Heart valve repair surgery

Abstract

A system and method for modifying a heart valve utilizing a leaflet crossing tool and a cutting element.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 364,263, entitled "Heart Valve Leaflet Modification," filed May 5, 2022, the entire contents of which are incorporated herein by reference. FIELD OF THEINVENTION

[0002] The present disclosure relates to novel and advantageous transcatheter valve repair devices. More specifically, the devices described herein address problems related to the treatment of diseases involving heart valves, such as the mitral, aortic, pulmonary, and tricuspid valves. [Background technology]

[0003] The following background is provided for the purpose of providing an overview of the context of the present disclosure. The work of the inventors of the present invention to the extent described in the background of this application, as well as aspects described herein that would not ordinarily be admitted as prior art at the time of filing, are not admitted expressly or impliedly as prior art to the present disclosure.

[0004] A common cardiovascular disease is valvular heart disease, which can affect a patient's heart valves through stenosis (i.e., stenosis), insufficiency (i.e., incompetence or regurgitation), or a combination of the two conditions. Valvular heart disease can lead to malignant remodeling of the heart's ventricles, leading to heart failure, significant morbidity, and reduced survival.

[0005] Although open-heart surgery is commonly performed for these conditions, transcatheter procedures to repair or replace the valve are often preferred, as transcatheter procedures offer a minimally invasive approach that can minimize perioperative and postoperative recovery times.

[0006] Transcatheter approaches to treating valvular heart disease include valve repair and total replacement, in which a prosthetic valve is implanted within the patient's native valve, or in the case of a malfunctioning or displaced prosthetic valve (e.g., valve-in-valve).

[0007] Transcatheter procedures for valvular heart disease are commonly performed with native valve leaflets or intact prosthetic material. Unfortunately, native leaflets or prosthetic material remaining in place can impede the success of subsequent repair or replacement. In some cases, the risk of interference is too high and the transcatheter procedure fails.

[0008] One specific example is transcatheter mitral valve replacement, in which a prosthetic valve is implanted into either the patient's own mitral valve anatomy or a previously placed prosthetic valve. Because the mitral annulus is in close proximity to the left ventricular outflow tract, transcatheter mitral valve replacement can position the native or prosthetic leaflets in the direction of systolic flow, potentially causing obstruction.

[0009] Another example is transcatheter aortic valve replacement, where a prosthetic valve is implanted either onto the patient's own aortic valve structure or onto a previously placed prosthetic valve. Due to the proximity of the aortic annulus to the coronary arteries, transcatheter aortic valve replacement can cause displacement of the native or prosthetic valve cusps near the origin of the coronary arteries, compromising coronary flow. Such coronary flow compromise can lead to myocardial infarction, ischemia, and death.

[0010] In yet another example, it may be desirable to modify or remove native or prosthetic leaflets in order to perform a valve repair or replacement. This may occur due to severe leaflet degeneration (e.g., bulging calcification). Such leaflet modification or removal may improve the safety of subsequent valve implantation and may also increase the effectiveness of the valve implantation by creating more space for the prosthetic valve (i.e., increased effective valve orifice area).

[0011] The challenges of open-heart surgery and the preference for transcatheter therapies dictate the need for catheter-based approaches to the modification and / or removal of native and prosthetic valve leaflets. Summary of the Invention

[0012] The following presents a simplified summary of one or more embodiments of the present disclosure to facilitate a basic understanding of these embodiments. This summary is not an extensive overview of all contemplated embodiments, nor is it intended to identify key or critical elements of all embodiments, nor is it intended to delineate the scope of any or all embodiments.

[0013] The present disclosure relates to a system and method for modifying and removing native and prosthetic leaflets. The present disclosure is comprised of a delivery catheter (DC), a leaflet crossing tool (LCT) and a cutting element (CE). Each part or the entire device includes a biocompatible material. In at least one embodiment, the DC is steerable and fits inside another steerable guide catheter (SGC). In at least one embodiment, the LCT is first positioned across the leaflet to determine the location and amount of cutting to be performed, and then engages with the CE. The CE assumes a size and shape appropriate for the tissue to be cut and is used to cut the leaflet. In at least one embodiment, the CE and leaflet crossing tool (LCT) function as a closed loop to capture and remove the cut leaflet tissue. In at least one alternative embodiment, the cut tissue is removed by mechanical aspiration through the SGC or the DC.

