Devices and methods for treating vascular occlusions

Abstract

Disclosed herein are systems and methods for intravascular treatment of clot material within a blood vessel of a human patient. In one embodiment, a system includes a coring element for coring and separating the clot material. The coring element can include a unitary structure having a first region, a second region, a third region, and a fourth region. The first region is proximal to 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, is 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 a vascular thrombus. The fourth region is distal to the third region, is generally tubular, and includes a second plurality of interconnected struts.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 949,967, filed December 18, 2019, entitled “DEVICES AND METHODS FORTREATING VASCULAR OCCLUSION”, which is incorporated herein by reference in its entirety. Technical Field

[0003] This technology generally relates to systems, methods, and apparatus for removing thrombi from blood vessels in human patients. Specifically, some embodiments of this technology relate to systems for removing thrombi from the superficial vascular system of human patients. Background Technology

[0004] Thrombosis is the localized coagulation or clotting of blood within a part of the circulatory system, while a thrombus is a blood clot that forms in situ within the vascular system. Venous thrombosis is a blood clot that forms within a vein. A common type of venous thrombosis is deep vein thrombosis (DVT), which is a blood clot that forms within a deep vein (e.g., primarily in the leg). Nonspecific signs of thrombosis may include pain, swelling, redness, heat, and congestion of superficial veins.

[0005] If a blood clot breaks off (embolism) and travels to the lungs, it can become a life-threatening pulmonary embolism (PE) (e.g., a blood clot in the lungs). Besides the potential for death from PE, deep vein thrombosis (DVT) can cause serious health problems such as post-thrombotic syndrome, which can lead to chronic swelling, pressure, pain, and ulcers due to damage to valves and blood vessels. Furthermore, DVT can directly or indirectly result in substantial healthcare costs due to treatment-related complications and the patient's inability to work.

[0006] Three processes are believed to lead to venous thrombosis (DVT). First, blood flow decreases (venous congestion); second, the tendency to clot increases (hypercoagulable state); and third, changes occur in the vessel wall. DVT typically begins within the valves of the veins in the lower leg, where the blood is relatively oxygen-deprived, activating certain biochemical pathways. Several conditions increase the risk of DVT, including diabetes, cancer, trauma, and antiphospholipid syndrome. Other risk factors include older age, surgery, activity limitations (such as bed rest, orthopedic casts, and long-haul flights), combined oral contraceptives, pregnancy, the postpartum period, and genetic factors. The incidence of DVT increases dramatically from childhood to old age, and in adulthood, approximately one in a thousand adults develop DVT each year.

[0007] Despite current devices and methods to prevent and / or treat DVT, many shortcomings remain unaddressed, such as high recurrence rates of DVT, use of devices not designed to remove large clots, and / or complex treatments involving multiple therapeutic devices and / or pharmaceuticals. Accordingly, there is a need for new devices, systems, and methods to treat thrombus and, in particular, DVT. BRIEF DESCRIPTION OF DRAWINGS

[0008] Many aspects of the 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.

[0009] FIG. 1 is a side view of a thrombectomy system configured in accordance with an embodiment of the technology.

[0010] FIG. 2A and FIG. 2B is a side view of a thrombus extraction assembly of a thrombectomy system configured in accordance with an embodiment of the technology, the thrombus extraction assembly including a thrombus extraction device in a partially open configuration and a fully open configuration, respectively.

[0011] FIGS. 3A-3D are an isometric view, a side view, a top view, and a back view, respectively, of a coring element of a thrombus extraction device configured in accordance with an embodiment of the technology.

[0012] FIG. 4 is a magnified side view of a thrombus extraction device in accordance with an embodiment of the technology, the thrombus extraction device coupled to a distal portion of a thrombus extraction assembly and in a fully open configuration.

[0013] FIG. 5A and FIG. 5B are side views of a dilator assembly of a thrombectomy system in a first configuration and a second configuration, respectively, configured in accordance with an embodiment of the technology.

[0014] FIG. 6 is a magnified cross-sectional side view of a portion of a thrombectomy system including a self-opening funnel configured in accordance with an embodiment of the technology.

[0015] FIGS. 7A-7D is a side view of a dilator assembly in accordance with an embodiment of the technology, the dilator assembly positioned within a guide assembly of a thrombectomy system, and illustrating various stages in a procedure or method for deploying a self-opening funnel.

[0016] FIG. 8A , FIG. 8C and FIG. 8D are cross-sectional side views of a control assembly of a dilator assembly configured in accordance with an embodiment of the technology, and FIG. 8Bis an enlarged cross-sectional isometric view of the control assembly.

[0017] FIGS. 9A-9C is a cross-sectional side view of a control assembly configured in accordance with another embodiment of the technology.

[0018] FIG. 10A and FIG. 10B is a partial cross-sectional side view of a control assembly configured in accordance with another embodiment of the technology.

[0019] FIG. 11 is a schematic illustration of an access technique for accessing a thrombus for treatment using a thrombectomy system in accordance with an embodiment of the technology.

[0020] FIGS. 12A-12C is a side view of a thrombectomy system positioned within a blood vessel during a thrombectomy procedure in accordance with an embodiment of the technology, and FIGS. 12D-12K is an enlarged side view of the thrombectomy system. DETAILED DESCRIPTION

[0021] The technology is generally directed to methods and systems for removing clot material (e.g., thrombus) from a blood vessel of a human patient. In some embodiments, a system for removing clot material (e.g., a thrombectomy system) includes a thrombus extraction device including (i) a coring element configured to core and separate clot material from a blood vessel wall, and (ii) a capture element configured to capture the cored and separated clot material. In some embodiments, the coring element includes a unitary structure having a first region proximal to a 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 mouth configured to core and separate clot material, and the third region can include a second mouth configured to core and separate clot material. 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 mouths are radially offset such that at least one of the first and second mouths is positioned and oriented to effectively core and separate clot material from within a blood vessel during a thrombus extraction procedure using the thrombus extraction device.

[0022] In some embodiments, a thrombectomy system includes a dilator assembly for deploying an expandable funnel coupled to a distal portion of an introducer sheath. The dilator assembly can include a first shaft defining an inner lumen, a second shaft slidably positioned within the inner lumen of the first shaft, and a retention sheath coupled to the second shaft and configured to receive and constrain the funnel therein. A control assembly including an actuator is operably coupled to the first shaft and the second shaft. Movement of the actuator to a first position is configured to advance the first shaft and the second shaft together distally to deploy the funnel from the retention sheath. Movement of the actuator 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 substantially uniform (e.g., constant diameter) outer surface. In one aspect of the technology, the substantially uniform outer surface of the dilator assembly is less likely to obstruct or otherwise damage the funnel or a blood vessel as the dilator assembly is retracted through the introducer sheath. In another aspect of the technology, the dilator assembly can be coupled to the introducer sheath to inhibit or even prevent inadvertent, premature deployment of the funnel.

[0023] While many embodiments are described below with respect to devices, systems, and methods for treating vascular thrombi (e.g., deep vein thrombosis (DVT)), other applications and other embodiments beyond those described herein are within the scope of the technology (e.g., intravascular procedures other than thrombus treatment, intravascular procedures for treating cerebral embolism, intravascular procedures for treating pulmonary embolism). In general, for example, devices, systems, and methods of the technology can be used for extraction of any material formation in a blood vessel (e.g., a venous or arterial blood vessel), such as cancerous growths, neoplasms, and the like. Moreover, several other embodiments of the technology can have different configurations, states, components, or procedures than those described herein. Moreover, it will be appreciated that references to FIGS. 1-12K Specific elements, substructures, advantages, uses, and / or other features of the described embodiments can be interchanged, substituted, or otherwise configured as appropriate from additional embodiments of the technology. Moreover, references to FIGS. 1-12K Suitable elements of the described embodiments can function as separate and / or independent devices. Accordingly, those skilled in the art will appreciate that the technology can have other embodiments with additional elements, or the technology can have embodiments without elements described below with reference to FIGS. 1-12K Other embodiments of several features shown and described.

[0024] With respect to the terms "distal" and "proximal" within this description, unless otherwise indicated, the terms can refer to the relative position of portions of the tube system with respect to an operator and / or a certain location in the vasculature. Also, as used herein, "rearward," "forward," "upward," "downward," and the like designations do not imply that the referenced components are limited to use in a particular orientation. It will be appreciated that such designations refer to the orientation of the referenced components as depicted in the drawings; the systems of the present technology can be used in any orientation that is suitable for the user.

[0025] The headings provided herein are for convenience only and shall not be deemed to

[0026] I. Selected embodiments of thrombectomy systems

[0027] FIG. 1 is a side view of a thrombectomy system 100 (which can also be referred to as a thrombus extraction system, clot removal system) configured in accordance with one embodiment of the present technology. In the illustrated embodiment, the thrombectomy system 100 includes a guide catheter assembly 102, an occluder or dilator assembly 104 (shown positioned within the guide catheter assembly 102), and a thrombus extraction assembly 106. Generally, the thrombectomy system 100 can be used to (i) access a portion of a blood vessel (e.g., a venous blood vessel of a human patient) that contains a thrombus (e.g., clot material); and (ii) remove all or a portion of that thrombus from the blood vessel. More particularly, for example, the guide catheter assembly 102 and the dilator assembly 104 can be partially advanced into the vasculature of a patient (e.g., a blood vessel or venous blood vessel of the patient). The dilator assembly 104 can be actuated to deploy a self-opening funnel (e.g., as described in greater detail below) that can be used to dilate a portion of the vasculature. The thrombus extraction assembly 106 can be advanced through the dilator assembly 104 and into the vasculature. The thrombus extraction assembly 106 can be actuated to remove a thrombus from the vasculature. The thrombus extraction assembly 106 can be withdrawn from the vasculature, and the dilator assembly 104 can be withdrawn from the vasculature. FIGS. 7A-7CThe thrombus extraction assembly 106 and attached thrombus extraction device can then be partially inserted through the introducer assembly 102 and deployed at and / or near the location of the thrombus in order to capture the thrombus. Finally, the thrombus extraction assembly 106 and / or the introducer assembly 102 can be removed from the patient along with the captured thrombus. In some embodiments, the thrombectomy system 100 and / or the method of operating the thrombectomy system 100 to remove a thrombus from a patient can include some features that are the same as or similar to those described in detail in (i) U.S. Patent No. 9,700,332, entitled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS,” filed September 16, 2016; and / or (ii) U.S. Patent No. 10,098,651, entitled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION,” filed April 26, 2017, both of which are incorporated by reference herein in their entireties.

