Embolic protection systems and related methods

Abstract

An embolism protection system (10) includes a blood vessel access device (100), a blood vessel reinfusion device (200), a filter (300), a conduit (400), and a blood vessel closure device (600). A vascular access device (100) is configured to percutaneously access a first blood vessel (20). The vascular reinfusion device (200) is configured to access a second blood vessel (30). The filter (300) is configured to collect embolism. The conduit (400) is configured to couple the vascular access device (100), the vascular reinfusion device (200), and the filter (300). A vessel closure device (600) is configured to percutaneously close an opening in a first vessel (20). The system is configured to direct blood flow from a first blood vessel (20) through the vascular access device (100), the filter (300), and the vascular reinfusion device (200) and into a second blood vessel (30).

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 422,345 (pending), filed on Nov. 8, 2022, and U.S. Provisional Application Serial No. 63 / 431,366 (pending), filed on Dec. 9, 2022, the disclosures of which are incorporated herein by reference in their entireties.

[0003] This application also relates to U.S. Patent Application Serial No. 17 / 546,947 (pending), filed on Dec. 9, 2021, and U.S. Patent Application Serial No. 17 / 546,958 (pending), filed on Dec. 9, 2021, the disclosures of which are incorporated herein by reference in their entireties. Technical Field

[0004] Embodiments generally relate to embolization protection devices, systems, and related methods for directly accessing blood vessels, providing embolization protection during treatment, and closing punctures or other openings in blood vessels. Background Art

[0005] Vascular access for neurotherapies poses risks of stroke and other complications caused by embolisms (loose arterial plaques) that may be generated during the procedure. One method currently provided for embolization protection is to place a temporary filter within the neurovascular artery to collect embolisms that may be generated during a common carotid artery (CCA) vascular stent implantation procedure. These filters are removed at the end of the procedure or at some time after the procedure.

[0006] Another method (and also the preferred method) of providing embolization protection involves creating retrograde carotid blood flow (flow reversal), such that blood flows from the cerebral blood vessels along the internal carotid artery and the external carotid artery (ICA and ECA, respectively) into the common carotid artery, and then the blood flow exits the patient via an introducer sheath, thereby allowing any generated embolisms (loose arterial plaques) to flow out of the brain and be filtered out of the blood flow before being re - introduced into the patient via the femoral vein.

[0007] Although the preferred method of embolization protection is the flow - reversal method, current flow - reversal devices on the market do not employ a direct carotid puncture method because the arterial puncture site cannot be percutaneously closed.

[0008] Vascular access for neurotherapeutics has traditionally been through the femoral artery or via a radial artery approach. When accessing the cerebral vasculature using traditional methods, neurotherapeutic devices must traverse a long and tortuous anatomy to reach the treatment site. The direct carotid puncture (DCP) method allows access to the common carotid artery (CCA), enabling the physician to reach the brain more quickly and without using a device that must traverse the typical femoral intervention path. The DCP method involves percutaneous puncture of the skin and arterial vessel to access the common carotid artery (CCA).

[0009] Currently, to close and seal a direct carotid puncture, a physician may manually suture prior to entering the common carotid artery and close the puncture with sutures after the procedure. Alternatively, direct pressure may be applied to the puncture site after the intervention until the vessel closes on its own. Direct pressure relies on blood coagulation at the puncture site but may be ineffective due to the lack of suitable anatomy near the common carotid artery. The time required to close the puncture with direct pressure may also be quite long. The blood pressure in the common carotid artery is high (100 to 200 mmHg), which further increases the difficulty of effectively closing a carotid puncture using direct pressure or other existing methods. Although the DCP method allows the physician to reach the brain more quickly, current arterial puncture closure methods still pose challenges.

[0010] Accordingly, despite the various advancements in the field, there remains a need for further improvement in devices, systems, and methods for accessing blood vessels, providing embolization protection, and sealing punctures or other openings in blood vessels. SUMMARY OF THE INVENTION

[0011] Generally, an embolization protection system is provided herein. The embolization 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 access a first blood vessel percutaneously. The vascular return device is configured to access a second blood vessel. The filter is configured to collect embolic material. The tubing is configured to couple the vascular access device, the vascular return device, and the filter. The vascular closure device is configured to close an opening in the first blood vessel percutaneously. The system is configured to direct blood flow from the first blood vessel through the vascular access device, the filter, and the vascular return device into the second blood vessel.

[0012] In some embodiments, the vascular closure device may be configured to access the first blood vessel through the vascular access device. The system may include a flow control device that is configured to be coupled to the vascular access device, the vascular return device, and the filter through the tubing and that may be configured to control blood flow from the first blood vessel to the second blood vessel.

[0013] In some embodiments, the vascular access device may include a vascular sealing portion configured to form a seal with at least a portion of the inner side of a first blood vessel when the vascular sealing portion is activated. The vascular sealing portion may include an expandable element, and activating the vascular sealing portion may include expanding the expandable element of the vascular sealing portion so that the vascular access device forms a seal with at least a portion of the inner side of the first blood vessel. In an alternative embodiment, the expandable element may include a balloon, and inflating the balloon may cause the vascular access device to form a seal with at least a portion of the inner side of the first blood vessel. In other embodiments, the vascular sealing portion may include a flexible material, and activating the vascular sealing portion may include compressing the flexible material to radially expand the flexible material so that the vascular access device forms a seal with at least a portion of the inner side of the first blood vessel. The vascular sealing portion may include a preformed structure, and activating the vascular sealing portion may cause the preformed structure to radially expand so that the vascular access device forms a seal with at least a portion of the inner side of the first blood vessel. The preformed structure may include a filamentous structure. The filamentous structure may include one of a thin film or a coating that at least partially covers the filamentous structure to prevent blood flow through the filamentous structure. The vascular access device may include a seal actuator configured to activate and / or deactivate the vascular sealing portion. Axially moving the seal actuator may activate and / or deactivate the vascular sealing portion.

[0014] In some embodiments, the vascular access device may be an introducer sheath. The blood vessel return device may be an introducer sheath. The vascular access device may include a radiopaque marker. The vascular closure device may be configured to percutaneously close an opening in a second blood vessel. The vascular closure device may be configured to enter the second blood vessel through the blood vessel return device.

[0015] The present invention also discloses an alternative embolization protection system. The alternative embolization protection system includes a vascular access device, a blood vessel return device, a filter, a flow control device, a conduit, and a vascular closure device. The vascular access device is configured to percutaneously access a first blood vessel. The vascular access device includes a vascular sealing portion configured to form a seal with at least a portion of the inner side of the first blood vessel when the vascular sealing portion is activated. The blood vessel return device is configured to access a second blood vessel. The filter is configured to collect embolic materials. The conduit is configured to couple the vascular access device, the blood vessel return device, the filter, and the flow control device. The vascular closure device is configured to percutaneously close an opening in the first blood vessel. The embolization protection system is configured to direct blood flow from the first blood vessel through the vascular access device, the filter, the flow control device, and the blood vessel return device and into the second blood vessel. The flow control device is configured to control the blood flow from the first blood vessel to the second blood vessel.

[0016] In some embodiments, the vascular closure device may be configured to enter a first blood vessel through a vascular access device. The vascular sealing portion may include an expandable element. Activating the vascular sealing portion may include expanding the expandable element of the vascular sealing portion so that the vascular access device forms a seal against at least a portion of the inner side of the first blood vessel. The expandable portion may include a balloon, and inflating the balloon may cause the vascular access device to form a seal against at least a portion of the inner side of the first blood vessel. The sealing portion may include a flexible material, and activating the vascular sealing portion may include compressing the flexible material to radially expand the flexible material so that the vascular access device forms a seal against at least a portion of the inner side of the first blood vessel. The sealing portion may include a preformed structure, and activating the vascular sealing portion may cause the preformed structure to radially expand so that the vascular access device forms a seal against at least a portion of the inner side of the first blood vessel. The preformed structure may include a filamentous structure. The filamentous structure may include at least one of a film or a coating that at least partially covers the filamentous structure to prevent blood flow through the filamentous structure. The vascular access device may include a seal actuator configured to activate and / or deactivate the vascular sealing portion. Axially moving the seal actuator may activate and / or deactivate the vascular sealing portion.

[0017] In some embodiments, the vascular access device may be an introducer sheath. The vascular return device may be an introducer sheath. The vascular access device may include a radiopaque marker. The vascular closure device may be configured to percutaneously close an opening in a second blood vessel. The vascular closure device may be configured to enter the second blood vessel through the vascular return device.

[0018] A method of providing embolization protection is provided herein. The method of providing embolization protection includes: percutaneously entering a first blood vessel using a vascular access device; percutaneously entering a second blood vessel using a vascular return device; coupling a filter and a tubing to the vascular access device and the vascular return device. The method includes establishing blood flow from the first blood vessel through the vascular access device, the filter, and the vascular return device into the second blood vessel. The method further includes percutaneously closing an opening in the first blood vessel.

