Devices and methods for treating vascular occlusion

Abstract

To provide favorable devices and methods for treating vascular occlusion.SOLUTION: Systems and methods for the intravascular treatment of clot material within a blood vessel of a human patient are disclosed herein. In one embodiment, a system includes a coring element for coring and separating the clot material. The coring element can comprise a unitary structure having a first region, a second region, a third region, and a fourth region. The first region is adjacent to a proximal portion of the unitary structure and includes a first mouth configured to core and separate the clot material. The second region is distal to the first region and generally tubular, and includes a first plurality of interconnected struts. The third region is distal to the second region and includes a second mouth configured to core and separate the vascular thrombus. The fourth region is distal to the third region and generally tubular, and includes a second plurality of interconnected struts.SELECTED DRAWING: Figure 3A

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 949,967, filed December 18, 2019, titled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION", which is hereby incorporated by reference in its entirety.

[0002] This technology generally relates to systems, methods, and devices for extracting thrombi from the blood vessels of a human patient. Specifically, some embodiments of this technology relate to systems for extracting thrombi from the occluded blood vessels of a human patient.

Background Art

[0003] Thrombosis is the local aggregation or coagulation of blood in a part of the circulatory system, and a thrombus is a blood clot formed in situ within the vascular system. A venous thrombus is a blood clot formed within a vein. A common type of venous thrombosis is deep vein thrombosis (DVT), which is the formation of a blood clot within a deep vein (e.g., mainly in the leg). Nonspecific signs of thrombosis can include pain, swelling, redness, warmth, and engorged superficial veins.

[0004] When a thrombus breaks off (embolizes) and flows towards the lungs, it can result in life - threatening pulmonary embolism (PE) (e.g., a blood clot in the lungs). In addition to the potential loss of life resulting from PE, DVT can lead to serious health problems such as post - thrombotic syndrome. This can cause chronic swelling, pressure, pain, and ulcers due to valve and vascular damage. Furthermore, DVT can directly or indirectly result in significant medical costs through the treatment of related complications and the patient's inability to work.

[0005] Three processes are thought to lead to venous thrombosis. The first is a decrease in blood flow (venous stasis), the second is an increased tendency to form clots (hypercoagulability), and the third is a change to the blood vessel wall. DVT formation usually begins inside the valves of the calf veins where the blood is in a relatively oxygen-deprived state, and certain biochemical pathways are activated. Some medical conditions increase the risk of DVT. For example, diabetes, cancer, trauma, and antiphospholipid antibody syndrome. Other risk factors include advanced age, surgery, immobility (such as being bedridden, in an orthopedic cast, and sitting during a long-distance flight), combined oral contraceptives, pregnancy, the postpartum period, and genetic factors. The rate of DVT increases dramatically from infancy to old age, and in adulthood, about 1 in 1,000 adults develops DVT each year.

[0006] There are current devices and methods for preventing and / or treating DVT, but there are still many unsolved drawbacks. For example, the high incidence of DVT recurrence, using devices not designed to remove large clot volumes, and / or being a complex treatment involving multiple treatment devices and / or medications. Therefore, new devices, systems, and methods for treating thrombi (especially DVT) are desired. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0007] The present technology generally relates to methods and systems for removing clots (e.g., thrombi) from the blood vessels of a human patient. In some embodiments, a system for removing a clot (e.g., a thrombectomy system) includes a thrombus extraction device, the thrombus extraction device including (i) a core-removing element configured to core out and separate the clot from the vessel wall, and (ii) a capture element configured to capture the cored-out and separated clot. In some embodiments, the core-removing element includes a unitary structure having a first region adjacent to the proximal portion of the unitary structure, a second region distal to the first region, a third region distal to the second region, and a fourth region distal to the third region. The first region can include a first opening configured to core out and separate the clot, and the third region can include a second opening configured to core out and separate the clot. The second and fourth regions can each be generally tubular and can include a plurality of interconnected struts. In one aspect of the technology, the first and second openings are radially offset and at least one of the first and second openings is positioned and oriented to effectively core out and separate the clot from within the blood vessel during a thrombectomy procedure using the thrombus extraction device.

[0008] In some embodiments, the thrombectomy system includes a dilator assembly for deploying an expandable funnel coupled to the distal portion of the introducer sheath. The dilator assembly can include a first shaft defining a lumen, a second shaft slidably positioned within the lumen of the first shaft, and a retention sheath coupled to the second shaft and configured to receive and restrain the funnel therein. A control assembly including a drive portion is operably coupled to the first and second shafts. Movement of the drive portion to a first position is configured to advance the first and second shafts distally together to deploy the funnel from the retention sheath. Movement of the drive portion to a second position is configured to advance the first shaft distally relative to the second shaft such that the first shaft and the retention sheath define a generally uniform (e.g., constant diameter) outer surface. In one aspect of the technology, when the dilator assembly retracts through the introducer sheath, it is less likely that the generally uniform outer surface of the dilator assembly will catch on the funnel or the blood vessel or otherwise cause damage. In another aspect of the technology, the dilator assembly can be coupled to the introducer sheath to prevent or even prevent premature deployment of the funnel at an unintended time. This specification also provides, for example, the following items. (Item 1) A core removal element for removing a vascular thrombus within a patient's blood vessel, wherein the core removal element includes a one-piece structure, the one-piece structure is a first region adjacent to the proximal portion of the one-piece structure, the first region including a first opening configured to remove the vascular thrombus; a second region distal to the first region, the second region being generally tubular and including a first plurality of interconnected struts; a third region distal to the second region, the third region including a second opening configured to remove the vascular thrombus; a fourth region distal to the third region, the fourth region being generally tubular and including a second plurality of interconnected struts. A core-removing element comprising (Item 2) The core-removing element according to item 1, wherein the first mouth portion is radially offset from the second mouth portion. (Item 3) The integral structure extends along a longitudinal axis, The core-removing element according to item 1, wherein the first region comprises a pair of first curved struts that curve in opposite directions around the longitudinal axis and intersect at a pair of first joints to define the first mouth portion. (Item 4) The integral structure extends along a longitudinal axis, The third region comprises (a) a pair of upper curved struts that curve around the longitudinal axis and intersect each other at an upper joint, and (b) a pair of lower curved struts that curve around the longitudinal axis and intersect each other at a lower joint, The core-removing element according to item 1, wherein the lower and upper curved struts define the second mouth portion. (Item 5) The lower and upper curved struts define (a) a first mouth portion opening in a first direction substantially orthogonal to the longitudinal axis and (b) a second mouth portion opening in a second direction substantially orthogonal to the longitudinal axis, The core-removing element according to item 4, wherein the first and second mouth portions define the second mouth portion. (Item 6) The core-removing element according to item 5, wherein the first direction is generally opposite to the second direction. (Item 7) The core-removing element according to item 1, wherein the core-removing element is expandable from a compressed delivery configuration to an expanded deployment configuration. (Item 8) The core-removing element according to item 7, wherein the core-removing element is configured to self-expand. (Item 9) The core-removing element according to item 8, wherein the core-removing element is formed from a shape memory material. (Item 10) The core-removing element according to item 1, wherein the fourth region of the integral structure is configured to be connected to a braided filament mesh structure. (Item 11) An expander assembly for deploying an expandable funnel coupled to a distal portion of an introducer sheath, the expander assembly comprising: a first shaft defining a lumen; a second shaft slidably positioned within the lumen of the first shaft; a retention sheath coupled to the second shaft and configured to receive and constrain the funnel therein; a control assembly including a drive portion operably coupled to the first and second shafts, wherein when the drive portion moves from a first position to a second position, the first and second shafts advance together to deploy the funnel from the retention sheath, and when the drive portion moves from the second position to a third position, the first shaft advances relative to the second shaft; An expander assembly comprising the above. (Item 12) The expander assembly according to item 11, wherein the retention sheath has substantially the same outer diameter as the first shaft. (Item 13) The expander assembly according to item 11, wherein when the drive portion moves from the second position to the third position, a distal portion of the first shaft contacts a proximal portion of the retention sheath. (Item 14) The control assembly comprises: a housing; a first shaft hub slidably positioned within the housing and coupled to the first shaft; a second shaft hub slidably positioned within the housing and coupled to the second shaft; The expander assembly according to item 11, comprising the above. (Item 15) The expander assembly according to item 14, wherein when the drive portion moves from the first position to the second position such that the first and second shafts advance together, the first shaft hub is configured to engage the second shaft hub. (Item 16) When the drive unit moves from the second position to the third position so that the first shaft advances relative to the second shaft, the first shaft hub is configured to disengage from the second shaft hub, the expander assembly according to item 14. (Item 17) When the drive unit moves from the first position to the second position so that the first and second shafts both advance, the first shaft hub is configured to engage with the second shaft hub, When the drive unit moves from the second position to the third position so that the first shaft advances relative to the second shaft, the first shaft hub is configured to disengage from the second shaft hub, the expander assembly according to item 14. (Item 18) The second shaft hub includes a first engagement feature, The housing includes a second engagement feature, When the drive unit moves from the second position to the third position, the first engagement feature is configured to engage with the second engagement feature at the second position to prevent movement of the second shaft hub, the expander of the assembly of item 14. (Item 19) The first engagement feature is a snap feature, The second engagement feature is a detent formed within the housing, the expander assembly according to item 18. (Item 20) Further includes a biasing member operably coupled to the first shaft hub, The biasing member is configured to bias the first shaft hub from the third position toward the second position, the expander assembly according to item 14. (Item 21) The control assembly further includes a housing, The drive unit is movable relative to the housing, The movement of the drive unit from the first position to the second position is a distal movement of the drive unit relative to the housing, The movement of the drive unit from the second position to the third position is a further distal movement of the drive unit relative to the housing, the dilator assembly according to item 11. (Item 22) The dilator assembly according to item 11, further comprising the introducer sheath and the funnel. (Item 23) A system for capturing a vascular thrombus within a patient's blood vessel, the system comprising: An introducer sheath having a distal portion; An expandable funnel coupled to the distal portion of the introducer sheath; A dilator assembly configured to be inserted through the introducer sheath and to deploy the expandable funnel, the dilator assembly comprising: A first shaft defining a lumen; A second shaft slidably positioned within the lumen of the first shaft; A holding sheath coupled to the second shaft and configured to receive and restrain the funnel therein; A control assembly including a drive unit operably coupled to the first and second shafts, wherein when the drive unit moves from a first position to a second position, the first and second shafts both advance distally to deploy the funnel from the holding sheath, and when the drive unit moves from the second position to a third position, the first shaft advances relative to the second shaft; A dilator assembly; A clot removal device configured to be inserted through the introducer sheath and to capture at least a portion of the vascular thrombus; A system. (Item 24) The clot removal device includes an expandable de-coring element coupled to an expandable capture element, The de-coring element is configured to separate at least a portion of the vascular thrombus from the wall of the blood vessel, The system according to item 23, wherein the capture element is configured to capture and hold a portion of the vascular thrombus separated from the wall of the blood vessel. (Item 25) The funnel has a first length when deployed from the holding sheath, The system according to item 23, wherein the core removal element has a second length shorter than the first length when expanded. (Item 26) A system for capturing a vascular thrombus in a patient's blood vessel, the system comprising: An introducer sheath having a distal portion, An expandable funnel coupled to the distal portion of the introducer sheath, An expander assembly configured to be inserted through the introducer sheath and expand the expandable funnel, A clot removal device configured to be inserted through the introducer sheath, the clot removal device including an expandable core removal element coupled to an expandable capture element, the core removal element including a first region including a first opening and a second region including a second opening, the first and second openings being configured to separate at least a portion of the vascular thrombus from the wall of the blood vessel, and the capture element being configured to capture and hold the portion of the vascular thrombus separated from the wall of the blood vessel. A system including. (Item 27) The system according to item 26, wherein the first opening is radially offset from the second opening. (Item 28) The core removal element is formed from a unitary structure including a plurality of struts, The struts define the first and second openings, The struts further define a plurality of gaps, The system according to item 27, wherein the first and second openings are larger than respective ones of the gaps.