[0028] In the illustrated embodiment, the introducer assembly 102 includes an elongated sheath 112, which can also be referred to as a shaft, a catheter, or the like. The sheath 112 defines an inner lumen (masked in FIG. 1 ; for example, identified as inner lumen 688 in FIG. 6 ; for example, identified as inner lumen 688 in The inner lumen of the sheath 112 is sized to slidably receive the dilator assembly 104 and the thrombus extraction assembly 106. For example, the dilator assembly 104 is shown in FIG. 1The sheath 112 is shown as being positioned partially within the sheath 112. The sheath 112 can be elastic and / or flexible, and can have any suitable length and diameter. In some embodiments, the sheath 112 can have an outer diameter of at least 10 French, at least 12 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, greater than 26 French, between 10 French and 26 French, between 14 French and 24 French, between 15 French and 21 French, between 16 French and 22 French, and / or any other or intervening size. In some embodiments, the lumen of the sheath 112 can have an inner diameter of at least 2 French, at least 10 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, between 11 French and 12 French, between 10 French and 22 French, between 14 French and 21 French, between 16 French and 20 French, and / or any other or intervening size. In some embodiments, the sheath 112 can include a radiopaque marker (not shown) positioned, for example, at its distal portion 113b.

[0029] 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 allow access to the lumen of the sheath 112 and 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 configured to maintain hemostasis during a thrombus extraction procedure by resisting fluid flow in a proximal direction through the sealable hub 114 as various components, such as portions of the dilator assembly 104 and / or the thrombus extraction assembly 106, are inserted through the sealable hub 114 for delivery through the sheath 112 to a treatment site in a blood vessel. More particularly, the sealable hub 114 can be a valve of the type disclosed in U.S. Patent Application No. 16 / 117,519, entitled “HEMOSTASIS VALVES AND METHODS OF USE,” filed August 30, 2018, which is incorporated by reference herein in its entirety. The sealable hub 114 can include one or more buttons or actuators that enable an operator to selectively seal / unseal the sealable hub 114.

[0030] The introducer assembly 102 can also include a suction port 116 connected to the sealable hub 114 (e.g., to a side port of the sealable hub 114) and / or the sheath 112 (e.g., to the proximal portion 113a of the sheath 112) via, for example, 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 includes a fluid control device 119 configured to selectively fluidically connect the suction port 116 to the lumen of the sheath 112. In the illustrated embodiment, the fluid control device 119 is a stopcock valve 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.

[0031] The dilator assembly 104 can include a control assembly 120 operably coupled to the retention sheath 122 via a first shaft (shaded in FIG. 1 ; e.g., identified as first shaft 580 in FIG. 5A and FIG. 5B ). In the illustrated embodiment, the first shaft of the dilator assembly 104 extends through the sealable hub 114 and the sheath 112 such that the retention sheath 122 is positioned distal of the distal portion 113b of the sheath 112. Moreover, the control assembly 120 is releasably coupled to (e.g., mated to, secured to) the sealable hub 114. Thus, the introducer assembly 102 can carry or hold the dilator assembly 104. As described in greater detail below with reference to FIGS. 5A-7D , the dilator assembly 104 (e.g., the retention sheath 122) is configured to (i) hold / restrain a self-expanding funnel (shaded in FIG. 1 ; e.g., identified as 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 an actuator 124 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 to the actuator to deploy / release the self-expanding funnel.

[0032] In some embodiments, the thrombectomy system 100 can also include a loading tool 108 (e.g., a loading funnel) for loading a self-expanding funnel into the dilator assembly 104 (e.g., into the retention sheath 122). In the illustrated embodiment, the loading tool 108 defines an inner lumen 127 therethrough and includes a first portion 126 having a varying diameter (e.g., a tapered portion such as a funnel portion) and a second portion 128 having a substantially constant diameter (e.g., a shaft portion). In other embodiments, the second portion 128 can have a partially varying diameter. The first portion 126 is configured (e.g., sized and shaped) to receive the self-expanding funnel and move the self-expanding funnel to a constrained configuration as the self-expanding funnel is advanced through the first portion 126. The inner lumen 127 of the loading tool 108 can be sized to allow the retention sheath 122 to pass completely through the loading tool 108.

[0033] In the illustrated embodiment, the thrombus extraction assembly 106 includes a catheter portion 130 and a handle portion 140 operably coupled to the catheter portion 130 (“handle 140”). In operation, the handle 140 is configured to be actuated / manipulated by a user to control (e.g., deploy) the catheter portion 130 and / or one or more components of a thrombus extraction device (not shown in FIG. 1 ; e.g., identified as the thrombus extraction device 250 in FIG. 2A and FIG. 2B that is coupled to the catheter portion 130.

[0034] 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 one another 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 be slidably fitted within the lumen of the outer shaft 132, and (ii) the inner shaft 134 can be configured to be slidably fitted within the lumen of the intermediate shaft 133. In some embodiments, the outer shaft 132 is configured (e.g., sized) to be slidably fitted within the sheath 112 of the introducer assembly 102, and can have, for example, a size of at least 8 French, at least 10 French, at least 11 French, at least 12 French, at least 14 French, at least 16 French, between 8 French and 14 French, between 11 French and 12 French, and / or any other or intermediate size. With this arrangement, each of the shafts 132-134 can be longitudinally displaced relative to one another and relative to the sheath 112 of the introducer assembly 102. In some embodiments, each of the shafts 132-134 can have the same length, while in other embodiments, one or more of the shafts 132-134 can have a different length. 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 one another and / or configured to be coaxially positioned relative to one another. For example, in some embodiments, the catheter portion can include three intermediate shafts, as described in detail in U.S. Patent No. 10,098,651, entitled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION,” filed on April 26, 2017, which is incorporated by reference herein in its entirety.

[0035] 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, intermediate shaft 133 is coupled to and extends distally from the distal portion 141b of handle 140. The distal portion 141b of handle 140 can include a lock feature 142, such as a spin lock. Lock feature 142 is configured to selectively engage and / or lockingly engage a mating feature 135 located proximate to the proximal portion 136a of outer shaft 132. In some embodiments, outer shaft 132 can slide proximally over intermediate shaft 133 until lock feature 142 engages mating feature 135, thereby fixing the position of outer shaft 132 relative to intermediate shaft 133. In some embodiments, intermediate shaft 133 is relatively longer than outer shaft 132 such that a portion of intermediate shaft 133 extends distally from the distal portion 136b of outer shaft 132 when outer shaft 132 is lockingly engaged with lock feature 142.

[0036] In the illustrated embodiment, handle 140 also includes a plunger 144 (e.g., an actuator) that is operably coupled to inner shaft 134 and is movable between a first, non-extended position (e.g., as shown in FIG. 1 1 A) and a second, extended position (e.g., as shown in FIG. 1 1 B). Accordingly, movement of plunger 144 relative to handle 140 displaces inner shaft 134 relative to handle 140, outer shaft 132, and / or intermediate shaft 133. For example, proximal retraction of plunger 144 from the first position to the second position can retract inner shaft 134 through intermediate shaft 133. In some embodiments, inner shaft 134 can have a length such that inner shaft 134 extends distally past the distal end of intermediate shaft 133 when plunger 144 is in the first position and the second position. In some embodiments, plunger 144 can be lockable in the first position and / or the second position to lock the position of inner shaft 134. In other embodiments, plunger 144 can be operably coupled to other components of catheter portion 130, such as intermediate shaft 133 and / or one or more additional shafts (not shown). FIG. 1 and FIG. 2A In the illustrated embodiment, handle 140 also includes a plunger 144 (e.g., an actuator) that is operably coupled to inner shaft 134 and is movable between a first, non-extended position (e.g., as shown in FIG. 1 1 A) and a second, extended position (e.g., as shown in FIG. 1 1 B). Accordingly, movement of plunger 144 relative to handle 140 displaces inner shaft 134 relative to handle 140, outer shaft 132, and / or intermediate shaft 133. For example, proximal retraction of plunger 144 from the first position to the second position can retract inner shaft 134 through intermediate shaft 133. In some embodiments, inner shaft 134 can have a length such that inner shaft 134 extends distally past the distal end of intermediate shaft 133 when plunger 144 is in the first position and the second position. In some embodiments, plunger 144 can be lockable in the first position and / or the second position to lock the position of inner shaft 134. In other embodiments, plunger 144 can be operably coupled to other components of catheter portion 130, such as intermediate shaft 133 and / or one or more additional shafts (not shown). FIG. 2B

[0037] In the illustrated embodiment, thrombus extraction assembly 106 also includes a first flush port 138 connected to outer shaft 132 and a second flush port 148 connected to handle 140. First flush port 138 can be fluidly connected to the lumen of outer shaft 132 to allow for flushing of the lumen of outer shaft 132. Second flush port 148 can be fluidly connected to the lumen of intermediate shaft 133 (e.g., via the interior of handle 140) to allow for flushing of the lumen of intermediate shaft 133.

[0038] ​The thrombus extraction assembly 106 can include and / or be connected to a thrombus extraction device configured to core and capture a thrombus of a patient. For example, FIG. 2A and FIG. 2B are FIG. 1 side views of the thrombus extraction assembly 106 operably coupled to a thrombus extraction device 250 configured in accordance with embodiments of the present technology. 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. When positioned within the outer shaft 132, the thrombus extraction device 250 can be in an undeployed, constrained (e.g., unexpanded) position.

[0039] Referring to FIG. 2A and FIG. 2B together, the thrombus extraction device 250 includes an expandable coring element 252 and an expandable capture element 254 coupled (e.g., attached to, connected to, integrally formed with) to the coring element 252. The coring element 252 is positioned proximally of the capture element 254. In the illustrated embodiment, the coring element 252 includes (i) a proximal portion 253a coupled to the intermediate shaft 133 (e.g., to 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 the inner shaft 134 (e.g., to a distal portion of the inner shaft 134). As shown, the outer shaft 132 is displaced proximally relative to the handle 140 such that the mating feature 135 of the outer shaft 132 contacts / engages the lock feature 142 of the handle 140. As a result of this positioning of the outer shaft 132 relative to the handle 140, each of the intermediate shaft 133, the inner shaft 134, and the thrombus extraction device 250 extend distally beyond the distal portion 136b of the outer shaft 132.

[0040] In some embodiments, the thrombus extraction device 250 can also include an atraumatic tip 258. In some embodiments, the atraumatic tip 258 can include a radiopaque marker to aid in positioning the thrombus extraction device 250 within a patient’s vasculature. The thrombus extraction device 250 can additionally or alternatively include one or more radiopaque markers located on, for example, the outer shaft 132 (e.g., the distal portion 136b of the outer shaft 132), the intermediate shaft 133 (e.g., a distal portion of the intermediate shaft 133), and or other components of the thrombus extraction device 250. In some embodiments, the atraumatic tip 258 can define a channel configured to receive a guidewire therethrough.

[0041] In FIG. 2AIn the partially open configuration shown in FIG. 1, the plunger 144 of the handle 140 is in a first position. In contrast, in the fully open configuration shown in FIG. 2, the plunger 144 is in a second position (e.g., retracted proximally away from the handle 140) such that the inner shaft 134 is retracted proximally relative to the intermediate shaft 133. This proximal retraction of the inner shaft 134 relative to the intermediate shaft 133 forces the coring element and the capture element 254 to fully open, as described in more detail below with reference to FIG. 3. FIG. 2B In the fully open configuration shown in FIG. 2, the plunger 144 is in a second position (e.g., retracted proximally away from the handle 140) such that the inner shaft 134 is retracted proximally relative to the intermediate shaft 133. This proximal retraction of the inner shaft 134 relative to the intermediate shaft 133 forces the coring element and the capture element 254 to fully open, as described in more detail below with reference to FIG. 3. FIG. 4 In some embodiments, the inner shaft 134 and the intermediate shaft 133 can be directly locked together via, for example, (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 is limited (rather than fixed) relative to the position of the intermediate shaft 133. For example, the inner shaft 134 can be dynamically locked to the plunger 144 via a compliant spring (e.g., a tension spring, a compression spring), which allows for limited movement of the inner shaft 134 relative to the intermediate shaft 133 when the plunger 144 is locked in the second position.

