Recaptureable funnel-shaped conduits and related systems and methods

Abstract

This document discloses systems and methods for endovascular treatment of intravascular clot material in human patients. In one embodiment, a funnel catheter assembly includes an outer shaft and an inner shaft extending through and coaxial with the outer shaft. An expandable funnel is coupled to a distal portion of the inner shaft. The funnel catheter assembly also includes a control assembly operatively coupled to the proximal portion of the outer shaft and configured to move the outer shaft between a first position and a second position. In the first position, the outer shaft is at least partially positioned above the funnel to constrain the funnel in a compressed state. In the second position, the outer shaft is retracted proximally relative to the funnel, allowing the funnel to expand into an expanded state.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 035,605, filed June 5, 2020, entitled “RECAPTURABLE FUNNEL CATHETERS, AND ASSOCIATED SYSTEMS AND METHODS”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This technology generally relates to systems, methods, and apparatus for embolic protection during procedures involving the removal of thrombi from blood vessels of human patients. Background Technology

[0004] Thrombosis is a localized clot or blockage of blood within a part of the circulatory system, and 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 superficial venous congestion.

[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 life-threatening consequences of 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 result in substantial medical costs, directly or indirectly, through the treatment of related complications and the patient's inability to work.

[0006] Three processes are believed to lead to venous thrombosis (DVT). The first is a decrease in blood flow rate (venous stasis), the second is an increased tendency to clot (hypercoagulable state), and the third is changes in the vessel wall. DVT typically begins in the valves of the veins in the lower leg, where the blood is relatively hypoxic, which activates certain biochemical pathways. Several medical 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, orthotic casts, and long-haul flights), oral contraceptives, pregnancy, the postpartum period, and genetic factors. The incidence of DVT increases dramatically from childhood to old age; as adults, approximately 1 in 1,000 adults develop DVT each year.

[0007] Although devices and methods exist for the prevention and / or treatment of deep vein thrombosis (DVT), many drawbacks remain to be addressed, such as the high incidence of DVT recurrence, the lack of devices designed to remove large clot volumes, and / or complex treatments involving multiple devices and / or medications. Therefore, new devices, systems, and methods for treating thrombosis, particularly DVT, are needed. Attached Figure Description

[0008] Many aspects of this technology can be better understood by referring to the following figures. The components in the figures are not necessarily drawn to scale. Instead, the focus is on clearly illustrating the principles of this disclosure.

[0009] Figure 1 This is a partially transparent and partially cross-sectional side view of a funnel conduit assembly according to an embodiment of the present technology.

[0010] Figure 2A and Figure 2B This is a side view of the funnel-shaped conduit assembly in the first and second positions, respectively, according to an embodiment of the present technology.

[0011] Figure 3 This is a side view of a funnel conduit assembly in a first position according to an embodiment of the present technology, wherein an expander is inserted through the funnel conduit assembly.

[0012] Figure 4 This is a side view of a funnel conduit assembly including a non-self-expanding funnel according to an embodiment of the present technology.

[0013] Figures 5 to 8 This is a schematic diagram illustrating various thrombectomy techniques for removing thrombi from blood vessels in human patients using a funnel catheter assembly, according to an embodiment of the present technology.

[0014] Figure 9A and Figure 9B These are enlarged, partially transparent side views and cross-sectional side views of a portion of a funnel conduit assembly according to an additional embodiment of the present technology.

[0015] Figure 9C According to embodiments of the present technology Figure 9A and 9B An enlarged cross-sectional view of a portion of the funnel-shaped conduit assembly.

[0016] Figures 10A to 10C The embodiments of this technology are respectively located in the sheathed position, partially sheathed or intermediate position, and sheath-free position. Figure 9A and Figure 9B Side view of the funnel-shaped conduit assembly.

[0017] Figure 11This is a flowchart of a process or method for operating a funnel catheter assembly during an intravascular procedure according to an embodiment of the present technology. Detailed Implementation

[0018] This technology generally relates to methods and systems for removing clot material (e.g., thrombi) from blood vessels in human patients. More specifically, this technology relates to funnel catheter assemblies configured to provide embolic protection during clot removal or other intravascular procedures. In some embodiments, a funnel catheter assembly includes an outer shaft and an inner shaft extending through and coaxial with the outer shaft. An expandable funnel (such as a self-expanding funnel) is coupled to a distal portion of the inner shaft. The funnel catheter assembly also includes control components operatively coupled to the proximal portion of the outer shaft. The funnel catheter assembly can be actuated by an operator (e.g., a physician) to move the outer shaft between a first position and a second position. In the first position, the outer shaft is at least partially positioned above the funnel to constrain the funnel in a compressed state. In the second position, the outer shaft is retracted proximally relative to the funnel, allowing the funnel to expand into an expanded state. Therefore, the funnel catheter assembly enables the funnel to be sheathed and re-sheathed during intravascular procedures via the movement of the outer axis between the first and second positions.

[0019] In one aspect of this technology, the control component is operable to compress the funnel after it has expanded within the patient's blood vessel. This allows the funnel catheter assembly to be repositioned within the blood vessel without completely withdrawing it from the patient. Similarly, the funnel catheter assembly can be completely withdrawn from the patient in a first position (e.g., at the end of a thrombectomy procedure), where the funnel is compressed within its outer axis. Therefore, the funnel catheter assembly is configured to inhibit or even prevent the funnel from contacting the vessel wall during its movement within the blood vessel. This helps to mitigate potential harm / damage to the patient that might result from moving the funnel through the blood vessel or associated organ in its expanded state.

[0020] Although numerous embodiments are described below with respect to devices, systems, and methods for treating vascular thrombosis (e.g., deep vein thrombosis (DVT)), other applications and embodiments besides those described herein are also within the scope of this technology (e.g., endovascular procedures other than embolization therapy, endovascular procedures for treating cerebral embolism, endovascular procedures for treating pulmonary embolism, etc.). Generally speaking, for example, the devices, systems, and methods of this technology can be used to remove any material formations in blood vessels (e.g., veins or arteries), such as cancerous growths, vegetations, etc. Furthermore, several other embodiments of this technology may have different configurations, states, components, or procedures than those described herein. Moreover, it should be understood that, according to additional embodiments of this technology, reference can be made to… Figures 1 to 11The specific elements, substructures, advantages, uses, and / or other features of the described embodiments may be appropriately interchanged, substituted, or otherwise configured with each other. Furthermore, references... Figures 1 to 11 Suitable elements of the described embodiments can be used as stand-alone devices and / or complete units. Therefore, those skilled in the art will accordingly understand that the present technology can have other embodiments with additional elements, or that the present technology can have other embodiments without the following references. Figures 1 to 11 The features shown and described.

