Recaptureable funnel catheter, and related systems and methods

Abstract

To provide suitable recapturable funnel catheters, and associated systems and method.SOLUTION: Systems and methods for the intravascular treatment of clot material within a blood vessel of a human patient are disclosed herein. In one embodiment, a funnel catheter assembly includes an outer shaft and an inner shaft extending through and coaxial with the outer shaft. An expandable funnel can be coupled to a distal portion of the inner shaft. The funnel catheter assembly further includes a control assembly operably coupled to a 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 arranged at least partially over the funnel to constrain the funnel in a compressed state. In the second position, the outer shaft is retracted proximally relative to the funnel such that the funnel can expand to an expanded state.SELECTED DRAWING: Figure 10C

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 035,605, filed on June 5, 2020, and entitled "RECAPTURABLE FUNNEL CATHETERS, AND ASSOCIATED SYSTEMS AND METHODS", which is hereby incorporated by reference in its entirety.

[0002] (Field of the Invention) The present technology generally relates to systems, methods, and devices for embolic protection during procedures for extracting thrombi from the blood vessels of a human patient.

Background Art

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

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

[0005] Three processes are thought to lead to venous thrombosis (DVT). The first is reduced blood flow (venous stasis), the second is increased tendency to clot (hypercoagulation), and the third is changes in the blood vessel walls. DVT formation typically begins inside the valves of the calf veins where blood is relatively deprived of oxygen, which activates a specific biochemical pathway. Several medical conditions increase the risk of DVT, including diabetes, cancer, trauma, and antiphospholipid syndrome. Other risk factors include older age, surgery, immobilization (such as bed rest, orthopedic casts, and sitting on long flights), use of oral contraceptives, pregnancy, postnatal period, and genetic factors. The rate of DVT increases dramatically from childhood to old age, and in adults, about 1 in 1,000 adults develops DVT each year.

[0006] While current devices and methods exist for the prevention and / or treatment of DVT, several shortcomings remain unresolved, including a high incidence of DVT recurrence, the use of devices not designed to remove large clotting volumes, and / or complex treatments involving multiple therapeutic devices and / or medications. Therefore, new devices, systems, and methods for treating thrombosis, particularly DVT, are desired. [Overview of the project] [Means for solving the problem]

[0007] This technology generally relates to methods and systems for removing coagulation material (e.g., thrombi) from the blood vessels of human patients. More specifically, this technology relates to funnel catheter assemblies configured to provide embolic protection during decoction or other endovascular procedures. In some embodiments, the funnel catheter assembly includes an outer shaft and an inner shaft extending through the outer shaft and coaxial with the outer shaft. An expandable funnel, such as a self-expanding funnel, may be coupled to the distal portion of the inner shaft. The funnel catheter assembly further includes a control assembly operably coupled to the proximal portion of the outer shaft. The funnel catheter assembly may 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 positioned at least partially over the funnel so as to restrain the funnel in a compressed state. In the second position, the outer shaft is retracted proximal to the funnel so as to allow the funnel to expand into an expanded state. Therefore, the funnel catheter assembly allows the funnel to be exposed to or covered from the sheath during endovascular procedures via the movement of the outer shaft between a first position and a second position.

[0008] In one aspect of this technology, the control assembly is operable to compress the funnel after it has been expanded within the patient's blood vessel. This allows the funnel catheter assembly to be repositioned within the blood vessel without completely withdrawing the funnel catheter assembly from the patient. Similarly, the funnel catheter assembly can be completely withdrawn from the patient in a first position where the funnel is compressed inside the outer shaft (e.g., at the end of a thrombectomy procedure). Thus, the funnel catheter assembly is configured to prevent or block the funnel from coming into contact with the blood vessel wall during the movement of the funnel catheter assembly within the blood vessel. This can help prevent injury / damage to the patient that may otherwise be caused by moving the funnel through the blood vessel or related organs in an expanded state. The present invention provides, for example, the following: (Item 1) A funnel catheter assembly, The outer shaft defines the lumen, An internal shaft extending through the lumen and having a proximal portion and a distal portion, An expandable funnel connected to the distal portion of the inner shaft, The system comprises a control assembly configured to move the funnel between a first position and a second position, In the first position, the funnel is confined within the lumen of the outer shaft, A funnel catheter assembly in which, in the second position, the funnel is positioned at least partially outside the lumen of the outer shaft so that the funnel can expand. (Item 2) The funnel catheter assembly according to item 1, wherein the control assembly is connected to the outer shaft and configured to move the outer shaft relative to the inner shaft. (Item 3) The funnel catheter assembly according to item 1, wherein the control assembly includes an actuator that is movable to move the funnel between a first position and a second position. (Item 4) The funnel catheter assembly described in item 3, wherein the actuator is a slider. (Item 5) The funnel catheter assembly according to item 1, wherein the funnel includes a proximal portion and a distal portion, and the proximal portion of the funnel is connected to the distal portion of the inner shaft. (Item 6) The funnel catheter according to item 5, wherein the distal portion of the funnel is connected to the outer shaft. (Item 7) The funnel catheter assembly according to item 1, further comprising a sealable hub and a side port, wherein the side port is rotatably connected between the control assembly and the sealable hub. (Item 8) A funnel catheter assembly, The outer shaft defines the outer lumen, An inner shaft extending through the outer lumen and having a proximal portion and a distal portion, An expandable funnel connected to the distal portion of the inner shaft, The system comprises a control assembly operably connected 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 positioned at least partially on the funnel so as to constrain the funnel in the radial direction. A funnel catheter assembly in which, in the second position, the outer shaft is retracted proximal to the funnel so that the funnel can expand radially. (Item 9) The funnel catheter assembly according to item 8, wherein the control assembly includes a housing and an actuating member, the actuating member being connected to the proximal portion of the outer shaft, and the actuating member being slidable along the housing to move the outer shaft between a first position and a second position. (Item 10) The funnel catheter assembly according to item 8, wherein the funnel is configured to self-expand. (Item 11) The funnel catheter assembly according to item 8, wherein the funnel is non-self-expanding, and the funnel is further connected to the distal portion of the outer shaft, and the movement of the outer shaft from the first position to the second position is configured to expand the funnel. (Item 12) The funnel catheter assembly according to item 11, wherein the distal portion of the funnel is connected to the distal portion of the outer shaft via one or more tethers. (Item 13) The funnel catheter assembly described in item 8, wherein the internal shaft defines an internal lumen sized to receive a dilator. (Item 14) A method for manipulating a funnel catheter assembly during an endovascular procedure on a patient, wherein the method is Inserting at least partially the inner shaft, outer shaft, and funnel of the funnel catheter assembly into the patient's vascular structure, The process involves advancing the inner shaft, the outer shaft, and the funnel together to their deployed position within the vascular structure of the patient, wherein the funnel is covered within the lumen of the outer shaft during the advancement. To expose the funnel and allow the funnel to expand to the expanded position, the outer shaft is moved relative to the inner shaft, Maintaining the funnel in the expanded position for at least a portion of the endovascular procedure, To cover the lumen of the outer shaft with the funnel, the outer shaft is moved relative to the inner shaft and / or the inner shaft is moved relative to the outer shaft, A method comprising withdrawing the funnel catheter assembly from the patient. (Item 15) The method of item 14, wherein the funnel is self-expandable, and moving the outer shaft relative to the inner shaft to expose the funnel allows the funnel to self-expand to the expanded position. (Item 16) Moving the outer shaft relative to the inner shaft to expose the funnel includes moving a slider of a control assembly of the funnel catheter assembly from a first position to a second position, the slider being connected to a proximal portion of the outer shaft, the method according to item 14. (Item 17) Moving the outer shaft relative to the inner shaft to expose the funnel includes rotating a rotatable element of a control assembly of the funnel catheter assembly from a first position to a second position, the method according to item 14. (Item 18) The funnel is non-self-expanding, and the method further includes actuating the funnel to expand it to the expanded position, the method according to item 14. (Item 19) Inserting the inner shaft, the outer shaft, and the funnel into the vasculature of the patient further includes at least partially inserting a dilator disposed within the inner shaft into the vasculature of the patient, Advancing the inner shaft, the outer shaft, and the funnel further includes advancing the inner shaft, the outer shaft, the funnel, and the dilator together to the deployment position, the method according to item 14. (Item 20) Moving the outer shaft relative to the inner shaft to expose the funnel includes moving the outer shaft in a first direction, and the method further includes moving the outer shaft relative to the inner shaft to cover the funnel by moving the outer shaft in a second direction opposite to the first direction, the method according to item 14.