[0014] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. It will be understood that each embodiment of the present disclosure can be modified in various obvious respects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0015] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as forming various embodiments of the disclosure, it is believed the disclosure will be better understood from the following description taken in conjunction with the accompanying drawings, in which:

[0016] [Figure 1] Figure 1 is a cross-sectional view of the heart showing the aortic valve (AV), mitral valve (MV), left ventricular outflow tract (LVOT), anterior mitral valve leaflet (AML), posterior mitral valve leaflet (PML), left ventricle (LV), and left atrium (LA). The anterior (A) and posterior (P) portions of the MV are marked.

[0017] [Figure 2A] FIG. 2A is a superior view of the MV showing the AML, PML, and free edge (FE) of the leaflets, with the A, P, mid (Med), and lateral (Lat) portions marked, in cross section during systole. [Figure 2B] Figure 2B is a superior view of the MV showing the AML, PML, and free edge (FE) of the leaflets, with the A, P, mid (Med), and lateral (Lat) portions marked, in cross section during diastole.

[0018] [Diagram 3] 3 illustrates one embodiment of an LCT and CE delivered into a DC and a steerable SGC. The CE is shown in a loop shape that can expand and change shape to accommodate the amount and location of tissue to be removed.

[0019] [Figure 4A] FIG. 4A illustrates various embodiments of LCT for capturing across excised tissue. [Figure 4B] FIG. 4B illustrates various embodiments of LCT for capturing across excised tissue. [Figure 4C] FIG. 4C illustrates various embodiments of LCT for capturing across excised tissue. [Figure 4D] FIG. 4D illustrates various embodiments of LCT for capturing across excised tissue. [Figure 4E] FIG. 4E illustrates various embodiments of LCT for capturing across excised tissue. [Figure 4F] FIG. 4F illustrates various embodiments of LCT for capturing across excised tissue. [Figure 4G] FIG. 4G illustrates various embodiments of LCT for capturing across excised tissue. [Figure 4H] FIG. 4H illustrates various embodiments of LCT for capturing across excised tissue.

[0020] [Figure 5A] FIG. 5A illustrates a technique using the present disclosure to modify and remove leaflet tissue including the MV, showing the aorta, left atrium (LA), MV, and left ventricle (LV). [Figure 5B] FIG. 5B illustrates a technique using the present disclosure to modify and remove leaflet tissue including the MV, showing the aorta, LA, MV, and LV. [Figure 5C] FIG. 5C illustrates a technique using the present disclosure to modify and remove leaflet tissue including the MV, showing the aorta, LA, MV, and LV. [Figure 5D] FIG. 5D illustrates a technique using the present disclosure to modify and remove leaflet tissue including the MV, showing the aorta, LA, MV, and LV. [Figure 5E] FIG. 5E illustrates a technique using the present disclosure to modify and remove leaflet tissue including the MV, showing the aorta, LA, MV, and LV. [Figure 5F] FIG. 5F illustrates a technique using the present disclosure to modify and remove leaflet tissue including the MV, showing the aorta, LA, MV, and LV.

[0021] [Figure 5G] FIG. 5G illustrates an embodiment for modifying and removing leaflet tissue. [Figure 5H] FIG. 5H illustrates an embodiment for modifying and removing leaflet tissue. [Figure 5I] FIG. 5I illustrates an embodiment for modifying and removing leaflet tissue. [Figure 5J] FIG. 5J illustrates an embodiment for modifying and removing leaflet tissue. [Figure 5K] FIG. 5K illustrates an embodiment for modifying and removing leaflet tissue. [Figure 5L] FIG. 5L illustrates an embodiment for modifying and removing leaflet tissue.

[0022] [Figure 6A] FIG. 6A illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6B] FIG. 6B illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6C] FIG. 6C illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6D] FIG. 6D illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6E] FIG. 6E illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6F] FIG. 6F illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6G]FIG. 6G illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6H] FIG. 6H illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6I] FIG. 6I illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6J] FIG. 6J illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed. [Figure 6K] FIG. 6K illustrates a MV after use of the present disclosure in some embodiments, where a portion of the leaflet has been removed and a new leaflet edge (NE) has been formed.

