Transcatheter system for detachment and removal of clip attached to heart valve

Abstract

A system is directed to removing a clip attached to a heart valve of an individual. The system includes a blade configured to make cuts around the clip while the clip is attached to at least one leaflet of the heart valve. The system further includes a catcher configured to capture the clip and surrounding debris resulting from the cuts during a removal process. The system also includes a snare having a handle and a single loop formed at one end of the handle, the single loop being configured to receive a portion of the clip for stabilizing the clip while one or more of the cuts are being made.

Description

TRANSCATHETER SYSTEM FOR DETACHMENT AND REMOVAL OF CLIP ATTACHED TO HEART VALVECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application includes a claim of priority under 35 U.S.C. §119(e) to U.S. provisional patent application No. 63 / 735,450, filed December 18, 2024, the entirety of which are hereby incorporated by reference.FIELD OF INVENTION

[0001] This invention relates to devices, systems and methods for detachment and removal of a clip attached to a heart valve.BACKGROUND

[0002] The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Valvular heart disease is characterized by damage to or a defect in one of the four heart valves: the mitral, aortic, tricuspid or pulmonary. The mitral and tricuspid valves control the flow of blood between the atria and the ventricles (the upper and lower chambers of the heart). The tricuspid valve having three leaflets is on the right side of the heart, separating the right atrium and right ventricle. The mitral valve having two leaflets is on the left side, between the left atrium and left ventricle. The pulmonary valve controls the blood flow from the heart to the lungs, and the aortic valve governs blood flow between the heart and the aorta, and thereby to the blood vessels in the rest of the body. The mitral and aortic valves are most frequently affected by valvular heart disease.

[0004] Transcatheter valve therapies are one treatment option for patients. For example, transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is a procedure for patients with severe symptomatic aortic stenosis (narrowing of the aortic valve opening) who are not candidates for traditional open chest surgery or are high-risk operable candidates. In these procedures, a replacement valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. The most common form of valvular heart disease is mitral regurgitation (MR), in which the two leaflets (anterior and posterior) of the mitral valve do not close properly when the heart14937-3010-0091 6065472-000954WOPTpumps out blood. One procedure for MR is edge-to-edge leaflet repair. This procedure uses a suture, a percutaneous suture (e.g., Edwards’ MOBIUS™) or a clip (e.g., Abbott’s MitraClip™ and Edwards Lifesciences’ The PASCAL Precision system) to bring the anterior and posterior leaflets together at their middle points, creating a double-orifice mitral valve. As a result, leaflet coaptation is re-established to reduce MR. The present invention can also be used for other types of clips used in repair of heart valves including the mitral valve and tricuspid valve. One example of clips used in repair of the tricuspid clip is TriClip™ system (Abbott), but the clip is not limited thereto. The clip has arms that grasp the edges of the valve leaflets and pin them together. Multiple clips (typically one to three) may be used depending on the patient's specific anatomy and the severity of the leak.

[0005] MitraClip™ procedures are generally considered safe and effective, with a reported success rate of 90-95% in reducing mitral regurgitation (MR) severity. However, MitraClip™ failure can occur in approximately 5-10% of cases and is associated with a high rate of moderate-to-severe MR and death during follow-up. When the clip fails, there are only a few options to fix it, such as putting in another clip or having surgery to repair or replace the valve. Several attempts have been made in the past to address the problem of failed MitraClip™ procedures. One approach is to reposition the clip using a transseptal approach, but this technique is associated with a higher risk of complications, such as cardiac tamponade and embolization. Another option is to place an additional clip to reinforce the failed one, but this may not be feasible in all cases, and it also carries an increased risk of complications.

[0006] Similarly, failure can occur in tricuspid clip procedures. A tricuspid clip procedure is a minimally invasive repair for a leaky tricuspid heart valve, also known as transcatheter edge-to-edge repair (TEER). For example, a specialized clip is delivered to the heart via a catheter inserted through a vein in the groin, and the clip is used to grasp and bring the valve leaflets together, reducing blood backflow. In general, the clip can attach to any two of the anterior, posterior, and septal leaflets of the tricuspid valve. Therefore, the mechanism for clip removal remains the same or similar as for both the mitral valve and the tricuspid valve, since both the mitral clip and the tricuspid clip engage only two leaflets at a time. The removal procedure for the tricuspid clip involves making the cut and removing the clip in the same manner as done for mitral clip retrieval. The primary difference between the mitral clip removal procedure and the tricuspid clip removal procedure is that multiple clips are often placed in the tricuspid valve, and thus, these steps must be repeated for each clip, removing them one by one for the tricuspid clip removal procedure. If the tricuspid clip fails, the need for tricuspid valve replacement may increase. In such cases, the tricuspid clip must be removed to achieve an24937-3010-0091 6065472-000954WOPToptimal outcome and fully eliminate the regurgitant jet.

