Apparatus for transcatheter aortic valve replacement extraction

Abstract

Provided herein is an apparatus, method, and system for Transcatheter Aortic Valve Replacement extraction. The apparatus may include: an outer housing; an inner shaft configured to move in a first direction relative to the outer housing and in a second direction relative to the outer housing opposite the first direction; a plurality of hooks, each of the plurality of hooks having a first end connected to the inner shaft and a second end, where each of the plurality of hooks defines a deployed position where the second end is distal from the outer housing and a retracted position where the second end is proximal the outer housing; and a debris catcher proximate a distal end of the outer housing, the debris catcher defining a deployed position opened to receive debris and a stowed position closed to trap debris.

Description

APPARATUS AND METHOD FOR TRANSCATHETER AORTIC VALVE REPLACEMENTEXTRACTIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 681,400, filed on August 9, 2024, the contents of which are herein incorporated by reference in their entirety.TECHNOLOGICAL FIELD

[0002] Provided herein is an apparatus and method for Transcatheter Aortic Valve Replacement (TAVR) extraction and, more specifically, for an apparatus and method for effective and safer removal of an implanted TAVR type valve.BACKGROUND

[0003] Valvular heart disease occurs when one or more of the four heart valves (aortic, mitral, tricuspid, or pulmonary) is damaged and not functioning properly.

[0004] The majority of the deaths attributed to valvular heart disease are due to diseases of the aortic valve. Aortic Valve Stenosis (AVS) is the most common valvular disease in the United States.

[0005] Aortic Valve Disease (AVD) is treated with aortic valve replacement operations, wherein a bioprosthetic valve is implanted to replicate the function of the native valve. This can be done via a Surgical Aortic Valve Replacement (SAVR), an open-heart operation wherein the bioprosthetic valve is implanted into the patient’s aorta. Alternatively, surgeons can employ a Transcatheter Aortic Valve Replacement (TAVR), a procedure wherein a catheter-based delivery system guides the bioprosthetic to the aortic annulus via a peripheral artery.

[0006] Bioprosthetic valves are implanted to function as new aortic valves for patients in TAVR procedures and surgical aortic valve replacement (SAVR). However, these valves eventually fail, possessing an effective lifespan of about 5 - 10 years, meaning that most patients will need an additional valve intervention after the initial one. Many younger patients need more than one valve replacement in their lifetimes. In a typical life cycle, these valves can fail due to- 1 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2Prosthetic Valve Endocarditis (PVE), Structural Valve Dysfunction (SVD), and valve migration, among other factors. Current treatment for failure includes either inserting a new TAVR within a failed one (redo-TAVR) or removing the TAVR completely and replacing the valve (explant- TAVR) via an open surgical procedure Indications for explant-TAVR over redo-TAVR include PVE, unsuitable patient anatomy, risk of coronary obstruction, and multiple concurrent cardiovascular disease, making it a risky but necessary alternative for many patients with failed TAVRs. Explant-TAVR is the fastest-growing cardiothoracic procedure in the United States, in large part because of patient indications and infeasibility of multiple redo-TAVRs over a lifetime.

[0007] The current explant-TAVR procedure is an open-heart surgery wherein surgeons cut into the aorta to expose the valve; subsequently crushing and compressing it using Kocher clamps to facilitate removal. Other tools such as freer elevators or scalpels are used to separate the frame of the device from the aorta, facilitating the key crushing step. In many cases neoendothelialization - ingrowth of tissue into the frame for valves placed for more than a year - necessitates additional care given the risks of disintegrating the coronary sinus and needing to repair the aortic root, which are both undesirable for patient mortality.

