WO2025144809A1 - Devices and methods for severing aortic valve leaflets - Google Patents

Abstract

A device for severing leaflets of an aortic valve includes a catheter, a filter, and a severing device. The catheter is inserted into the aorta and positioned adjacent to the aortic valve. The filter is coupled to the catheter and moves longitudinally along a central axis of the catheter. The filter at least partially captures the leaflets of the aortic valve after being severed. The severing component is coupled to the catheter and can sever the leaflets via current flowing through the severing component. The severing component is movable longitudinally along the central axis of the catheter to direct the severed leaflets toward the filter.

Description

DEVICES AND METHODS FOR SEVERING AORTIC VALVE LEAFLETS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/614,783, filed December 26, 2023, which is hereby incorporated by reference herein in its entirety.

TECHNICAL FIELD

[0002] The present disclosure relates generally to a device for severing leaflets of an aortic valve, and more particularly, to a device for severing leaflets of an aortic valve that includes a wire loop or a plurality of spikes to sever the leaflets, and a filter to capture the severed leaflets.

BACKGROUND

[0003] The insertion of an artificial aortic valve in an aorta of an individual can cause problems such as coronary obstruction if the leaflets of the prior aortic valve inadvertently block the opening of the coronary arteries in the aorta. Managing the leaflets of the prior aortic valve using current devices and methods is ineffective. Thus, new devices and methods are needed for severing leaflets of an aortic valve.

SUMMARY

[0004] According to a first implementation of the present disclosure, a device for severing one or more leaflets of an aortic valve of an individual includes a catheter, a filter, and a severing component. The catheter is configured to be inserted into an aorta of the individual and positioned adjacent to the aortic valve. The filter is coupled to the catheter and is movable longitudinally along a central axis of the catheter. The filter is configured to capture the one or more leaflets of the aortic valve before or after being severed. The severing component is coupled to the catheter and is configured to sever the one or more leaflets. The severing component is movable longitudinally along the central axis of the catheter to direct the one or more severed leaflets toward the filter.

[0005] In some examples of the first implementation, the severing component is an electrically conductive wire loop. The wire loop can be moved past the leaflets to the far side of the aortic valve. The filter and the wire loop can be moved toward each other to capture the leaflets, and current can be flowed through the wire loop to sever the leaflets. [0006] In some examples of the first implementation, the severing component is a plurality of electrically conductive spikes. The spikes can be moved toward the leaflets so that the tips of the spikes contact the leaflets. Current can be flowed through the spikes to form apertures in the leaflets where the tips of the spikes contact the leaflets, and the tips will then protrude through the apertures. The spikes can be moved back toward the catheter while current continues to flow through the spikes to sever the leaflets and move them toward the filter.

[0007] In a second implementation of the present disclosure, a method for severing one or more leaflets of an aortic valve of an individual includes inserting a catheter into an aorta of the individual. The catheter includes a filter and a severing device that are both movable longitudinally along a central axis of the catheter. The method further includes moving the severing component in a first direction toward the one or more leaflets of the aortic valve until the severing component is in contact with the one or more leaflets, such that the filter is positioned between the catheter and the severing component. The method further includes causing current to flow through the severing component to at least partially sever the one or more leaflets. The method further includes moving the severing component in a second direction toward the catheter to at least partially cause the one or more leaflets to be captured by the filter. The method further includes removing the catheter from the aorta of the individual to remove the one or more severed leaflets.

[0008] The above summary is not intended to represent each implementation or every aspect of the present disclosure. Additional features and benefits of the present disclosure are apparent from the detailed description and figures set forth below.

BRIEF DESCRIPTION OF THE FIGURES

[0009] The foregoing and other advantages of the present disclosure will become apparent upon reading the following detailed description and upon reference to the drawings.

[0010] FIG. 1 A shows a first implementation of a device for severing aortic valve leaflets, according to aspects of the present disclosure.

[0011] FIG. IB shows a filter of the device of FIG. 1A, according to aspects of the present disclosure.

[0012] FIG. 1C shows a severing component of the device of FIG. 1 A, according to aspects of the present disclosure.

[0013] FIG. 2A shows a second implementation of a device for severing aortic valve leaflets, according to aspects of the present disclosure.

[0014] FIG. 2B shows a filter of the device of FIG. 2A, according to aspects of the present disclosure.