[0019] Methods of providing embolization protection can include coupling a flow control device to a conduit, directing blood flow through the flow control device, and using the flow control device to control blood flow from a first blood vessel to a second blood vessel. The first blood vessel can be the carotid artery. The second blood vessel can be the femoral vein. Entering the second blood vessel can include percutaneous entry into the second blood vessel using a vascular return device. The method can include percutaneous closure of an opening in the second blood vessel. The method can include forming a seal with a vascular access device at least partially against the inner side of the first blood vessel. Forming a seal with the vascular access device at least partially against the inner side of the first blood vessel can include expanding a vascular seal portion of the vascular access device. The vascular seal portion of the vascular access device can include a balloon, and the method can include inflating the balloon. Forming a seal with the vascular access device at least partially against the inner side of the first blood vessel can also include compressing a flexible material of the vascular seal portion of the vascular access device to radially expand the flexible material. Forming a seal with the vascular access device at least partially against the inner side of the first blood vessel can include activating a preformed structure of the vascular seal portion of the vascular access device to radially expand the preformed structure. Forming a seal with the vascular access device at least partially against the inner side of the first blood vessel can include using a seal actuator to activate and / or deactivate the vascular seal portion of the vascular access device. The method can include axially moving the seal actuator to activate and / or deactivate the vascular seal portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic diagram of an illustrative embolization protection system.

[0021] Figure 2 is Figure 1 a side view of an illustrative vascular access device of the embolization protection system.

[0022] Figure 2A is Figure 2 a cross-sectional view of the vascular access device.

[0023] Figure 2B is Figure 2 a side view of the vascular access device with the vascular seal portion in an activated state.

[0024] Figure 3 is Figure 1 a side view of an illustrative vascular return device of the embolization protection system.

[0025] Figure 3A is Figure 3 a cross-sectional view of the vascular return device.

[0026] Figure 4 is Figure 1 a side view of an illustrative filter, flow control device, and three-way valve of the embolization protection system.

[0027] Figure 5A Depicting a percutaneous insertion into a blood vessel Figure 2 of a blood vessel access device.

[0028] Figure 5B Depicting Figure 2 a blood vessel access device that forms a seal at least partially against the inner side of the blood vessel.

[0029] Figure 6 Depicting a percutaneous insertion into a blood vessel Figure 3 of a blood vessel return device.

[0030] Figure 7A And 7B are cross-sectional views of alternative illustrative blood vessel access devices.

[0031] Figure 8A And 8B are cross-sectional views of another illustrative blood vessel access device.

[0032] Figure 9 is a schematic view of an alternative illustrative embolization protection system.

[0033] Figure 10A is a side view of an alternative illustrative blood vessel access device.

[0034] Figure 10B Is Figure 10A a cross-sectional view of a blood vessel access device.

[0035] Figure 11 Depicting a percutaneous insertion into a blood vessel Figure 10A of a blood vessel access device.

[0036] Figure 12 is a perspective view of an illustrative blood vessel closure device.

[0037] Figure 13A 、 13B And 13C are Figure 12 perspective views of the suture mechanism at the distal end of a blood vessel closure device.

[0038] Figure 14 Shows Figure 12 a blood vessel closure device inserted into Figure 2 a blood vessel access device.

[0039] Figures 15A to 15J Is Figure 12 a series of progressive side views of the distal end of a blood vessel closure device during a suturing operation.

[0040] Figure 16 is a perspective view of an alternative illustrative blood vessel closure device.

[0041] Figure 17 Is Figure 16Exploded sectional view of the handle of the vascular closure device.

[0042] Figure 18A 、 18B and 18C are Figure 16 Perspective view of the suturing mechanism at the distal end of the vascular closure device.

[0043] Figure 19A is Figure 16 Top view of the handle of the vascular closure device.

[0044] Figure 19B is Figure 16 Sectional view of the suturing mechanism of the vascular closure device.

[0045] Figure 20A is Figure 16 Top view of the handle of the vascular closure device.

[0046] Figure 20B is Figure 16 Sectional view of the suturing mechanism of the vascular closure device.

[0047] Figure 21A is Figure 16 Sectional view of the handle of the vascular closure device.

[0048] Figure 21B is Figure 16 Sectional view of the suturing mechanism of the vascular closure device.

[0049] Figure 22A is Figure 16 Sectional view of the handle of the vascular closure device.

[0050] Figure 22B is Figure 16 Sectional view of the suturing mechanism of the vascular closure device.

[0051] Figure 23A is Figure 16 Sectional view of the handle of the vascular closure device.

[0052] Figure 23B is Figure 16 Sectional view of the suturing mechanism of the vascular closure device.

[0053] Figure 24A is Figure 16 Sectional view of the handle of the vascular closure device.

[0054] Figure 24B is Figure 16 Sectional view of the suturing mechanism of the vascular closure device.

[0055] Figure 25 is Figure 16Perspective view of the handle of a vascular closure device.

[0056] Figures 26A to 26J is Figure 16 A series of progressive side views of the distal end of a vascular closure device during a suturing operation.

[0057] Figure 27 Top view of an alternative illustrative vascular closure device handle.

[0058] Figure 28 Top view of another illustrative vascular closure device handle. Detailed Description

[0059] The present disclosure generally relates to devices, systems, and methods for accessing blood vessels, providing embolization protection, and sealing puncture sites or other openings in blood vessels. An embolization protection device and / or system is described herein. The embolization protection system is described as directly accessing the common carotid artery (CCA), but can also be used to access other blood vessels. The embolization protection system provides embolization protection during neurovascular treatments such as transcarotid artery revascularization (TCAR). The system also includes a suturing device for percutaneously sealing an opening in a blood vessel such as the carotid artery or femoral vein. The devices, systems, and methods can also be used during other treatments or surgical procedures.

[0060] The direct carotid puncture (DCP), blood flow reversal, and closure system disclosed herein is designed to be used, for example, as an embolization protection device that can directly access the common carotid artery and provide embolization protection by allowing retrograde blood flow from the common carotid artery to the femoral vein during neurovascular (neural) treatments such as TCAR.

[0061] Figure 1 Schematic diagram of an illustrative embolization protection system 10. In this illustrative example, when used on a patient 12, the embolization protection system 10 allows retrograde blood flow from the patient's common carotid artery 20 to the femoral vein 30, with the blood flow direction as shown by arrow 14. In this illustrative embodiment, the embolization protection system 10 includes a vascular access device 100, a blood return device 200, a filter 300, a tubing 400, a flow control device 500, a three-way valve 550, and a vascular closure device 600 (see Figure 12 ). As used herein, the terms "blood vessel", "blood tube", "artery", "vein", and their like forms refer to any part of the circulatory system that transports blood in the human body.

[0062] Figure 2 Side view of an illustrative vascular access device 100. Figure 2AA cross-sectional view detailing the construction of the vascular access device 100. In this illustrative embodiment, the vascular access device 100 is an introducer sheath configured to access a blood vessel (such as the carotid artery) percutaneously. The vascular access device 100 has a proximal portion 102, a distal portion 104, an interface 110, an introducer sheath 140, and a vascular seal portion 160.

[0063] As used herein when describing various embodiments from the perspective of a user of a surgical device, "proximal" may refer to a direction generally toward the user of the instrument, and "distal" may refer to a direction generally away from the user of the instrument. Similarly, in the case of inserting a surgical device into a patient, from the perspective of the user of the instrument, "proximal" may refer to a direction generally away from the patient's body, and "distal" may refer to a direction generally toward the patient's body. As a reference, arrow 106 generally points proximally, and arrow 108 generally points distally.

[0064] The interface 110 includes a body 112, a side port 114, an inflation port 116, a rear interface body 118, a central lumen 120, a front interface body 122, a strain relief 124, a dilator seal 126, a compression washer 128, and a lock 130. The outer surface of the interface 110 may include indentations or other surface features to improve the ergonomics of the interface 110. For example, the side port 114 may be used to vent air from the vascular access device 100 at the start of a procedure. In this embodiment, the side port 114 serves as a conduit for retrograde blood flow during embolization protection as described herein.

[0065] Referring again to Figure 2 and 2A , the dilator seal 126 is designed to seal blood flow without an external valve (such as a Tuohy Borst valve). The user can use a guide wire, dilator, and other interventional devices through the dilator seal 126 to access the central lumen 120 located proximal to the interface 110 at the proximal portion 102 without concern for blood backflow. When a device (such as a dilator) is not passing through the central lumen 120, the dilator seal 126 remains in the closed position. The lock 130 located in the rear interface body 118 allows a device (such as a dilator) to be locked into the interface 110 before or during a procedure (such as vascular dilation). The lock 130 allows for easy removal of the device (such as a dilator) from the vascular access device 100 when the procedure is complete.