Brief Description of the Drawings

[0009] Many aspects of this technology can be better understood by referring to the following drawings. The components in the drawings are not necessarily to scale. Rather, the focus is on clearly illustrating the principles of this disclosure. [Figure 1] This is a partially transparent, partially cross-sectional side view of a funnel catheter assembly according to an embodiment of this technology. [Figure 2A] These are side views of the funnel catheter assembly at the first and second positions according to an embodiment of the present technology. [Figure 2B] These are side views of the funnel catheter assembly at the first and second positions according to an embodiment of the present technology. [Figure 3] This is a side view of a funnel catheter assembly in a first position with a dilator inserted, according to an embodiment of the present technology. [Figure 4] This is a side view of a funnel catheter assembly, including a non-self-expanding funnel, according to an embodiment of the present technology. [Figure 5] This schematic diagram illustrates various thrombectomy techniques for removing blood clots from the blood vessels of human patients using a funnel catheter assembly according to an embodiment of this technology. [Figure 6] This schematic diagram illustrates various thrombectomy techniques for removing blood clots from the blood vessels of human patients using a funnel catheter assembly according to an embodiment of this technology. [Figure 7] This schematic diagram illustrates various thrombectomy techniques for removing blood clots from the blood vessels of human patients using a funnel catheter assembly according to an embodiment of this technology. [Figure 8] This schematic diagram illustrates various thrombectomy techniques for removing blood clots from the blood vessels of human patients using a funnel catheter assembly according to an embodiment of this technology. [Figure 9A] These are an enlarged partial transmissive side view and a side cross-sectional view of a portion of a funnel catheter assembly according to an additional embodiment of this technology, respectively. [Figure 9B]These are an enlarged partial transmissive side view and a side cross-sectional view of a portion of a funnel catheter assembly according to an additional embodiment of this technology, respectively. [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. [Figure 10A] Figures 9A and 9B are side views of the funnel catheter assembly according to an embodiment of this technology, showing the covered position, a partially exposed or intermediate position, and the exposed position, respectively. [Figure 10B] Figures 9A and 9B are side views of the funnel catheter assembly according to an embodiment of this technology, showing the covered position, a partially exposed or intermediate position, and the exposed position, respectively. [Figure 10C] Figures 9A and 9B are side views of the funnel catheter assembly according to an embodiment of this technology, showing the covered position, a partially exposed or intermediate position, and the exposed position, respectively. [Figure 11] This is a flowchart of a process or method for operating a funnel catheter assembly during an intravascular procedure according to an embodiment of this technology. [Modes for carrying out the invention]

[0010] Many embodiments described herein relate to devices, systems, and methods for treating vascular thrombosis (e.g., deep vein thrombosis (DVT)), but other uses and embodiments beyond those described herein are within the scope of the technology (e.g., endovascular procedures other than those for treating embolism, endovascular procedures for treating cerebral embolism, endovascular procedures for treating pulmonary embolism, etc.). In general, for example, devices, systems, and methods of the technology can be used to extract any formation of material within blood vessels (e.g., venous or arterial vessels), such as cancerous growth, pathological growth, etc. In addition, some other embodiments of the technology may have different structures, states, components, or procedures than those described herein. Furthermore, it will be understood that certain elements, substructures, advantages, uses, and / or other features of the embodiments described with reference to Figures 1 to 11 can be appropriately interchanged, replaced, or otherwise configured according to additional embodiments of the technology. Furthermore, preferred elements of the embodiments described with reference to Figures 1 to 11 can be used as standalone and / or integrated devices. Accordingly, those skilled in the art will understand that the present technology may have other embodiments having additional elements, or that the present technology may have other embodiments that do not have some of the features shown and described below with reference to Figures 1 to 11.

[0011] In this description, unless otherwise specified, the terms “distal” and “proximal” refer to the relative position of a portion of the catheter subsystem to the operator and / or a position within the vascular structure. Furthermore, as used herein, designations such as “posterior,” “anterior,” “superior,” and “inferior” do not imply limiting the use of the referenced component to a specific orientation. Such designations are understood to refer to the orientation of the referenced component as shown in the figures. The system of this technology can be used in any orientation suitable for the user.

[0012] The headings provided herein are for convenience only and should not be construed as limiting the subject matter disclosed.

[0013] I. Selected Embodiments of Funnel Catheter Assemblies Figure 1 is a partially transparent, partially cross-sectional side view of a funnel catheter assembly 100 according to an embodiment of the present technology. In the illustrated embodiment, the funnel catheter 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, catheter, 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 can each be terminated at a proximal end / terminus, and the distal portions 107b and 109b can each be terminated at a distal end / terminus. The shafts 102 and 104 can be elastic and / or flexible and can have any preferred length and diameter.

[0014] In the illustrated embodiment, the funnel catheter assembly 100 further includes a sealable hub 110 connected to the proximal portion 109a of the inner shaft 104. In some embodiments, as will be described in more detail below with reference to Figures 9A-9C, the sealable hub 110 may be rotatably connected to the inner shaft 104 so 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 have 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 a thrombectomy procedure) by blocking or preventing the proximal flow of fluid through the sealable hub 110 as various components (e.g., dilator assemblies, thrombectomy devices, etc.) are inserted through the sealable hub 110 and delivered to a treatment site in the blood vessel through the inner shaft 104. More specifically, the sealable hub 110 may be a valve of the type disclosed in U.S. Patent Application No. 16 / 117,519, filed August 30, 2018, entitled "HEMOSTASIS VALVES AND METHODS OF USE," which is incorporated herein by reference in its entirety. The sealable hub 110 may include one or more buttons or actuators that allow an operator to selectively seal / unseal the sealable hub 110.