[0015] FIG. 2C shows a severing component of the device of FIG. 2A, according to aspects of the present disclosure.

[0016] FIG. 2D shows an alternative implementation of the device of FIG. 2A, according to aspects of the present disclosure.

[0017] FIG. 3 A shows a third implementation of a device for severing aortic valve leaflets, according to aspects of the present disclosure.

[0018] FIG. 3B shows an alternative implementation of the device of FIG. 3 A, according to aspects of the present disclosure.

[0019] FIG. 4 shows a fourth implementation of a device for severing aortic valve leaflets, according to aspects of the present disclosure.

[0020] FIG. 5 shows a flowchart of a method for severing aortic valve leaflets, according to aspects of the present disclosure.

[0021] While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the present disclosure is not intended to be limited to the particular forms disclosed. Rather, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

DETAILED DESCRIPTION

[0022] Transcathether aortic valve replacement is a procedure to replace a faulty aortic valve with an artificial aortic valve, also referred to as a bioprosthetic aortic valve. The procedure is commonly performed valve-in-valve, which means that the new artificial aortic valve is inserted into the existing aortic valve. This procedure can be performed to replace the patient’s original natural aortic valve, but can also be performed to replace an existing artificial aortic valve that was previously inserted into the patient.

[0023] The aortic valve generally has three flaps that are referred to as leaflets. When the aortic valve is closed, the leaflets are flat and block the entrance into the aorta from the left ventricle of the heart. When the aortic valve is open, the leaflets fold outward into the aorta to allow blood to flow into the aorta from the left ventricle. When the aortic valve is replaced using the valve-in-valve procedure, the new artificial aortic valve is inserted into the opening of the existing aortic valve, and the leaflets of the existing aortic valve (natural or artificial) are folded outward into the aorta. However, depending on the structure of the patient’s heart, the leaflets from the old aortic valve and/or a portion of the new artificial aortic valve may block the openings of the left coronary artery and/or the right coronary artery (also referred to as the coronary ostia), which are located in the aorta, superior to the aortic valve. Disclosed herein are devices and methods for severing the leaflets of the old aortic valve in order to prevent the leaflets from blocking the coronary ostia and reducing and/or eliminating the risk of coronary artery obstruction.

[0024] FIG. 1A illustrates a device 100 for severing aortic valve leaflets that includes a catheter 110, a filter 120 coupled to the catheter 110, and a wire loop 130 coupled to the catheter. FIG. IB shows a separate view of the filter 120, and FIG. 1C shows a separate view of the wire loop 130. The filter 120 and the wire loop 130 will generally be positioned within the hollow interior of the catheter 110 as the catheter 110 is inserted into the patient’s body and advanced into the patient’s aorta. The filter 120 and the wire loop 130 are independently movable relative to the catheter 110. Generally, both the filter 120 and the wire loop 130 are longitudinally movable along the central axis of the catheter 110. However, the actual path of the filter 120 and the wire loop 130 as they move may not be directly along the central axis (e.g., the path may be off-center slightly), and/or the path may not be a completely linear.

[0025] FIG. 1A shows the device 100 being used to sever a leaflet 12 of an aortic valve 10. To use the device 100, the catheter 110 is inserted until it is positioned in close proximity to the aortic valve 10. The wire loop 130 is moved toward and past the leaflet 12 such that the filter 120 is positioned on a first side of the aortic valve 10 (nearer to the catheter 110) and the wire loop 130 is positioned on an opposing second side of the aortic valve 10 (farther away from the catheter 110). The filter 120 can then be moved toward the leaflet 12 from the second side of the aortic valve 10 as the wire loop 130 is moved toward the leaflet 12 from the first side of the aortic valve 10, such that the leaflet 12 is captured between the filter 120 and the wire loop 130.

[0026] The wire loop 130 is made from an electrically conductive material and is coupled to an electrical power source. Current is caused to flow through the wire loop 130 after the leaflet 12 is captured between the filter 120 and the wire loop 130, when the wire loop 130 is contacting the leaflet 12. The current flowing through the wire loop 130 severs the leaflet 12 from the aortic valve 10. The filter 120 and the wire loop 130 can then be moved back toward the catheter 110, and in some cases into the catheter 110. The catheter 110 is then removed from the patient’s body. While FIG. 1A only illustrates a single leaflet 12, the device 100 can generally be used to sever all leaflets (which is generally three leaflets, but could be more or less) of the aortic valve 10 at the same time. The wire loop 130 has a sufficient diameter such that the wire loop 130 is able to contact all of the leaflets of the aortic valve 10 when it is moved past the leaflets to the second side of the aortic valve 10.