[0007] Currently, there are no specific transcatheter technologies available for removing a failed clip. Surgical removal may be an option, but this approach carries a higher risk for patients who are not good candidates for surgery due to their comorbidities. In some cases, medical management may be the only option, but this can lead to a poor quality of life and a decreased life expectancy. However, for patients who cannot undergo surgery, it is crucial to have a way to remove the failed clip device so that other options for fixing the valve can be explored. Unfortunately, there are currently no specific catheter-based tools available to remove a failed clip.

[0008] Therefore, there is a clear need for a safe and effective device to detach and remove the failed clip used for repair of heart valves, which can potentially open up additional transcatheter repair or replacement options for the patient. In particular, there is a need for improved technologies for detaching and retrieving the clip from the anterior and / or posterior leaflets of the mitral valve and / or the septal, posterior, and / or anterior leaflets of the tricuspid valve without open-heart surgery for patients who have failed clip procedures and are not good candidates for surgery. There is also a need for a safe and effective device to detach and remove the failed transcatheter clip used for tricuspid valve repair performed by a minimally invasive procedure. The present disclosure provides a solution for these and other needs that improve patient outcomes and quality of life.SUMMARY

[0009] In one aspects of the present disclosure, a system for removing a clip attached to a heart valve of an individual is provided. The system includes a blade configured to make cuts around the clip while the clip is attached to at least one leaflet of the heart valve; a catcher configured to capture the clip and surrounding debris resulting from the cuts during a removal process; and a snare having a handle and a single loop formed at one end of the handle. The single loop is configured to receive a portion of the clip for stabilizing the clip while one or more of the cuts are being made.

[0010] In another aspect of the present disclosure, a method for cutting and retrieving a clip attached to a heart valve of an individual is provided. The method includes inserting a sheath into the atrium of the individual; deploying a catcher through the sheath into the atrium; deploying a snare to the atrium through the sheath and navigating the snare to a target site around the clip; opening a loop of the snare around the clip; tightening the snare to secure the clip for minimizing lateral movement of the clip; deploying a blade through the sheath to34937-3010-0091 6065472-000954WQPTposition the blade in the atrium and making cuts around the clip; pulling the snare with the cut clip into the catcher to capture and retrieve the clip; and withdrawing the catcher and the snare from the atrium, through the sheath, to extract the catcher containing the clip from the individual

[0011] The foregoing summary is not intended to represent each embodiment or every aspect of the present disclosure. Rather, the summary merely provides an example of some of the novel aspects and features set forth herein. The above features and advantages, and other features and advantages of the present disclosure, will be readily apparent from the following detailed description of representative embodiments and modes for carrying out the present approach, when taken in connection with the accompanying drawings and the appended claims.BRIEF DESCRIPTION OF DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, exemplify the embodiments of the present invention and, together with the description, serve to explain and illustrate principles of the invention. The drawings are intended to illustrate major features of the exemplary embodiments in a diagrammatic manner. The drawings are not intended to depict every feature of actual embodiments nor relative dimensions of the depicted elements, and are not drawn to scale.

[0013] FIG. 1 is an illustration of a system for removing a clip attached to a heart valve, according to an embodiment of the disclosure.

[0014] FIG. 2A is an illustration of a blade of the system illustrated in FIG. 1, according to an embodiment of the disclosure.

[0015] FIG. 2B is an illustration of a catcher of the system illustrated in FIG. 1, according to an embodiment of the disclosure.

[0016] FIG. 2C is an illustration of a snatcher of the system illustrated in FIG. 1, according to an embodiment of the disclosure.

[0017] FIG. 3 is a flowchart illustrating a method for cutting and retrieving a clip attached to a heart valve of an individual, according to an embodiment of the disclosure.

[0018] FIG. 4A is a schematic illustrating securing a clip attached to a heart valve with a snatcher, according to an embodiment of the disclosure.

[0019] FIG. 4B is a schematic illustrating retrieving a cut clip by pulling a snare with the clip into a catcher, according to an embodiment of the disclosure.

