Figure 12A] FIG. 12A illustrates a variation of a mechanical engagement element that includes a wire structure adapted to act as a lasso. [Figure 12B] FIG. 12B is a diagram showing the above modification. [Figure 13A] FIG. 13A illustrates an additional embodiment of a mechanical engagement element. [Figure 13B] FIG. 13B illustrates the above embodiment. [Figure 13C] FIG. 13C illustrates the above embodiment. [Figure 13D] FIG. 13D illustrates the above embodiment. [Figure 14A] FIG. 14A illustrates one embodiment of a nested frame approach to the funnel and mechanical engagement elements of a thrombectomy device. [Figure 14B] FIG. 14B illustrates the above embodiment. [Figure 15A] FIG. 15A illustrates an example of an array link including an example layer arrangement of mechanical engagement elements as described herein. [Figure 15B] FIG. 15B is a diagram showing the above example. [Figure 15C] FIG. 15C shows the above example. [Figure 15D] FIG. 15D shows the above example. [Figure 15E] FIG. 15E is a diagram showing the above example. [Figure 15F] FIG. 15F shows the above example. [Figure 16A] FIG. 16A is a diagram illustrating an example orientation and arrangement of a mechanical engagement element array having one or more layers as described herein. [Figure 16B] FIG. 16B is a diagram illustrating the exemplary orientation and configuration. [Figure 16C]FIG. 16C is a diagram illustrating the exemplary orientation and configuration. [Figure 16D] FIG. 16D illustrates the exemplary orientation and configuration. [Figure 16E] FIG. 16E is a diagram illustrating the exemplary orientations and configurations. [Figure 16F] FIG. 16F illustrates the exemplary orientation and configuration. [Figure 16G] FIG. 16G illustrates the exemplary orientation and configuration. [Figure 17A]

[0025] FIG. 17A illustrates an example of a distal end of a thrombectomy device including a funnel, a funnel framework, a framework of mechanical engagement elements, and a mechanical engagement element. [Figure 17B] FIG. 17B is a diagram showing the above example. [Figure 18A] FIG. 1 illustrates one embodiment of a funnel including three mechanical engagement elements. [Figure 18B] FIG. 2 is a diagram illustrating the embodiment. [Figure 18C] FIG. 2 is a diagram illustrating the embodiment. [Figure 18D] FIG. 18B illustrates an embodiment similar to FIG. 18A except for the design of the six mechanical engagement elements. [Figure 18E] FIG. 18C illustrates an embodiment similar to FIG. 18B except for the above design. [Figure 18F] FIG. 18D illustrates an embodiment similar to FIG. 18C except for the above design. [Figure 19A] FIG. 1 is a side view of a thrombus removal device including a sheath or delivery catheter. [Figure 19B]

[0029] A top view of this open configuration includes mechanical engagement elements that rest inside any "pockets" within the flexible material. [Figure 19C]

[0030] FIG. 2 is another side view of the thrombus removal device, in this example showing the sheath advanced distally relative to the thrombus removal device so that the sheath engages or contacts the framework structure of the mechanical engagement element and pushes the structure distally. [Figure 19D]FIG. 3 is a top view of this closed or engaged configuration showing a pocket 30 in the flexible material and a view of the mechanical engagement element being pulled towards the aspiration lumen of the device. [Figure 20A] FIG. 20A illustrates an alternative embodiment in which the mechanical engagement elements are concealed by a flexible material when in the open configuration. [Figure 20B] FIG. 20B illustrates the above embodiment. [Figure 20C] FIG. 20C illustrates the above embodiment. [Figure 21] 1 is a flow chart illustrating a method for assessing the volume of clot removed during treatment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0097] Detailed Description

[0186] This application is related to the disclosures in International Application No. PCT / US2021 / 020915, filed March 4, 2021 (the '915 application), and International Application No. PCT / US2022 / 033024, filed June 10, 2022 (the '024 application), the disclosures of which are incorporated herein by reference for all purposes. The '915 and '024 applications describe general mechanisms for capturing and removing blood clots. For example, multiple fluid streams are directed toward the clot to fragment the material.

[0098]

[0187] The present technology is generally directed to clot removal systems and associated methods. A system configured according to an embodiment of the present technology can include, for example, an elongate catheter having a distal portion configured to be positioned within a patient's blood vessel, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the clot with pressurized fluid, an aspiration mechanism configured to aspirate the clot fragments, and one or more lumens extending at least partially from the proximal portion to the distal portion.

[0099]

[0188] The terms used in the description presented below are intended to be interpreted in the broadest possible manner, even when used in conjunction with a detailed description of certain specific embodiments of the present technology. Although certain terms may be emphasized below, any terms intended to be interpreted in some limited manner are clearly and specifically defined in the Detailed Description section of this invention. In addition, the present technology can include other embodiments that are within the scope of the examples but are not described in detail in connection with the figures.

[0100]

[0189] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the technology. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0101]

[0190] Throughout this specification, references to relative terms such as, for example, "substantially," "approximately," and "about" are used herein to mean plus or minus 10% of the stated value.

[0102]

[0191] Although some embodiments herein are described in the context of thrombus removal, it is recognized that the technology can be used and / or modified to remove other types of emboli that may occlude blood vessels, such as fat, tissue, or foreign bodies. In addition, although some embodiments herein are described in the context of thrombus removal from the pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to the removal of thrombi and / or emboli from other parts of the vascular system (e.g., neurovascular, coronary, intraventricular, or peripheral applications of the heart). Also, although some embodiments are discussed in the context of macerating the thrombus with a fluid, the technology can be adapted to be used with other techniques (e.g., ultrasound, mechanical, enzymatic, etc.) for fragmenting the thrombus into smaller fragments or particles.

[0103]

[0192] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed technology.

[0193] System for thrombus removal

[0194] As presented above, the present technology is generally directed to a clot removal system. Such a system includes an elongated catheter having a distal portion positionable within a patient's blood vessel (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the clot with pressurized fluid, an aspiration mechanism configured to aspirate the clot fragments, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the system herein is configured to engage a clot within a patient's blood vessel, fragment the clot into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid stream (e.g., jet) functions to cut or macerate the clot before, during, and / or after at least a portion of the clot enters the aspiration lumen or funnel of the system. Fragmentation helps prevent clogging of the aspiration lumen, and fragmentation allows the clot removal system to macerate large, hard clots that could not otherwise be aspirated. As used herein, "thrombus" and "embolism" are used somewhat interchangeably in various respects. Typically, a thrombus is a portion of clotted blood that has stopped moving through the vascular system and has become lodged or stuck, whereas an embolus is a portion of clotted blood that has moved through the vascular system and ultimately become a thrombus, and may further become a larger thrombus by collecting other emboli or blood clots on the thrombus.

[0104]

[0195] It should be appreciated that although the description may refer to the removal of a "thrombus," this should be understood to encompass the removal of thrombus fragments and other emboli as provided herein.

[0105]

[0196] According to embodiments of the present technology, a fluid delivery mechanism can provide multiple fluid streams (e.g., jets) to the fluid opening of the thrombus removal system to macerate, cut, fragment, pulverize and / or urge the thrombus to be removed from the proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen that extends at least partially from the proximal portion to the distal portion of the thrombus removal system adapted for fluid communication with an aspiration pump (e.g., a vacuum source). In operation, the aspiration pump can generate a volume of lower pressure in the aspiration lumen near the proximal portion of the thrombus removal system to urge the aspiration of the thrombus from the distal portion to the proximal portion.

[0106]

[0197] FIG. 1 illustrates a distal portion 10 of a thrombus removal system according to an embodiment of the present technology. Section AA of FIG. 1A illustrates an elevational cross-sectional view of the distal portion. The exemplary section AA of FIG. 1A depicts a funnel 20 positioned at the distal end of the distal portion 10, adapted to engage a thrombus and / or a tissue (e.g., blood vessel) wall to aid in the collection, fragmentation, and / or removal of the thrombus. The funnel can have a variety of shapes and constructions, as would be understood by one of ordinary skill in the art from the description herein. The exemplary section AA of FIG. 1A depicts a dual-walled thrombus removal device construction having an outer wall / tube 40 and an inner wall / tube 50. A suction lumen 55 is formed by the inner wall 50 and is centrally located. A substantially annular volume forms at least one fluid lumen 45 between the outer wall 40 and the inner wall 50. The fluid lumen 45 is adapted for fluid communication with a fluid delivery mechanism. One or more openings (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombus removal system such that they are in fluid communication with the fluid lumen 45 and the irrigation manifold 25. In operation, the ports 30 are adapted to direct (e.g., be pressurized) fluid toward a thrombus engaged with the distal portion 10 of the thrombus removal system.

[0107]

[0198] In various embodiments, the system can have an average flow velocity in the fluid lumen of up to 20 m / s to achieve consistent and successful aspiration of the clot. In some embodiments, the fluid source itself can deliver fluid to the jet in a pre-programmed sequence, including a pulsed sequence or some combination of pulsatile and constant flow. In these embodiments, the average pulsed fluid velocity can be up to 20 m / s, but the peak fluid velocity in the lumen can be up to 30 m / s or more during the pulsation of the fluid source. In some embodiments, the jet or opening has an opening size of 0.005 inches to 0.020 inches to avoid undesirable spraying of the fluid. In some embodiments, the system can have a minimum vacuum or aspiration pressure of 15 inHg to remove the target clot after it has been macerated or comminuted at said jet.

[0108]

[0199] The thrombus removal system can be sized and configured to access and remove thrombus in various locations or vessels within a patient's body. The dimensions of the system may vary depending on the target location, but it should be understood that generally similar features and components described herein may be implemented in a thrombus removal system regardless of application. For example, a thrombus removal system configured to remove a pulmonary embolism (PE) from a patient may have an outer wall / tube sized approximately 3.7-4.3 mm (11-13 Fr), or preferably 4.0 mm (12 Fr), and an inner wall / tube sized approximately 2.3-3.0 mm (7-9 Fr), or preferably 2.7 mm (8 Fr). Meanwhile, deep vein thrombosis (DVT) devices may have an outer wall / tube size of approximately 3.0-3.7 mm (9-11 Fr), or preferably 3.3 mm (10 Fr), and an inner wall / tube size of 2.0-3.0 mm (6-9 Fr), or preferably 2.5 mm (7.5 Fr). Further applications are provided for ischemic stroke and peripheral embolism applications.

[0109]

[0200] Section BB in FIG. 1B illustrates in plan view a portion of the thrombus removal system proximal to the infundibulum and irrigation manifold. Section BB depicts outer wall 140, inner wall 150, aspiration lumen 155, and fluid lumen 145. In some embodiments, in cross section, aspiration lumen 155 is substantially circular and fluid lumen 145 is substantially toroidal shaped (e.g., cross section 70). It will be appreciated that alternative constructions and / or arrangements of inner wall 150 and outer wall 140 will produce variations in the cross-sectional shapes of aspiration lumen 155 and fluid lumen 145. For example, inner wall 150 can be shaped to form aspiration lumen 155 that is substantially elliptical, circular, rectilinear, rectangular, pentagonal, or hexagonal in cross section. Inner wall 150 and outer wall 140 can be shaped and arranged to form fluid lumen 145 that is generally crescent-shaped, diamond-shaped, or irregular in cross section. For example, with reference to cross-section BB in Figure 1C, the region between inner wall 150 and outer wall 140 can include one or more wall structures 165 (e.g., as in cross-section 80) that form respective fluid lumens 145. Wall structures 165 can be formed by lamination between outer wall 140 and inner wall 150, or by extrusion of multiple lumens forming multiple wall structures.