[0027] FIG. 2A illustrates a device 200 for severing aortic valve leaflets that includes a catheter 210, a filter 220 coupled to the catheter 210, and a plurality of spikes 230 coupled to the catheter. The catheter 210 can be the same as or similar to the catheter 110 of the device 100, and the filter 220 can be the same as or similar to the filter 120 of the device 100. In the illustrated implementation, the plurality of spikes 230 includes a first spike 232A and a second spike 232B. In other implementations however, the plurality of spikes 230 may include more than two spikes. In further implementations, the device 200 may include only a single spikes instead of the plurality of spikes 230.

[0028] FIG. 2B shows a separate view of the filter 220, and FIG. 2C shows a separate view of the first spike 232A. The filter 220 and the plurality of spikes 230 will generally be positioned within the hollow interior of the catheter 210 as the catheter 210 is inserted into the patient’s body and advanced into the patient’s aorta. The filter 220 and the plurality of spikes 230 are independently movable relative to the catheter 210. Generally, both the filter 220 and the plurality of spikes 230 are longitudinally movable along the central axis of the catheter 210. However, the actual path of the filter 220 and the plurality of spikes 230 as they move may not be directly along the central axis (e.g., the path may be off-center slightly), and/or the path may not be a completely linear.

[0029] FIG. 2A shows the device 200 being used to sever a leaflet 12 of an aortic valve 10. To use the device 200, the catheter 210 is inserted until it is positioned in close proximity to the aortic valve 10. The plurality of spikes 230 is moved away from the catheter 210 and toward the leaflet 12. In response to the plurality of spikes 230 moving longitudinally away from the catheter 210, the tips 234A of the first spike 232A and the tips 234B of the second spike 232B radially expand away from each other. Generally, the plurality of spikes 230 will be arranged circumferentially, so that the tips of the spikes 230 form a circle for any radial position of the tips. When the plurality of spikes 230 is in the desired position relative to the catheter 210, the tips of the spikes 230 will generally be located at the base of the leaflets of the aortic valve 10 or close to the base of the leaflets of the aortic valve 10. In the illustrated implementation, the tip 234A of the first spike 232A is disposed in a pocket 14A that forms between the leaflet 12 and the wall of the aorta, and the tip 234B of the second spikes 232B is disposed in a pocket 14B that forms between the leaflet 12 and the wall of the aorta. These pockets 14A and 14B may also be referred to as sinuses. If the aortic valve 10 is a native aortic valve, the pockets 14A and 14B may be referred to as native sinuses. If the aortic valve 10 is an artificial aortic valve, the pockets 14A and 14B may be referred to as neo-sinuses.

[0030] In some implementations, the catheter 210 is inserted into the aorta to a point where the tips 234A and 234B reach their fully radially expanded position as the plurality of spikes 230 as a whole reaches its desired longitudinal position, which is when the tips 234A and 234B disposed in the pockets 14A and 14B. In other implementations, the tips 234A and 234B may reach their fully radially expanded position before the plurality of spikes 230 as a whole reaches its desired longitudinal position. In those implementations, once the tips 234A and 234B reach their fully radially expanded position, the plurality of spikes 230 will be further moved longitudinally until the tips 234A and 234B are disposed in the pockets 14A and 14B, without the tips of the plurality of spikes 230 radially expanding any further.

[0031] The first spike 232A and the second spike 232B are each made from an electrically conductive material and are coupled to an electrical power source, similar to the wire loop 130. Current is caused to flow through the first spike 232A and the second spike 232B as the tips 234A and the tips 234B contact the leaflet 12, which causes small apertures to be formed in the leaflet 12 where the tips 234A and the tips 234B contact the leaflet 12. The tips 234A and the tips 234B will extend slightly through these apertures to allow the first spike 232A and the second spike 232B to grip the leaflet 12. The plurality of spikes 230 can then be moved longitudinally back toward the catheter 210 and the filter 220 as current is continued to be flowed through the first spike 232A and the second spike 232B. The current flowing through the first spike 232A and the second spike 232B as the tips 234A and the tips 234B retract radially inward severs the leaflet 12 from the aortic valve 10. Once the leaflet 12 is severed, the filter 220 can be moved toward the plurality of spikes 230 and/or the plurality of spikes 230 can continue to be moved toward the catheter 210 and the filter 220, which causes the severed leaflet 12 to be captured by the filter 220. Once the severed leaflet 12 is captured, the catheter 210 (into which the filter 220 and the plurality of spikes 230 may have been moved) is then removed from the patient’s body.

