Embolic protection systems and related methods

Abstract

The embolic protection system (10) includes a vascular access device (100), a vascular return device (200), a filter (300), tubing (400), and a vascular closure device (600). The vascular access device (100) is configured to percutaneously access a first vessel (20). The vascular return device (200) is configured to access a second vessel (30). The filter (300) is configured to collect emboli. The tubing (400) is configured to connect the vascular access device (100), the vascular return device (200), and the filter (300). The vascular closure device (600) is configured to percutaneously close an opening in the first vessel (20). The system is configured to direct blood flow from a first vessel (20), through a vascular access device (100), a filter (300), and a vascular return device (200), and into a second vessel (30).

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 422,345 (pending), filed November 3, 2022, and U.S. Provisional Patent Application No. 63 / 431,366 (pending), filed December 9, 2022, the disclosures of which are incorporated by reference herein in their entireties.

[0002] This application is also related to U.S. Patent Application No. 17 / 546,947 (pending), filed December 9, 2021, and U.S. Patent Application No. 17 / 546,958 (pending), filed December 9, 2021, the disclosures of which are incorporated by reference herein in their entireties.

[0003] SUMMARY OF THE INVENTION Embodiments relate generally to embolic protection devices, systems, and associated methods for directly accessing a blood vessel, providing embolic protection during treatment, and sealing punctures or other openings in a blood vessel. [Background technology]

[0004] Vascular access for neurotherapy involves the risk of stroke and other complications due to emboli (loosened arterial plaque) that may be generated during the procedure. One current method of providing embolic protection involves placing a temporary filter inside the neurovascular artery to collect emboli that may be generated, for example, during a common carotid artery (CCA) vascular stent procedure. The filter is removed at the end of the procedure or at some time after the procedure.

[0005] Another method of providing embolic protection, and a preferred technique, involves creating retrograde carotid flow (flow reversal), which directs blood from the cerebral vasculature through the internal and external carotid arteries (ICA / ECA, respectively) into the common carotid artery, where it exits the patient through an introducer sheath, allowing generated emboli (liberated arterial plaque) to flow out of the cerebral cortex and be filtered out of the bloodstream before being reintroduced into the patient via the femoral vein.

[0006] The preferred approach to embolic protection is blood flow reversal, but blood flow reversal devices currently on the market do not utilize the direct carotid artery puncture approach due to their lack of ability to percutaneously close the arterial puncture site.

[0007] Vascular access for neurotherapy is traditionally achieved through the femoral artery or using a radial access technique. For vascular access to the brain using traditional techniques, neurotherapy devices must navigate long, tortuous sections of anatomy to gain access to the treatment site. The direct carotid puncture (DCP) method of accessing the CCA allows physicians quicker access to the brain and eliminates the need for devices that must be threaded through the typical femoral interventional pathway. The DCP method involves percutaneous puncture of the skin and arterial vessels to access the CCA.

[0008] Currently, to close and seal a direct carotid artery puncture, physicians can manually apply sutures before accessing the common carotid artery, and the sutures are used to close the puncture after the procedure. Alternatively, direct pressure may be applied to the site after the intervention until the vessel seals itself. Applying direct pressure to the site relies on blood clotting at the puncture site and may be ineffective due to a lack of appropriate anatomy near the common carotid artery onto which pressure can be applied. The time period required to close the puncture with direct pressure can also be very long. The common carotid artery carries blood at high pressures (100-200 mmHg), which further complicates the ability to effectively close a carotid artery puncture with direct pressure or other current methods. While the DCP method provides physicians with faster access to the brain, current methods of arterial puncture closure pose challenges. Summary of the Invention [Problem to be solved by the invention]

[0009] Thus, despite the various advances already made in this field, there remains a need for further improvements in devices, systems, and methods for accessing blood vessels, providing embolic protection, and sealing punctures or other openings in blood vessels. [Means for solving the problem]

[0010] Generally, an embolic protection system is provided herein. The embolic protection system includes a vascular access device, a vascular return device, a filter, tubing, and a vascular closure device. The vascular access device is configured to percutaneously access a first vessel. The vascular return device is configured to access a second vessel. The filter is configured to collect emboli. The tubing is configured to connect the vascular access device, the vascular return device, and the filter. The vascular closure device is configured to percutaneously close an opening in the first vessel. The system is configured to direct blood flow from the first vessel, through the vascular access device, the filter, and the vascular return device, and into the second vessel.

[0011] In some embodiments, the vascular closure device can be configured to access the first vessel through the vascular access device. The system can include a flow control device configured to be tubing-coupled to the vascular access device, the vascular return device, and the filter, and configured to control blood flow from the first vessel to the second vessel.

[0012] In some embodiments, the vascular access device may include a vascular sealing portion configured to at least partially seal the vascular access device against the inside of the first vessel when actuated. The vascular sealing portion may include an expandable element, and actuating the vascular sealing portion may include expanding the expandable element of the vascular sealing portion to at least partially seal the vascular access device against the inside of the first vessel. In alternative embodiments, the expandable element may include a balloon, and inflating the balloon may at least partially seal the vascular access device against the inside of the first vessel. In other embodiments, the vascular sealing portion may include a compliant material, and actuating the vascular sealing portion may include compressing the compliant material to radially expand the compliant material to at least partially seal the vascular access device against the inside of the first vessel. The vascular sealing portion may include a preformed structure, and actuating the vascular sealing portion may radially expand the preformed structure to at least partially seal the vascular access device against the inside of the first vessel. The preformed structure may include a wire structure. The wire structure may include at least one of a membrane or a coating at least partially covering the wire structure to prevent blood flow through the wire structure. The vascular access device may include a sealing actuator configured to activate and / or deactivate the vascular sealing portion. Axial movement of the sealing actuator may activate and / or deactivate the vascular sealing portion.

[0013] In some embodiments, the vascular access device can be an introducer sheath. The vascular return device can be an introducer sheath. The vascular access device can include a radiopaque marker. The vascular closure device can be configured to percutaneously close an opening in a second vessel. The vascular closure device can be configured to access the second vessel through the vascular return device.

[0014] An alternative embolic protection system is also disclosed. The alternative embolic protection system includes a vascular access device, a vascular return device, a filter, a flow control device, tubing, and a vascular closure device. The vascular access device is configured to percutaneously access a first vessel. The vascular access device includes a vascular sealing portion configured to at least partially seal the vascular access device against the inside of the first vessel when activated. The vascular return device is configured to access a second vessel. The filter is configured to collect emboli. The tubing is configured to connect the vascular access device, the vascular return device, the filter, and the flow control device. The vascular closure device is configured to percutaneously close an opening in the first vessel. The embolic protection system is configured to direct blood flow from the first vessel through the vascular access device, the filter, the flow control device, and the vascular return device to the second vessel. The flow control device is configured to control blood flow from the first vessel to the second vessel.

[0015] In some embodiments, the vascular closure device can be configured to access a first vessel through the vascular access device. The vascular sealing portion can include an expandable element. Actuating the vascular sealing portion can include expanding the expandable element of the vascular sealing portion to at least partially seal the vascular access device against the inside of the first vessel. The expandable portion can include a balloon, and inflating the balloon at least partially seals the vascular access device against the inside of the first vessel. The sealing portion can include a flexible material, and actuating the vascular sealing portion can include compressing the flexible material to radially expand the flexible material to at least partially seal the vascular access device against the inside of the first vessel. The sealing portion can include a preformed structure, and actuating the vascular sealing portion can radially expand the preformed structure to at least partially seal the vascular access device against the inside of the first vessel. The preformed structure can include a wire structure. The wire structure can include at least one of a membrane or a coating at least partially covering the wire structure to prevent blood flow through the wire structure. The vascular access device can include a sealing actuator configured to activate and / or deactivate the vascular sealing portion. Axial movement of the sealing actuator can activate and / or deactivate the vascular sealing portion.

[0016] In some embodiments, the vascular access device can be an introducer sheath. The vascular return device can be an introducer sheath. The vascular access device can include a radiopaque marker. The vascular closure device can be configured to percutaneously close an opening in a second vessel. The vascular closure device can be configured to access the second vessel through the vascular return device.

[0017] A method for providing embolic protection is provided herein. The method for providing embolic protection includes percutaneously accessing a first vessel with a vascular access device, accessing a second vessel with a vascular return device, and connecting a filter and tubing to the vascular access device and the vascular return device. The method includes establishing blood flow from the first vessel through the vascular access device, the filter, and the vascular return device to the second vessel. The method also includes percutaneously closing an opening in the first vessel.

[0018] A method for providing embolic protection may include coupling a flow control device to tubing, directing blood flow through the flow control device, and controlling blood flow from a first vessel to a second vessel with the flow control device. The first vessel may be a carotid artery. The second vessel may be a femoral vein. Accessing the second vessel may include percutaneously accessing the second vessel with a vascular return device. The method may include percutaneously closing an opening in the second vessel. The method may include at least partially sealing the vascular access device against the inside of the first vessel. At least partially sealing the vascular access device against the inside of the first vessel may include expanding a vascular sealing portion of the vascular access device. The vascular sealing portion of the vascular access device may include a balloon, and the method may include inflating the balloon. At least partially sealing the vascular access device against the inside of the first vessel may include compressing a flexible material of the vascular sealing portion of the vascular access device to radially expand the flexible material. At least partially sealing the vascular access device against the inside of the first vessel may include actuating a preformed structure of a sealing portion of the vascular access device to radially expand the preformed structure. At least partially sealing the vascular access device against the inside of the first vessel may include activating and / or deactivating the vascular sealing portion of the vascular access device with a sealing actuator. The method may include axially moving the sealing actuator to activate and / or deactivate the vascular sealing portion. [Brief explanation of the drawings]