[0015] The funnel catheter assembly 100 may further include a suction port 112 connected, for example, via a connecting tube 114 to a sealable hub 110 (e.g., a side port of the sealable hub 110) and / or to an inner shaft 104 (e.g., a proximal portion 109a of the inner shaft 104). The suction port 112 may be connected to a syringe connector 116 which can be selectively connected to a syringe or other suction device, or the suction port 112 may be connected to other suitable elements. In some embodiments, the funnel catheter assembly 100 includes a fluid control device 118 configured to selectively fluidize the suction port 112 to the lumen 108 of the inner shaft 104. In the illustrated embodiment, the fluid control device 118 is a plug operably connected to the connecting tube 114 between the lumen 108 of the inner shaft 104 and the suction port 112. In other embodiments, the fluid control device 118 may be a clamp or another suitable valve. In some embodiments, a vacuum source (not shown: e.g., a syringe) may be connected to a syringe connector 116 and used to aspirate the lumen 108 of the inner shaft 104. In some embodiments, as will be described in more detail below with reference to Figures 9A-9C, the aspiration port 112 and connecting tube 114 may be rotatable relative to a sealable hub 110 and / or the inner shaft 104.

[0016] In the illustrated embodiment, the funnel 120 is connected to the distal portion 109b of the inner shaft 104. As will be described in more detail below, in the operation of the funnel catheter assembly 100 during an endovascular procedure, the funnel 120 is configured to expand (e.g., radially) to align with the blood vessel and / or other body cavities (e.g., of an organ) and to function as a proximal or distal thrombus / embolus protection device to prevent any thrombus from moving through the funnel 120 and forming an embolus in an undesirable location (e.g., the right heart, pulmonary artery, another arterial space, etc.). The funnel 120 can be fused to the distal portion 109b of the inner shaft 104 and / or attached to the inner shaft 104 via welding, adhesive, fasteners, etc. In Figure 1, the funnel catheter assembly 100 is in a first position / state / configuration in which the distal portion 107b of the outer shaft 102 extends beyond the distal portion 109b of the inner shaft 104, and the funnel 120 is at least partially (e.g., completely) positioned within the lumen 106 of the outer shaft 102. The funnel 120 can be configured to expand (e.g., self-expanding), and thus the funnel 120 can be in a first constrained position / state / configuration when the funnel catheter assembly 100 is in the first position. In some embodiments, the funnel 120 can be formed from at least one of a castle-style nitinol braid, a nitinol braid stent, laser-cut nitinol, a laser-cut polymer tube, an injection-molded polymer structure, or an inflatable balloon. In some embodiments, the funnel 120 can be provided with a mesh having a pore size small enough to prevent the passage of thrombi through the pores of the mesh. In some embodiments, the funnel 120 can be blood permeable. In some embodiments, the funnel 120 may include a cover that is permeable to or impermeable to blood, covering at least a portion of it.

[0017] In the illustrated embodiment, the proximal portion 107a of the outer shaft 102 is operably connected to a control assembly 130. The control assembly 130 is operable to move the outer shaft 102 distally and proximal to the inner shaft 104, thereby confining the funnel 120 within or releasing it from 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 actuator 134 operably / movably connected to the housing 132. The housing 132 defines a lumen 135 extending between its proximal and distal portions 133a,b. The proximal portion 133a of the housing 132 can be connected to a sealable hub 110. In some embodiments, the proximal portion 133a of the housing 132 is integrally formed with the sealable hub 110.

[0018] In the illustrated embodiment, the actuator 134 includes a body portion 136 positioned within the lumen 135 of the housing 132 and connected to the proximal portion 107a of the outer shaft 102 via, for example, adhesive, fasteners, welding, etc. The actuator 134 further includes one or more gripping members 138 extending from the body portion 136 to the outside of the lumen 135. More specifically, the gripping members 138 may extend through corresponding slots 140 formed within / alongside the housing 132. The housing 132 may define a proximal end 142a and a distal end 142b for each of the slots 140. In some embodiments, the control assembly 130 may include one or more of the gripping members 138 and corresponding slots 140 than the two shown.

[0019] During operation, the operator (e.g., a physician) can slide the actuator 134 along the housing 132 to advance the outer shaft 102 distally or retract it proximal to the inner shaft 104, thereby constraining or releasing the funnel 120, respectively. More specifically, Figures 2A and 2B are side views of the funnel catheter assembly 100 in a first and second position, respectively, according to an embodiment of the present technology. Referring together to Figures 1 to 2B, in order to move the funnel catheter assembly 100 from the first position (Figures 1 and 2A) to the second position (Figure 2B), the operator grasps the gripping member 138 of the actuator 134 and slides the gripping member 138 proximal to the housing 132 (for example, in the direction of arrow P in Figure 2A), thereby driving the main body portion 136 through the lumen 135, and thereby driving the outer shaft 102 proximal to the inner shaft 104. As the distal portion 107b of the outer shaft 102 moves proximal through the funnel 120, the funnel 120 is released / exposed from within the lumen 106 of the outer shaft 102, thereby expanding the funnel 120. In some embodiments, the actuator 134 can abut against the proximal end 142a of the slot 140 in a second position so that the housing 132 prevents further proximal movement of the outer shaft 102.

[0020] In some embodiments, the distal end of the outer shaft 102 is positioned at or proximal to the distal end of the inner shaft 104 in a second position such that the funnel 120 is completely free from the lumen 106 of the outer shaft 102 (e.g., positioned completely outside the lumen 106). In other embodiments, the distal end of the outer shaft 102 may be positioned distal to the distal end of the inner shaft 104 in a second position such that the funnel 120 is only partially free from the lumen 106 of the outer shaft 102. Furthermore, as shown in Figure 2B, the funnel 120 may have a conical portion 222 (e.g., a truncated conical portion) and a cylindrical portion 224 once expanded. In other embodiments, the funnel 120 may have other suitable shapes. For example, in some embodiments, the funnel 120 can be inverted relative to the embodiment shown in Figure 2B. In other words, the cylindrical portion 224 of the funnel 120 can be connected to the distal portion 109b of the inner shaft 104, and the conical portion 222 extends distally from the cylindrical portion 224.

[0021] To move the funnel catheter assembly 100 from a second position (Figure 2B) to a first position (Figures 1 and 2A), the operator grasps the gripping member 138 of the actuator 134 and slides the gripping member 138 distal to the housing 132 (for example, in the direction of arrow D in Figure 2B) to drive the main body portion 136 through the lumen 135, thereby driving the outer shaft 102 distal to the inner shaft 104. The funnel 120 is captured / covered within the lumen 106 of the outer shaft 102 as the distal portion 107b of the outer shaft 102 moves distally on the funnel 120, thereby crushing / compressing the funnel 120 within the lumen 106. In some embodiments, the actuator 134 can abut against the distal end 142b of the slot 140 in the first position so that the housing 132 prevents further distal movement of the outer shaft 102.