[0110]

[0201] Sections BB in Figures 1D-1H show additional examples of portions of the thrombus removal system that are proximal to the infundibulum and irrigation manifold. Similar to the embodiments described above, the portions in these examples can include an outer wall 140, an inner wall 150, and an aspiration lumen 155. In addition, the illustrated portions of the thrombus removal system can include an intermediate wall 170 disposed between the outer wall 140 and the inner wall 150. The intermediate wall 170 allows for the annular space between the inner and outer walls to be further divided into multiple different fluid lumens and / or auxiliary lumens. For example, referring to Figure 1D, the intermediate wall can be substantially hexagonal in shape, and the annular space can include multiple fluid lumens 145a-141 and multiple auxiliary lumens 175a-175f. As shown in Figure 1D, the fluid lumens can be formed by any combination of the outer wall 140 and the intermediate wall 170, or between the intermediate wall 170, the inner wall 150, and two auxiliary lumens. For example, fluid lumen 145a is formed in the space between outer wall 140 and intermediate wall 170. However, fluid lumen 145g is formed in the space between intermediate wall 170, inner wall 150, auxiliary lumen 175a, and auxiliary lumen 175b. In general, the fluid lumens are configured to carry a flow of fluid, such as saline, from a saline source of the system to one or more ports / openings / orifices of the system. The auxiliary lumens can be configured for multiple functions. In some embodiments, the auxiliary lumens can be coupled to a fluid / saline source and an opening used as an additional fluid lumen. In other embodiments, the auxiliary lumens can be configured as steering ports and can include guidewires or steering wires within the lumen for steering the thrombus removal system. Additionally, in other embodiments, the auxiliary lumens can be configured to carry electrical, mechanical, or fluid connections to one or more sensors. For example, the system may include one or more electrical, optical, or fluid-based sensors disposed along any length of the system. The sensors can be used to provide feedback to the system during therapy (e.g., sensors can be used to detect clogs and initiate a clog removal protocol, or determine the appropriate therapy mode based on sensor feedback such as sequence of injection pulses, sequence of suction, and / or proper functioning of the system).Thus, the auxiliary port can be used to connect to sensors, for example, via electrical, optical, mechanical / wire, and / or fluid connections. It is also envisioned that the fluid and auxiliary lumens can be configured to carry and deliver other fluids, such as thrombolytic drugs or radiopaque contrast injections, to the target tissue site during treatment.

[0111]

[0202] It should be understood that in some embodiments, all fluid lumens are fluidly connected to all of the jets or openings of the thrombus removal device. Thus, when a flow of fluid is delivered from the fluid lumen(s) to the jets, all of the jets are actuated at once with a fluid jet. However, it should also be understood that in some embodiments, the fluid lumens are separate or different, and these different fluid lumens may be fluidly coupled to one or more jets, but not to all of the jets of the device. In these embodiments, a subset of the jets can be controlled by delivering fluid only to the fluid lumens that are coupled to the subset of jets. This allows for additional functionality of the device where designated jets can be actuated in a user-defined or pre-determined order.

[0112]

[0203] In various embodiments, the fluid pressure is generated by a pump (either at the console or handle). The fluid is accelerated as it exits through a port at the distal end and is directed towards the target clot. In this way, a wider variety of cost-effective components can be used to form the catheter while still maintaining a highly effective device for clot removal. As described in more detail below.

[0113]

[0204] Section BB of FIG. 1E illustrates another embodiment of the portion of the thrombus removal system that is proximal to the infundibulum and irrigation manifold. Similar to the embodiment of FIG. 1D, this embodiment also includes an intermediate wall 170. However, the intermediate wall in this example is substantially rectangular, facilitating the formation of fluid lumens 145a-145k and auxiliary lumens 175a-175d. The example shown in section BB of FIG. 1F is similar to the example of the embodiment of FIG. 1E, but this embodiment includes only fluid lumens 145a-145d. Fluid lumens 145e-145k from the embodiment of FIG. 1E are not used as fluid lumens in this embodiment. They can be lumens that are, for example, empty, evacuated, filled with insulating material, and / or filled with radiopaque material or any other material that may be useful for visualizing the thrombus removal system during therapy. Embodiment 1F includes the same four auxiliary ports as illustrated and described in the embodiment of FIG. 1E.

[0114]

[0205] Section BB of FIG. 1G illustrates another example of a portion of the thrombus removal system that is proximal to the infundibulum and irrigation manifold. As with the embodiment described above, the illustrated portion of the thrombus removal system can include an intermediate wall 170 disposed between the outer wall 140 and the inner wall 150. However, this embodiment includes four distinct fluid lumens 145a-d formed by a wall structure 165. As with the embodiment of FIG. 1C, the wall structure 165 can be formed by lamination between the outer wall 140 and the inner wall 150 or by extrusion of multiple lumens forming multiple wall structures. As shown, this embodiment can include a pair of auxiliary lumens 175a and 175b, which can be used, for example, for steering or sensor connection as described above.

[0115]

[0206] Section BB in FIG. 1H is another similar embodiment in which a middle wall and an outer wall can be used to form fluid lumens 145a and 145b. Auxiliary lumens 175a and 175b can be formed in the space between the middle wall and the inner wall. It should be understood that the middle wall can contact the outer wall to create independent fluid lumens 145a and 145b. However, it should be understood that in other embodiments, the middle wall may not contact the outer wall, which would facilitate a single annular fluid lumen as shown by fluid lumen 145 in section BB in FIG. 1I. In another embodiment, as shown in section BB in FIG. 1J, inner wall 150 and outer wall 140 may not be concentric, which would facilitate the formation of a thicker or wider annular space and / or fluid lumen 145 on one side of the device relative to the other side. As shown in FIG. 1J, the distance between the exemplary outer wall 140 and the inner wall at the top (e.g., 12 o'clock) portion of the device is greater than the distance between the outer wall and the inner wall at the bottom (e.g., 6 o'clock) portion of the device.

[0116]

[0207] 1K illustrates in plan view a portion of the thrombus removal system including the irrigation manifold 225. View CC depicts an outer wall 240, an inner wall 250, a fluid lumen 245, an aspiration lumen 255, and ports 230 for directing the respective fluid flows 210.

[0117]

[0208] Detail view 101 of FIG. 1L illustrates an elevational cross-sectional view of a portion of irrigation manifold 25 including a plurality of ports 230 formed in inner wall 250. In some embodiments, the thickness of one or more walls of the thrombus removal system may vary along its axial length and / or its circumference. As shown in detail view 101, inner wall 250 has a first thickness 265 in a region 250 that is proximal to irrigation manifold 25 and a second thickness 270 in a region 235 that includes ports 230. In some embodiments, second thickness 270 is greater than first thickness 265. First thickness 265 can correspond to the overall wall thickness of inner wall 50 and / or outer wall 40, which can be about 0.10 mm to about 0.60 mm, or any value within the aforementioned range. The second thickness 270 can be about 0.20 mm to about 0.70 mm, about 0.70 mm to about 0.90 mm, or about 0.90 mm to about 1.20 mm. The second thickness 270 can be any value within the aforementioned ranges. The dimensions of the second thickness 270 can be selected to provide a fluid path through the port 230 that generates a substantially laminar flow for the fluid flow directed therethrough when the fluid delivery mechanism delivers fluid through the fluid lumen 245 at a typical operating pressure. Such operating pressures can be about 10 psi to about 60 psi, about 60 psi to about 100 psi, or about 100 psi to about 150 psi. The operating pressure of the fluid delivery mechanism can be any value within the aforementioned ranges of values. In some embodiments, the fluid delivery mechanism operates in a high pressure mode having a pressure of about 150 psi to about 250 psi, about 250 psi to about 350 psi, about 350 psi to about 425 psi, or about 425 psi to about 500 psi, or up to 1,000 psi. The operating pressure of the fluid delivery mechanism in the high pressure mode can be any value within the aforementioned range of values.

[0118]

[0209] The manifold is configured to increase the fluid pressure and / or flow rate of the fluid. When the fluid is delivered to the fluid lumen(s) by the fluid delivery mechanism at a first pressure and / or a first flow rate, the manifold is configured to increase the pressure of the fluid to a second pressure and / or increase the flow rate of the fluid to a second flow rate. The second pressure and / or the second flow rate can be higher than the first pressure and / or the first flow rate. As a result, the manifold can be configured to increase a relatively low operating pressure and / or flow rate generated by the fluid delivery mechanism to a relatively high pressure and / or high flow rate generated by the port / fluid stream.

[0119]

[0210] In some embodiments, the profile (cross-sectional dimension) of port 230 varies along its length (e.g., is non-cylindrical). Variation in the cross-sectional dimension of the port can modify and / or adjust the characteristics of the fluid flow along port 230. For example, a reduction in the cross-sectional dimension can accelerate the fluid flow through port 230 (for a given volume of fluid). In some embodiments, port 230 can be conical (e.g., tapered) along its length such that its smallest dimension is located at the distal end of port 230, distal relative to the direction of fluid flow.

[0120]

[0211] In some embodiments, the ports 230 are configured to direct the fluid flow along a selected path. FIGS. 2A-2E illustrate various embodiments of arrangements of the ports 230 for directing the respective fluid streams 210. In some embodiments, such as those shown in FIGS. 2A and 2B, at least two ports 230 are arranged to generate (e.g., respective) fluid streams 210 that intersect at an intersection region 237 of the clot removal system. The intersection region 237 can be a region of increased fluid momentum, turbulence, shear, and / or energy transfer relative to the individual fluid streams that are not directed to combine at the intersection. The increased fluid momentum and / or energy transfer at the intersection can advantageously fragment the clot more efficiently and / or quickly. As described above, the fluid streams can be configured to accelerate and cause cavitation and / or other effects to further promote fragmentation of the target clot. In some embodiments, the intersection region can be formed from at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, or at least 10 fluid streams 210. The intersection region can be substantially near (e.g., 237) or away from (e.g., 238 and 239 in the embodiment of FIG. 2D) the central axis 290 of the thrombus removal system. In some embodiments, at least two intersection regions (e.g., 238 and 239) are formed. In some embodiments, one or more ports 230 are positioned to direct the fluid stream 210 along an oblique angle relative to the central axis of the thrombus removal system. The operating pressure of the fluid delivery mechanism may be selected to approach a minimum target fluid velocity for the fluid stream 210 delivered from the port 230. The target fluid velocity of the fluid stream 210 can be about 5 meters per second (m / s), about 8 m / s, about 10 m / s, about 12 m / s, or about 15 m / s. Additionally, the target fluid velocity in some embodiments can range from greater than 15 m / s up to 150 m / s. At these higher velocities (e.g., greater than about 15 m / s, or greater than 20 m / s), the fluid stream may be configured to generate cavitation in the targeted thrombus or tissue.It has been found that when fluid exits the ports at these flow rates, it can produce a cavitation effect at the focal area of ​​the intersecting or impinging fluid streams, or at the boundaries of one or more of the fluid streams in addition. The exact specifications may vary based on the size of the catheter, but in general, at least one of the fluid streams should be accelerated to such a high velocity to produce cavitation, as described in detail below. The target fluid velocity of the fluid stream 210 can be any value within the range of values ​​mentioned above. In some embodiments, the at least two ports 230 are adapted to deliver the respective fluid streams at different fluid velocities (i.e., speed and direction) for a given pressure of the fluid delivery mechanism. In some embodiments, the at least two ports 230 are adapted to deliver the respective fluid streams at substantially the same fluid velocity for a given pressure of the fluid delivery mechanism. In some embodiments, one port is adapted to deliver the fluid at a high velocity, and each one or more other ports are adapted to deliver the fluid at a relatively low velocity. Advantageously, the increased cross-sectional area of ​​the fluid lumen 145 reduces the required operating pressure of the fluid delivery mechanism to achieve a target fluid velocity of the fluid flow.