[0042] The thrombus extraction assembly 106 can include one or several features configured to secure the thrombus extraction device 250, and particularly the coring element 252 and / or the expandable capture element 254, in a fully open position. As used herein, fully open describes a condition in which the thrombus extraction device 250 is continuously biased open by one or several forces in addition to the self-opening force generated by the thrombus extraction device 250. In some embodiments, fully open occurs when the thrombus extraction device 250 is deployed and when 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 additionally, fully open can occur when the thrombus extraction device 250 is deployed and biased open via a spring that is directly or indirectly connected to the thrombus extraction device 250. Thus, when the thrombus extraction device 250 is fully open, a force less than the minimum radial compression force does not change the diameter of the thrombus extraction device 250. Thus, when fully open, the thrombus extraction device 250 can maintain at least a desired radial force on the blood vessel as the thrombus extraction device 250 is pulled through the blood vessel. In some embodiments, the thrombus extraction device 250 can be sized such that the thrombus extraction device 250 fits against and / or exerts a desired force on the blood vessel wall when fully open.

[0043] In some embodiments, the plunger 144 can be locked in the second position, for example, by rotating the plunger 144 relative to the handle 140 to engage one or several locking features on the plunger 144 and / or in the handle 140. Locking the plunger 144 in the second position secures the position of the inner shaft 134 relative to the intermediate shaft 133, thereby securing the thrombus extraction device 250 in the fully open position. In other embodiments, the inner shaft 134 and the intermediate shaft 133 can be directly locked together via, for example, (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 is limited (rather than fixed) relative to the position of the intermediate shaft 133. For example, the inner shaft 134 can be dynamically locked to the plunger 144 via a compliant spring (e.g., a tension spring, a compression spring), which allows for limited movement of the inner shaft 134 relative to the intermediate shaft 133 when the plunger 144 is locked in the second position.

[0044] II. Selected embodiments of coring elements

[0045] FIGS. 3A-3D respectively configured in accordance with embodiments of the present technology FIG. 2A and FIG. 2B isometric, side, top, and (proximally-facing) rear views of a coring element 252 of a thrombus extraction device 250. Referring to FIGS. 3A-3D together, the coring element 252 includes a plurality of struts 360 that together define a plurality of voids or holes 362. The struts 360 can have a variety of shapes and sizes, and in some embodiments, the struts 360 can have a thickness and / or diameter of between about 0.05 inches to 0.15 inches, between about 0.075 inches to 0.125 inches, between about 0.09 inches to 0.1 inches, about 0.096 inches, and / or other dimensions. Generally, the struts 360 can together form a single, holed structure configured to core and separate a portion of a thrombus (e.g., a vascular thrombus) from a blood vessel that includes the thrombus. In some embodiments, the coring element 252 can include a stent or stent-like device.

[0046] As best shown in FIG. 3B and FIG. 3C the coring element 252 includes a first region 363 including the proximal portion 253a, a second region 364 distal of the first region 363, a third region 365 distal of the second region 364, and a fourth region 366 distal of the third region 365 and including the 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 than the second region 364 and the fourth region 366. For example, the first region 363 can include a pair of curved struts 367 (individually identified as a first strut 367a and a second strut 367a, as best shown in FIG. 3A and FIG. 3C ) that curve in opposite directions around a central axis L of the coring element 252 and that intersect and / or terminate at a pair of first junctions 361 (individually 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 (individually 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 around the central axis L, and (ii) a pair of curved upper struts 369 (individually identified as a first upper strut 369a and a second upper strut 369b, shown together inFIG. 3A and FIG. 3C The pair of curved upper struts extend distally from the upper second junction point 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 rotationally offset from the second mouth portion 372b. In other embodiments, the first mouth portion 372a can be positioned differently relative to the second mouth portion 372b (e.g., in different rotational and / or longitudinal orientations) and / or the second mouth portion 372 can include more than two separate portions (e.g., three, four, or more openings). Generally speaking, the first and second mouths 370, 372 can be defined in / by regions of the coring element 252 having different porosities.

[0047] In some embodiments, the coring element 252 is made from a shape memory material, such as a shape memory alloy and / or a shape memory polymer. For example, the coring element 252 can include nitinol and / or a nitinol alloy. Similarly, the coring element 252 can be manufactured using a variety of techniques, including welding, laser welding, cutting, laser cutting, and / or uncrimping. For example, the coring element 252 can be first laser cut from a piece of nitinol (e.g., a nitinol tube), and then expanded and / or uncrimped. Generally, the size (e.g., length and diameter) of the coring 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 coring element 252 can have a length M of between about 0.2 inches and 5 inches (e.g., between about 1.5 inches and 2.5 inches, between about 1.75 inches and 2.25 inches, between about 1.9 inches and 2.0 inches, between about 1.5 inches and 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, the coring element 252 can have a diameter D of between about 2 mm and 50 mm (e.g., between about 4 mm and 25 mm, between about 6 mm and 20 mm, between about 8 mm and 16 mm) in a fully expanded and unconstrained position within a blood vessel. In some embodiments, the length M of the coring element 252 can be selected based on the fully expanded and unconstrained diameter D of the coring element 252 to prevent unwanted dumping and / or rotation of the coring element 252 within a blood vessel during operation. Generally, the length M and the unconstrained diameter D of the coring element 252 will vary depending on the size of the blood vessel for which the coring element 252 is designed. For example, the coring element 252 will generally have a smaller length M and diameter D when designed for a smaller (e.g., 4 mm) blood vessel as opposed to a larger (e.g., 25 mm to 35 mm) blood vessel.

[0048] The coring element 252 is configured to core (e.g., shear, separate) a thrombus as the coring element is advanced / retracted through the thrombus within a blood vessel in a fully expanded configuration. For example, as described below with reference to FIGS. 3A-3C, the coring element 252 can be configured to core a thrombus 302 as the coring element 252 is advanced / retracted through the thrombus 302 in a fully expanded configuration. FIGS. 12D-12KDescribed in greater detail, the coring element 252 can be proximally retracted through the thrombus to core the thrombus. As the coring element 252 is retracted through the thrombus, the fully flared diameter of the coring element 252 will flexibly accommodate to match the diameter of the vessel. More specifically, the first and second jaws 370, 372 are configured (e.g., sized, shaped, and / or positioned) to provide the majority of the coring function (e.g., coring force) during operation of the coring element 252. For example, the proximally facing surfaces of the struts 367 can define a first leading edge that cuts through and cores the thrombus. Similarly, the proximally facing surfaces of the lower and upper struts 368, 369 can define a second leading edge that can also cut through and core the thrombus. In some embodiments, portions of the struts 367, lower struts 368, and / or upper struts 369 can be sharpened and / or can include cutting elements (e.g., knives or knife edges) attached or otherwise integrated therewith to further facilitate coring of the thrombus.

[0049] In one aspect of the technology, the first jaw 370 and the second jaw 372 are longitudinally offset relative to one another. Further, the leading edges of the struts 367 and the leading edges of the lower and upper struts 368, 369 are differently oriented such that, for example, when the coring element 252 is positioned within a vessel, the first jaw 370 and the second jaw 372 are oriented at different angles. The arrangement can more effectively core the thrombus compared to, for example, a coring element that includes only a single jaw (e.g., only the first jaw 370). It is contemplated that the coring element 252 provides a greater coring length for engaging the vessel wall and coring (e.g., adherent) thrombus compared to a coring element having only a single jaw. Further, the coring element 252 can be relatively flexible at the first and third regions 363, 365 that include fewer struts 360 than the second and fourth regions 364, 366. For example, the coring element 252 can flex / bend at the first and / or second articulation points 361, 371. In some embodiments, the first and second articulation points 361, 371 enable the coring element 252 to flex in different directions (e.g., laterally and vertically). In one aspect of the technology, this ability of the coring element 252 to flex can allow the coring element 252 to maintain a selected orientation even when moving through tortuous vessels. In another aspect of the technology, the arrangement of the first and second jaws 370, 372 ensures that at least one of the first jaw 370, the first jaw portion 372a, and the second jaw portion 372b is positioned and oriented to effectively core the thrombus from within the vessel during a thrombus extraction procedure using the coring element 252. In some embodiments, the first jaw 370 and / or the second jaw 372 can further facilitate collapse of the coring element 252 to an unflared configuration.

[0050] exist FIGS. 3A-3D In the embodiment illustrated, the first connection feature 374 and the second connection feature 376 are coupled to the core-taking element 252. See below for reference. FIG. 4 In more detail, intermediate shaft 133 ( FIG. 1 The inner shaft 134 can be operatively coupled to the first connecting feature 374, and the inner shaft 134 can be operatively coupled to the second connecting feature 376 for controlling the operation of the core element 252 (e.g., movement and opening). In the illustrated embodiment, the first connecting feature 374 is a ring coupled to the proximal portion 253a of the core element 252 and more specifically to the lower first engagement point 361a. In other embodiments, the first connecting feature 374 may be positioned on different portions of the core element 252 (e.g., at the upper first engagement point 361b, on one of the supports 367). Similarly, the second connecting feature 376 may also be a ring and can be coupled to one or more of the supports 360 in the second region 364 or another region of the core element 252. FIG. 3D As best seen in some embodiments, the first connecting feature 374 may have a diameter E1 greater than the diameter E2 of the second connecting feature 376, and the first and second connecting features 374, 376 may be axially aligned along an axis extending parallel to the central axis L of the core element 252. In other embodiments, the first and second connecting features 374, 376 may have other shapes and / or configurations and / or may be arranged differently from each other. The first and second connecting features 374, 376 may be made of the same material as the core element 252 or may be made of a different material. Similarly, the first and second connecting features 374, 376 may be integrally formed with the core element 252 and / or may be attached to the core element 252 via one or more of the following methods: welding, adhesive, mechanical fasteners, etc.

[0051] FIG. 4is a magnified side view of a thrombus extraction device 250 according to one embodiment of the technology, coupled to a distal portion of the thrombus extraction assembly 106 and in a fully flared configuration. In the illustrated embodiment, the coring element 252 is coupled to the intermediate shaft 133 (e.g., to a distal portion of the intermediate shaft 133) via a first connection feature 374. In some embodiments, the coring element 252 is fixedly coupled to the intermediate shaft 133 such that movement of the intermediate shaft 133 also moves the coring element 252. A proximal portion 255a of the capture element 254 is connected to a distal portion 253b of the coring element 252. In some embodiments, the capture element 254 is formed on the distal portion 253b of the coring element 252 such that the thrombus extraction device 250 is a single / unitary structure. For example, the capture element 254 can comprise a mesh woven onto the distal portion 253b of the coring element 252 (e.g., a woven filament mesh structure). In some embodiments, a distal portion 255b of the capture element 254 is coupled to the inner shaft 134 (e.g., to a distal portion of the inner shaft 134).