[0021] Regarding the terms "distal" and "proximal" in this specification, unless otherwise stated, these terms refer to the relative position of the parts of the tubular system with respect to the operator and / or their position within the vascular system. Furthermore, as used herein, the names "backward," "forward," "upward," "downward," etc., do not imply limitation of the referenced components to a particular orientation. It should be understood that such names refer to the orientation of the referenced components as shown in the accompanying drawings; systems of this technology can be adapted for use in any orientation by the user.

[0022] The titles provided in this article are for convenience only and should not be construed as limiting the topics disclosed.

[0023] I. Selected implementation scheme for the funnel conduit assembly

[0024] Figure 1 This is a partially transparent and partially cross-sectional side view of a funnel-shaped conduit assembly 100 according to an embodiment of the present technology. In the illustrated embodiment, the funnel-shaped conduit assembly 100 includes an elongated outer shaft 102 and an elongated inner shaft 104 coaxial with the outer shaft 102. The outer shaft 102 and the inner shaft 104 (“shafts 102, 104”) may also be referred to as a sheath, conduit, hollow member, etc. The outer shaft 102 defines a lumen 106 and includes a proximal portion 107a and a distal portion 107b. The inner shaft 104 extends through the lumen 106 of the outer shaft 102 and similarly defines a lumen 108, and includes a proximal portion 109a and a distal portion 109b. The proximal portions 107a and 109a may each terminate at a proximal end / terminus, and the distal portions 107b and 109b may each terminate at a distal end / terminus. Shafts 102, 104 may be elastic and / or flexible and may have any suitable length and diameter.

[0025] In the illustrated embodiment, the funnel conduit assembly 100 further includes a sealable hub 110 coupled to the proximal portion 109a of the inner shaft 104. In some embodiments, as referenced below... Figures 9A to 9CIn more detail, the sealable hub 110 is rotatably coupled to the inner shaft 104, such that the sealable hub 110 can rotate independently of the inner shaft 104. The sealable hub 110 is configured to allow access to the lumen 108 of the inner shaft 104 and may be self-sealing and / or may include a self-sealing seal. For example, in the illustrated embodiment, the sealable hub 110 is a hemostatic valve configured to maintain hemostasis (e.g., during thrombus aspiration) by inhibiting or even preventing fluid from flowing proximally through the sealable hub 110 when various components (e.g., dilator assembly, thrombus aspiration device, etc.) are inserted through the sealable hub 110 to be delivered through the inner shaft 104 to the treatment site in the blood vessel. More specifically, the sealable hub 110 may be a valve of the type disclosed in U.S. Patent Application 16 / 117,519, filed August 30, 2018, entitled “HEMOSTASIS VALVES AND METHODS OF USE,” the entire contents of which are incorporated herein by reference. The sealable hub 110 may include one or more buttons or actuators that enable an operator to selectively seal / unseal the sealable hub 110.

[0026] The funnel guide assembly 100 may also include an aspiration port 112 connected via, for example, a connecting tube 114 to a sealable hub 110 (e.g., a side port connected to the sealable hub 110) and / or an inner shaft 104 (e.g., a proximal portion 109a connected to the inner shaft 104). The aspiration port 112 may be connected to a syringe connector 116, which may be selectively coupled to a syringe or other aspiration device, or the aspiration port 112 may be connected to other suitable elements. In some embodiments, the funnel guide assembly 100 includes a fluid control device 118 configured to selectively fluidly connect the aspiration port 112 to a lumen 108 of the inner shaft 104. In the illustrated embodiment, the fluid control device 118 is a stopcock operatively coupled to the connecting tube 114 between the lumen 108 of the inner shaft 104 and the aspiration port 112. In other embodiments, the fluid control device 118 may be a clamp or other suitable valve. In some embodiments, a vacuum source (not shown; for example, a syringe) may be coupled to syringe connector 116 and used to aspirate the lumen 108 of inner shaft 104. In some embodiments, as referenced below... Figures 9A to 9C In more detail, the suction port 112 and the connecting tube 114 are rotatable relative to the sealable hub 110 and / or the inner shaft 104.

[0027] In the illustrated embodiment, the funnel 120 is coupled to the distal portion 109b of the inner shaft 104. As described in more detail below, during operation of the funnel catheter assembly 100 during intravascular procedures, the funnel 120 is configured to expand (e.g., radially expand) to juxtapose with a blood vessel and / or other body lumen (e.g., the lumen of an organ) and act as a proximal or distal thromboembolism protection device that inhibits any thrombus from moving through the funnel 120 and embolizing at an unwanted location (e.g., right heart, pulmonary artery, another arterial space, etc.). The funnel 120 may be fused to the distal portion 109b of the inner shaft 104 and / or attached to the inner shaft 104 via welding, adhesives, fasteners, etc. Figure 1 In the first position / state / configuration, the funnel catheter assembly 100 is positioned such that the distal portion 107b of the outer shaft 102 extends beyond the distal portion 109b of the inner shaft 104, such that the funnel 120 is at least partially (e.g., completely) positioned within the lumen 106 of the outer shaft 102. The funnel 120 may be configured to expand (e.g., self-expand), and thus, when the funnel catheter assembly 100 is in the first position, the funnel 120 may be in a first constrained position / state / configuration. In some embodiments, the funnel 120 may be formed of at least one of a honeycomb nitinol braid, a nitinol braided support, laser-cut nitinol, a laser-cut polymer tube, a injection-molded polymer structure, or an inflatable balloon. In some embodiments, the funnel 120 may include a mesh with sufficiently small pores to prevent thrombi from passing through the mesh. In some embodiments, the funnel 120 may be blood-permeable. In some embodiments, the funnel 120 may include a blood-permeable or blood-impermeable covering over at least a portion thereof.

[0028] In the illustrated embodiment, the proximal portion 107a of the outer shaft 102 is operatively coupled to the control assembly 130. The control assembly 130 is operable to move the outer shaft 102 distally and proximally relative to the inner shaft 104 to constrain and release the funnel 120 from within the lumen 106 of the outer shaft 102. More specifically, in the illustrated embodiment, the control assembly 130 includes: (i) a housing 132 having a proximal portion 133a and a distal portion 133b; and (ii) an actuating member 134 operatively / movably coupled to the housing 132. The housing 132 defines a lumen 135 extending between its proximal portion 133a and distal portion 133b. The proximal portion 133a of the housing 132 is coupled to a sealable hub 110. In some embodiments, the proximal portion 133a of the housing 132 is integrally formed with the sealable hub 110.

[0029] In the illustrated embodiment, the actuating member 134 includes a body portion 136 positioned within a cavity 135 of the housing 132 and coupled to a proximal portion 107a of the outer shaft 102 via, for example, adhesive, fasteners, welding, etc. The actuating member 134 also includes one or more clamping members 138 extending from the body portion 136 beyond the cavity 135. More specifically, the clamping members 138 may extend through corresponding slots 140 formed in / along the housing 132. The housing 132 may define a proximal end 142a and a distal end 142b for each slot in the slots 140. In some embodiments, the control assembly 130 may include one or more of the clamping members 138 and the corresponding slots 140 shown.