[0121]

[0212] In some embodiments, the fluid streams are configured to create angular momentum that is imparted to the clot. In some instances, angular momentum is imparted to the clot by application of a) at least one fluid stream 210 directed at an oblique angle from the port 230, and / or b) at least two fluid streams 210 having different fluid velocities. For example, fluid streams that pass close to, but do not necessarily intersect each other, may create a "swirl" or rotational energy in the clot material. Advantageously, the angular momentum created in the clot may impart a force (e.g., centrifugal force) that aids in the fragmentation and removal of the clot. Rotating the clot may facilitate delivery of the clot material to the jet. For example, in a large, amorphous clot, the soft material may be easily sucked or fragmented by the fluid stream, whereas the hard fibrin may be located away from the fluid stream. Rotating or swirling the clot moves the material around and delivers the harder clot material to the jet. Swirling may also slam the clot against the inside of the infundibulum for further fragmentation.

[0122]

[0213] 3A-3H depict various configurations of fluid streams 410 directed from respective ports 430. The fluid streams 410 can be directed along paths that are substantially orthogonal, proximal, and / or distal to the flow axis 405 (similar to the flow axis 305). In some embodiments, at least two fluid streams are directed in different directions relative to the flow axis 405. In some embodiments, at least two fluid streams are directed in the same direction (e.g., proximal) relative to the flow axis 405. In some embodiments, at least a first fluid stream is directed orthogonally, at least a second fluid stream is directed proximally, and at least a third fluid stream is directed distally relative to the flow axis 405. Angle α may characterize the angle at which the fluid streams 410 are directed relative to an axis orthogonal to the flow axis 405 (e.g., as shown in cross-sections DD of FIGS. 3G and 3H ). The fluid flow intersection region can be within an interior portion of the thrombus removal system and / or external (e.g., distal) to the thrombus removal system. In some embodiments, the fluid flow that is directed in a nominal direction (e.g., distal) by the port 430 is deflected along an altered path (e.g., proximally) by the (e.g., suction) pressure generated by the suction mechanism during operation.

[0123]

[0214] 4A-4D illustrate various configurations of a clot removal system 600 including a clot removal device 602, a vacuum source and canister 604, and a fluid source 606. In some embodiments, the vacuum source and canister and the fluid source are housed in a console unit that is removably connected to the clot removal device. A fluid pump can be housed in the console or in the handle of the device. The console can include one or more CPUs, electronic controllers, or microcontrollers configured to control all functions of the system. The clot removal device 602 can include a funnel 608, a flexible shaft 610, a handle 612, and one or more controllers 614 and 616. For example, in the embodiment shown in FIG. 4A, the device can include a finger switch or trigger 614 and a foot pedal or switch 616, which can be used to control aspiration and irrigation, respectively. Alternatively, as shown in the embodiment of FIG. 4B, the device can include only a foot switch 616 that can be used to control both functions, or in FIG. 4C, the device can include only a footstool 616 that is also used to control both functions. It is also envisioned that embodiments can include only a finger switch for controlling both the aspiration and irrigation functions. As shown in FIG. 4A, a vacuum source can be coupled to the aspiration lumen of the device with a vacuum line 618. Any blood clots or other debris removed from the patient during therapy can be stored in a vacuum canister 604. Similarly, a fluid source (e.g., a saline bag) can be coupled to the fluid lumen of the device with a fluid line 620.

[0124]

[0215] Still referring to FIG. 4A, electronics lines 622 can couple any electronics / sensors etc. from the device to the system console / controller. The system console including the CPUs / electronic controllers can be configured to monitor fluid and pressure levels and adjust automatically or in real time as needed. In some embodiments, the CPUs / electronic controllers are configured to control vacuum and irrigation as well as electromechanically stop and start both systems in response to sensor data such as pressure data, flow data etc.

[0125]

[0216] As mentioned above, suction occurs down a central lumen of the device and is provided by a vacuum pump in the console, which may include a container to collect any clots or debris that is removed from the patient.

[0126]

[0217] 4D is a close-up view of a console of a clot removal system that can include a vacuum source and canister 604 and a fluid source 606. In some embodiments, the canister 604 and / or the fluid source 606 can include features designed and configured to aid in determining or estimating the progress of therapy, including determining or estimating the amount (e.g., volume) or percentage of clot removed. Additionally, the canister 604 and / or the fluid source 606 can include features designed and configured to aid in determining the amount of fluid (e.g., jet) delivered to the patient and / or the amount of blood removed or aspirated from the patient.

[0127]

[0218] 4D, the canister 604 can include a sensor 607. In one embodiment, the sensor 607 can include one or more weigh scales configured to measure or sense the weight of the fluid and biological material inside the canister. The weigh scale(s) can be zeroed prior to therapy and can provide a real-time gravimetric measurement of the amount of fluid and / or biological material removed or aspirated from the patient during the clot removal procedure.

[0128]

[0219] In some embodiments, the canister itself can include a drain sized or with a filter configured to allow fluid (such as blood and / or saline) to be drained from the canister while preventing clot material or other biological tissue from being drained from the canister. In this way, the canister and weighing scale(s) can only measure the weight of the removed clot, and not the blood and / or saline. Optionally, the blood and other fluids, such as saline, can be drained into a separate canister (not shown) and then used to determine the amount of blood removed from the patient in addition to the amount of clot removed. In one example, the fluid source 606 can also include a sensor 609 that can be used to track the amount of fluid or saline delivered to the patient by the injection. The sensor 609 can include, for example, an additional weighing scale, or optionally any other sensor configured to measure the flow of fluid, such as a flow sensor. The fluid delivered by the fluid source 606 can be measured by the sensor 609 and subtracted from the fluid drained into the separate (not shown) canister. Thus, the amount of clot can be determined by weighing scale 607 in canister 604, and the amount of blood can be calculated in a separate container by subtracting the volume collected from the amount of saline delivered.

[0129]

[0220] In another embodiment, the sensor 607 on or in the canister 604 can include a camera. In some embodiments, the camera can include a miniature camera or a fiber optic camera. In some examples, the camera can be configured to take real-time images of the canister to provide a visual guide to the user as to what is being aspirated from the patient. For example, the user can visualize the amount and / or size of the clot being removed. Images from the camera can be displayed to the user, such as on a display that provides additional information regarding the status of the system, the device, and the procedure.

[0130]

[0221] In other embodiments, the sensor 607 on or in the canister 604 can include other types of sensors, such as optical sensors, flow sensors, etc. In general, sensors can be used to monitor or characterize the amount and / or type of substance or fluid entering the canister to provide additional information to the user regarding the status of the therapy.

[0131]

[0222] A mechanical manipulation feature (e.g., a grabber arm) for engagement with tissue or material at the distal end of the device.

[0223] Some embodiments of the clot removal device may include features that allow for mechanical manipulation or engagement with tissue or material at the distal end of the device. These features may be referred to herein as mechanical engagement elements, grabber arms, fangs, mechanical manipulation arms, mechanical cutting arms, and the like. The grabber arms are generally designed and configured to engage the clot and draw it into the distal end of the device (e.g., the infundibulum and / or aspiration lumen). In various examples, the mechanical engagement elements disclosed herein are configured to achieve some combination of drawing the clot into the infundibulum, drawing the clot into a jet surface, drawing the clot into the aspiration lumen, and / or fragmenting or cutting the clot pieces into pieces small enough to be aspirated through the aspiration lumen. Although the clot removal systems described herein generally include an aspiration lumen and one or more fluid streams or jets, it should be understood that the grabber arms may be implemented in devices without an aspiration lumen or without one or more fluid streams or jets. Additionally, the devices described herein generally include an expandable funnel at the distal end of the device, however, it should be understood that some embodiments having a mechanical engagement element may not include an expandable funnel, but may instead include some other structure at or near the distal end of the device.

[0132]

[0224] The mechanical engagement element can include an arrangement of fangs, arms, or actuatable members positionable at the distal end of a device, such as a thrombus removal device. In some embodiments, the mechanical engagement element is positioned within the distal end of the device (e.g., within the infundibulum of the device), while other embodiments contemplate positioning the mechanical engagement element outside the distal end (e.g., the infundibulum) or within the aspiration lumen of the device.

[0133]

[0225] The mechanical engagement elements described herein do not include any components that extend distally beyond the distal end of the expandable member or infundibulum. Generally, all actuation or movement of the mechanical engagement elements occurs within the confines of the expandable member or infundibulum. In some embodiments, the mechanical engagement elements may include cutting or serrated edges, sharp tips, or shearing / pinching mechanisms of action on the target clot or tissue. Maintaining the entirety of the mechanical engagement elements within the infundibulum or expandable member improves patient safety and prevents inadvertent damage, cutting, or penetration of sensitive tissues such as vessel walls.

[0134]

[0226] The mechanical engagement elements described herein may generally include an at-rest state in which the mechanical engagement element is generally not occluding the central or aspiration lumen of the device (e.g., near, adjacent to, or resting against an inner wall of the expandable member or funnel). The mechanical engagement element may also include an actuated or closed state in which the mechanical engagement element is manipulated to move either axially and / or radially toward the central or aspiration lumen of the device. However, in some embodiments, the rest state includes the engagement member extending into the expandable member or funnel, and an actuated state in which the engagement member is close to, resting against, or in contact with the funnel or expandable member. In some embodiments, this manipulation moves the mechanical engagement element axially toward the central or aspiration lumen, and in other embodiments, manipulation moves the mechanical engagement element radially across the expandable member or funnel toward or across the central axis of the opening.

[0135]

[0227] Generally, actuation or manipulation of the mechanical engagement element results in movement along a pivot axis within the expandable member or funnel. The pivot axis provides an inflection point between the mechanical engagement element and the actuation member (e.g., puller wire, outer sheath, etc.). Although this disclosure has discussed movement of the mechanical engagement element as being either axial (e.g., distal to proximal) or radial (e.g., across the funnel or expandable member), it should be understood that because the mechanical engagement elements of this disclosure typically move along a pivot axis, the movement characteristics may be more complex (e.g., the mechanical engagement element may first swing radially toward the center of the expandable member or funnel, and then swing more axially toward the opening or aspiration lumen of the device).

[0136]

[0228] The mechanical engagement elements described herein are also typically oriented or pointed inwardly toward the central axis of the device (as opposed to pointing outwardly toward the vessel wall).