[0020] FIG. 5A is a schematic side view of a mitral valve illustrating cutting a clip that is attached to leaflets of the mitral valve with a blade, according to an embodiment of the44937-3010-0091 6065472-000954WOPTdisclosure.

[0021] FIG. 5B is a schematic top view of the mitral valve shown in FIG. 5A, according to an embodiment of the disclosure.

[0022] FIG. 6 is a schematic view of a tricuspid valve illustrating cutting a clip that is attached to leaflets of the tricuspid valve with a blade, according to an embodiment of the disclosure. The abbreviations stand for the chambers of the heart (right atrium (RA), right ventricle (RV), and left ventricle (LV), left atrium (LA) not shown in the drawing) and pulmonary veins (PV).

[0023] 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 OF THE INVENTION

[0024] Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Szy cher’s Dictionary of Medical Devices CRC Press, 1995, may provide useful guidance to many of the terms and phrases used herein. One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials specifically described.

[0025] In some embodiments, properties such as dimensions, shapes, relative positions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified by the term “about.” For purposes of the present detailed description, unless specifically disclaimed, and where appropriate, the singular includes the plural and vice versa. The word “including” means “including without limitation.” Moreover, words of approximation, such as “about,” “almost,” “substantially,” “approximately,” and the like, can be used herein to mean “at,” “near,” “nearly at,” “within 3-5% of,” “within acceptable manufacturing tolerances of,” or any logical combination thereof. Similarly, terms “vertical” or “horizontal” are intended to additionally include “within 3-5% of’ a vertical or horizontal orientation, respectively. Additionally, words of direction, such as “top,” “bottom,” “left,”54937-3010-0091 6065472-000954WOPT“right,” “above,” and “below” are intended to relate to the equivalent direction as depicted in a reference illustration; as understood contextually from the object(s) or element(s) being referenced, such as from a commonly used position for the object(s) or element(s); or as otherwise described herein.

[0026] Various examples of the invention will now be described. The following description provides specific details for a thorough understanding and enabling description of these examples. One skilled in the relevant art will understand, however, that the invention may be practiced without many of these details. Likewise, one skilled in the relevant art will also understand that the invention can include many other obvious features not described in detail herein. Additionally, some well-known structures or functions may not be shown or described in detail below, so as to avoid unnecessarily obscuring the relevant description.

[0027] The terminology used below is to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific examples of the invention. Indeed, certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.

[0028] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any inventions or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular inventions. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

[0029] Similarly, while operations may be depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described program components and64937-3010-0091 6065472-000954WOPTsystems can generally be integrated together in a single software product or packaged into multiple software products.

[0030] One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials described. For purposes of the present invention, the following terms are defined below.

[0031] In various embodiments, the devices, systems and methods described herein are configured for humans. One of skill in the art would readily appreciate that the devices, systems and methods described herein could be customized for use in almost any mammal in which a heart valve may be replaced. In various embodiments, the device is delivered transseptally or transapically.

[0032] “Mammal” as used herein refers to any member of the class Mammalia, including but not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; rodents such as mice, rats, hamsters and guinea pigs; and so on. In certain embodiments, the mammal is a human subject. The term does not denote a particular age or sex. Thus, adult and newborn subjects, as well as fetuses, whether male or female, are intended to be included within the scope of this term.

[0033] In various embodiments, the appropriate guide wires, sheaths and catheters for use with the devices, systems and methods described herein will be apparent to a person of skill in the art, for example, as described in Ye et al. (Transapical aortic valve implantation in humans. Ye J, Cheung A, Lichtenstein SV, Carere RG, Thompson CR, Pasupati S, Webb JG. J Thorac Cardiovasc Surg. 2006 May; 131(5): 1194-6), Lichtenstein et al. (Transapical transcatheter aortic valve implantation in humans: initial clinical experience. Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S, Webb JG. Circulation. 2006 Aug 8; 114 (6):591-6. Epub 2006 Jul 31), Kurra et al. (Pre-procedural imaging of aortic root orientation and dimensions: comparison between X-ray angiographic planar imaging and 3- dimensional multidetector row computed tomography. Kurra V, Kapadia SR, Tuzcu EM, Halliburton SS, Svensson L, Roselli EE, Schoenhagen P. JACC Cardiovasc Interv. 2010 Jan;3 (1): 105-13.), Wake et al. (Computed tomography angiography for transcatheter aortic valve replacement. Wake N, Kumamaru K, Prior R, Rybicki FJ, Steigner ML. Radiol Technol. 201374937-3010-0091 6065472-000954WOPTMar-Apr;84(4):326-40.), and Little et al. (Multimodality noninvasive imaging for transcatheter aortic valve implantation: a primer. Little SH, Shah DJ, Mahmarian JJ. Methodist Debakey Cardiovasc J. 2012 Apr-Jun;8(2):29-37.), all of which are incorporated by reference herein in their entirety as fully set forth.