[0009] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

Brief Description of the Drawings

[0010]

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DETAILED DESCRIPTION OF THE INVENTION

[0011] Many of the embodiments are described below with respect to devices, systems, and methods for treating vascular thrombi (e.g., deep vein thrombosis (DVT)), but other applications and other embodiments other than those described herein are also within the scope of the technology (e.g., endovascular procedures other than embolism treatment, endovascular procedures for treating cerebral embolism, endovascular procedures for treating pulmonary embolism). Generally, for example, using the devices, systems, and methods of the technology, any formation of materials within a blood vessel (e.g., a vein or arterial blood vessel), such as a cancerous growth, a pathological growth, etc., can be extracted. Further, some other embodiments of the technology can have configurations, states, components, or procedures different from those described herein. Also, of course, the specific elements, substructures, advantages, usage methods, and / or other features of the embodiments described with reference to FIGS. 1-12K can be suitably exchanged, substituted, or otherwise configured with each other by further embodiments of the technology. Further, the suitable elements of the embodiments described with reference to FIGS. 1-12K can be used as stand-alone and / or self-standing devices. Accordingly, those skilled in the art will understand that the technology can have other embodiments with additional elements, or that the technology can have other embodiments without some of the features illustrated and described below with reference to FIGS. 1-12K.

[0012] Regarding the terms "distal" and "proximal" used within this description, unless otherwise indicated, the terms can refer to the relative position of a portion of a catheter subsystem with respect to an operator and / or a location within a vasculature structure. Also, as used herein, notations such as "rearward", "forward", "upward", "downward", etc. are not intended to limit the referenced component to use in a particular orientation. Of course, such notations refer to the orientation of the reference component as illustrated in the figures. The systems of the technology can be used in any orientation suitable for the user.

[0013] The headings given herein are for convenience only and should not be construed as limiting the disclosed subject matter.

[0014] I. Selected Embodiments of the Thrombus Extraction System FIG. 1 is a side view of a thrombus extraction system 100 (which can also be referred to as a thrombus removal system or a clot removal system) configured according to an embodiment of the present technology. In the illustrated embodiment, the thrombus extraction system 100 includes an introducer assembly 102, an obturator or dilator assembly 104 (shown as being located within the introducer assembly 102), and a thrombus extraction assembly 106. Generally, the thrombus extraction system 100 can be used to (i) access a portion of a blood vessel (e.g., a vein of a human patient) containing a thrombus (e.g., a clot), and (ii) remove all or a portion of the thrombus from the blood vessel. More specifically, for example, the introducer assembly 102 and the dilator assembly 104 can be advanced partially into a patient's vasculature (e.g., the patient's blood vessel or vein). The dilator assembly 104 can be actuated to deploy a self-expanding funnel (e.g., as shown in FIGS. 7A - 7C) and then removed from the introducer assembly 102. Next, the thrombus extraction assembly 106 and an attached thrombus extraction device can be partially inserted through the introducer assembly 102 and deployed at and / or near the location of the thrombus to capture the thrombus. Finally, the thrombus extraction assembly 106 and / or the introducer assembly 102 can be removed from the patient together with the captured thrombus. In some embodiments, the thrombus extraction system 100 for removing a thrombus from a patient and / or the method of operating the thrombus extraction system 100 can include some features that are the same as or similar to those of the thrombus extraction systems described in detail in the following documents. (i) U.S. Patent No. 9,700,332 (filed on September 16, 2016), titled "INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS" and / or (ii) U.S. Patent No. 10,098,651 (filed on April 26, 2017), titled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION". Both documents are incorporated herein by reference in their entirety.

[0015] In the illustrated embodiment, introducer assembly 102 includes an elongate sheath 112 (which may also be referred to as a shaft, catheter, etc.). Sheath 112 defines a lumen (hidden in FIG. 1 and identified, for example, as lumen 688 in FIG. 6) and includes a proximal portion 113a and a distal portion 113b. The proximal portion 113a can terminate at a proximal end and the distal portion 113b can terminate at a distal end. The size of the lumen of sheath 112 is provided to slidably receive dilator assembly 104 and thrombus extraction assembly 106. For example, dilator assembly 104 is shown to be partially located within sheath 112 of FIG. 1. Sheath 112 can be elastic and / or flexible and can have any suitable length and diameter. In some embodiments, the outer diameter of sheath 112 can be at least 10 French, at least 12 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, at least 26 French, greater than 26 French, 10 French to 26 French, 14 French to 24 French, 15 French to 21 French, 16 French to 22 French, and / or any other or intermediate size. In some embodiments, the inner diameter of the lumen of sheath 112 can be at least 2 French, at least 10 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, 11 French to 12 French, 10 French to 22 French, 14 French to 21 French, 16 French to 20 French, and / or any other or intermediate size. In some embodiments, sheath 112 can include a radiopaque marker (not shown), for example, located at its distal portion 113b.

[0016] The introducer assembly 102 further includes a sealable hub 114 coupled to the proximal portion 113a of the sheath 112. The sealable hub 114 is configured to provide access to the lumen of the sheath 112, can be self-sealing, and / or can include a self-sealing seal. For example, in the illustrated embodiment, the sealable hub 114 is a hemostasis valve. The hemostasis valve is configured to maintain hemostasis during a thrombus extraction procedure by preventing fluid flow in the proximal direction through the sealable hub 114 when various components (e.g., portions of the dilator assembly 104 and / or the thrombus extraction assembly 106) are inserted through the sealable hub 114 such that they are delivered through the sheath 112 to a treatment site within a blood vessel. More specifically, the sealable hub 114 can be of the type disclosed in U.S. Patent Application No. 16 / 117,519, filed August 30, 2018, titled "HEMOSTASIS VALVES AND METHODS OF USE", which is hereby incorporated by reference in its entirety. The sealable hub 114 can include one or more buttons or actuators that allow an operator to selectively seal / unseal the sealable hub 114.

[0017] The introducer assembly 102 can further include a sealable hub 114 (e.g., a side port of the sealable hub 114) and / or a sheath 112 (e.g., the proximal portion 113a of the sheath 112) that includes a suction port 116 connected, for example, via a connecting tube 118. The suction port 116 can be connected to a syringe connector 117 that can be selectively coupled to a syringe or other suction device, or the suction port 116 can be connected to other suitable elements. In some embodiments, the introducer assembly 102 can include a fluid control device 119 configured to selectively and fluidly connect the suction port 116 to the lumen of the sheath 112. In the illustrated embodiment, the fluid control device 119 is a stopcock operably coupled to the connecting tube 118 between the lumen of the sheath 112 and the suction port 116. In other embodiments, the fluid control device 119 can be a clamp or another suitable valve.

[0018] The expander assembly 104 can include a control assembly 120 operably coupled to the retention sheath 122 via a first shaft (hidden in FIG. 1, e.g., identified as the first shaft 580 in FIGS. 5A and 5B). In the illustrated embodiment, the first shaft of the expander assembly 104 extends through the sealable hub 114 and the sheath 112 such that the retention sheath 122 is positioned distal to the distal portion 113b of the sheath 112. Also, the control assembly 120 is removably coupled (e.g., engaged, fixed) to the sealable hub 114. Thus, the introducer assembly 102 can carry or hold the expander assembly 104. As will be described in more detail later with reference to FIGS. 5A-7D, the expander assembly 104 (e.g., the retention sheath 122) is configured to (i) hold / restrain a self-expanding funnel (hidden in FIG. 1, e.g., identified as the funnel 690 in FIG. 6) attached to the distal portion 113b of the sheath 112, and (ii) release / deploy the self-expanding funnel. More specifically, for example, the control assembly 120 can include a drive portion 124. The drive portion 124 is movable (e.g., in the direction of arrow A in FIG. 1) to advance the retention sheath 122 relative to the sheath 112 (and the self-expanding funnel) attached thereto to deploy / release the self-expanding funnel.

[0019] In some embodiments, the thrombectomy system 100 can further include a mounting tool 108 (e.g., a mounting funnel). The mounting tool 108 is used when mounting a self-expanding funnel into the expander assembly 104 (e.g., into the retention sheath 122). In the illustrated embodiment, the mounting tool 108 defines a lumen 127 therethrough and includes a first portion 126 (e.g., a tapered portion such as a funnel portion) with a varying diameter and a second portion 128 (e.g., a shaft portion) with a substantially constant diameter. In other embodiments, the second portion 128 can have a partially varying diameter. The configuration (e.g., size and shape) of the first portion 126 is provided to receive a self-expanding funnel and move the self-expanding funnel to a constrained configuration when advancing the self-expanding funnel through the first portion 126. The size of the lumen 127 of the mounting tool 108 can be provided such that the retention sheath 122 can pass completely through the mounting tool 108.

[0020] In the illustrated embodiment, the thrombus extraction assembly 106 includes a catheter portion 130 and a handle portion 140 (the "handle 140") operably coupled to the catheter portion 130. During operation, the handle 140 is configured to be driven / operated by a user to control (e.g., deploy) one or more components of the catheter portion 130 and / or a thrombus extraction device (not shown in FIG. 1, e.g., identified as the thrombus extraction device 250 in FIGS. 2A and 2B) coupled to the catheter portion 130.

[0021] In the illustrated embodiment, the catheter portion 130 includes an outer shaft 132, an intermediate shaft 133, and an inner shaft 134 that are slidable relative to each other and coaxially aligned. For example, each of the shafts 132-134 can define a lumen (e.g., a central axial lumen), and (i) the intermediate shaft 133 can be configured (e.g., sized and shaped) to slidably fit within the lumen of the outer shaft 132, and (ii) the inner shaft 134 can be configured to slidably fit within the lumen of the intermediate shaft 133. In some embodiments, the outer shaft 132 (e.g., sized) is configured to slidably fit within the sheath 112 of the introducer assembly 102, and for example, the size can be at least 8 French, at least 10 French, at least 11 French, at least 12 French, at least 14 French, at least 16 French, 8 French to 14 French, 11 French to 12 French, and / or any other or intermediate size. This arrangement allows the shafts 132-134 to be longitudinally displaced relative to each other and relative to the sheath 112 of the introducer assembly 102. In some embodiments, the shafts 132-134 can each be the same length, but in other embodiments, one or more of the shafts 132-134 can be of different lengths. For example, in some embodiments, the intermediate shaft 133 can be longer than the outer shaft 132, and the inner shaft 134 can be longer than the intermediate shaft 133. In other embodiments, the catheter portion 130 can include any number of shafts (e.g., catheters, sheaths) that are slidable relative to each other and / or configured to be coaxially positioned relative to each other. For example, in some embodiments, the catheter portion can include three intermediate shafts as described in detail in the following document. U.S. Patent No. 10,098,651 (filed April 26, 2017), titled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION". This document is hereby incorporated by reference in its entirety into this specification.

[0022] The handle 140 includes a proximal portion 141a (e.g., a plunger portion) and a distal portion 141b (e.g., a locking portion). In the illustrated embodiment, the intermediate shaft 133 is coupled to the distal portion 141b of the handle 140 and extends distally therefrom. The distal portion 141b of the handle 140 can include a locking feature 142 (e.g., a spin lock, etc.). The locking feature 142 is configured to selectively engage and / or engage fixedly with an engaging feature 135 disposed near the proximal portion 136a of the outer shaft 132. In some embodiments, the outer shaft 132 can be positioned relative to the intermediate shaft 133 by sliding proximally on the intermediate shaft 133 until the locking feature 142 engages the engaging feature 135. In some embodiments, the intermediate shaft 133 is relatively longer than the outer shaft 132, and when the outer shaft 132 engages fixedly with the locking feature 142, a portion of the intermediate shaft 133 extends distally from the distal portion 136b of the outer shaft 132.

[0023] In the illustrated embodiment, the handle portion 140 further includes a plunger 144 (e.g., a drive portion). The plunger 144 is operably coupled to the inner shaft 134 and is movable between a first non-extended position (e.g., as shown in FIGS. 1 and 2A) and a second extended position (e.g., as shown in FIG. 2B). Thus, when the plunger 144 moves relative to the handle portion 140, the inner shaft 134 is displaced relative to the handle portion 140, the outer shaft 132, and / or the intermediate shaft 133. For example, when the plunger 144 is proximally retracted from the first position to the second position, the inner shaft 134 can be retracted through the intermediate shaft 133. In some embodiments, the length of the inner shaft 134 can be such that when the plunger 144 is in both the first and second positions, the inner shaft 134 extends distally beyond the distal end of the intermediate shaft 133. In some embodiments, the plunger 144 can be lockable in the first position and / or the second position to lock the position of the inner shaft 134. In other embodiments, the plunger 144 can be operably coupled to other components of the catheter portion 130 (e.g., the intermediate shaft 133 and / or one or more additional shafts (not shown)).