[0032] While FIG. 2A only shows the first spike 232A with one tip 234A disposed in one pocket 14A and the second spike 232B with one tip 234B disposed in one pocket 14B, other implementations may include any suitable number of spikes with any suitable number of the tips thereof disposed in any suitable number of pockets. In general, the tip of each of the plurality of spikes 230 is moved longitudinally until it contacts one of the leaflets of the aortic valve 10. In some cases, each tip may contact its own leaflet. In other cases, multiple tips may contact one or more of the leaflets. In any case, once each respective tip is disposed in a pocket and contacts a leaflet, current is flowed through the spikes until each respective tip extends through the aperture formed in the respective leaflet. The tips can then be retracted radially inward as current continues to flow to fully sever the leaflets and pull them toward the filter 220.

[0033] FIG. 2D shows a device 250 for severing aortic valve leaflets. Device 250 is generally identical to device 200, and includes the catheter 210, the filter 220 coupled to the catheter 210, and the plurality of spikes 230 coupled to the catheter. However, device 200 also includes an additional filter 260 that can be extended past the leaflet 12 to the far side of the aortic valve 10. As the spikes 230 are severing the leaflet 12 and/or after the spikes 230 have severed the leaflet 12, the filter 260 can be moved toward the filter 220 so that the severed leaflet 12 is sandwiched between the filter 220 and the filter 260.

[0034] FIG. 3 A illustrates a device 300 for severing aortic valve leaflets that includes a catheter 310, a filter 320 coupled to the catheter 310, and a plurality of spikes 330 coupled to the catheter 310. The device 300 is generally identical to the device 200, except that the filter 320 and the plurality of spikes 330 are integrated into a single component. Thus, the filter 320 and the plurality of spikes 330 are not able to move toward and away from the catheter 310 independently, but instead move together. As the plurality of spikes 330 is moved longitudinally toward the leaflet 12 of the aortic valve 10, the filter 320 also moves toward the leaflet 12. The rest of the operation of the device 300 is generally identical to that of the device 200. Electric current can be flowed through the plurality of spikes 330 so that the tips of the spikes 330 form apertures in the leaflet 12 into which the tips will extend. The plurality of spikes 330 can then be moved back toward the catheter 310, which radially the tips radially inward to fully sever the leaflet 12. Because the filter 320 is coupled to and position in close proximity with the spikes 330, the leaflets will be captured by the filter 320 as they are severed by the spikes 330.

[0035] FIG. 3B shows a device 350 for severing aortic valve leaflets. Device 350 is generally identical to device 300, and includes the catheter 310, the filter 320 coupled to the catheter 310, and the plurality of spikes 330 coupled to the catheter. However, device 300 also includes an additional filter 360 that can be extended past the leaflet 12 to the far side of the aortic valve 10. As the spikes 330 are severing the leaflet 12 and/or after the spikes 330 have severed the leaflet 12, the filter 360 can be moved toward the filter 320 so that the severed leaflet 12 is sandwiched between the filter 320 and the filter 360.

[0036] FIG. 4 shows a device 400 for severing aortic valve leaflets. Device 400 is similar to the other devices disclosed herein, and includes a catheter 410, a first filter 420A, a second filter 420B, and a plurality of electrically conductive hooks 430. The hooks 430 act similar to the spikes 230. The catheter 410 can be inserted until it is positioned in close proximity to the aortic valve 10. The second filter 420B can then be moved toward and past the leaflets 12 of the aortic valve 10, so that the first filter 420A and the hooks 430 are positioned on a first side of the aortic valve 10 (nearer to the catheter 410) and the second filter 420B is positioned on the opposing second side of the aortic valve 10 (further away from the catheter 410).