[0030] In operation, the operator (e.g., a doctor) can slide the actuating member 134 along the housing 132 to advance the outer shaft 102 distally and retract it proximally relative to the inner shaft 104, thereby constraining and releasing the funnel 120, respectively. More specifically, Figure 2A and Figure 2B This is a side view of the funnel-shaped conduit assembly 100 in a first position and a second position, respectively, according to an embodiment of the present technology. (See also:) Figures 1 to 2B In order to move the funnel conduit assembly 100 from the first position ( Figure 1 and Figure 2A Move to the second position ( Figure 2B The operator can clamp the clamping member 138 of the actuating member 134 and hold the clamping member 138 toward the proximal side relative to the housing 132 (e.g., along the housing 132). Figure 2A The outer shaft 102 (in the direction of arrow P) slides to drive the body portion 136 through the lumen 135, thereby driving the outer shaft 102 proximally relative to the inner shaft 104. As the distal portion 107b of the outer shaft 102 moves proximally past the funnel 120, the funnel 120 is released / removed from the lumen 106 of the outer shaft 102, thereby allowing the funnel 120 to expand. In some embodiments, the actuating member 134 may abut the proximal end 142a of the slot 140 in a second position, such that the housing 132 inhibits further proximal movement of the outer shaft 102.

[0031] In some embodiments, the distal end of the outer shaft 102 is positioned in a second position at or near the distal end of the inner shaft 104, such that the funnel 120 is completely released from the lumen 106 of the outer shaft 102 (e.g., completely outside the lumen). In other embodiments, the distal end of the outer shaft 102 may be positioned in a second position distal to the distal end of the inner shaft 104, such that the funnel 120 is only partially released from the lumen 106 of the outer shaft 102. Furthermore, as... Figure 2BAs shown, funnel 120 may have a conical portion 222 (e.g., a truncated conical portion) and a cylindrical portion 224 (once expanded). In other embodiments, funnel 120 may have other suitable shapes. For example, in some embodiments, funnel 120 may be relative to... Figure 2B The embodiment shown is reversed. That is, the cylindrical portion 224 of the funnel 120 can be connected to the distal portion 109b of the inner shaft 104, while the tapered portion 222 extends distally from the cylindrical portion 224.

[0032] In order to move the funnel conduit assembly 100 from the second position ( Figure 2B Move to the first position ( Figure 1 and Figure 2A The operator can clamp the clamping member 138 of the actuating member 134 and hold the clamping member 138 distally relative to the housing 132 (e.g., along the...). Figure 2B The outer shaft 102 (in the direction of arrow D) slides to drive the body portion 136 through the lumen 135, thereby driving the outer shaft 102 distally relative to the inner shaft 104. As the distal portion 107b of the outer shaft 102 moves distally over the funnel 120, the funnel 120 is captured in / sheathed within the lumen 106 of the outer shaft 102, thereby folding / compressing the funnel 120 within the lumen 106. In some embodiments, the actuating member 134 may abut the distal end 142b of the slot 140 in a first position, such that the housing 132 inhibits further distal movement of the outer shaft 102.

[0033] In some embodiments, the actuating member 134 is configured to be releasably secured / locked to the housing 132 in a first and second position to suppress or even prevent unintended movement of the actuating member 134. For example, refer again Figure 1 The housing 132 of the control assembly 130 may include: (i) proximal engaging members 144a (e.g., tabs, protrusions, etc.) configured to engage the actuating member 134 in a first position; and (ii) distal engaging members 144b configured to engage the actuating member 134 in a second position. More specifically, in some embodiments, the proximal engaging members 144a and the distal engaging members 144b may mate with corresponding slots / grooves in the actuating member 134 (e.g., formed in / on the clamping member 138) to releasably secure the actuating member 134 in either the first or second position via a snap-fit ​​arrangement.

[0034] In some embodiments, the inner shaft 104 is sized to slidably receive one or more medical devices inserted through the sealable hub 110 during endovascular procedures (such as thrombectomy procedures) using the funnel catheter assembly 100. For example, Figure 3This is a side view of the funnel conduit assembly 100 in a first position according to an embodiment of the present technology, wherein the expander 350 is inserted through the sealable hub 110 and the inner shaft 104. Figure 1 The dilator 350 extends fully through the inner shaft 104 and past the distal end of the distal portion 107b of the outer shaft 102, such that the distal end 352 (e.g., an atraumatic end) is positioned outside the distal end of the outer shaft 102.

[0035] In some embodiments, the dilator 350 and the funnel catheter assembly 100 together define a guide assembly that can be inserted into a patient (e.g., a human patient) and subsequently used to introduce an endovascular medical device into the patient. For example, the dilator 350 and the funnel catheter assembly 100 can be inserted together into a patient's blood vessel and advanced through the patient's blood vessel to a target location within the vessel. The dilator 350 can then be retracted proximally through the funnel catheter assembly 100, and the funnel catheter assembly 100 can be moved to a second position to allow the funnel 120 to expand at the target location.

[0036] Let's refer to each other. Figures 1 to 3 In one aspect of this technology, the inner shaft 104 is the "working" shaft of the funnel catheter assembly 100, which can aspirate and / or receive various medical components (e.g., dilator 350). In contrast, the outer shaft 102 is used to compress / expand the funnel 120. Therefore, the dimensions of shafts 102 and 104 can be configured to maximize the size of the inner shaft 104 to allow for the insertion of larger components or to provide greater suction / power. For example, the inner diameter of the outer shaft 102 may be only slightly larger than the outer diameter of the inner shaft 104. In some embodiments, the outer diameter of the inner shaft 104 may be at least 10 French, at least 12 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, at least 26 French, greater than 26 French, between 10 and 26 French, between 14 and 24 French, between 15 and 21 French, between 16 and 22 French, and / or any other or intermediate size. In some embodiments, the inner diameter of the lumen 108 of the inner shaft 104 may be at least 2 French, at least 10 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, between 11 and 12 French, between 10 and 22 French, between 14 and 21 French, between 16 and 20 French, and / or any other or intermediate size.

[0037] In another aspect of this technology, the control component 130 can be operated via movement of the actuating member 134 from a second position to a first position to compress the funnel 120 after it has expanded within the blood vessel. This allows the funnel catheter assembly 100 to be repositioned within the blood vessel without completely removing it from the patient. For example, after (i) introducing the funnel catheter assembly 100 into the blood vessel with the dilator 350 and (ii) removing the dilator 350, the funnel catheter assembly 100 can be repositioned proximally simply by moving the funnel catheter assembly 100 back to the first position to fold the funnel 120 and then retracting the funnel catheter assembly 100 proximally. To reposition the funnel catheter assembly 100 distally, the dilator 350 can be reinserted, and the funnel catheter assembly 100 can be pushed proximally in the first position while the funnel 120 is compressed. Similarly, the funnel catheter assembly 100 can be completely withdrawn from the patient in a first position (e.g., at the end of a thrombectomy procedure), with the funnel 120 compressed within the lumen 106 of the outer shaft 102. Therefore, the funnel catheter assembly 100 is configured to inhibit or even prevent the funnel 120 from contacting the vessel wall during advancement / withdrawal. This helps to mitigate potential harm / damage to the patient that might result from moving the funnel 120 through a blood vessel or associated organ in an inflated state.