[0052] In the illustrated embodiment, the inner shaft 134 is slidably extendable through the second connection feature 376. That is, the inner shaft 134 can have an outer diameter that is smaller than a 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 comprise a stop feature 478 configured to engage the second connection feature 376 of the coring element 252 to effect flaring of the coring element 252. In some embodiments, the stop feature 478 can comprise a polymeric member and / or a metallic member affixed to a portion of the inner shaft 134 that is distal to the second connection feature 376.

[0053] When the inner shaft 134 is proximally retracted relative to the coring element 252 via, for example, movement of the plunger 144( FIG. 1 to FIG. 3) from the first position to the second position, the stop feature 478 is configured (e.g., sized and shaped) to contact and engage the second connection feature 376. With this arrangement, the coring element 252 is selectively coupled to the inner shaft 134 such that the stop feature 478 can apply a proximally directed force to the coring element 252 that can cause all or a portion of the coring element 252 to flare to the fully flared configuration. For example, movement of the inner shaft 134 can forcibly flare at least a first region 363( FIG. 3B and FIG. 3C ) of the coring element between the first and second connection features 374, 376. In some embodiments, the second connection feature 376 can be differently positioned relative to the coring element 252 such that more or less of the coring element 252 is forcibly flared when the stop feature 478 is pulled onto the second connection feature 376.

[0054] In some embodiments, the capture element 254 can include a woven filament mesh structure, such as a resilient filament braid 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. Because the distal portion 255b of the capture element 254 is coupled to the inner shaft 134, axial movement of the inner shaft 134 causes the capture element 254 to open / shorten and collapse / lengthen. 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 stretch 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, together with reference to FIG. 2A , FIG. 2B and FIG. 4 , distal movement of the plunger 144 can move the capture element 252 to a fully collapsed position before the plunger 144 reaches a fully depressed first position shown in FIG. 2A . Thus, continued distal movement of the plunger 144 (e.g., from the second position to the first position) can pull the coring element 252 to collapse / lengthwise extend the coring element 252. That is, the plunger 144, the inner shaft 134, and the capture element 254 can collectively act to lengthen / collapse the coring element 252 while the capture element 254 is fully collapsed upon distal pressing of the plunger 144. In other embodiments, the inner shaft 134 can be selectively uncoupled from the capture element 254 such that proximal displacement of the inner shaft 134 causes the coring element 252 to open without effecting any movement of the capture element 254. In some embodiments, the capture element 254 can have a length of (i) between about 5 inches to 30 inches (e.g., between about 10 inches to 20 inches, about 16 inches) in a collapsed configuration and (ii) between about 1 inch to 25 inches (e.g., between about 10 inches to 20 inches, about 11 inches) in an open configuration.

[0055] In some embodiments, the capture element 254 can be formed by a braider and / or a weaver, while in other embodiments, the capture element 254 can be hand-braided and / or woven. In some embodiments, the capture element 254 is formed as a tubular braid and then further shaped using a heat setting process. The braid can be a tubular braid of thin metal wires such as Nitinol (a nickel-titanium alloy), platinum, cobalt-chrome alloy, stainless steel, tungsten, or titanium. In some embodiments, the capture element 254 can be formed at least in part from a cylindrical braid of elastic filaments. Thus, the braid can be subject to radial constraint without plastic deformation, such that it can self-open upon release of the radial constraint. Such a braid of elastic filaments can be referred to herein as a “self-opening braid.” In some embodiments, the thickness of the braided filaments can be less than about 0.15 mm. In some embodiments, the braid can be made from filaments and / or threads having a diameter ranging from about 0.05 mm to 0.25 mm. In some embodiments, braided filaments of different diameters can be combined to impart different properties, including: stiffness, elasticity, structure, radial force, pore size, emboli capture or filtration capabilities, etc. In some embodiments, the capture element 254 and / or the coring element 252 can be coated to reduce their surface friction / abrasion (e.g., for arterial applications). Likewise, the capture element 254 and / or the coring element 252 can be covered with a thin film (e.g., via dipping or spraying) to form a non-permeable membrane to contain clots without allowing the clots to embed in the interstices of the capture element 254 and / or the coring element 252, thereby facilitating cleaning. In some embodiments, the number of filaments used to form the capture element 254 can range between about 20 to 300 (e.g., including 144 filaments, 244 filaments). In some embodiments, the size of the pores formed by the capture element 254 (e.g., in the elongated portion 477) can range between about 0.05 mm to 4.0 mm (e.g., between about 0.5 mm to 2.5 mm, less than 0.4 mm).

[0056] III. Selected embodiments of dilator assemblies and associated methods

[0057] FIG. 5A and FIG. 5B are side views of the dilator assembly 104 in a first configuration and a second configuration, respectively, configured in accordance with embodiments of the present technology. FIG. 1 are side views of the dilator assembly 104 in a first configuration and a second configuration, respectively, configured in accordance with embodiments of the present technology. FIG. 5A and FIG. 5BThe dilator 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 dilator assembly 104 can also include a second shaft or sheath 582 that is slidably positioned on the first shaft 580 and operably coupled to the control assembly 120. In other words, 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 are axially displaceable relative to one another. In the illustrated embodiment, the first shaft 580 is longer than the second shaft 582 such that the retention sheath 122 is positioned distal to a distal portion 583b (opposite a proximal portion 583a) of the second shaft 582. The control assembly 120 also includes a housing 595 configured to engage (e.g., mate with) the sealable hub 114 of the introducer assembly 102( FIG. 1 ) when the dilator assembly 104 is in the first configuration.

[0058] The retention sheath 122 includes a proximal portion 585a and a distal portion 585b. In the illustrated embodiment, the distal portion 585a includes an atraumatic 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 atraumatic tip 584 is radiopaque.

[0059] When the dilator assembly 104 is in the first configuration shown in FIG. 5A , the second shaft 582 is positioned proximally (e.g., retracted) relative to the first shaft 580 such that the first engagement feature 586 does not engage the second engagement feature 589. As described in greater detail below with reference to FIG. 7A , when the dilator assembly 104 is in the first configuration, the first engagement feature 586 is configured to engage (e.g., connect, mate with) a distal portion 113b of the sheath 112 of the introducer assembly 102( FIG. 1 ). In some embodiments, the engagement of the first engagement feature 586 with the sheath 112 can form a seal.

[0060] When the dilator assembly 104 is in the second configuration FIG. 5Bsecond shaft 582 is configured to engage the first engagement feature 586 of the retention sheath 122. As shown, the second shaft 582 can have a diameter that is equal to or substantially equal to an outer diameter of the retention sheath 122, such that the dilator assembly 104 has a uniform or substantially uniform (e.g., smooth) outer surface in the second configuration. That is, there are no steps or interruptions in the outer surface, for example, 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, engagement of the first and second engagement features 586, 589 can form a seal. In some embodiments, an operator can move the dilator assembly 104 from the first configuration to the second configuration by actuating the actuator 124 of the control assembly 120 (e.g., by advancing the actuator 124 in the direction of arrow A). More particularly, as described below with reference to FIGS. 6A-6C, actuation of the actuator 124 can (i) advance the first and second shafts 580, 582 together distally relative to the sheath 112, and then (ii) advance the second shaft 582 distally relative to the first shaft 580. FIGS. 7A-7D In more detail, actuation of the actuator 124 can (i) advance the first and second shafts 580, 582 together distally relative to the sheath 112, and then (ii) advance the second shaft 582 distally relative to the first shaft 580.

[0061] FIG. 6 is a cross-sectional side view of a portion of the thrombectomy system 100 shown in FIG. 1 is a cross-sectional side view of a portion of the thrombectomy system 100 shown in FIG. 6 is a cross-sectional side view of a portion of the thrombectomy system 100 shown in

[0062] The first shaft 580 of the dilator assembly 104 extends through the lumen 688 of the sheath 112 and at least partially through the lumen 693 of the housing portion 692. In the illustrated embodiment, a portion of the tip 584 snugly receives a distal portion (e.g., a distal end) 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 by other means. As shown, the second shaft 582 extends through the lumen 693 of the housing portion 692 and is secured to the retention sheath 122 by the second engagement feature 589 of the second shaft 582 engaging the first engagement feature 586 of the retention sheath 122. FIG. 6It is further shown that the first shaft 580 and the tip 584 can define a continuous lumen 691 for receiving a guidewire (not shown). In some embodiments, the guidewire can have a diameter of 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.

[0063] In the illustrated embodiment, the inner diameter Fl of the housing portion 692 is greater than the outer diameter F2 of the first shaft 580, such that an annular retention / receiving space 694 is formed between the outer surface of the first shaft 580 and the inner surface of the housing portion 692. The receiving space 694 is configured (e.g., sized and shaped) to receive and / or retain the funnel 690 in a constrained configuration. Thus, in some embodiments, the funnel 690 can have a diameter that substantially matches the inner diameter Fl of the housing portion 692 when the funnel 690 is in the 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., sealingly engage) the distal portion 113b of the sheath 112.

[0064] FIGS. 7A-7D is a side view illustrating various stages in a process or method for deploying the funnel 690 according to embodiments of the present technology. Referring first to FIG. 7A , the dilator assembly 104 is initially positioned within the introducer assembly 102 in a first configuration FIG. 5A such that (i) the outer housing 595 of the control assembly 120 is coupled to / engages the sealable hub 114, and (ii) the first engagement feature 586 of the retention sheath 122 sealingly engages the distal portion 113b of the sheath 112. In other embodiments, the first engagement feature 586 need not sealingly engage the sheath 112. In FIG. 7A , the initial position shown in FIG. 6 , the actuator 124 of the control assembly 120 is in a first position (e.g., a fully retracted position), and the funnel 690 is housed within the retention sheath 122 in a constrained configuration, as shown in

[0065] 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 venous vessel of a patient percutaneously through, for example, an access site such as a popliteal artery access site, a femoral artery access site, an internal jugular vein access site, and / or other access sites. In some embodiments, the assemblies 102, 104 are inserted through another introducer sheath (not shown). In some embodiments, the assemblies 102, 104 are advanced within the venous vessel to a treatment location with the distal portion 113b of the sheath 112 proximal to (e.g., proximal of) a thrombus in the venous vessel.

[0066] See FIG. 7B After locating components 102 and 104, funnel 690 can be deployed via, for example, the following operations (for clarity, ... FIG. 7B and FIG. 7C (shown as transparent): Actuator 124 is moved from the first position ( FIG. 7B The actuator 124 is moved to a second position (e.g., intermediate position, intermediate stroke position, delivery position) to move the first and second axes 580, 582 distally relative to the sheath 112. The distal forward movement of the first axis 580 causes the retaining sheath 122 to move distally past and away from the funnel 690. When the funnel 690 is no longer constrained by the retaining sheath 122, the funnel 690 is configured from open to open (e.g., unconstrained). In other embodiments, the control assembly 120 is configured such that moving the actuator 124 from the first position to the second position moves only the first axis 580 of the expander assembly 104 distally, rather than the first and second axes 580, 582 together.