[0019] [Figure 1] 1 is a schematic diagram of an exemplary embolic protection system. [Figure 2] 2 is a side view of an exemplary vascular access device of the embolic protection system of FIG. 1. [Figure 2A] 3 is a cross-sectional view of the vascular access device of FIG. 2. [Figure 2B]3 is a side view of the vascular access device of FIG. 2 with the vascular sealing portion activated. [Figure 3] 2 is a side view of an exemplary vascular return device of the embolic protection system of FIG. 1. [Figure 3A] FIG. 4 is a cross-sectional view of the vascular return device of FIG. 3. [Figure 4] 2 is a side view of an exemplary filter, flow control device, and three-way valve of the embolic protection system of FIG. 1. [Figure 5A] 3 is a diagram of the vascular access device of FIG. 2 percutaneously inserted into a blood vessel. [Figure 5B] 3 is a diagram of the vascular access device of FIG. 2 at least partially sealed against the inside of a blood vessel. [Figure 6] 4 is a diagram of the vascular retrieval device of FIG. 3 inserted percutaneously into a blood vessel. [Figure 7A] 10A-10C are cross-sectional views of alternative exemplary vascular access devices. [Figure 7B] 10A-10C are cross-sectional views of alternative exemplary vascular access devices. [Figure 8A] 10A-10C are cross-sectional views of another exemplary vascular access device. [Figure 8B] 10A-10C are cross-sectional views of another exemplary vascular access device. [Figure 9] FIG. 1 is a schematic diagram of an alternative exemplary embolic protection system. [Figure 10A] 10A-10C are cross-sectional views of alternative exemplary vascular access devices. [Figure 10B] 10B is a cross-sectional view of the vascular access device of FIG. 10A. [Figure 11] FIG. 10B is a diagram of the vascular access device of FIG. 10A inserted percutaneously into a blood vessel. [Figure 12] 1 is a perspective view of an exemplary vascular closure device. [Figure 13A] 13 is a perspective view of a suturing mechanism at the distal end of the vascular closure device of FIG. 12. [Figure 13B] 13 is a perspective view of a suturing mechanism at the distal end of the vascular closure device of FIG. 12. [Figure 13C]13 is a perspective view of a suturing mechanism at the distal end of the vascular closure device of FIG. 12. [Figure 14] 13 is a diagram of the vascular closure device of FIG. 12 inserted through the vascular access device of FIG. 2. [Figure 15A] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15B] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15C] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15D] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15E] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15F] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15G] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15H] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15I] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 15J] 13A-13C are a series of progressive side views of the distal end of the vascular closure device of FIG. 12 during a suturing procedure. [Figure 16] 10 is a perspective view of an alternative exemplary vascular closure device. [Figure 17] 17 is an exploded cross-sectional view of the handle of the vascular closure device of FIG. 16. [Figure 18A] FIG. 17 is a perspective view of a suturing mechanism at the distal end of the vascular closure device of FIG. 16. [Figure 18B] FIG. 17 is a perspective view of a suturing mechanism at the distal end of the vascular closure device of FIG. 16. [Figure 18C]FIG. 17 is a perspective view of a suturing mechanism at the distal end of the vascular closure device of FIG. 16. [Figure 19A] FIG. 17 is a top view of the handle of the vascular closure device of FIG. 16. [Figure 19B] 17 is a cross-sectional view of the suturing mechanism of the vascular closure device of FIG. 16. [Figure 20A] FIG. 17 is a top view of the handle of the vascular closure device of FIG. 16. [Figure 20B] 17 is a cross-sectional view of the suturing mechanism of the vascular closure device of FIG. 16. [Figure 21A] 17 is a cross-sectional view of the handle of the vascular closure device of FIG. 16. [Figure 21B] 17 is a cross-sectional view of the suturing mechanism of the vascular closure device of FIG. 16. [Figure 22A] 17 is a cross-sectional view of the handle of the vascular closure device of FIG. 16. [Figure 22B] 17 is a cross-sectional view of the suturing mechanism of the vascular closure device of FIG. 16. [Figure 23A] 17 is a cross-sectional view of the handle of the vascular closure device of FIG. 16. [Figure 23B] 17 is a cross-sectional view of the suturing mechanism of the vascular closure device of FIG. 16. [Figure 24A] 17 is a cross-sectional view of the handle of the vascular closure device of FIG. 16. [Figure 24B] 17 is a cross-sectional view of the suturing mechanism of the vascular closure device of FIG. 16. [Figure 25] FIG. 17 is a perspective view of a handle of the vascular closure device of FIG. 16. [Figure 26A] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26B] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26C] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26D] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26E]17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26F] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26G] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26H] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26I] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 26J] 17A-17C are a series of progressive side views of the distal end of the vascular closure device of FIG. 16 during a suturing procedure. [Figure 27] FIG. 10 is a top view of an alternative exemplary vascular closure device handle. [Figure 28] FIG. 10 is a top view of another exemplary vascular closure device handle. DETAILED DESCRIPTION OF THE INVENTION

[0020] The present disclosure generally relates to devices, systems, and methods for accessing blood vessels, providing embolic protection, and sealing punctures or other openings in blood vessels. Embolic protection devices and / or systems are described herein. The embolic protection system is described as directly accessing the common carotid artery (CCA), but may also be used to access other blood vessels. The embolic protection system provides embolic protection during neurovascular therapy (neurotherapy), such as transcarotid artery revascularization (TCAR). The system also includes a suturing device for percutaneously sealing openings in blood vessels, such as the carotid artery or femoral vein. The devices, systems, and methods may also be used in the course of other medical or surgical procedures.

[0021] The direct carotid puncture (DCP), blood flow reversal, and closure system disclosed herein is intended for use as an embolic protection device that can directly access, for example, the common carotid artery and provide embolic protection by allowing retrograde blood flow from the common carotid artery to the femoral vein during neurovascular (neuro) procedures such as TCAR.

[0022] FIG. 1 is a schematic of an exemplary embolic protection system 10. In this illustrative example, when used with a patient 12, the embolic protection system 10 allows retrograde blood flow from the patient's common carotid artery 20 to the patient's femoral vein 30, in the direction of blood flow indicated by arrow 14. In this exemplary embodiment, the embolic protection system 10 includes a vascular access device 100, a vascular return device 200, a filter 300, tubing 400, a flow control device 500, a three-way valve 550, and a vascular closure device 600, seen in FIG. 12. As used herein, the terms "vessel," "blood vessel," "artery," "vein," and similar forms refer to any portion of the circulatory system that transports blood through the human body.

[0023] Figure 2 is a side view of an exemplary vascular access device 100. Figure 2A is a cross-sectional view detailing the structure of vascular access device 100. In this exemplary embodiment, vascular access device 100 is an introducer sheath configured to percutaneously access a blood vessel, such as a carotid artery. Vascular access device 100 has a proximal end portion 102, a distal end portion 104, a hub 110, a sheath 140, and a vascular sealing portion 160.

[0024] As used herein to describe various embodiments from the perspective of a surgical device user, "proximal" can refer to a direction generally toward the device user, while "distal" can refer to a direction generally away from the device user. Similarly, in the context of a surgical device being inserted into a patient's body from the perspective of the device user, "proximal" can refer to a direction generally away from the patient's body, and "distal" can refer to a direction generally toward the patient's body. For reference, arrow 106 points generally proximally, and arrow 108 points generally distally.

[0025] The hub 110 comprises a body 112, a side port 114, an inflation port 116, a rear hub body 118, a central lumen 120, a front hub body 122, a strain relief 124, an expansion seal 126, a compression washer 128, and a locking portion 130. The exterior surface of the hub 110 may include indentations or other surface features to improve the ergonomics of the hub 110. The side port 114 may be used to flush air from the vascular access device 100, for example, at the beginning of a procedure. In this embodiment, the side port 114 serves as a conduit for retrograde blood flow during embolic protection, as described herein.

[0026] 2 and 2A , the expansion seal 126 is designed to seal blood flow without the need for an external valve, such as a Tuohy Borst valve. A user can access the central lumen 120 at the proximal end portion 102 of the hub 110, for example, with guidewires, dilators, and other interventional devices, through the expansion seal 126 without concern for backflow and bleeding. The expansion seal 126 remains in a closed position when a device, such as a dilator, is not passing through the central lumen 120. A locking feature 130 positioned on the rear hub body 118 can lock a device, such as a dilator, to the hub 110 before or during a procedure, such as a vasodilation. The locking feature 130 can easily remove a device, such as a dilator, from the vascular access device 100 when the procedure is complete.

[0027] The sheath 140 has a distal end portion 142 and a proximal end portion 144. The proximal end portion 144 of the sheath 140 passes through the strain relief 124 and is coupled to the hub 110. The sheath 140 also includes an outer jacket 146, an inner liner 148, a reinforcement portion 150, a central lumen 152, an inflation lumen 154, one or more radiopaque markers 156, and a vascular sealing portion. In this exemplary embodiment, the inner liner 148 provides a smooth surface for an interventional device to slide within. The reinforcement portion 150 includes cross-wrapped fibers and / or wires. The cross-wrapped fibers and / or wires of the reinforcement portion 150 provide flexibility and kink resistance to the sheath 140 while maintaining the tensile strength of the sheath 140. The sheath 140 needs to be flexible yet resistant to kinking, for example, during procedures that require advancing the vascular access device 100 through tissue during the procedure. A hydrophilic coating may be applied to the exterior surface of the sheath to reduce friction during insertion and removal procedures. A central lumen 152 extends from the distal end portion 142 to the proximal end portion 144 of the sheath 140 and is aligned with the central lumen 120 of the hub 110. A radiopaque marker 156 is positioned in the distal end portion 142 of the sheath 140. The radiopaque marker 156 is used in conjunction with a medical imaging device during the procedure to assist the user in guiding the distal end portion 142 of the sheath 140 to a desired location within the blood vessel. The radiopaque marker 156 may also be positioned elsewhere in the sheath 140.

[0028] FIG. 2B is a perspective view of an exemplary vascular access device 100 showing the vascular sealing portion 160 being actuated. Referring to FIGS. 2, 2A, and 2B, the vascular access device 100 has a vascular sealing portion 160 positioned at the distal end portion 142 of the sheath 140. The vascular sealing portion 160 is configured to at least partially seal the distal end portion 142 of the sheath 140 against the inside of the blood vessel when actuated. In the illustrated embodiment, the vascular sealing portion 160 comprises an expandable element 162. Actuating the vascular sealing portion 160 includes expanding the expandable element 162 of the vascular sealing portion 160 to at least partially seal the vascular access device 100 against the inside of the blood vessel. In the illustrated embodiment, the expandable element 162 is an inflatable element including a balloon. Inflating the balloon at least partially seals the vascular access device 100 against the inside of the blood vessel.