[0038] In some embodiments, the funnel catheter assembly 100 and / or the method of operating the funnel catheter assembly 100 may include some features that are the same as or similar to those of thrombectomy systems (e.g., guide assemblies) described in the following U.S. patents: (i) U.S. Patent 9,700,332, filed September 16, 2016, entitled “INTRAVASCULAR TREATMENT OF VASCULAROCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS”; and / or (ii) U.S. Patent 10,098,651, filed April 26, 2017, entitled “DEVICES AND METHODS FOR TREATINGVASCULAR OCCLUSION”, the entire contents of which are incorporated herein by reference.

[0039] In other embodiments, the control component 130 may be configured to otherwise drive distal and proximal movement of the outer shaft 102. For example, the actuation component 134 may include a rotatable member (e.g., a ring gear, a auger, a rotatable handle, etc.) coupled to the outer shaft 102. In some embodiments, the rotatable member may be a ratchet member that can rotate to a plurality of discrete positions between a first position and a second position.

[0040] Similarly, in other embodiments, the control assembly 130 may be operatively coupled to the inner shaft 104 instead of the outer shaft 102. Thus, operation of the control assembly 130 may move the inner shaft 104 and the sealable hub 110 relative to the outer shaft 102 to move the funnel conduit assembly 100 between a first position and a second position, thereby constraining / compressing and releasing / expanding the funnel 120, respectively.

[0041] In other embodiments, the funnel 120 may be operatively coupled to the outer shaft 102 such that movement of the outer shaft 102 between a first position and a second position causes the funnel 120 to expand. More specifically, for example, Figure 4 This is a side view of a funnel conduit assembly 100 including a non-self-expanding funnel 420 according to an embodiment of the present technology. In some embodiments, the funnel 420 may have the same features as described above. Figures 1 to 3 The funnel 120 described in detail has a similar shape, but may be formed from one or more non-self-expanding materials, such as metals (e.g., non-thermally activated metals), plastics, fibers, polymers, etc. In the illustrated embodiment, the funnel 420 is connected to the distal portion 109b of the inner shaft 104 via a plurality of flexible fasteners 426. Figure 1 (i) and (ii) the distal portion 107b of the outer shaft 102. The tether 426 is configured (e.g., shaped, sized, and / or positioned) such that movement of the control assembly 130 from a first position to a second position pulls the tether 426, thereby pulling the funnel and expanding it as the funnel 420 is removed from the sheath within the outer shaft 102.

[0042] In some embodiments, the funnel conduit assembly 100 may include a means for actuating / manipulating the funnel 420 (or referencing...). Figures 1 to 3 The funnel 120 described in detail may include one or more features. For example, the control assembly 130 may include an actuating member 454 (schematically shown) operably coupled to the funnel 420 via one or more control lines 462 (e.g., wires, tethers, rigid members, etc.). The actuating member 454 may be a slider, a rotatable member, or other component configured to apply force to the funnel 420 via the control lines 462. In some embodiments, the control lines 462 may be asymmetrically / eccentrically coupled to the funnel 420, such that actuation of the actuating member 454 causes the funnel 420 to bend away from the longitudinal axis of axes 102, 104. In one aspect of the art, this arrangement may be used to help guide the funnel 420 into tortuous areas within a patient's body that would otherwise be difficult to position (e.g., tortuous blood vessels, left atrial appendage (LAA), etc.). Additionally or alternatively, the funnel conduit assembly 100 may include one or more components (e.g., a drawstring) for guiding (e.g., bending, deflecting, etc.) the outer shaft 102 and / or the inner shaft 104 to facilitate the positioning of the funnel 420.

[0043] II. The selected implementation scheme for embolism protection using funnel-shaped catheter assemblies.

[0044] Let's refer to each other. Figures 1 to 4 The funnel catheter assembly 100 can be used in numerous procedures to capture thrombi and prevent thrombus embolism in parts of a patient's vascular system. For example, Figures 5 to 8 This is a schematic diagram illustrating various thrombectomy techniques for removing thrombi from a blood vessel (BV) of a human patient using a funnel catheter assembly 100, according to various embodiments of the present technology.

[0045] First refer to Figure 5 In some embodiments, the thrombus T (e.g., clot material) can be accessed through the popliteal access site 560. The funnel catheter assembly 100 can extend from the popliteal access site 560 to a deployment position 562 in the vessel BV, where the funnel 120 (or funnel 420) can be deployed. The deployment position 562 can be close to and proximal to the thrombus T. After the funnel catheter assembly 100 moves from a first position to a second position to expand the funnel 120, the funnel 120 can be at least partially juxtaposed with the wall of the vessel BV, as referenced above. Figures 1 to 4 Describe in detail.

[0046] In the illustrated embodiment, the thrombus aspiration device 564 is (i) inserted through the funnel catheter assembly 100, (ii) passed through the thrombus T in the direction of blood flow, and (iii) expanded distally to the thrombus T. The thrombus aspiration device 564 may include a core-collecting element 565 (e.g., a stent-like device) and a trapping element 566 (e.g., a woven mesh bag). In some embodiments, part or all of the thrombus aspiration device 564 may extend into one of the iliac veins and / or the inferior vena cava. After distal expansion of the thrombus T, the thrombus aspiration device 564 may retract through the thrombus T and through the funnel 120 into the lumen 108 of the inner shaft 104. Figure 1During retraction, the core-retrieval element 565 can core / dissociate the thrombus T, and the capture element 566 can capture all or part of the thrombus T. In some embodiments, the thrombus aspiration device 564 and the associated thrombectomy procedure may be substantially similar to or identical to the thrombus aspiration device and associated method described in detail in the following patents: (i) U.S. Patent 9,700,332, filed September 16, 2016, entitled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS”; and / or (ii) U.S. Patent 10,098,651, filed April 26, 2017, entitled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION”, the entire contents of which are incorporated herein by reference.

[0047] In one aspect of this technology, as the thrombus aspiration device 564 and the captured thrombus T retract through the funnel 120, the funnel 120 can capture / retain any thrombus T that detaches from the thrombus aspiration device 564 when it is compressed into the inner shaft 104. Therefore, the funnel 120 can inhibit the upward migration of portions of the thrombus T, where embolism may occur. In some embodiments, a vacuum (e.g., pre-vacuum) can be applied to the inner shaft 104 at any point during the retraction of the thrombus aspiration device 564 (e.g., via a coupling to...). Figure 1 (The syringe of syringe connector 116 shown). In some embodiments, the application of vacuum can generate momentary or near-momentary suction at the distal portion 109b of the inner shaft 104, which can aspirate any remaining portion of the thrombus T into and / or through the inner shaft.