[0022] In some embodiments, the actuarial member 134 is configured to be releasably fixed / locked to the housing 132 in first and second positions to restrict or prevent unintended movement of the actuarial member 134. For example, referring again to Figure 1, the housing 132 of the control assembly 130 may include (i) a proximal engaging member 144a (e.g., a tab, projection, etc.) configured to engage with the actuarial member 134 in a first position, and (ii) a distal engaging member 144b configured to engage with the actuarial member 134 in a second position. More specifically, in some embodiments, the proximal and distal engaging members 144a,b can engage with corresponding slots / grooves in the actuarial member 134 (e.g., formed in / on the gripping member 138) to releasably fix the actuarial member 134 in a first or second position via a snap-fit ​​configuration.

[0023] In some embodiments, the inner shaft 104 is sized to slidably receive one or more medical instruments inserted through the sealable hub 110 during endovascular procedures using the funnel catheter assembly 100, such as thrombectomy. For example, Figure 3 is a side view of the funnel catheter assembly 100 in a first position, according to an embodiment of the art, with the dilator 350 inserted through the sealable hub 110 and the lumen 108 of the inner shaft 104 (Figure 1). The dilator 350 can extend all the way through the inner shaft 104 and past the distal end of the distal portion 107b of the outer shaft 102, such that the distal tip 352 (e.g., non-traumatic tip) is positioned beyond the distal end of the outer shaft 102.

[0024] In some embodiments, the dilator 350 and the funnel catheter assembly 100 together define an introducer assembly that can be inserted into a patient (e.g., a human patient) and subsequently used to introduce an intravascular medical device into the patient. For example, the dilator 350 and the funnel catheter assembly 100 can be inserted into the patient's blood vessel and advanced together through the patient's blood vessel to a target location within the vessel. The dilator 350 can then be retracted proximal through the funnel catheter assembly 100, and the funnel catheter assembly 100 can be moved to a second position to expand the funnel 120 at the target location.

[0025] Referring together to Figures 1-3, in one aspect of this technology, the inner shaft 104 is the “working” shaft of the funnel catheter assembly 100, which is to be aspirated and / or to receive various medical components (e.g., dilators 350). In contrast, the outer shaft 102 is used to compress / expand the funnel 120. Thus, the shafts 102, 104 can be sized to maximize the size of the inner shaft 104, allowing larger components to be inserted through it, or to provide greater suction force / power. For example, the outer shaft 102 may have an inner diameter that is only slightly larger than the outer diameter of the inner shaft 104. In some embodiments, the inner shaft 104 may 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, at least 26 French, greater than 26 French, 10 to 26 French, 14 to 24 French, 15 to 21 French, 16 to 22 French, and / or any other size or intermediate size. In some embodiments, the lumen 108 of the inner shaft 104 may 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, 11 to 12 French, 10 to 22 French, 14 to 21 French, 16 to 20 French, and / or any other size or intermediate size.

[0026] In another embodiment of this technology, the control assembly 130 is operable to compress the funnel 120 after it has been expanded in a blood vessel via the movement of an actuarial member 134 from a second position to a first position. This allows the funnel catheter assembly 100 to be repositioned in a blood vessel without completely withdrawing the funnel catheter assembly 100 from the patient. For example, (i) the funnel catheter assembly 100 is introduced into a blood vessel together with the dilator 350, and (ii) after the dilator 350 is removed, the funnel catheter assembly 100 can be repositioned proximal by simply returning the funnel catheter assembly 100 to the first position to fold the funnel portion 120, and then retracting the funnel catheter assembly 100 proximal. To reposition the funnel catheter assembly 100 distally, the dilator 350 can be reinserted, and the funnel catheter assembly 100 can be pushed proximal in the first position while the funnel 120 remains compressed. Similarly, the funnel catheter assembly 100 can be completely withdrawn from the patient in a first position where the funnel 120 is compressed within the lumen 106 of the outer shaft 102 (for example, at the end of a thrombectomy procedure). Thus, the funnel catheter assembly 100 is configured to prevent or block the funnel 120 from coming into contact with the wall of a blood vessel during advancement / retraction. This can help prevent injury / damage to the patient that may otherwise be caused by moving the funnel 120 through a blood vessel or related organ in an expanded state.

[0027] In some embodiments, the funnel catheter assembly 100 and / or the method for operating the funnel catheter assembly 100 may include some features the same or similar to those of a thrombectomy system (e.g., an introducer assembly) described in detail in (i) U.S. Patent No. 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 No. 10,098,651 filed April 26, 2017, entitled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION,” both of which are incorporated herein by reference in their entirety.

[0028] In other embodiments, the control assembly 130 may be configured to drive the distal and proximal movement of the outer shaft 102 in other ways. For example, the actuator 134 may comprise a rotatable member (e.g., a ring gear, a corkscrew, a rotatable handle, etc.) connected to the outer shaft 102. In some embodiments, the rotatable member may be a ratchet member rotatable to a plurality of distinct positions between a first position and a second position.

[0029] Similarly, in other embodiments, the control assembly 130 may be operably connected to the inner shaft 104 instead of the outer shaft 102. Thus, the operation of the control assembly 130 can move the inner shaft 104 and the sealable hub 110 relative to the outer shaft 102, thereby moving the funnel catheter assembly 100 between a first position and a second position, thereby constraining / compressing and releasing / expanding the funnel 120, respectively.

[0030] In yet another embodiment, the funnel 120 may be operably connected to the outer shaft 102 such that movement of the outer shaft 102 between a first position and a second position expands the funnel 120. More specifically, for example, Figure 4 is a side view of a funnel catheter assembly 100 including a non-self-expanding funnel 420 according to an embodiment of the present art. In some embodiments, the funnel 420 may have a shape similar to the funnel 120 described in detail above with reference to Figures 1 to 3, but may be formed from one or more non-self-expanding materials such as metal (e.g., non-thermally activated metal), plastic, fiber, or polymer. In the illustrated embodiment, the funnel 420 is connected via a plurality of flexible tethers 426 to (i) the distal portion 109b of the inner shaft 104 (Figure 1) and (ii) the distal portion 107b of the outer shaft 102. The tether 426 is configured such that the movement of the control assembly 130 from a first position to a second position pulls the tether 426, thereby pulling and expanding the funnel 420 (e.g., shaping, sizing, and / or positioning) as the funnel 420 is exposed from within the outer shaft 102.

[0031] In some embodiments, the funnel catheter assembly 100 may include one or more features for acting on / operating the funnel 420 (or funnel 120, which will be described in detail with reference to Figures 1-3). For example, the control assembly 130 may include an actuating member 454 (as schematically shown) operably connected 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 connected to the funnel 420 such that the actuation of the actuating member 454 bends the funnel 420 away from the longitudinal axis of the shafts 102, 104. In one aspect of this technology, this configuration can be used to help guide the funnel 420 into a winding area of ​​a patient (e.g., a winding blood vessel, the left atrial appendage (LAA), etc.) where it might otherwise be difficult to position the funnel 420. In addition, or alternatively, the funnel catheter assembly 100 may include one or more components (e.g., tension wires) for guiding (e.g., bending, flexing, etc.) the outer shaft 102 and / or the inner shaft 104 to facilitate the placement of the funnel 420.