[0066] Sheath 140 has a distal portion 142 and a proximal portion 144. The proximal portion 144 of sheath 140 passes through strain relief 124 and is coupled to interface 110. Sheath 140 also includes an outer tube 146, an inner liner tube 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 illustrative embodiment, inner liner tube 148 provides a lubricious surface for the interventional device to slide therein. Reinforcement portion 150 includes cross-wound filaments and / or wires. The cross-wound filaments and / or wires of reinforcement portion 150 provide flexibility and kink resistance to sheath 140 while maintaining the tensile strength of sheath 140. For example, during a procedure where vascular access device 100 needs to be advanced through tissue, sheath 140 needs to have both flexibility and kink resistance. A hydrophilic coating can be applied to the outer surface of the sheath to reduce friction during insertion and removal procedures. Central lumen 152 extends from the distal portion 142 of sheath 140 to the proximal portion 144 and is aligned with the central lumen 120 of interface 110. Radiopaque marker 156 is located at the distal portion 142 of sheath 140. Radiopaque marker 156 is used to assist the user in guiding the distal portion 142 of sheath 140 to a desired location within a blood vessel during a procedure in which it is used in conjunction with a medical imaging device. Radiopaque marker 156 can be located at other positions on sheath 140.

[0067] Figure 2B Perspective view of illustrative vascular access device 100, showing vascular sealing portion 160 in an activated state. Refer to Figure 2 、 2A and 2B, vascular access device 100 has a vascular sealing portion 160 located at the distal portion 142 of sheath 140. Vascular sealing portion 160 is configured to form a seal with at least a portion of the inner side of the blood vessel against the distal portion 142 of sheath 140 when vascular sealing portion 160 is activated. In this illustrative embodiment, vascular sealing portion 160 includes an expandable element 162. Activating vascular sealing portion 160 includes expanding the expandable element 162 of vascular sealing portion 160, thereby forming a seal with at least a portion of the inner side of the blood vessel against vascular access device 100. In this illustrative embodiment, expandable element 162 is an inflatable element including a balloon. Inflating the balloon forms a seal with at least a portion of the inner side of the blood vessel against vascular access device 100.

[0068] In this illustrative embodiment, the inflation chamber 154 is coupled to the inflation port 116 on the interface 110 and extends to and is coupled to the vascular sealing portion 160 at the distal portion 142 of the sheath 140. When the vascular access device 100's vascular sealing portion 160 is positioned within a blood vessel, the user injects fluid into the inflation port 116, and the fluid passes through the inflation chamber 154 into the vascular sealing portion 160, causing the expandable portion 162 to expand and / or inflate (see Figure 2B ), and causing the vascular access device 100 to form a seal against at least a portion of the inner side of the blood vessel. Withdrawing fluid from the inflation port 116 will cause the expandable portion 162 to contract and / or deflate (see Figure 2 ), thereby withdrawing the vascular sealing portion 160 from within the blood vessel.

[0069] Figure 3 Perspective view of an illustrative vascular access device 200. Figure 3A Cross-sectional view detailing the structure of the vascular access device 200. In this illustrative embodiment, the vascular access device 200 is an introducer sheath for percutaneous access to a blood vessel (such as the femoral vein). The vascular access device 200 has a proximal portion 202, a distal portion 204, an interface 210, and a sheath 240. For reference, arrow 206 generally points proximally and arrow 208 generally points distally. The interface 210 includes a body 212, a side port 214, a rear interface body 218, a central lumen 220, a front interface body 222, a strain relief 224, a dilator seal 226, and a compression washer 228. The outer surface of the interface 210 may include indentations or other surface features to improve the ergonomics of the interface 210.

[0070] The dilator seal 226 is designed to seal the blood flow without an external valve (such as a Tuohy Borst valve). The user can access the proximal portion 202 of the interface 210, such as a guide wire, a dilator, and an interventional device, through the dilator seal 226 without concern for blood backflow. When a device (such as a dilator) is not passing through the central lumen 220, the dilator seal 226 remains in the closed position. The rear interface body 218 includes a lock 230 that allows a device (such as a dilator) to be locked into the interface 210 before or during a procedure (such as vascular dilation). The lock 230 allows the device (such as a dilator) to be easily removed from the vascular access device 200 after the procedure is completed. The side port 214 can be used to vent air from the vascular access device 200 at the start of the procedure. As described herein, the side port 214 serves as a conduit for retrograde blood flow during embolization protection.

[0071] The sheath 240 has a distal portion 242 and a proximal portion 244. The proximal portion 244 of the sheath 240 passes through the strain relief member 224 and is coupled to the interface 210. The sheath 240 further includes an outer cannula 246, an inner cannula 248, a reinforcement portion 250, a central lumen 252, and one or more radiopaque markers 256. In this illustrative embodiment, the reinforcement portion 250 includes cross-wound filaments and / or wires that provide flexibility and kink resistance to the sheath 240 while maintaining the tensile strength of the sheath 240. For example, during a surgical procedure, the sheath 240 needs to be flexible and kink resistant, as is the case during a procedure where it is necessary to advance the blood vessel retrieval device 200 through tissue. The central lumen 252 extends from the distal portion 242 to the proximal portion 244 of the sheath 240 and is aligned with the central lumen 220 of the interface 210. The radiopaque marker 256 is located at the distal portion 242 of the sheath 240. The radiopaque marker 256 is used in conjunction with a medical imaging device during a surgical procedure to assist a user in guiding the distal portion 242 of the sheath 240 to a desired location within a blood vessel. The radiopaque marker 256 can be located at other positions on the sheath 250.

[0072] Figure 4 is a side view of an illustrative filter 300, flow control device 500, and three-way valve 550 of the embolization protection system 10. In this illustrative embodiment, the filter 300 is configured to filter blood and collect emboli (plaques) generated during a surgical 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 embolization protection while allowing sufficient blood flow during the surgical procedure. As shown by arrow 14, when the filter 300 is in use, blood flows through the inlet 304, through the filter element 302 into the filter 300, and out through the outlet 306.

[0073] In this illustrative embodiment, the flow control device 500 has an inlet 502 and an outlet 504. As shown by arrow 14, when the flow control device 500 is in use, blood flows through the inlet 502 into the flow control device 500, through the flow control device 500, and out through the outlet 504. The flow control device 500 is configured to control blood flow. In some embodiments, the flow control device 500 can be adjusted by a user, for example, while in alternative embodiments, the flow control device 500 can automatically adjust blood flow. In alternative embodiments, the flow control device 500 can be used, for example, to reduce blood flow during a surgical procedure. In some embodiments, the flow control device 500 can be used to start or stop blood flow (such as at the start and / or end of a surgical procedure). In some embodiments, the flow control device 500 can be a stopcock (two-way or three-way), while in alternative embodiments, the flow control device 500 can be other types of valves and / or restrictors. In some embodiments, the flow control device 500 can be coupled proximal to the filter 300, while in other embodiments, the flow control device 500 can be integrated with the filter 300, for example, as part of a filter assembly.

[0074] In this illustrative embodiment, the three-way valve 550 has an inlet 552, an outlet 554, and an access port 556. As shown by arrow 14, when the three-way valve 550 is in use, blood flows through the inlet 552 into the three-way valve 550, through the three-way valve 550, and out through the outlet 554. The three-way valve 550 is configured to provide the user with the access port 556 at the start or during a surgical procedure for injecting saline or contrast agent into the patient. The three-way valve 550 also allows air to be expelled from the embolization protection system 10 at the start of a surgical procedure (such as a retrograde blood flow procedure). In some embodiments, the three-way valve 550 can be used in combination with the filter 300 and / or the flow control device 500.

[0075] Reference Figure 1 and Figure 4 , in this illustrative embodiment, the tubing 400 couples the vascular access device 100, the vascular return device 200, the filter 300, the three-way valve 550, and the flow control device 500. As shown by arrow 14, the tubing 400 is configured to direct blood flow from the common carotid artery 20 through the vascular access device 100, the filter 300, the three-way valve 550, the flow control device 500, and the vascular return device 200 and into the femoral vein 30.

[0076] Figure 1 , 5A , 5B, and 6 illustrate a method of percutaneously accessing a blood vessel and establishing retrograde blood flow to provide embolization protection during another medical procedure (such as a neurovascular procedure). In this example, the blood vessels used to establish retrograde blood flow are the common carotid artery 20 and the femoral vein 30.Figure 5A Depict a vascular access device 100 inserted percutaneously into the common carotid artery 20, where the sheath 140 is aligned with the lumen of the common carotid artery 20. Figure 5B Depict a vascular access device 100 forming a seal at least partially against the medial side of the common carotid artery 20. Figure 6 Depict a vascular return device 200 inserted percutaneously into the femoral vein 30.

[0077] Use ultrasound or other non-invasive methods to determine the common carotid artery 20 and the suitable location for percutaneous access to the common carotid artery 20. Using ultrasound or other suitable methods, guide the needle and guide wire to the determined access location on the common carotid artery 20. Pierce the common carotid artery 20 with the needle and insert the guide wire into the common carotid artery 20. Insert the dilator into the vascular access device 100 and guide it along the guide wire to form 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 portion 142 of the sheath 140 of the vascular access device 100 can enter the interior of the common carotid artery 20.