[0048] Next reference Figure 6 In some implementations, the thrombus T can be accessed via the internal jugular vein access site 670. Figure 6 (Not shown; for example, located below the iliac vein or femoral vein), and the funnel catheter assembly 100 can be inserted into the patient via the internal carotid artery access site 670. The funnel catheter assembly 100 can extend from the internal carotid artery access site 670 to an extended position 672, in which the funnel 120 (or funnel 420) can be extended proximally to the thrombus T. In the illustrated embodiment, the outer axis 102 and the inner axis 104 (in...) Figure 6(Obstructed) The thrombus extends from the internal carotid artery access site 670 through the superior and inferior vena cava to a common iliac vein at an unfolding location 672 within one of the common iliac veins. In some embodiments, the unfolding location 672 may be located, for example, within the inferior vena cava, within one of the iliac veins, within one of the femoral veins, within the popliteal vein, anterior to or outside the iliac arch, or near the thrombus T and / or at any other location proximal to the thrombus. In some embodiments, the thrombus retrieval device 564 may be inserted through the funnel-shaped catheter assembly 100 and withdrawn through the thrombus T to capture the thrombus T, as referenced above. Figure 5 Describe in detail.

[0049] In one aspect of this technology, access to the thrombus T via the internal carotid artery access site 670 allows the funnel 120 to be positioned downstream of the thrombus T. Therefore, the funnel 120 can capture any thrombus T that may dislodge and carry downstream toward the heart during operation of the thrombus removal device 564. In another aspect of this technology, before withdrawing the funnel catheter assembly 100 at the end of the thrombectomy procedure, the funnel 120 can be compressed, for example, by moving the actuating member 134 from a second position to a first position, as referenced above. Figures 1 to 4 A detailed description is provided. This prevents the funnel 120 from being pulled through the patient's heart (e.g., through the right atrium) in the unfolded configuration, which could potentially damage the heart.

[0050] Next reference Figure 7 In some embodiments, the thrombus aspiration device 564 may use a separate guide assembly 774 to enter the thrombus T through the popliteal access site 560, while the funnel catheter assembly 100 may be accessed via the internal jugular vein access site 670. Figure 6 The funnel 120 is inserted into the patient's body. During a thrombectomy procedure using the thrombus aspiration device 564, the funnel 120 can expand at the unfolded position 672. Therefore, the funnel 120 can capture any thrombus material T that may dislodge and flow downstream during the procedure. In the illustrated embodiment, the thrombus aspiration device 564 is inserted through the outer shaft 776 of the guide assembly 774. In one aspect of this technology, the outer shaft 776 can be manufactured relatively larger than the inner shaft 104 compared to using the funnel-conduit assembly 100 as the guide for the thrombus aspiration device 564, because the outer shaft 102 does not need to be positioned around the inner shaft to constrain the funnel 120. This allows the thrombus aspiration device 564 to be manufactured larger and / or enables the generation of greater suction force through the outer shaft 776.

[0051] Next reference Figure 8 In some embodiments, the thrombus removal device 564 may use the guide assembly 774 to pass through the popliteal access site 560 to enter the thrombus T, while the funnel catheter assembly 100 may be inserted into the patient via the femoral artery access site 880. The funnel catheter assembly 100 may cross the common iliac vein to reach the deployment position 672 or another suitable deployment position.

[0052] In other embodiments, the infundibulum catheter assembly 100 can be inserted into the patient via other venous or arterial access sites and can be used in a wide variety of procedures. Other applications of the infundibulum catheter assembly 100 include, but are not limited to:

[0053] Internal jugular vein (IJ) access is used to extend into the inferior vena cava (IVC) for the treatment of deep vein thrombosis (DVT) in the lower extremities.

[0054] IJ pathway, used to unfold in IVC in order to remove IVC filters and / or treat thrombi in IVC;

[0055] IJ access is used to open up deep veins in the lower extremity veins (iliac vein, femoral vein, popliteal vein, etc.) in order to treat lower extremity DVT;

[0056] Common femoral vein (CFV) access is used to extend into the superior vena cava (SVC) for the treatment of upper extremity DVT and / or SVC thrombosis;

[0057] The CFV access is used to open up the veins of the upper limb (brachial vein, subclavian vein, axillary vein, etc.) for the treatment of upper limb DVT and / or SVC thrombosis.

[0058] The CFV pathway is used to open within the pulmonary artery (PA) for the treatment of pulmonary embolism.

[0059] The CFV pathway and the transseptal pathway are used to open within the left atrial orifice and left atrial appendage (LAA) to remove thrombi.

[0060] The internal carotid artery (ICA) access is used to extend into the common carotid artery (CCA) for carotid endarterectomy (CEA).

[0061] ICA pathway, used to open in the descending thoracic aorta for the treatment of thrombi in the thoracic and / or abdominal aorta (AA) and / or aortic thrombi;

[0062] ICA pathway, used to open in the descending aorta / thoracic aorta for the treatment of renal thrombosis;

[0063] ICA access is used for intra-arterial placement to treat superior mesenteric artery (SMA) thrombosis (MAT).

[0064] The common femoral artery (CFA) access is used to treat atherosclerosis in the brachial, radial, popliteal, or dorsalis pedis arteries.

[0065] CFA access, used to extend in the common iliac artery for the treatment of aortic thrombosis and / or occlusion;

[0066] CFA access, used to extend within the abdominal aorta for the treatment of renal artery thrombosis; and / or

[0067] The CFA pathway is used to extend within the aorta for the treatment of thoracic and / or AA thrombosis and / or aortic thrombosis.

[0068] Figure 9A and Figure 9B These are, respectively, enlarged, partially transparent side views and cross-sectional side views of a portion of a funnel-shaped conduit assembly 900 according to an additional embodiment of the present technology. (See also:) Figure 9A and Figure 9B The funnel conduit assembly 900 may include features that are structurally and functionally similar to those described in the above reference. Figures 1 to 8 The corresponding features of the funnel conduit assembly 100 described in detail are at least substantially similar, or identical in structure and performance, and can operate in a substantially similar or identical manner to the funnel conduit assembly 100. In the illustrated embodiment, for example, the funnel conduit assembly 900 includes a sealable hub 110, a connecting tube 114, a suction port 112, an outer shaft 102, and an inner shaft 104 (in... Figure 9A (The middle is obstructed). The funnel conduit assembly 900 also includes a control assembly 930, which includes a housing 932 and an actuating member 934 having a pair of clamping members 938. Figure 9B As shown, the actuating member 934 includes a hub 936 positioned within the housing 932 and coupled to an outer shaft 102 (e.g., the proximal portion 107a of the outer shaft 102). The actuating member 934 is movable (e.g., slidable) relative to the housing 932 to position the outer shaft 102 relative to the inner shaft 104 and a funnel (e.g., attached to its distal portion). Figure 10B and Figure 10C The funnel 120 shown is pushed forward / retracted.