[0024] In the illustrated embodiment, the thrombus extraction assembly 106 further includes a first flush port 138 connected to the outer shaft 132 and a second flush port 148 connected to the handle portion 140. The first flush port 138 can be fluidly connected to the lumen of the outer shaft 132 to enable flushing of the lumen of the outer shaft 132. The second flush port 148 can be fluidly connected to the lumen of the intermediate shaft 133 (e.g., via an inner portion of the handle portion 140) to enable flushing of the lumen of the intermediate shaft 133.

[0025] The thrombus extraction assembly 106 can include and / or be coupled to a thrombus extraction device configured to remove and capture thrombi from a patient. For example, FIGS. 2A and 2B are side views of the thrombus extraction assembly 106 of FIG. 1 operably coupled to a thrombus extraction device 250 configured in accordance with an embodiment of the present technique. The thrombus extraction device 250 is shown in FIG. 2A in a deployed and partially expanded configuration and in FIG. 2B in a deployed and fully expanded configuration. The thrombus extraction device 250 can be placed in a non-deployed constrained (e.g., non-expanded) position when located within the outer shaft 132.

[0026] Referring to both FIGS. 2A and 2B, the thrombus extraction device 250 includes an expandable core removal element 252 and an expandable capture element 254 coupled (e.g., attached, connected, integrally formed) to the core removal element 252. The core removal element 252 is positioned proximal to the capture element 254. In the illustrated embodiment, the core removal element 252 includes (i) a proximal portion 253a coupled to an intermediate shaft 133 (e.g., a distal portion of the intermediate shaft 133) and (ii) a distal portion 253b coupled to a proximal portion 255a of the capture element 254. Further, a distal portion 255b of the capture element 254 is coupled to an inner shaft 134 (e.g., a distal portion of the inner shaft 134). As shown, the outer shaft 132 is shifted proximally relative to the handle 140 such that the engagement feature 135 of the outer shaft 132 contacts / engages the lock feature 142 of the handle 140. This positioning of the outer shaft 132 relative to the handle 140 causes the intermediate shaft 133, the inner shaft 134, and the thrombus extraction device 250 to each extend distally beyond the distal portion 136b of the outer shaft 132.

[0027] In some embodiments, the thrombus extraction device 250 can further include a non-invasive tip 258. In some embodiments, the non-invasive tip 258 can include radiopaque markers that assist in positioning the thrombus extraction device 250 intravascularly within a patient. The thrombus extraction device 250 can, in addition or alternatively, include one or more radiopaque markers disposed on, for example, the outer shaft 132 (e.g., the distal portion 136b of the outer shaft 132), the intermediate shaft 133 (e.g., the distal portion of the intermediate shaft 133), and / or other components of the thrombus extraction device 250. In some embodiments, the non-invasive tip 258 can define a path configured to receive a guidewire.

[0028] In the partially expanded configuration shown in FIG. 2A, the plunger 144 of the handle 140 is in a first position. In contrast, in the fully expanded configuration shown in FIG. 2B, the plunger 144 is in a second position (e.g., retracting proximally away from the handle 140) such that the inner shaft 134 retracts proximally relative to the intermediate shaft 133. By retracting the inner shaft 134 proximally relative to the intermediate shaft 133 in this manner, the core removal element and the capture element 254 are forced to fully expand. This will be described in more detail later with reference to FIG. 4.

[0029] The thrombus extraction assembly 106 can include one or more features configured to fix the thrombus extraction device 250, specifically the deflating element 252 and / or the expandable capture element 254, in a fully expanded position. As used herein, full expansion refers to a state in which the thrombus extraction device 250 is continuously biased in the expansion direction by one or more forces other than the self-expansion force generated by the thrombus extraction device 250. In some embodiments, full expansion occurs when the thrombus extraction device 250 is deployed and the plunger 144 is in the second position (e.g., when the inner shaft 134 is retracted proximally relative to the intermediate shaft 133). Alternatively or in addition, full expansion can occur when the thrombus extraction device 250 is deployed and biased in the expansion direction via a spring directly or indirectly connected to the thrombus extraction device 250. Thus, when the thrombus extraction device 250 is fully expanded, the diameter of the thrombus extraction device 250 does not change with a force smaller than the minimum radial compression force. Thus, when fully expanded, the thrombus extraction device 250 can maintain at least a desired radial force against the blood vessel when the thrombus extraction device 250 is withdrawn through the blood vessel. In some embodiments, the dimensions of the thrombus extraction device 250 can be selected such that when fully expanded, the thrombus extraction device 250 approaches the wall of the blood vessel and / or applies a desired force to the wall of the blood vessel.

[0030] In some embodiments, locking the plunger 144 in the second position can be accomplished, for example, by rotating the plunger 144 relative to the handle 140, thereby engaging one or more locking features on the plunger 144 and / or within the handle 140. By locking the plunger 144 in the second position, the position of the inner shaft 134 relative to the intermediate shaft 133 is fixed, and as a result, the thrombus extraction device 250 is fixed in the fully extended position. In other embodiments, directly locking both the inner shaft 134 and the intermediate shaft 133 together can be accomplished, for example, by (i) a static coupling in which the position of the inner shaft 134 is fixed relative to the position of the intermediate shaft 133, or (ii) a dynamic coupling in which the position of the inner shaft 134 relative to the intermediate shaft 133 is restricted (rather than fixed). For example, dynamically locking the inner shaft 134 to the plunger 144 can be accomplished via a stretchable spring (e.g., a tension spring, a compression spring), such that when the plunger 144 is locked in the second position, restricted movement of the inner shaft 134 relative to the intermediate shaft 133 is possible.

[0031] II. SELECTED EMBODIMENTS OF THE DE-CORING ELEMENT Figures 3A - 3D are, respectively, an isometric view, a side view, a top view, and a rear view (facing the proximal direction) of the de-coring element 252 of the thrombus extraction device 250 of Figures 2A and 2B constructed in accordance with an embodiment of the present technology. Referring to Figures 3A - 3D together, the de-coring element 252 includes a plurality of struts 360 that together define a plurality of gaps or holes 362. The struts 360 can have various shapes and sizes, and in some embodiments, the thickness and / or diameter of the struts 360 can be about 0.05 - 0.15 inches, about 0.075 - 0.125 inches, about 0.09 - 0.1 inches, about 0.096 inches, and / or other dimensions. Generally, the struts 360 can together form a single fenestrated structure configured to de-core and separate a portion of a thrombus (e.g., a vascular thrombus) from a blood vessel containing the thrombus. In some embodiments, the de-coring element 252 can include a stent or a stent-like device.

[0032] As best shown in FIGS. 3B and 3C, the core removal element 252 includes a first region 363 including a proximal portion 253a, a second region 364 distal to the first region 363, a third region 365 distal to the second region 364, and a fourth region 366 distal to the third region 365 and including a distal portion 253b. The second region 364 and the fourth region 366 can be generally tubular. The first region 363 and the third region 365 have relatively fewer struts 360 compared to the second region 364 and the fourth region 366. For example, the first region 363 can have a pair of curved struts 367 (specifically identified as a first strut 367a and a second strut 367a as best shown in FIGS. 3A and 3C). The pair of curved struts 367 curve in opposite directions about the central axis L of the core removal element 252 and intersect and / or terminate at a pair of first junctions 361 (specifically identified as a lower first junction 361a and an upper first junction 361b) to define a proximal first mouth 370. The third region 365 can include (i) a pair of curved lower struts 368 (specifically identified as a first lower strut 368a and a second lower strut 368b shown together in FIG. 3A) that extend distally from a lower second junction 371a and curve about the central axis L, and (ii) a pair of curved upper struts 369 (specifically identified as a first upper strut 369a and a second upper strut 369b shown together in FIGS. 3A and 3C) that extend distally from an upper second junction 371b and curve about the central axis L. The lower and upper struts 368, 369 together define a distal first mouth portion 372a and a distal second mouth portion 372b (collectively “second mouth 372”). In the illustrated embodiment, the first mouth portion 372a is rotated out of alignment with the second mouth portion 372b. In other embodiments, the first mouth portion 372a can be positioned differently (e.g., different rotation and / or longitudinally) from the second mouth portion 372b, and / or the second mouth 372 can include more than two distinct portions (e.g., three, four, or more openings). Generally, the first and second mouths 370, 372 can be defined by / within regions of different porosity of the core removal element 252.

[0033] In some embodiments, the core removal element 252 is formed from a shape memory material (e.g., shape memory alloy and / or shape memory polymer). For example, the core removal element 252 can include nitinol and / or nitinol alloy. Similarly, the core removal element 252 can be formed using various techniques such as welding, laser welding, cutting, laser cutting, and / or expanding. For example, the core removal element 252 can first be laser cut from a piece of nitinol (e.g., nitinol tube) and then expanded and / or stretched. Generally, the size (e.g., length and diameter) of the core removal element 252 can be selected based on the size (e.g., diameter) of the blood vessel from which the thrombus is to be extracted. In some embodiments, the length M of the core removal element 252 can be about 0.2 to 5 inches (e.g., about 1.5 to 2.5 inches, about 1.75 to 2.25 inches, about 1.9 to 2.0 inches, about 1.5 to 1.8 inches, about 1.6 inches, about 1.7 inches, about 1.96 inches, about 3.0 inches, about 4.0 inches, less than 0.5 inches). In some embodiments, in the unconstrained fully expanded position within the blood vessel, the diameter D of the core removal element 252 can be about 2 to 50 mm (e.g., about 4 to 25 mm, about 6 to 20 mm, about 8 to 16 mm). In some embodiments, to prevent unwanted tilting and / or rotation of the core removal element 252 within the blood vessel during operation, the length M of the core removal element 252 can be selected based on the fully expanded unconstrained diameter D of the core removal element 252. Generally, the length M and the unconstrained diameter D of the core removal element 252 vary depending on the size of the blood vessel for which the core removal element 252 is designed. For example, the core removal element 252 generally has a smaller length M and diameter D when designed for a smaller (e.g., 4 mm) blood vessel rather than a larger (e.g., 25 to 35 mm) blood vessel.

[0034] The core removal element 252 is configured to core (e.g., shear, separate) a thrombus from within a blood vessel as the core removal element advances / retracts through the thrombus in a fully expanded configuration. For example, as will be described in more detail later with reference to FIGS. 12D - 12K, the core removal element 252 can be retracted proximally through the thrombus to core the thrombus. When the core removal element 252 is retracted through the thrombus, the fully expanded diameter of the core removal element 252 flexibly adapts to match the diameter of the blood vessel. More particularly, the configuration (e.g., size, shape, and / or position) of the first and second mouths 370, 372 is provided to effect most of the core removal function (e.g., core removal force) during operation of the core removal element 252. For example, the surface of the strut 367 facing in the proximal direction can define a first leading edge that cores the thrombus by cutting it open. Similarly, the surfaces of the lower and upper struts 368, 369 facing in the proximal direction can also define a second leading edge that can core the thrombus by cutting it open. In some embodiments, a portion of the strut 367, the lower strut 368, and / or the upper strut 369 can be sharpened and / or can have a cutting element (e.g., a knife or knife edge) attached or otherwise integrated to further facilitate core removal of the thrombus.

[0035] In one aspect of the present technique, the first mouth portion 370 and the second mouth portion 372 are longitudinally offset relative to each other. Also, the leading edges of the strut 367 and the lower and upper struts 368, 369 are differently oriented such that, for example, when the de-coring element 252 is within a blood vessel, the first mouth portion 370 and the second mouth portion 372 are oriented at different angles. The arrangement may be more effective in de-coring thrombus compared to, for example, a case where the de-coring element includes only a single mouth portion (e.g., only the first mouth portion 370). The de-coring length of the de-coring element 252 for engaging the wall of the blood vessel to de-core (e.g., adhesive) thrombus is expected to be longer than that of a de-coring element with only a single mouth portion. Also, the de-coring element 252 can be made relatively flexible in the first region 363 and the third region 365, which have fewer struts 360 than the second region 364 and the fourth region 366. For example, the de-coring element 252 can bend / curve at the first junction 361 and / or the second junction 371. In some embodiments, the first and second junctions 361, 371 allow the de-coring element 252 to bend in different directions (e.g., lateral and vertical). In one aspect of the present technique, the ability of the de-coring element 252 to bend in this way allows the de-coring element 252 to maintain a selected orientation even when moving through a tortuous blood vessel. In another aspect of the present technique, the arrangement of the first and second mouth portions 370 and 372 ensures that at least one of the first mouth portion 370, the first mouth portion part 372a, and the second mouth portion part 372b is positioned and oriented to effectively de-core thrombus from within the blood vessel during a thrombus extraction procedure using the de-coring element 252. In some embodiments, the first mouth portion 370 and / or the second mouth portion 372 can further facilitate folding the de-coring element 252 into a non-expanded configuration.