[0037] After the second filter 420B is moved toward the far side of the aortic valve 10 and the aortic valve 10 is positioned between (i) the first filter 420 A and the hook 430) and (ii) the second filter 420B, the hooks 430 can be moved so that the tip of each of the hooks 430 is disposed in one of the pockets of the aortic valve 10. In some implementations, the first filter 420A and the hooks 430 are independently movably , so that the hooks 430 can be advanced toward the pockets of the aortic valve 10 while the first filter 420A remains stationary. In other implementations, the first filter 420 A and the hooks 430 move together toward the aortic valve 10 so that the ends of the hooks 430 are disposed in the pockets.

[0038] In any implementation, electrical current can be caused to flow through the hooks 430 while the ends of the hooks 430 contact the leaflet 12, which causes small apertures to be formed in the leaflet 12 where the ends of the hooks 430 contact the leaflet 12. The ends of the hooks 430 will extend slightly through these apertures to allow the hooks 430 to grip the leaflet 12. The hooks 430 can then be moved longitudinally back toward the catheter 410 and the first filter 420A as current is continued to be flowed through the hooks 430, which aids in fully severing the leaflet 12.

[0039] As the hooks 430 are severing the leaflet 12 and/or after the hooks 430 have severed the leaflet 12, the second filter 420B can be moved toward the first filter 420A so that the severed leaflet 12 is sandwiched between the first filter 420A and the second filter 420B. In some implementations, the second filter 420B is moved toward the first filter 420A as the current is flowing through the hooks 430 and the hooks 340 are moving back toward the first filter 420A, which aids in fully severing the leaflet 12. In other implementations, the hooks 430 are used to fully sever the leaflet 12 before the second filter 420B moves back toward the first filter 420. In any implementations, the movement of the second filter 420B back toward the first filter 420A causes the severed leaflet 12 to be captured between the first filter 420A and the second filter 420B, similar to how the severed leaflet 12 can be captured between the filter 120 and the wire loop 130 of device 100. Once the severed leaflet 12 is captured, the catheter 410 (into which the first filter 420A, the second filter 420B, and the hooks 430 may have been moved) is then removed from the patient’s body. [0040] In some implementations, the hooks 430 do not expand or retract radially like the spikes do in other devices disclosed herein. In other implementations however, the hooks 430 may expand and retract radially. In these implementations, once the ends of the hooks 430 extend through the apertures in the leaflet 12, the hooks 430 are retracted radially as they move back toward the first filter 420A to aid in severing the leaflet 12.

[0041] Referring generally to any of the devices disclosed herein, while the specific implementations illustrated herein include a wire loop (device 100), a plurality of spikes (devices 200, 250, 300, and 350), or a plurality of hooks (device 400) other implementations may use other types of severing devices, such as blades, lasers, heat-based tools, etc. In general, a device according to the present disclosure will include a catheter, at least one filter that is longitudinally movable relative to the catheter and can capture severed leaflets, and a severing component that can be used to sever the leaflets. In some of these devices, the filter and the severing device move independently. In others of these devices, the filter and the severing component move together. Some of these devices may include an additional filter that can aid in capturing the severed leaflets. These devices can be used to partially or fully sever leaflets of an aortic valve, which may be a natural aortic valve and/or an artificial aortic valve.

[0042] Any of the filters discussed herein can be made from any suitable medical-grade material. For example, in some implementations, the filter is made form nitinol, which is a biocompatible nickel-titanium alloy that is flexible and elastic, and well-suited for navigating blood vessels. Other materials also may be used, including materials in combination with nitinol.

[0043] FIG. 5 is a flowchart of a method 500 for severing one or more leaflets of an aortic valve. The method 500 can be implemented using, for example, any of the devices 100, 200, 250, 300, 350, or 400, or any other suitable device that includes a catheter, at least one filter, and a severing device. Method 500 can be used to sever leaflets of a natural aortic valve, an artificial aortic valve, or both.

[0044] Step 502 of method 500 includes inserting a catheter into the aorta of an individual. The catheter can be any of the catheter 110, 210, 310, or 410, but also may be any other suitable catheter. In general, the catheter will have a hollow interior with a filter and a severing component housed therein, that are longitudinally movable generally along the central axis of the catheter.