[0029] In this exemplary embodiment, inflation lumen 154 is coupled to inflation port 116 in hub 110 and extends to and is coupled to vascular sealing portion 160 in distal end portion 142 of sheath 140. While vascular sealing portion 160 of vascular access device 100 is inside a blood vessel, a user injects fluid into inflation port 116, which flows through inflation lumen 154 and into vascular sealing portion 160, thereby expanding and / or inflating expandable portion 162, as seen in FIG. 2B , and at least partially sealing vascular access device 100 against the inside of the blood vessel. Withdrawing fluid from inflation port 116 contracts and / or deflates expandable portion 162, as seen in FIG. 2B , allowing vascular sealing portion 160 to be withdrawn from inside the blood vessel.

[0030] FIG. 3 is a perspective view of an exemplary vascular retrieval device 200. FIG. 3A is a cross-sectional view detailing the structure of the vascular retrieval device 200. In this exemplary embodiment, the vascular retrieval device 200 is an introducer sheath configured to percutaneously access a blood vessel, such as the femoral vein. The vascular retrieval device 200 has a proximal end portion 202, a distal end portion 204, a hub 210, and a sheath 240. For reference, arrow 206 points generally proximally and arrow 208 points generally distally. The hub 210 includes a body 212, a side port 214, a rear hub body 218, a central lumen 220, a front hub body 222, a strain relief 224, an expansion seal 226, and a compression washer 228. The outer surface of the hub 210 may include indentations or other surface features to improve the ergonomics of the hub 210.

[0031] The expansion seal 226 is designed to seal blood flow without the need for an external valve, such as a Tuohy Borst valve. A user can access the proximal end portion 202 of the hub 210, for example, with guidewires, dilators, and interventional devices, through the expansion seal 226 without concern for backflow and bleeding. The expansion seal 226 remains in a closed position when a device, such as a dilator, is not passing through the central lumen 220. The rear hub body 218 includes a locking portion 230 that locks a device, such as a dilator, to the hub 210 before or during a procedure, such as vasodilation. The locking portion 230 allows a device, such as a dilator, to be easily removed from the vascular retrieval device 200 when the procedure is complete. The side port 214 can be used to flush air from the vascular retrieval device 200 at the beginning of a procedure. The side port 214 serves as a conduit for retrograde blood flow during embolic protection, as described herein.

[0032] Sheath 240 has a distal end portion 242 and a proximal end portion 244. Proximal end portion 244 of sheath 240 passes through strain relief 224 and is coupled to hub 210. Sheath 240 also includes an outer jacket 246, an inner liner 248, a reinforcement portion 250, a central lumen 252, and one or more radiopaque markers 256. In the illustrated embodiment, reinforcement portion 250 comprises cross-wrapped fibers and / or wires that provide flexibility and kink resistance to sheath 240 while maintaining the tensile strength of sheath 240. Sheath 240 needs to be flexible yet resistant to kink, for example, during procedures that require advancement of vascular retrieval device 200 through tissue during the procedure. A central lumen 252 extends from the distal end portion 242 to the proximal end portion 244 of the sheath 240 and is aligned with the central lumen 220 of the hub 210. A radiopaque marker 256 is positioned in the distal end portion 242 of the sheath 240. The radiopaque marker 256 is used during the procedure in conjunction with a medical imaging device to assist the user in guiding the distal end portion 242 of the sheath 240 to the desired location within the blood vessel. The radiopaque marker 256 may also be positioned elsewhere in the sheath 240.

[0033] 4 is a side view of an exemplary filter 300, flow control device 500, and three-way valve 550 of the embolic protection system 10. In this exemplary embodiment, the filter 300 is configured to filter blood and collect emboli (plaque) generated during a procedure, such as a neurovascular procedure. The filter 300 has a filter element 302, an inlet 304, and an outlet 306. The filter element 302 is configured to filter blood and collect emboli to provide embolic protection while allowing sufficient blood flow during the procedure. When the filter 300 is in use, blood flows into the filter 300 through the inlet 304, through the filter element 302, and out through the outlet 306, as indicated by arrows 14.

[0034] In this exemplary embodiment, flow control device 500 has an inlet 502 and an outlet 504. As indicated by arrows 14, when flow control device 500 is in use, blood flows into flow control device 500 through inlet 502, through flow control device 500, and out through outlet 504. Flow control device 500 is configured to control the flow of blood. In some embodiments, flow control device 500 may be adjustable, for example, by a user, although in alternative embodiments, flow control device 500 may automatically adjust blood flow. In alternative embodiments, flow control device 500 may be used, for example, to reduce blood flow during a procedure. In some embodiments, flow control device 500 may be used to start or stop blood flow, such as, for example, at the beginning and / or end of a procedure. In some embodiments, flow control device 500 may be a stopcock valve (two-way or three-way), although in alternative embodiments, flow control device 500 may be other types of valves and / or flow restrictors. In some embodiments, the flow control device 500 may be proximally coupled to the filter 300, while in other embodiments the flow control device 500 may be integral with the filter 300, for example, as part of a filter assembly.

[0035] In this exemplary embodiment, three-way valve 550 has an inlet 552, an outlet 554, and an access port 556. When three-way valve 550 is in use, blood flows into three-way valve 550 through inlet 552, through three-way valve 550, and out through outlet 554, as indicated by arrows 14. Three-way valve 550 is configured to provide a user with access port 556 for injecting saline or contrast into the patient at the beginning or during a procedure. Three-way valve 550 also allows for the removal of air from embolism protection system 10 at the beginning of a procedure, such as a retrograde blood flow procedure. In some embodiments, three-way valve 550 can be combined with filter 300 and / or flow control device 500.

[0036] 1-4 , in this exemplary embodiment, tubing 400 connects vascular access device 100, vascular return device 200, filter 300, three-way valve 550, and flow control device 500. As shown by arrow 14, tubing 400 is configured to direct blood flow from common carotid artery 20, through vascular access device 100, filter 300, three-way valve 550, flow control device 500, and vascular return device 200, and into femoral vein 30.

[0037] Figures 1, 5A, 5B, and 6 illustrate a method of percutaneously accessing a blood vessel and establishing retrograde blood flow to provide embolic protection while other medical procedures, such as the neurovascular procedures described herein, are being performed. In this example, the blood vessels accessed to establish retrograde blood flow are the common carotid artery 20 and the femoral vein 30. Figure 5A depicts the vascular access device 100 being percutaneously inserted into the common carotid artery 20 with the sheath 140 aligned with the lumen of the common carotid artery 20. Figure 5B depicts the vascular access device 100 at least partially sealed against the interior of the common carotid artery 20. Figure 6 depicts the vascular return device 200 being percutaneously inserted into the femoral vein 30.

[0038] The common carotid artery 20 and a suitable location for percutaneously accessing the common carotid artery 20 are identified using ultrasound or other non-invasive methods. Using ultrasound or other suitable methods, a needle and guidewire are directed to the identified access location in the common carotid artery 20. The common carotid artery 20 is punctured with the needle and a guidewire is inserted into the common carotid artery 20. A dilator is inserted into the vascular access device 100 and directed along the guidewire to create an opening in the common carotid artery 20. The dilator is used to dilate the opening in the common carotid artery 20 so that the distal end portion 142 of the sheath 140 of the vascular access device 100 can access the interior of the common carotid artery 20.

[0039] The vascular access device 100 is percutaneously inserted into the common carotid artery 20 with the sheath 140 aligned with the lumen of the common carotid artery 20, as seen in FIGURE 5A. Fluid is injected into the inflation port 116 of the hub 110, expanding the expandable element 162 of the vascular sealing portion 160 of the vascular access device 100, as seen in FIGURE 5B. The vascular sealing portion 160 is expanded to engage the inside of the common carotid artery 20, at least partially sealing the vascular access device 100 against the inside of the common carotid artery 20. In this example, at least partially sealing the vascular access device 100 against the inside of the common carotid artery 20 temporarily prevents antegrade blood flow from the brachiocephalic trunk 22 into the common carotid artery 20, as indicated by arrow 16 in FIGURE 5A.

[0040] Similar to the previously described method of accessing the common carotid artery 20, in this example, the femoral vein 30 and a suitable location for percutaneously accessing the femoral vein 30 are identified using ultrasound or other non-invasive methods. Using ultrasound or other suitable methods, a needle and guidewire are directed to the access location in the femoral vein 30. The femoral vein 30 is punctured with the needle, and a guidewire is inserted into the femoral vein 30. A dilator is inserted into the vascular retrieval device 200 and directed along the guidewire to create an opening in the femoral vein 30. The dilator is used to dilate the opening in the femoral vein 30 so that the distal end portion 242 of the sheath 240 of the vascular retrieval device 200 can access the interior of the femoral vein 30. The vascular retrieval device 200 is percutaneously inserted into the femoral vein 30 with the sheath 240 aligned with the lumen of the femoral vein 30, as seen in FIG. 6 .

[0041] 1 and 4 , in the illustrated example, tubing 400 is connected to the side port 114 of the vascular access device 100 and to the inlet 552 of the three-way valve 550. The tubing 400 is connected to the outlet 554 of the three-way valve 550 and to the inlet 502 of the flow control device 500. The tubing 400 is connected to the outlet 504 of the flow control device 500 and to the inlet 304 of the filter 300. The tubing 400 is connected to the outlet 306 of the filter 300 and to the side port 214 of the vascular return device 200. Alternatively, the filter 300, the flow control device 500, and the three-way valve 550 may be connected in any order between the vascular access device 100 and the vascular return device 200. The filter 300, flow control device 500, and / or three-way valve 550 may be connected to the vascular access device 100 and / or the vascular return device 200 before the vascular access device 100 is inserted into the common carotid artery 20 and / or before the vascular return device 200 is inserted into the femoral artery 30.