[0036] In the embodiments illustrated in FIGS. 3A - 3D, the first connection feature 374 and the second connection feature 376 are coupled to the core removal element 252. As will be described in more detail later with reference to FIG. 4, the intermediate shaft 133 (FIG. 1) can be operably coupled to the first connection feature 374 and the inner shaft 134 can be operably coupled to the second connection feature 376 to control the operation (e.g., movement and expansion) of the core removal element 252. In the illustrated embodiment, the first connection feature 374 is a ring coupled to the proximal portion 253a of the core removal element 252, more specifically, the lower first joint 361a. In other embodiments, the first connection feature 374 can be positioned at a different portion of the core removal element 252 (e.g., at one of the struts 367 at the upper first joint 361b). Similarly, the second connection feature 376 can also be a ring and can be coupled to one or more of the struts 360 in the second region 364 or another region of the core removal element 252. As best seen in FIG. 3D, in some embodiments, the diameter E1 of the first connection feature 374 can be larger than the diameter E2 of the second connection feature 376, and the first and second connection features 374, 376 can be axially aligned along an axis extending parallel to the central axis L of the core removal element 252. In other embodiments, the first and second connection features 374, 376 can have other shapes and / or configurations and / or can be arranged differently relative to each other. The first and second connection features 374, 376 can be made of the same material as the core removal element 252 or a different material than the core removal element 252. Similarly, the first and second connection features 374, 376 can be formed integrally with the core removal element 252 and / or can be attached to the core removal element 252 via one or more of, for example, a weld, an adhesive, a mechanical fastener, etc.

[0037] FIG. 4 is an enlarged side view of a thrombectomy device 250 in a fully expanded configuration according to an embodiment of the present technique, attached to the distal portion of the thrombus extraction assembly 106. In the illustrated embodiment, the decoring element 252 is attached to the intermediate shaft 133 (e.g., the distal portion of the intermediate shaft 133) via a first connection feature 374. In some embodiments, the decoring element 252 is fixedly attached to the intermediate shaft 133 such that movement of the intermediate shaft 133 also causes movement of the decoring element 252. The proximal portion 255a of the capture element 254 is connected to the distal portion 253b of the decoring element 252. In some embodiments, the capture element 254 is formed on the distal portion 253b of the decoring element 252 such that the thrombectomy device 250 has a single / one-piece structure. For example, the capture element 254 can include a mesh (e.g., a braided filament mesh structure) woven onto the distal portion 253b of the decoring element 252. In some embodiments, the distal portion 255b of the capture element 254 is attached to the inner shaft 134 (e.g., the distal portion of the inner shaft 134).

[0038] In the illustrated embodiment, the inner shaft 134 extends slidably through a second connection feature 376. That is, the outer diameter of the inner shaft 134 can be made smaller than the diameter E2 (FIG. 4) of the second connection feature 376 such that the second connection feature 376 is slidable along the inner shaft 134. The inner shaft 134 can include a stop feature 478 configured to engage the second connection feature 376 of the decoring element 252 and cause expansion of the decoring element 252. In some embodiments, the stop feature 478 can include a polymeric member and / or a metallic member added to a portion of the inner shaft 134 distal from the second connection feature 376.

[0039] The stop feature 478 (e.g., size and shape) is configured to contact and engage the second connection feature 376 when, for example, the inner shaft 134 is retracted proximally relative to the core removal element 252 via movement of the plunger 144 (Figs. 1-3) from a first position to a second position. This arrangement allows the stop feature 478 to apply a proximally directed force to the core removal element 252 that can expand all or a portion of the core removal element 252 to a fully expanded configuration, such that the core removal element 252 is selectively coupled to the inner shaft 134. For example, when the inner shaft 134 moves, at least a first region 363 (Figs. 3B and 3C) of the core removal element between the first and second connection features 374, 376 can be forced to expand. In some embodiments, the second connection feature 376 can be positioned differently relative to the core removal element 252 such that more or less of the core removal element 252 is forced to expand when the stop feature 478 is pulled relative to the second connection feature 376.

[0040] In some embodiments, the capture element 254 can include a braided filament mesh structure (e.g., a braid of elastic filaments having a generally tubular elongated portion 477 and a distal tapered portion 479). In other embodiments, the capture element 254 can be any porous structure and / or can have other suitable shapes, sizes, and configurations. Since the distal portion 255b of the capture element 254 is coupled to the inner shaft 134, axial movement of the inner shaft 134 expands / contracts and folds / extends the capture element 254. For example, proximal movement of the inner shaft 134 can compress the capture element 254 along its longitudinal axis such that (i) the radius of the capture element 254 increases and (ii) the length of the capture element 254 decreases. Conversely, distal movement of the inner shaft 134 can extend the capture element 254 along its longitudinal axis such that (i) the radius of the capture element 254 decreases and (ii) the length of the capture element 254 increases. In some embodiments, referring to FIGS. 2A, 2B, and 4 together, distal movement of the plunger 144 can move the capture element 252 to a fully folded position before the plunger 144 reaches the fully depressed first position shown in FIG. 2A. Thus, continued distal movement of the plunger 144 (e.g., from the second position toward the first position) can pull the decoring element 252 to fold / elongate the decoring element 252 longitudinally. That is, when the plunger 144 is pushed distally while the capture element 254 is fully folded, the plunger 144, the inner shaft 134, and the capture element 254 can act collectively to stretch / fold the decoring element 252. In other embodiments, the inner shaft 134 can be selectively separated from the capture element 254 such that proximal displacement of the inner shaft 134 expands the decoring element 252 without causing any movement of the capture element 254. In some embodiments, the length of the capture element 254 can be (i) about 5-30 inches (e.g., about 10-20 inches, about 16 inches) in the folded configuration and (ii) about 1-25 inches (e.g., about 10-20 inches, about 11 inches) in the expanded configuration.

[0041] In some embodiments, the capture element 254 can be formed by a knitting machine and / or a loom, while in other embodiments, the capture element 254 can be knitted and / or woven manually. In some embodiments, after forming the capture element 254 as a tubular braid, a heat setting process is further used for shaping. The braid can be, for example, a tubular braid of thin metal wires such as nitinol (nickel-titanium alloy), platinum, cobalt-chromium alloy, stainless steel, tungsten, or titanium. In some embodiments, the capture element 254 can be formed from a cylindrical braid of at least partially elastic filaments. Thus, the braid can be radially constrained without plastic deformation so that it can self-expand when the radial constraint is released. Such a braid of elastic filaments can be referred to herein as a "self-expanding braid". In some embodiments, the thickness of the braid filaments can be less than about 0.15 mm. In some embodiments, the braid can be made from filaments and / or wires having a diameter in the range of about 0.05 - 0.25 mm. In some embodiments, braid filaments of different diameters can be combined to impart different properties (such as stiffness, elasticity, structure, radial force, pore size, thrombus capture or filtering ability, etc.). In some embodiments, the capture element 254 and / or the decoring element 252 can be coated to reduce their surface friction / wear (for example, for arterial applications). Similarly, the capture element 254 and / or the decoring element 252 can be covered with a film (for example, via dip or spray coating) to form a non-permeable membrane so that thrombi are not embedded in the gaps of the capture element 254 and / or the decoring element 252, and thus the thrombi can be contained, resulting in facilitated cleaning. In some embodiments, the number of filaments used to form the capture element 254 can be about 20 - 300 (for example, including 144 filaments, 244 filaments). In some embodiments, the size of the pores formed by the capture element 254 (for example, in the elongated portion 477) can be about 0.05 - 4.0 mm (for example, about 0.5 mm - 2.5 mm, less than 0.4 mm).

[0042] III. Selected Embodiments of the Expander Assembly and Related Methods Figures 5A and 5B are side views of the expander assembly 104 of FIG. 1 in a first configuration and a second configuration, respectively, constructed in accordance with an embodiment of the present technology. Referring to FIGS. 5A and 5B together, the expander assembly 104 includes a first shaft or sheath 580 that extends between and operably couples the control assembly 120 and the retention sheath 122. The expander assembly 104 can further include a second shaft or sheath 582 that is slidably positioned on the first shaft 580 and is operably coupled to the control assembly 120. Stated another way, the second shaft 582 can define a lumen sized to slidably receive the first shaft 580 such that the first and second shafts 580, 582 can be axially displaced relative to each other. In the illustrated embodiment, the first shaft 580 is longer than the second shaft 582, and the retention sheath 122 is positioned distally of the distal portion 583b (opposite the proximal portion 583a) of the second shaft 582. The control assembly 120 further includes a housing 595 configured to engage (e.g., mate with) the sealable hub 114 (FIG. 1) of the introducer assembly 102.

[0043] The retention sheath 122 includes a proximal portion 585a and a distal portion 585b. In the illustrated embodiment, the distal portion 585a includes a non-traumatic tip 584, and the proximal portion 585a includes a first engagement feature 586. Similarly, the distal portion 583b of the second shaft 582 includes a second engagement feature 589. In some embodiments, the non-traumatic tip 584 is radiopaque.

[0044] When the expander assembly 104 is in the first configuration shown in FIG. 5A, the second shaft 582 is positioned (e.g., retracted) proximally relative to the first shaft 580, and the first engagement feature 586 does not engage the second engagement feature 589. As will be described in detail later with reference to FIG. 7A, when the expander assembly 104 is in the first configuration, the first engagement feature 586 is configured to engage (e.g., connect, engage) with the distal portion 113b (FIG. 1) of the sheath 112 of the introducer assembly 102. In some embodiments, a seal can be formed when the first engagement feature 586 engages the sheath 112.

[0045] When the expander assembly 104 is in the second configuration (FIG. 5B), the second engagement feature 589 of the second shaft 582 is configured to engage the first engagement feature 586 of the retention sheath 122. As shown, the diameter of the second shaft 582 can be made equal to or substantially equal to the outer diameter of the retention sheath 122 so that the expander assembly 104 has a uniform or substantially uniform (e.g., smooth) outer surface in the second configuration. That is, for example, there are no steps or discontinuities on the outer surface between the first shaft 580 and the retention sheath 122. In other embodiments, the second shaft 582 and the retention sheath 122 can have different diameters, and the first and second engagement features 586, 589 can be configured to provide a smooth transition between the second shaft 582 and the retention sheath 122. In some embodiments, a seal can be formed when the first engagement feature 586 engages the second engagement feature 589. In some embodiments, the operator can move the expander assembly 104 from the first configuration to the second configuration by driving the drive portion 124 of the control assembly 120 (e.g., by advancing the drive portion 124 in the direction of arrow A). More specifically, as will be described in detail later with reference to FIGS. 7A-7D, when the drive portion 124 is driven, (i) the first and second shafts 580, 582 can be advanced distally together relative to the sheath 112, and (ii) the second shaft 582 can be advanced distally relative to the first shaft 580.

[0046] FIG. 6 is an enlarged cross-sectional side view of a portion of the thrombus extraction system 100 shown in FIG. 1. More specifically, shown in FIG. 6 is a self-expanding funnel 690 coupled to the distal portion 113b of the sheath 112 of the introducer assembly 102 and restrained within the retention sheath 122 of the expander assembly 104, according to an embodiment of the present technique. In the illustrated embodiment, the retention sheath 122 includes a shell portion 692 coupled to the tip portion 584 and defining a lumen 693. In some embodiments, the shell portion 692 and the tip portion 584 are integrally formed together, while in other embodiments, the tip portion 584 can be made a separate component coupled to the shell portion 692, for example, by positioning at least a portion of the tip portion 584 within the lumen 693 and securing the shell portion 692 to the tip portion 584 (e.g., by adhesive, friction fit).

[0047] The first shaft 580 of the expander assembly 104 extends through the lumen 688 of the sheath 112 and at least partially through the lumen 693 of the shell portion 692. In the illustrated embodiment, a portion of the tip portion 584 snugly receives the distal portion (e.g., the distal end portion) of the first shaft 580 to secure the first shaft 580 to the retention sheath 122. In other embodiments, the first shaft 580 can be coupled to the retention sheath 122 in other ways. Further, as shown in FIG. 6, the first shaft 580 and the tip portion 584 can define a continuous lumen 691 for receiving a guide wire (not shown). In some embodiments, the diameter of the guide wire can be about 0.038 inches, 0.035 inches, about 0.018 inches, 0.014 inches, greater than about 0.38 inches, less than about 0.1 inches, or less than about 0.05 inches.