[0078] Insert the vascular access device 100 percutaneously into the common carotid artery 20, where the sheath 140 is aligned with the lumen of the common carotid artery 20 (see Figure 5A ). Inject fluid into the inflation port 116 of the fluid injection interface 110 to expand the expandable element 162 of the vascular seal portion 160 of the vascular access device 100 (see Figure 5B ). The vascular seal portion 160 expands such that the vascular seal portion 160 engages with the interior of the common carotid artery 20, thereby forming a seal at least partially against the medial side of the common carotid artery 20 with the vascular access device 100. In this example, forming a seal at least partially against the medial side of the common carotid artery 20 with the vascular access device 100 will temporarily block the forward blood flow, as shown by the arrow 16 in Figure 5A , from the brachiocephalic artery 22 to the common carotid artery 20.

[0079] Similar to the method of accessing the common carotid artery 20 described above, in this example, use ultrasound or other non-invasive methods to identify the femoral vein 30 and the suitable location for percutaneous access to the femoral vein 30. Using ultrasound or other suitable methods, guide the needle and guide wire to the access location on the femoral vein 30. Pierce the femoral vein 30 with the needle and insert the guide wire into the femoral vein 30. Insert the dilator into the vascular return device 200 and guide it along the guide wire to form an opening in the femoral vein 30. The dilator is used to dilate the opening in the femoral vein 30 so that the distal portion 242 of the sheath 240 of the vascular return device 200 can enter the interior of the femoral vein 30. Insert the vascular return device 200 percutaneously into the femoral vein 30, with the sheath 240 aligned with the lumen of the femoral vein 30 (see Figure 6 ).

[0080] Refer to Figure 1 and 4, in this illustrative example, the conduit 400 is coupled to the side port 114 of the vascular access device 100 and the inlet 552 of the three-way valve 550. The conduit 400 is coupled to the outlet 554 of the three-way valve 550 and the inlet 502 of the flow control device 500. The conduit 400 is connected to the outlet 504 of the flow control device 500 and the inlet 304 of the filter 300. The conduit 400 is connected to the outlet 306 of the filter 300 and 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 can be connected between the vascular access device 100 and the vascular return device 200 in any order. The filter 300, the flow control device 500, and / or the three-way valve 550 can 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 the vascular return device 200 is inserted into the femoral artery 30.

[0081] Reference Figure 1 and 4 , in this illustrative example, after the vascular access device 100 forms a seal against at least a portion of the inner side of the common carotid artery 20, the vascular return device 200 has entered the femoral vein 30, and the conduit 400 connects the vascular access device 100, the three-way valve 550, the flow control device 500, the filter 300, and the vascular return device 200, retrograde blood flow as shown by arrow 14 is established. At least partially sealing the vascular access device 100 to the interior of the common carotid artery 20 also temporarily blocks the forward blood flow from the brachiocephalic artery 22 to the common carotid artery 20 as shown by arrow 16. Establishing retrograde blood flow includes guiding retrograde blood flow from the internal carotid artery 24 and the external carotid artery 26 to the common carotid artery 20. The retrograde blood flow is guided into the sheath 140 and exits through the side port 114 of the vascular access device 100, flows through the conduit 400, the three-way valve 550, the flow control device 500, the filter 300, and flows into the side port 214 and out of the sheath 240 of the vascular return device 200. The retrograde blood flow is ultimately guided 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 to flow from the common carotid artery 20 to the femoral vein 30.

[0082] In this illustrative embodiment, the 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, the blood flow from the carotid artery 20 to the femoral vein 30 can be automatically controlled by the flow control device 500. In certain cases, if the retrograde blood flow is too high for the patient, the patient may become disoriented (dizzy) or lose consciousness (faint) due to blood being diverted from the brain. The flow control device 500 can be used to reduce the blood flow to prevent the patient from becoming disoriented or losing consciousness. During certain medical procedures, the flow control device 500 can be used to reduce and / or stop the blood flow to prevent other clinical situations.

[0083] The filter 300 captures any emboli (plaques) generated during a surgical procedure, such as a neurovascular procedure. Once retrograde blood flow is established, a neurovascular procedure can be performed under the embolic protection provided by the filter 300. Such procedures may include TCAR (transcarotid artery revascularization), thrombectomy, aneurysm embolization, etc.

[0084] After the procedure is completed, antegrade blood flow is restored. The flow control device 500 can be used to block the retrograde blood flow. In this illustrative embodiment, fluid is withdrawn from the inflation port 116, causing the expandable portion 162 of the vascular sealing portion 160 of the vessel access device 100 to contract and / or deflate (see Figure 5A ). Contracting and / or deflating the expandable portion 162 withdraws the vascular sealing portion 160 from the interior of the vessel, thereby allowing the antegrade blood flow indicated by arrow 16 to be restored.

[0085] Figure 7A and 7B are cross-sectional views detailing the construction of an alternative vessel access device 100a. Generally, the construction and operation of the vessel access device 100a are similar to those of the above-described vessel access device 100, and the vessel access device 100a can be replaced with other vessel access devices, or any features of the vessel access device 100a can be used in various other embodiments in accordance with the present disclosure. The same reference numerals denote the same components. For the sake of brevity, the following description will minimize redundant descriptions and focus on the differences between the vessel access device 100a and the vessel access device 100.

[0086] In this illustrative embodiment, the vessel access device 100a has a proximal portion 102a, a distal portion 104a, an interface 110a, a sheath 140a, and a vascular sealing portion 160a. As a reference, arrow 106 generally points proximally and arrow 108 generally points distally. The interface 110a includes an anterior interface body 112a, a side port 114a, a posterior interface body 118a, a central lumen 120a, a strain relief 124a, a dilator seal 126a, a compression gasket 128a, a lock 130a, and a seal actuator 170a.

[0087] Sheath 140a has a distal portion 142a and a proximal portion 144a. Sheath 140a further includes an outer cannula 146a, an inner cannula 148a, a reinforcing portion 150a, a central lumen 152a, an activation member 154a, and one or more radiopaque markers 156a.

[0088] A vascular sealing portion 160a is located at the distal portion 142a of sheath 140a. The vascular sealing portion 160a is configured to form a seal such that at least a portion of the distal portion 142a of sheath 140a of the vascular access device 100a abuts against the inner side of a blood vessel (such as the carotid artery) when the vascular sealing portion 160a is activated. In this illustrative embodiment, the vascular sealing portion 160a is a flexible material 162a. The flexible material 162a may include silicone, polyurethane, or other similar suitable and flexible materials. The activation member 154a is coupled to the vascular sealing portion 160a at the distal portion 142a of sheath 140a and to a seal actuator 170a at the hub 110a.

[0089] The seal actuator 170a includes a handle 172a coupled to a follower 174a, which is coupled to the proximal end of the activation member 154a. The follower 174a is configured to move within the front interface body 112a of the interface 110a along the central axis of the vascular access device 100a. Axially moving the seal actuator 170a in the proximal direction (as shown by arrows 106 and 182a) causes the activation member 154a to move in the proximal direction and activates the vascular sealing portion 160a. Activating the vascular sealing portion 160a includes axially compressing the flexible material 162a, which causes the flexible material 162a to radially (circumferentially) expand (see Figure 7B ), thereby forming a seal such that at least a portion of the vascular access device 100a abuts against the inner side of the blood vessel. Axially moving the seal actuator 170a in the distal direction (as shown by arrows 108 and 182a) causes the activation member 154a to move in the distal direction and deactivates the vascular sealing portion 160a (see Figure 7A ). Deactivating the vascular sealing portion 160a includes axially decompressing the flexible material 162a, causing it to radially retract, thereby pulling the vascular sealing portion 160a out of the blood vessel. In this illustrative example, the seal actuator 170a includes a handle 172a. In other embodiments, the seal actuator 170a may include a knob, a lever, a button, or any other device or structure for moving the follower 174a and the activation member 154a to activate and / or deactivate the vascular sealing portion 160a.

[0090] Figure 8A and 8BA cross-sectional view detailing the structure of the alternative vascular access device 100b. Generally speaking, the structure and operation of the vascular access device 100b are similar to those of the above-mentioned vascular access devices 100 and 100a, and the vascular access device 100b can be replaced by other vascular access devices, or any features of the vascular access device 100b can be used in various other embodiments according to the present disclosure. The same reference numerals represent the same components. For the sake of brevity, the following description will minimize redundant descriptions and focus on the differences between the vascular access device 100b and the vascular access devices 100 and 100a.