[0034] FIG. 1 shows an example system 100 that may be utilized for cutting and retrieving a clip 150 attached to a heart valve of an individual. In particular, the system 100 may be utilized for retrieving a failed clip 150 used to prevent / reduce mitral regurgitation in an individual who cannot undergo surgery. Although a mitral clip / mitral valve is shown as an example in the drawings, the clip is not limited thereto. The clip 150 may be any clip that is used for repair of heart (valves). For example, the system 100 is designed to remove a failed clip 150 through a minimally invasive procedure, ensuring safety and efficacy while reducing the need for open-heart surgery. It is crucial to have a way to remove the failed clip device 150 so that other options for fixing the valve can be explored. Unfortunately, there are currently no specific catheter-based tools available to remove a failed clip 150. Disclosed herein is a device / system 100 that can detach the clip 150 from the anterior leaflet, leaving it attached to the posterior leaflet for potential future transcatheter intervention. Alternatively, the device / system 100 could detach both leaflets and remove the clip 150 from the body.

[0035] The device / system 100 is provided to ensure that it can accurately and reliably detach the clip 150 without damaging the heart tissue or causing other complications. The goal for this device / system 100 would be to improve the options for patients who have failed heart valve clip procedures and are not good candidates for surgery. The device / system 100 could provide an alternative to surgery by allowing for the removal of the failed clip and opening up the possibility of additional transcatheter repair or replacement options.

[0036] Referring to FIG. 1, in general, the system 100 includes three components: a blade 110, a filter / catcher 120 (referred to as “catcher” hereinafter), and a snare 130. Each component plays a crucial role in the capture and removal of the clip 150, while minimizing the risk of debris embolization. In general, the system 100 or the components 110, 120, 130 may be deployed to a target area in the heart (for example, left atrium (LA)) through a sheath 140 or a catheter inserted into the target area. For left-sided procedures, like mitral clips, mitral valve replacement, or left atrial appendage closure, access is through the LA, which requires a transseptal puncture. For tricuspid clips, typically access is through the femoral vein directly into the right atrium, and no septal puncture is needed. This difference does not change the procedural steps when using the system 100 according to various embodiments. In the present disclosure, the atrium may be the left atrium or the right atrium depending on the type / target84937-3010-0091 6065472-000954WOPTof the procedure.

[0037] Each of the blade 110, catcher 120, and snare 130 may be deployed individually or together depending on the circumstances. In one embodiment, the deployment of the system 100 may follow a defined sequence: first, the sheath 140 is advanced into the atrium, followed by positioning of the catcher 120. Then the snare 130 is released to secure the clip 150. After stabilization, the cutting blade 110 is deployed to incise the tissue surrounding the clip 150, allowing the clip 150 to be freed and retracted into the catcher 120 for removal. Generally, the catcher 120 is deployed before the snare 140 is deployed. That is, the catcher 120 is released first, and then the snare 130 is used to capture the clip 150, and finally, the blade 110 is deployed to cut the surrounding tissue. However, the sequence of deployment may be changed depending on the circumstances.

[0038] Referring to FIG. 1 and FIG. 2A, the blade 110 is designed to make precise circular cuts around the clip 150, ensuring it remains attached to the leaflets. The blade 110 may be angled or curved to allow smooth maneuverability in the LA's confined space. The blade 110 may be made of medical-grade stainless steel or titanium for strength, sharpness, and corrosion resistance. A biocompatible coating minimizes friction and tissue trauma. For example, the dimensions of the blade 110 may be as follows: Length: about 10 millimeters (mm) - about 15 mm or 10 mm-15 mm for adequate reach; Width: about 2 mm-about 3 mm or 2 mm-3 mm, balancing maneuverability and cutting efficiency. The tip 201 of the blade 110 may be sharp and curved for easy insertion and effective cutting.