[0023] [Figure 7A] FIG. 7A is a cross-sectional view of the heart focusing on the AV. [Figure 7B] FIG. 7B is a cross-sectional view of the heart focusing on the AV. [Figure 7C] FIG. 7C is a cross-sectional view of the heart focusing on the AV. [Figure 7D] FIG. 7D is a cross-sectional view of the heart focusing on the AV. [Figure 7E] FIG. 7E is a cross-sectional view of the heart focusing on the AV. [Figure 7F] FIG. 7F is a cross-sectional view of the heart focusing on the AV.

[0024] [Figure 8A] FIG. 8A shows an AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed. [Figure 8B]FIG. 8B shows an AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed. [Figure 8C] FIG. 8C shows an AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed. [Figure 8D] FIG. 8D shows the AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed. [Figure 8E] FIG. 8E shows an AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed. [Figure 8F] FIG. 8F shows an AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed. [Figure 8G] FIG. 8G shows an AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed. [Figure 8H] FIG. 8H shows an AV after use of the present disclosure, showing the left (L), right (R), and non-coronary (N) cusps, as well as portions of the cusps removed and new cusp edges (NE) formed.

[0025] [Figure 9A] FIG. 9A illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots. [Figure 9B] FIG. 9B illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots. [Figure 9C]FIG. 9C illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots. [Figure 9D] FIG. 9D illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots. [Figure 9E] FIG. 9E illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots. [Figure 9F] FIG. 9F illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots. [Figure 9G] FIG. 9G illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots. [Figure 9H] FIG. 9H illustrates various embodiments of CE that can be used to ablate leaflet tissue, with the ablation elements of the CE indicated by dots.

[0026] [Figure 10] FIG. 10 is a diagram showing an embodiment of the LCT.

[0027] [Figure 11] FIG. 11 is a diagram showing an embodiment of the CE.

[0028] [Figure 12] Figure 12 is a rendering of the mitral valve.

[0029] [Figure 13A] FIG. 13A illustrates a method of modifying the leaflets of the mitral valve. [Figure 13B] FIG. 13B illustrates a method of modifying the leaflets of the mitral valve. [Figure 13C] FIG. 13C illustrates a method of modifying the leaflets of the mitral valve. [Figure 13D] FIG. 13D illustrates a method of modifying the leaflets of the mitral valve. [Figure 13E] FIG. 13E illustrates a method of modifying the leaflets of the mitral valve. [Figure 13F] FIG. 13F illustrates a method of modifying the leaflets of the mitral valve.

[0030] [Figure 14] FIG. 14 illustrates elements of the method used to modify the leaflets of the mitral valve.

[0031] [Figure 15] FIG. 15 illustrates elements of the method used to modify the leaflets of the mitral valve.

[0032] [Figure 16] FIG. 16 illustrates elements of the method used to modify the leaflets of the mitral valve.

[0033] [Figure 17] FIG. 17 illustrates modification of the valve leaflets. Detailed Description

[0034] The present disclosure relates to the treatment of disease of the aortic root and ascending aorta with a device deployed via a catheter. Although embodiments are described in this disclosure with respect to the aortic root and ascending aorta of a patient, these embodiments may be applied to any valve in a patient's heart, and the disclosure herein should not be construed as limited to these applications. The embodiments described herein may also be applied to the repair of other valves and chambers in the human heart.

[0035] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of some embodiments. However, it will be apparent to one skilled in the art that the embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, units and / or circuits have not been described in detail so as not to obscure the discussion.

[0036] The cardiac valve leaflets may be natural or prosthetic. Modification and / or removal of cardiac valve leaflets may be performed to directly restore valve function, or to facilitate subsequent repair by other means, or to treat with valve replacement. Modification and / or removal of cardiac valve leaflets should be tailored to the patient and subsequent treatment indications.

[0037] Referring to FIG. 1 and FIG. 2A to FIG. 2B, the MV is typically composed of two leaflets, the AML and the PML, and the FE of both leaflets, and the junctions between these realize the valve function during systole and diastole.

[0038] When performing transcatheter MV replacement (TMVR), the AML is usually left intact. The residual AML surrounds the new valve frame and protrudes into the native left ventricular outflow tract (LVOT). LVOT flow obstruction by TMVR can occur in a variety of situations, including when the native LVOT is relatively small in size, is set at an unfavorable angle to the MV, or is configured such that the TMVR prosthetic frame protrudes into the LVOT.