[0067] The funnel 690 may include various shapes and sizes and may be made of various materials. In some embodiments, in the open configuration, the funnel 690 may have (i) a diameter D greater than and / or equal to that of the core-taking element 252 when the core-taking element 252 is in the fully open configuration. FIG. 3B and FIG. 3C (ii) the maximum diameter of the funnel 690, and (ii) the minimum diameter substantially equal to the outer diameter of the sheath 112. In some embodiments, the funnel 690 may have a length M greater than and / or equal to that of the core-taking element 252. FIGS. 3A-3D The length N of the funnel 690 is such that the core extractor 252 can be received and housed within the funnel 690. In other embodiments, the length N of the funnel 690 may be less than the length M of the core extractor 252. In some embodiments, the funnel 690 may have a conical portion, and specifically, a truncated conical portion. In some embodiments, the funnel 690 may be formed from at least one of toothed nitinol braid, nitinol braided support, laser-cut nitinol, laser-cut polymer tube, injection-molded polymer structure, or inflatable balloon. In some embodiments, the funnel 690 may include a mesh with a sufficiently small aperture to prevent thrombi from passing through the mesh openings. In some embodiments, the funnel 690 may be blood-permeable.

[0068] See FIG. 7C After funnel 690 has been deployed, expander assembly 104 can be moved to a second configuration. FIG. 5B For example, the operator can move the actuator 124 of the control assembly 120 from the second position ( FIG. 7B) to a third position (e.g., a fully advanced position) to distally advance the second shaft 582 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. 6B, the second shaft 582 is advanced 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. 6C, the second shaft 582 is advanced 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. FIG. 7D As shown in FIG. 6B, after moving the dilator assembly 104 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 proximally retracted through the lumen of the sheath 112 and out of the sealable hub 114 of the introducer assembly 102.

[0069] Referring to FIGS. 6A-6C together, FIGS. 7A-7D In one aspect of the technology, moving the dilator assembly 104 to the second configuration prior to retracting the dilator assembly 104 from the introducer assembly 102 can inhibit or even prevent the dilator assembly 104 from damaging the funnel 690 or other components of the introducer assembly 102 during retraction of the dilator assembly 104. More specifically, if the dilator assembly 104 did not include the second shaft 582, proximally retracting the retention sheath 122 into the sheath 112 can cause the retention sheath 122 (e.g., the first engagement feature 586) to impede or damage the deployed funnel 690. However, because the second shaft 582 has a diameter that is equal to or substantially equal to the outer diameter of the retention sheath 122, the dilator assembly 104 has a uniform or substantially uniform (e.g., smooth) outer surface in the second configuration and is therefore less likely to impede or otherwise damage the funnel 690, the sealable hub 114, and / or other components of the introducer assembly 102 during retraction. 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.

[0070] In another aspect of the technology, movement of the actuator 124 from the first position to the third position (i) advances the first and second shafts 580, 582 together to deploy the funnel 690 (e.g., when the actuator 124 moves from the first position to the second position) and (ii) advances the second shaft 582 relative to the first shaft 580 (e.g., when the actuator 124 moves from the second position to the third position) such that the dilator assembly 104 has a substantially uniform outer diameter. This “double action” allows the control assembly 120 to be coupled to the sealable hub 114 during both deployment of the funnel 690 and advancement of the second shaft 582 toward the first shaft 580. This can advantageously inhibit or prevent inadvertent advancement of the sheath 122 and, thus, premature deployment of the funnel 690. For example, if the funnel 690 were to be prematurely deployed (potentially increasing trauma to the patient and duration of the thrombectomy procedure), it is often necessary to remove the dilator assembly 104 and the introducer assembly 102 from the patient entirely in order to reload the funnel 690. In contrast, some conventional dilator assemblies include a “floating” dilator (e.g., not locked to or engaged with the introducer assembly) such that inadvertent bumping or other forces on the dilator assembly can cause corresponding movement of the dilator assembly.

[0071] FIG. 8A , FIG. 8C and FIG. 8D is a cross-sectional side view of a control assembly 120 configured in accordance with embodiments of the technology, and FIG. 8B is an enlarged cross-sectional isometric view of the control assembly. In FIG. 8A and FIG. 8B , the actuator 124 is in a first position shown in FIG. 7A , in FIG. 8C , the actuator 124 is in a second position shown in FIG. 7B , and in FIG. 8D , the actuator 124 is in a third position shown in FIG. 7C .

[0072] Referring first to FIG. 8A , the control assembly 120 includes a proximal portion 801a and a distal portion 801b and defines an inner lumen 802 extending therethrough between the proximal and distal portions 801a, b. In the illustrated embodiment, the 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 inner lumen 802 of the control assembly 120, and in some embodiments, can receive a guide wire (not shown) therethrough. The connection portion 806 is configured to mate / engage with the sealable hub 114 of the introducer assembly 102 to secure the control assembly 120 thereto, as described above with reference to FIGS. 7A-7CDetailed description. For example, in some embodiments, the connection portion 806 can include a snap feature (e.g., having one or more teeth, a flange), a twist lock (e.g., a bayonet or luer fitting), and / or other features for engaging and / or locking to the sealable hub 114.

[0073] Reference is made together FIG. 8A and FIG. 8B In the illustrated embodiment, the control assembly 120 further includes a first hub 810 and a second hub 850. The first hub 810 is configured to be coupled to the first shaft 580 of the dilator assembly 104, and the second hub 850 is configured to be coupled to the second shaft 582 of the dilator assembly 104. For clarity, the first and second shafts 580, 582 are not shown in FIGS. 8A-8D In the illustrated embodiment, the second hub 850 is connected to (e.g., integrally formed with) an actuator 124 that extends outside of the housing 595 and is configured to be distally advanced and / or proximally retracted by an operator. The first 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 ) that extend radially and / or axially away from the first body portion 812 and into a corresponding first track 830 formed in the housing 595. The second 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) that extend radially and / or axially away from the second body portion 852 and into a corresponding second track 840 formed in the housing 595.

[0074] In the illustrated embodiment, the first track 830 includes one or more proximal stops 832 (masked in FIG. 8A and FIG. 8B shown in FIG. 8C ), one or more distal stops 834, and a distal end 835. In some embodiments, the first track 830 can include a pair of opposing (e.g., diametrically opposing) proximal stops 832 and a pair of opposing distal stops 834. The second track 840 includes a first portion 842 having a first track width or height G1 FIG. 8A , and a second portion 844 having a second track width or height G2 FIG. 8A that is greater than the first track width G1. In some embodiments, a transition (e.g., a ramp or step) between the first and second portions 842, 844 of the second track 840 is substantially aligned on and / or adjacent to the distal stops 834 of the first track 830.

[0075] In operation, the first and second hubs 810, 850 are configured to slide within the inner cavity 802 along the first and second tracks 830, 840, respectively. In some embodiments, the first and / or second engagement features 814, 854 are flexible such that they can flex / bend as the first and second hubs 810, 850 are moved along the first and second tracks 830, 840. The configuration / arrangement of the first and second hubs 810, 850 and the first and second tracks 830, 840, e.g., the arrangement of the proximal and distal stops 832, 834, the first portion 842, and / or the second portion 844, can facilitate movement of the dilator assembly 104 from a first configuration FIG. 5A ) to a second configuration FIG. 5B ).

[0076] More specifically, in a first position shown in FIG. 8A and FIG. 8B , the actuator 124 is positioned at a proximal-most position along the housing 595. For example, the first hub 810 can abut a proximal wall portion 807 of the housing 595. In the first position, the first portion 842 of the second track 840 compresses (e.g., presses, constrains) the second engagement features 854 of the second hub 850 radially inward toward the first hub 810 and engages with the first hub (e.g., with the first body portion 812). In other words, when the second hub 850 is in a relaxed state unconstrained by the first portion 842 of the second track 840, the distance (e.g., diameter) of the second hub 850 between the second engagement features 854 can be greater than the first diameter G1. With this arrangement, the second hub 850 is fixed to the first hub 810 such that movement of the actuator 124 along the first portion 842 of the second track 840 causes movement of the first and second hubs 810, 850. In some embodiments, the first body portion 812 of the first hub 810 can include various features (e.g., grooves, channels, teeth) for cooperating with the second engagement features 854 of the second hub 850 to fix the first and second hubs 810, 850 together.

[0077] Further, in the first position, at least a portion of the first engagement features 814 of the first hub 810 can be positioned proximally of the proximal stop 832 FIG. 8C and FIG. 8D . The proximal stop 832 can thus hold the first hub 810, and the second hub 850 and actuator 124 fixed thereto, in the first position until a predetermined force is applied to the actuator 124 in the distal direction. In one aspect of the technology, this arrangement can inhibit inadvertent distal advancement of the first shaft 580, and thus premature deployment of the funnel 690 FIGS. 7A-7C). In some embodiments, when a predetermined force is applied to the actuator 124, the first engagement feature 814 flexes inwardly such that the first shaft hub 810 can slide distally therefrom.

[0078] Accordingly, reference is made to FIGS. 8A-8C , after the first engagement feature 814 disengages the proximal stop 832, the actuator 124 can be advanced distally from the first position to a second position shown in FIG. 8C When the actuator 124 is moved distally, the first and second shaft hubs 810, 850 move distally together, thereby advancing the first and second shafts 580, 582 together, as shown in FIG. 7B , 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. More specifically, the distal end 835 of the first track 830 and / or the distal stop 834 can engage the first engagement feature 814 to prevent the first shaft hub 810 (and thus the first shaft 580) from moving distally any further. At the same time, the second portion 844 of the second track 840 of larger diameter allows the second engagement feature 854 to move radially outwardly (e.g., flex radially outwardly toward the relaxed state) and not engage the first shaft hub 810. That is, the control assembly 120 is configured such that 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 first track 840 at substantially the same time as the first engagement feature 814 of the first shaft hub 810 reaches / engages the distal stop 834 of the first track 830.

[0079] Accordingly, as shown in FIG. 8D , the second shaft hub 850 can leave the first shaft hub 810 behind and further advance distally to a third position. As the second shaft hub 850 moves distally while the first shaft hub 810 remains stationary, the second shaft 582 is advanced distally toward the retention sheath 122, as shown in FIG. 7C In some embodiments, the second shaft hub 850 can abut the distal wall portion 809 of the housing 595 in the third position.

[0080] Reference is made to FIGS. 5A-8DIn one aspect of the technology, the control assembly 120 facilitates movement of the dilator assembly 104 from the first configuration to the second configuration upon a single movement of the actuator 124 from the first position to the third position. As described above, this advantageously allows the control assembly 120 to remain coupled to the sealable hub 114 throughout deployment of the funnel 690, which controls deployment of the funnel 690 and prevents the funnel 690 from being inadvertently deployed. It is contemplated that this reduces the likelihood of other components of the system, such as the retention sheath 122, catching on the funnel 690 as the dilator is retracted through the sheath 112. Moreover, deployment of the funnel 690 and advancement of the second shaft 582 are achieved with a single stroke, and thus are greatly simplified.