[0032] II. Selected Embodiments of Procedures Utilizing Funnel Catheter Assemblies for Embolism Protection Referring together to Figures 1 to 4, the funnel catheter assembly 100 can be used in a multitude of procedures to capture thrombi and prevent them from forming embolisms in parts of the patient's vascular structure. For example, Figures 5 to 8 are schematic diagrams illustrating various thrombectomy techniques for removing thrombi T from the blood vessels (BVs) of human patients using the funnel catheter assembly 100 according to various embodiments of the present technology.

[0033] Referring first to Figure 5, in some embodiments, the thrombus T (e.g., coagulation material) can be accessed through the popliteal access site 560. The funnel catheter assembly 100 can extend from the popliteal access site 560 to an deployment position 562 in the vessel BV from which the funnel 120 (or funnel 420) can be deployed. The deployment position 562 can be near and proximal to the thrombus T. The funnel 120 can at least partially juxtapose with the vessel wall BV after the funnel catheter assembly 100 has been moved from a first position to a second position to expand the funnel 120, as described in detail above with reference to Figures 1 to 4.

[0034] In the illustrated embodiment, the thrombectomy device 564 is (i) inserted through a funnel catheter assembly 100, (ii) passed through the thrombus T in the direction of blood flow, and (iii) expanded distal to the thrombus T. The thrombectomy device 564 may include a coring element 565 (e.g., a stent-like device) and a capture element 566 (e.g., a braided mesh bag). In some embodiments, part or all of the thrombectomy device 564 may extend into one of the iliac veins and / or inferior vena cava. After expanding distal to the thrombus T, the thrombectomy device 564 may be retracted through the thrombus T into the lumen 108 of the inner shaft 104 (Figure 1) through the funnel 120. During retraction, the coring element 565 may coring / separating the thrombus T, and the capture element 566 may capture all or part of the thrombus T. In some embodiments, the thrombectomy device 564 and associated thrombectomy procedures may be generally similar to, or identical to, the thrombectomy devices and associated methods described in detail in (i) U.S. Patent No. 9,700,332, filed September 16, 2016, titled “INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS,” and / or (ii) U.S. Patent No. 10,098,651, filed April 26, 2017, titled “DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION,” both of which are incorporated herein by reference in their entirety.

[0035] In one aspect of this technology, when the thrombectomy device 564 and the captured thrombus T are retracted through the funnel 120, the funnel 120 can capture / hold any of the thrombus T that would be released from the thrombectomy device 564 as the thrombectomy device 564 is compressed into the inner shaft 104. Thus, the funnel 120 can prevent any portion of the thrombus T from moving upstream where they could potentially form an embolus. In some embodiments, a vacuum (e.g., a pre-filled vacuum) can be applied to the inner shaft 104 at any point during the retraction of the thrombectomy device 564 (e.g., via a syringe connected to a syringe connector 116 shown in Figure 1). In some embodiments, the application of a vacuum can generate instantaneous or near-instantaneous suction in the distal portion 109b of the inner shaft 104, which can draw any remaining portion of the thrombus T into and / or through the inner shaft 104.

[0036] Referring now to Figure 6, in some embodiments, the thrombus T (not shown in Figure 6; for example, located below the iliac or femoral vein) may be accessed through an internal jugular vein access site 670, and the funnel catheter assembly 100 may be inserted into the patient's body via the internal jugular vein access site 670. The funnel catheter assembly 100 may extend from the internal jugular vein access site 670 to a deployment position 672 in which the funnel 120 (or funnel 420) can be deployed proximal to the thrombus T. In the illustrated embodiment, the lateral shaft 102 and the medial shaft 104 (hidden in Figure 6) extend from the internal jugular vein access site 670 through the superior and inferior vena cava to a deployment position 672 in one of the common iliac veins. In some embodiments, the deployment position 672 may be located, for example, in one of the inferior vena cava, one of the iliac veins, the femoral vein, the popliteal vein, anterior to or beyond the iliac arch, or any other location close to and / or proximal to the thrombus T. In some embodiments, the thrombectomy device 564 can be inserted through a funnel catheter assembly 100 to capture a thrombus T, as described in detail above with reference to Figure 5, and withdrawn through the thrombus T.

[0037] In one aspect of this technology, the funnel 120 can be positioned downstream of the thrombus T by accessing it via the internal jugular vein access site 670. Thus, the funnel 120 can capture any thrombus T that may become detached during the operation of the thrombectomy device 564 and be carried downstream toward the heart. In another aspect of this technology, the funnel 120 can be compressed by moving the actuator 134 from a second position to a first position, for example, as described in detail above with reference to Figures 1 to 4, before withdrawing the funnel catheter assembly 100 at the end of the thrombectomy procedure. This prevents the funnel 120 from being withdrawn in an expanded configuration through the patient's heart (e.g., through the right atrium), which could potentially damage the heart.

[0038] Referring now to Figure 7, in some embodiments, the thrombus T may be accessed by the thrombectomy device 564 through the popliteal access site 560 using a separate introducer assembly 774, while the funnel catheter assembly 100 may be inserted into the patient's body through the internal jugular vein access site 670 (Figure 6). The funnel 120 can be expanded in the deployed position 672 during the thrombectomy procedure using the thrombectomy device 564. Thus, the funnel 120 can capture any thrombotic material T that may detach and flow downstream during the procedure. In the illustrated embodiment, the thrombectomy device 564 is inserted through the outer shaft 776 of the introducer assembly 774. In one aspect of the art, compared to using the funnel catheter assembly 100 as an introducer for the thrombectomy device 564, the outer shaft 776 can be made relatively larger than the inner shaft 104 because it is not necessary to position the outer shaft 102 around it to restrain the funnel 120. This allows the thrombectomy device 564 to be made larger and / or to generate greater suction force through the outer shaft 776.

[0039] Referring next to Figure 8, in some embodiments, the thrombus T may be accessed by a thrombectomy device 564 through a popliteal access site 560 using an introducer assembly 774, while a funnel catheter assembly 100 may be inserted into the patient's body through a femoral access site 880. The funnel catheter assembly 100 can traverse the common iliac vein to an deployment position 672 or another preferred deployment position.