[0008] Explant-TAVR has notable post-operative mortality risk due to calcium and thrombogenic particulates being released during valve extraction. This phenomenon is seen in initial SAVR and TAVR implantations as well, due in part to calcific aortic vascular disease (CAVD) generating thrombogenic particulates on native and bioprosthetic valves. Given the increasing amount of TAVR explants, as well as the decreasing median age for the procedure, solutions for the current risk and difficulties in explant surgery are essential. Postoperative explant-TAVR mortality is correlated with procedural complexity, time, and extent of tissue ingrowth. Finding ways to reduce these factors and decrease patient mortality is challenging.BRIEF SUMMARY

[0009] Embodiments of the present disclosure generally relate to an apparatus and method for removal of Transcatheter Aortic Valve Replacement (TAVR), specifically for providing surgeons a method and apparatus for removal of the valve replacement in a safe, timely, and- 2 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2efficient manner. Embodiments provided herein include an apparatus for Transcatheter Aortic Valve Replacement (TAVR) extraction including: an outer housing; an inner shaft configured to move in a first direction relative to the outer housing and in a second direction relative to the outer housing opposite the first direction; a plurality of hooks, each of the plurality of hooks having a first end connected to the inner shaft and a second end, where each of the plurality of hooks defines a deployed position where the second end is distal from the outer housing and a retracted position where the second end is proximal the outer housing; and a debris catcher beyond the distal end of the outer housing, the debris catcher defining a deployed position opened to receive debris and a stowed position closed to trap debris.

[0010] According to some embodiments each of the plurality of hooks has a range of motion relative to the outer housing of between about 30 degrees in a the retracted position and about 90 degrees in the deployed. According to certain embodiments a shape of the second end of each of the plurality of hooks is an arc. According to certain embodiments the arc of the second end of each of the plurality of hooks extends between 90 degrees and 135 degrees.

[0011] The inner shaft of an example embodiment moves in a first direction to cause each of the plurality of hooks to transition from the retracted position towards the deployed position, and the inner shaft moves in a second direction opposite the first direction to cause each of the plurality of hooks to transition from the deployed position to the retracted position. According to some embodiments the apparatus further includes a handle, wherein actuation of the handle causes the plurality of hooks to transition between the deployed position to the retracted position. According to certain embodiments the handle advances the inner shaft relative to the outer housing in the second direction using a ratchet mechanism, wherein the plurality of hooks transition from the deployed position to the retracted position in about three actuation cycles of the handle.

[0012] The debris catcher of an example embodiment includes: a tube slidably attached proximate the distal end of the outer housing; a filament extending through the tube; and a selfopening sack once deployed wherein the filament is attached to and encircles an opening of the self-opening sack. The tube of some embodiments is advanced in a second direction, toward the self-opening sack to move the debris catcher to the deployed position, and the tube is advanced- 3 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2in a first direction, opposite the second direction to move the debris catcher to the stowed position. According to some embodiments the filament is moved relative to the tube in the second direction to open the self-opening sack of the debris catcher, and wherein the filament is moved relative to the tube in the first direction to close the sack to retain any contents received into the self-opening sack.

[0013] Embodiments provided herein include a method for TAVR extraction including: inserting a distal end of a device into a heart valve containing a replacement valve, the device including outer housing containing an inner shaft configured to move in a first direction relative to the outer housing and in a second direction relative to the outer housing opposite the first direction; deploying a debris catcher proximate the distal end of the device, the debris catcher defining a deployed position opened to receive debris and a stowed position closed to trap debris, into the deployed position to receive debris; deploying a plurality of hooks, each of the plurality of hooks having a first end connected to the inner shaft and a second end, wherein each of the plurality of hooks defines a deployed position where the second end is distal from the outer housing and a retracted position where the second end is proximal the outer housing, into the retracted position to deform and compress the replacement valve; engaging the replacement valve with the second end of each of the plurality of hooks in the deployed position; retracting the plurality of hooks causing the replacement valve to collapse about the distal end of the device; and capturing debris from the replacement valve in the debris catcher. The method of some embodiments further include closing a sack of the debris catcher after retraction of the plurality of hooks. The method of some embodiments further includes moving the debris catcher with the closed sack to the stowed position.

[0014] Embodiments provided herein include apparatus for removal of a replacement valve including: an outer housing; a plurality of hooks extending from a distal end of the outer housing, where the hooks are configured to move between a retracted position and a deployed position, where the plurality of hooks are configured to engage the replacement valve in the deployed position, and to collapse the replacement valve in response to the plurality of hooks moving to the retracted position; and a debris catcher, wherein the debris catcher includes: a flexible tube attached to the outer housing; an opening mechanism to maximize the opening of- 4 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2the debris catcher in the available space, a filament extending through the flexible tube; and a self-opening sack wherein the filament attaches to an opening of the sack and is configured to move the sack between an open position and a closed position.