[0229] 5A-5B show top and side views, respectively, of one embodiment of a distal end 21 of the device that may include additional features for delivery and therapy. In the illustrated embodiment, the distal end 21 may include a frame 2200 that includes a plurality of petals that may include an outer frame 2202 and an inner frame 2204. In the illustrated embodiment, the distal end frame is shown having a total of six petals, but it should be understood that in other embodiments any number of petals may be implemented, including 2, 3, 4, 5, 6, 7, 8, 9, 10 or more petals. Also, while the petals and petal features are described independently herein, it should be understood that in some embodiments the frame is a one-piece design in which the entire structure including the plurality of petals is typically a one-piece structure and manufactured from a single piece of metal (e.g., the entire pattern is laser cut from a single piece of Nitinol or other suitable metal or material). The distal end frame structure after cutting and shaping can be a single piece of material (eg, Nitinol).

[0137]

[0230] 5A-5B, the frame can further include one or more mechanical engagement elements 2206 disposed near or adjacent the opening 2208 at the distal end. The mechanical engagement elements can face substantially inwardly (e.g., facing inwardly toward a central axis of the device). In some embodiments of the device (e.g., where the device is a thrombectomy removal device), the opening 2208 can coincide with an aspiration lumen of the device. As described in more detail below, the mechanical engagement elements can be manipulated or actuated such that a distal tip 2210 of the mechanical engagement element 2206 moves or rotates axially toward or away from the opening 2208.

[0138]

[0231] 5A-5B can be manually operated or actuated by a user of the device, such as by engaging with a pull wire or sliding / rotating an outer sheath over the device. In other embodiments, actuation or operation can be automated, such as by coupling the engagement element to a motor configured to actuate a pull wire or translate / rotate the outer sheath. The motor can be controlled by the user, such as by interacting with a user input device (button, lever, switch, trigger, etc.) on the handle or console of the device.

[0139]

[0232] 6A-6E illustrate the relative motion of the distal tip 2210 of the mechanical engagement element 2206 as it rotates towards the opening 2208. With reference to FIG. 6A, the funnel or expandable member is fully expanded, in which configuration the mechanical engagement element 2206 extends axially completely away from the opening 2208. In this configuration, the delivery sleeve 2212 is pulled proximally away from the distal end so as not to exert forward / distal pressure on the distal end, allowing the distal end to fully expand. Alternatively, the distal end may be pushed out of the delivery sheath.

[0140]

[0233] With reference to FIG. 6B, the delivery sleeve can be advanced slightly to apply pressure to or contact a portion of the distal end, including a portion of the outer frame (2202 in FIG. 5A) and / or inner frame (2204 in FIG. 5A). In some embodiments, the delivery sleeve can be manually operated or advanced, such as by a user of the device. In other embodiments, the delivery sleeve can be automatically actuated or operated, such as by a motor or other mechanical device. In further embodiments, the delivery sleeve can be rapidly actuated back and forth along the axis of the device. As the delivery sheath moves distally relative to the expanding funnel (e.g., relative to the expanding funnel), the inner frame and mechanical engagement elements and distal tip move or rotate substantially proximally in a direction toward the opening or aspiration lumen of the device. Note that in this embodiment, the mechanical engagement elements have a rest state in which they extend outward and into the funnel or expandable device. Actuating these mechanical engagement elements not only moves them proximally toward the opening, but also brings them closer to or into contact with the inner wall of the funnel or expandable member, thereby opening or unblocking the funnel. It should be noted that other embodiments described herein include the opposite configuration (i.e., in the resting state, the mechanical engagement element is positioned out of the way of the funnel, and in the actuated state, the mechanical engagement element extends into the funnel or expandable member).

[0141]

[0234] Each subsequent view of FIG. 6C, FIG. 6D, and FIG. 6E shows the delivery sleeve advanced slightly more distally over the distal end, with the distal tip and mechanical engagement element of the distal end moving or rotating proximally towards the opening and / or aspiration lumen of the device. It should be understood that the design of the distal end, including the inner and outer frames, allows the mechanical engagement element to be manipulated with the delivery sleeve while maintaining full expansion (or near full expansion) of the distal end / infundibulum. For example, the inner frame can be coupled to the mechanical engagement element, and as the delivery sleeve is advanced over the infundibulum, the inner frame can be designed to contact the sleeve and move the mechanical engagement element, while at the same time the outer frame can still maintain full expansion of the device so that it can fully contact the lumen or vessel. Note that the mechanical engagement element in FIG. 6A-FIG. 6E does not extend past the distal end of the expandable member or infundibulum (e.g., past the outer frame 2202). Thus, the outer frame or funnel / expandable member protects the outer tissue (e.g., blood vessel wall) from movement / rotation and actuation of the mechanical engagement elements, which can only interact with the target clot captured by the funnel / expandable member.

[0142]

[0235] 7A-7E illustrate the concept of actuating or manipulating the mechanical engagement element by contacting a selected portion of the distal end / funnel / frame with a delivery sleeve. With reference to FIG. 7A, a single petal 2200 is shown with its distal end not contacting the delivery sleeve. In this example, the distal end can be in its fully expanded configuration and the mechanical engagement element 2206 is moved completely axially away (or distal) from the opening or aspiration lumen of the device (not shown). With reference to FIG. 7B, a delivery sheath (not shown for illustrative purposes) is advanced distally over the device to contact the distal end at location 2214a. In one embodiment, the sheath is configured to contact only the inner frame 2204 of the distal end, which causes the mechanical engagement element 2206 to move or rotate toward the opening or aspiration lumen (or proximally relative to the position of the mechanical engagement element in FIG. 7A). FIG. 7C shows that the delivery sheath is advanced further distally to location 2214b, causing the mechanical engagement element to move or rotate closer to the opening (e.g., axially proximally relative to the device). Similarly, in FIG. 7D and FIG. 7E, the sheath is advanced further to locations 2214c and 2214d, respectively, causing further rotation / deflection / movement of the mechanical engagement element. As the sheath is moved past locations 2214a, b, c, and d, the tip of the engagement element 2206 begins to roll out of the fluid path. This results, in part, from interaction with the inner frame 2204. In the embodiment of FIG. 7E, it can be seen that the delivery sheath begins to contact the outer frame, which may cause some contraction or collapse of the distal end. In this embodiment, the distal end may be folded to such an extent that it does not fully contact the vessel wall. Typically, it is desirable not to collapse the infundibulum, so the user or system can be careful not to advance the sheath so far as to contact or compress the outer frame. In some embodiments, the device can include a stop limiter configured to prevent the sheath from collapsing or compressing the expandable member or infundibulum.

[0143]

[0236] The ability to manipulate the mechanical engagement elements provides additional functionality to medical devices such as thrombectomy removal devices during therapy. For example, in some embodiments, the mechanical engagement element(s) can be designed and configured to engage the clot in the infundibulum. In some embodiments, this physical or mechanical interaction with the clot can be leveraged to physically pull or move the clot into contact with the device. Depending on the configuration of the device (e.g., infundibulum, aspiration lumen, one or more jets, etc.), the mechanical engagement elements can be used to 1) pull the clot into contact with the jets or into the plane of the jets to fragment the clot and aspirate the clot, 2) pull the clot into or toward the aspiration lumen, and / or 3) prevent the clot from exiting the distal end or infundibulum of the device. The combination of the mechanical engagement elements, jets, and aspiration allows for clot removal functionality not previously achieved with other devices. This combination can also cut or help cut the clot while pushing it into the aspiration lumen or jetting surface.

[0144]

[0237] 8A-8C illustrate another embodiment of the distal end 21. This distal end frame design can still include a petal-shaped frame 2200 including an outer frame 2202 and an inner frame 2204. This embodiment is illustrated without the mechanical engagement elements previously described, but it should be understood that the variants can include one or more mechanical engagement elements. However, with reference to FIGS. 8B and 8C, alternating frame petals at the distal end can include different side profiles (contours) to customize how the funnel interacts with the delivery sheath. For example, with reference to FIG. 8B, it can be seen that the outermost side profile of the outer and inner frames, represented by reference numeral 2216, exhibits a substantially linear or straight profile. In contrast, the outermost side profile of the outer and inner frames in FIG. 8C, represented by reference numeral 2218, includes a slightly curved or bent profile. For illustrative purposes, returning to FIG. 8A, the edges of the petals or frames having a flat profile as shown in FIG. 8B can be represented by a (-) symbol, and the edges of the petals having a curved or bent profile as shown in FIG. 8C can be represented by a (+) symbol. In FIG. 8A, it can be seen that alternating petal edges can have alternating (+) and (-) side profiles. In this way, the work required to advance the delivery sheath over the funnel can be reduced. More specifically, if half of the petal edges have a (+) profile and half of the petal edges have a (-) profile, the advancement of the delivery sheath will only result in contact with the (+) profile edges, thereby reducing friction between the funnel and the sheath (e.g., contact with three petal edges instead of six). In addition, the (-) profile petal edges can be designed and configured to absorb some of the deformation caused by the advancement of the sheath, further reducing the force required.

[0145]

[0238] The embodiment of the distal end in Figures 9A-9B may include similar structures as those described above. However, in this embodiment, the distal end including the inner and outer frames may include a membrane 917 or other covering, such as an elastomeric covering (e.g., thermoplastic urethane, or silicone) or other membrane material known in the art. In some embodiments, the membrane 917 may fill the interior portion of the frame, including the portion surrounded by the inner and outer frames. In other embodiments, the membrane may cover the entirety of the frame.

[0146]

[0239] 10A-10D, various alternative embodiments of a mechanical engagement element 1006 that may be actuated manually or automatically (e.g., by a motor or other automatic actuation source) are depicted. As shown in FIGS. 10A-10B, the mechanical engagement element 1006 includes a distal portion 1008, a proximal portion 1010, and a hinge 1012 adapted to rotate and / or pivot the distal portion 1008 from a first resting position to a second actuated position. Actuation of the mechanical engagement element can generally be radial, i.e., within a given axial position within the distal end and / or catheter body (e.g., FIG. 10B). In some embodiments, the mechanical engagement element, when actuated, functions as a cutter (e.g., a blade or knife) to cut into any trapped portions of the clot. In some embodiments, the distal portion 1008 may be sharp or serrated to enhance cutting capabilities. Actuation of the mechanical engagement element can be accomplished by advancement or rotation of the outer catheter sheath, puller wire, or any other actuation approach described herein. FIGS. 10A-10B illustrate the mechanical engagement element in a resting configuration in which the distal portion 1008 is near or adjacent to the distal end or rim of the infundibulum, thereby not occluding or interfering with the central opening or lumen (e.g., aspiration lumen) of the distal end. In this illustrated embodiment, see FIG. 10C, the proximal portion 1010 can be rotated or actuated, such as by the outer sheath, such that the inwardly directed distal portion 1008 rotates across the distal portion (e.g., across the aspiration lumen). Movement of the mechanical engagement element about its pivot axis is indicated by the arrows in FIGS. 10C-10D. In the embodiment of FIGS. 10A-10D, only one such mechanical engagement element is shown, but it should be understood that any number of engagement elements (e.g., 2, 3, 4, or more mechanical engagement elements within the expandable member or infundibulum) can be implemented. It should also be noted that while the features shown in the embodiment of Figures 10A-10B include a proximal portion that is actuated by an outer sheath, other embodiments are envisioned in which there is no proximal portion, only an inwardly directed distal portion 1008, and actuation can be accomplished by other mechanisms, including, for example, a pull wire.