[0042] 1 and 4 , in this depicted example, retrograde blood flow, identified by arrow 14, is established after vascular access device 100 is at least partially sealed against the inside of common carotid artery 20, vascular return device 200 accesses femoral vein 30, and tubing 400 connects vascular access device 100, three-way valve 550, flow control device 500, filter 300, and vascular return device 200. At least partially sealing vascular access device 100 against the inside of common carotid artery 20 also temporarily prevents antegrade blood flow, indicated by arrow 16, from brachiocephalic trunk 22 into common carotid artery 20. Establishing retrograde blood flow includes directing retrograde blood flow from internal carotid artery 24 and external carotid artery 26 into common carotid artery 20. Retrograde blood flow is directed into the sheath 140 of the vascular access device 100, out through the side port 114, through the tubing 400, the three-way valve 550, the flow control device 500, the filter 300, into the side port 214 of the vascular return device 200, and out the sheath 240. The retrograde blood flow is ultimately directed from the vascular return device 200 into the femoral vein 30. The blood pressure in the common carotid artery 20 is higher than the blood pressure in the femoral vein 30, and it is this pressure difference between the common carotid artery 20 and the femoral vein 30 that allows retrograde blood flow from the common carotid artery 20 to the femoral vein 30.

[0043] In this exemplary embodiment, blood flow from the carotid artery 20 to the femoral vein 30 is controlled by adjusting and / or operating the flow control device 500. In some embodiments, blood flow from the carotid artery 20 to the femoral vein 30 may be automatically controlled by the flow control device 500. In some cases, if the retrograde blood flow is too great for the patient, the patient may become disoriented (dizzy) or unconscious (fainting) due to the flow of blood away from the patient's brain. The flow control device 500 may be used to reduce the flow of blood to prevent the patient from becoming disoriented or losing consciousness. During some medical procedures, the flow control device 500 may also be used to reduce and / or stop the flow of blood to prevent other clinical symptoms.

[0044] Filter 300 captures emboli (plaque) generated during procedures such as, for example, neurovascular procedures. Once retrograde blood flow is established, neurovascular procedures can be performed with the embolic protection provided by filter 300. Procedures can include transcarotid artery revascularization (TCAR), thrombectomy, aneurysm coil embolization, etc.

[0045] After the procedure is completed, antegrade blood flow is restored. A flow control device 500 may be used to stop retrograde blood flow. In this exemplary embodiment, fluid is withdrawn from inflation port 116, causing expandable portion 162 of vascular sealing portion 160 of vascular access device 100 to contract and / or deflate, as seen in FIG. 5A . Contracting and / or deflation of expandable portion 162 allows vascular sealing portion 160 to be withdrawn from inside the blood vessel, restoring antegrade blood flow, as indicated by arrow 16.

[0046] 7A and 7B are cross-sectional views detailing the structure of an alternative vascular access device 100a. Generally, vascular access device 100a is similar in structure and operation to previously described vascular access device 100, and in various other embodiments according to the present disclosure, vascular access device 100a may be substituted for other vascular access devices, or any features of vascular access device 100a may be used. Like numbers refer to like components. For brevity, the following description minimizes redundant description and focus on the differences between vascular access device 100a and vascular access device 100.

[0047] In this exemplary embodiment, vascular access device 100a has a proximal end portion 102a, a distal end portion 104a, a hub 110a, a sheath 140a, and a vascular sealing portion 160a. For reference, arrow 106 points generally proximally and arrow 108 points generally distally. Hub 110a includes a front hub body 112a, a side port 114a, a rear hub body 118a, a central lumen 120a, a strain relief 124a, an expansion seal 126a, a compression washer 128a, a locking portion 130a, and a sealing actuator 170a.

[0048] Sheath 140a has a distal end portion 142a and a proximal end portion 144a. Sheath 140a also includes an outer jacket 146a, an inner liner 148a, a reinforcement portion 150a, a central lumen 152a, an actuation member 154a, and one or more radiopaque markers 156a.

[0049] Vascular sealing portion 160a is positioned at distal end portion 142a of sheath 140a. When actuated, vascular sealing portion 160a is configured to at least partially seal distal end portion 142a of sheath 140a of vascular access device 100a against the inside of a blood vessel, such as the carotid artery. In the illustrated embodiment, vascular sealing portion 160a is a flexible material 162a. Flexible material 162a may include silicone, urethane, or other similarly suitable flexible materials. Actuating member 154a is coupled to vascular sealing portion 160a at distal end portion 142a of sheath 140a and to sealing actuator 170a at hub 110a.

[0050] Seal actuator 170a includes a handle 172a coupled to a follower 174a, which is coupled to the proximal end of actuating member 154a. Follower 174a is configured to move within front hub body 112a of hub 110a along the central axis of vascular access device 100a. Axial movement of seal actuator 170a, in the proximal direction indicated by arrows 106 and 180a, moves actuating member 154a proximally and actuates vascular sealing portion 160a. Actuating vascular sealing portion 160a includes axial compression of flexible material 162a, which causes flexible material 162a to expand radially (circumferentially), as seen in FIG. 7B, thereby at least partially sealing vascular access device 100a against the inside of a blood vessel. Axially moving seal actuator 170a in the distal direction indicated by arrows 108 and 182a moves actuation member 154a distally and deactivates vascular sealing portion 160a, as seen in FIG. 7A . Deactivating vascular sealing portion 160a includes axially compressing flexible material 162a, which causes flexible material 162a to retract radially, thereby withdrawing vascular sealing portion 160a from inside the blood vessel. In this illustrated example, seal actuator 170a includes handle 172a. In other embodiments, seal actuator 170a may include a knob, lever, button, or any other device or structure configured to move follower 174a and actuation member 154a to activate and / or deactivate vascular sealing portion 160a.

[0051] 8A and 8B are cross-sectional views detailing the structure of an alternative vascular access device 100b. Generally, vascular access device 100b is similar in structure and operation to previously described vascular access devices 100 and 100a, and in various other embodiments according to the present disclosure, vascular access device 100b may be substituted for other vascular access devices, or any features of vascular access device 100b may be used. Like numbers refer to like components. For brevity, the following description minimizes redundant description and focus on differences between vascular access device 100b and vascular access devices 100 and 100a.

[0052] In this exemplary embodiment, vascular access device 100b has a proximal end portion 102b, a distal end portion 104b, a hub 110b, a sheath 140b, and a vascular sealing portion 160b. For reference, arrow 106 points generally proximally and arrow 108 points generally distally. Hub 110b includes a front body 112b, a side port 114b, a rear hub body 118b, a central lumen 120b, a strain relief 124b, an expansion seal 126b, a compression washer 128b, a locking portion 130b, and a sealing actuator 170b.

[0053] Sheath 140b has a distal end portion 142b and a proximal end portion 144b. Sheath 140b also includes an outer jacket 146b, an inner liner 148b, a reinforcement portion 150b, a central lumen 152b, an actuation member 154b, and one or more radiopaque markers 156b.

[0054] Vascular access device 100b has a vascular sealing portion 160b positioned at a distal end portion 142b of sheath 140b. Vascular sealing portion 160b is configured to at least partially seal distal end portion 142b of sheath 140b of vascular access device 100b against the inside of a blood vessel when actuated. In the illustrated embodiment, vascular sealing portion 160b is a preformed structure 162b. As shown in FIG. 8A, preformed structure 162b is positioned inside sheath 140b in an unactuated or compressed state. As shown in FIG. 8B, preformed structure 162b is positioned outside sheath 140b when in an actuated or expanded state. In the illustrated embodiment, preformed structure 162b comprises a preformed wire structure. In some embodiments, the wire structure may include a membrane or coating that at least partially covers the preformed structure 162b to prevent blood flow through the wire structure of the preformed structure 162b.

[0055] Seal actuator 170b includes a handle 172b coupled to a follower 174b coupled to the proximal end of actuation member 154b. Follower 174b is configured to move within body 112b of hub 110b along the central axis of vascular access device 100b. Axial movement of seal actuator 170b in the distal direction indicated by arrows 108 and 180b moves actuation member 154b distally, thereby moving preformed structure 162b out of distal end 142b of sheath 140b. Once outside sheath 140b, preformed structure 162b is actuated and expands radially (circumferentially), as seen in FIG. 8B, thereby at least partially sealing vascular access device 100b against the inside of a blood vessel. Proximal movement of seal actuator 170b in the proximal direction indicated by arrows 106 and 182a moves outer jacket 146b distally, as seen in FIG. 8A , thereby moving preformed structure 162b inside sheath 140b and deactivating vascular sealing portion 160b. In this illustrated example, seal actuator 170b comprises handle 172b. In other embodiments, seal actuator 170b may comprise a knob, lever, button, or any other device or structure configured to move follower 174b and actuation member 154b to activate and / or deactivate vascular sealing portion 160b. In an alternative embodiment, follower 174b may be coupled to outer jacket 146b, and moving seal actuator 170b may move outer jacket 146b to activate and / or deactivate vascular sealing portion 160b.

[0056] FIG. 9 illustrates an alternative embolic protection system 10a. Generally, embolic protection system 10a is similar in structure and operation to previously described embolic protection system 10, and in various other embodiments according to the present disclosure, embolic protection system 10a may be replaced with other embolic protection systems, or any features of embolic protection system 10a may be used. Like numbers refer to like components. For brevity, the following description minimizes redundant description and focus on differences between embolic protection system 10 and embolic protection system 10a. In this exemplary embodiment, embolic protection system 10a includes a vascular access device 100c, a vascular return device 200, a filter 300, tubing 400, a flow control device 500, a three-way valve 550, and a vascular closure device 600, as seen in FIG. 12.

[0057] FIG. 10A is a side view of an exemplary vascular access device 100c. FIG. 10B is a cross-sectional view detailing the structure of vascular access device 100c. Generally, vascular access device 100c is similar in structure and operation to previously described vascular access devices 100, 100a, and 100b, and in various other embodiments according to the present disclosure, vascular access device 100c may be substituted for other vascular access devices, or any features of vascular access device 100c may be used. Like numbers refer to like components. For brevity, the following description minimizes redundant description and focus on differences between vascular access device 100c and vascular access devices 100, 100a, and 100b.