[0040] In other embodiments, the funnel catheter assembly 100 may be inserted into the patient's body via other venous or arterial access sites and may be used in a multitude of different procedures. For example, further applications of the funnel catheter assembly 100 include, but are not limited to, the following: Internal jugular (IJ) access for deployment into the inferior vena cava (IVC) for the treatment of deep vein thrombosis (DVT) in the lower extremities; IJ access for in-IVC deployment for removal of IVC filters and / or treatment of thrombi located within the IVC; IJ access for deploying into deep veins of the lower extremity (such as the iliac vein, femoral vein, and popliteal vein) for the treatment of lower extremity deep vein thrombosis (DVT); Common femoral vein (CFV) access for deployment within the superior vena cava (SVC) for the treatment of upper extremity DVT and / or SVC thrombosis; CFV access for deployment to upper extremity veins (brachiocephalic artery, subclavian artery, axillary vein, etc.) for the treatment of upper extremity DVT and / or SVC thrombosis; CFV access for deployment into the pulmonary artery (PA) for the treatment of pulmonary embolism; CFV access with transseptal access for deployment within the left atrial orifice and left atrial appendage (LAA) for thrombus removal; Internal carotid artery (ICA) access for deployment into the common carotid artery (CCA) for carotid endarterectomy (CEA); ICA access for deployment to the descending thoracic aorta for the treatment of thoracoabdominal and / or abdominal aortic (AA) thrombosis and / or aortic thrombosis; ICA access for deployment to the descending aorta / thoracic aorta for the treatment of renal thrombosis; ICA access for intra-arterial placement for the treatment of superior mesenteric artery (SMA) thrombosis (MAT); Common femoral artery (CFA) access for the treatment of atherosclerosis in the brachial artery, radial artery, popliteal artery, or dorsalis pedis artery; CFA access for deployment within the common iliac artery for the treatment of aortic thrombosis and / or occlusion; CFA access for deployment within the abdominal aorta for the treatment of renal artery thrombosis; and / or CFA access for deployment into the aorta for the treatment of thoracoabdominal and / or AA thrombosis and / or aortic thrombosis.

[0041] Figures 9A and 9B are enlarged partial transmissive side view and side cross-sectional view, respectively, of a portion of a funnel catheter assembly 900 according to an additional embodiment of the present technology. Referring together to Figures 9A and 9B, the funnel catheter assembly 900 may include several features that are at least generally similar in structure and function to, or identical in structure and function to, the corresponding features of the funnel catheter assembly 100 described in detail above with reference to Figures 1 to 8, and may operate in a generally similar or identical manner to the funnel catheter assembly 100. In the illustrated embodiment, for example, the funnel catheter assembly 900 includes a sealable hub 110, a connecting tube 114, a suction port 112, an outer shaft 102, and an inner shaft 104 (not clearly visible in Figure 9A). The funnel catheter assembly 900 further includes a housing 932 and a control assembly 930 including an actuating member 934 having a pair of gripping members 938. As shown in Figure 9B, the actuator 934 includes a hub 936 located within the housing 932 and connected to the outer shaft 102 (e.g., the proximal portion 107a of the outer shaft 102). The actuator 934 is movable (e.g., slidable) relative to the housing 932 to advance / retract the outer shaft 102 relative to the inner shaft 104 and a funnel attached to its distal portion (e.g., the funnel 120 shown in Figures 10B and 10C).

[0042] The funnel catheter assembly 900 is in a first covered position in Figure 9A, where the funnel is constrained by the outer shaft 102, and a second exposed position in Figure 9B, where the funnel is not constrained by the outer shaft 102. Referring to Figure 9A, in some embodiments, the housing 932 may include markings 931 indicating the position of the actuator 934 when the funnel is in the exposed position. In some embodiments, the proximal portion 933a of the housing 932 may include gripping features such as grooves 935, cross-hatch patterns 937, and / or other features to increase the gripping capacity of the housing 932. In some embodiments, an operator may grip the housing 932 (e.g., via grooves 935 and / or patterns 937) while (i) moving the actuator 934 relative to the housing 932, and / or (ii) moving the housing 932 relative to the actuator 934. In some embodiments, the funnel catheter assembly 900 may further include a locking mechanism 911 that can be attached to the sealable hub 110 (for example, to its button) to lock the sealable hub 110 in an open / exposed position.

[0043] In the illustrated embodiment, the funnel catheter assembly 900 further includes a sealable hub 110, a connecting tube 114, and a rotatable side port 950 that fluidly connects the inner shaft 104. Figure 9C 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 art. Referring to Figure 9C, the side port 950 defines a lumen 952 that provides a fluid path from the inner shaft 104 to the sealable hub 110. In the illustrated embodiment, the side port 950 includes a first groove 954 and a second groove 956, each extending circumferentially around the outer surface of the side port 950. The sealable hub 110 includes a first projection 964 located within the first groove 954, and the housing 932 includes a second projection 966 located within the second groove 956. The engagement of the first and second projections 964, 966 within the first and second grooves 954, 956 connects the housing 932 to the sealable hub 110. Furthermore, the first and second projections 964, 966 are rotatable within the first and second grooves 954, 956, so that the sealable hub 110, the side port 114, and the housing 932 can rotate independently of each other while remaining connected to one another.

[0044] In some embodiments, the control assembly 930 may further include a connector 958 connected to the proximal portion 109a of the inner shaft 104 and at least partially positioned between the side port 950 and the housing 932. The connector 958 may be rotatable within the housing 932 so that the housing 932 can rotate independently of the connector 958 and the inner shaft 104. Thus, in some embodiments of the art, rotation of the sealable hub 110, the side port 950 (e.g., the suction port 112 shown in Figures 9B and 9C), and / or the housing 932 does not substantially rotate the inner shaft 104. This can help prevent the funnel attached to the inner shaft 104 from rotating in the blood vessel during a procedure using the funnel catheter assembly 900, while still allowing movement of the other components of the sealable hub 110, the side port 950, and / or the funnel catheter assembly 900.

[0045] Figures 10A to 10C are side views of the funnel catheter assembly 900 in a covered position, a partially exposed or intermediate position, and an exposed position according to embodiments of the Art. Referring together to Figures 10A to 10C, the funnel catheter assembly 900 can be moved between the covered position and the exposed position by moving the actuator 934 relative to the housing 932, and / or by moving the housing 932 (and the connected sealable hub 110) relative to the actuator 934. In some embodiments, for example, the operator can slide the actuator 134 relative to the housing 932 in the direction indicated by arrow P in Figure 10B to retract the outer shaft 102 and expose the funnel 120. In some aspects of the Art, moving the actuator 934 rather than the housing 932 moves only the outer shaft 102 so that the funnel 120 remains in a constant or nearly constant position (e.g., a stationary position). In other embodiments, the operator can advance the housing 932 relative to the actuator 934 in the direction indicated by arrow D in Figure 10A to expose the funnel 120. In some aspects of the art, moving the housing 932 relative to the actuator 934 advances the inner shaft 104 and the funnel 120 distally relative to the outer shaft 102.

[0046] In the exposed position shown in Figure 10C, the actuator 934 may be positioned adjacent to or near the marking 931 to indicate to the operator that the funnel 120 is deployed. In some embodiments, to re-cover the funnel 120 (for example, from the exposed position shown in Figure 10C to the covered position shown in Figure 10A), the operator can retract the housing 932 relative to the actuator 934 (for example, in the direction of arrow P) to retract the funnel 120 into the outer shaft 102. In some aspects of the art, such a retraction motion can be intuitive to the user because the movement of the housing 932 is in the same direction as the removal / crushing of the funnel 120. Nevertheless, in other embodiments, the operator can re-cover the funnel 120 into the outer shaft 102 by advancing the actuator 934 relative to the housing 932.