[0015] According to some embodiments each of the plurality of hooks includes a range of motion relative to the outer housing of between about 30 degrees in a the retracted position and about 90 degrees in the deployed. According to some embodiments a shape of an end of each of the plurality of hooks is an arc. The device of some embodiments further includes: an inner shaft, wherein each of the plurality of hooks are hingedly attached to the inner shaft and extend through respective apertures in the outer housing. According to some embodiments movement of the inner shaft in a first direction relative to the outer housing causes the plurality of hooks to move to the deployed position, where movement of the inner shaft in a second direction opposite the first relative to the housing causes the plurality of hooks to move to the retracted position. According to certain embodiments the plurality of hooks are driven between the deployed position and the stowed position by the respective aperture for each of the plurality of hooks based on the relative movement of the inner shaft. According to certain embodiments the inner shaft is moved relative to the outer housing in the second direction by a ratchet mechanism.

[0016] According to some embodiments, the debris catcher comprises a flexible tube; a wire running through the flexible tube; and a self-opening sack wherein the wire is threaded through a hole in the top of the circular sack. According to some embodiments, the debris catcher further comprises a slider connected to the wire configured to deploy the debris catcher into the deployed position when slid in a first direction and configured to deploy the debris catcher into the stowed position when slid in a second direction, opposite the first direction.BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

[0018] FIG. 1 illustrates a Transcatheter Aortic Valve Replacement (TAVR) extraction device according to an example embodiment of the present disclosure;- 5 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2

[0019] FIG.2 illustrates a detail view of a distal end of a TAVR extraction device depicting a plurality of hooks extending in a deployed position relative to an outer casing of the device according to an example embodiment of the present disclosure;

[0020] FIG.3 is an exploded view of the distal end of the TAVR extraction device according to an example embodiment of the present disclosure;

[0021] FIG.4 illustrates a detail view of one of the plurality of hooks of a TAVR extraction device in a retracted position relative to the outer casing according to an example embodiment of the present disclosure;

[0022] FIG.5 illustrates a detail view of one of the plurality of hooks of a TAVR extraction device in a deployed position relative to the outer casing according to an example embodiment of the present disclosure;

[0023] FIG.5 illustrates the detail view of FIG. 4 with the one of the plurality of hooks in a stowed position relative to the outer casing according to an example embodiment of the present disclosure;

[0024] FIG.6 illustrates the distal end of a TAVR extraction device inserted into a failed TAVR with the plurality of hooks in the retracted position according to an example embodiment of the present disclosure;

[0025] FIG. 7 illustrates the distal end of a TAVR extraction device inserted into a failed TAVR with the plurality of hooks in the deployed position according to an example embodiment of the present disclosure;

[0026] FIG.8 illustrates the distal end of a TAVR extraction device inserted into a failed TAVR with the plurality of hooks in the retracted position collapsing the failed TAVR onto the device according to an example embodiment of the present disclosure; and

[0027] FIG.9 illustrates a Transcatheter Aortic Valve Replacement (TAVR) extraction device including a debris catcher depicted in a deployed position according to an example embodiment of the present disclosure.DETAILED DESCRIPTION- 6 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2

[0028] Example embodiments of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

[0029] The current explant-TAVR procedure is an open-heart surgery wherein surgeons cut into the aorta to expose the artificial valve; subsequently crushing and compressing the artificial valve using clamps to facilitate removal while they dissect around it. Other tools such as freer elevators or scalpels are used to separate the frame of the device from the aorta, facilitating the key crushing step. In many cases neoendothelialization - ingrowth of tissue into the frame for valves placed for more than a year - necessitates additional care given the risks of disintegrating the coronary sinus and needing to repair the aortic root, which are both undesirable for patient mortality. This process produces debris at the site of removal which falls into the heart cavity which is in a dependent position relative to the valve being removed, which is undesirable and potentially problematic.