[0045] Step 504 of method 500 includes moving the severing component from the catheter toward one or more leaflets of the aortic valve. In implementations where the severing component of the device is a wire loop (e.g., the wire loop 130 of the device 100), step 504 can include moving the wire loop toward and past the leaflets of the aortic valve so that the filter and the wire loop are disposed on opposite sides of the aortic valve. In implementations where the severing component of the device is a plurality of spikes (e.g., the plurality of spikes 230 of the device 200, the plurality of spikes 230 of the device 250, the plurality of spikes 330 of the device 300, or the plurality of spikes 330 of the device 350), step 504 can include moving the spikes toward the leaflets of the aortic valve until the tips of the spikes contact the leaflets. In implementations where the severing component of the device is a plurality of hooks (e.g., the plurality of hooks 430 of the device 400), step 504 can include moving the hooks toward the leaflets of the aortic valve until the ends of the hooks contact the leaflets.

[0046] In implementations where the device includes two filters (e.g., device 250, device 350, device 400, etc.), the second filter is generally moved toward and past the leaflets of the aortic valve prior to the severing component being moved toward the leaflets of the aortic valve. However, in some cases the second filter may be able to pass through the severing component and to the far side of the aortic valve, such that the second filter is moved toward and past the leaflets of the aortic valve after the severing component is moved toward the leaflets of the aortic valve. Alternatively, the severing component and the second filter could move toward the leaflets of the aortic valve simultaneously. In these cases, once the second filter reaches the leaflets, the second filter will continue to be advanced to the far side of the aortic valve, while the severing component will stop once it reaches the leaflets.

[0047] Step 506 of method 500 includes causing current to flow through the severing component to at least partially sever the leaflets of the aortic valve. Step 508 of method 500 includes moving the severing component back toward the catheter to at least partially cause the leaflets to be captured by the filter.

[0048] In implementations where the severing component of the device is a wire loop (e.g., the wire loop 130 of the device 100), step 508 is performed before 506. Thus, after the wire loop has been moved past the leaflets, the wire loop is moved back toward the catheter from the far side of the aortic valve. Generally, the filter in these implementations will be moved toward the leaflets from the near side of the aortic valve simultaneously with the wire loop moving toward the leaflets from the far side of the aortic valve, such that the leaflets will be captured between the filter and the wire loop. Step 506 can then be performed, which will include causing current to flow through the wire loop to fully sever the leaflets. As used herein, references to “fully severing” the leaflets includes at least the use of the wire loop to completely detach the leaflets from the aortic valve. [0049] In implementations where the severing component of the device is a plurality of spikes (e.g., the plurality of spikes 230 of the device 200, the plurality of spikes 230 of the device 250, the plurality of spikes 330 of the device 300, or the plurality of spikes 330 of the device 350) or a plurality of hooks (e.g., the plurality of hooks 430 of the device 400), step 506 is performed first, when the tips of the spikes or hooks are contacting the leaflets. Causing the current to flow through the spikes or hooks forms apertures in the leaflets. As used herein, references to “partially severing” the leaflets may include forming these apertures in the leaflets by causing current to flow through the spikes or hooks. The tips of the spikes or hooks will protrude into the apertures to aid in gripping the leaflets, and the spikes or hooks are then moved back toward the catheter to at least partially cause the leaflets to be captured by the filter. In these implementations, the current can continue to be flowed through the spikes or hooks as the spikes or hooks move back toward the catheter, such that steps 506 and 508 are at least partially performed at the same time. Generally, the tips of the spikes will retract radially inward as the spikes move toward the catheter, which in combination with the current flowing will cause the leaflets to be fully severed from the aortic valve.

[0050] In implementations where the filter and the spikes or hooks move independently, step 508 can also include moving the filter toward the plurality of spikes or hooks as the plurality of spikes or hooks moves toward the catheter and the filter, such that the leaflets are captured by the filter. In implementations where the filter and the plurality of spikes or hooks do not move separately from each other, the leaflets will be captured by the filter during step 508 as the movement of the filter and the severing component back toward the catheter severs the leaflets.

[0051] In implementations where the device includes two filters (e.g., device 250, device 350, device 400), the second filter is generally moved back toward the catheter after the leaflets are severed, so that the severed leaflets can be captured between the first filter and the second filter. However, in some cases the spikes or hooks may fully sever the leaflets (which may involve some movement of the spikes or hooks back toward the catheter) before the second filter is moved back toward the catheter.

[0052] In general, the movement of the severing component back toward the catheter in step 508 can occur before the current is flowed through the severing component in step 506, after the current is flowed through the severing component in step 506, or at least partially while the current is flowed through the severing component in step 506.