[0039] In such cases, the protrusion of the new valve frame surrounded by AML may impede blood flow during systole, leading to reduced stroke volume, reduced cardiac output, and possibly death. The likelihood of LVOT obstruction with TMVR is predicted by preoperative imaging with cardiac computed tomography or echocardiography. Patients with a high likelihood of LVOT obstruction with TMVR are usually unable to undergo TMVR placement due to intraoperative risks.

[0040] Below we describe the off-label use of catheters, snares, and wires for resection and modification of AML (also known as the "LAMPOON" procedure), which is limited by relative lack of control over the site and amount of resection and the inability to remove leaflet tissue.

[0041] Described herein are tools and methods for accurate and precise excision and removal of MV leaflets, minimizing the risk of LVOT obstruction due to TMVR and allowing more patients to receive beneficial treatment for the treatment of mitral valve disease.

[0042] 3 illustrates at least one embodiment having an LCT and CE delivered via a DC housed within a steerable SGC. The LCT consists of a needle or straight segment 300 with a crossing element 302 at its distal end that is actuated by mechanical and / or electrical energy. The LCT is used at the target site of the leaflet to cross the leaflet. As shown in FIG. 4A, in at least one embodiment, the LCT is a straight element.

[0043] As shown in Figures 4B-4H, in another embodiment, the LCT can be preformed into a foldable configuration and may be spiral, square or rectangular, circular or elliptical, bent, or other geometric shape with a proximal portion P that can be used as an adhesion mechanism to adhere tissue. In at least one embodiment, the proximal portion P is exposed after crossing the leaflets. In at least one embodiment, the proximal portion P is foldable to have an anchoring function to hold the leaflet tissue after cutting. In at least one embodiment, the LCT includes one or more elements E that allow for energy delivery to ablate the leaflet tissue.

[0044] 5A-5F illustrate modification and / or removal of leaflet tissue, including the MV, in accordance with at least one embodiment of the present disclosure.

[0045] Referring to FIG. 5A, the system is delivered to the desired leaflet site with the SGC and the DC positioned adjacent to the AML.

[0046] Referring to Figure 5B, the SGC is withdrawn, thereby exposing the DC. The LCT is then advanced out of the DC. The LCT is then used to engage and cross the AML, e.g., by radiofrequency, electrical, or mechanical energy, before being advanced further into the LV.

[0047] The location selected for placement and engagement of the LCT is based on the location and amount of leaflet tissue resection and / or removal desired, as indicated by the bi-directional arrow. For example, the LCT may be placed closer to the annulus to target more tissue, or closer to the free edge (FE) of the leaflet to target less tissue. The CE may be placed to cross any segment of the MV close to the FE or MV annulus, as desired.

[0048] 5C, the CE is then advanced through the MV orifice and manipulated to encircle the LCT in at least one embodiment. In at least one alternative embodiment, the CE has a distal end that allows it to pass directly through the leaflets, similar to the function of the LCT. In this latter example, one may choose to perform the crossing of the CE as described above so as not to modify the FE of the MV.

[0049] 5D and 5E, the CE is positioned over the LCT and then retracted proximally to engage the MV leaflets, as shown by the directional arrows, and using mechanical and / or electrical forces, the CE resects the leaflet tissue. In one embodiment, the resected tissue remains attached onto the LCT, and the CE is configured to close around the resected tissue and hold it against the LCT to capture the resected leaflet tissue.

[0050] Referring to FIG. 5F, in at least one alternative embodiment, the resected leaflet tissue is held in place by an attachment mechanism in the form of at least one proximal portion P of the LCT that is exposed prior to resection. As previously discussed, in at least one embodiment, the proximal portion P may be helical, square or rectangular, circular or elliptical, or other geometric shape, and together with the proximal portion P, may be preformed into a foldable configuration. In at least one embodiment, the retention element may have a braid or adhesive material that facilitates adhesion of the resected tissue to the LCT. In at least one embodiment, the proximal portion P may have a geometric configuration that is exposed after leaflet crossing.

[0051] The LCT and CE application procedures can be applied multiple times to the same MV leaflet or to different locations on the MV, including both the AML and PML, to modify and remove tissue as needed. The shape and size of the CE and LCT can be varied to suit the patient's needs and subsequent treatments.