[0081] In some embodiments, the actuator 124 can be moved proximally (e.g., from the third position toward the first position) to facilitate loading of the funnel 690. For example, when the control assembly 120 is in the third position, the dilator assembly 104 can be inserted into the sheath 112 such that the retention sheath 122 extends from the distal portion 113b of the sheath 112 and distally beyond the funnel 690. The operator can then move the actuator 124 to the second position, thereby forcing the second shaft hub 850 into engagement with the first shaft hub 810 via the narrowing of the second track 840 from the second portion 844 to the first portion 842. The loading tool 108 FIG. 1 ) can be slid proximally past the retention sheath 122 and the funnel 690 until the funnel 690 is fully enclosed by the loading tool 108 and / or until the funnel 690 is in a constrained configuration. The operator can then move the actuator 124 from the second position to the first position to retract the retention sheath 122 past the funnel 690, thereby loading / capturing the funnel 690 within the receiving space 694 of the retention sheath 122. Finally, the loading tool 108 can be removed.

[0082] In other embodiments, control assemblies according to the technology can include other components and / or configurations for facilitating the following dual actions: (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 provide a uniform outer surface that facilitates retraction of the dilator assembly 104. For example, FIGS. 9A-9C is a control assembly 920 including an actuator 124 positioned in a first position, a second position, and a third position FIGS. 7A-7C that is configured according to another embodiment of the technology.

[0083] The control assembly 920 can include some features generally similar to the control assembly 120 described in detail above with reference to FIGS. 1-8. For example, reference is made to FIGS. 8A-8D the detailed description of the control assembly 120 above with reference to FIGS. 1-8. FIGS. 9A-9CThe control assembly 920 includes a first shaft hub 910 coupled to the first shaft 580 of the dilator assembly 104, and a second shaft hub 950 coupled to the second shaft 582 of the dilator assembly 104. In the illustrated embodiment, the second shaft hub 950 is connected to (e.g., integrally formed with) an actuator 124 that extends outside of a housing 995 of the control assembly 920 and is configured to be distally advanced and / or proximally retracted by an operator. The first and second shaft hubs 910, 950 are configured to at least partially slide through an internal lumen 902 extending through the housing 995.

[0084] In the illustrated embodiment, the control assembly 920 further includes an elongate member 960 (shown as transparent in FIGS. 9A-9C for clarity) having (i) a proximal portion 961a positioned proximally of the first shaft hub 910 and (ii) a distal portion 961b positioned distally of 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, such as a compression spring, extends between the proximal portion 961a of the elongate member 960 and the first shaft hub 910. In some embodiments, a proximal portion 965a of the biasing member 964 is connected to the proximal portion 961a of the elongate member 960, and a distal portion 965b of the biasing member 964 is connected to the first shaft hub 910.

[0085] The control assembly 920 can further include a stop member 970 coupled to the first shaft 580 (e.g., coupled to a proximal portion of the first shaft 580). The stop member 970 is configured to at least partially slide through the internal lumen 902 of the housing during operation of the control assembly 920, and can be entirely contained within the housing 995 (e.g., as shown in FIG. 9B and FIG. 9C ). Alternatively, the stop member 970 can extend entirely or partially outside of the housing 995 (e.g., as shown in FIG. 9A ). As shown in FIG. 9B , the stop member 970 has a dimension (e.g., diameter) H1 that is greater than a dimension H2 of a stop portion 972 of the housing 995. With this arrangement, the stop member 970 is configured to contact the stop portion 972 of the housing 995, thereby preventing the first shaft 580 (and the retention sheath 122 attached thereto) from being advanced distally further.

[0086] Referring to FIG. 9AIn the first position, the first hub 910 engages (e.g., mates with) the second hub 950 such that a distal forward movement of the actuator 124 moves both the first and second hubs 910, 950. In addition, the biasing member 964 is in a balanced state and thus does not exert any force on, for example, the first hub 910. In some embodiments, the actuator 124 and / or the second hub 950 can include a first engagement feature 954 (e.g., a nub, a protrusion) that can engage (e.g., mate with) a corresponding first detent 957 in the housing 995 to releasably secure the actuator 124 in the first position until a predetermined force is applied to the actuator in the distal direction. In some embodiments, when the predetermined force is applied to the actuator 124, the first engagement feature 954 can flex outward and away from the first detent 957 to permit distal movement of the first and second hubs 910, 950.

[0087] Accordingly, with reference to FIG. 9A and FIG. 9B after the first engagement feature 954 disengages the first detent 957, the actuator 124 can be moved distally from the first position to a second position. As the actuator 124 moves distally, the first and second hubs 910, 950 move distally together, thereby moving the first and second shafts 580, 582 distally together, as shown in FIG. 7B More specifically, the biasing member 964 can exert a force on the first hub 910 to move the first hub 910 with the second hub 950. When the stop member 970 contacts the stop portion 972, the first hub 910 is prevented from moving distally further.

[0088] Accordingly, with reference to FIG. 9B and FIG. 9C When the actuator 124 is moved distally further to a third position, the second hub 950 can leave the first hub 910 behind. As the second hub 950 moves distally while the first hub 910 remains stationary, the second shaft 582 moves distally toward the retention sheath 122, as shown in FIG. 7C In some embodiments, the second hub 950 can abut a distal wall portion 909 of the housing 995 in the third position, which prevents the second hub 950 from moving further distally. As FIG. 9CThe diagram further illustrates that moving the second hub 950 forward to the third position compresses the biasing member 964 between the stationary first hub 910 and the proximal portion 961a of the elongated member 960, which continues to move with the second hub 950. In some embodiments, the biasing force applied by the biasing member 964 may facilitate the actuator 124 to subsequently move from the third position to the second position. In some embodiments, the actuator 124 may include a second engagement feature 958 (e.g., a bump, protrusion) that engages (e.g., mates) a corresponding second stop 959 in the housing 995 to releasably hold the actuator 124 in the third position until a predetermined force is applied to the actuator in the proximal direction. In some embodiments, this force may be less than the force required to disengage the first engagement feature 954 from the first stop 957 due to the biasing force of the biasing member 964. In other embodiments, the stopper 959 may include a track (e.g., an L-shaped track) and the second hub 950 may be rotatable to rotate the second engagement feature 958 into the track to releasably secure the actuator 124 in a third position.

[0089] In other embodiments, the stop member 970 is not configured to stop the distal forward movement of the first shaft 580. Instead, the stop member 970 may alternatively be a Luer flush port 970 (or another component) that simply moves with the first shaft 580, or may be omitted entirely. In these embodiments, the first shaft hub 910 can be referenced... FIGS. 8A-8D The first hub 810, described in detail, moves along a track (not shown) formed in the housing 995 in a similar manner. For example, the first hub 910 may include a first engaging or snap-fit ​​feature 914 (in... FIGS. 9A-9C Only one first engagement feature 914 is visible in the housing 995. This first engagement or snap-fit ​​feature (i) extends radially and / or axially away from the main body portion of the first hub 910, (ii) extends away from the elongated member 960, and (iii) extends into a track within the housing 995. The track may include features configured (e.g., positioned and shaped) to reach the first hub 910 at... FIG. 9B The second position shown in the diagram includes a stop or other feature (not shown) that prevents the first hub 910 from moving further to the distal side.

[0090] FIG. 10A and FIG. 10B This is a partial cross-sectional side view of a control component 1020 configured according to another embodiment of the present technology. Generally, the control component is movable between: (i) a first position (e.g., FIG. 10A (as shown in the diagram), wherein the second axis 582 is retracted proximally relative to the first axis 580, as... FIG. 5A and FIG. 7A As shown in the middle; and (ii) the third position (as shown in the middle);FIG. 10B (as shown in the diagram), wherein the second axis 582 is moved distally forward relative to the first axis 580 to form a generally consistent outer surface of the expander assembly 104, as... FIG. 5B and FIG. 7C As shown in the figure. In one aspect of this technology, the control component 1020 does not include an intermediate second position ( FIG. 7B Instead of moving directly to the first position, it moves smoothly between the third position.

[0091] Control component 1020 may include the same components as described above. FIGS. 8A-9C The control components 120 and / or 920, described in detail, share some generally similar features. For example, see [link to relevant documentation]. FIG. 10A and FIG. 10B The control assembly 1020 includes an actuator 1024 (e.g., a plunger 1024) capable of moving / moving through an inner cavity 1002 relative to the housing 1095. The plunger 1024 is coupled to (i) a first hub 1010, which is coupled to a first shaft 580 of the expander assembly 104; and (ii) a second hub 1050, which is coupled to a second shaft 582 of the expander assembly 104. For clarity, in FIG. 10A and FIG. 10B The first and second axes 580 and 582 are not shown in the diagram.

[0092] In the illustrated embodiment, the second hub 1050 includes an engagement feature 1054, which is configured (e.g., its size and shape are designed to) be located at the plunger 1024. FIG. 10A The first position shown engages with a corresponding stop portion 1056 formed in the housing 1095. The first hub 1010 is configured to slide along a track 1080 formed in / along a portion of the plunger 1024. In some embodiments, the track 1080 includes at least one stop 1084 at its distal portion, and the at least one stop is configured to stop / prevent distal forward movement of the first hub 1010. In other embodiments, the housing 1095 may include a flange or other component configured to stop distal forward movement of the first hub 1010.

[0093] A first biasing member 1064 (e.g., a compression spring) extends between the first hub 1010 and the proximal portion 1096 of the housing 1095 and is operatively coupled (e.g., connected) to the first hub and the proximal portion. A second biasing member 1066 (e.g., a compression spring) extends between the first hub and the second hubs 1010, 1050 and is operatively coupled (e.g., connected) to the first hub and the second hub. FIG. 10AIn the first position shown in FIG. 106, both the first and second biasing members 1064, 1066 are compressed and under load, and thus push the first and second hubs 1010, 1050 distally, respectively. In some embodiments, the first biasing member 1064 has a greater compressive force than the second biasing member 1066.