[0069] Funnel-shaped conduit assembly 900 in Figure 9A The funnel is positioned in the first sheathing position, where it is constrained by the outer shaft 102, and... Figure 9B The middle part is in the second sheath removal position, where the funnel is not constrained by the outer shaft 102. (Reference) Figure 9AIn some embodiments, housing 932 may include a mark 931 indicating the location of actuating member 934 where the funnel is in the unsheathed position. In some embodiments, the proximal portion 933a of housing 932 may include clamping features such as grooves 935, crosshair patterns 937, and / or other features to increase the clamping capability of housing 932. In some embodiments, an operator may clamp housing 932 (e.g., via grooves 935 and / or patterns 937) while (i) moving actuating member 934 relative to housing 932 and / or (ii) moving housing 932 relative to actuating member 934. In some embodiments, funnel conduit assembly 900 may also include a locking mechanism 911 that can be attached to sealable hub 110 (e.g., attached to its button) to lock sealable hub 110 in an open / unsealed position.

[0070] In the illustrated embodiment, the funnel conduit assembly 900 also includes a rotatable side port 950 that fluidly connects the sealable hub 110, the connecting tube 114, and the inner shaft 104. Figure 9C This is an enlarged isometric cross-sectional view of a portion of the sealable hub 110, the rotatable side port 950, and the control assembly 930 according to an embodiment of the present technology. Reference Figure 9C Side port 950 defines a cavity 952 that provides a fluid path from inner shaft 104 to sealable hub 110. In the illustrated embodiment, side port 950 includes a first recess 954 and a second recess 956, each extending circumferentially around an outer surface of side port 950. Sealable hub 110 includes a first protrusion 964 positioned in the first recess 954, and housing 932 includes a second protrusion 966 positioned in the second recess 956. Engagement of the first protrusion 964 and the second protrusion 966 in the first recess 954 and the second recess 956 connects housing 932 to sealable hub 110. Furthermore, the first protrusion 964 and the second protrusion 966 are rotatable within the first recess 954 and the second recess 956, such that sealable hub 110, side port 114, and housing 932 can each rotate independently of each other while remaining connected together.

[0071] In some embodiments, the control assembly 930 may further include a connector 958 that is coupled to the proximal portion 109a of the inner shaft 104 and is at least partially positioned between the side port 950 and the housing 932. The connector 958 is rotatable within the housing 932, such that the housing 932 can rotate independently of the connector 958 and the inner shaft 104. Therefore, in some aspects of this technology, the hub 110, the side port 950 (e.g., Figure 9B and Figure 9CRotation of the aspiration port 112 (shown) and / or housing 932 will substantially not rotate the inner shaft 104. This helps prevent the funnel attached to the inner shaft 104 from rotating within the blood vessel during procedures using the funnel catheter assembly 900, while still allowing movement of the sealable hub 110, side port 950, and / or other components of the funnel catheter assembly 900.

[0072] Figures 10A to 10C This is a side view of the funnel catheter assembly 900 in the sheathed position, partially sheathed or intermediate position, and sheathless position according to an embodiment of the present technology. (See also:) Figures 10A to 10C The funnel conduit assembly 900 can be moved between a sheathed position and a desheathed position by moving the actuating member 934 relative to the housing 932 and / or by moving the housing 932 (and the coupled sealable hub 110) relative to the actuating member 934. In some embodiments, for example, an operator can move the actuating member 134 relative to the housing 932 along a path... Figure 10B Slide the outer shaft 102 in the direction indicated by arrow P to retract the outer shaft 102, thereby removing the sheath from the funnel 120. In some aspects of this technology, moving the actuating member 934 instead of the housing 932 moves only the outer shaft 102, such that the funnel 120 is held in a constant or substantially constant position (e.g., a resting position). In other embodiments, the operator can move the housing 932 relative to the actuating member 934 along the direction indicated by arrow P to retract the outer shaft 102, thereby removing the sheath from the funnel 120. Figure 10A The direction indicated by arrow D in the diagram is used to advance the funnel 120 to remove the sheath. In some aspects of this technology, moving the housing 932 relative to the actuating member 934 causes the inner shaft 104 and the funnel 120 to advance distally relative to the outer shaft 102.

[0073] exist Figure 10C As shown in the desheathing position, the actuating member 934 can be positioned adjacent to or near the mark 931 to indicate to the operator that the funnel 120 has been deployed. In some embodiments, in order to re-sheath the funnel 120 (e.g., from...) Figure 10C The location shown is where the sheath is removed. Figure 10A (As shown in the sheathed position), the operator can retract the housing 932 relative to the actuating member 934 (e.g., in the direction of arrow P) to pull the funnel 120 into the outer shaft 102. In some aspects of this art, this retraction movement may be intuitive to the user because the movement of the housing 932 is in the same direction as the removal / folding of the funnel 120. However, in other embodiments, the operator can advance the actuating member 934 relative to the housing 932 to sheath the funnel 120 within the outer shaft 102.

[0074] Figure 11This is a flowchart of a process or method 1110 for operating funnel catheter assembly 100 and / or funnel catheter assembly 900 (collectively, "funnel catheter assembly") during an intravascular procedure according to an embodiment of the present technology. Although for illustrative purposes, Figures 1 to 10C Some features of method 1110 are described in the context of the illustrated embodiment, but those skilled in the art will readily understand that method 1110 can be performed using other suitable systems and / or apparatuses described herein.

[0075] At box 1111, method 1110 includes inserting a funnel catheter assembly into a patient via a vascular site. For example, the dilator 350, outer shaft 102, and inner shaft 104 may be inserted together through a venous or arterial access site.

[0076] At box 1112, method 1110 includes advancing the funnel catheter assembly to a deployment position within the patient's vascular system. For example, the dilator 350, outer shaft 102, and inner shaft 104 may be advanced together through the vascular system to the selected deployment position. The funnel catheter assembly may be advanced to a first position such that the funnel 120 is constrained / compressed within the outer shaft 102. The deployment position may be a portion of a blood vessel, a portion of the heart, or other suitable location.

[0077] At frame 1113, method 1110 includes inflating the funnel 120 in the deployed position. For example, the control assembly 130 of the funnel catheter assembly 100 may be moved from a first position to a second position to release the funnel 120 from within the outer shaft 102 / remove the sheath from the funnel, thereby allowing the funnel 120 to inflate in the deployed position. Similarly, the actuation member 934 may slide relative to the housing 932 to remove the sheath from the funnel 120. After inflating, the funnel 120 may be juxtaposed / contacted with anatomical structures (such as blood vessel walls) surrounding the deployed position. In some embodiments, the dilator 350 may be removed from the funnel catheter assembly before inflating the funnel 120.