[0052] 5G-5L illustrate modification and / or removal of leaflet tissue including the MV in accordance with another embodiment of the present disclosure.

[0053] The system is delivered to the desired leaflet site along with the SGC, and the DC is positioned adjacent to the AML in a manner similar to that shown in FIG. 5A.

[0054] Referring to FIG. 5G, the SGC is withdrawn, thereby exposing the DC. The LCT is then advanced from the DC. The LCT is then used to engage and cross the AML, e.g., by radio frequency, electrical, or mechanical energy, before being advanced further into the LV. The LCT has a retention element in the form of a barb B at or near its tip, and an attachment mechanism in the form of a tensioning element TE proximal to the barb B for tensioning the leaflets in this procedure.

[0055] The location selected for placement and engagement of the LCT is based on the location and amount of leaflet tissue resection and / or removal desired, as indicated by the bi-directional arrow. For example, the LCT may be placed closer to the annulus to target more tissue, or closer to the free edge (FE) of the leaflet to target less tissue. The CE may be placed to cross any segment of the MV close to the FE or MV annulus, as desired.

[0056] Referring to Figure 5H, the CE is then advanced through the MV orifice and in at least one embodiment is manipulated to encircle the LCT. In at least one alternative embodiment, the CE has a distal end that allows it to pass directly through the leaflets, similar to the function of the LCT. In this latter example, one may choose to perform the crossing of the CE as described above so as not to modify the FE of the MV.

[0057] 5I-5J, the CE is placed over the LCT and then retracted proximally to engage the MV leaflets, as indicated by the directional arrows. The tensioning element TE acts as a "backstop" or holds the leaflets in tension against the CE as they are retracted to engage the MV leaflets. In other words, the TE opposes the cutting force of the LCT. Then, using mechanical and / or electrical forces, the CE resects the leaflet tissue. In one embodiment, the resected tissue remains attached on the LCT, and the CE is configured to close around the resected tissue and hold it against the LCT to capture the resected leaflet tissue.

[0058] Referring to FIG. 5K, in at least one alternative embodiment, the excised leaflet tissue is held or secured by at least the barbs B of the LCT.

[0059] In yet another embodiment, instead of barbs, a structure similar to the tension element TE can be incorporated into the tip. The operation of this embodiment is similar to that described in the previous embodiment.

[0060] The LCT and CE application procedures can be applied multiple times to the same MV leaflet or to different locations on the MV, including both the AML and PML, to modify and remove tissue as needed. The shape and size of the CE and LCT can be varied to suit the patient's needs and subsequent treatments.

[0061] 6A-6K show a MV where a portion of the leaflet has been removed and a newly formed leaflet edge (NE) has been formed using at least some embodiments of the present disclosure. The amount and configuration of leaflet tissue removed will vary depending on the shape and size of the CE and the location of the LCT intersection.

[0062] Similar to the methods used for MV, other native and prosthetic heart valve leaflets can be modified or removed with the present invention. Unlike MV, the leaflets of the heart valves and prosthetic valves are most commonly in a three-leaflet configuration, but the technical applications of the present invention are similar regardless of the number of leaflets present and whether the leaflets are native or in a prosthetic valve. SGCs and DCs can be used to approach the leaflets antegrade or retrograde to modify and remove them according to the present disclosure.

[0063] For example, Figures 7A-7F show the use of the present disclosure for the aortic valve AV. With reference to Figure 7A, following vascular access to the ascending aorta, the DC is advanced to one of the aortic valve leaflets. With reference to Figure 7B, the ablation element of the LCT is used to engage and cross the AV leaflets, e.g., by electrical, mechanical energy, and then advanced further into the LV. As described above for the MV, the placement location of the LCT is based on the desired location and amount of leaflet tissue ablation and / or removal. For example, the user may place the LCT closer to the aortic annulus to target relatively more tissue or the LCT closer to the FE to target relatively less tissue. The LCT may be placed to cross any segment of the AV close to the FE or AV annulus (i.e., the L leaflet, R leaflet, or N leaflet) as desired.

[0064] Referring to FIG. 7C, the CE is then advanced through the AV orifice and in at least one embodiment is manipulated to surround the LCT. In at least one alternative embodiment, the LCT has a distal end that allows it to pass directly through the leaflets, similar to the function of the CE (using mechanical or electrical energy). In this latter example, one may choose to perform the crossing of the LCT in place to maintain the native FE of the AV. The CE may be delivered across the AV in its own sheath or in a deployed state.