[0030] Explant-TAVR or TAVR implant removal has notable post-operative mortality risk due to calcium and thrombogenic particulates being released during valve extraction. This phenomenon is seen in initial TAVR implantations as well, due in part to CAVE) generating thrombogenic particulates on native and bioprosthetic valves. Given the increasing amount of TAVR explants, as well as the decreasing median age for the procedure. Postoperative explant- TAVR mortality is correlated with procedural complexity, time, and extent of tissue ingrowth. Finding ways to reduce these factors and decrease patient mortality is challenging.

[0031] Embodiments of the present disclosure generally relate to an apparatus and method for Transcatheter Aortic Valve Replacement (TAVR) extraction and, more specifically, for providing surgeons a method and apparatus for removal of a failed or failing valve replacement in a safe, timely, and efficient manner while mitigating the challenges described above. Embodiments described herein include a surgical device provided to remove failed TAVRs during open-heart surgery. Failed TAVRs can only be removed using explant surgery, but this- 7 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2procedure remains complex. Variation in surgeons’ skills, adherence of the valve to surrounding tissue, patient anatomy, and difficulty removing the valve using existing surgical tools and procedures means the operation remains lengthy, high-risk, and heavily dependent on individual surgeons’ experience. These facts indicate an opportunity to improve the TAVR explant procedure with the introduction of an easy-to-use and efficient medical device designed for explant surgeries.

[0032] While embodiments described herein generally reference TAVR, embodiments can be employed with surgical aortic valve replacement (SAVR) for replacement or removal. As such, while the figures and descriptions generally describe TAVR, one of ordinary skill in the art will appreciate that the system of example embodiments can be used with removal and / or replacement of SAVR.

[0033] The surgical device described herein utilizes an outer housing, an inner shaft, a plurality of hooks, and a debris catcher to simplify the extraction of TAVRs in open-heart surgeries while mitigating risks and effectively removing a failed implant along with any resultant debris. Embodiments described herein include other structures described in detail below that provide added convenience for surgeons.

[0034] According to an example use, it is presumed that a patient has been diagnosed with a failed or failing prosthetic valve and that removal is required. Whether replacement is to be performed and how such replacement is performed is beyond the scope of the present disclosure. According to embodiments described herein a surgeon deploys the disclosed apparatus to remove a failed TAVR from a patient in open-heart surgery. The device of example embodiments is inserted within a valve of the heart where the failed TAVR is positioned. A distal end of the device is positioned within or through the failed TAVR such that the failed TAVR encircles an outer housing of the device.

[0035] Once the surgical device is in the proper position, the surgeon causes an inner shaft of the device to move in a first direction relative to the outer housing that, in turn, causes a plurality of hooks to begin a transition from a retracted position to a deployed position. This retracted position is the initial position of the hooks of the surgical device to enable the tool to be readily inserted into the valve of the patient and to be received within the failed TAVR. The- 8 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2deployment of the hooks is performed such that the hooks become positioned in a deployed position, whereby the hooks extend through apertures in the failed TAVR. When the hooks extend through the apertures of the failed TAVR, they may press into tissue of the valve; however, the shape of an end of the hooks at the deployed position are rounded to avoid trauma to the tissue. As will be further detailed below, the hooks move relative to the stationary outer housing such that as they are deployed, they engage the annulus framework of the failed TAVR.

[0036] Once the hooks are deployed through the failed TAVR, the hooks can be retracted. This is performed by the surgeon advancing the inner shaft in a second direction relative to the outer housing, which causes the hooks to move back along their hinged arc toward the outer housing. In doing so, the hooked ends of the hooks engage the failed TAVR and grasp the framework of the failed TAVR. The retraction motion continues as the surgeon continues to move the inner shaft in the second direction, which causes the hooks to compress the failed TAVR toward the outer housing. This dislodges the failed TAVR and reduces a cross section of the failed TAVR from the in-situ position within the valve to a considerably narrower dimension free of the walls of the valve better enabling dissection of the valve from the adherent tissue. Once compressed and the hooks are returned to proximate their retracted position, the failed TAVR is ready for removal, and the surgeon may withdraw the device from the valve with the failed TAVR attached.