[0039] Referring to FIG. 1 and FIG. 2B, the catcher 120 may be collapsible and configured to capture the clip 150 and surrounding debris during the removal process. The expandable structure of the catcher 120 may fit snugly within the sheath 140 during insertion and deploys to an optimal size in the heart. The catcher 120 may be made of polyurethane (PU) for flexibility, strength, and biocompatibility. For example, dimensions of the catcher 120 may be as follows: Deployed Diameter: about 25 mm-about 30 mm or 25 mm-30 mm for ample capture surface area; Pore Size: about 200 microns-about 400 microns or 200 microns-400 microns, allowing blood flow while capturing debris. The shape of the catcher 120 may be conical, with a fully covered tip 203 and mesh structure (filter) 205 for efficient capture and retrieval.

[0040] Referring to FIG. 1 and FIG. 2C, the snare 130 includes a handle 207 and a single-loop snare 209 extending from one end of the handle 207. The snare 130 is configured to stabilize the clip 150 during retrieval, preventing lateral movement. In general, the snare 130 may be made of nitinol for super elasticity, with a polytetrafluoroethylene (PTFE) coating to94937-3010-0091 6065472-000954WOPTreduce friction and tissue trauma. The same snare 130 may be used for both mitral clip and tricuspid clip removal although sizes of the mitral clip and tricuspid clip may be different because the diameter of the single-loop snare 209 can be adjusted. Alternatively, a differently sized snare 130 may be provided for each of the mitral clip and tricuspid clip to accommodate the differently sized clips. The snare 130 may be customized or available in various sizes to accommodate different clip sizes.

[0041] For example, the dimensions of the snare 130 is as follows:• Loop Diameter: about 8 mm-about 10 mm or 8 mm-10, or about 8 mm-about 25 mm or 8 mm-25 mm in an expanded state for a secure fit around the clip 150 - when the snare 130 or the single-loop snare 209 is in a collapsed state, the single-loop maintains a profile of about 4 mm to about 6 mm to ensure compatibility with the delivery sheath 140; and• Length: about 100 centimeters (cm) to about 130 cm, or about 120 cm - sufficient for smooth navigation and effective capture of the clip 150, and the length may correspond to a length from the femoral vein to reach the clip 150. In one embodiment, the length of the snare 130 corresponds to the entire length including the handle 207 and the single-loop snare 209.The control mechanism for the snare 130 includes a sliding or rotating handle 207 that ensures precise tightening of the single-loop snare 209 around the clip 150. The snare 130 is primarily controlled through the delivery sheath 140, which incorporates a locking mechanism. This system allows the snare 130 to be released and rotated to properly engage the clip 150. Once the clip 150 is securely captured, the snare 130 is locked to ensure stable and reliable fixation.

[0042] FIG. 3 shows a flow chart illustrating a method 300 for performing a transcatheter procedure for detaching and removing a failed clip, in accordance with an embodiment. The method 300 will be described with respect to FIGS. 4 A - 6, although it will be appreciated that the method 300 may be implemented for any transcatheter heart valve without departing from the scope of the disclosure. FIG. 5 A illustrates cutting a clip 150 that is attached to leaflets of the mitral valve with the blade 110, and FIG. 6 illustrates cutting a clip 150 that is attached to leaflets of the tricuspid valve with the blade 110. FIG. 5B is a schematic top view of the mitral valve shown in FIG. 5 A, including two leaflets held by the clip 150. The schematic view of the tricuspid valve shown in FIG. 6 is similar to the schematic view of the mitral valve except for the number of leaflets shown.

[0043] At step 302, the method 300 includes inserting a sheath 140 into the left atrium104937-3010-0091 6065472-000954WOPTof the individual where a clip 150 is located. In one example, the sheath 140, for example a 20 French (Fr) sheath, is inserted through the femoral or internal jugular vein. However, the sheath size is not limited to 20 Fr, and for example, the Fr sheath size may be 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 22, or 24. For example, inserting the sheath 140 at step 302 includes advancing the sheath 140 to the inferior vena cava and into the right atrium (RA) and performing a transseptal puncture to access the left atrium (LA).

[0044] Next, at step 304 (and also referring to FIGs. 4Aand 4B), the method 300 includes deploying the catcher 120 through the sheath 140 into the LA, ensuring proper expansion to capture debris around the clip 150 (for example, mitral clip or MitraClip™ or tricuspid clip or TriClip™).

[0045] Next, at step 306, the method 300 includes navigating the snare 130 to the clip 150 using the same sheath 140 (e.g., as shown in FIG. 4A).

[0046] Next, at step 308, the method 300 includes opening the snare loop 209 around the clip 150 and tightening it securely by adjusting the diameter of the single-loop snare 209, minimizing lateral movement, such that the clip 150 is secured by the snare 130.