[0048] In the illustrated embodiment, the inner diameter F1 of the shell portion 692 is greater than the outer diameter F2 of the first shaft 580, and an annular retention / receiving space 694 is formed between the outer surface of the first shaft 580 and the inner surface of the shell portion 692. The receiving space 694 (e.g., size and shape) is configured to receive and / or retain the funnel 690 in a constrained configuration. Thus, in some embodiments, the diameter of the funnel 690 can be made to substantially match the inner diameter F1 of the shell portion 692 when the funnel 690 is in a constrained configuration. In some embodiments, when the funnel 690 is retained within the retention sheath 122, the first engagement feature 586 of the retention sheath 122 can engage (e.g., seal and engage) the distal portion 113b of the sheath 112.

[0049] Figures 7A - 7D are side views illustrating various stages in a process or method for deploying the funnel 690 according to an embodiment of the present technology. Referring first to Figure 7A, the dilator assembly 104 is initially positioned within the introducer assembly 102 in a first configuration (Figure 5A), where (i) the housing 595 of the control assembly 120 is coupled / engaged to the sealable hub 114, and (ii) the first engagement feature 586 of the retention sheath 122 is sealingly engaged to the distal portion 113b of the sheath 112. In other embodiments, the first engagement feature 586 need not sealingly engage the sheath 112. In the initial position shown in Figure 7A, the drive portion 124 of the control assembly 120 is in a first position (e.g., fully retracted position), and the funnel 690 is housed in a constrained configuration within the retention sheath 122 as shown in Figure 6.

[0050] In the arrangement shown in FIG. 7A, the introducer assembly 102 and the dilator assembly 104 (collectively "assemblies 102, 104") can be used to access a patient's venous blood vessel percutaneously, for example, through an access site (e.g., a popliteal access site, a femoral access site, an internal jugular vein access site, and / or other access sites). In some embodiments, assemblies 102, 104 are inserted through another introducer sheath (not shown). In some embodiments, assemblies 102, 104 are advanced within the venous blood vessel to a treatment position where the distal portion 113b of sheath 112 is proximal to (e.g., proximal to) a thrombus within the venous blood vessel.

[0051] Referring to FIG. 7B, after positioning assemblies 102, 104, the deployment of the funnel 690 (shown transparently in FIGS. 7B and 7C for clarity) can be performed, for example, by moving the drive unit 124 from a first position (FIG. 7B) to a second position (e.g., an intermediate position, an intermediate stroke position, a dropped position), thereby advancing both the first and second shafts 580, 582 distally relative to the sheath 112. The distal advancement of the first shaft 580 causes the retention sheath 122 to move distally beyond the funnel 690 and away from the funnel 690. When the funnel 690 is no longer constrained by the retention sheath 122, the funnel 690 self-expands into an expanded (e.g., unconstrained) configuration. In other embodiments, the control assembly 120 is configured such that, by moving the drive unit 124 from the first position to the second position, only the first shaft 580 of the dilator assembly 104 is advanced distally, rather than advancing both the first and second shafts 580, 582 distally together.

[0052] The funnel 690 can include various shapes and sizes and can be formed from various materials. In some embodiments, in the expanded configuration, the funnel 690 can have a maximum diameter that is greater than and / or equal to the diameter D (Figs. 3B and 3C) of the core removal element 252 when the core removal element 252 is in the fully expanded configuration, and (ii) can have a minimum diameter that is substantially equal to the outer diameter of the sheath 112. In some embodiments, the length N of the funnel 690 can be greater than and / or equal to the length M (Figs. 3A - 3D) of the core removal element 252 so that the core removal element 252 can be received and accommodated within the funnel 690. In other embodiments, the length N of the funnel 690 can be less than the length M of the core removal element 252. In some embodiments, the funnel 690 can have a conical portion, specifically, a frustoconical portion. In some embodiments, the funnel 690 can be formed from at least one of a cast nitinol braid, a nitinol braided stent, a laser cut nitinol, a laser cut polymer tube, an injection molded polymer structure, or an inflatable balloon. In some embodiments, the funnel 690 can include a mesh having a pore size small enough to prevent thrombus from passing through the pores of the mesh. In some embodiments, the funnel 690 can be permeable to blood.

[0053] Referring to FIG. 7C, after the funnel 690 is deployed, the dilator assembly 104 can be moved to a second configuration (FIG. 5B). For example, the operator can move the drive portion 124 of the control assembly 120 from a second position (FIG. 7B) to a third position (e.g., a fully advanced position) to advance the second shaft 582 distally relative to the first shaft 580 until the second engagement feature 589 of the second shaft 582 engages the first engagement feature 586 of the retention sheath 122. As shown in FIG. 7D, after the dilator assembly 104 is moved to the second configuration, the dilator assembly 104 can be fully retracted and withdrawn from the introducer assembly 102. For example, the dilator assembly 104 can be withdrawn proximally from the sealable hub 114 of the introducer assembly 102 through the lumen of the sheath 112.

[0054] Referring to FIGS. 7A-7D together, in one aspect of the present technique, by moving the dilator assembly 104 to a second configuration before retracting the dilator assembly 104 from the introducer assembly 102, it is possible to prevent or even prevent the dilator assembly 104 from damaging the funnel 690 or other components of the introducer assembly 102 while the dilator assembly 104 is retracting. More specifically, if the dilator assembly 104 did not include the second shaft 582, when the retention sheath 122 retracts proximally and into the sheath 112, the retention sheath 122 (e.g., the first engagement feature 586) could catch or damage the deployed funnel 690. However, since the diameter of the second shaft 582 is equal to or substantially equal to the outer diameter of the retention sheath 122, in the second configuration the dilator assembly 104 has a uniform or substantially uniform (e.g., smooth) outer surface, and thus is less likely to catch or otherwise damage the funnel 690, the sealable hub 114, and / or other components of the introducer assembly 102 while retracting. In other embodiments, the second shaft 582 and the retention sheath 122 can have different diameters, and the first and second engagement features 586, 589 can be configured to provide a smooth transition between the second shaft 582 and the retention sheath 122.

[0055] In another aspect of the present technology, as the drive unit 124 moves from the first position to the third position, (i) both the first and second shafts 580, 582 are advanced together to deploy the funnel 690 (e.g., when the drive unit 124 moves from the first position to the second position), and (ii) the second shaft 582 is advanced relative to the first shaft 580 (e.g., when the drive unit 124 moves from the second position to the third position) so that the dilator assembly 104 has a generally uniform outer diameter. This "dual action" allows the control assembly 120 to be coupled to the sealable hub 114 between both the deployment of the funnel 690 and the advancement of the second shaft 582 towards the first shaft 580. This advantageously prevents or guards against inadvertently advancing the retention sheath 122, and as a result, premature deployment of the funnel 690. For example, if the funnel 690 is prematurely deployed, it is often necessary to completely remove the dilator assembly 104 and the introducer assembly 102 from the patient in order to reload the funnel 690. This potentially increases trauma to the patient and the time of the thrombectomy procedure. In contrast, some conventional dilator assemblies include a "floating" (e.g., not locked or engaged with the introducer assembly) dilator, and inadvertent collisions or other forces on the dilator assembly can cause corresponding movement of the dilator assembly.

[0056] Figures 8A, 8C, and 8D are cross-sectional side views of a control assembly 120 configured according to an embodiment of the present technology, and Figure 8B is an enlarged cross-sectional isometric view of the control assembly 120 configured according to an embodiment of the present technology. In Figures 8A and 8B, the drive unit 124 is in the first position shown in Figure 7A, in Figure 8C, the drive unit 124 is in the second position shown in Figure 7B, and in Figure 8D, the drive unit 124 is in the third position shown in Figure 7C.

[0057] Referring initially to FIG. 8A, control assembly 120 includes a proximal portion 801a and a distal portion 801b, defining a lumen 802 that extends therethrough between the proximal and distal portions 801a, b. In the illustrated embodiment, control assembly 120 includes a sealable member 804 at or near the proximal portion 801a and a connection portion 806 at or near the distal portion 801b. The sealable member 804 can be configured to selectively seal the lumen 802 of control assembly 120 and, in some embodiments, can receive a guide wire (not shown) therethrough. As described in detail above with reference to FIGS. 7A - 7C, connection portion 806 is configured to engage / mate with the sealable hub 114 of introducer assembly 102 to secure control assembly 120 thereto. For example, in some embodiments, connection portion 806 can be a snap feature (e.g., having one or more teeth, flanges), a twist lock (e.g., bayonet or luer type fitting), and / or other features that can include features for engaging and / or locking to sealable hub 114.

[0058] Referring to both FIGS. 8A and 8B, in the illustrated embodiment, the control assembly 120 further includes a first shaft hub 810 and a second shaft hub 850. The first shaft hub 810 is configured to be coupled to the first shaft 580 of the expander assembly 104, and the second shaft hub 850 is configured to be coupled to the second shaft 582 of the expander assembly 104. For clarity, the first and second shafts 580, 582 are not shown in FIGS. 8A-8D. In the illustrated embodiment, the second shaft hub 850 is connected to (e.g., integrally formed with) the drive unit 124. The drive unit 124 extends outside the housing 595 and is configured to be advanced distally and / or retracted proximally by an operator. The first shaft hub 810 includes a first body portion 812 and one or more first engagement or snap features 814 (only one first engagement feature 814 is visible in FIGS. 8A-8D). The engagement or snap feature 814 extends radially and / or axially away from the first body portion 812 and into a corresponding first track 830 formed within the housing 595. The second shaft hub 850 similarly includes a second body portion 852 and second engagement or snap features 854 (e.g., a pair of similar or identical second engagement features 854). The second engagement or snap features 854 extend radially and / or axially away from the second body portion 852 and into a corresponding second track 840 formed within the housing 595.

[0059] In the illustrated embodiment, the first track 830 includes one or more proximal detents 832 (hidden in FIGS. 8A and 8B and shown in FIG. 8C), one or more distal detents 834, and a distal end 835. In some embodiments, the first track 830 can include a pair of opposing (e.g., radially opposite) proximal detents 832 and a pair of opposing distal detents 834. The second track 840 includes a first portion 842 (FIG. 8A) having a first track width or height G1 and a second portion 844 (FIG. 8A) having a second track width or height G2 that is greater than the first track width G1. In some embodiments, the transition (e.g., slope or step) between the first and second portions 842, 844 of the second track 840 is substantially aligned on and / or proximate to the distal detent 834 of the first tack 830.

[0060] In operation, the first and second shaft hubs 810, 850 are configured to slide within the lumen 802 along the first and second tracks 830, 840, respectively. In some embodiments, the first engagement feature 814 and / or the second engagement feature 854 are flexible and can bend / curve when the first and second shaft hubs 810, 850 move along the first and second tracks 830, 840. The configuration / arrangement of the first and second shaft hubs 810, 850 and the first and second tracks 830, 840 (e.g., the arrangement of the proximal and distal detents 832, 834, the first portion 842, and / or the second portion 844) can facilitate movement of the dilator assembly 104 from the first configuration (FIG. 5A) to the second configuration (FIG. 5B).

[0061] More specifically, at the first position shown in FIGS. 8A and 8B, the drive unit 124 is located at the most proximal position along the housing 595. For example, the first shaft hub 810 can abut against the proximal wall portion 807 of the housing 595. At the first position, the first portion 842 of the second track 840 compresses (e.g., presses, constrains) the second engagement feature 854 of the second shaft hub 850 radially inward toward the first shaft hub 810 to engage the first shaft hub 810 (e.g., the first body portion 812). In other words, when the second shaft hub 850 is in a relaxed state and there is no constraint by the first portion 842 of the second track 840, the distance (e.g., diameter) of the second shaft hub 850 between the second engagement features 854 can be made larger than the first diameter G1. With this arrangement, the second shaft hub 850 is fixed to the first shaft hub 810, and both the first and second shaft hubs 810, 850 move by the movement of the drive unit 124 along the first portion 842 of the second track 840. In some embodiments, the first body portion 812 of the first shaft hub 810 can include various features (e.g., grooves, paths, teeth) for engaging with the second engagement feature 854 of the second shaft hub 850, and as a result, the first and second shaft hubs 810, 850 are fixed together.