[0058] In this exemplary embodiment, vascular access device 100c has a proximal end portion 102c, a distal end portion 104c, a hub 110c, and a sheath 140c. For reference, arrow 106 points generally proximally and arrow 108 points generally distally. Hub 110c includes a body 112c, a side port 114c, a rear hub body 118c, a central lumen 120c, a front hub body 122c, a strain relief 124c, an expansion seal 126c, a compression washer 128c, and a locking portion 130c. Sheath 140c has a distal end portion 142c and a proximal end portion 144c. Sheath 140c also includes an outer jacket 146c, an inner liner 148c, a reinforcement portion 150c, a central lumen 152c, and one or more radiopaque markers 156c.

[0059] Figures 1 and 11 illustrate a method of percutaneously accessing a blood vessel and establishing retrograde blood flow to provide embolic protection while another medical procedure is being performed. In this example, the blood vessels accessed to establish retrograde blood flow are the common carotid artery 20 and the femoral vein 30. Figure 11 depicts a vascular access device 100c being percutaneously inserted into the common carotid artery 20 with a sheath 140c aligned with the lumen of the common carotid artery 20. In this alternative embodiment, the vascular access device 100c is inserted into the common carotid artery 20. The sheath 140c of the vascular access device 100c is aligned with the lumen of the common carotid artery 20. The outer diameter 180c of the sheath 140c is dimensionally similar to the inner diameter of the lumen of the common carotid artery 20. Due to the similarity of the outer diameter of the sheath 140c and the inner diameter of the lumen of the common carotid artery 20, retrograde blood flow is established without the need for additional sealing of the vascular access device 100c against the inside of the common carotid artery 20.

[0060] Described herein are devices and methods for percutaneously closing an opening in a blood vessel. Figure 12 is a perspective view of an exemplary vascular closure device 600 configured to percutaneously close and seal a puncture or opening in a blood vessel, such as, for example, the carotid artery or femoral vein. In this exemplary embodiment, the vascular closure device 600 is configured for use with a vascular access device 100. In some embodiments, the vascular closure device 600 is configured for use with a vascular return device 200. The vascular closure device 600 enables single-suture closure of a blood vessel, such as, for example, the common carotid artery 20 and / or the femoral vein 30, via a minimally invasive percutaneous procedure.

[0061] The vascular closure device 600 includes a handle 612 at a proximal end portion and a suturing mechanism 614 at a distal end portion. For reference, arrow 602 points generally proximally and arrow 604 points generally distally. As used herein, "suture," "suture," and like forms of these terms refer to any flexible tensile element or member, regardless of form or material, suitable for approximating tissue. As used herein, a "tensioning member" may be a staple suture, a multifilament suture, a metallic suture, or any other suitable tensile member. An elongate shaft 616 extends between the handle 612 and the suturing mechanism 614. A strain relief 623 is generally secured between the relatively rigid handle 612 and the more flexible shaft 616 to more evenly distribute forces between the handle 612 and the shaft 616.

[0062] The handle 612 includes one or more actuation mechanisms and one or more suture needles, as disclosed herein, necessary to operate the suturing mechanism 614. In this exemplary embodiment, the actuation mechanisms include a sliding suturing mechanism actuator 620 that operates the suturing mechanism 614 and a plunger-type needle actuator 622 that operates the suturing needle. While the actuators are shown and described as being manually driven, one or more of the actuators may be motorized, mechanically utilized, or otherwise assisted.

[0063] 13A and 13B are perspective views of the distal end of shaft 616 and suturing mechanism 614. FIG. 13C is a perspective view of the distal end of shaft 616 and suturing mechanism 614, with a portion of shaft 616 and suturing mechanism 614 shown in phantom. The suturing mechanism 614 includes a needle guide 615 and a pivot element 624. Pivot element 624 is secured to the distal end of needle guide 615 by a pivot 626 that pivots pivot element 624 from an orientation in which the longitudinal extension of pivot element 624 is generally aligned with the central axis of shaft 616, as shown in FIG. 13A, to an orientation transverse to the central axis of shaft 616, as shown in FIG. 13B. The aligned orientation of pivot element 624 shown in FIG. 13A is an insertion and removal orientation. The transverse orientation of pivot element 624 shown in FIG. 13B is a deployment orientation that facilitates endovascular suturing. The suturing mechanism actuator 620 is coupled to a pivot element 624 by an actuation wire 630, see Figure 12. The pivot element 624 includes an elongated flexible connecting member 648 in a passageway 652, see Figure 15E.

[0064] 12 and 13C, the distal end of the vascular closure device 600 comprises a first needle 640 and a second needle 642. The first needle 640 is a two-piece needle having a first needle tip 640a that is detachable from a first needle body 640b, for example, using a friction fit. Looking at FIG. 15F, an elongated suture or tension member 650 is coupled to the first needle tip 640a. The second needle 642 has a unitary (i.e., fixed) second needle tip 642a. As used herein, the term "unitary" includes not only fully unitary structures but also structures in which the second needle tip 642a is fixedly (i.e., not "detachably") coupled to the second needle 642. Shaft 616 may be a multi-lumen flexible catheter with one lumen supporting actuator wire 630, two lumens supporting first and second needles 640 and 642, and a fourth lumen that may be used as a blood port to indicate to a user when the distal end of vascular closure device 600 has entered a blood vessel. First and second needles 640 and 642 are coupled to a needle actuator 622. First and second needles 640 and 642 are deployed or moved distally by pushing needle actuator 622 forward or distally. Pulling needle actuator 622 proximally retracts first and second needles 640 and 642.

[0065] 12 and 13A-13C, when the suturing mechanism actuator 620 is in the neutral position, the pivot element 624 is in the insertion and removal orientation shown in FIG. 13A. Pulling or moving the suturing mechanism actuator 620 proximally pulls the actuation wire 630, actuating the suturing mechanism 614 and pivoting the pivot element 624 from the insertion and removal orientation shown in FIG. 13A to the deployed orientation shown in FIG. 13B. The suturing mechanism actuator 620 can be mechanically locked in place, for example, by being moved within a "J-shaped" or "L-shaped" slot in the handle 612. Releasing or moving the suturing mechanism actuator 620 in a forward or distal direction will pivot the pivot element 624 from the deployed orientation shown in FIG. 13B to the insertion and removal orientation shown in FIG. 13A.

[0066] 14 shows the distal end of vascular closure device 600 and suturing mechanism 614 being inserted through vascular access device 100. Depth markers or indicators on shaft 616 of vascular closure device 600 provide visual feedback to the user as to how far vascular closure device 600 has been inserted into vascular access device 100. Expanding seal 126, see FIG. 2A , seals against shaft 616 of vascular closure device 600 to minimize or prevent blood loss.

[0067] 15A-15J are side views of the distal end of shaft 616 and suturing mechanism 614 of vascular closure device 600. Figures 15A-15J progressively illustrate additional structures and functions of vascular closure device 600, specifically, the distal end portion and suturing mechanism 614 closing and sealing a puncture or opening 662 in the wall of a blood vessel 660, such as the common carotid artery 20 or femoral vein 30, as seen in Figure 1.

[0068] In this illustrated example, prior to using the vascular closure device 600, the vascular sealing portion 160 of the vascular access device 100 is retracted to restore antegrade blood flow in the common carotid artery 20, as seen in FIG. 1 . Referring to FIG. 15A , the distal end of the needle guide 615, with the pivot element 624 in an insertion and removal orientation, is inserted into the vascular access device 100 and blood vessel 660. The vascular closure device 600 is internally exchanged with the vascular access device 100 while in the blood vessel 660. The vascular closure device 600 is inserted into the blood vessel 660 prior to removal of the vascular access device 100. A depth marker or indicator on the shaft 616 of the vascular closure device 600 provides visual feedback to the user as to how far the vascular closure device 600 has been inserted into the vascular access device 100. The vascular access device 100 is withdrawn from the blood vessel 660. The pivot element 624 is rotated within the blood vessel 660 from the insertion and removal orientation shown in FIG. 15B to the deployed orientation shown in FIG. 15C. As shown in FIG. 15D, the pivot element 624 is pulled proximally against the interior of the vessel wall 660a. Referring to FIG. 15E, the first needle 640 and the second needle 642 are deployed or moved distally through the vessel wall 660a adjacent the opening 662, with the first needle tip 640a and the second needle tip 642a coupled to the end of the coupling member 648. Referring to FIG. 15F, the first needle body 640b and the second needle 642 are retracted proximally. The first needle tip 640a is detached from the first needle body 640b. As second needle 642 is pulled proximally, second needle 642 pulls linking member 648 through passageway 652 in pivot element 624. Second needle 642 pulls flexible linking member 648, first needle tip 640a, and tension member 650 through vessel wall 660a adjacent opening 662.

[0069] Referring to FIG. 15G, pivot element 624 is actuated into an insertion and removal orientation to pull vascular closure device 600, specifically suturing mechanism 614, proximally and remove it from opening 662 in blood vessel 660. As shown in FIG. 15H, suturing mechanism 614 is removed from opening 662, tensioning member 650 pulls opening 662 closed, and suture knot 664 is deployed. Suture knot 664 can be of any desired configuration suitable for tying a suture, such as a type that automatically tightens when at least one end of tensioning member 650 is tensioned. In some embodiments, suture knot 664 can be a "Tennessee Slider" style knot. Knot 664 is tightened against the outside of blood vessel 660 to close and seal opening 662, as shown in FIG. 15I, and the end of tensioning member 650 is trimmed, as shown in FIG. 15J.

[0070] The method of percutaneously closing an opening 662 in a blood vessel 660 also includes percutaneously closing an opening in a femoral vein 30 using a vascular closure device 600, as seen in Figure 1. The method of closing the femoral vein 30 is similar to the method described above, with the primary difference being the use of a vascular return device 200 instead of a vascular access device 100.