[0047] Next, at step 310, the method 300 includes deploying the blade 110 through the sheath 140 and positioning the blade 110 to make circular cuts approximately 1 mm-2 mm from the clip 150. FIGS. 5A and 5B show exemplary cuts made with the blade 110, the broken lines in drawings indicating perforation or cut out portion(s) around the clip 150. Ensure precise cuts while maintaining clip 150 attachment to the leaflets.

[0048] Next, at step 312, the method 300 includes gently pulling the snare 130 and clip 150 into the catcher 120, stabilizing the assembly. Then, at step 314, the method 300 includes slowly withdrawing the catcher 120 and snare 130 through the sheath 140 while maintaining alignment, as shown in FIG. 4B. The catcher 120 containing the clip 150 is removed from the body in a smooth, controlled motion, monitoring for signs of debris embolization throughout the process.

[0049] The above-described method 300 is an exemplary way to remove the failed clip device so that other options for fixing the heart valve can be explored. The above-described system 100 can detach the valve clip 150 from the anterior leaflet, leaving it attached to the posterior leaflet for potential future transcatheter intervention. Alternatively, the system 100 could detach both anterior and posterior leaflets and remove the clip 150 from the body. The above-described system 100 and method 300 can accurately and reliably detach the clip without damaging the heart tissue or causing other complications. The above-described system 100 and method 300 could improve the options for patients who have failed clip procedures and are not114937-3010-0091 6065472-000954WOPTgood candidates for surgery. The system 100 could provide an alternative to surgery by allowing for the removal of the failed clip and opening up the possibility of additional transcatheter repair or replacement options.

[0050] The disclosed system and method provide a unique advantage over existing solutions by allowing for safe and effective detachment and removal of a failed clip, which can potentially open up additional transcatheter repair or replacement options for the patient. Compared to existing solutions, such as repositioning the clip or placing an additional clip, the disclosed system and method provide a more-targeted and precise approach that minimizes the risk of complications. Additionally, the disclosed system and method potentially reduces the need for surgical intervention, which carries a higher risk for patients who are not good candidates for surgery due to their comorbidities.

[0051] Furthermore, the disclosed system and method offer a more-flexible approach by allowing for the detachment of the clip from the anterior leaflet and leaving the clip on the posterior leaflet for future transcatheter intervention, or the detachment of both leaflets and removal of the clip from the body. This provides a range of options for physicians to choose from depending on the patient's unique situation. Overall, the disclosed system and method improve upon existing solutions by providing a safe, effective, and flexible solution that potentially improves patient outcomes and quality of life.

[0052] One of ordinary skill in the art would readily recognize that the method described above could involve other additional steps, which are not described in detail here. These additional steps include, but are not limited to, anesthesia, sterilization, heparinization, accessing the patient’s heart via various routes such as femoral, transseptal, transaortic and transapical approaches, ventricular pacing, stitching of the access site or percutaneous femoral closure. For example, more information on these procedures are described in Ye et al. (Transapical aortic valve implantation in humans. Ye J, Cheung A, Lichtenstein SV, Carere RG, Thompson CR, Pasupati S, Webb JG. J Thorac Cardiovasc Surg. 2006 May; 131(5): 1194- 6), Lichtenstein et al. (Transapical transcatheter aortic valve implantation in humans: initial clinical experience. Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S, Webb JG. Circulation. 2006 Aug 8; 114 (6):591-6. Epub 2006 Jul 31), Kurra et al. (Preprocedural imaging of aortic root orientation and dimensions: comparison between X-ray angiographic planar imaging and 3-dimensional multidetector row computed tomography. Kurra V, Kapadia SR, Tuzcu EM, Halliburton SS, Svensson L, Roselli EE, Schoenhagen P. JACC Cardiovasc Interv. 2010 Jan;3 (1): 105-13.), Wake et al. (Computed tomography angiography for transcatheter aortic valve replacement. Wake N, Kumamaru K, Prior R,124937-3010-0091 6065472-000954WOPTRybicki FJ, Steigner ML. Radiol Technol. 2013 Mar-Apr;84(4):326-40.), and Little et al. (Multimodality noninvasive imaging for transcatheter aortic valve implantation: a primer. Little SH, Shah DJ, Mahmarian JJ. Methodist Debakey Cardiovasc J. 2012 Apr-Jun;8(2):29- 37.), all of which are incorporated by reference herein in their entirety as fully set forth.