[0062] Also, at the first position, at least a portion of the first engagement feature 814 of the first shaft hub 810 can be positioned more proximally than the proximal detent 832 (FIGS. 8C and 8D). Thus, the proximal detent 832 can hold the first shaft hub 810 (and the second shaft hub 850 and the drive unit 124 fixed thereto) in the first position until a predetermined force is applied to the drive unit 124 in the distal direction. In one aspect of the present technology, this arrangement can prevent the unintentional distal advancement of the first shaft 580 (and thus the premature deployment of the funnel 690 (FIGS. 7A - 7C)). In some embodiments, when a predetermined force is applied to the drive unit 124, the first engagement feature 814 bends inward, and as a result, the first shaft hub 810 can slide distally.

[0063] Thus, referring to FIGS. 8A - 8C together, after the first engagement feature 814 disengages from the proximal detent 832, the drive portion 124 can be advanced distally from the first position to the second position shown in FIG. 8C. When the drive portion 124 is moved distally, the first and second shaft hubs 810, 850 move distally together until the first shaft hub 810 reaches the distal end 835 of the first track 830 and / or the second shaft hub 840 reaches the second portion 844 of the second track 840 (as a result, the first and second shafts 580, 582 advance together as shown in FIG. 7B). More specifically, the distal end 835 and / or the distal detent 834 of the first track 830 can engage the first engagement feature 814 to prevent the first shaft hub 810 (and thus the first shaft 580) from moving further distally. At the same time, the larger - diameter second portion 844 of the second track 840 allows the second engagement feature 854 to move radially outward (e.g., bend radially outward towards a relaxed state) and disengage from engagement with the first shaft hub 810. That is, the control assembly 120 is configured such that substantially simultaneously with the first engagement feature 814 of the first shaft hub 810 reaching / engaging the distal detent 834 of the first track 830, the second engagement feature 854 of the second shaft hub 850 reaches the transition point between the first and second portions 842, 844 of the second track 840.

[0064] Thus, as shown in FIG. 8D, the second shaft hub 850 can advance further distally to a third position, leaving the first shaft hub 810 behind. As shown in FIG. 7C, when the second shaft hub 850 moves distally while the first shaft hub 810 remains stationary, the second shaft 582 advances distally towards the retaining sheath 122. In some embodiments, the second shaft hub 850 can abut against the distal wall portion 809 of the housing 595 at the third position.

[0065] Referring to FIGS. 5A - 8D together, in one aspect of the present technology, the control assembly 120 facilitates the movement of the expander assembly 104 from the first configuration to the second configuration only as a single movement of the drive portion 124 to the first through third positions. As described above, this advantageously allows the control assembly 120 to be coupled to the sealable hub 114 at any time during the deployment of the funnel 690, such that the deployment of the funnel 690 is controlled and the funnel 690 is prevented from being inadvertently deployed. This is expected to reduce the likelihood that other components of the system (e.g., the retention sheath 122) will catch on the funnel 690 as the expander retracts through the sheath 112. Also, the deployment of the funnel 690 and the advancement of the second shaft 582 are realized by a single stroke, thus being very simplified.

[0066] In some embodiments, the drive portion 124 can be moved in the proximal direction (e.g., from the third position towards the first position) to facilitate the attachment of the funnel 690. For example, when the control assembly 120 is in the third position, the expander assembly 104 can be inserted into the sheath 112 such that the retention sheath 122 extends distally beyond the funnel 690 from the distal portion 113b of the sheath 112. The operator can then move the drive portion 124 to the second position to force the second shaft hub 850 to engage the first shaft hub 810 by narrowing the second track 840 from the second portion 844 to the first portion 842. Next, the attachment tool 108 (FIG. 1) can be slid proximally over the retention sheath 122 and the funnel 690 until the funnel 690 is fully encapsulated by the attachment tool 108 and / or until the funnel 690 is in a constrained configuration. The operator can then move the drive portion 124 from the second position to the first position to retract the retention sheath 122 over the funnel 690, thereby mounting / capturing the funnel 690 within the receiving space 694 of the retention sheath 122. Finally, the attachment tool 108 can be removed.

[0067] In other embodiments, the control assembly according to the present technology can include other components and / or configurations for facilitating the dual action of: (i) advancing the first and second shafts 580, 582 to deploy the funnel 690; and (ii) advancing the second shaft 582 relative to the first shaft 580 to obtain a uniform outer surface that facilitates the retraction of the expander assembly 104. FIGS. 9A-9C are cross-sectional side views of a control assembly 920 including a drive unit 124 in a first position, a second position, and a third position (FIGS. 7A-7C), configured according to another embodiment of the present technology, for example.

[0068] The control assembly 920 can include some features that are substantially similar to those of the control assembly 120 already described in detail with reference to FIGS. 8A-8D. For example, referring to FIGS. 9A-9C together, the control assembly 920 includes a first shaft hub 910 coupled to the first shaft 580 of the expander assembly 104 and a second shaft hub 950 coupled to the second shaft 582 of the expander assembly 104. In the illustrated embodiment, the second shaft hub 950 is connected (e.g., integrally formed) to the drive unit 124. The drive unit 124 extends outside the housing 995 of the control assembly 920 and is configured to be advanced distally and / or retracted proximally by an operator. The first and second shaft hubs 910, 950 are configured to slide at least partially through a lumen 902 that extends through the housing 995.

[0069] In the illustrated embodiment, the control assembly 920 further includes an elongate member 960 (shown transparently in FIGS. 9A-9C for clarity). The elongate member 960 has (i) a proximal portion 961a located proximal to the first shaft hub 910 and (ii) a distal portion 961b located distal to the first shaft hub 910 and coupled to the second shaft hub 950. The first shaft hub 910 can be slidably positioned within the elongate member 960. A biasing member 964 (e.g., a compression spring) extends between the proximal portion 961a of the elongate member 960 and the first shaft hub 910. In some embodiments, the proximal portion 965a of the biasing member 964 is connected to the proximal portion 961a of the elongate member 960, and the distal portion 965b of the biasing member 964 is connected to the first shaft hub 910.

[0070] The control assembly 920 can further include a stop member 970 coupled to the first shaft 580 (e.g., the proximal portion of the first shaft 580). The stop member 970 is configured to slide at least partially through the lumen 902 of the housing during operation of the control assembly 920 and can be fully housed within the housing 995 (e.g., as shown in FIGS. 9B and 9C) and / or can extend fully or partially outside the housing 995 (e.g., as shown in FIG. 9A). As shown in FIG. 9B, the dimension (e.g., diameter) H1 of the stop member 970 is greater than the dimension H2 of the stop portion 972 of the housing 995. This arrangement causes the stop member 970 to contact the stop portion 972 of the housing 995, and as a result, is configured to prevent the first shaft 580 (and the retention sheath 122 attached thereto) from advancing further distally.

[0071] Referring to FIG. 9A, in the first position, the first shaft hub 910 engages (e.g., meshes) with the second shaft hub 950 such that both the first and second shaft hubs 910, 950 move with the distal advancement of the drive unit 124. Also, since the biasing member 964 is in an equilibrium state, it does not exert any force on the first shaft hub 910, for example. In some embodiments, the drive unit 124 and / or the second shaft hub 950 can include a first engagement feature 954 (e.g., a ridge, a protrusion). The first engagement feature 954 engages (e.g., meshes) with a corresponding first detent 957 within the housing 995 to removably fix the drive unit 124 in the first position until a predetermined force is applied to the drive unit in the distal direction. In some embodiments, when a predetermined force is applied to the drive unit 124, the first engagement feature 954 bends outward from the first detent 957 to allow the first and second shaft hubs 910, 950 to move distally.

[0072] Accordingly, referring to FIGS. 9A and 9B together, after the first engagement feature 954 disengages from the engagement with the first detent 957, the drive unit 124 can advance distally from the first position to the second position. When the drive unit 124 moves distally, the first and second shaft hubs 910, 950 move distally together until the stop member 970 reaches and contacts the stop portion 972 of the housing 995 (as a result, advancing the first and second shafts 580, 582 together as shown in FIG. 7B). More specifically, the biasing member 964 can exert a force on the first shaft hub 910 to move the second shaft hub 950 together with the first shaft hub 910. When the stop member 970 contacts the stop portion 972, the further distal advancement of the first shaft hub 910 is stopped.

[0073] Accordingly, referring to both FIGS. 9B and 9C, when the drive portion 124 moves further distally to the third position, the second shaft hub 950 can leave the first shaft hub 910 behind. As the second shaft hub 950 moves distally while the first shaft hub 910 remains stationary, the second shaft 582 advances distally toward the retention sheath 122, as shown in FIG. 7C. In some embodiments, the second shaft hub 950 can abut against the distal wall portion 909 of the housing 995 at the third position, preventing the second shaft hub 950 from advancing further distally. Further, as shown in FIG. 9C, when the second shaft hub 950 is advanced to the third position, the biasing member 964 is compressed between the first shaft hub 910 (which remains stationary) and the proximal portion 961a of the elongate member 960 (which continues to move with the second shaft hub 950). In some embodiments, the biasing force exerted by the biasing member 964 can facilitate subsequent movement of the drive portion 124 from the third position to the second position. In some embodiments, the drive portion 124 can include a second engagement feature 958 (e.g., a ridge, a protrusion). The second engagement feature 958 can engage (e.g., mate with) a corresponding second detent 959 within the housing 995 to removably fix the drive portion 124 in the third position until a predetermined force is applied to the drive portion in the proximal direction. In some embodiments, this force can be made less than the force required to disengage the first engagement feature 954 from the first detent 957 due to the biasing force of the biasing member 964. In other embodiments, the detent 959 can include a track (e.g., an L-shaped track). The second shaft hub 950 can be rotated to rotate the second engagement feature 958 into the track to removably fix the drive portion 124 in the third position.

[0074] In other embodiments, the stop member 970 is not configured to stop the distal advancement of the first shaft 580. Instead, the stop member 970 can instead be a luer flash port 970 (or another component) that simply moves with the first shaft 580, or it can be omitted altogether. In such embodiments, the first shaft hub 910 can move along a track (not shown) formed within the housing 995 similar to the first shaft hub 810 described in detail with reference to FIGS. 8A - 8D. For example, the first shaft hub 910 can include a first engagement or snap feature 914 (only one first engagement feature 914 is visible in FIGS. 9A - 9C). The first engagement or snap feature 914 extends (i) radially and / or axially away from the body portion of the first shaft hub 910, (ii) from an elongate member 960, and (iii) into a track within the housing 995. The track can include a detent or other feature (not shown) configured (e.g., positioned and shaped) to stop the first shaft hub 910 from moving further distally when the first shaft hub 910 reaches the second position shown in FIG. 9B.

[0075] FIGS. 10A and 10B are partial cross - sectional side views of a control assembly 1020 configured according to another embodiment of the present technology. Generally, the control assembly is movable between (i) a first position (shown in FIG. 10A) where the second shaft 582 has retracted proximally relative to the first shaft 580, as shown in FIGS. 5A and 7A, and (ii) a third position (shown in FIG. 10B) where the second shaft 582 has advanced distally relative to the first shaft 580 to form a generally uniform outer surface of the expander assembly 104, as shown in FIGS. 5B and 7C. In one aspect of the present technology, the control assembly 1020 moves fluidly between the first and third positions without including an intermediate second position (FIG. 7B).

[0076] The control assembly 1020 can include some features that are substantially similar to those of control assembly 120 and / or control assembly 920, which have already been described in detail with reference to FIGS. 8A-9C. For example, referring to FIGS. 10A and 10B together, the control assembly 1020 includes a drive portion 1024 (e.g., a plunger 1024) that is movable relative to / through the lumen 1002 of the housing 1095. The plunger 1024 is coupled to (i) a first shaft hub 1010 that is coupled to the first shaft 580 of the expander assembly 104 and (ii) a second shaft hub 1050 that is coupled to the second shaft 582 of the expander assembly 104. The first and second shafts 580, 582 are not shown in FIGS. 10A and 10B for clarity.

[0077] In the illustrated embodiment, the second shaft hub 1050 includes an engagement feature 1054. The engagement feature 1054 (e.g., size and shape) is configured to engage a corresponding stop portion 1056 formed within the housing 1095 when the plunger 1024 is in the first position shown in FIG. 10A. The first shaft hub 1010 is configured to slide along a track 1080 formed within / along a portion of the plunger 1024. In some embodiments, the track 1080 includes at least one detent 1084 at its distal portion and is configured to stop / block the distal advancement of the first shaft hub 1010. In other embodiments, the housing 1095 can include a flange or other component configured to stop the distal advancement of the first shaft hub 1010.