[0053] Finally, step 510 of method 500 includes removing the catheter from the aorta of the individual. Generally, the filter and the severing component (and the severed leaflets captured by the filter) will have moved back into the hollow interior of the catheter, so that the removal of the catheter from the aorta also removes the filter, the severing component, and the severed leaflets.

[0054] One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the claims can be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other claims or combinations thereof, to form one or more additional implementations and/or claims of the present disclosure.

[0055] While the present disclosure has been described with reference to one or more particular embodiments or implementations, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present disclosure. Each of these implementations and obvious variations thereof is contemplated as falling within the spirit and scope of the present disclosure. It is also contemplated that additional implementations according to aspects of the present disclosure may combine any number of features from any of the implementations described herein.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A device for severing one or more leaflets of an aortic valve of an individual, the device comprising: a catheter configured to be inserted into an aorta of the individual and positioned adjacent to the aortic valve; a filter coupled to the catheter and movable longitudinally along a central axis of the catheter, the filter being configured to capture the one or more leaflets of the aortic valve before or after being severed; and a severing component coupled to the catheter and configured to sever the one or more leaflets, the severing component being movable longitudinally along the central axis of the catheter to direct the one or more severed leaflets toward the filter.

2. The device of claim 1, wherein the severing component is electrically conductive, and wherein causing current to flow through the severing component at least partially severs the one or more leaflets.

3. The device of claim 2, wherein the severing component is an electrically conductive wire loop, and wherein causing current to flow through the wire loop fully severs the one or more leaflets.

4. The device of claim 3, wherein the wire loop is configured to move longitudinally away from the catheter such that the filter is disposed on a first side of the aortic valve and the wire loop is disposed on the opposing second side of the aortic valve.

5. The device of claim 4, wherein moving the filter longitudinally toward the one or more leaflets from the first side of the aortic valve and moving the wire loop longitudinally toward the one or more leaflets from the second side of the aortic valve causes the one or more leaflets to be captured between the filter and the wire loop.

6. The device of claim 5, wherein causing current to flow through the wire loop after the one or more leaflets are captured between the filter and the wire loop severs the one or more leaflets.

7. The device of claim 6, wherein after the one or more leaflets are severed, the filter and the wire loop are both movable longitudinally toward the catheter to remove the one or more severed leaflets from the aortic valve.

8. The device of claim 2, wherein the severing component includes a plurality of electrically conductive spikes.

9. The device of claim 8, wherein causing current to flow through the plurality of spikes when a tip of each of the plurality of spikes contacts one of the one or more leaflets causes an aperture to form in each of the one or more leaflets, such that a tip of each spike extends through the aperture in the one of the one or more leaflets.

10. The device of claim 9, wherein the plurality of spikes are movable longitudinally toward and away from the catheter, wherein the tips of the plurality of spikes expand radially outward away from each other in response to the plurality of spikes moving longitudinally away from the catheter, and wherein the tips of the plurality of spikes retract radially inward toward each other in response to the plurality of spikes moving longitudinally toward the catheter.

11. The device of claim 10, wherein after the apertures have been formed in each of the one or more leaflets and the tip of each spike extends through the aperture in one of the one or more leaflets, causing current to flow through the plurality of spikes as the plurality of spikes move longitudinally toward the catheter severs the one or more leaflets and causes the one or more leaflets to move toward the catheter and be captured by the filter.

12. The device of claim 11, wherein after the one or more severed leaflets are captured by the filter, the filter is movable longitudinally toward the catheter to remove the one or more severed leaflets from the aortic valve.

13. The device of any one of claims 8 to 12, wherein the filter and the plurality of spikes are each separately coupled to the catheter such that the filter is longitudinally movable independently from the plurality of spikes.

14. The device of any one of claims 8 to 12, wherein the filter and the plurality of spikes are integrated into a single component that is coupled to the catheter, such that the filter and the plurality of spikes are not independently longitudinally movable.

15. The device of claim 2, wherein the severing component includes a plurality of electrically conductive hooks.

16. The device of claim 15, wherein causing current to flow through the plurality of hooks when a tip of each of the plurality of hooks contacts one of the one or more leaflets causes an aperture to form in each of the one or more leaflets, such that a tip of each hook extends through the aperture in the one of the one or more leaflets.