[0037] As noted above, this procedure can produce debris such as calcium broken away from the failed TAVR as it compresses, ingrowth tissue into the framework of the failed TAVR, and possibly a portion of the failed TAVR as it is compressed. This debris can be dangerous to a patient. Embodiments described herein further include a debris catcher, which can be deployed before deployment of the hooks, or before retraction of the hooks whereby the failed TAVR is compressed such that resultant debris is collected by the debris catcher. The debris catcher of an example embodiment, described further below, defines a deployed position where the surgeon move the debris catcher to be positioned to receive debris, and a stowed position where the debris caught by the debris catcher is captured and configured for withdrawal with the surgical device.- 9 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2

[0038] FIG.1 illustrates a diagram of a Transcathetera Aortic Valve Replacement (TAVR) extraction device 100 according to an example embodiment of the present disclosure. As shown, the device includes an outer housing 103 within which an inner shaft 105 extends and is configured to move in a first direction relative to the outer housing 103 shown generally by arrow 110 and in a second direction relative to the outer housing 103 shown generally by arrow 120, opposite the first direction. The illustrated embodiment includes an inner shaft 105 extending through the outer housing 103, through a handle assembly 102, to an aft end of the device 100 away from the outer housing 103. However, in some embodiments the inner shaft 105 may not extend beyond the outer housing 103 or the handle assembly 102 depending upon the configuration.

[0039] In the illustrated embodiment, the inner shaft 105 is configured to be advanced in the first direction by a surgeon drawing a back end 106 of the inner shaft in the first direction. The handle assembly 102 is configured to engage and advance the inner shaft 105 in the second direction responsive to actuation of the actuator 112. The actuator 112 of the illustrated embodiment is pulled against a biasing force of a spring 114 to advance the inner shaft 105, while the spring 114 biases and returns the actuator 112 to an original position after advancing of the inner shaft. While a handle assembly 102 employing an actuator 112 and a spring 114 is depicted in the illustrated embodiment of FIG. 1, other mechanisms can be employed to move the inner shaft 105 relative to the outer housing 103.

[0040] Also shown in FIG. 1 are a plurality of hooks 104 disposed in a deployed or substantially deployed position where a hooked end of a respective hook is away from or distal to the outer housing 103. The function of these hooks 104 and their operation will be described in greater detail below.

[0041] FIG. 2 illustrates a detail view of a distal end of a TAVR extraction device including the plurality of hooks 104 extending in a deployed position relative to the outer housing 103 according to an example embodiment of the present disclosure. Each of the plurality of hooks 104 includes a first end 202 connected to the inner shaft (not visible in FIG. 2), a second end 206, and a middle portion 204 defined between the two ends. In some embodiments, the first end 202 comprises a hinge component that cooperates with the inner shaft to form a connection that- 10 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2enables angular movement of each of the plurality of hooks 104 between the retracted position and the illustrated deployed position.

[0042] In some embodiments, the second end 206 of each of the plurality of hooks 104 is a hooked end specifically configured to connect to a framework of a failed TAVR. According to some embodiments, it is preferable that the configuration of the plurality of hooks 104 is such that each hook as one or two hooks positioned for deployment at a same or very similar position along a length of the outer housing so as to provide equal-and-opposite forces on a valve perimeter as it is compressed by retraction of the hooks 104. In the illustrated embodiment, there are six hooks 104 arranged as three pairs, with each pair disposed opposite another hook at a same position along a length of the outer housing 103. This enables engagement of the hooks 104 with the framework of the failed TAVR at different positions along a length of the framework to better compress the framework along its entire length for effective removal.

[0043] Also visible in FIG. 2 are apertures 124 into which the hooks 104 at least partially advance during retraction. The apertures 124 are sized such that the hooks 104 have some degree of travel as the inner shaft moves within the outer housing 103. The movement of the inner shaft relative to the outer housing 103 causes the hooks to retract and compresses the failed TAVR forcibly based on the apertures interacting with the hooks themselves.