[0078] A first biasing member 1064 (e.g., a compression spring) extends between a first shaft hub 1010 and a proximal portion 1096 of the housing 1095 and is operatively coupled (e.g., connected) thereto. A second biasing member 1066 (e.g., a compression spring) extends between the first and second shaft hubs 1010, 1050 and is operatively coupled (e.g., connected) thereto. In the first position shown in FIG. 10A, both the first and second biasing members 1064, 1066 are loaded and compressed, thus pushing the first and second shaft hubs 1010, 1050 distally, respectively. In some embodiments, the compression force of the first biasing member 1064 is greater than that of the second biasing member 1066.

[0079] In the first position shown in FIG. 10A, the plunger 1024 is locked in a retracted position in the proximal direction by the engagement of the engagement feature 1054 with the stop portion 1056 of the housing 1095. To move the control assembly 1020 to the third position shown in FIG. 10B, the operator can rotate the plunger 1024 (e.g., as indicated by arrow I in FIG. 10A) to unlock the second shaft hub 1050 and the plunger 1024. When the lock of the plunger 1024 is released, the first biasing member 1064 is configured to drive the first shaft hub 1010 distally until the first shaft hub 1010 stops by / drops into the detent 1084. In one aspect of the present technology, since the first biasing member 1064 is stronger than the second biasing member 1066, the second biasing member 1066 remains substantially compressed until the first shaft hub 1010 engages the detent 1084. Therefore, both the first and second shaft hubs 1010, 1050 (and thus both the first and second shafts 580, 582) move together until the first shaft hub 1010 reaches the detent 1084. And the second biasing member 1066 is configured to drive the second shaft hub 1050 distally relative to the first shaft hub 1010 (e.g., away from the first shaft hub 1010). In the third position shown in FIG. 10B, the first and second biasing members 1064, 1066 bias distally on the first and second shaft hubs 1010, 1050 to maintain the control assembly 1020 in the third position. This arrangement causes the first and second shafts 580, 582 to automatically move from the first configuration (FIG. 5A) to the second configuration (FIG. 5B), and as shown in FIGS. 7A - 7D, to deploy the funnel and prepare to retract the expander assembly 104.

[0080] In other embodiments, the first and second biasing members 1064, 1066 can be arranged in opposite configurations. For example, the first biasing member 1064 can extend between the first and second shaft hubs 1010, 1050 and be operatively coupled thereto, and the second biasing member 1066 can extend between the second shaft hub 1050 and the distal portion 1098 of the housing 1096 and be operatively coupled thereto. Similarly, the compressive force of the second biasing member 1066 can be made greater than that of the first biasing member 1064. Thus, the first and second biasing members 1064, 1066 can bias the control assembly 1020 to the first position. To move the control assembly 1020 to the third position, the user can advance the plunger 1024 against the compressive forces of the first and second biasing members 1064, 1066 until the second shaft hub 1050 reaches the third position. In some embodiments, the user can then rotate the plunger 1024 to lock the control assembly 1020 in the third position.

[0081] IV. Selected Embodiments of Thrombectomy Methods FIG. 11 is a schematic diagram of an introduction technique for accessing and treating a thrombus 1190 by a thrombus extraction system 100 according to an embodiment of the present technology. The thrombus 1190 (e.g., a clot) can be found within the blood vessel 1196 and accessed through an access site 1192 (e.g., a popliteal access site, or other venous or arterial access site). The introducer assembly 102 can extend from the popliteal access site 1192 (or other venous or arterial access site) to a deployment position 1194 where the self-expanding funnel 690 can be deployed in proximity to the thrombus 1190. As will be described in detail later with reference to FIGS. 12A - 12K, the thrombus extraction device 250 can be passed through the thrombus 1190 in the direction of blood flow and then retracted through the thrombus 1190 in the direction of blood flow. During retraction, the de-coring element 252 can de-core / separate the thrombus 1190, and the capture element 254 can capture all or part of the thrombus 1190. In some embodiments, part or all of the thrombus extraction device 250 can extend into one of the iliac vein and / or the inferior vena cava.

[0082] More specifically, FIGS. 12A - 12C are side views and FIGS. 12D - 12M are enlarged side views of the thrombus extraction system 100 positioned within the blood vessel 1196 during a thrombus extraction procedure for treating (e.g., removing) the thrombus 1190 according to an embodiment of the present technology.

[0083] FIG. 12A illustrates the thrombus extraction system 100 positioned within the blood vessel 1196 after (i) deploying the self-expanding funnel 690 (e.g., as described in detail with reference to FIGS. 5A - 10B), (ii) removing the dilator assembly 104 from the introducer assembly 102, and (iii) advancing the outer shaft 132 of the thrombus extraction assembly 106 through the sheath 112 and the thrombus 1190. The distal advancement of the outer shaft 132 through the thrombus 1190 may or may not be in the direction of blood flow.

[0084] FIG. 12B illustrates the thrombectomy system 100 after the thrombus extraction device 250 has been advanced through the outer shaft 132 to a deployed position distal to the thrombus 1190. In some embodiments, the thrombus extraction device 250 can be constrained within the outer shaft 132 and inserted, along with the outer shaft 132, into the lumen of the sheath 112 via the sealable hub 114. In some embodiments, the deployment of the thrombus extraction device 250 can be effected by advancing the thrombus extraction device 250 beyond the distal portion 136b of the sheath 112 and / or by retracting the outer shaft 132 relative to the thrombus extraction device 250 until the thrombus extraction device 250 extends beyond the distal portion 136b of the outer shaft 132.

[0085] FIG. 12C illustrates the thrombectomy system 100 after the thrombus extraction device 250 has been fully expanded. In some embodiments, at least a portion of the core removal element 252 and / or the capture element 254 contacts the wall 1297 of the blood vessel 1196 in the fully expanded position. As already described in detail with reference to FIGS. 2A and 2B, in some embodiments, the thrombus extraction device 250 can be fully expanded by moving the plunger 144 from a first position to a second position and fixing the plunger 144 in the second position, thereby fixing the relative position of the inner shaft 134 relative to the intermediate shaft 133.

[0086] Generally, FIGS. 12D-12K illustrate the manner in which the thrombus extraction device 250 retracts proximally through the thrombus 1190 to capture at least a portion of the thrombus 1190 and the manner in which the thrombus extraction device 250 and the captured thrombus 1190 subsequently retreat together within the funnel 690 and the sheath 112.

[0087] Referring initially to FIG. 12D, by retracting proximally the thrombus extraction device 250, the decoring element 252 separates and / or decorates the distal portion 1298b of the thrombus 1190 from the wall 1297 of the blood vessel 1196. As shown in FIG. 12E, by continuing to retract proximally the thrombus extraction device 250 through the thrombus 1190, the capture element 254 captures the distal portion 1298b of the thrombus 1190 therein. FIGS. 12F-12H illustrate the manner in which the thrombus extraction device 250 further retracts proximally to further separate, decore, and / or capture the thrombus 1190. As seen in FIG. 12H, as the thrombus extraction device 250 retracts proximally toward the funnel 690 and the sheath 112, the proximal portion 1298a of the thrombus 1190 is decored and captured.

[0088] As already described in detail with reference to FIGS. 3A-4, the decoring element 252 can include both the first mouth 370 and the second mouth 372 (identified in FIG. 12D). Thus, the first mouth 370, the first mouth portion 372a, and / or the second mouth portion 372b can facilitate the decoring / separation of the thrombus 1190 while the thrombus extraction device 250 retracts proximally. In one aspect of the technology, the first mouth 370 and the second mouth 372 are radially offset from each other, and it is possible, even if the blood vessel 1196 is highly tortuous and / or the thrombus 1190 is strongly adhered to the wall 1297 of the blood vessel 1196, to ensure that at least one of the first mouth 370 and the second mouth 372 is positioned and oriented to effectively decore the thrombus 1190.

[0089] In some embodiments, as shown in FIGS. 12I and 12G, the thrombus extraction device 250 can be retracted proximally until the proximal portion 253a of the core removal element 252 is received (e.g., positioned) within the funnel 690. More specifically, the thrombus extraction device 250 can be retracted proximally until all or a portion of the first opening 370 and / or the second opening 372 of the core removal element 252 is received within the funnel 690. In some embodiments, when one or both of the first and second openings 370, 372 are located within the funnel 690, the thrombus extraction device 250 can be moved or converted from an expanded deployed state to a compressed state to compress and secure the thrombus 1190 captured by the thrombus extraction device 250. In some embodiments, for example, the intermediate shaft 133 (FIG. 12H) can be unlocked and / or disengaged from the inner shaft 134 (e.g., via user actuation of the plunger 144 shown in FIGS. 1-2B) to allow the inner shaft 134 to advance distally relative to the intermediate shaft 133 to fold or compress the thrombus extraction device 250.

[0090] After the thrombus extraction device 250 is folded, the thrombus extraction device 250 can be retracted proximally through the funnel 690 and into the sheath 112 as shown in FIG. 12K. The thrombus extraction device 250 can be continuously retracted proximally until the thrombus extraction device 250 and the thrombus 1190 captured thereby are fully received within the sheath 112. In some embodiments, the thrombus extraction device 250 and the thrombus 1190 captured thereby can then be withdrawn through the sheath 112 and the sealable hub 114 (FIG. 12B).

[0091] In some embodiments, a vacuum (e.g., a pre-filled vacuum) can be applied to the sheath 112 at any point while the thrombus extraction device 250 is retracting. In some embodiments, application of the vacuum creates an instantaneous or near-instantaneous suction at the distal portion of the sheath 112 to aspirate any remaining portions of the thrombus 1190 into and / or through the sheath 112. For example, the suction generated can aspirate any of the thrombus 1190 captured or extruded by the funnel 690. Also, in some embodiments, application of the vacuum can facilitate the smooth retraction of the captured thrombus 1190 through the sheath 112. For example, a burst of suction generated by application of the vacuum can help prevent clogging of the sheath 112 and / or can help break up (e.g., fragment) obstacles formed within the sheath 112 during retraction.