17. The device of claim 16, wherein after the apertures have been formed in each of the one or more leaflets and the tip of each hooks extends through the aperture in one of the one or more leaflets, causing current to flow through the plurality of hooks as the plurality of hooks move longitudinally toward the catheter severs the one or more leaflets and causes the one or more leaflets to move toward the catheter and be captured by the filter.

18. The device of claim 17, wherein after the one or more severed leaflets are captured by the filter, the filter is movable longitudinally toward the catheter to remove the one or more severed leaflets from the aortic valve.

19. The device of any one of claims 15 to 18, wherein the filter and the plurality of hooks are each separately coupled to the catheter such that the filter is longitudinally movable independently from the plurality of hooks.

20. The device of any one of claims 15 to 18, wherein the filter and the plurality of hooks are integrated into a single component that is coupled to the catheter, such that the filter and the plurality of hooks are not independently longitudinally movable.

21. The device of any one of claims 8 to 20, further comprising an additional filter that is movable longitudinally along the central axis of the catheter.

22. The device of any claim 21, wherein the severing component is positioned between the filter and the additional filter.

23. The device of claim 21 or claim 22, wherein the additional filter is configured to move longitudinally away from the catheter such that the additional filter is disposed on the opposing second side of the aortic valve.

24. The device of claim 23, wherein moving the additional filter longitudinally toward the catheter as current is flowing through the severing component, after current has flowed through the severing component, or both, causes the one or more severed leaflets to be captured between the filter and the additional filter.

25. The device of any one of claims 1 to 24, wherein the aortic valve is a natural aortic valve or an artificial aortic valve.

26. A method for severing one or more leaflets of an aortic valve of an individual, the method comprising: inserting a catheter into an aorta of the individual, the catheter including a filter and a severing component both movable longitudinally along a central axis of the catheter; moving the severing component in a first direction toward the one or more leaflets of the aortic valve until the severing component is in contact with the one or more leaflets, such that the filter is positioned between the catheter and the severing component; causing current to flow through the severing component to at least partially sever the one or more leaflets; moving the severing component in a second direction toward the catheter to at least partially cause the one or more leaflets to be captured by the filter; and removing the catheter from the aorta of the individual to remove the one or more severed leaflets.

27. The method of claim 26, wherein the severing component is a wire loop.

28. The method of claim 27, wherein moving the severing component in the first direction toward the one or more leaflets includes moving the wire loop past the one or more leaflets such that the filter and the wire loop are positioned on opposite sides of the aortic valve.

29. The method of claim 28, wherein moving the severing component in the second direction includes moving the wire loop toward the one or more leaflets before the current is caused to flow through the wire loop.

30. The method of claim 29, further comprising moving the filter from a first side of the aortic valve toward the one or more leaflets simultaneously with moving the wire loop from an opposing second side of the aortic valve toward the one or more leaflets, such that the one or more leaflets are captured between the filter and the wire loop.

31. The method of claim 30, wherein the current is caused to flow through the wire loop after the one or more leaflets are captured between the filter and the wire loop to fully sever the one or more leaflets.

32. The method of claim 26, wherein the severing component includes a plurality of spikes.

33. The method of claim 32, wherein moving the severing component in the first direction toward the one or more leaflets includes moving the plurality of spikes toward the one or more leaflets such that a tip of each of the plurality of spikes contacts one of the one or more leaflets.

34. The method of claim 33, wherein the current is caused to flow through the plurality of spikes when the tip of each of the plurality of spikes contacts one of the one or more leaflets, such that an aperture is formed where each of the tips contacts one of the one or more leaflets, each respective tip extending through the aperture formed by the respective tip.

35. The method of claim 34, wherein the tips of the plurality of spikes retract radially inward toward each other as the plurality of spikes is moved in the second direction to fully sever the one or more leaflets and pull the severed one or more leaflets toward the filter such that the severed one or more leaflets are captured by the filter.

36. The method of claim 35, wherein the filter is movable independently from the plurality of spikes, and wherein the method further comprises moving the filter in the first direction toward the plurality of spikes as the plurality of spikes moved in the second direction toward the filter to capture the one or more leaflets by the filter.

37. The method of claim 26, wherein the severing component is moved in the second direction before current is caused to flow through the severing component, after current is caused to flow through the severing component, or while current is caused to flow through the severing component.

38. The method of any one of claims 26 to 37, wherein the aortic valve is a natural aortic valve or an artificial aortic valve.