[0047] Figure 11 is a flowchart of a process or method 1110 for operating funnel catheter assemblies 100 and / or 900 (collectively referred to as “Funnel Catheter Assembly”) during an intravascular procedure, according to embodiments of the present technology. While some features of method 1110 are described in the context of the embodiments shown in Figures 1 to 10C for illustrative purposes, those skilled in the art will readily understand that method 1110 can be performed using other suitable systems and / or devices described herein.

[0048] In block 1111, method 1110 includes inserting a funnel catheter assembly into the patient's body via a vascular site. For example, the dilator 350, outer shaft 102, and inner shaft 104 can be inserted together through a venous or arterial access site.

[0049] In block 1112, method 1110 includes advancing a funnel catheter assembly to a deployment position within the patient's vascular structure. For example, the dilator 350, outer shaft 102, and inner shaft 104 can be advanced together through the vascular structure to a selected deployment position. The funnel catheter assembly can be advanced to a first position such that the funnel 120 is confined / compressed within the outer shaft 102. The deployment position can be a portion of a blood vessel, a portion of the heart, or another preferred location.

[0050] In block 1113, method 1110 includes expanding the funnel 120 to the deployed position. For example, the control assembly 130 of the funnel catheter assembly 100 can be moved from a first position to a second position to release / expose the funnel 120 from within the outer shaft 102, thereby allowing the funnel 120 to expand to the deployed position. Similarly, the actuarial member 934 can be slid against the housing 932 to expose the funnel 120. After expansion, the funnel 120 can be juxtaposed with / in contact with anatomical structures surrounding the deployed position, such as a blood vessel wall. In some embodiments, the expander 350 can be removed from the funnel catheter assembly before expanding the funnel 120.

[0051] In block 1114, method 1110 optionally includes compressing and repositioning the funnel 120. For example, the control assembly 130 can be moved from a second position to a first position to restrain / cover the funnel 120 within the outer shaft 102. Similarly, the housing 932 of the funnel catheter assembly 900 can be retracted proximal to the actuarial member (and / or the actuarial member 934 can be advanced distal to the housing) to cover the funnel 120. The funnel catheter assembly can then be repositioned to a different deployment position (block 1112) and expanded again (block 1113). In some embodiments, the expander 350 can be reinserted into the funnel catheter assembly 100 before the funnel catheter assembly 100 is repositioned.

[0052] In block 1115, method 1110 includes maintaining the funnel 120 in an expanded position during the endovascular procedure. As described in detail above, the funnel 120 can capture any thrombus released during the endovascular procedure to prevent embolus formation elsewhere in the patient's vascular structure.

[0053] In block 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 can be moved from a second position to a first position to restrain / cover the funnel 120 within the outer shaft 102, and the funnel catheter assembly 100 can then be withdrawn proximal to and from the vascular access site. Similarly, the housing 932 of the funnel catheter assembly 900 can be retracted proximal to the actuarial member (and / or the actuarial member 934 can be advanced distal to the housing) to cover the funnel 120.

[0054] Examples Several aspects of this technology are described in the following examples. 1. A funnel catheter assembly, The outer shaft defines the lumen, An internal shaft extending through the lumen and having a proximal and distal portion, An expandable funnel connected to the distal portion of the internal shaft, A control assembly configured to move a funnel between a first position and a second position, In the first position, the funnel is confined within the lumen of the outer shaft. In a second position, the funnel catheter assembly is positioned at least partially outside the lumen of the outer shaft so that the funnel can expand. 2. The funnel catheter assembly according to Embodiment 1, wherein the control assembly is connected to the outer shaft and configured to move the outer shaft relative to the inner shaft. 3. A funnel catheter assembly according to Example 1 or Example 2, wherein the control assembly includes an actuator that is movable to move the funnel between a first position and a second position. 4. The funnel catheter assembly according to Example 3, wherein the actuator is a slider. 5. A funnel catheter assembly according to any one of Examples 2 to 4, wherein the funnel includes a proximal portion and a distal portion, and the proximal portion of the funnel is connected to the distal portion of an internal shaft. 6. The funnel catheter according to Example 5, wherein the distal portion of the funnel is connected to an outer shaft. 7. A funnel catheter assembly according to any one of Examples 1 to 6, further comprising a sealable hub and a side port, wherein the side port is rotatably connected between a control assembly and the sealable hub. 8. Funnel catheter assembly, The outer shaft defines the outer lumen, An internal shaft extending through the outer lumen and having a proximal and distal portion, An expandable funnel connected to the distal portion of the internal shaft, The system comprises a control assembly operably connected 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 positioned at least partially on the funnel so as to constrain the funnel radially. In a second position, the outer shaft is retracted proximal to the funnel, in a funnel catheter assembly, so that the funnel can expand radially. 9. The funnel catheter assembly according to Embodiment 8, wherein the control assembly includes a housing and an actuating member, the actuating member being connected to the proximal portion of an outer shaft, and the actuating member being slidable along the housing to move the outer shaft between a first position and a second position. 10. A funnel catheter assembly according to Example 8 or Example 9, wherein the funnel is configured to self-expand. 11. The funnel catheter assembly according to Example 8 or Example 9, wherein the funnel is non-self-expanding, and the funnel is further connected to the distal portion of the outer shaft, and the movement of the outer shaft from a first position to a second position is configured to expand the funnel. 12. The funnel catheter assembly according to Example 11, wherein the distal portion of the funnel is connected to the distal portion of the outer shaft via one or more tethers. 13. A funnel catheter assembly according to any one of Examples 8 to 12, wherein the inner shaft defines an inner lumen sized to receive a dilator. 14. A method for manipulating a funnel catheter assembly during an endovascular procedure on a patient, wherein the method is Inserting the inner shaft, outer shaft, and funnel of the funnel catheter assembly at least partially into the patient's vascular structure, The process involves advancing the inner shaft, outer shaft, and funnel together to their deployment position within the patient's vascular structure, wherein the funnel is covered within the lumen of the outer shaft during advancement. In order to expose the funnel and allow the funnel to expand to its expanded position, the outer shaft is moved relative to the inner shaft, Maintaining the funnel in an expanded position for at least part of the endovascular procedure, To cover the lumen of the outer shaft with the funnel, the outer shaft is moved relative to the inner shaft and / or the inner shaft is moved relative to the outer shaft, A method comprising withdrawing a funnel catheter assembly from a patient. 15. The method of Example 14, wherein the funnel is self-expandable, and moving the outer shaft relative to the inner shaft to expose the funnel allows the funnel to self-expand to an expanded position. 16. The method according to Example 14 or Example 15, wherein moving the outer shaft relative to the inner shaft to expose the funnel includes moving a slider of the control assembly of the funnel catheter assembly from a first position to a second position, the slider being connected to the proximal portion of the outer shaft. 17. The method according to any one of Examples 14 to 16, wherein moving the outer shaft relative to the inner shaft to expose the funnel includes rotating a rotatable element of the control assembly of the funnel catheter assembly from a first position to a second position. 18. The method according to any one of Examples 14, 16, and 17, wherein the funnel is non-self-expanding, and the method further comprises acting on the funnel to expand it to an expanded position. 19. Inserting the inner shaft, outer shaft, and funnel into the patient's vascular structure further includes at least partially inserting the dilator positioned within the inner shaft into the patient's vascular structure. The method according to any one of Examples 14 to 18, further comprising advancing the inner shaft, outer shaft, and funnel to advance the inner shaft, outer shaft, funnel, and expander together to the deployed position. 20. The method according to any one of Examples 14 to 19, wherein moving the outer shaft relative to the inner shaft to expose the funnel includes moving the outer shaft in a first direction, and the method further includes moving the outer shaft relative to the inner shaft to cover the funnel by moving the outer shaft in a second direction opposite to the first direction.