[0044] FIG. 3 illustrates an exploded view of the distal end of the device including the hooks 104, the outer housing 103 shown split, and the inner shaft 105. Also shown are the hooks 104 removed from the connection with the inner shaft 105. The illustrated embodiment of FIG. 3 depicts one possible mechanism for a hinge connection between the inner shaft 105 and the hooks 104. As shown, the hooks 104 can include a hinge receiving aperture 109 that is received within an opening 121 in the inner shaft 105. A hinge pin 129 is received through a pin hole 127 within the inner shaft 105, through a respective hinge receiving aperture 109 of a hook 104, and through the pin hole 127 on an opposite side of the hook. This connection provides a hinged connection between each hook 104 and the inner shaft 105.

[0045] FIGS. 4 and 5 illustrate how the inner shaft 105 movement relative to the outer housing 103 causes movement of the hooks 104 between the deployed position and the retracted position. As shown in FIG. 4, the hook 104 is in the retracted position relative to the outer- 11 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2housing 103. An axis 134 along which the hook 104 extends is disposed at an angle 150 relative to the axis 154 along which the inner shaft 105 and the outer housing 103 extend. The angle 150 may be, for example, about 25 degrees to about 40 degrees. This angle is intended to reduce the overall diameter of the tool for insertion of the tool into the heart valve, but also to provide sufficient motion of the hooks 104 relative to the outer housing 103 to sufficiently compress the failed TAVR. The aperture 124 is positioned with a first edge 123 of the aperture where movement of the inner shaft 105 relative to the outer housing 103 causes the first edge 123 of the aperture to drive the hook 104 toward the retracted position about the hinge of the hook 104.

[0046] FIG. 5 illustrates the hook 104 in the deployed position relative to the outer housing 103. In the illustrated deployed position, the hook 104 extends along an axis 134 at an angle of about 90 degrees relative to the axis 154 along which the inner shaft 105 and the outer housing 103 extend, shown by angle 160. Also shown is a second edge 125 of the aperture 124. As the inner shaft 105 moves in the second direction, shown by arrow 110 relative to the outer housing 103, the second edge 125 of the aperture 124 drives the hook 104 to the deployed position illustrated in FIG. 5. Optionally, the hooks 104 may be biased toward a retracted position or a deployed position, such that the force against the hook by one of the first edge 123 or the second edge 125 may not be necessary or may assist the bias. Such bias could be driven by a spring, for example, within the inner shaft 105 against the hook 104 about the hinge.

[0047] FIGS. 6-8 illustrate an example use case of the surgical device described herein. As shown in FIG. 6, a portion of a distal end 300 of a device is inserted within a failed TAVR 320 in the valve of a patient. As shown in FIG. 6, the hooks 304 of the distal end 300 of the surgical device are in the retracted position upon insertion into the failed TAVR 320. FIG. 7 illustrates the hooks 304 moved to the deployed position relative to the distal end 300 of the surgical device. As the hooks 304 are moved to the deployed position, the second end 306 extend through the failed TAVR 320, pressing the tissue beyond the failed TAVR away from the failed TAVR in the region of the hook 304. This enables the second end 306 of the hooks 304 to engage the failed TAVR. FIG. 8 illustrates the hooks 304 of the distal end 300 of the surgical device once again retracted. However, after the hooks 304 engage the failed TAVR 320 they grab and compress the failed TAVR as they are returned to the retracted position. While the illustration of- 12 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2FIGX. 6-8 depict only a portion of the surgical device and failed TAVR, the plurality of hooks employed by the device engage the failed TAVR 320 along its length to compress the failed TAVR along its length, as shown in the localized section in FIG. 8. The original position of the external reaches of the failed TAVR 320 are illustrated as dashed lines 322, reflecting the degree to which the surgical device is able to compress the failed TAVR for safer and more effective removal.

[0048] The removal of a failed TAVR may result in undesirable debris as calcium accumulation on the framework of a failed TAVR may crumble as the failed TAVR is compressed using the technique outlined above. Further, tissue that has grown into or around a TAVR may be pulled away from the valve and become debris. This debris can be detrimental to the health of the patient, such that embodiments described herein may further include a debris catcher to catch and remove any such debris.