[0147]

[0240] 11A-11D, a variation of the mechanical engagement elements of FIGS. 10A-10D is shown, but with elements disposed facing radially inward and actuated via a hinge or pivot region to move proximally or distally. As shown, actuation of the mechanical engagement element(s) 1106 can be accomplished with a pull wire 1118. In another embodiment, actuation can include advancement of the outer catheter over the outer portion of the actuation element (as in the embodiment of FIGS. 10A-10D), with the hinge pivoting the inner region proximally. In the embodiment of FIGS. 11A-11B, the mechanical engagement members can have a static configuration as shown in FIG. 11A, where the mechanical engagement members rest against the distal end, frame, or funnel, distal to the pivot 1112. Actuation then causes the mechanical engagement elements to swing down or proximally toward the lumen or aspiration lumen of the device, as indicated by the arrows. 11C-11D, the mechanical engagement member 1106 can have a static configuration in which the mechanical engagement member is proximal to the pivot 1112, in this case within the lumen or aspiration lumen of the device. Actuation then causes the mechanical engagement element to swing upward or distally toward the distal end or infundibulum of the device, as indicated by the arrow. As with the embodiments described above, the mechanical engagement member can be actuated to rotate either manually or automatically, such as by manipulating the outer sheath, by manipulating the puller wire, or by manipulating the sheath or puller wire using a motor or other automated feature.

[0148]

[0241] 12A-12B, another variation of the mechanical engagement element 1106 includes a wire structure adapted to act as a lasso or noose. In this embodiment, the mechanical engagement element 1206 may include a noose-like structure 1214, an anchor 1216, and a pull wire or actuator 1218. When the pull wire is pulled, a portion of the mechanical engagement element is held in place by the anchor 1216 while a portion of the mechanical engagement element can slip through the noose-like structure 1214, causing the mechanical engagement element to fold back on itself like a slip knot, as shown in FIG. 12B. The mechanical engagement element may have a first configuration that is generally open, as shown in FIG. 12A, and a second actuated configuration that is closed relative to the first configuration. The second configuration may include a lasso movement across a portion of the center or lumen and / or distal end of the catheter. Additionally, the movement of the mechanical engagement element across the distal end may be configured to cut into and fragment the captured clot or tissue. The lasso actuator may be actuated by a pull wire 1218, or actuator. The lasso can be reversibly transitioned from a first configuration to a second configuration. The lasso and / or drawstring can be of Nitinol construction. In some embodiments, the lasso has a shapeset configuration that corresponds to the first (open) configuration, and after actuation, the lasso tends to return to the open configuration.

[0149]

[0242] As discussed above, several embodiments of actuation for the mechanical engagement element can be implemented. In one embodiment, the outer sheath is cooperatively coupled to the medical device such that relative movement (e.g., advancement and / or rotation) between the outer sheath and the medical device results in actuation of the mechanical engagement element. In one embodiment, retraction (proximal movement) of an interference element such as a puller wire or similar actuation element causes the mechanical engagement element to pivot and / or rotate about a hinge.

[0150]

[0243] Further embodiments of mechanical engagement elements are shown in Figures 13A-13D. In the example of Figure 13A, one or more of the mechanical engagement elements can include a serrated or cutting edge 34. The serrated or cutting edge can be designed and configured to aid in cutting or macerating the clot(s) or tissue at the distal end of the device upon actuation of the mechanical engagement element. The cutting or serrated edge can be along the entire length of the mechanical engagement element or along only a portion of the length of the mechanical engagement element (e.g., only along the distal portion).

[0151]

[0244] FIG. 13B shows another example of mechanical engagement elements including multiple arms or engagement structures for each mechanical engagement element. In FIG. 13B, actuation of mechanical engagement element 26 can actuate both arms 22a and 22b inwardly toward the central or aspiration lumen of the device. It should be understood that some examples can include two, three, four, or more arms for each mechanical engagement element. In the illustrated example, the multiple arms for each mechanical engagement element allow the mechanical engagement elements to operate at multiple heights within the distal end or funnel of the device, potentially increasing the cutting or clot engagement capabilities of the mechanical engagement elements and allowing engagement with clots at multiple levels or heights within the funnel.

[0152]

[0245] 13C-13D illustrate embodiments in which the mechanical engagement elements in the distal end or funnel of the device can be offset or positioned in different ways to enhance or modify the mechanical interaction between the mechanical engagement elements and the clot(s) or tissue. For example, in FIG. 13C, the mechanical engagement elements can be designed and configured to impact to pinch one or more clots in the funnel at pinch point 1303. In this example, mechanical engagement elements on either side of the funnel or distal end are shown, and the distal tips of the mechanical engagement elements are designed to contact each other upon actuation. In one embodiment, the mechanical engagement elements can be positioned to first impact and pinch the clot material and then pull the clot towards the aspiration lumen as actuation of the mechanical engagement elements continues. In embodiments in which there are more than two mechanical engagement elements, it should be understood that not all mechanical engagement elements must be designed to impact and pinch the clot. In some instances, only two of the mechanical engagement elements may be arranged in this manner, with the other mechanical engagement elements operating similarly to the other mechanical engagement element embodiments described herein, however, in some embodiments, all of the mechanical engagement elements may be designed and configured to impact at a single point (e.g., a pinch point).

[0153]

[0246] In the embodiment of Figure 13D, the distal ends of two or more mechanical engagement elements can be offset to create a shearing action 1305 (e.g., scissor-like) upon actuation of the mechanical engagement elements. Similar to the embodiment of Figure 13C, an embodiment is provided in which the distal ends of two or more mechanical engagement elements are offset (in other words, displaced). However, it should be understood that not all mechanical engagement elements need to be offset, and some mechanical engagement elements can operate similarly to the other mechanical engagement element embodiments described above that simply actuate to draw clot material inwardly toward the aspiration lumen.

[0154]

[0247] 14A-14B illustrate one embodiment of a nested frame approach for the infundibulum or distal end 20 and mechanical engagement element array 22 of the medical device 10. As shown in FIGS. 14A-14B, the infundibulum 20 can include a infundibulum frame structure 24 disposed distally relative to a mechanical engagement element frame structure 26. In some embodiments, the infundibulum frame structure is separate or unattached from the mechanical engagement element frame structure 26. The infundibulum frame structure 24 can provide radial stiffness and support to the infundibulum 20. In some embodiments, the infundibulum frame structure 24 can include a shape memory material (e.g., Nitinol) to facilitate automatic expansion of the infundibulum (e.g., when a sheath or covering for the infundibulum is removed). The engagement element frame structure 26 can be configured to actuate the mechanical engagement element array such that individual mechanical engagement elements grab or engage clots and pull them proximally into the infundibulum and / or toward the aspiration lumen and / or spout of the device. In one embodiment, the device sheath (not shown, but described above in other embodiments) is configured to be moved distally over the axis of the medical device to engage the mechanical engagement element frame structure 26 without engaging the infundibulum frame structure, which causes one or more mechanical engagement elements of the mechanical engagement element array 22 to pivot or move about an axis within the expandable member or infundibulum. A nested frame structure that positions the engagement element frame structure proximally relative to the infundibulum frame structure allows actuation and movement of the mechanical engagement elements without collapsing the infundibulum or distal end.

[0155]

[0248] The mechanical engagement element array 22 illustrated in FIG. 14A shows one example of an array having multiple mechanical engagement elements 22a circumferentially disposed around or within the distal end of the medical device 10. Actuation of the mechanical engagement elements 22a can advance the distal tip of each mechanical engagement element in the array toward the central axis of the medical device to grasp, manipulate, cut, macerate, or otherwise physically engage thrombus material. In some embodiments, the mechanical engagement elements can be configured to contact, pinch, or shear past another one at the central axis of the device, and in other embodiments, the mechanical engagement elements are short enough to leave an opening open at the central axis of the device even when actuated or closed. Although a single layer array is illustrated in FIGS. 14A and 14B, other embodiments can include a mechanical engagement element array that includes one or more levels or layers of mechanical engagement elements (e.g., as in the embodiment of FIG. 13B). Each layer of the mechanical engagement element is selectively actuatable independent of the other layers, allowing for selective engagement of the thrombus material depending on the location of the thrombus within the infundibulum or the distal end.

[0156]

[0249] 15A-15F show additional examples of mechanical engagement element arrangements from cross-sectional views showing various example engagement configurations and examples of different mechanical engagement element layers. While the mechanical engagement elements in FIG. 15A-15F are shown in isolation for illustrative purposes, it should be understood that they can be disposed entirely within the expandable member or funnel (not shown), similar to the previously described embodiments. Additionally, these mechanical engagement elements can include an actuation mechanism coupled to the engagement elements (e.g., pull wires, outer sheath, motor, etc.) such that the mechanical engagement elements rotate or move within the expandable member / funnel during actuation.

[0157]

[0250] Referring to FIG. 15A, a mechanical engagement element array is shown that includes three layers of mechanical engagement elements 60a, 60b, 60c axially displaced from one another. Mechanical engagement element 60c may be a distal layer of mechanical engagement elements that can be actuated toward each other and a central point (e.g., a pinch point) to grab, cut, or otherwise engage thrombus material. Mechanical engagement elements 60b and 60a may be actuated in combination with mechanical engagement element 60c, actuated independently from 60c, or in combinations where one or more mechanical engagement elements of each layer 60c, 60b, and 60a are actuable. Different layers of mechanical engagement elements may be configured to interact with thrombus material in different ways. In some examples, some mechanical engagement elements or layers may be configured to retain thrombus material within the medical device (e.g., in the infundibulum or distal end), while other mechanical engagement elements or layers are configured to cut, pinch, pull, twist, or rotate thrombus or tissue material. For example, mechanical engagement elements 60c may be configured to converge toward each other to contain thrombus material or tissue within the funnel or prevent thrombus material or tissue from exiting the funnel, while mechanical engagement elements 60b and / or 60a may be actuated to cut, pinch, pull, twist or rotate the thrombus material.

[0158]

[0251] In some examples, one or more layers of mechanical engagement elements may be actuated independently of other mechanical engagement element layers. In some examples, one or more layers of mechanical engagement elements may be actuated in combination with one or more additional mechanical engagement element layers. For example, with reference to FIG. 15A, one or more mechanical engagement elements or mechanical engagement element layers may be actuated independently of one another, e.g., mechanical engagement element 60a may be retracted proximally after engaging the thrombus material, while mechanical engagement element layers 60b and 60c may remain statically engaged to the thrombus material such that mechanical engagement element layer 60a may cut, tear, or otherwise separate a proximal segment of the thrombus material therein. In some examples, one or more mechanical engagement element layers may work in conjunction with one another to manipulate the thrombus material.