[0071] FIG. 16 is a perspective view of an alternative vascular closure device 700. In this exemplary embodiment, vascular closure device 700 is configured for use with vascular access device 100. In some embodiments, vascular closure device 700 is configured for use with vascular retrieval device 200. Vascular closure device 700 allows for single-suture closure of a blood vessel, such as a carotid artery, femoral vein, or other blood vessel, via a minimally invasive, percutaneous procedure. Generally, vascular closure device 700 is similar in structure and operation to previously described vascular closure device 600, and in various other exemplary embodiments according to the present disclosure, vascular closure device 700 may be substituted for other vascular closure devices, or any features of vascular closure device 700 may be used. Like numerals refer to like components. For brevity, the following description minimizes redundant description and focus on the differences between vascular closure device 700 and vascular closure device 600.

[0072] The suturing device 700 includes a handle 712 at a proximal end portion and a suturing mechanism 714 at a distal end portion. For reference, arrow 702 points generally proximally and arrow 704 points generally distally. An elongated shaft 716 extends between the handle 712 and the suturing mechanism 714. FIG. 17 is an exploded perspective view showing the handle 712. With reference to FIGS. 16 and 17, the handle 712 includes a pivoting, lever-type suturing mechanism actuator 720 coupled to and configured to operate the suturing mechanism 714. The handle 712 also includes first and second needle actuators 722a, 722b with biasing members or coil springs 725, 727. Other forms of biasing members may be used in place of the springs 725, 727. A flexible strain relief 723 is generally secured between the relatively rigid handle 712 and the more flexible shaft 716 to more evenly distribute forces between them. A rotatable handle portion 712a is held to the remainder of the handle 712 by a fastener 770. Although the actuators 720, 722a, 722b are shown and described herein as being manually driven, one or more of the actuators may be motorized, mechanically utilized, or otherwise assisted.

[0073] 18A, 18B, and 18C are perspective views of the distal end of the shaft 716 and the suturing mechanism 714. The suturing mechanism 714 includes a needle guide 715 and a pivot element 724 secured to the distal end of the needle guide 715 by a pivot 726. FIG. 18A shows the pivot element 724 in an insertion and removal orientation in which the longitudinal extension of the pivot element 724 is generally aligned with the longitudinal axes of the needle guide 715 and the shaft 716. FIGS. 18B and 18C show the pivot element 724 in first and second deployed orientations, respectively, in which the longitudinal extension of the pivot element 724 is transverse to the longitudinal axes of the needle guide 715 and the shaft 716. The pivot 726 pivots or rotates the pivot element 724 between the insertion and removal orientation and the first and second deployed orientations. As described below, the first and second deployed orientations of the pivot element 724 facilitate a suturing procedure to close a puncture or opening in a blood vessel. Rotating or pivoting the suturing mechanism actuator 720 on the handle 712 moves the pivot element 724 between the insertion and removal orientations and the first and second deployed orientations.

[0074] Figure 19A is a top view of handle 712 of vascular closure device 700, and Figure 19B is a cross-sectional view of suturing mechanism 714 in the insertion and removal orientation. Figure 20A is a top view of handle 712 of vascular closure device 700, and Figure 20B is a cross-sectional view of suturing mechanism 714 in the first deployed orientation. Figure 21A is a cross-sectional view of handle 712 of vascular closure device 700, and Figure 21B is a cross-sectional view of suturing mechanism 714 in the first deployed orientation.

[0075] 19A and 19B, the distal end portion of the vascular closure device 700 includes a first needle 740 and a second needle 742 that are either fully integral with or fixedly coupled to the respective wires 744, 746. The first needle 740 is a two-piece needle having a first needle tip 740a that is detachable from a first needle body 740b using, for example, a friction fit. An elongated suture or tension member 750 is coupled to the first needle tip 740a. The second needle 742 has an integral second needle tip 742a. ​​The first needle 740 and the second needle 742 may be fully integral with or fixedly coupled to the respective wires 744, 746. Elements 740, 742, 744, and 746 can be, for example, solid wire-like members or hollow (e.g., hypotubes). The wire-like or hypotube element 744 coupled to the first needle 740 is fixed to the first needle actuator 722a, while the wire-like or hypotube element 746 coupled to the second needle 742 is fixed to the actuator 722b.

[0076] 21A and 21B, suturing mechanism actuator 720 is coupled to pivot element 724 by actuation wire 730. A first loop 730a of wire 730 is fixed to pivot element 724 at point 732, and a second loop 730b of wire 730 is fixed for rotation with suturing mechanism actuator 720. Pivot element 724 includes a flexible linkage 748. Shaft 716 may be a multi-lumen flexible catheter with one lumen supporting actuator wire 730, two lumens supporting first and second needles 740 and 742, and a fourth lumen that may be used as a blood port to indicate to a user when the distal end of vascular closure device 700 has entered a blood vessel.

[0077] Figure 22A is a cross-sectional view of handle 712 of vascular closure device 700, and Figure 22B is a cross-sectional view of suturing mechanism 714 in a first deployment orientation. Figure 23A is a cross-sectional view of handle 712 of vascular closure device 700, and Figure 23B is a cross-sectional view of suturing mechanism 714 in a second deployment orientation. Figure 24A is a cross-sectional view of handle 712 of vascular closure device 700, and Figure 24B is a cross-sectional view of suturing mechanism 714 in the second deployment orientation.

[0078] 19A-24B progressively illustrate additional structure and operation of vascular closure device 700. As previously mentioned, FIGS. 19A and 19B illustrate the vascular closure device with suturing mechanism 714 in an insertion and removal orientation. When suturing mechanism actuator 720 is in the aligned or neutral position shown in FIG. 19A, pivot element 724 is in the insertion and removal orientation shown in FIG. 19B. Suturing mechanism actuator 720 is pivoted or rotated clockwise or in a first direction to the position shown in FIG. 20A to pivot or rotate pivot element 724 to the first deployed orientation shown in FIG. 20B. While the pivot element 724 is in the first deployed orientation, the first needle 740 is deployed or moved distally by pushing the first needle actuator 722a in the distal direction as indicated by arrow 743 against the bias of the spring 725, thereby moving the first needle 740 distally toward a connecting member 748 attached to the pivot element 724.

[0079] 21A and 21B show the positions of the first needle actuator 722a, spring 725, and first needle 740 after rotating the suturing mechanism actuator 720 and pushing the first needle actuator 722a distally. The first needle tip 740a engages and connects with the first end of the coupling member 748. As shown in FIG. 20A, the suturing mechanism actuator 720 also impedes movement of the actuator 722b, thereby preventing unintended deployment of the second needle 742. The suturing mechanism actuator 720 may be held in place or temporarily locked by a detent or other suitable structure. As shown in FIGS. 22A and 22B, when released, the first needle actuator 722a is moved proximally by the extension of the spring 725, thereby retracting the needle body 740b proximally and decoupling it from the first needle tip 740a.

[0080] 22A and 22B through 23A and 23B, suturing mechanism actuator 720 is rotated in a second, or counterclockwise, direction to rotate pivot element 724 to its second, deployed orientation as shown in FIG. 23B. Actuator 722b is pushed distally against the bias of spring 727, thereby moving second needle 742 distally and engaging and connecting needle second tip 742a with the second end of coupling member 748. When actuator 722b is released as indicated by the arrow in FIG. 23A, the extension of spring 727 pulls second needle 742, including second tip 742a, proximally, carrying coupling member 748 and attached first needle tip 740a and tension member 750 with second needle 742, as shown in FIG. 24A and 24B. Linking member 748 is secured to pivot element 724 in a "one-way" connection such that it can only move from pivot element 724 in the direction shown in Figure 24B. A rotatable portion 712a positioned at the proximal end portion of handle 712 is rotated, as further shown in Figure 25, to expose opening 729 to allow removal of actuator 722b and to withdraw second needle 742, linking member 748, first needle tip 740a, and tension member 750 in the proximal direction as shown in Figure 24B.

[0081] 26A-26J are elevational views of the distal end of shaft 716 and suturing mechanism 714. Figures 26A-26J progressively illustrate additional structures and functions of vascular closure device 700, specifically, the distal end portion and suturing mechanism 714 closing and sealing an opening 662 in the wall of a blood vessel 660, such as a carotid artery or femoral vein.

[0082] 26A , the distal end of needle guide 715, with pivot element 724 in the insertion and removal orientation, is inserted into vascular access device 100 and blood vessel 660. Vascular closure device 700 is internally exchanged with vascular access device 100 while in blood vessel 660, similar to the procedure previously described for vascular closure device 600. Vascular closure device 700 is inserted into blood vessel 660 prior to removal of vascular access device 100. Depth markers or indicators on shaft 716 of vascular closure device 700 provide visual feedback to the user as to how far vascular closure device 700 has been inserted into vascular access device 100.

[0083] The suturing mechanism 714 is actuated within the vessel 660, causing the pivot element 724 to pivot to a first deployed orientation shown in FIGURE 26B. The pivot element 724 is pulled proximally against the interior of the vascular wall 660a, causing a slight proximal pull on the vascular closure device 700, causing a slight proximal pull on the needle guide 715, as shown in FIGURE 26B. The vascular access device 100 is pulled rearward or proximally along the shaft 716 while the suturing mechanism 714 remains within the vessel 660. The vascular access device 100 remains in surrounding relationship to the shaft 716 during the remainder of the procedure, and the vascular closure device 700 is ready for deployment of the first and second suture needles 740, 742, and the remainder of the procedure as described herein. With pivot element 724 in this position, first needle 740 is deployed through vessel wall 660a adjacent opening 662, and first needle tip 740a connects with a first end of connecting member 748, as shown in FIGURE 26C. First needle body 740b is retracted proximally, and first needle tip 740a is detached from first needle body 740b, leaving tension member 750 secured to first needle tip 740a and first needle tip 740a connected to connecting member 748, as seen in FIGURE 26D.