[0049] FIG. 9 illustrates an example embodiment of a device 400 similar to the device 100 of FIG. 1; however, the device of FIG. 9 further includes debris catcher 450. The device 400 includes outer housing 403, inner shaft 405, and hooks 404 similar to those of the device 100 of FIG. 1. Further, the handle assembly 402 may function in the same manner. Additionally shown in FIG. 4 is a debris catcher housing 430 is attached to a distal end of the device 400. The debris catcher housing 430 is configured to receive therein the debris catcher in a stowed position, where the debris catcher 450 is substantially housed within the debris catcher housing. The debris catcher 450 is formed of two primary components including a filament 435 and a selfopening sack 440. The filament 435 forms a loop about a top of the self-opening sack 440 and is attached to the top of the sack to form an opening into the self-opening sack. The self-opening sack can open in a manner similar to a coiled spring unrolling, where the self-opening sack is deployed to substantially cover the aortic outflow track and / or the left ventricular cavity.

[0050] The filament 435 is fed through tube 445, where the tube extends along the outer housing 403 of the device 400 and through the debris catcher housing 430. The filament 435 is pushed through the tube in the second direction shown by arrow 420 to cause the sack to open, and the filament 435 is drawn through the tube in the first direction shown by arrow 410 to close the opening to the sack. The tube 445 itself is moved in the second direction to push the debris- 13 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2catcher 450 from the stowed position within the debris catcher housing 430 to the deployed position as shown in FIG. 9.

[0051] In practice, a distal tip of the device 400 is inserted into the valve of a patient to a location within a failed TAVR with the debris catcher in the stowed position. Upon reaching the proper position, the debris catcher 450 is deployed by a surgeon pushing on the tube 445 to drive the debris catcher from the debris catcher housing 430. Once the debris catcher is moved to the deployed position, the surgeon advances the fdament 435 in the second direction shown by arrow 420 to open the sack 440 of the debris catcher. The surgeon may then perform the TAVR removal as described above during which debris may be loosened. The debris is caught in the sack 440 of the open debris catcher 450 during the surgery. Once the surgery is complete and the failed TAVR is collapsed about the distal end of the device 400, the sack 440 of the debris catcher 450 is closed by the surgeon pulling on an end 455 of the filament 435 to close the opening of the sack 440. The surgeon can then pull on the tube 445 to pull the closed debris catcher 450 into the debris catcher housing 430 into the stowed position.

[0052] Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.- 14 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2

Claims

PCT / US25 / 41215 08 August 2025 (08.08.2025)CLAIMS1. An apparatus for Transcatheter Aortic Valve Replacement (TAVR) extraction comprising: an outer housing; an inner shaft configured to move in a first direction relative to the outer housing and in a second direction relative to the outer housing opposite the first direction; a plurality of hooks, each of the plurality of hooks having a first end connected to the inner shaft and a second end, wherein each of the plurality of hooks defines a deployed position where the second end is distal from the outer housing and a retracted position where the second end is proximal the outer housing; and a debris catcher proximate a distal end of the outer housing, the debris catcher defining a deployed position opened to receive debris and a stowed position closed to trap debris.

2. The apparatus of claim 1, wherein each of the plurality of hooks comprises a range of motion relative to the outer housing of between about 30 degrees in a the retracted position and about 90 degrees in the deployed position.

3. The apparatus of claim 1, wherein a shape of the second end of each of the plurality of hooks is an arc.

4. The apparatus of claim 3, wherein the arc of the second end of each of the plurality of hooks extends between 90 degrees and 135 degrees.

5. The apparatus of claim 1, wherein the inner shaft moving in a first direction causes each of the plurality of hooks to transition from the retracted position towards the deployed position, and the inner shaft moving in a second direction opposite the first direction causes each of the plurality of hooks to transition from the deployed position to the retracted position.- 15 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2PCT / US25 / 41215 08 August 2025 (08.08.2025)6. The apparatus of claim 1, wherein the apparatus further comprises a handle, wherein actuation of the handle causes the plurality of hooks to transition between the deployed position to the retracted position.