[0078] At block 1114, method 1110 optionally includes compressing and repositioning the funnel 120. For example, control assembly 130 may be moved from a second position to a first position to constrain / sheath the funnel 120 within the outer shaft 102. Similarly, housing 932 of funnel conduit assembly 900 may retract proximally relative to the actuating member (and / or actuating member 934 may advance distally relative to the housing) to sheath the funnel 120. The funnel conduit assembly can then be repositioned to different deployed positions (block 1112) and re-expanded (block 1113). In some embodiments, expander 350 may be reinserted into funnel conduit assembly 100 prior to repositioning it.

[0079] At box 1115, method 1110 includes holding funnel 120 in an expanded position during intravascular procedure. As described in detail above, funnel 120 can capture thrombi that dislodge during intravascular procedure to prevent them from embolizing in other parts of the patient's vascular system.

[0080] At frame 1116, method 1110 includes compressing the funnel 120 and withdrawing the funnel catheter assembly 100 from the patient. For example, the control assembly 130 of the funnel catheter assembly 100 may be moved from a second position to a first position to restrain / sheath the funnel 120 within / within the outer shaft 102, after which the funnel catheter assembly 100 may be withdrawn proximally from the vascular access site. Similarly, the housing 932 of the funnel catheter assembly 900 may be retracted proximally relative to the actuating member (and / or the actuating member 934 may be advanced distally relative to the housing) to sheath the funnel 120.

[0081] III. Example

[0082] Several aspects of this technology are illustrated in the following embodiments:

[0083] 1. A funnel-shaped conduit assembly, the funnel-shaped conduit assembly comprising:

[0084] An outer shaft that defines a lumen;

[0085] An inner shaft extends through the lumen and has a proximal portion and a distal portion;

[0086] An expandable funnel, which is connected to the distal portion of the inner shaft; and

[0087] A control component configured to move the funnel between a first position and a second position, wherein

[0088] In this first position, the funnel is constrained within the cavity of the outer shaft, and

[0089] In this second position, the funnel is at least partially positioned outside the lumen of the outer shaft, allowing the funnel to expand.

[0090] 2. The funnel-shaped conduit assembly according to embodiment 1, wherein the control assembly is coupled to the outer shaft and configured to move the outer shaft relative to the inner shaft.

[0091] 3. The funnel conduit assembly according to Embodiment 1 or Embodiment 2, wherein the control assembly includes an actuator capable of moving to move the funnel between the first position and the second position.

[0092] 4. The funnel-shaped conduit assembly according to embodiment 3, wherein the actuator is a slider.

[0093] 5. The funnel conduit assembly according to any one of embodiments 2 to 4, wherein the funnel includes a proximal portion and a distal portion, and wherein the proximal portion of the funnel is coupled to the distal portion of the inner shaft.

[0094] 6. The funnel-shaped conduit according to embodiment 5, wherein the distal portion of the funnel is connected to the outer shaft.

[0095] 7. The funnel conduit assembly according to any one of embodiments 1 to 6, the funnel conduit assembly further comprising a sealable hub and a side port, wherein the side port is rotatably connected between the control assembly and the sealable hub.

[0096] 8. A funnel-shaped conduit assembly, the funnel-shaped conduit assembly comprising:

[0097] An outer shaft that defines an external lumen;

[0098] An inner shaft extends through the outer lumen and has a proximal portion and a distal portion;

[0099] An expandable funnel, which is connected to the distal portion of the inner shaft; and

[0100] A control assembly, operably coupled to the proximal portion of the outer shaft and configured to move the outer shaft between a first position and a second position, wherein...

[0101] In this first position, the outer shaft is at least partially positioned above the funnel to radially constrain the funnel, and

[0102] In this second position, the outer shaft retracts proximally relative to the funnel, allowing the funnel to expand radially.

[0103] 9. The funnel conduit assembly according to embodiment 8, wherein the control assembly includes a housing and an actuating member, wherein the actuating member is coupled to a proximal portion of the outer shaft, and wherein the actuating member is slidable along the housing to move the outer shaft between the first position and the second position.

[0104] 10. The funnel conduit assembly according to Example 8 or Example 9, wherein the funnel is configured to self-expand.

[0105] 11. The funnel conduit assembly according to Embodiment 8 or Embodiment 9, wherein the funnel is non-self-expanding, wherein the funnel is also coupled to a distal portion of the outer shaft, and wherein movement of the outer shaft from the first position to the second position is configured to expand the funnel.

[0106] 12. The funnel-shaped conduit assembly according to embodiment 11, wherein the distal portion of the funnel is connected to the distal portion of the outer shaft via one or more tethering elements.

[0107] 13. The funnel-shaped conduit assembly according to any one of embodiments 8 to 12, wherein the inner shaft defines dimensions configured to receive the internal lumen of the dilator.

[0108] 14. A method of manipulating a funnel catheter assembly during an intravascular procedure on a patient, the method comprising:

[0109] The inner shaft, outer shaft, and funnel of the funnel catheter assembly are at least partially inserted into the patient's vascular system;

[0110] The inner shaft, the outer shaft, and the funnel are advanced together to the unfolded position within the patient's vascular system, wherein the funnel is sheathed within the lumen of the outer shaft during the advancement.

[0111] Move the outer shaft relative to the inner shaft to remove the sleeve from the funnel and allow the funnel to expand to the expanded position;

[0112] The funnel is held in the expanded position for at least a portion of the intravascular procedure;

[0113] Moving the outer shaft relative to the inner shaft and / or moving the inner shaft relative to the outer shaft to sleeve the funnel within the lumen of the outer shaft; and

[0114] The funnel catheter assembly was removed from the patient's body.

[0115] 15. The method according to embodiment 14, wherein the funnel is self-expanding, and wherein moving the outer shaft relative to the inner shaft to remove the sheath from the funnel includes allowing the funnel to self-expand to the expanded position.

[0116] 16. The method according to embodiment 14 or embodiment 15, wherein moving the outer shaft relative to the inner shaft to remove the sheath from the funnel includes moving a slider of a control component of the funnel conduit assembly from a first position to a second position, and wherein the slider is engaged with a proximal portion of the outer shaft.

[0117] 17. The method according to any one of embodiments 14 to 16, wherein moving the outer shaft relative to the inner shaft to remove the sheath from the funnel includes rotating a rotatable element of the control assembly of the funnel conduit assembly from a first position to a second position.

[0118] 18. The method according to any one of embodiments 14, 16 and 17, wherein the funnel is non-self-expanding, and wherein the method further comprises actuating the funnel to expand to the expanded position.

[0119] 19. The method according to any one of Examples 14 to 18, wherein

[0120] Inserting the inner shaft, the outer shaft, and the funnel into the patient's vascular system also includes at least partially inserting an expander positioned within the inner shaft into the patient's vascular system; and

[0121] Advancing the inner shaft, the outer shaft, and the funnel also includes advancing the inner shaft, the outer shaft, the funnel, and the expander together to the unfolded position.