[0091] In this illustrative embodiment, the vascular access device 100b has a proximal portion 102b, a distal portion 104b, an interface 110b, a sheath 140b, and a vascular sealing portion 160b. As a reference, arrow 106 generally points proximally, and arrow 108 generally points distally. The interface 110b includes a front body 112b, a side port 114b, a rear interface body 118b, a central lumen 120b, a strain relief 124b, a dilator seal 126b, a compression gasket 128b, a lock 130b, and a seal actuator 170b.

[0092] The sheath 140b has a distal portion 142b and a proximal portion 144b. The sheath 140b also includes an outer catheter 146b, a liner tube 148b, a reinforcing portion 150b, a central lumen 152b, an activation member 154b, and one or more radiopaque markers 156b.

[0093] The vascular access device 100b has a vascular sealing portion 160b located at the distal portion 142b of the sheath 140b. The vascular sealing portion 160b is configured to form a seal by at least partially abutting the distal portion 142b of the sheath 140b of the vascular access device 100b against the inner side of the blood vessel when the vascular sealing portion 160b is activated. In this illustrative embodiment, the vascular sealing portion 160b is a preformed structure 162b. As Figure 8A shown, the preformed structure 162b is located inside the sheath 140b in a non-activated or compressed state. As Figure 8B shown, the preformed structure 162b is located outside the sheath 140b in an activated or expanded state. In this illustrative embodiment, the preformed structure 162b includes a preformed filamentous structure. In some embodiments, the filamentous structure may include a film or coating that at least partially covers the preformed structure 162b to prevent blood flow through the filamentous structure of the preformed structure 162b.

[0094] The seal actuator 170b includes a handle 172b that is coupled to a follower 174b, which is coupled to the proximal end of an activation member 154b. The follower 174b is configured to move within the body 112b of the interface 110b along the central axis of the vascular access device 100b. Axially moving the seal actuator 170b in the distal direction (as shown by arrows 108 and 182b) causes the activation member 154b to move in the distal direction, thereby moving the preformed structure 162b out of the distal end 142b of the sheath 140b. Once out of the sheath 140b, the preformed structure 162b is activated and expands radially (circumferentially) (see Figure 8B ), thereby forming a seal with the vascular access device 100b at least partially against the inner side of the blood vessel. Moving the seal actuator 170b proximally in the proximal direction (as shown by arrows 106 and 180b) causes the outer cannula 146b to move in the distal direction, thereby moving the preformed structure 162b inside the sheath 140b and deactivating the vascular seal portion 160b (see Figure 8A ). In this illustrative example, the seal actuator 170b includes a handle 172b. In other embodiments, the seal actuator 170b can include a knob, lever, button, or any other device configured to move the follower 174b and the activation member 154b to activate and / or deactivate the vascular seal portion 160b. In an alternative embodiment, the follower 174b can be coupled to the outer cannula 146b, and moving the seal actuator 170b can move the outer cannula 146b to activate and / or deactivate the vascular seal portion 160b.

[0095] Figure 9 An alternative embolization protection system 10a is shown. Generally, the structure and operation of the embolization protection system 10a are similar to those of the embolization protection system 10 described above, and in various other embodiments in accordance with the present disclosure, the embolization protection system 10a can be replaced with other embolization protection systems, or any features of the embolization protection system 10a can be used. The same reference numerals denote the same components. For the sake of brevity, the following description will minimize redundant descriptions and focus on the differences between the embolization protection system 10 and the embolization protection system 10a. In this illustrative embodiment, the embolization protection system 10a includes a vascular access device 100c, a blood return device 200, a filter 300, a tubing 400, a flow control device 500, a three-way valve 550, and a vascular closure device 600 (see Figure 12 ).

[0096] Figure 10A Side view of an illustrative vascular access device 100c. Figure 10BA cross-sectional view detailing the structure of the vascular access device 100c. Generally speaking, the structure and operation of the vascular access device 100c are similar to those of the above-mentioned vascular access devices 100, 100a, and 100b, and the vascular access device 100c can be replaced by other vascular access devices, or any features of the vascular access device 100c can be used in various other embodiments according to the present disclosure. The same reference numerals represent the same components. For the sake of brevity, the following description will minimize redundant descriptions and focus on the differences between the vascular access device 100c and the vascular access devices 100, 100a, and 100b.

[0097] In this illustrative embodiment, the vascular access device 100c has a proximal portion 102c, a distal portion 104c, an interface 110c, and a sheath 140c. As a reference, arrow 106 generally points proximally, and arrow 108 generally points distally. The interface 110c includes a body 112c, a side port 114c, a rear interface body 118c, a central lumen 120c, a front interface body 122c, a strain relief 124c, a dilator seal 126c, a compression washer 128c, and a lock 130c. The sheath 140c has a distal portion 142c and a proximal portion 144c. The sheath 140c also includes an outer catheter 146c, a liner tube 148c, a reinforcing portion 150c, a central lumen 152c, and one or more radiopaque markers 156c.

[0098] Figure 1 and Figure 11 Disclosed is a method for percutaneously accessing a blood vessel and establishing retrograde blood flow to provide embolization protection during another medical procedure. In this example, the blood vessels used to establish retrograde blood flow are the common carotid artery 20 and the femoral vein 30. Figure 11 Depicted is the vascular access device 100c percutaneously inserted into the common carotid artery 20, where the sheath 140c is 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 similar in size to the inner diameter of the lumen of the common carotid artery 20. Since the outer diameter of the sheath 140c is similar to the inner diameter of the lumen of the common carotid artery 20, retrograde blood flow can be established without forming an additional seal by pressing the vascular access device 100c against the inner side of the common carotid artery 20.

[0099] Devices and methods for percutaneously closing an opening in a blood vessel are described herein. Figure 12Perspective view of an illustrative vascular closure device 600 configured to percutaneously close and seal a puncture or opening in a blood vessel, such as the carotid artery or femoral vein. In this illustrative embodiment, the vascular closure device 600 is configured to be used with a vascular access device 100. In some embodiments, the vascular closure device 600 is configured to be used with a vascular backhaul device 200. The vascular closure device 600 allows single suture closure of a blood vessel, such as the common carotid artery 20 and / or femoral vein 30, via a minimally invasive percutaneous approach.

[0100] The vascular closure device 600 includes a handle 612 at the proximal portion and a suture mechanism 614 at the distal portion. For reference, arrow 602 generally points proximally and arrow 604 generally points distally. As used herein, "suture", "suturing" and their like forms refer to any flexible tensile element or member, regardless of its form or material, and suitable for suturing tissue. As used herein, a "tensile member" can be a monofilament suture, a multifilament suture, a metal suture or any other suitable tensile member. An elongate shaft 616 extends between the handle 612 and the suture mechanism 614. A strain relief 623 is typically fixed 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.

[0101] The handle 612 includes one or more actuation mechanisms for operating the suture mechanism 614 and one or more suture needles as described herein. In this exemplary embodiment, the actuation mechanisms include a sliding suture mechanism actuator 620 for operating the suture mechanism 614 and a plunger needle actuator 622 for operating the suture needle. While the actuators are shown and described as manually driven, one or more of the actuators can be motorized, mechanically lever-driven or otherwise assisted-driven.

[0102] Figure 13A and 13B are perspective views of the distal end of the shaft 616 and the suture mechanism 614. Figure 13C is a perspective view of the distal end of the shaft 616 and the suture mechanism 614, with portions of the shaft 616 and the suture mechanism 614 shown in dashed lines. The suture mechanism 614 includes a needle guide 615 and a pivot element 624. The pivot element 624 is fixed to the distal end of the needle guide 615 by a pivot 626 that allows the pivot element 624 to pivot from Figure 13A shown with the longitudinal direction of the pivot element 624 generally aligned with the central axis of the shaft 616 towards pivoting to a orientation such as Figure 13B shown transverse to the central axis of the shaft 616. The alignment orientation of the pivot element 624 as shown in Figure 13A is the insertion and removal orientation. As shown in Figure 13BThe lateral orientation of the pivot element 624 shown is the deployment orientation to facilitate suturing operations within a blood vessel. The suturing mechanism actuator 620 (see Figure 12 ) is coupled to the pivot element 624 via an actuating wire 630. The pivot element 624 includes an elongate flexible coupling member 648 in a channel 652 (see Figure 15E ).

[0103] Refer to Figure 12 and 13C , the distal end of the vascular closure device 600 includes a first needle 640 and a second needle 642. The first needle 640 is a two-piece needle having a first needle tip 640a separable from a first needle body 640b, for example, by a friction fit. An elongate suture or tension member 650 is coupled to the first needle tip 640a (see Figure 15F ). The second needle 642 has an integral (i.e., fixed) second needle tip 642a. The term "integral" herein encompasses both a completely integral structure and a structure in which the second needle tip 642a is fixedly (i.e., non-removably) coupled to the second needle 642. The shaft 616 can be a multi-lumen flexible catheter, with an actuator wire 630 in one lumen, the first and second needles 640, 642 in two lumens, and a fourth lumen that can serve as a blood port for indicating when the distal end of the vascular closure device 600 has entered a blood vessel. The first and second needles 640, 642 are coupled to a needle actuator 622. By pressing the needle actuator 622 in the forward or distal direction, the first and second needles 640, 642 are deployed or moved distally. Pulling the needle actuator 622 in the proximal direction retracts the first needle 640 and the second needle 642 in the proximal direction.