7. The apparatus of claim 6, wherein the handle advances the inner shaft relative to the outer housing in the second direction using a ratchet mechanism, wherein the plurality of hooks transition from the deployed position to the retracted position in about three actuation cycles of the handle.

8. The apparatus of claim 1, wherein the debris catcher comprises: a tube slidably attached proximate the distal end of the outer housing; a filament extending through the tube; and a self-opening sack once deployed wherein the filament is attached to and encircles an opening of the self-opening sack.

9. The apparatus of claim 8, wherein the tube is advanced in a second direction, toward the self-opening sack to move the debris catcher to the deployed position, and the tube is advanced in a first direction, opposite the second direction to move the debris catcher to the stowed position.

10. The apparatus of claim 9, wherein the filament is moved relative to the tube in the second direction to open the self-opening sack of the debris catcher, and wherein the filament is moved relative to the tube in the first direction to close the sack to retain any contents received into the self-opening sack.

11. A method for TAVR extraction comprising: inserting a distal end of a device into a heart valve containing a replacement valve, the device including outer housing containing an inner shaft configured to move in a first- 16 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2PCT / US25 / 41215 08 August 2025 (08.08.2025) direction relative to the outer housing and in a second direction relative to the outer housing opposite the first direction; deploying a debris catcher proximate the distal end of the device, the debris catcher defining a deployed position opened to receive debris and a stowed position closed to trap debris, into the deployed position to receive debris; deploying a plurality of hooks, each of the plurality of hooks having a first end connected to the inner shaft and a second end, wherein each of the plurality of hooks defines a deployed position where the second end is distal from the outer housing and a retracted position where the second end is proximal the outer housing, into the retracted position to deform and compress the replacement valve; engaging the replacement valve with the second end of each of the plurality of hooks in the deployed position; retracting the plurality of hooks causing the replacement valve to collapse about the distal end of the device; and capturing debris from the replacement valve in the debris catcher.

12. The method of claim 11, further comprising closing a sack of the debris catcher after retraction of the plurality of hooks.

13. The method of claim 12, further comprising moving the debris catcher with the closed sack to the stowed position.

14. An apparatus for removal of a replacement valve comprising: an outer housing; a plurality of hooks extending from a distal end of the outer housing, wherein the plurality of hooks are configured to move between a retracted position and a deployed position, wherein the plurality of hooks are configured to engage the replacement valve in the deployed position, and to collapse the replacement valve in response to the plurality of hooks moving to the retracted position; and- 17 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2PCT / US25 / 41215 08 August 2025 (08.08.2025) a debris catcher, wherein the debris catcher comprises: a flexible tube attached to the outer housing; a filament extending through the flexible tube; and a self-opening sack wherein the filament attaches to an opening of the sack and is configured to move the sack between an open position and a closed position.

15. The apparatus of claim 14, wherein each of the plurality of hooks comprises a range of motion relative to the outer housing of between about 30 degrees in the retracted position and about 90 degrees in the deployed position.

16. The apparatus of claim 14, wherein a shape of an end of each of the plurality of hooks is an arc.

17. The apparatus of claim 14, further comprising: an inner shaft, wherein each of the plurality of hooks are hingedly attached to the inner shaft and extend through respective apertures in the outer housing.

18. The apparatus of claim 17, wherein movement of the inner shaft in a first direction relative to the outer housing causes the plurality of hooks to move to the deployed position, wherein movement of the inner shaft in a second direction opposite the first direction relative to the outer housing causes the plurality of hooks to move to the retracted position.

19. The apparatus of claim 18, wherein the plurality of hooks are driven between the retracted position and the deployed position by a respective aperture for each of the plurality of hooks based on relative movement of the inner shaft.

20. The apparatus of claim 19, wherein the inner shaft is moved relative to the outer housing in the second direction by a ratchet mechanism.- 18 -AttyDktNo: 049648 / 633123LEGAL02 / 46183962v2

Images