[0122] 20. The method according to any one of embodiments 14 to 19, wherein moving the outer shaft relative to the inner shaft to remove the sleeve from the funnel includes moving the outer shaft along a first direction, and wherein the method further includes moving the outer shaft relative to the inner shaft to sleeve the funnel by moving the outer shaft along a second direction opposite to the first direction.

[0123] IV. in conclusion

[0124] The above detailed description of the embodiments of this technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments and examples of this technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications can be made within the scope of this technology. For example, although the steps are given in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide other embodiments.

[0125] Based on the foregoing, it should be understood that this document has described specific embodiments of the technology for illustrative purposes, but has not shown or described in detail well-known structures and functions to avoid unnecessarily obscuring the description of the embodiments of this technology. Where the context permits, singular or plural terms may also include plural or singular terms respectively.

[0126] Furthermore, unless the word “or” is explicitly limited to referring only to a single item excluding other items in a list involving two or more items, its use in such lists should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” means, throughout, at least including the mentioned features, without excluding any further number of the same features and / or features of other types. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the art. Furthermore, while advantages associated with certain embodiments of the art have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the art. Therefore, this disclosure and related art may include other embodiments not expressly shown or described herein.

Claims

1. A funnel-shaped conduit assembly, the funnel-shaped conduit assembly comprising: An outer shaft that defines an external lumen and has a proximal portion and a distal portion; An inner shaft extends through the outer lumen and has a proximal portion and a distal portion, the inner shaft defining an inner lumen; An expandable funnel, the expandable funnel being connected to the distal portion of the inner shaft; and control components, the control components including (a) A housing having a proximal portion and a distal portion and defining a housing lumen and (b) An actuator movably coupled to the housing, wherein The inner shaft extends at least partially through the housing cavity and is fixed in a suitable position longitudinally relative to the housing in a direction extending between the proximal and distal portions of the housing. The proximal portion of the outer shaft is at least partially located within the housing cavity and operatively coupled to the actuator. The actuator is configured to be actuated to move at least partially the proximal portion of the outer shaft through the housing cavity, thereby moving the funnel between a first position and a second position. In the first position, the funnel is constrained within the outer cavity of the outer shaft, and In the second position, the funnel is at least partially positioned outside the outer cavity of the outer shaft, allowing the funnel to expand. A side port having a proximal portion and a distal portion, wherein the distal portion of the side port is rotatably coupled to the proximal portion of the housing, and wherein the side port defines a side port lumen fluidly coupled to the internal lumen. and A hemostatic valve, rotatably coupled to the proximal portion of the side port, wherein the hemostatic valve is actuable to selectively provide fluid into the internal lumen and the side port lumen.

2. The funnel-shaped conduit assembly of claim 1, wherein the actuator is fixedly coupled to the outer shaft and configured to slide the outer shaft relative to the inner shaft.

3. The funnel conduit assembly of claim 2, wherein the actuator is configured to be actuated to move at least partially the proximal portion of the outer shaft through the housing lumen toward the proximal portion of the housing, thereby moving the funnel from the first position to the second position.

4. The funnel conduit assembly of claim 3, wherein the actuator comprises (a) a body portion at least partially located within the housing lumen and fixedly coupled to a proximal portion of the outer shaft and (b) a clamping member extending from the body portion outside the housing lumen and configured to be gripped by a user and slid at least partially proximal to the proximal portion of the housing to correspondingly move the body portion and the proximal portion of the outer shaft through the housing lumen, thereby moving the funnel from the first position to the second position.

5. The funnel conduit assembly of claim 1, wherein the funnel includes a proximal portion and a distal portion, and wherein the proximal portion of the funnel is coupled to the distal portion of the inner shaft.

6. The funnel-shaped conduit of claim 5, wherein the distal portion of the funnel is coupled to the outer shaft.

7. The funnel-shaped conduit assembly of claim 1 further includes a connector fixedly coupled to a proximal portion of the inner shaft, wherein the connector is rotatably coupled within the housing lumen.

8. The funnel catheter assembly of claim 7, wherein the side port, the hemostatic valve, and the housing are configured to rotate independently of the connector and the inner shaft.

9. The funnel-shaped conduit assembly of claim 1, wherein the side port further defines a branch lumen fluidly connected to the side port lumen, and further comprises: The suction port is fluidly connected to the branch lumen; A suction device, which is fluidly connected to the suction port; and A fluid control device fluidly connected along the suction port, wherein the fluid control device is actuable to selectively fluidly connect the suction device to the internal lumen.

10. The funnel-shaped conduit assembly of claim 1, wherein the proximal portion of the outer shaft is constrained to move only through the housing lumen between the proximal portion of the housing and the distal portion of the housing.

11. A funnel-shaped conduit assembly, the funnel-shaped conduit assembly comprising: An outer shaft that defines an external lumen and has a proximal portion and a distal portion; An inner shaft extends through the outer lumen and has a proximal portion and a distal portion, the inner shaft defining an inner lumen; An expandable funnel, the expandable funnel being connected to the distal portion of the inner shaft; and control components, the control components including (a) A housing having a proximal portion and a distal portion and defining a housing lumen and (b) An actuating member movably coupled to the housing, wherein The inner shaft extends at least partially through the housing cavity and is fixed in a suitable position longitudinally relative to the housing in a direction extending between the proximal and distal portions of the housing. The proximal portion of the outer shaft is at least partially located within the housing cavity and operatively coupled to the actuating member. The actuating member is configured to move at least partially through the proximal portion of the outer shaft between a first position and a second position. In the first position, the distal portion of the outer shaft is at least partially positioned above the funnel to radially constrain the funnel, and In the second position, the distal portion of the outer shaft retracts proximally relative to the funnel, allowing the funnel to expand radially. A side port having a proximal portion and a distal portion, wherein the distal portion of the side port is rotatably coupled to the proximal portion of the housing, and wherein the side port defines a side port lumen fluidly coupled to the internal lumen. and A hemostatic valve, rotatably coupled to the proximal portion of the side port, wherein the hemostatic valve is actuable to selectively provide fluid into the internal lumen and the side port lumen.

12. The funnel-shaped conduit assembly of claim 11, wherein the actuating member is slidable along the housing to move the proximal portion of the outer shaft between the first position and the second position.

13. The funnel conduit assembly of claim 11, wherein the funnel is configured to self-expand.

14. The funnel conduit assembly of claim 11, wherein the funnel is non-self-expanding, wherein the funnel is also coupled to a distal portion of the outer shaft, and wherein movement of the proximal portion of the outer shaft from the first position to the second position is configured to expand the funnel.

15. The funnel-shaped conduit assembly of claim 14, wherein the distal portion of the funnel is connected to the distal portion of the outer shaft via one or more tethering elements.

16. The funnel-shaped conduit assembly of claim 11, wherein the inner shaft is sized to receive the internal lumen of the dilator.

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