[0094] In FIG. 10A the first position shown in FIG. 106, the plunger 1024 is locked in a proximally retracted position by engaging 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. 107, the operator can rotate the plunger 1024 (e.g., as indicated by arrow I in FIG. 106) to unlock the second hub 1050 and the plunger 1024. FIG. 10B In the third position shown in FIG. 107, the first and second biasing members 1064, 1066 can bias the first and second hubs 1010, 1050 distally to maintain the control assembly 1020 in the third position. With this arrangement, the first and second shafts 580, 582 are automatically moved from the first configuration (FIG. 106) to the second configuration (FIG. 107), thereby deploying the funnel and preparing the dilator assembly 104 for retraction. FIG. 10A In the third position shown in FIG. 107, the first and second biasing members 1064, 1066 can bias the first and second hubs 1010, 1050 distally to maintain the control assembly 1020 in the third position. With this arrangement, the first and second shafts 580, 582 are automatically moved from the first configuration (FIG. 106) to the second configuration (FIG. 107), thereby deploying the funnel and preparing the dilator assembly 104 for retraction. FIG. 10B In the third position shown in FIG. 107, the first and second biasing members 1064, 1066 can bias the first and second hubs 1010, 1050 distally to maintain the control assembly 1020 in the third position. With this arrangement, the first and second shafts 580, 582 are automatically moved from the first configuration (FIG. 106) to the second configuration (FIG. 107), thereby deploying the funnel and preparing the dilator assembly 104 for retraction. FIG. 5A In the third position shown in FIG. 107, the first and second biasing members 1064, 1066 can bias the first and second hubs 1010, 1050 distally to maintain the control assembly 1020 in the third position. With this arrangement, the first and second shafts 580, 582 are automatically moved from the first configuration (FIG. 106) to the second configuration (FIG. 107), thereby deploying the funnel and preparing the dilator assembly 104 for retraction. FIG. 5B FIGS. 7A-7D In the third position shown in FIG. 107, the first and second biasing members 1064, 1066 can bias the first and second hubs 1010, 1050 distally to maintain the control assembly 1020 in the third position. With this arrangement, the first and second shafts 580, 582 are automatically moved from the first configuration (FIG. 106) to the second configuration (FIG. 107), thereby deploying the funnel and preparing the dilator assembly 104 for retraction.

[0095] ​In other embodiments, the first biasing member and the second biasing members 1064, 1066 may be arranged in an opposite configuration. For example, the first biasing member 1064 may extend between and operatively connect the first and second hubs 1010, 1050, and the second biasing member 1066 may extend between the second hub 1050 and a distal portion 1098 of the housing 1096 and operatively connect the second hub and the distal portion. Similarly, the second biasing member 1066 may have a greater compressive force than the first biasing member 1064. Therefore, the first biasing member and the second biasing members 1064, 1066 may bias the control assembly 1020 to a first position. To move the control assembly 1020 to a third position, the user may overcome the compressive forces of the first biasing member and the second biasing members 1064, 1066 to move the plunger 1024 forward until the second hub 1050 reaches the third position. In some implementations, the user can then rotate the plunger 1024 to lock the control assembly 1020 in a third position.

[0096] IV. Selected embodiments of thrombectomy methods

[0097] FIG. 11 This is a schematic diagram of an introduction technique according to one embodiment of the present technology for accessing a thrombus 1190 for treatment using a thrombectomy system 100. The thrombus 1190 (e.g., clot material) may be located in a blood vessel 1196 and enters through an entry point 1192, such as a popliteal artery entry point or other venous or arterial entry point. A guide assembly 102 may extend from the popliteal artery entry point 1192 or other venous or arterial entry point to a deployment location 1194, where a self-opening funnel 690 can be deployed, and the deployment location may be close to the thrombus 1190. See below for reference. FIGS. 12A-12K In more detail, the thrombus aspiration device 250 may pass through the thrombus 1190 in the direction of blood flow and then retract through the thrombus 1190 in the direction of blood flow. During retraction, the core-retrieving element 252 may core / dissociate the thrombus 1190, and the capturing element 254 may capture all or part of the thrombus 1190. In some embodiments, some or all of the thrombus aspiration device 250 may extend into one of the iliac vein and / or the inferior vena cava.

[0098] More specifically, FIGS. 12A-12C This is a side view of a thrombectomy system 100 positioned within a blood vessel 1196 during a thrombectomy procedure for treating (e.g., removing) a thrombus 1190, according to an embodiment of the present technology. FIGS. 12D-12K This is an enlarged side view of the thrombectomy system.

[0099] FIG. 12AThe thrombectomy system 100 is illustrated after the following operations: (i) deployment of the self-expanding funnel 690 (e.g., as referenced above with respect to FIGS. 5A-10B The detailed description); (ii) removal of the dilator assembly 104 from the introducer assembly 102; and (iii) advancement of 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 can be in line with or opposite the direction of blood flow.

[0100] FIG. 12B The thrombectomy system 100 is illustrated after the thrombus extraction device 250 is advanced through the outer shaft 132 to a deployment position distal of the thrombus 1190. In some embodiments, the thrombus extraction device 250 can be constrained within the outer shaft 132 and inserted into the lumen of the sheath 112 via the sealable hub 114 along with the outer shaft 132. In some embodiments, the thrombus extraction device 250 can be deployed by advancing the thrombus extraction device 250 beyond the distal portion 136b of the sheath 112 and / or retracting the outer shaft 132 relative to the thrombus extraction device 250 until the thrombus extraction device 250 is beyond the distal portion 136b of the outer shaft 132.

[0101] FIG. 12C The thrombectomy system 100 is illustrated after the thrombus extraction device 250 is fully expanded. In some embodiments, at least a portion of the coring element 252 and / or the capture element 254 contacts the wall 1297 of the blood vessel 1196 in the fully expanded position. As referenced above with respect to FIG. 2A and FIG. 2B In some embodiments, the thrombus extraction device 250 can be fully expanded by moving the plunger 144 from the first position to the second position and securing the plunger 144 in the second position, thereby fixing the relative position of the inner shaft 134 relative to the middle shaft 133, as referenced above with respect to

[0102] Generally speaking, FIGS. 12D-12K The thrombus extraction device 250 is illustrated being proximally retracted through the thrombus 1190 to capture at least a portion of the thrombus 1190, and subsequently the thrombus extraction device 250 and the captured thrombus 1190 are jointly retracted into the funnel 690 and the sheath 112.

[0103] Referring first to FIG. 12D Proximal retraction of the thrombus extraction device 250 causes the coring element 252 to decouple and / or core the distal portion 1298b of the thrombus 1190 from the wall 1297 of the blood vessel 1196, as shown in FIG. 12E Continued proximal retraction of the thrombus extraction device 250 through the thrombus 1190 causes the capture element 254 to capture the distal portion 1298b of the thrombus 1190 therein, as shown in FIGS. 12F-12HThe thrombus extraction device 250 is illustrated further proximally retracted, which results in further dissection, coring, and / or capture of the thrombus 1190. As seen in FIG. 12H the proximal portion 1298a of the thrombus 1190 is cored and captured as the thrombus extraction device 250 is proximally retracted toward the funnel 690 and the sheath 112.

[0104] As referenced above in the FIGS. 3A-4 Detailed Description, the coring element 252 can include a first mouth 370 and a 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 coring / dissection of the thrombus 1190 during proximal retraction of the thrombus extraction device 250. In one aspect of the technology, the first mouth 370 and the second mouth 372 are radially offset relative to one another, which can increase coring efficiency by ensuring that at least one of the first mouth 370 and the second mouth 372 is positioned and oriented to effectively core the thrombus 1190, even when the blood vessel 1196 is very tortuous and / or the thrombus 1190 is very firmly adhered to the wall 1297 of the blood vessel 1196.

[0105] In some embodiments, as shown in FIG. 12I and FIG. 12G , the thrombus extraction device 250 can be proximally retracted until a proximal portion 253a of the coring element 252 is housed (e.g., positioned) within the funnel 690. More specifically, the thrombus extraction device 250 can be proximally retracted until all or a portion of the first mouth 370 and / or the second mouth 372 of the coring element 252 is housed within the funnel 690. In some embodiments, when one or both of the first mouth and the second mouth 370, 372 is positioned within the funnel 690, the thrombus extraction device 250 can be moved or transitioned from an open 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 decoupled from the inner shaft 134 (e.g., via user actuation of the plunger 144 shown in FIGS. 1-2B ) so that the inner shaft 134 can be distally advanced relative to the intermediate shaft 133 to collapse or compress the thrombus extraction device 250.

[0106] After the thrombus extraction device 250 has been collapsed, the thrombus extraction device 250 can be proximally retracted through the funnel 690 and into the sheath 112, as shown in FIG. 12KThe thrombus extraction device 250 can continue to be proximally retracted until the thrombus extraction device 250 and captured thrombus 1190 are fully housed within the sheath 112. In some embodiments, the thrombus extraction device 250 and captured thrombus 1190 can then be withdrawn through the sheath 112 and sealable hub 114 FIG. 12B ).

[0107] In some embodiments, a vacuum (e.g., a pre-loaded vacuum) can be applied to the sheath 112 at any point during retraction of the thrombus extraction device 250. In some embodiments, application of the vacuum can create an instantaneous or near-instantaneous suction force at a distal portion of the sheath 112, which can draw any remaining portions of the thrombus 1190 into and / or through the sheath 112. For example, the generated suction force can draw any of the thrombus 1190 captured or extruded by the funnel 690. Further, in some embodiments, application of the vacuum can facilitate smooth retraction of the captured thrombus 1190 through the sheath 112. For example, a burst of suction force generated by application of the vacuum can help inhibit clogging of the sheath 112 and / or help break up (e.g., fragment) clogs formed in the sheath 112 during retraction.

[0108] V. Examples

[0109] Several aspects of the technology are set forth in the following examples:

[0110] 1. A coring element for coring a vascular thrombus within a patient’s blood vessel, the coring element comprising:

[0111] a unitary structure having—

[0112] a first region proximal to a proximal portion of the unitary structure, wherein the first region includes a first mouth configured to core the vascular thrombus;

[0113] a second region distal to the first region, wherein the second region is substantially tubular and includes a first plurality of interconnected struts;

[0114] a third region distal to the second region, wherein the third region includes a second mouth configured to core the vascular thrombus; and

[0115] a fourth region distal to the third region, wherein the fourth region is substantially tubular and includes a second plurality of interconnected struts.

[0116] 2. The coring element of example 1, wherein the first mouth is radially offset from the second mouth.

[0117] 3. The coring element of examples 1 or 2, wherein the unitary structure extends along a longitudinal axis, and 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 junctions to define the first mouth.

[0118] 4. The coring element of any of examples 1-3, wherein the unitary structure extends along a longitudinal axis, wherein the third region comprises (a) a pair of upper curved struts that curve around the longitudinal axis and intersect each other at an upper junction, and (b) a pair of lower curved struts that curve around the longitudinal axis and intersect each other at a lower junction, and wherein the lower curved struts and the upper curved struts define the second mouth.

[0119] 5. The coring element of example 4, wherein the lower curved struts and the upper curved struts define (a) a first mouth portion that is open in a first direction that is generally orthogonal to the longitudinal axis, and (b) a second mouth portion that is open in a second direction that is generally orthogonal to the longitudinal axis, and wherein the first mouth portion and the second mouth portion define the second mouth.

[0120] 6. The coring element of example 5, wherein the first direction is generally opposite the second direction.

[0121] 7. The coring element of any of examples 1-6, wherein the coring element is capable of being uncoiled from a compressed delivery configuration to an uncoiled deployment configuration.

[0122] 8. The coring element of example 7, wherein the coring element is configured to self-uncoil.

[0123] 9. The coring element of example 8, wherein the coring element is made of a shape memory material.

[0124] 10. The coring element of any of examples 1-9, wherein the fourth region of the unitary structure is configured to be connected to a braided filament mesh structure.