[0104] Refer to Figure 12 , 13A -13C, when the suturing mechanism actuator 620 is in the neutral position, the pivot element 624 is in the Figure 13A shown insertion and removal orientation. Pulling or moving the suturing mechanism actuator 620 in the proximal direction pulls the drive wire 630 and activates the suturing mechanism 614, causing the pivot element 624 to pivot from the Figure 13A shown insertion and removal orientation to the Figure 13B shown deployment orientation. The suturing mechanism actuator 620 can be mechanically locked in place, for example, by moving within a "J"-shaped or "L"-shaped slot in the handle 612. Releasing or moving the suturing mechanism actuator 620 in the forward or distal direction will allow the pivot element 624 to pivot from the Figure 13B shown deployment orientation to the Figure 13A shown insertion and removal orientation.

[0105] Figure 14Shows the distal end of the vascular closure device 600 inserted into the vascular access device 100 and the suture mechanism 614. Depth markings or indicators on the shaft 616 of the vascular closure device 600 provide visual feedback to the user as to the depth to which the vascular closure device 600 should be inserted into the vascular access device 100. The dilator seal 126 (see Figure 2A ) forms a seal against the shaft 616 of the vascular closure device 600, thereby minimizing or preventing blood loss.

[0106] Figures 15A to 15J Is a side view of the distal end of the shaft 616 of the vascular closure device 600 and the suture mechanism 614. Figures 15A to 15J Step - by - step shows additional structures and functions of the vascular closure device 600, particularly the distal portion and the suture mechanism 614 closing and sealing a perforation or opening 662 (e.g., in the wall of the common carotid artery 20 or femoral vein 30) in the blood vessel 660 (see Figure 1 ).

[0107] In this illustrative example, prior to using the vascular closure device 600, the vascular seal portion 160 of the vascular access device 100 is deflated to restore antegrade blood flow in the common carotid artery 20 (see Figure 1 ). See Figure 15A , the distal end of the needle guide 615 (with the pivot element 624 in the insertion and removal orientation) is inserted into the vascular access device 100 and into the blood vessel 660. The vascular closure device 600 is internally exchanged with the vascular access device 100 within the blood vessel 660. Before removing the vascular access device 100, the vascular closure device 600 is inserted into the blood vessel 660. Depth markings or indicators on the shaft 616 of the vascular closure device 600 provide visual feedback to the user as to the depth to which the vascular closure device 600 should be inserted into the vascular access device 100. The vascular access device 100 is withdrawn from the blood vessel 660. The pivot element 624 rotates within the blood vessel 660 from the Figure 15B shown insertion and removal orientation to the Figure 15C shown deployment orientation. As shown in Figure 15D , the pivot element 624 is pulled proximally against the interior of the blood vessel wall 660a. See Figure 15E , the first and second needles 640, 642 pass through the blood vessel wall 660a near the opening 662 and are deployed or moved distally, and the first and second needle tips 640a, 642a are coupled to the ends of the coupling member 648. See Figure 15F, the first needle body 640b and the second needle 642 are retracted proximally. The first needle tip 640a is separated from the first needle body 640b. When the second needle 642 is pulled in the proximal direction, the second needle 642 will pull the coupling member 648 through the channel 652 in the pivot element 624. The second needle 642 pulls the flexible coupling member 648, the first needle tip 640a, and the tension member 650 through the blood vessel wall 660a adjacent to the opening 662.

[0108] See Figure 15G , the pivot element 624 is actuated to its insertion and removal orientation to allow the vascular closure device 600 (specifically, the suture mechanism 614) to be pulled proximally and removed from the opening 662 in the blood vessel 660. As Figure 15H shown, when the suture mechanism 614 is removed from the opening 662, the tension member 650 tightens the opening 662, and the suture knot 664 is deployed. The suture knot 664 can be any desired knot suitable for tying a suture, such as a type that automatically tightens when at least one end of the tension member 650 is pulled. In some embodiments, the suture knot 664 can be a "Tennessee Slider" knot. The knot 664 is abutted against the outer side of the blood vessel 660 to close and seal the opening 662 (as Figure 15I shown), and the end of the tension member 650 is trimmed (as Figure 15J shown).

[0109] A method for percutaneously closing an opening 662 in a blood vessel 660 can also include using the vascular closure device 600 to percutaneously close an opening in the femoral vein 30 (see Figure 1 ). The method for closing the femoral vein 30 is similar to the above method, with the main difference being the use of the vascular return device 200 instead of the vascular access device 100.

[0110] Figure 16 FIG. is a perspective view of an alternative vascular closure device 700. In this illustrative embodiment, the vascular closure device 700 is configured to be used with the vascular access device 100. In some embodiments, the vascular closure device 700 is configured to be used with the vascular return device 200. The vascular closure device 700 allows for single suture closure of a blood vessel (such as the carotid artery, femoral vein, or other blood vessels) via a minimally invasive percutaneous approach. Generally, the structure and operation of the vascular closure device 700 are similar to those of the above-described vascular closure device 600, and the vascular closure device 700 can be replaced with other vascular closure devices, or any features of the vascular closure device 700 can be used in various other exemplary embodiments in accordance with the present disclosure. The same reference numerals represent the same components. For the sake of brevity, the following description minimizes redundant descriptions and focuses on the differences between the vascular closure device 700 and the vascular closure device 600.

[0111] The suture device 700 includes a handle 712 at the proximal portion and a suture mechanism 714 at the distal portion. For reference, arrow 702 generally points proximally and arrow 704 generally points distally. An elongate shaft 716 extends between the handle 712 and the suture mechanism 714. Figure 17 is an exploded perspective view showing the handle 712. Refer to Figure 16 and 17 As shown in and, the handle 712 includes a pivot lever type suture mechanism actuator 720 that is coupled to the suture mechanism 714 and configured to operate the suture mechanism. 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 instead of springs 725, 727. A flexible strain relief member 723 is typically fixed between the relatively rigid handle 712 and the more flexible shaft 716 to more evenly distribute forces between these components. A rotatable handle portion 712a is fixed to the remainder of the handle 712 by a fastener 770. Although the actuators 720, 722a, 722b shown and described herein are manually driven, one or more actuators may be motorized, mechanically lever driven, or otherwise assisted in driving.

[0112] Figure 18A 、 18B and 18C are perspective views of the distal end of the shaft 716 and the suture mechanism 714. The suture mechanism 714 includes a needle guide 715 and a pivot element 724 that is fixed to the distal end of the needle guide 715 by a pivot 726. Figure 18A shows the pivot element 724 in an insertion and removal orientation that aligns the longitudinal direction of the pivot element 724 generally with the longitudinal axis of the needle guide 715 and the shaft 716. Figure 18B shows the longitudinal direction of the pivot element 724 generally aligned with the longitudinal axis of the needle guide 715 and the shaft 716. Figure 18B and 18C show the pivot element 724 in first and second deployed orientations, respectively, where the longitudinal direction of the pivot element 724 is transverse to the longitudinal axis of the needle guide 715 and the shaft 716. The pivot 726 allows the pivot element 724 to pivot or rotate 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 assist in a suture procedure to close a puncture or opening in a blood vessel. Rotating or pivoting the suture mechanism actuator 720 on the handle 712 moves the pivot element 724 between the insertion and removal orientation and the first and second deployed orientations.

[0113] Figure 19A is a top view of the handle 712 of the blood vessel closure device 700, Figure 19B is a cross-sectional view of the suture mechanism 714 in the insertion and removal orientation.Figure 20A Top view of the handle 712 of the vascular closure device 700 Figure 20B Cross-sectional view of the suturing mechanism 714 in the first deployed orientation Figure 21A Cross-sectional view of the handle 712 of the vascular closure device 700 Figure 21B Cross-sectional view of the suturing mechanism 714 in the first deployed orientation

[0114] See Figure 19A and 19B The distal portion of the vascular closure device 700 includes a first needle 740 and a second needle 742 that are fully integrally formed with or fixedly coupled to respective wires 744, 746. The first needle 740 is a two-piece needle having a first needle tip 740a that is removable from a first needle body 740b, for example, by friction fit. An elongate suture or tension member 750 is coupled to the first needle tip 740a. The second needle 742 includes an integrally formed second needle tip 742a. The first and second needles 740, 742 may be fully integrally formed with or fixedly coupled to the respective wires 744, 746. Elements 740, 742, 744, and 746 may be, for example, solid linear members or hollow members (e.g., hypotubes). The linear or hypotube element 744 coupled to the first needle 740 is fixed to the first needle actuator 722a; and the linear or hypotube element 746 coupled to the second needle 742 is fixed to the actuator 722b