[0159]

[0252] 15A, the mechanical engagement element layers 60a, 60b, and 60c may be actuated in series or any other order relative to one another. For example, the thrombus removal device may engage the thrombus material, and one or more mechanical engagement element layers may be actuated to engage the thrombus material. For example, the mechanical engagement element layer 60a may engage a proximal segment of the thrombus material, then the mechanical engagement element layer 60b may then engage the thrombus material, and then a subsequent distal mechanical engagement element layer (e.g., mechanical engagement element layer 60c) may engage. In some examples, the sequence of engagement may be configured to pull or displace the entire thrombus proximally within the thrombus removal device or toward the cutting surface of the device's jet. For example, mechanical engagement element layer 60a may engage a proximal segment of the thrombus material and be retracted proximally, while mechanical engagement element layer 60b is actuated to engage the thrombus material and support proximal displacement of the thrombus material, followed by a subsequent distal mechanical engagement element layer that engages the thrombus and retracts it proximally, drawing the entire thrombus proximally toward a thrombus removal device (e.g., an aspiration catheter).

[0160]

[0253] 15A and 15B show examples of how one or more mechanical engagement element layers can engage a clot. For example, FIG. 15B illustrates mechanical engagement elements 61a and 61b (e.g., mechanical engagement elements on opposite sides of the same layer) designed and configured to impact to pinch one or more clots in the funnel or distal end. In this example, mechanical engagement elements on opposite sides of the funnel are shown, and the distal tips of the mechanical engagement elements are designed to contact each other upon actuation. In one embodiment, the mechanical engagement elements can be positioned to first impact and pinch the clot material and then pull the clot toward the aspiration lumen as actuation of the mechanical engagement elements continues. It should be understood that in embodiments where there are more than two mechanical engagement elements, not all mechanical engagement elements must be designed to impact and pinch the clot. In some examples, only two of the mechanical engagement elements can be positioned in this manner, and other mechanical engagement elements can operate similarly to other mechanical engagement element embodiments described herein. However, in some embodiments, all of the mechanical engagement elements can be designed and configured to impinge at a single point (eg, a central point at the funnel or distal end).

[0161]

[0254] FIG. 15C illustrates another example of how one or more mechanical engagement element layers may engage a thrombus. In this example, the tips of the mechanical engagement elements of two or more mechanical engagement elements may be offset to create a shearing action (e.g., scissors-like) upon actuation of the mechanical engagement elements. In some examples, the offset configuration in this manner may be configured to shear a segment of the thrombus. In some examples, the offset configuration may be configured to manipulate or displace the thrombus material for engagement with one or more mechanical engagement element layers. For example, mechanical engagement elements 62b and 62a may be configured to engage different areas of the thrombus to enhance engagement and accommodate the thrombus in a particular orientation, while one or more additional mechanical engagement element layers impact the thrombus material proximally or distally from mechanical engagement element layer 62.

[0162]

[0255] In some examples, a mechanical engagement element layer may include multiple offset mechanical engagement elements configured to be actuated independently or in combination with one another to engage the thrombus and hold the thrombus material in a stationary position, while one or more of the mechanical engagement element layers may be actuated to impact (e.g., shear, cut, macerate, etc.) the thrombus. In some examples, one or more of the mechanical engagement elements of a layer may be configured to engage the thrombus to rotate the thrombus material. As described herein, closure of the mechanical engagement elements in a layer or array may be configured to engage the thrombus material and impart a rotational force to the material by closing around an opening like an iris.

[0163]

[0256] FIG. 15D illustrates a mechanical engagement element array configuration in which one or more mechanical engagement elements or layers may incorporate apertures and fluid lumens to deliver fluid streams from mechanical engagement element 63a. The fluid delivery mechanism may provide multiple fluid streams (e.g., jets) through one or more apertures in the mechanical engagement element array to the fluid apertures of the thrombus removal system. For example, the one or more fluid streams delivered by the mechanical engagement elements may be configured to macerate, cut, fragment, pulverize, and / or urge the thrombus to be removed from the proximal portion of the thrombus removal system. Mechanical engagement elements 63b and 63b may be configured to hold, cut, twist, slice, pinch, or rotate the thrombus material, while mechanical engagement element 63a may be configured to provide a fluid stream or jet that contacts the thrombus material sufficient to fragment a segment of the thrombus at or near mechanical engagement element 63a. The resulting proximal segment of thrombus material may be retracted by mechanical engagement element 63b, while layer 63 can retain the proximal segment of thrombus material to prevent or reduce potential distal migration of the thrombus material. In some examples, sequential severing of the thrombus material by the mechanical engagement element layers can be facilitated by proximal and distal retention of the thrombus material, while one or more intermediate mechanical engagement element layers impact the thrombus material to shear or otherwise fragment the thrombus so that the proximal layer (e.g., 63b) can retract the proximal thrombus material segment into the thrombus removal device.

[0164]

[0257] Similar to FIG. 15D, FIG. 15E illustrates an exemplary configuration in which the mechanical engagement elements 64a and 64b incorporating apertures and fluid flow are offset. As described herein, jets from the mechanical engagement elements 64a and 64b may be configured to shear or otherwise fragment the thrombus material. The distal mechanical engagement element layer 64c may be configured to retain and encase the thrombus material within the distal end of the thrombus removal device while the fluid flow from the mechanical engagement elements 64a and 64b impacts the thrombus material. For example, the distal mechanical engagement element layer 64c may be configured to reduce thrombus fragments exiting the array while the intermediate and proximal layers engage and fragment the thrombus material.

[0165]

[0258] In some examples, one or more mechanical engagement elements or layers may include different properties configured to impact the thrombus material in various ways. For example, some mechanical engagement elements may be stiffer than other features. The stiffer features may improve the cutting, maceration, or engagement of the thrombus material. In some examples, the stiffer mechanical engagement elements may be configured to cut, macerate, or otherwise deform the thrombus material, while the more flexible mechanical engagement elements may be configured to support the stiffer cutting member to contain, hold, or otherwise manipulate the thrombus material. FIG. 15F illustrates an example where the mechanical engagement element 65a or any other feature may have increased stiffness, rigidity, or shape to provide a cutting impact to the thrombus material. The mechanical engagement element 65b may be stiff enough to hold the thrombus material, while the mechanical engagement element 65a may be configured to impact the thrombus material to cut, tear, macerate, or otherwise deform the thrombus material at the proximal end of the array for improved aspiration of the fragments of thrombus material separated by the mechanical engagement element 65b.

[0166]

[0259] In addition, FIG. 15F illustrates an example of improved articulation of the mechanical engagement elements relative to one another. For example, the space between mechanical engagement elements 65b may illustrate a pinch point that is substantially in the center of the thrombus removal device or toward a central axis, while distal layer 65c is illustrated as overlapping mechanical engagement elements that can be configured to engage the thrombus at multiple points or regions to improve engagement with the thrombus material and prevent distal migration or inadvertent detachment of a distal segment of the thrombus material. Mechanical engagement element 65a may be a single mechanical engagement element or a single actuable mechanical engagement element from layers that can be actuated to pull against a proximal portion of the thrombus material. For example, mechanical engagement element 65a may be actuated to engage the thrombus at a proximal segment of the thrombus material, and the mechanical engagement element may be retractable while layers 65b and 65c maintain stationary engagement with the thrombus material, whereby mechanical engagement element 65a can cut, tear, or otherwise separate the thrombus material proximally into the thrombus removal device.

[0167]

[0260] In some embodiments, the stiffness of the mechanical engagement element frame structure can be adjusted independently of the stiffness of the infundibulum frame structure. For example, it may be desirable to have the infundibulum as conforming as possible to avoid scratching or damaging delicate vascular structures. At the same time, it may be desirable to have the mechanical engagement element frame structure and mechanical engagement element that are stiffer than the infundibulum to provide improved clot engagement or maceration. Alternatively, it may be desirable for the mechanical engagement element to be more conforming than the infundibulum itself. In any case, in some embodiments, the mechanical engagement element frame structure is stiffer than the infundibulum frame structure, and in other embodiments, the mechanical engagement element frame structure is less stiff than the infundibulum frame structure. Alternatively, the mechanical engagement element frame structure may have substantially the same stiffness as the infundibulum frame structure.

[0168]

[0261] 16A-16G show cross-sectional views of a mechanical engagement element array disposed within an expandable member or funnel as viewed from the distal end of the medical device. The layers of mechanical engagement elements within the array may be configured to actuate and extend outwardly, inwardly, laterally, diagonally, orthogonally, etc., or combinations thereof, to engage or otherwise impact thrombus material within the distal end of the thrombus removal device. With reference to FIG. 16A, one or more layers may include multiple mechanical engagement elements 70 configured to actuate and surround toward or beyond a central point (e.g., a central axis). In some examples, the mechanical engagement elements 70 can be actuated or controlled independently, in groups, in unison, or some combination thereof.

[0169]

[0262] In FIG. 16B, another example of a layer of mechanical engagement elements 71a is shown closing in a cyclonic or cylindrical shape around the central axis 71. The mechanical engagement elements 71a may be arranged in a single layer or may be offset relative to one another. The cylindrical closing of the mechanical engagement elements 71a may resemble an aperture closing around a central opening and may be controllable through articulation of the mechanical engagement elements to increase or decrease the opening provided around the central axis 71. In some examples, the mechanical engagement elements may be configured to completely close to retain or cut the thrombus material therein. In some examples, the mechanical engagement elements 71a may be configured to sequentially close relative to one another to rotate the thrombus material retained therein. In other examples, the mechanical engagement elements 71a may be actuated or controlled independently, in groups, in unison, or some combination thereof.

[0170]

[0263] 16C, the layers may include one or more teeth with different dimensions or articulation levels. For example, mechanical engagement elements 72a may be longer or extend further toward each other, while mechanical engagement elements 72b may extend to the central axis 72 or to some point short of the central axis. For example, mechanical engagement elements 72a may be configured to shear the thrombus material while mechanical engagement elements 72b laterally support the sheared thrombus material. In some examples, mechanical engagement elements 72a and 72b can be actuated or controlled independently, in groups, in unison, or some combination thereof.

[0171]

[0264] FIG. 16D, similar to FIG. 16B, illustrates an example of one or more mechanical engagement elements or layers 73a / 73b configured to engage thrombus material when actuated to close around a central opening 73 in a cylindrical or cyclonic manner. Here, multiple layers of mechanical engagement elements are shown to close in a concentric cyclonic manner. However, one or more layers may be actuated to wrap around the central opening in a clockwise direction, and one or more layers may be configured to close in a counterclockwise direction. In some examples, all layers may be configured to close or otherwise adjust the central opening in a clockwise direction. In some examples, all layers may be configured to close or otherwise adjust the central opening in a counterclockwise direction. In some examples, one or more layers may close or otherwise adjust the size of the opening in a clockwise direction, while one or more additional layers may close or adjust the opening in a counterclockwise direction. For example, one or more layers may be configured to twist thrombus material therein. In some examples, the mechanical engagement elements 73a / 73b can be actuated or controlled independently, in groups, in concert, or some combination thereof.

[0172]

[0265] In some examples, as shown in FIG. 16E, the dimensions of the mechanical engagement elements 74a may be configured to engage the thrombus material to hold the thrombus without shearing it. The mechanical engagement elements 74a are positioned at a distance from each other around the circumference of the distal end of the thrombus removal device to penetrate or engage the thrombus material without shearing it. In some examples, the one or more layers may be configured to penetrate and hold the thrombus material. In some examples, the one or more layers may be configured to engage or apply pressure to the thrombus material without penetrating it. In some examples, engaging the thrombus material in this manner may support one or more additional layers to shear, separate, cut, macerate, or otherwise segment the thrombus material. In some examples, the mechanical engagement elements 74a may be actuated or controlled independently, in groups, in unison, or some combination thereof.