[0125] 11. A dilator assembly for deploying an expandable funnel coupled to a distal portion of an introducer sheath, the dilator assembly comprising:

[0126] a first shaft defining an inner lumen;

[0127] a second shaft slidably positioned within the inner lumen of the first shaft;

[0128] a retention sheath coupled to the second shaft and configured to receive and constrain the funnel therein; and

[0129] a control assembly including an actuator operably coupled to the first shaft and the second shaft, wherein movement of the actuator from a first position to a second position causes the first shaft and the second shaft to advance together to deploy the funnel from the retention sheath, and wherein movement of the actuator from the second position to a third position causes the first shaft to advance relative to the second shaft.

[0130] 12. The dilator assembly of example 11, wherein the retention sheath has substantially the same outer diameter as the first shaft.

[0131] 13. The dilator assembly of example 11 or example 13, wherein movement of the actuator from the second position to the third position causes a distal portion of the first shaft to contact a proximal portion of the retention sheath.

[0132] 14. The dilator assembly of any of examples 11-13, wherein the control assembly includes—

[0133] a housing;

[0134] a first shaft hub slidably positioned within the housing and coupled to the first shaft; and

[0135] a second shaft hub slidably positioned within the housing and coupled to the second shaft.

[0136] 15. The dilator assembly of example 14, wherein the first shaft hub is configured to engage the second shaft hub when the actuator is moved from the first position to the second position such that the first shaft and the second shaft advance together.

[0137] 16. The dilator assembly of example 14 or example 15, wherein the first shaft hub is configured to disengage the second shaft hub when the actuator is moved from the second position to the third position such that the first shaft advances relative to the second shaft.

[0138] 17. The dilator assembly of any of examples 14-16, wherein the first shaft hub is configured to engage the second shaft hub when the actuator is moved from the first position to the second position such that the first shaft and the second shaft advance together, and wherein the first shaft hub is configured to disengage the second shaft hub when the actuator is moved from the second position to the third position such that the first shaft advances relative to the second shaft.

[0139] 18. The dilator assembly of any of examples 14-17, wherein the second hub comprises a first engagement feature, wherein the housing comprises a second engagement feature, and wherein the first engagement feature is configured to engage the second engagement feature at the second position to prevent movement of the second hub when the actuator is moved from the second position to the third position.

[0140] 19. The dilator assembly of example 18, wherein the first engagement feature is a snap feature, and wherein the second engagement feature is a detent formed in the housing.

[0141] 20. The dilator assembly of any of examples 14-19, further comprising a biasing member operably coupled to the first hub, wherein the biasing member is configured to bias the first hub from the third position toward the second position.

[0142] 21. The dilator assembly of any of examples 11-20, wherein the control assembly further comprises a housing, wherein the actuator is movable relative to the housing, wherein the movement of the actuator from the first position to the second position is distal movement of the actuator relative to the housing, and wherein the movement of the actuator from the second position to the third position is further distal movement of the actuator relative to the housing.

[0143] 22. The dilator assembly of any of examples 11-21, further comprising the introducer sheath and the funnel.

[0144] 23. A system for capturing a vascular thrombus within a blood vessel of a patient, the system comprising:

[0145] an introducer sheath having a distal portion;

[0146] an expandable funnel coupled to the distal portion of the introducer sheath;

[0147] a dilator assembly configured to be inserted through the introducer sheath and to deploy the expandable funnel, wherein the dilator assembly comprises—

[0148] a first shaft defining an inner lumen;

[0149] a second shaft slidably positioned within the inner lumen of the first shaft;

[0150] a retention sheath coupled to the second shaft and configured to receive and constrain the funnel therein; and

[0151] a control assembly comprising an actuator operably coupled to the first shaft and the second shaft, wherein movement of the actuator from a first position to a second position causes the first shaft and the second shaft to advance distally together to deploy the funnel from the retention sheath, and wherein movement of the actuator from the second position to a third position causes the first shaft to advance relative to the second shaft; and

[0152] a clot removal device configured to be inserted through the guide sheath to capture at least a portion of the vascular thrombus.

[0153] 24. The system of example 23, wherein the clot removal device comprises an expandable coring element coupled to an expandable capture element, wherein the coring element is configured to separate at least a portion of the vascular thrombus from a wall of the blood vessel, and wherein the capture element is configured to capture and retain the portion of the vascular thrombus separated from the wall of the blood vessel.

[0154] 25. The system of example 23 or example 24, wherein the funnel has a first length when deployed from the retention sheath, and wherein the coring element has a second length when expanded that is less than the first length.

[0155] 26. A system for capturing a vascular thrombus within a blood vessel of a patient, the system comprising:

[0156] a guide sheath having a distal portion;

[0157] an expandable funnel coupled to the distal portion of the guide sheath;

[0158] a dilator assembly configured to be inserted through the guide sheath and deploy the expandable funnel; and

[0159] a clot removal device configured to be inserted through the guide sheath, wherein the clot removal device comprises an expandable coring element coupled to an expandable capture element, wherein the coring element comprises a first region comprising a first mouth and a second region comprising a second mouth, wherein the first mouth and the second mouth are configured to separate at least a portion of the vascular thrombus from a wall of the blood vessel, and wherein the capture element is configured to capture and retain the portion of the vascular thrombus separated from the wall of the blood vessel.

[0160] 27. The system of example 26, wherein the first mouth is radially offset from the second mouth.

[0161] 28. The system of example 27, wherein the coring element is formed from a unitary structure comprising a plurality of struts, wherein the struts define the first mouth and the second mouth, wherein the struts further define a plurality of voids, and wherein the first mouth and the second mouth are larger than each of the voids.

[0162] VI. Conclusion

[0163] The foregoing detailed description of implementations of the technology has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the technology to the precise form disclosed, and various equivalents modifications and variations are possible in the scope of the technology. For example, although steps are presented in a given order, alternative implementations can perform steps in a different order. Various implementations described herein can also be combined to provide further implementations.

[0164] In light of the foregoing, specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail in order to avoid unnecessarily obscuring the description of specific embodiments of the technology. Where the context permits, singular or plural terms can also include a plural or singular term, respectively.

[0165] Furthermore, the word “or” as used herein in the context of listing items in a list should be interpreted, in accordance with its normal usage, as inclusive of at least either of the items in the list, but not necessarily both, unless explicitly indicated otherwise. Additionally, the term “comprising” is used throughout to mean including at least the recited feature, such that other features are not precluded. It will also be understood that specific embodiments have been described herein for purposes of illustration, but that various modifications can be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments that have not been expressly shown or described herein.

Claims

1. A coring element for coring a vascular thrombus within a blood vessel of a patient, the coring element comprising: a unitary structure extending along a longitudinal axis, wherein the unitary structure comprises: a first region proximal to a proximal portion of the unitary structure, wherein the first region comprises a pair of curved struts extending from a common proximal junction to a distal junction to define a first mouth configured to core the vascular thrombus when the unitary structure is proximally retracted against the vascular thrombus to core the vascular thrombus, wherein the proximal junction is radially offset from the longitudinal axis; a second region distal to the first region, wherein the second region comprises a first plurality of interconnected struts forming a first cell; a third region distal to the second region, wherein the third region comprises: (a) a pair of upper curved struts curved about the longitudinal axis and intersecting each other at an upper junction, and (b) a pair of lower curved struts curved about the longitudinal axis and intersecting each other at a lower junction, and wherein the lower junction is opposite the upper junction relative to the longitudinal axis, the upper curved struts and the lower curved struts defining a second mouth and a third mouth, the second mouth being opposite the third mouth relative to the longitudinal axis; and a fourth region distal to the third region, wherein the fourth region comprises a second plurality of interconnected struts forming a second cell, wherein the first mouth, the second mouth, and the third mouth are larger than each of the first cell and the second cell; and a connection feature coupled to the proximal junction, wherein the connection feature is configured to couple to a shaft for proximally retracting the unitary structure against the vascular thrombus.

2. The coring element of claim 1, wherein the first mouth is radially offset from the second mouth and the third mouth relative to the longitudinal axis.

3. The coring element of claim 1, wherein the pair of curved struts are curved in opposite directions about the longitudinal axis.

4. The coring element of claim 1, wherein the coring element is capable of being expanded from a compressed delivery configuration to an expanded deployment configuration.

5. The coring element of claim 4, wherein the coring element is made of a shape memory material and is configured to self-expand.

6. The coring element of claim 1, wherein the fourth region is substantially tubular, wherein the second region is substantially tubular.

7. The coring element of claim 6, wherein the first mouth is radially offset from the second mouth and the third mouth relative to the longitudinal axis.

8. The coring element of claim 6, wherein the coring element is capable of being expanded from a compressed delivery configuration to an expanded deployment configuration.

9. The coring element of claim 8, wherein the coring element is made of a shape memory material and is configured to self-expand.

10. The coring element of claim 6, wherein the fourth region of the unitary structure is configured to be connected to a braided filament mesh structure.

11. The coring element of claim 1, wherein the unitary structure has a length of 1.1 - 2.5 inches.

12. The coring element of claim 1, wherein the unitary structure has a diameter of 3 - 14 millimeters.

13. The coring element of claim 1, wherein the second region is substantially tubular.

14. The coring element of claim 1, wherein the unitary structure is configured to be advanced over a guidewire having a diameter of 0.014 inches, 0.018 inches, or 0.035 inches.

15. The coring element of claim 1, wherein the unitary structure extends around an interior region, and wherein the connection feature is configured to be coupled to a shaft for proximal retraction of the unitary structure against a vascular thrombus such that the vascular thrombus at least partially enters the interior region through the first mouth of the unitary structure.

16. The coring element of claim 1, wherein the first mouth comprises a closed cell defined by the pair of curved struts, and wherein the second mouth comprises a closed cell defined by a plurality of interconnected struts.

17. The coring element of claim 1, wherein the first mouth extends substantially along a first plane, and wherein the first plane is at a non-parallel angle relative to the longitudinal axis.

18. The coring element of claim 1, wherein, The upper curved strut and the lower curved strut comprise leading edges configured to core a vascular thrombus.

19. The coring element of claim 1, wherein, The coring element is configured to bend at a third region at the lower junction and the upper junction.

20. A thrombectomy system comprising an elongated member; an expandable funnel coupled to a distal portion of the elongated member; a shaft, wherein the shaft is advanceable through the elongated member; and the coring element of any of claims 1-19, wherein the connection feature of the coring element is coupled to the shaft.

21. The thrombectomy system of claim 20, wherein the funnel has a first length, and wherein the coring element has a second length that is less than the first length.

22. The thrombectomy system of claim 20, wherein the funnel comprises at least one of a toothed nitinol braid, a nitinol braided stent, a laser cut nitinol, a laser cut polymer tube, or an injection molded polymer structure.

23. A thrombectomy system comprising: an elongated member; an expandable balloon coupled to a distal portion of the elongated member; a shaft, wherein the shaft is advanceable through the elongated member; and the coring element of any of claims 1-19, wherein the connection feature of the coring element is coupled to the shaft.

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