[0053] The various methods and techniques described above provide a number of ways to carry out the application. Of course, it is to be understood that not necessarily all objectives or advantages described can be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods can be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as taught or suggested herein. A variety of alternatives are mentioned herein. It is to be understood that some preferred embodiments specifically include one, another, or several features, while others specifically exclude one, another, or several features, while still others mitigate a particular feature by inclusion of one, another, or several advantageous features.

[0054] Furthermore, the skilled artisan will recognize the applicability of various features from different embodiments. Similarly, the various elements, features and steps discussed above, as well as other known equivalents for each such element, feature or step, can be employed in various combinations by one of ordinary skill in this art to perform methods in accordance with the principles described herein. Among the various elements, features, and steps some will be specifically included and others specifically excluded in diverse embodiments.

[0055] Although the application has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the application extend beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and modifications and equivalents thereof.

[0056] In some embodiments, the terms “a” and “an” and “the” and similar references used in the context of describing a particular embodiment of the application (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, “such as”) provided134937-3010-0091 6065472-000954WOPTwith respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

[0057] Preferred embodiments of this application are described herein, including the best mode known to the inventors for carrying out the application. Variations on those preferred embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the application can be practiced otherwise than specifically described herein. Accordingly, many embodiments of this application include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the application unless otherwise indicated herein or otherwise clearly contradicted by context.

[0058] All patents, patent applications, publications of patent applications, and other material, such as articles, books, specifications, publications, documents, things, and / or the like, referenced herein are hereby incorporated herein by this reference in their entirety for all purposes, excepting any prosecution file history associated with same, any of same that is inconsistent with or in conflict with the present document, or any of same that may have a limiting affect as to the broadest scope of the claims now or later associated with the present document. By way of example, should there be any inconsistency or conflict between the description, definition, and / or the use of a term associated with any of the incorporated material and that associated with the present document, the description, definition, and / or the use of the term in the present document shall prevail.

[0059] It is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly, embodiments of the present application are not limited to that precisely as shown and described.144937-3010-0091 6065472-000954WOPT

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A system for removing a clip attached to a heart valve of an individual, the system comprising: a blade configured to make cuts around the clip while the clip is attached to at least one leaflet of the heart valve; a catcher configured to capture the clip and surrounding debris resulting from the cuts during a removal process; and a snare having a handle and a single loop formed at one end of the handle, the single loop being configured to receive a portion of the clip for stabilizing the clip while one or more of the cuts are being made.

2. The system of claim 1, wherein the heart valve is a mitral valve or a tricuspid valve.

3. The system of claim 2, wherein the mitral valve has undergone an edge-to-edge repair (TEER) procedure and / or the clip on the at least one leaflet brings leaflets of the mitral valve or the tricuspid valve together to reduce leakage.

4. The system of any one of claim 2 or claim 3, wherein the clip is a MitraClip™ or TriClip™ and / or the clip holds anterior and posterior leaflets of the mitral valve or anterior, posterior, and septal leaflets of the tricuspid valve.

5. The system of claim 4, wherein the anterior and posterior leaflets of the mitral valve or any two of the anterior, posterior, and septal leaflets of the tricuspid valve are joined and brought together by the clip at middle points of the anterior and posterior leaflets of the mitral valve or the two of the anterior, posterior, and septal leaflets of the tricuspid valve.

6. The system of claim 5, wherein a double orifice is generated in the mitral valve by the TEER.

7. The system of any one of claims 1 to 6, wherein, after the cuts are made around the clip, the clip remains attached to the at least one leaflet.154937-3010-0091 6065472-000954WQPT8. The system of any one of claims 1 to 7, wherein the blade has a cutting edge that is angled or curved.

9. The system of any one of claims 1 to 8, wherein the blade is made of a medical-grade stainless steel or titanium.

10. The system of any one of claims 1 to 9, wherein the blade has a biocompatible coating.

11. The system of any one of claims 1 to 10, wherein the blade is sized and configured to be introduced into the left atrium of the individual through a sheath, the sheath being inserted from the inferior vena cava to provide access to the heart.

12. The system of any one of claims 1 to 11, wherein the blade has a length in a range of about 10 millimeters (mm) to about 15 mm.

13. The system of any one of claims 1 to 12, wherein the blade has a width in a range of about 2 mm to about 3 mm.

14. The system of any one of claims 1 to 13, wherein the blade has a sharp and curved tip.

15. The system of any one of claims 1 to 14, wherein the catcher has a conical shape.

16. The system of any one of claims 1 to 15, wherein the catcher has an expandable structure.

17. The system of any one of claims 1 to 16, wherein the catcher includes a fully covered tip that is connected to a filter portion, the filter portion having a mesh structure.