[0115] See Figure 21A and 21B The suturing mechanism actuator 720 is coupled to the pivot element 724 by a drive wire 730. A first loop 730a of the wire 730 is fixed to the pivot element 724 at point 732, while a second loop 730b of the wire 730 is fixed to rotate with the suturing mechanism actuator 720. The pivot element 724 includes a flexible coupling member 748. The shaft 716 may be a multi-lumen flexible catheter, with one lumen carrying the drive wire 730, two lumens carrying the first and second needles 740, 742, and the fourth lumen may be used as a blood port to indicate to the user when the distal end of the vascular closure device 700 has entered a blood vessel

[0116] Figure 22A Cross-sectional view of the handle 712 of the vascular closure device 700 Figure 22B Cross-sectional view of the suturing mechanism 714 in the first deployed orientation Figure 23A Cross-sectional view of the handle 712 of the vascular closure device 700 Figure 23B Cross-sectional view of the suturing mechanism 714 in the second deployed orientation Figure 24A Cross-sectional view of the handle 712 of the vascular closure device 700 Figure 24B Cross-sectional view of the suturing mechanism 714 in the second deployed orientation

[0117] Figures 19A to 24B The additional structure and operation of the vascular closure device 700 are shown step by step. As described above, Figure 19A and 19B A vascular closure device is shown, where the suture mechanism 714 is in the insertion and removal orientation. When the suture mechanism actuator 720 is in the Figure 19A aligned or neutral position shown, the pivot element 724 is in the Figure 19B insertion and removal orientation shown. The suture mechanism actuator 720 pivots or rotates clockwise or in a first direction to the Figure 20A position shown, causing the pivot element 724 to pivot or rotate to the Figure 20B first deployment orientation shown. When the pivot element 724 is in the first deployment orientation, the first needle 740 is deployed or moved distally by pushing the first needle actuator 722a in the distal direction shown by arrow 743 and overcoming the bias of spring 725, causing the first needle 740 to move distally towards the coupling member 748 attached to the pivot element 724.

[0118] Figure 21A and 21B Show the positions of the first needle actuator 722a, spring 725, and first needle 740 after rotating the suture 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 Figure 20A shown, the suture mechanism actuator 720 also prevents any movement of actuator 722b, thus preventing accidental deployment of the second needle 742. The suture mechanism actuator 720 can be held or temporarily locked in place by a ratchet or other suitable structure. As Figure 21B and 21B shown, 22A and 22B, when released, the first needle actuator 722a moves proximally due to the expansion of spring 725, causing the needle body 740b to retract proximally and decoupling the needle body 740b from the first needle tip 740a.

[0119] As Figure 22A and 22B to Figure 23A and 23B shown, the suture mechanism actuator 720 rotates in a second or counterclockwise direction to rotate the pivot element 724 into its second deployment orientation, as Figure 23B shown. Actuator 722b is pushed distally against the bias of spring 727, causing the second needle 742 to move distally and causing the second needle tip 742a of the needle to engage and connect with the second end of the coupling member 748. When actuator 722b is as Figure 23AWhen released as indicated by the arrow in, the expansion of spring 727 pulls the second needle 742 (including the second needle tip 742a) proximally, and drives the coupling member 748, the attached first needle tip 740a, and the tension member 750, as Figure 24A and 24B shown. The coupling member 748 is fixed to the pivot member 724 by a "one-way" connection, enabling it to move out of the pivot member 724 only in the Figure 24B direction shown. The rotatable part 712a located at the proximal portion of the handle 712 rotates, as Figure 25 shown, to expose the opening 729, thereby allowing the actuator 722b to be removed and enabling the second needle 742, the coupling member 748, the first needle tip 740a, and the tension member 750 to be pulled out in the proximal direction (as Figure 24B shown).

[0120] Figures 26A to 26J Front view of the distal end of shaft 716 and suture mechanism 714. Figures 24A to 2 4J progressively shows additional structures and functions of the vascular closure device 700, particularly the distal portion and the suture mechanism 714 for closing and sealing the opening 662 in the wall of the blood vessel 660 (such as the carotid artery or femoral vein).

[0121] Refer to Figure 26A , the distal end of the needle guide 715 (where the pivot element 724 is in the insertion and removal orientation) is inserted into the blood vessel access device 100 and into the blood vessel 660. The vascular closure device 700 is internally exchanged with the blood vessel access device 100 within the blood vessel 660, similar to the surgery for the vascular closure device 600 described above. Before removing the blood vessel access device 100, the vascular closure device 700 is inserted into the blood vessel 660. The depth markings or indicators on the shaft 716 of the vascular closure device 700 provide visual feedback to the user on the depth to which the vascular closure device 700 should be inserted into the blood vessel access device 100.

[0122] The suture mechanism 714 is activated within the blood vessel 660, and the pivot element 724 pivots to the first deployment orientation, as Figure 26B shown. By slightly pulling the vascular closure device 700 proximally, thereby pulling the needle guide 715, the pivot element 724 is pulled proximally against the interior of the blood vessel wall 660a, as Figure 26BAs shown. The vascular access device 100 is pulled backward or proximally along the shaft 716 while the suture mechanism 714 remains within the blood vessel 660. The vascular access device 100 remains in position about the shaft 716 for the remainder of the procedure, and the vascular closure device 700 is ready to deploy the first and second suture needles 740, 742 and complete the remaining procedure described herein. Once the pivot element 724 is in this position, the first needle 740 is deployed through the vessel wall 660a near the opening 662, and the first needle tip 740a is connected to the first end of the coupling member 748, as Figure 26C shown. The first needle body 740b is retracted proximally, and the first needle tip 740a is separated from the first needle body 740b while maintaining the tension member 750 fixed to the first needle tip 740a and the first needle tip 740a being coupled to the coupling member 748 (see Figure 26D ).

[0123] As Figure 26D and 26E shown, the pivot element 724 is rotated approximately 190° to a second deployment orientation. The second needle 742 moves distally through the vessel wall 660a, near the opening 662, and connects the second needle tip 742a to the second end of the coupling member 748. As Figure 26F shown, the second needle 742, the coupling member 748, the first needle tip 740a, and the tension member 750 are pulled in the proximal direction through the vessel wall 660a. As Figure 26G shown, the pivot element 724 is rotated to the insertion and removal orientation, thereby allowing the vascular closure device 700, particularly the needle guide 715 and the suture mechanism 714, to be pulled proximally and removed from the blood vessel 660 (see Figure 26H ). As further shown in FIG. 24H, the suture knot 764 is deployed. The suture knot 764 can be of any desired shape suitable for tying a suture, such as a type that automatically tightens when at least one end of the tension member 750 is pulled. As shown in FIG. 24I, the knot 764 is tightened against the outer side of the blood vessel 660 to close and seal the opening 662, and then the ends of the tension member 750 are trimmed as shown in FIG. 24J.

[0124] Figure 27 is a top view of an illustrative alternative vascular closure device handle 712'. Generally, the structure and operation of the handle 712' are similar to the handle 712 described above, and in various other embodiments according to the present disclosure, the handle 712' can be replaced with other handles, or any features of the handle 712' can be used. The same reference numerals denote the same components. For the sake of brevity, the following description will minimize redundant descriptions and focus on the differences between the handle 712 and the handle 712'.

[0125] The handle 712' includes a rotatable suture mechanism actuator 720' that operates in a manner similar to the suture mechanism actuator 720 described above. Rotating the suture mechanism actuator 720' can pivot the pivot element 724 from the insertion and removal orientation (see Figure 18A ) to the first deployed orientation (see Figure 18B ). The user moves the first needle 740 distally by sliding the button 780' forward or distally to engage the pivot element 724 (see Figure 18B ). Similar to the handle 712, a spring return mechanism (not shown) is coupled to the button 780' and the first needle 740. Rotate the suture mechanism actuator 720' to pivot the pivot element 724 to the second deployed orientation (see Figure 18C ). By pressing the plunger 782' in the distal or forward direction, the second needle 742 moves distally (see Figure 18C ). The plunger 782' can also be coupled to a spring-biased return mechanism (not shown) and can be fully removed in the proximal direction to remove the second needle 742 and the tension member 750, as described above. The remaining operation of the handle 712' is similar to that of the handle 712.

[0126] Figure 28 is a top view of an illustrative alternative vascular closure device handle 712”. Generally, the handle 712” is constructed and operates similarly to the handles 712 and 712' described above, and in various other embodiments in accordance with the present disclosure, the handle 712” can be replaced with other handles, or any features of the handle 712” can be used. The same reference numerals represent the same components. For the sake of brevity, the following description will minimize redundant descriptions and focus on the differences between the handles 712 and 712' and the handle 712”.