[0065] Referring to FIG. 7D, the CE is positioned over the LCT and then retracted proximally to engage the AV leaflets, as indicated by the directional arrows.

[0066] 7E, the CE cuts off the leaflet tissue, for example using mechanical and / or electrical forces, and in one embodiment, the cut tissue remains attached to the LCT and the CE closes to hold the cut leaflet tissue as a complement to the LCT.

[0067] 7F, in at least one alternative embodiment, the resected leaflet tissue is held in place by at least one proximal element P of the LCT, which in one embodiment is exposed prior to resection (as discussed above, the proximal element P can be useful during the resection process to assist in applying a counterforce). As discussed above, in at least one embodiment, such a retaining element P can be helical, square or rectangular, circular or oval, or other geometric shape, and can be preformed into a foldable configuration. The retaining element P can have a braid or adhesive material that facilitates adhesion of the resected tissue to the LCT.

[0068] 8A-8H, an embodiment is shown in which a portion of the leaflet is removed and a new leaflet edge (NE) is formed on the AV leaflet. The location, size, and amount of tissue removed from the ablation will vary depending on the location of the LCT and the configuration of the CE. The present invention can be used to treat multiple locations on the AV.

[0069] 9A-9H, various embodiments of a CE that can be used to ablate leaflet tissue are shown. The ablation features on the CE are indicated by dots on the wire portion of the CE. In at least one embodiment, the CE has multiple ablation components that can be positioned depending on the desired ablation configuration.

[0070] Several types of ablation configurations for CE are contemplated, including those disclosed in U.S. Publication No. 2022 / 0265311, entitled "Method and Apparatus for Removing Heart Valve Therapy," which is incorporated by reference in its entirety.

[0071] In at least one embodiment, mechanical suction can be used to hold the severed leaflets in place as they are removed from the body.

[0072] In at least one embodiment, the capture basket may be deployed distally or proximally to help hold the severed leaflet in place as it is removed from the body. In at least one embodiment, the basket facilitates passage of the excised leaflet tissue into the delivery catheter for removal. A basket configuration usable in this method is disclosed in U.S. Publication No. 2022 / 0265311, entitled "Method and Apparatus for Removing Heart Valve Therapy," which is incorporated herein by reference in its entirety.

[0073] 10, an additional embodiment of the LCT 100 of the present disclosure is disclosed. In one embodiment, the LCT 100 has three extensions 102 that are used to penetrate and cross the leaflet tissue. In one embodiment, the tips of the extensions include electrodes that apply ablation energy, such as RF energy, to the leaflet tissue.

[0074] 11, an additional embodiment of a CE 110 of the present disclosure is shown. The CE 110 includes a loop that can ablate tissue in a manner similar to the previously described CE embodiments. In one embodiment, the CE 110 includes an electrode that applies electrical ablation energy to the leaflet tissue.

[0075] Referring to FIG. 12, a rendering of the mitral valve MV having an anterior mitral leaflet 120 and a posterior mitral leaflet 122 is shown.

[0076] 13A-13F, a method according to the present disclosure is shown with FIG. 13A showing an extension 102 of an LCT 100 puncturing or penetrating an anterior mitral valve leaflet 120.

[0077] Referring to FIG. 13B, the CE 110 extends into the left ventricle through the mitral valve opening and is directed toward the extension 102 of the LCT 100.

[0078] 13C, the CE 110 is secured around the extension 102 and positioned so that the electrodes contact the anterior mitral valve leaflet tissue 120. Referring to FIG.

[0079] Referring to FIG. 13D, the electrodes of the CE 110 are actuated to cause an ablative effect on tissue of the anterior mitral valve leaflet 120.

[0080] Referring to FIG. 13E, the CE 110 is withdrawn and the excised tissue 132 is resected from the anterior mitral valve leaflet 120 and retained on or near the extension 102 of the LCT 100.

[0081] Referring to FIG. 13F, the final leaflet configuration after removal of the LCT 100 is depicted.

[0082] 14 and 15, renderings are shown of the operations shown in FIGS. 13A and 13C, respectively, taking place.