18. The system of claim 17, wherein the filter portion is collapsible.

19. The system of any one of claims 1 to 18, wherein the catcher is made of polyurethane.

20. The system of any one of claims 1 to 19, wherein, after the catcher is deployed to the left atrium, the catcher has a diameter in a range of about 25 mm to about 30 mm.164937-3010-0091 6065472-000954WQPT21. The system of any one of claims 17 to 20, wherein, after the catcher is deployed to the left atrium, the filter portion has a pore size in a range of about 200 microns to about 400 microns.

22. The system of any one of claims 1 to 21, wherein the snare is movable in response to sliding or rotational motion of the handle, the snare being further configured to prevent lateral movement of the cut clip and surrounding debris during the retrieval process.

23. The system of any one of claims 1 to 22, wherein the single loop of the snare is adjustable between an open configuration and a tight configuration.

24. The system of any one of claims 1 to 23, wherein the snare is made of nitinol.

25. The system of any one of claims 1 to 24, wherein the snare has a polytetrafluoroethylene (PTFE) coating.

26. The system of any one of claims 1 to 25, wherein the single loop of the snare has a diameter in a range of about 8 mm to about 10 mm or in a range of about 8 mm to about 25 mm in an expanded state, the single loop maintaining a profile of about 4 mm to about 6 mm in a collapsed state.

27. A method for cutting and retrieving a clip that is attached to a heart valve of an individual, the method comprising: inserting a sheath into the left or right atrium of the individual; deploying a catcher through the sheath into the left or right atrium; deploying a snare to the left or right atrium through the sheath and navigating the snare to a target site around the clip; opening a loop of the snare around the clip; tightening the snare to secure the clip for minimizing lateral movement of the clip; deploying a blade through the sheath to position the blade in the left or right atrium and making cuts around the clip; pulling the snare with the cut clip into the catcher to capture and retrieve the clip; and174937-3010-0091 6065472-000954WQPTwithdrawing the catcher and the snare from the left or right atrium, through the sheath, to extract the catcher containing the clip from the individual.

28. The method of claim 27, wherein the inserting of the sheath includes: inserting a 20 Fr sheath through the femoral or internal jugular vein of the individual; advancing the sheath into the right or left atrium of the individual; and. accessing the left or right atrium.

29. The method of claim 27, wherein the catcher includes a fully covered tip that is connected to a filter portion having a mesh structure, the filter portion being collapsible such that the catcher is expanded when deployed into the left or right atrium for capturing debris around the cut clip.

30. The method of claim 27, wherein the heart valve is a mitral valve or tricuspid valve.

31. The method of claim 30, wherein the mitral valve has undergone an edge-to-edge repair (TEER) procedure.

32. The method of claim 31, wherein the clip is a mitral clip or MitraClip™ or tricuspid clip or TriClip™, the clip holding leaflets of the mitral valve or the tricuspid valve such that the leaflets are joined and brought together by the clip at middle points of the leaflets.

33. The method of any one of claims 27 to 32, wherein after the cuts are made around the clip, the clip remains attached to the at least one leaflet.

34. The method of any one of claims 27 to 33, wherein the snare has a handle and a single loop formed at one end of the handle.

35. The method of claim 34, wherein the snare is movable in response to sliding or rotational movement of the handle, the snare being configured to prevent lateral movement of the cut clip and surrounding debris during the pulling.

36. The method of any one of claims 34 to 35, wherein the cuts are generally circular cuts made about 1 mm to 2 mm from the clip.184937-3010-0091 6065472-000954WOPT37. The method of any one of claims 27 to 36, wherein the withdrawing of the catcher and the snare includes maintaining alignment of the catcher and the snare.

38. The method of any one of claims 27 to 37, wherein the method is minimally invasive and performed without open-heart surgery.

39. The method of any one of claims 27 to 38, wherein the catcher and the snare are deployed into the left or right atrium together.

40. The method of any one of claims 27 to 39, wherein the catcher and the snare are opened simultaneously in the left or right atrium.

41. The method of any one of claims 27 to 40, wherein the snare captures and guides the cut clip into the catcher, the catcher being positioned to intercept the clip.

42. The method of any one of claims 27 to 41, further comprising withdrawing the sheath to facilitate secured and controlled removal of the clip.194937-3010-0091 6065472-000954WOPT

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