[0084] As shown in Figures 26D and 26E, the pivot element 724 is rotated approximately 190° to a second deployment orientation. The second needle 742 is moved distally through the vessel wall 660a adjacent the opening 662 to connect the second needle tip 742a with the second end of the connecting member 748. As shown in Figure 26F, the second needle 742, connecting member 748, first needle tip 740a, and tension member 750 are pulled proximally through the vessel wall 660a. As shown in Figure 26G, the pivot element 724 is rotated to an insertion and removal orientation, causing the vascular closure device 700, specifically the needle guide 715 and suturing mechanism 714, to be pulled proximally and removed from the blood vessel 660, as seen in Figure 26H. As further shown in Figure 26H, the suture knot 764 is deployed. Suture knot 764 can be in the form of any desired knot suitable for tying a suture, such as a type that automatically tightens when at least one end of tension member 750 is pulled. Knot 764 is tightened against the outside of vessel 660 to close and seal opening 662, as shown in FIG. 261, and the end of tension member 750 is trimmed, as shown in FIG. 26J.

[0085] 27 is a top view of an alternative exemplary vascular closure device handle 712'. Generally, handle 712' is similar in structure and operation to previously described handle 712, and in various other embodiments according to the present disclosure, handle 712' may be replaced with other handles, or any features of handle 712' may be used. Like numbers refer to like components. For the sake of brevity, the following description minimizes redundant description and focus on the differences between handle 712 and handle 712'.

[0086] The handle 712' includes a rotatable suturing mechanism actuator 720' that operates similarly to the suturing mechanism actuator 720 described previously. The suturing mechanism actuator 720' is rotated to rotate the pivoting element 724 from the insertion and removal orientation seen in FIG. 18A to the first deployed orientation seen in FIG. 18B. The user slides the button 780' forward or distally to move the first needle 740 distally to engage the pivoting element 724, as seen in FIG. 18B. Similar to the handle 712, a spring return mechanism (not shown) is coupled to the button 780' and the first needle 740. The suturing mechanism actuator 720' is rotated to pivot the element 724 to the second deployed orientation, as seen in FIG. 18C. The second needle 742 is moved distally by depressing the plunger 782' in a distal or forward direction, as seen in FIG. 18C. The plunger 782' can also be coupled to a spring return mechanism (not shown) and can be fully removed in a proximal direction to remove the second needle 742 and tension member 750, as previously described. The remainder of the operation of the handle 712' is similar to the described operation of the handle 712.

[0087] FIG. 28 is a top view of an alternative exemplary vascular closure device handle 712″. Generally, handle 712″ is similar in structure and operation to previously described handles 712 and 712′, and in various other embodiments according to the present disclosure, handle 712″ can be replaced with other handles, or any features of handle 712″ may be used. Like numbers refer to like components. For the sake of brevity, the following description minimizes redundant description and focus on the differences between handles 712 and 712′ and handle 712″.

[0088] Handle 712" includes actuators in the form of sliding buttons 780", 790" and plunger 782". A user moves sliding button 790" forward or distally to rotate pivot element 724 from the insertion and removal orientation seen in FIG. 18A to a first deployed orientation seen in FIG. 18B. A user moves or slides button 780" forward or distally to move first needle 740 distally to engage pivot element 724, as seen in FIG. 18B. A spring return mechanism (not shown) is coupled to button 780" and first needle 740. A user moves sliding button 790" rearward or proximally to pivot element 724 to its second transverse orientation, as seen in FIG. 18C. The second needle 742 is moved distally by depressing the plunger 782" in a distal or forward direction. The plunger 782" can also be coupled to a spring return mechanism (not shown) and can be fully removed in a proximal direction to remove the second needle 742 and tension member 750, as previously described. The remainder of the operation of the handle 712" is similar to the described operation of the handles 712 and 712'.

[0089] While the present invention has been illustrated by the description of specific embodiments thereof, and the embodiments have been described in considerable detail, it is not intended to restrict or in any way limit the scope of the appended claims to such details. The various features discussed herein can be used alone or in any combination within and between the various embodiments. Additional advantages and modifications will be readily apparent to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope or spirit of the general inventive concept. [Explanation of symbols]

[0090] 10, 10a Embolic Protection System 14 Direction of retrograde blood flow 16 Direction of antegrade blood flow 20 Common carotid artery 24 Internal carotid artery 26 External carotid artery 30 femoral vein 100, 100a, 100b, 100c Vascular access device 102, 102a, 102b, 102c proximal end portion 104, 104a, 104b, 104c distal end portion 106 Proximal 108 Distal 110, 110a, 110b, 110c hubs 112, 112c main body 112a Front hub body 112b Front body 114, 114a, 114b, 114c side ports 116 Inflation port 118, 118a, 118b, 118c Rear hub body 120, 120a, 120b, 120c central lumen 122, 122c front hub body 124, 124a, 124b, 124c Strain relief section 126, 126a, 126b, 126c expansion seal 128, 128a, 128b, 128c compression washers 130, 130a, 130b, 130c Locking part 140, 140a, 140b, 140c sheath 142, 142a, 142b, 142c distal end portion 144, 144a, 144b, 144c proximal end portion 146, 146a, 146b outer jacket 148, 148a, 148b Inner liner 150, 150a, 150b reinforcement part 152, 152a, 152b central lumen 154 Inflated Lumen 154a, 154b operating members 156, 156a, 156b Radiopaque markers 160, 160a, 160b Vascular sealing part 162 Extensible Elements 162a Flexible material 162b Preformed Structures 170a, 170b Sealing actuator 172a, 172b handle 174a, 174b Follower 180a proximal direction 180b distal direction 182a distal direction 182a proximal direction 182b distal direction 200 Vascular Return Device 202 Proximal end portion 204 Distal end section 206 Proximal 208 Distal 210 Hub 230 Locking part 240 Sheath 242 Distal end section 244 Proximal end portion 246 outer jacket 248 Inner liner 250 Reinforcement part 252 Central lumen 256 Radiopaque Markers 300 filters 400 Piping 500 Flow Control Device 502 Entrance 504 Exit 550 Three-way valve 552 Entrance 554 Exit 556 Access Port 600 Vascular Closure Device 602 Proximal 604 Distal 612 Handle 614 Suture mechanism 615 Needle guide 616 Long and thin shaft 620 Suture Mechanism Actuator 623 Distortion relief part 624 Pivoting element 626 Pivot 630 Actuator wire 640 First Needle 640a First needle tip 640b First needle body 642 Second Needle 642a Second needle tip 648 Flexible connecting member 650 Sutures, tension members 652 Passage 660 Blood vessels, vasculature 660a Vascular wall 662 Puncture, opening 664 Suture Knot 700 Vascular closure devices, suture devices 702 Proximal 704 Distal 712, 712', 712" handle 712a Rotatable handle part 714 Suture mechanism 715 Needle guide 716 Long and thin shaft 720, 720' Suture mechanism actuator 722a First needle actuator 722b Second needle actuator 723 Distortion relief part 724 Pivoting element 725, 727 biasing member, coil spring 726 Pivot 730 Actuation Wire 730a First Loop 730b Second Loop 732 points 740 First Suture Needle 740a First needle tip 740b First needle body 742 Second Suture Needle 742a Second needle tip 744, 746 Wire, wire-like elements, hypotube elements 748 Flexible connecting member 750 Tensile Members 764 Suture Knots 770 Fasteners 780' Button 780", 790" sliding button 782', 782" plunger

Claims

1. 1. An embolic protection system comprising: a vascular access device configured to percutaneously access an interior of a first vessel; a vascular retrieval device configured to access the interior of the second vessel; a filter configured to collect emboli; tubing configured to connect the vascular access device, the vascular return device, and the filter; a vascular closure device configured to percutaneously close and seal an opening in the first vessel, comprising: a proximal end comprising a handle with a needle actuator; an elongated shaft coupled to the handle; a suturing mechanism coupled to a distal end of the elongate shaft, the suturing mechanism configured to be actuated within the first vessel and comprising a pivot element; first and second needles associated with the suturing mechanism, the first and second needles configured to be directed through a first vessel wall adjacent the opening in the first vessel, at least one of the first and second needles coupled to the needle actuator and configured to be directed through the first vessel wall with the needle actuator; a tension member coupled to the first needle; and a connecting member associated with the suturing mechanism, the connecting member having a first connecting member end configured to be coupled to the first needle and a second connecting member end configured to be coupled to the second needle, the connecting member configured to pull the tensioning member through the first vessel wall to close and seal the opening in the first vessel. a vascular closure device comprising: Equipped with The embolic protection system is configured to direct blood flow from the first vessel, through the vascular access device, the filter, and the vascular return device, and into the second vessel.

2. The embolic protection system of claim 1 , wherein the vascular closure device is configured to access the interior of the first vessel through the vascular access device.

3. the system further comprising a flow control device configured to be coupled to the vascular access device, the vascular return device, and the filter by the tubing; The embolic protection system of claim 1 , wherein the flow control device is configured to control the blood flow from the first vessel to the second vessel.

4. 10. The embolic protection system of claim 1, wherein the vascular access device comprises a vascular sealing portion configured, when actuated, to at least partially seal the vascular access device against the interior of the first vessel.

5. the vascular sealing portion comprises an expandable element; 5. The embolic protection system of claim 4, wherein actuating the vascular sealing portion comprises expanding the expandable element of the vascular sealing portion to at least partially seal the vascular access device against the interior of the first vessel.

6. 6. The embolic protection system of claim 5, wherein the expandable element comprises a balloon, and wherein inflating the balloon at least partially seals the vascular access device against the interior of the first vessel.

7. 5. The embolic protection system of claim 4, wherein the vascular sealing portion comprises a flexible material, and wherein actuating the vascular sealing portion comprises compressing the flexible material to radially expand the flexible material and thereby at least partially seal the vascular access device against the interior of the first vessel.

8. the vessel sealing portion comprises a preformed structure; 5. The embolic protection system of claim 4, wherein the preformed structure is in an unactuated or compressed state when the sealing portion is positioned inside the distal end portion of the vascular access device, and positioning the preformed structure outside the distal end portion of the vascular access device activates the vascular sealing portion and radially expands the preformed structure to at least partially seal the vascular access device against the interior of the first vessel.

9. 10. The embolic protection system of claim 8, wherein the preformed structure comprises a wire structure.

10. 10. The embolic protection system of claim 9, wherein the wire structure includes at least one of a membrane or a coating at least partially covering the wire structure to prevent blood flow through the wire structure.