[0173]

[0266] In some examples, the thrombus removal device may include an arrangement having any number of layers of mechanical engagement elements, each of which may be configured to manipulate thrombus material therein as described herein, for example, a proximal layer may be configured to shear a proximal thrombus segment and a distal layer may be configured to shear, hold, apply fluid pressure, surround, rotate, macerate, etc., or combinations thereof, to a different segment of thrombus material therein.

[0174]

[0267] 16F illustrates another example of one or more layers of mechanical engagement elements in a mechanical engagement element array having different shapes, properties, and associated functions. Layer 75c can be a distal layer configured to be actuated closed in a cyclonic manner, while proximal layers 75a and 75b can be configured to close in a twisted manner about a central axis. In some examples, the proximal layer can be configured to hold thrombus material to the proximal segment, while one or more distal layers shear, cut, or separate thrombus material from the distal portion outside of the thrombus removal device. In some examples, mechanical engagement elements 75a-75c can be actuated or controlled independently, in groups, in unison, or some combination thereof.

[0175]

[0268] In some examples, any layer may incorporate openings and fluid lumens to provide one or more jets, as described herein. For example, with reference to FIG. 16F, layer 75b may be configured to generate one or more jets or fluid streams to detach or otherwise dislodge a proximal segment of thrombus material that may be aspirated or drawn proximally within the thrombus removal device.

[0176]

[0269] FIG. 16G illustrates yet another example of layers having overlapping mechanical engagement elements 76a that can be configured to laterally or cyclonically close around a central lumen (e.g., opening) 76. In this example, the mechanical engagement elements can be configured to slice the thrombus at the central opening 76. In some examples, the layer so configured can be a distal layer configured to encase all or a portion of the thrombus material within the distal end of the thrombus removal device. For example, the thrombus can be engaged by the distal end of the thrombus removal device and the distal layer (e.g., mechanical engagement elements 76a) can be actuated to encase the thrombus material therein, enabling retraction of the entire thrombus and / or one or more proximal layers to impact the thrombus material for removal via an aspiration catheter and / or via proximal retraction of the thrombus removal device.

[0177]

[0270] In some examples, the distal tip shape of the mechanical engagement element may be configured to engage or otherwise impact the thrombus material to manipulate or deform (e.g., shear, cut, macerate, etc.) the thrombus material therein. For example, referring to FIG. 16A, the distal tip shape is substantially a point or piercing tip, while FIG. 16G shows an example of a rounded or blunt tip. In some examples, the distal tip may be configured to impact the thrombus material. In some examples, the lateral edges or sides of one or more of the mechanical engagement elements may be configured to impact the thrombus material. In some examples, the combination of the tip and the lateral edges may be configured to engage or impact the thrombus material. In some examples, the surfaces (e.g., distal face and / or proximal face) may be configured to impact the thrombus material. For example, the surface of the mechanical engagement element or elements may be smooth, or irregular with teeth, knurled, or otherwise textured to enhance engagement and manipulation of the thrombus material.

[0178]

[0271] As described herein, one or more mechanical engagement elements, layers, or arrays of mechanical engagement elements may be actuated simultaneously, independently, selectively, or combinations thereof. In some examples, any layer may be actuated based on actuation or impact of one or more layers. For example, a proximal layer may be actuated, and one or more distal layers may be subsequently actuated once the proximal layer is actuated to engage the thrombus material. Some examples of articulation of layers or mechanical engagement elements may include alternating mechanical engagement elements (e.g., every other mechanical engagement element) or any pattern of subsequent actuation. Such actuation or articulation of the mechanical engagement elements may be configured to grab and / or pull the thrombus material. Some examples of articulation of layers or mechanical engagement elements may include sequential actuation of one or more mechanical engagement elements or layers (e.g., mechanical engagement element 1, mechanical engagement element 2, mechanical engagement element 3, etc.). Such actuation may be configured to twist and / or rotate the thrombus material. Some examples of articulation of layers or mechanical engagement elements may include a varied axial position (e.g., offset or height of the mechanical engagement elements). Such actuation may be configured to hold, grab, pull, etc., the thrombus material. Some examples of articulation of layers or mechanical engagement elements may include a varied radial overlap of one or more mechanical engagement elements of the layers. For example, the mechanical engagement elements may be overlapping, scissors, hooks, curved, etc., or combinations thereof. Such actuation may be configured to pinch, cut, shear, etc., or combinations thereof, the thrombus material. Some examples of articulation of layers or mechanical engagement elements may include a throttling closure (e.g., cyclonic, tangentially aligned closure). Such actuation may be configured to twist and / or rotate the thrombus material.

[0179]

[0272] In some examples, the mechanical engagement elements can help contain the clot within the distal end of the device, but do not cut, macerate, or otherwise disrupt the clot. In one example, one or more mechanical engagement elements can be actuated or positioned to contain the clot within the infundibulum, and the suction and / or jetting can be intermittently vibrated to break up the clot and move it away from the patient. In some examples, the jetting or fluid flow can be sequenced with the actuation of the mechanical engagement elements. For example, jetting can be initiated when the mechanical engagement element is actuated and stopped when the mechanical engagement element is not actuated. In some examples, jetting can be initiated only after the mechanical engagement element is fully deployed or actuated, or when the mechanical engagement element is not deployed. Any combination of sequential jetting and actuation of the mechanical engagement elements is envisioned.

[0180]

[0273] In some examples, actuation of one or more mechanical engagement elements in the array may be based on manipulation or engagement of an elongate member in operable communication with the mechanical engagement elements. As described above, the sheath may be manipulated either axially or rotationally to actuate the mechanical engagement elements. This movement of the sheath may be motorized or automatic. In other examples, a pull wire may be coupled to the mechanical engagement element and configured to actuate the mechanical engagement element when the pull wire is engaged by a user or other actuation interface. In some examples, the pull wire can be attached to or coupled to a motor configured to mechanically adjust the position of the pull wire to operate the mechanical engagement element. In some examples, actuation of the mechanical engagement element may be performed by a pneumatic system configured to adjust pressure on the layer or mechanical engagement element for selective articulation of one or more mechanical engagement elements, layers, or arrays. In some examples, operating the mechanical engagement element may be facilitated by a thermal or electrical process. Actuation of the mechanical engagement element may be controlled, for example, with a user interface (e.g., a button or GUI on a handle or console of the system). In some examples, a single user interface may be configured to control all the mechanical engagement elements at once. In other embodiments, multiple user interfaces or buttons can be configured to control the mechanical engagement elements independently or in groups. For example, one or more of the mechanical engagement elements may include a material or be otherwise configured to respond to changes in temperature or electrical impulses transmitted to the mechanical engagement elements. In some examples, one or more of the mechanical engagement elements may be configured to be automatically activated upon contact (e.g., sufficient contact) with thrombus material within the distal end of the thrombus removal device. In some examples, activation and articulation of the one or more mechanical engagement elements may be performed by engagement with a handle at the proximal end of the thrombus removal device (e.g., outside the patient in use). One or more of the engagement elements may be selectively controlled by a user to engage or otherwise activate the mechanical engagement elements and initiate their associated functions.In some examples, the one or more mechanical engagement elements may be actuated by a sheath or delivery catheter. For example, the sheath is advanced distally toward the mechanical engagement element, causing actuation of the mechanical engagement element by pressure exerted by the distal end of the sheath on the mechanical engagement element. In some examples, the proximal layer may be configured to propagate or transmit the actuation force to a subsequent layer (e.g., a distal layer).

[0181]

[0274] 17A-17B show an example of a distal end of a thrombus removal device including a funnel 20, a funnel frame structure 22, a mechanical engagement element frame structure 24, and a mechanical engagement element 1708. In this embodiment, the funnel includes a compliant material surrounding the funnel frame structure and at least a portion of the mechanical engagement element frame structure and the mechanical engagement element. In some examples, the mechanical engagement element frame structure is at least partially covered or encapsulated by the compliant material, and the mechanical engagement element itself is not covered by the compliant material. In some embodiments, the compliant material can include a polycarbonate-based thermoplastic urethane material, such as Chronoflex.

[0182]

[0275] In Fig. 17A, the mechanical engagement elements are shown in an open configuration, in which they are expanded outwardly and positioned adjacent or abutting the pliable material. In Fig. 17B, the mechanical engagement elements are shown in a closed or actuated configuration, in which they are moved inwardly from the infundibulum, optionally toward the aspiration lumen of the thrombus removal device. As with other embodiments described herein, the mechanical engagement elements can be actuated or controlled independently, in groups, in unison, or any combination thereof.

[0183]

[0276] 18A-18C illustrate an embodiment of a funnel including three mechanical engagement elements 1808. FIG. 18A shows the mechanical engagement elements in an open configuration, and FIG. 18B shows the mechanical engagement elements in a closed or actuated configuration. FIG. 18C is a side view of a funnel including a funnel framing structure and a mechanical engagement element framing structure with a flexible material embedded or surrounded by a flexible material. FIG. 18D-18F show a similar view, except with a six mechanical engagement element design. Note that in both of these embodiments, the mechanical engagement elements are exposed or positioned outside of the flexible material in both the open and closed configurations. As with other embodiments described herein, the mechanical engagement elements can be actuated or controlled independently, in groups, in unison, or any combination thereof.

[0184]

[0277] FIG. 19A is a side view of a thrombus removal device including a sheath or delivery catheter 28. In this example, the sheath 28 is positioned proximal to the distal end and the mechanical engagement element framework 26, and the mechanical engagement elements can assume their expanded position or configuration (e.g., the mechanical engagement elements can expand outward to abut or rest against or within the flexible material of the infundibulum). FIG. 19B is a top view of this open configuration, and the mechanical engagement elements rest inside an optional "pocket" 30 in the flexible material. In the illustrated example, the pocket can have the same shape as the mechanical engagement elements, so that the mechanical engagement elements can be recessed from the interior of the infundibulum when in the expanded or open configuration. In one example, the pocket has a depth and shape that allows the mechanical engagement elements to be flush with the interior surface of the infundibulum and the flexible material.

[0185]

[0278] 19C is another side view of the thrombus removal device. In this example, as the sheath 28 is advanced distally relative to the thrombus removal device, the sheath engages or contacts the mechanical engagement element frame structure and pushes the structure distally. As the mechanical engagement element frame structure advances distally, the mechanical engagement element itself assumes a closed or actuated configuration. As with other embodiments described herein, the sheath can be moved automatically (e.g., with a motor) or manually by a user.

[0186]

[0279] 19D is a top view of this closed or actuated configuration, showing pockets 30 in the pliable material and a view of mechanical engagement elements 22 pivoting or moving inwardly towards the aspiration lumen of the device. As with other embodiments described herein, the mechanical engagement elements can be actuated or controlled independently, in groups, in unison, or any combination thereof.