[0127] The handle 712” includes actuators in the form of sliding buttons 780”, 790” and a plunger 782”. The user moves the sliding button 790” forward or distally to rotate the pivot element 724 from the insertion and removal orientation (see Figure 18A ) to the first deployed orientation (see Figure 18B ). The user moves or slides the button 780” forward or distally to move the first needle 740 distally to engage the pivot element 724 (see Figure 18B ). A spring return mechanism (not shown) is coupled to the button 780” and the first needle 740. The user moves the sliding button 790” backward or proximally to pivot the element 724 to its second transverse orientation (see Figure 18C)。By pressing the plunger 782” in the distal or forward direction, the second needle 742 moves distally. The plunger 782” can also be coupled to a spring-biased return mechanism (not shown) and can be completely removed in the proximal direction, thereby removing the second needle 742 and the tension member 750, as described above. The remaining operation of the handle 712” is similar to that of the handles 712 and 712'.

[0128] While the invention has been illustrated by the description of specific embodiments and these embodiments have been described in considerable detail, this is not meant to limit the scope of the appended claims to these details. The various features discussed herein can be used alone or in any combination within or between the embodiments. Other advantages and modifications will be readily apparent to those skilled in the art. Accordingly, the invention in its broader aspects is not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Thus, modifications may be made to these details without departing from the scope or spirit of the general inventive concept.

Claims

1. An embolization protection system, the system comprising: A vascular access device configured to enter a first blood vessel percutaneously; A vascular return device configured to enter a second blood vessel; A filter configured to collect emboli; A tubing configured to couple the vascular access device, the vascular return device, and the filter; And A vascular closure device configured to percutaneously close an opening in the first blood vessel; Wherein the system is configured to direct blood flow from the first blood vessel through the vascular access device, the filter, and the vascular return device and into the second blood vessel.

2. The system according to claim 1, wherein the vascular closure device is configured to enter the first blood vessel through the vascular access device.

3. The system according to claim 1, further comprising a flow control device, the flow control device being configured to be coupled to the vascular access device, the vascular return device, and the filter through the tubing; Wherein the flow control device is configured to control the blood flow from the first blood vessel to the second blood vessel.

4. The system according to claim 1, wherein the vascular access device includes a vascular sealing portion, the vascular sealing portion being configured to form a seal against at least a portion of the inner side of the first blood vessel when the vascular sealing portion is activated.

5. The system according to claim 4, wherein the vascular sealing portion includes an expandable element; Wherein activating the vascular sealing portion includes expanding the expandable element of the vascular sealing portion, thereby forming a seal against at least a portion of the inner side of the first blood vessel by the vascular access device.

6. The system according to claim 5, wherein the expandable element includes a balloon, and inflating the balloon forms a seal against at least a portion of the inner side of the first blood vessel by the vascular access device.

7. The system according to claim 4, wherein the vascular sealing portion includes a flexible material, and activating the vascular sealing portion includes compressing the flexible material to radially expand the flexible material, thereby forming a seal against at least a portion of the inner side of the first blood vessel by the vascular access device.

8. The system according to claim 4, wherein the vascular sealing portion includes a preformed structure, and activating the vascular sealing portion allows the preformed structure to radially expand, thereby forming a seal against at least a portion of the inner side of the first blood vessel by the vascular access device.

9. The system according to claim 8, wherein the preformed structure includes a filamentous structure.

10. The system according to claim 9, wherein the filamentous structure includes at least one of a film or a coating that at least partially covers the filamentous structure to prevent blood flow through the filamentous structure.

11. The system according to claim 4, wherein the vascular access device further includes a seal actuator configured to activate and / or deactivate the vascular sealing portion.

12. The system according to claim 11, wherein axially moving the seal actuator activates and / or deactivates the vascular sealing portion.

13. The system according to claim 1, wherein the vascular access device comprises an introducer sheath.

14. The system according to claim 1, wherein the vascular return device comprises an introducer sheath.

15. The system according to claim 1, wherein the vascular access device comprises a radiopaque marker.

16. The system according to claim 1, wherein the vascular closure device is configured to percutaneously close the opening in the second blood vessel.

17. The system according to claim 16, wherein the vascular closure device is configured to enter the second blood vessel through the vascular return device.

18. An embolization protection system, the system comprising: a vascular access device configured to percutaneously access a first blood vessel and comprising a vascular sealing portion configured to, when activated, form a seal with at least a portion of the vascular access device against the inner side of the first blood vessel; a vascular return device configured to access a second blood vessel; a filter configured to collect emboli; a flow control device; a conduit configured to couple the vascular access device, the vascular return device, the filter, and the flow control device; and a vascular closure device configured to percutaneously close the opening in the first blood vessel; wherein the system is configured to direct blood flow from the first blood vessel through the vascular access device, the filter, the flow control device, and the vascular return device and into the second blood vessel, and the flow control device is configured to control the blood flow from the first blood vessel to the second blood vessel.

19. The system according to claim 18, wherein the vascular closure device is configured to enter the first blood vessel through the vascular access device.

20. The system according to claim 18, wherein the vascular sealing portion comprises an expandable element, and activating the vascular sealing portion comprises expanding the expandable element of the vascular sealing portion so that the vascular access device forms a seal with at least a portion of the vascular access device against the inner side of the first blood vessel.

21. The system according to claim 18, wherein the expandable portion comprises a balloon, and inflating the balloon causes the vascular access device to form a seal with at least a portion of the vascular access device against the inner side of the first blood vessel.

22. The system according to claim 18, wherein the sealing portion comprises a flexible material, and activating the vascular sealing portion comprises compressing the flexible material to radially expand the flexible material so that the vascular access device forms a seal with at least a portion of the vascular access device against the inner side of the first blood vessel.

23. The system according to claim 18, wherein the sealing portion comprises a preformed structure, and activating the vascular sealing portion allows the preformed structure to radially expand so that the vascular access device forms a seal with at least a portion of the vascular access device against the inner side of the first blood vessel.

24. The system according to claim 21, wherein the preformed structure comprises a filamentous structure.

25. The system according to claim 22, wherein the filamentous structure includes at least one of a thin film or a coating that at least partially covers the filamentous structure to prevent blood flow through the filamentous structure.

26. The system according to claim 18, wherein the vascular access device further includes a sealing actuator configured to activate and / or deactivate the vascular sealing portion.

27. The system according to claim 24, wherein axially moving the sealing actuator activates and / or deactivates the vascular sealing portion.

28. The system according to claim 18, wherein the vascular access device includes an introducer sheath.

29. The system according to claim 18, wherein the vascular return device includes an introducer sheath.

30. The system according to claim 18, wherein the vascular access device includes a radiopaque marker.

31. The system according to claim 18, wherein the vascular closure device is configured to percutaneously close the opening in the second blood vessel.

32. The system according to claim 16, wherein the vascular closure device is configured to enter the second blood vessel through the vascular return device.

33. A method of providing embolization protection, the method comprising: percutaneously accessing a first blood vessel using a vascular access device; accessing a second blood vessel using a vascular return device; coupling a conduit to the vascular access device and the vascular return device; coupling a filter to the conduit; establishing blood flow from the first blood vessel through the vascular access device, the filter, and the vascular return device and into the second blood vessel; and percutaneously closing the opening in the first blood vessel.

34. The method according to claim 33, further comprising: coupling a flow control device to the conduit; directing the blood flow through the flow control device; and controlling the blood flow from the first blood vessel to the second blood vessel using the flow control device.

35. The method according to claim 33, wherein the first blood vessel is the carotid artery.

36. The method according to claim 33, wherein the second blood vessel is the femoral vein.

37. The method according to claim 33, wherein accessing the second blood vessel includes percutaneously accessing the second blood vessel using the vascular return device.

38. The method according to claim 33, further comprising percutaneously closing the opening in the second blood vessel.

39. The method according to claim 33, further comprising forming a seal with at least a portion of the vascular access device against the inner side of the first blood vessel.

40. The method according to claim 39, wherein forming a seal with at least a portion of the vascular access device against the inner side of the first blood vessel includes expanding the vascular sealing portion of the vascular access device.

41. The method according to claim 40, wherein the vascular sealing portion of the vascular access device includes a balloon; and the method further comprises inflating the balloon.

42. The method according to claim 39, wherein forming a seal with the vascular access device at least partially against the inner side of the first blood vessel further comprises compressing the flexible material of the vascular seal portion of the vascular access device to radially expand the flexible material.

43. The method according to claim 39, wherein forming a seal with the vascular access device at least partially against the inner side of the first blood vessel further comprises activating a preformed structure of the seal portion of the vascular access device to allow the preformed structure to radially expand.

44. The method according to claim 39, wherein forming a seal with the vascular access device at least partially against the inner side of the first blood vessel further comprises using a seal actuator to activate and / or deactivate the vascular seal portion of the vascular access device.

45. The method according to claim 44, further comprising axially moving the seal actuator to activate and / or deactivate the vascular seal portion.

46. Any device, method, or combination thereof as disclosed herein.

47. Any combination of any two or more of the foregoing claims.

48. Any combination of elements of one or more of the foregoing claims.

49. A device comprising any combination of elements as disclosed herein.

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