11. 5. The embolic protection system of claim 4, wherein the vascular access device further comprises a sealing actuator configured to activate and / or deactivate the vascular sealing portion.

12. The embolic protection system of claim 11 , wherein axially moving the sealing actuator activates and / or deactivates the vascular sealing portion.

13. The embolic protection system of claim 1 , wherein the vascular access device comprises an introducer sheath.

14. The embolic protection system of claim 1 , wherein the vascular return device comprises an introducer sheath.

15. The embolic protection system of claim 1 , wherein at least one of the vascular access device or the vascular return device comprises a radiopaque marker.

16. 10. The embolic protection system of claim 1, wherein the vascular closure device is configured to percutaneously close and seal an opening in the second vessel.

17. 17. The embolic protection system of claim 16, wherein the vascular closure device is configured to access the interior of the second vessel through the vascular return device.

18. the vascular closure device further comprising a suturing mechanism actuator coupled to the suturing mechanism for moving the suturing mechanism to an actuated orientation; The embolic protection system of claim 1 , wherein the pivot element is configured to be moved into a deployed orientation within the vessel by the suturing mechanism actuator.

19. The embolic protection system of claim 1 , wherein the connecting member comprises a flexible connecting member.

20. 10. The embolic protection system of claim 1, wherein the first needle comprises a needle body and a detachable tip coupled to the tension member, the detachable tip configured to be coupled to a first end of the connecting member.

21. the suturing mechanism is configured to be directed through the vascular access device; 10. The embolic protection system of claim 1, wherein the vascular access device is configured to be withdrawn from the first vessel while the suturing mechanism remains in the first vessel.

22. 1. An embolic protection system comprising: a vascular access device configured to percutaneously access an interior of a first vessel, the vascular access device comprising a vascular sealing portion configured to at least partially seal the vascular access device against the interior of the first vessel when actuated; a vascular retrieval device configured to access the interior of the second vessel; a filter configured to collect emboli; a flow control device; tubing configured to connect the vascular access device, the vascular return device, the filter, and the flow control device; a vascular closure device configured to percutaneously close and seal an opening in the first vessel, comprising: a proximal end comprising a handle with a needle actuator; an elongated shaft coupled to the handle; a suturing mechanism coupled to a distal end of the elongate shaft, the suturing mechanism configured to be actuated within the first vessel and comprising a pivot element; first and second needles associated with the suturing mechanism, the first and second needles configured to be directed through a first vessel wall adjacent the opening in the first vessel, at least one of the first and second needles coupled to the needle actuator and configured to be directed through the first vessel wall with the needle actuator; a tension member coupled to the first needle; and a connecting member associated with the suturing mechanism, the connecting member having a first connecting member end configured to be coupled to the first needle and a second connecting member end configured to be coupled to the second needle, the connecting member configured to pull the tensioning member through the first vessel wall to close and seal the opening in the first vessel. a vascular closure device comprising: Equipped with The embolic protection system is configured to direct blood flow from the first vessel through the vascular access device, the filter, the flow control device, and the vascular return device to the second vessel, and the flow control device is configured to control the blood flow from the first vessel to the second vessel.

23. 23. The embolic protection system of claim 22, wherein the vascular closure device is configured to access the interior of the first vessel through the vascular access device.

24. 23. The embolic protection system of claim 22, wherein the vascular sealing portion comprises an expandable element, and actuating the vascular sealing portion comprises expanding the expandable element of the vascular sealing portion to at least partially seal the vascular access device against the interior of the first vessel.

25. 23. The embolic protection system of claim 22, wherein the expandable element comprises a balloon, and wherein inflating the balloon at least partially seals the vascular access device against the interior of the first vessel.

26. 23. The embolic protection system of claim 22, wherein the sealing portion comprises a compliant material, and wherein actuating the vascular sealing portion comprises compressing the compliant material to radially expand the compliant material and thereby at least partially seal the vascular access device against the interior of the first vessel.

27. the sealing portion comprises a preformed structure; 23. The embolic protection system of claim 22, wherein the preformed structure is in an unactuated or compressed state when the sealing portion is positioned inside the distal end portion of the vascular access device, and positioning the preformed structure outside the distal end portion of the vascular access device activates the vascular sealing portion and radially expands the preformed structure to at least partially seal the vascular access device against the interior of the first vessel.

28. 28. The embolic protection system of claim 27, wherein the preformed structure comprises a wire structure.

29. 30. The embolic protection system of claim 28, wherein the wire structure includes at least one of a membrane or a coating at least partially covering the wire structure to prevent blood flow through the wire structure.

30. 23. The embolic protection system of claim 22, wherein the vascular access device further comprises a sealing actuator configured to activate and / or deactivate the vascular sealing portion.

31. 31. The embolic protection system of claim 30, wherein axially moving the sealing actuator activates and / or deactivates the vascular sealing portion.

32. 23. The embolic protection system of claim 22, wherein the vascular access device comprises an introducer sheath.

33. 23. The embolic protection system of claim 22, wherein the vascular return device comprises an introducer sheath.

34. 23. The embolic protection system of claim 22, wherein at least one of the vascular access device or the vascular return device comprises a radiopaque marker.

35. 23. The embolic protection system of claim 22, wherein the vascular closure device is configured to percutaneously close an opening in the second vessel.

36. 23. The embolic protection system of claim 22, wherein the vascular closure device is configured to access the second vessel through the vascular return device.

37. the vascular closure device further comprising a suturing mechanism actuator coupled to the suturing mechanism for moving the suturing mechanism to an actuated orientation; 23. The embolic protection system of claim 22, wherein the pivot element is configured to be moved by the suturing mechanism actuator to a deployed orientation within the vessel.

38. 23. The embolic protection system of claim 22, wherein the connecting member comprises a flexible connecting member.

39. 23. The embolic protection system of claim 22, wherein the first needle comprises a needle body and a detachable tip coupled to the tension member, the detachable tip configured to be coupled to a first end of the connecting member.

40. the suturing mechanism is configured to be directed through the vascular access device; 23. The embolic protection system of claim 22, wherein the vascular access device is configured to be withdrawn from the first vessel while the suturing mechanism remains in the first vessel.

41. 1. A method of providing embolic protection, comprising: percutaneously accessing an interior of a first vessel with a vascular access device; accessing the interior of the second vessel with a vascular retrieval device; connecting tubing to the vascular access device and the vascular return device; connecting a filter to the piping; establishing blood flow from the first vessel through the vascular access device, the filter, and the vascular return device to the second vessel; percutaneously closing the opening in the first vessel by directing a suturing mechanism through the vascular access device and into the interior of the first vessel, withdrawing the vascular access device from the first vessel, actuating a pivot element within the first vessel to direct first and second needles through a first vessel wall adjacent the opening in the first vessel, directing a tensioning member with the first needle through the first vessel wall adjacent the opening in the first vessel, coupling the first and second needles to a connecting member, withdrawing the suturing mechanism from the first vessel, pulling the connecting member and the tensioning member with the second needle through the first vessel wall, and tightening the tensioning member to close and seal the opening in the first vessel. A method comprising:

42. connecting a flow control device to the tubing; directing the blood flow through the flow control device; controlling the blood flow from the first vessel to the second vessel with the flow control device; 42. The method of claim 41, further comprising:

43. 42. The method of claim 41, wherein the first vessel is a carotid artery.

44. 42. The method of claim 41, wherein the second vessel is a femoral vein.

45. 42. The method of claim 41, wherein accessing the interior of the second vessel comprises percutaneously accessing the second vessel with the vascular retrieval device.

46. 42. The method of claim 41, further comprising at least partially sealing the vascular access device against the inside of the first vessel.

47. 47. The method of claim 46, wherein at least partially sealing the vascular access device against the interior of the first vessel comprises expanding a vascular sealing portion of the vascular access device.

48. the vascular sealing portion of the vascular access device comprises a balloon; 48. The method of claim 47, further comprising inflating the balloon.

49. 47. The method of claim 46, wherein at least partially sealing the vascular access device against the interior of the first vessel further comprises compressing a flexible material of a vascular sealing portion of the vascular access device to radially expand the flexible material.

50. 47. The method of claim 46, wherein at least partially sealing the vascular access device against the interior of the first vessel further comprises actuating a preformed structure of a sealing portion of the vascular access device to radially expand the preformed structure.

51. 47. The method of claim 46, wherein at least partially sealing the vascular access device against the interior of the first vessel further comprises actuating a vascular sealing portion of the vascular access device with a sealing actuator.

52. 52. The method of claim 51, further comprising axially moving the sealing actuator to actuate the vascular sealing portion.

53. 42. The method of claim 41, wherein withdrawing the vascular access device from the first vessel while the suturing mechanism remains in the first vessel thereby inhibits blood from exiting the first vessel through the opening in the first vessel.

54. 42. The method of claim 41, wherein actuating the pivot element further comprises actuating the pivot element to a deployed orientation.

55. 42. The method of claim 41, further comprising moving the pivot element of the suturing mechanism to a removal orientation before withdrawing the suturing mechanism from the first vessel.

56. 42. The method of claim 41, further comprising the steps of percutaneously closing the opening in the second vessel by directing a suturing mechanism through the vascular retrieval device and into the interior of the second vessel, withdrawing the vascular retrieval device from the second vessel, actuating a pivot element within the second vessel to direct first and second needles through a second vessel wall adjacent an opening in the second vessel, directing a tensioning member with the first needle through the second vessel wall adjacent the opening in the second vessel, coupling the first and second needles to a connecting member, withdrawing the suturing mechanism from the second vessel, pulling the connecting member and the tensioning member with the second needle through the second vessel wall, and tightening the tensioning member to close and seal the opening in the second vessel.

57. 57. The method of claim 56, wherein actuating the pivot element further comprises actuating the pivot element to a deployed orientation.

58. 57. The method of claim 56, further comprising moving the pivot element of the suturing mechanism to a removal orientation before withdrawing the suturing mechanism from the second vessel.

59. 57. The method of claim 56, wherein withdrawing the vascular retrieval device from the second vessel while the suturing mechanism remains in the second vessel thereby inhibits blood from exiting the second vessel through the opening in the second vessel.

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