[0187]

[0280] 20A-20C illustrate an alternative embodiment in which the mechanical engagement elements are hidden by a flexible material when in the open configuration. FIG. 20A is a bottom view of the funnel 20, showing the frame structure of the mechanical engagement elements and the funnel frame structure embedded or covered by a flexible material. FIG. 20B shows the funnel including the mechanical engagement elements in an open configuration in which the mechanical engagement elements themselves are recessed into a pocket in the flexible material. In this example, the mechanical engagement elements are configured to pass through slits 32 in the flexible material, which allows the mechanical engagement elements to transition from an open configuration shown in FIG. 20B in which the mechanical engagement elements are not visible and are covered by the flexible material, and a closed or actuated configuration in FIG. 20C in which the mechanical engagement elements 22 pivot, move, or pass through the slit(s) 32 to grab, cut, engage, or manipulate the clot in the funnel. As with other embodiments described herein, the mechanical engagement elements can be actuated or controlled independently, in groups, in unison, or some combination thereof.

[0188]

[0281] In some examples, any of the mechanical engagement elements described herein may be positionable or disposable within the infundibulum framework or the expandable distal or tip end of a medical device as described herein. In some examples, the mechanical engagement elements may be positioned within the infundibulum framework until they are actuated to engage thrombus material therein. For example, a layer having any number of mechanical engagement elements may be positioned within the pliable material of the infundibulum framework and, when actuated, may transition from within or on the infundibulum framework to engage thrombus material.

[0189]

[0282] Assessment of treatment effectiveness / completion

[0283] Provided herein are systems and methods for assessing the effectiveness and / or completion progress of a thrombectomy treatment. In some embodiments, the methods can be implemented entirely in software located on or in communication with the thrombectomy device itself. In other embodiments, the methods can be implemented in combination with hardware located on or within the device that provides additional information to the system / device regarding the progress of the treatment.

[0190]

[0284] In one embodiment, a method of assessing efficacy or monitoring progress of a treatment can include assessing or determining the amount of clot removal based on pre-treatment imaging (e.g., CT). With reference to the flowchart of Figure 21, the method can include obtaining a pre-treatment image of the clot to be removed or treated, at step 2102. In some embodiments, this can include obtaining a CT image, an ultrasound image, an MRI image, or other high resolution or quality image of the target clot.

[0191]

[0285] At step 2104, the method may then include performing a thrombectomy procedure on the target clot or clots using any of the devices and methods described herein.

[0192]

[0286] Next, in step 2106, the method can include determining or calculating the volume of the clot removed from the patient during the thrombectomy procedure. In some embodiments, this determination is made entirely in software, such as an algorithm that compares pre-treatment imaging to post-treatment imaging, determines the volume of the pre-treatment clot relative to the post-treatment clot, and identifies the volume or percentage of the clot that was removed.

[0193]

[0287] In other embodiments, the determination can be based on sensor feedback from the thrombectomy device. For example, flow and / or pressure sensors on the outside of the thrombectomy device or inside the aspiration lumen of the device can be used to measure or estimate the amount of clot removed in real time. Alternatively, contrast agent can be delivered into the target area during treatment, such as at the jet or another contrast agent lumen, to enable real time imaging of the clot removal. In some embodiments, contrast agent can be delivered from or near the infundibulum of the device. In some embodiments, additives can be added to the contrast agent that can attach to the clot(s) and increase the visibility of the clot as it is removed under real time imaging. This allows software or image processing solutions to estimate or determine the amount of clot removed during therapy.

[0194]

[0288] In some embodiments, completion of therapy can be determined or assessed based on a scoring system that is a composite of performance parameters (e.g., volume removed by step 2106 above) and / or physiological parameters (Sp02 increase / decrease, HR, respiratory rate, etc., return to normal range).

[0195]

[0289] Although the embodiments herein have been described as intended to remove blood clots from a patient's vasculature, other applications of this technology are provided. For example, the devices described herein can be used for gastrointestinal procedures, including breaking down and removing hardened stool from a patient's digestive tract, such as the patient's intestines or colon. In one embodiment, the device can be inserted into the patient's colon or intestines (such as through the anus) and advanced to the site of the hardened stool. The suction system can then be activated to engage the hardened stool with an engagement member (e.g., the infundibulum) of the device. Finally, the jet or irrigation can be activated to break off the hardened stool pieces and aspirate them into the system. Any of the techniques described above for controlling the system or removing blood clots can be applied to removing hardened stool.

[0196]

[0290] As one skilled in the art will appreciate from the disclosure herein, various components of the thrombus removal system described above may be omitted without departing from the scope of the present technology. As previously discussed, for example, the present technology may be used and / or modified to remove other types of emboli that may occlude blood vessels, such as fat, tissue, or foreign bodies. Additionally, although some embodiments herein are described in the context of thrombus removal from the pulmonary artery, the disclosed technology may be applied to the removal of thrombi and / or emboli from other parts of the vasculature (e.g., in neurovascular, coronary, or peripheral applications). Similarly, additional components not expressly described above may be added to the thrombus removal system without departing from the scope of the present technology. Thus, the systems described herein are not limited to those configurations expressly identified, but rather encompass variations and modifications of the described systems. conclusion

[0291] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the exact form disclosed above. Specific embodiments of the present technology, and examples thereof, are described above for illustrative purposes, but as those skilled in the art will recognize, various equivalent modifications are possible within the scope of the present technology. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. Various embodiments described herein may be combined to provide further embodiments.

[0197]

[0292] From the above, it will be understood that, although specific embodiments of the present technology have been described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0198]

[0293] Unless the context clearly dictates otherwise, throughout the description and examples, the words "comprises," "comprising," and the like, should be construed in an inclusive sense, i.e., "including, but not limited to," and not in an exclusive or exhaustive sense. As used herein, the terms "connected," "coupled," or any variation thereof, refer to any direct or indirect connection or coupling between two or more elements, and the coupling between the elements may be physical, logical, or a combination thereof. In addition, the words "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole, and not to any particular portions of this application. Where the context permits, words in the above detailed description using the singular or plural may each be in the plural or singular. As used herein, the term "and / or," such as "A and / or B," refers to A only, B only, and A and B. In addition, the term "comprising" is used throughout to mean including at least the recited feature(s), but not to the exclusion of any more of the same features and / or other features of additional types. Although specific embodiments have been described herein for purposes of illustration, it will also be understood that various modifications may be made without departing from the technology. Furthermore, while advantages associated with some embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, but not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and related technology may include other embodiments not expressly shown or described herein.

Claims

1. an elongate catheter having an aspiration lumen; a suction source coupled to the suction lumen; an expandable funnel coupled to the aspiration lumen and the elongate catheter; at least one mechanical engagement element disposed within the expandable funnel, the at least one mechanical engagement element operable to move the at least one mechanical engagement element within the expandable funnel.

2. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the aspiration lumen.

3. 2. The thrombus removal device of claim 1, wherein the at least one mechanical engagement element is operable to move the at least one mechanical engagement element substantially radially within the expandable funnel, across at least a portion of the expandable funnel.

4. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a cutting portion.

5. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a blunt tip.

6. a fluid source; a fluid lumen positioned in the elongate catheter and in fluid communication with the fluid source; 10. The thrombus removal device of claim 1, further comprising: an injection orifice positioned near or within the expandable funnel and in fluid communication with the fluid lumen, the injection orifice configured to deliver a fluid flow into the aspiration lumen or the expandable funnel.

7. The thrombus removal device of claim 6 , wherein the at least one mechanical engagement element is operable to move the at least one mechanical engagement element within the expandable funnel toward the fluid flow.

8. 7. The thrombus removal device of claim 6, wherein the at least one mechanical engagement element is in fluid communication with the fluid lumen and is further configured to provide a second fluid flow into the aspiration lumen or the expandable funnel.

9. The thrombus removal device of claim 1 , wherein the expandable funnel includes a funnel rim configured to self-expand the funnel to a fully expanded configuration.

10. 10. The thrombus removal device of claim 9, wherein the expandable funnel further comprises a flexible material disposed over at least a portion of the funnel rim.

11. 10. The thrombus removal device of claim 9, further comprising an actuatable rim mechanically coupled to the at least one mechanical engagement element, the actuatable rim being at least partially positioned proximally from the infundibulum rim.

12. 12. The thrombus removal device of claim 11, further comprising a sheath configured to slide axially over the elongate catheter, wherein relative movement between the sheath and the elongate catheter to bring the sheath into contact with the actuatable frame moves the at least one mechanical engagement element within the expandable funnel.

13. 13. The thrombus removal device of claim 12, wherein contacting the sheath with the actuatable frame does not collapse the expandable funnel or reduce the diameter of the expandable funnel.

14. 10. The thrombus removal device of claim 9, wherein the at least one mechanical engagement element is hingedly coupled to the infundibulum rim.

15. 15. The thrombus removal device of claim 14, wherein a distal portion of the at least one mechanical engagement element extends from the hinge into the expandable funnel and a proximal portion of the at least one mechanical engagement element extends outside the funnel.

16. 16. The thrombus removal device of claim 15, further comprising a sheath configured to slide axially over the elongate catheter, wherein relative movement between the sheath and the elongate catheter to bring the sheath into contact with the proximal portion of the at least one mechanical engagement element moves the distal portion of the at least one mechanical engagement element about the hinge within the expandable funnel.

17. 16. The thrombus removal device of claim 15, further comprising a sheath configured to rotate about the elongate catheter, wherein rotating the sheath into contact with the proximal portion of the at least one mechanical engagement element causes the distal portion of the at least one mechanical engagement element to hinge within the expandable funnel.

18. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a pair of mechanical engagement elements configured to collide at a pinch point upon actuation.

19. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a pair of mechanical engagement elements configured to create a shearing action upon actuation.

20. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a plurality of mechanical engagement elements collectively actuated as a group.

21. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a plurality of individually and independently actuated mechanical engagement elements.

22. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a first group of mechanical engagement elements that are actuatable independently from a second group of mechanical engagement elements.

23. 2. The thrombus removal device of claim 1, wherein the at least one mechanical engagement element includes a first mechanical engagement element disposed within the expandable funnel at a first axial position and a second mechanical engagement element disposed within the expandable funnel at a second axial position distal to the first axial position.

24. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element comprises a plurality of mechanical engagement elements configured to move toward a central point within the expandable funnel.

25. The thrombus removal device of claim 10 , wherein the at least one mechanical engagement element comprises a stationary configuration that positions the at least one mechanical engagement element adjacent to or against the pliable material.

26. 11. The thrombus removal device of claim 10, wherein the flexible material further comprises at least one pocket corresponding to each of the at least one mechanical engagement elements, the at least one mechanical engagement element comprising a stationary configuration for positioning the at least one mechanical engagement element within a corresponding pocket in the flexible material.

27. 11. The thrombus removal device of claim 10, wherein the flexible material further comprises at least one slit corresponding to each of the at least one mechanical engagement elements, the at least one mechanical engagement element comprising a static configuration in which the at least one mechanical engagement element is covered by the flexible material and an actuated configuration in which the at least one mechanical engagement element moves through a corresponding slit into the expandable funnel.

28. The thrombus removal device of claim 1 , wherein actuation of the at least one mechanical engagement element causes the at least one mechanical engagement element to rotate within the expandable funnel.

29. 2. The thrombus removal device of claim 1, wherein the elongate catheter extends along a longitudinal axis, and further wherein the expandable funnel and at least a portion of the at least one mechanical engagement element are configured to maintain their respective axial positions relative to the longitudinal axis during actuation of the at least one mechanical engagement element.

30. The thrombus removal device of claim 1 , wherein the at least one mechanical engagement element does not extend beyond the distal end of the expandable funnel. The apparatus described.

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