[0092] V. EXAMPLES The following examples illustrate some aspects of the present technology. Example 1. A core removal element for removing a vascular thrombus within a patient's blood vessel, wherein the core removal element includes a one-piece structure, the one-piece structure includes a first region adjacent to the proximal portion of the one-piece structure, the first region including a first orifice configured to remove the vascular thrombus; a second region distal to the first region, the second region being substantially tubular and including a first plurality of interconnected struts; a third region distal to the second region, the third region including a second orifice configured to remove the vascular thrombus; a fourth region distal to the third region, the fourth region being substantially tubular and including a second plurality of interconnected struts; and the core removal element. Example 2. The first mouth part is radially offset from the second mouth part, the core removal element of Example 1. Example 3. The integral structure extends along the longitudinal axis, The first region includes a pair of first curved struts that curve in opposite directions around the longitudinal axis and intersect at a pair of first joints to define the first mouth part, the core removal element of Example 1 or Example 2. Example 4. The integral structure extends along the longitudinal axis, The third region includes (a) a pair of upper curved struts that curve around the longitudinal axis and intersect each other at an upper joint, and (b) a pair of lower curved struts that curve around the longitudinal axis and intersect each other at a lower joint, The lower and upper curved struts define the second mouth part, the core removal element of any one of Examples 1 to 3. Example 5. The lower and upper curved struts define (a) a first mouth part opening in a first direction substantially orthogonal to the longitudinal axis and (b) a second mouth part opening in a second direction substantially orthogonal to the longitudinal axis, The first and second mouth parts define the second mouth part, the core removal element of Example 4. Example 6. The first direction is generally opposite to the second direction, the core removal element of Example 5. Example 7. The core removal element is expandable from a compressed delivery configuration to an expanded deployment configuration, the core removal element of any one of Examples 1 to 6. Example 8. The core removal element is configured to self-expand, the core removal element of Example 7. Example 9. The core removal element is formed from a shape memory material, the core removal element of Example 8. Example 10. The fourth region of the integral structure is configured to be connected to a braided filament mesh structure, the core removal element of any one of Examples 1 to 9. Example 11. An expander assembly for deploying an expandable funnel coupled to a distal portion of an introducer sheath, the expander assembly comprising: a first shaft defining a lumen; a second shaft slidably positioned within the lumen of the first shaft; a retention sheath coupled to the second shaft and configured to receive and restrain the funnel therein; a control assembly including a drive portion operably coupled to the first and second shafts, wherein when the drive portion moves from a first position to a second position, the first and second shafts advance together to deploy the funnel from the retention sheath, and when the drive portion moves from the second position to a third position, the first shaft advances relative to the second shaft; An expander assembly comprising: Example 12. The expander assembly of Example 11, wherein the retention sheath has substantially the same outer diameter as the first shaft. Example 13. The expander assembly of Example 11 or 13, wherein when the drive portion moves from the second position to the third position, a distal portion of the first shaft contacts a proximal portion of the retention sheath. Example 14. The control assembly comprises: a housing; a first shaft hub slidably positioned within the housing and coupled to the first shaft; a second shaft hub slidably positioned within the housing and coupled to the second shaft; The expander assembly according to any one of Examples 11 to 13, comprising: Example 15. The expander assembly of Example 14, wherein the first shaft hub is configured to engage the second shaft hub when the drive portion moves from the first position to the second position such that the first and second shafts advance together. Example 16. When the drive unit moves from the second position to the third position such that the first shaft advances relative to the second shaft, the first shaft hub is configured to disengage from the second shaft hub, the expander assembly of Example 14 or Example 15. Example 17. When the drive unit moves from the first position to the second position such that the first and second shafts both advance, the first shaft hub is configured to engage with the second shaft hub, When the drive unit moves from the second position to the third position such that the first shaft advances relative to the second shaft, the first shaft hub is configured to disengage from the second shaft hub, the expander assembly of any one of Examples 14 - 16. Example 18. The second shaft hub includes a first engagement feature, The housing includes a second engagement feature, When the drive unit moves from the second position to the third position, the first engagement feature is configured to engage with the second engagement feature at the second position to prevent movement of the second shaft hub, the expander of the assembly of any one of Examples 14 - 17. Example 19. The first engagement feature is a snap feature, The second engagement feature is a detent formed within the housing, the expander assembly of Example 18. Example 20. Further includes a biasing member operably coupled to the first shaft hub, The biasing member is configured to bias the first shaft hub from the third position towards the second position, the expander assembly of any one of Examples 14 - 19. Example 21. The control assembly further includes a housing, The drive unit is movable relative to the housing, The movement of the drive part from the first position to the second position is a distal movement of the drive part with respect to the housing, The movement of the drive part from the second position to the third position is a further distal movement of the drive part with respect to the housing, an expander assembly according to any one of Examples 11 to 20. Example 22. An expander assembly according to any one of Examples 11 to 21, further comprising the introducer sheath and the funnel. Example 23. A system for capturing a blood clot in a patient's blood vessel, the system comprising: An introducer sheath having a distal portion; An expandable funnel coupled to the distal portion of the introducer sheath; An expander assembly configured to be inserted through the introducer sheath and deploy the expandable funnel, the expander assembly comprising: A first shaft defining a lumen; A second shaft slidably positioned within the lumen of the first shaft; A retention sheath coupled to the second shaft and configured to receive and restrain the funnel therein; A control assembly including a drive part operably coupled to the first and second shafts, wherein when the drive part moves from a first position to a second position, the first and second shafts both advance distally to deploy the funnel from the retention sheath, and when the drive part moves from the second position to a third position, the first shaft advances relative to the second shaft; An expander assembly including; A clot removal device configured to be inserted through the introducer sheath and capture at least a portion of the blood clot; A system including. Example 24. The clot removal device includes an expandable de-coring element coupled to an expandable capture element, The de-coring element is configured to separate at least a portion of the blood clot from the wall of the blood vessel. The capture element is configured to capture and hold a portion of the vascular thrombus separated from the wall of the blood vessel, the system of Example 23. Example 25. The funnel has a first length when deployed from the retention sheath, The core removal element, when expanded, has a second length shorter than the first length, the system of Example 23 or Example 24. Example 26. A system for capturing a vascular thrombus within a patient's blood vessel, the system comprising: An introducer sheath having a distal portion, An expandable funnel coupled to the distal portion of the introducer sheath, An expander assembly configured to be inserted through the introducer sheath and to deploy the expandable funnel, A clot removal device configured to be inserted through the introducer sheath, the clot removal device including an expandable core removal element coupled to an expandable capture element, the core removal element including a first region including a first opening and a second region including a second opening, the first and second openings being configured to separate at least a portion of the vascular thrombus from the wall of the blood vessel, the capture element being configured to capture and hold the portion of the vascular thrombus separated from the wall of the blood vessel, the clot removal device; and A system including the above. Example 27. The first opening is radially offset from the second opening, the system of Example 26. Example 28. The core removal element is formed from a unitary structure including a plurality of struts, The struts define the first and second openings, The struts further define a plurality of gaps, The first and second openings are larger than the respective gaps, the system of Example 27.

[0093] VI. Conclusion The foregoing detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the exact forms disclosed above. Specific embodiments of the present technology and examples thereof have been described above for purposes of illustration, but as will be apparent to those skilled in the art, various equivalent modifications are possible within the scope of the present technology. For example, although steps are shown in a given order, alternative embodiments may perform the steps in a different order. Combining the various embodiments described herein may result in further embodiments.

[0094] From the foregoing, it should be understood that, while specific embodiments of the present technology have been described herein for purposes of illustration, well-known structures and functions have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present technology. When the context permits, singular or plural terms may respectively include plural or singular terms.

[0095] Also, unless the term "or" is explicitly limited to mean only a single item exclusive of the others in a list of two or more items, the use of "or" in such a list should be construed to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Further, the term "comprising" is used throughout to mean including at least the described feature(s) such that any more of the same features and / or additional types of other features are not excluded. Also, although specific embodiments have been described herein for purposes of illustration, it should be understood that various changes may be made without departing from the present technology. Further, although the advantages associated with some embodiments of the present technology have been described in the context of these embodiments, other embodiments may exhibit such advantages, and not all embodiments necessarily need to exhibit such advantages in order to fall within the scope of the present technology. Accordingly, the present disclosure and related technologies may include other embodiments not explicitly illustrated or described herein.

Claims

1. 1. A coring element for coring a vascular thrombus in a blood vessel of a patient, comprising: the coring element includes a unitary structure extending along a longitudinal axis; The integral structure is a first region adjacent a proximal portion of the unitary structure, the first region including a first port configured to core the vascular thrombus when the unitary structure is retracted proximally relative to the vascular thrombus; a second region distal to the first region, the second region being tubular and including a first plurality of interconnected struts forming first cells; a third region distal to the second region, the third region including a second mouth, a third mouth, and a fourth mouth; a fourth region distal to the third region, the fourth region including a second plurality of interconnected struts forming a second cell, the first port, the second port, the third port, and the fourth port being larger than each of the first cell and the second cell; and 4. A core removal element, comprising:

2. A corer element as described in claim 1, wherein the first mouth portion is defined by a pair of curved struts extending from a common proximal joint to a distal joint, the common proximal joint being radially offset from the longitudinal axis.

3. The corer element of claim 2, further comprising a connection feature coupled to the common proximal joint, the connection feature being configured to be coupled to a shaft for retracting the integral structure proximally relative to the vascular thrombus.

4. The core removal element of claim 3, wherein the fourth region is configured not to be attached to the shaft.

5. The corer element of claim 1, further comprising a connection feature coupled to the first region, the connection feature configured to be coupled to a shaft for retracting the integral structure proximally relative to the vascular thrombus, the connection feature being radially offset from the longitudinal axis.

6. The core removal element of claim 1, wherein the fourth region is configured not to be attached to the shaft.

7. The core removal element of claim 1, wherein the fourth region is tubular.

8. The core removal element of claim 1, wherein the first mouth portion includes a closed cell defined by the pair of curved struts, and the second mouth portion, the third mouth portion, and the fourth mouth portion each include a closed cell defined by a plurality of interconnected struts.

9. The core removal element of claim 1, wherein the first mouth portion extends along a first plane, the first plane being angled at a non-parallel angle relative to the longitudinal axis.

10. The core removal element of claim 1, wherein the integral structure is configured to bend in the third region.

11. The core removal element of claim 1, wherein the second mouth portion, the third mouth portion, and the fourth mouth portion are rotationally offset from one another around the longitudinal axis.

12. The coring element of claim 1 , wherein the coring element is expandable from a compressed delivery configuration to an expanded deployed configuration.

13. The coring element of claim 12 , wherein the coring element is configured to be self-expanding.

14. The coring element of claim 13 , wherein the coring element is formed from a shape memory material.

15. The core removal element of claim 1, wherein the fourth region is configured to be connected to a braided filament mesh structure.

16. The corer element of claim 1, wherein the second mouth portion, the third mouth portion, and the fourth mouth portion are further configured to core the vascular thrombus when the integral structure is retracted proximally relative to the vascular thrombus.

17. A system for capturing a vascular thrombus in a blood vessel of a patient, the system comprising: an introducer sheath having a distal portion; an expandable funnel coupled to the distal portion of the introducer sheath; an outer shaft insertable through the introducer sheath; an inner shaft insertable through the outer shaft; a clot removal device coupled to the inner shaft, the clot removal device including a unitary structure extending along a longitudinal axis; Including, The integral structure is a first region adjacent a proximal portion of the unitary structure, the first region including a first mouth; a second region distal to the first region, the second region being tubular and including a first plurality of interconnected struts forming first cells; a third region distal to the second region, the third region including a second mouth, a third mouth, and a fourth mouth; a fourth region distal to the third region, the fourth region including a second plurality of interconnected struts forming a second cell, the first port, the second port, the third port, and the fourth port being larger than each of the first cell and the second cell; and Including, the clot removal device is configured to be compressed within the outer shaft and expanded outside the outer shaft; The system, wherein the inner shaft is configured to be retracted proximally with the clot removal device expanded outside of the outer shaft such that the clot removal device is retracted against the vascular thrombus and the first port, the second port, the third port, and / or the fourth port core the vascular thrombus.

18. The system of claim 17, wherein the fourth region is not attached to the internal shaft.

19. The system described in claim 17, wherein the first mouth portion is defined by a pair of curved struts extending from a common proximal joint to a distal joint, the common proximal joint being radially offset from the longitudinal axis.

20. The system described in claim 19, wherein the clot removal device further includes a connection feature coupled to the common proximal joint, the connection feature being configured to be coupled to the inner shaft.

21. The system of claim 17, wherein the clot removal device further includes a connection feature coupled to the first region, the connection feature configured to be coupled to the inner shaft, the connection feature being radially offset from the longitudinal axis.

22. The system described in claim 17, wherein the internal shaft is fixedly connected to a first region of the integral structure.

23. The system of claim 17, wherein the fourth region of the integral structure is tubular.

24. The system of claim 17, wherein the clot removal device is configured to self-expand when outside the outer shaft.

25. A system for capturing a vascular thrombus in a blood vessel of a patient, the system comprising: an introducer sheath having a distal portion; an expandable funnel coupled to the distal portion of the introducer sheath; an outer shaft insertable through the introducer sheath; an inner shaft insertable through the outer shaft; A clot removal device; Including, The clot removal device comprises: A unitary structure extending along a longitudinal axis, said unitary structure comprising: a first region adjacent a proximal portion of the unitary structure, the first region including a pair of curved struts extending from a common proximal junction to a distal junction to define a first mouth, the proximal junction being radially offset from the longitudinal axis; a second region distal to the first region, the second region being tubular and including a first plurality of interconnected struts forming first cells; a third region distal to the second region, the third region including a second mouth; and a fourth region distal to the third region, the fourth region including a second plurality of interconnected struts forming a second cell, the first mouth and the second mouth being larger than each of the first cell and the second cell; and a connection feature coupled to the proximal junction, the connection feature being coupled to the inner shaft; Including, the clot removal device is configured to be compressed within the outer shaft and expanded outside the outer shaft; The system is configured such that the inner shaft is retracted proximally with the clot removal device expanded outside of the outer shaft such that the clot removal device is retracted against the vascular thrombus and the first port and / or the second port core the vascular thrombus.

26. The system described in claim 25, wherein the internal shaft is fixedly coupled to the connection feature.

27. The system of claim 25, wherein the fourth region of the integral structure is tubular.

28. The system of claim 25, wherein the clot removal device is configured to self-expand when outside the external shaft.

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