[0083] 16, another embodiment of a method according to the present disclosure is shown. Following penetration of the extension 102 through the tissue of the anterior mitral valve leaflet 120, the LCT 100 is further advanced to stretch and elongate the tissue of the anterior mitral valve leaflet into a conical or "teepee" like shape. Such action creates tension or contraction in the tissue to facilitate the cutting action of the CE 110.

[0084] 17, an embodiment of the leaflet modification achieved is shown as having a triangular shape with a leaflet modification length 172 and a leaflet modification width 174. Depending on the desired placement of the LCT 100 and the configuration of the CE 110, as described in other embodiments of the present disclosure, there are many different positions and shapes of leaflet modification that can be achieved.

[0085] As used herein, the term "one embodiment" or "example" means that a particular element, feature, structure, or characteristic described in connection with this embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in the specification do not necessarily all refer to the same embodiment.

[0086] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," or any other variations thereof, are intended to include a non-exclusive inclusion. For example, a process, method, article, or device that includes a list of elements is not necessarily limited to only those elements but can include other elements not expressly listed or inherent to such process, method, article, or device.

[0087] Furthermore, the use of "a" or "an" is used to describe elements and components of the embodiments herein. This is done merely for convenience and to give a general sense of the description. The description should be read to include one or at least one, and the singular also includes the plural unless it is clear that it is meant otherwise.

[0088] Moreover, the figures depict preferred embodiments for purposes of illustration only, and those skilled in the art will readily recognize from the description herein that alternative embodiments of the structures and methods shown herein may be used without departing from the principles described herein.

[0089] Those skilled in the art will appreciate further alternative structural and functional designs upon consideration of this disclosure. Although specific embodiments and applications have been illustrated and described above, it should be understood that the disclosed embodiments are not limited to the precise structures and components disclosed herein. It will be apparent to those skilled in the art that various modifications, changes and variations can be made in the arrangement, operation and details of the methods and apparatus disclosed herein without departing from the spirit and scope as defined by the appended claims.

Claims

1. It is a system for correcting heart valve leaflets. Delivery catheter and A valve leaflet crossing tool including an adhesion mechanism for bonding tissue, wherein the valve leaflet crossing tool, in the operating configuration of the system, advances from the delivery catheter, A resection element comprising a loop-shaped wire portion to which electroresection energy is applied, wherein the resection element advances from the delivery catheter in the operating configuration of the system, A system characterized by comprising the following features.

2. The system according to claim 1, characterized in that the bonding mechanism is linear, spiral, square or rectangular, circular or elliptical, or curved.

3. The system according to claim 2, characterized in that the bonding mechanism is a pre-formed foldable configuration.

4. The system according to claim 3, characterized in that the pre-formed foldable configuration has a single notch or a plurality of notches.

5. The system according to claim 1, characterized in that the crossing element comprises three extensions, each including an electrode to which cutting energy is applied.

6. The system according to claim 1, characterized in that the wire portion includes a plurality of electrodes to which cutting energy is applied.

7. The system according to claim 1, characterized in that the loop of the wire portion consists of a circular loop shape, an arched loop shape, a mushroom-shaped loop shape, a triangular loop shape, an elongated loop shape, an angled loop shape, an eight-shaped loop shape, a square loop shape, or a rectangular loop shape.

8. The system according to claim 1, further comprising a tension element in the form of an enlarged support on the valve leaflet crossing tool.

9. The system according to claim 8, characterized in that the valve leaflet crossing tool has a barb at or near the distal end.

10. The system according to claim 1, characterized in that the bonding mechanism is a pre-formed foldable configuration, the wire portion includes a plurality of electrodes to which cutting energy is applied, and the loop of the wire portion consists of a circular loop shape, an arched loop shape, a mushroom-shaped loop shape, a triangular loop shape, an elongated loop shape, an angled loop shape, an eight-shaped loop shape, a square loop shape, or a rectangular loop shape.

11. The system according to claim 1, wherein the valve leaflet crossing tool further comprises a distal end of a needle or elongated segment that provides mechanical, high-frequency, and / or electrical energy for puncturing the cardiac valve leaflets.

12. The system according to claim 1, characterized in that the bonding mechanism is a braid.

13. The system according to claim 1, characterized in that the adhesive mechanism is foldable to have a fixing function for holding the valve leaflet tissue.

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