[0055] IV. Conclusion The above detailed description of embodiments of the Art is not intended to be exhaustive or to limit the Art to the exact forms disclosed above. While specific embodiments and examples of the Art are described above for illustrative purposes, various equivalent modifications are possible within the scope of the Art, as will be apparent to those skilled in the art. For example, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. Further embodiments may be provided by combining the various embodiments described herein.

[0056] From the foregoing, it will be understood that while specific embodiments of the present technology are described herein for illustrative purposes, well-known structures and functions are not shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0057] Furthermore, unless the word “or” is explicitly limited to mean only a single item that is exclusive to the other items in a list of two or more items, the use of “or” in such a list 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. Furthermore, the term “comprising” is used throughout to mean including at least the enumerated features, so as not to exclude any more identical features and / or other features of additional types. While certain embodiments are described herein for illustrative purposes, it will be understood that various modifications can be made without departing from the Art. Furthermore, while some advantages related to certain embodiments of the Art have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments are necessarily required to exhibit such advantages in order to fall within the scope of the Art. Thus, the Disclosure and related Art may encompass other embodiments not expressly shown or described herein.

Claims

1. A funnel catheter assembly, An outer shaft that defines the outer lumen and has a proximal portion and a distal portion, An inner shaft extending through the outer lumen and having a proximal portion and a distal portion, wherein the inner shaft defines the inner lumen, An expandable funnel connected to the distal portion of the inner shaft, wherein the funnel extends distally from the distal portion of the inner shaft, A control assembly connected to the proximal portion of the outer shaft and the proximal portion of the inner shaft, the control assembly including an actuator, the actuator being operable to cause relative movement between the inner shaft and the outer shaft to move the funnel between (a) a constrained state in which the outer shaft extends over the funnel and (b) an unconstrained state in which the funnel is positioned outside the outer shaft and extends to at least partially enclose the volume, A side port connected to the control assembly, wherein the side port is fluid-connected to the inner lumen, and the side port is configured to be fluid-connected to a suction source configured to suction the inner lumen and thereby suction the volume of the funnel, and A funnel catheter assembly equipped with the following features.

2. The funnel catheter assembly according to claim 1, wherein the control assembly has a proximal portion and a distal portion, the side port has a proximal portion and a distal portion, and the distal portion of the side port is rotatably connected to the proximal portion of the control assembly.

3. The funnel catheter assembly according to claim 2, further comprising a hemostatic valve having a proximal portion and a distal portion, wherein the distal portion of the hemostatic valve is rotatably connected to the proximal portion of the side port.

4. The funnel catheter assembly according to claim 3, wherein the control assembly, the side port, and the hemostatic valve are configured to rotate independently of each other.

5. The funnel catheter assembly according to claim 3, wherein the hemostatic valve is operable to selectively provide fluid access to the inner lumen.

6. The funnel catheter assembly according to claim 3, further comprising a connector fixedly connected to the proximal portion of the inner shaft, wherein the connector is rotatably connected within the control assembly.

7. The funnel catheter assembly according to claim 6, wherein the side port, the hemostatic valve, and the control assembly are configured to rotate independently of the connector and the inner shaft.

8. The side port is further provided with a first groove in the proximal portion of the side port and a second groove in the distal portion of the side port. The first groove and the second groove extend circumferentially around the outer surface of the side port, The distal portion of the hemostatic valve is provided with a first projection positioned within the first groove, The funnel catheter assembly according to claim 3, wherein the proximal portion of the control assembly further comprises a second projection disposed within the second groove.

9. The funnel catheter assembly according to claim 8, wherein the first projection is constrained to rotate circumferentially within the first groove, and the second projection is constrained to rotate circumferentially within the second groove.

10. The funnel catheter assembly according to claim 8, wherein the hemostatic valve, the side port, and the control assembly remain connected to each other and rotate independently of each other.

11. The side port defines a first lumen extending between the proximal portion of the side port and the distal portion of the side port. The first lumen is fluidly connected to the inner lumen, The side port further includes a side port connector between the proximal portion of the side port and the distal portion of the side port. The side port connector defines a second lumen, the second lumen branches off from the first lumen and is fluidly connected to the inner lumen via the first lumen. The funnel catheter assembly according to claim 2, wherein the second lumen is configured to be fluidly connected to the suction source.

12. The funnel catheter assembly according to claim 11, further comprising a hemostatic valve having a proximal portion and a distal portion, wherein the distal portion of the hemostatic valve is rotatably connected to the proximal portion of the side port.

13. A suction tube connected to the side port connector and fluid-connected to the second lumen, The aforementioned suction source, A fluid control device fluid-connected along the suction tube and Furthermore, The funnel catheter assembly according to claim 11, wherein the suction source is fluidly connected to the suction tube, and the fluid control device is operable to selectively fluidize the suction source to the inner lumen via the first lumen and the second lumen.

14. The funnel catheter assembly according to claim 1, wherein the funnel is configured to self-expand in the unrestrained state.

15. The funnel catheter assembly according to claim 1, wherein the funnel is non-self-expanding, and the movement of the actuator that moves the funnel between the constrained state and the unconstrained state mechanically expands the funnel.

16. The funnel catheter assembly according to claim 1, further comprising one or more tethers extending between the funnel and the distal portion of the outer shaft, wherein the movement of the actuator that moves the funnel between the constrained state and the unconstrained state mechanically expands the funnel by pulling the one or more tethers.

17. The funnel catheter assembly according to claim 1, wherein the control assembly extends along the longitudinal axis, and the proximal portion of the inner shaft is fixedly connected to the control assembly with respect to the longitudinal axis.

18. The funnel catheter assembly according to claim 1, wherein the actuator is a slider.

19. The funnel catheter assembly according to claim 1, wherein the actuator is fixedly connected to the outer shaft and is operable to move the outer shaft relative to the inner shaft.

20. The funnel catheter assembly according to claim 19, wherein the control assembly extends along the longitudinal axis, and the proximal portion of the inner shaft is fixedly connected to the control assembly with respect to the longitudinal axis.

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